What are TCT and CRF? 

The Cardiovascular Research Foundation (CRF), based in New York City, is an independent, academically-focused nonprofit organization dedicated to improving the survival and quality of life for people with heart disease through high quality research and education. Transcatheter Cardiovascular Therapeutics (TCT) is CRF’s annual scientific symposium, focusing on interventional cardiovascular medicine. For more than 25 years, TCT has featured major medical research breakthroughs and gathered leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field. For more information, visit www.crf.org and www.tctconference.com.

Results of ISAR-CLOSURE Trial Reported at TCT 2014

Large randomized trial compares use of vascular closure devices to manual compression in patients undergoing transfemoral coronary angiography

A new clinical trial found that vascular closure devices (VCD) are non-inferior to manual compression in patients undergoing transfemoral coronary angiography. Findings were reported at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. 

Vascular closure devices help achieve more rapid hemostasis after coronary angiography; however, the safety and efficacy of these devices compared to standard manual compression remains controversial. Some meta-analyses have suggested an increased risk of vascular complications with VCD compared with manual compression, while other studies have demonstrated a reduction in bleeding complications with VCD.

The ISAR-CLOSURE trial compared outcomes after arteriotomy closure with two different vascular closure devices with manual compression after diagnostic angiography performed through the femoral access route. The multicenter, open-label clinical trial randomized 4,524 patients undergoing diagnostic coronary angiography via the common femoral artery to receive either manual compression (n=1,509) or one of two vascular closure devices (St. Jude Medical’s FemoSeal VCD n=1,509; Cordis Corporation’s Exoseal VCD n= 1,506). 

The primary endpoint was vascular access site complications including the composite of hematoma greater than or equal to five centimeters, arterio-venous fistula, pseudoaneurysm, access-site related bleeding, acute ipsilateral leg ischemia, the need for vascular surgical or interventional treatment, and local infection at 30 days after randomization. Secondary endpoints included time to hemostasis, repeat manual compression, and device failure. A secondary comparison between the two VCDs was also performed. 

After 30 days, the VCD group reported access site complications in 6.9 percent of patients compared to 7.9 percent in the manual compression group, establishing non-inferiority of VCD. The most common complication in both groups was hematoma formation, followed by pseudoaneurym formation. Time to hemostasis was shorter in the VCD group (median 1 minute [.5-2.0] vs. 10 minutes [10-15], p<0.001), while the VCD group had a higher rate of repeat manual compressions (1.8 percent vs. 0.7 percent, p=0.003). 

The secondary comparison found that the intravascular Femoseal VCD was associated with a tendency towards less vascular access-site complications as compared to the extravascular Exoseal VCD (6.0 percent vs. 7.8 percent, p=0.043). (Due to multiple comparisons, a p-value of 0.025 was considered statistically significant.) In addition, time-to-hemostasis was shorter and device deployment failures were less frequent with the FemoSeal VCD compared to the Exoseal VCD. 

“In patients undergoing transfemoral coronary angiography, VCDs are non-inferior to manual compression in terms of vascular access site complications and reduced time-to-hemostasis,” said lead investigator Stefanie Schulz, MD from Deutsches Herzzentrum München in Germany. “The increase in efficacy of VCD with no trade-off in safety provides a sound rationale for the use of VCD over manual compression in daily routine.” 

The ISAR-CLOSURE trial received no extramural funding. Dr. Schulz reported no disclosures.

ABSORB II Study Shows Abbott’s Dissolving Stent Comparable to the World’s Leading Heart Stent

One-year results show Abbott’s Absorb Bioresorbable Vascular Scaffold provides comparable results across several measures and lower rates of angina than a best-in-class drug-eluting stent

Abbott announced positive one-year clinical results from ABSORB II, the world’s first prospective, randomized, controlled trial comparing the safety and effectiveness of the dissolving Absorb bioresorbable vascular scaffold (BVS) to Abbott’s metallic Xience family of drug-eluting stents (DES). The trial, conducted primarily in Europe, included 501 people with coronary artery disease (CAD). The results were featured at a late-breaking session at the 26th Transcatheter Cardiovascular Therapeutics (TCT).

At one year, overall clinical outcomes for Absorb were comparable to Xience, and people treated with Absorb experienced a significantly lower rate of angina. Unlike a metallic stent, which cages the vessel, Absorb is more flexible and dissolves over time, leaving behind a treated vessel free of a permanent implant with the potential to flex, pulse and dilate in response to various demands on the heart.^1,2

“The results of ABSORB II provide international doctors with additional confidence to use Absorb to treat their patients based on randomized clinical data showing that Absorb provides comparable results at one year to a best-in-class metallic drug-eluting stent in traditional endpoints,” said Patrick W. Serruys, MD, PhD, professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator of the ABSORB II trial. “Additionally, the lower rate of chest pain observed in people treated with Absorb is a promising finding that shows that Absorb may offer people unique quality of life benefits beyond the excellent clinical outcomes already offered with drug-eluting stents.”   

At one year, the patient-oriented clinical endpoint of all death, all heart attacks and all revascularization was 7.3 percent for Absorb and 9.1 percent for Xience (p=0.47). The device-oriented clinical endpoint of target lesion failure (TLF) was 4.8 percent for Absorb and 3.0 percent for Xience (p=0.35) at one year. The individual components of these composite endpoints were also comparable between the two treatment groups. The rates of stent thrombosis (ST) observed for Absorb at one year were low at 0.6 percent for definite ST and 0.9 percent for definite/probable ST.       

The data also showed that during the course of one year, people treated with Absorb were less likely to experience angina once they left the hospital than those treated with Xience, at a rate of 16.4 percent versus 25.6 percent (p=0.01), respectively.³ Angina has a significant impact on quality of life and healthcare costs.⁴ Overall, people who have angina following a coronary stent procedure use more healthcare resources, including additional diagnostic and treatment tools to try to identify the source of angina, than those without angina.  In addition, they typically have a lower quality of life because they are less likely to lead active lifestyles than those people without angina.^5,6,7 Reducing the burden of angina could help people live healthier lives and reduce costs to the healthcare system. 

The primary endpoint of the ABSORB II trial is vessel motion at three years, at which time Absorb has fully dissolved. Without a permanent stent caging the vessel, the vessel has the potential to return to a more natural state. Clinical endpoints and quality of life measures will be assessed annually for up to three years. Imaging endpoints will be assessed at three years.

At TCT this year, data from approximately 1,500 people treated with Absorb in single-arm trials was released publicly for the first time. These data add to the positive results seen in the ABSORB II randomized trial by demonstrating excellent results, including in real-world settings, and strong clinical outcomes in a subgroup of people out to three years. 

About the Absorb Bioresorbable Vascular Scaffold. Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants, such as dissolving sutures. Absorb is called a scaffold to indicate its temporary structure, and the scaffold provides support to the vessel until the artery can stay open on its own.  Absorb slowly dissolves into the blood vessel, leaving behind a vessel that has the potential to resume more natural function and movement because it is not restricted by a permanent metallic stent.^1,2  

Absorb is an investigational device, limited by United States law to investigational use and is not approved or available for sale in the United States. Absorb is the world’s first drug-eluting bioresorbable vascular scaffold to become commercially available in international markets. Abbott announced CE Mark in Europe in January 2011, and the product is now available in more than 60 countries worldwide and has been used to treat approximately 60,000 people. Visit Abbott at www.abbott.com.

Notes/references

1. Absorb completely dissolves except for two pairs of tiny metallic markers, which help guide placement and remain in the artery to enable a physician to see where the device was placed.
2. Preliminary evidence suggests that natural vessel function is possible with Absorb and may improve long-term outcomes.
3. Data excludes angina episodes that occurred during hospital stay or in the 7 days after the procedure if the patient was still in the hospital at that time.
4. Javitz HS, Ward MM, Watson JB, et al. Cost of illness of chronic angina. Am J Manag Care. 2004; 10: S358-S369.
5. Kempf J, Buysman E, Brixner D. Health Resource Utilization and Direct Costs Associated with Angina for Patients with Coronary Artery Disease in a US Managed Care Setting. Am Health Drug Benefits. 2011; 4(6): 353-361. 
6. Hlatky MA, Boothroyd DB, Melsop KA, et al. Medical costs and quality of life 10 to 12 years after randomization to angioplasty or bypass surgery for multivessel coronary artery disease. Circulation. 2004; 110: 1960-1966.
7. Kohn et al. Impact of angina frequency on health utility values of patients with chronic stable angina. Health and Quality of Life Outcomes. 2014; 12: 39.

Significant Patient Benefits With Edwards Sapien Valve Demonstrated in 5-Year PARTNER Trial Data

Transcatheter valve durability sustained through five years

Edwards Lifesciences Corporation announced the presentation of five-year clinical outcomes for inoperable patients treated in the PARTNER trial, a prospective randomized trial for transcatheter aortic valve replacement (TAVR) in patients deemed too sick for open-heart surgery. The data were presented as part of the late-breaking clinical trials session at the 26th Transcatheter Cardiovascular Therapeutics (TCT).

“These longer term results from PARTNER’s inoperable cohort indicated that TAVR was associated with a continued significant mortality benefit, persistent symptom benefit and a statistically significant reduction in rehospitalizations,” said Michael J. Mack, MD, chair, cardiovascular service line, Baylor Scott & White Health. “It is reassuring now five years later that in this very ill and elderly patient group facing a high likelihood of mortality, more patients treated with Sapien experienced sustained improvements in functional heart status and fewer repeat hospitalizations — two measures that signify an improvement in quality of life.

The Edwards family of Sapien valves are the most studied transcatheter heart valves in history and have been used in the treatment of more than 85,000 patients globally.

The prospective, multicenter PARTNER trial provided the initial experience with transcatheter aortic valve replacement in the United States.  The trial documented the outcomes of 358 inoperable aortic stenosis (AS) patients treated at 21 centers between 2007 and 2009.  In Cohort B of the PARTNER trial, inoperable patients with severe, symptomatic aortic stenosis were evenly randomized to receive either transfemoral TAVR with the Sapien valve or standard therapy, which included balloon aortic valvuloplasty or medical management of symptoms. The one- and two-year results from The PARTNER Trial were published in The New England Journal of Medicine.  

Additional company information can be found at www.edwards.com.

Medtronic CoreValve System Sustains Positive Outcomes Through Two Years in Extreme Risk Patients

TCT late-breaking first report reveals high survival, low stroke rates and sustained valve performance

Medtronic, Inc. announced new data showing that transcatheter aortic valve replacement (TAVR) with the CoreValve system continued to provide safe and effective treatment, while maintaining exceptional rates of survival out to two years for patients who were considered too ill or frail to have their aortic valves replaced through traditional open-heart surgery. Without treatment, these patients had a 50 percent chance of death at one year.

Two-year results from 305 patients treated with the CoreValve System in the Extreme Risk Study of the CoreValve U.S. Pivotal Trial were presented during a late-breaking first report session at the Transcatheter Cardiovascular Therapeutics (TCT) 2014 Conference. Consistent with the positive one-year clinical results, all-cause mortality (36.5 percent) and major stroke (5.1 percent) at two years were low for this extreme risk cohort.

The CoreValve device continued to demonstrate sustained favorable hemodynamic performance at two years as evidenced by low, single-digit mean gradients of 8.7 mmHg; this is consistent with one-month and one-year rates (8.7 mmHg and 8.9 mmHg, respectively). Low rates of paravalvular leak (PVL) seen at one year were maintained, with just 4.4 percent of all treated patients experiencing moderate to severe PVL at two years.

The study also found that the marked improvement patients experienced in heart failure symptoms at one year (as measured by NYHA Class) was maintained at two years: 92 percent of heart failure patients improved at least one class by two years, and 58 percent of patients improved at least two classes by two years.

“The fact that nearly two out of three patients are alive at two years with low rates of stroke and re-hospitalization, and with substantial improvements in heart failure symptoms, is remarkable given patients’ complex medical conditions, extreme frailty and inability to have a surgical procedure,” said Steven Yakubov, MD, who was an investigator in the CoreValve U.S. Pivotal Trial and is medical director at OhioHealth Research Foundation and system chief of Advanced Structural Heart Disease at OhioHealth. “In addition, the sustained hemodynamic performance of the valve gives us confidence in the durability of CoreValve therapy.”

The CoreValve system is approved by the U.S. Food and Drug Administration (FDA) for patients at extreme risk and high risk for surgery. Since receiving CE (Conformité Européenne) Mark in 2007, the CoreValve System has been implanted in more than 65,000 patients in more than 60 countries.

Marie Claude Morice Presented With Master Clinical Operator Award at TCT 

Prize honors physician for technical excellence and innovation

Marie Claude Morice, MD, was presented the TCT 2014 Geoffrey O. Hartzler Master Clinical Operator Award in a ceremony held during the 26th Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation (CRF). The award is given each year to a physician who has advanced the field of interventional cardiovascular medicine through technical excellence and innovation. Dr. Morice, a world-renowned interventional cardiologist, is the first woman to be recognized with this award.

A widely respected physician and researcher, Dr. Morice has participated in clinical research activities for the past 20 years resulting in more than 250 peer-reviewed publications. She is the co-founder of the French “Coronary Stenting without Coumadin” study group. She also served as the principal investigator of the RAVEL study, the first worldwide, randomized study on drug-eluting stents. The study showed that sirolimus-eluting stents improve prevention of neointimal proliferation, restenosis, and associated clinical events compared with bare-metal stents and helped usher in a new era in interventional cardiology. Most recently, as part of the executive committee of the SYNTAX trial, Dr. Morice directs a subgroup focusing on patients with left main disease, which has led to significant changes in European and American guidelines for the treatment of coronary left main disease.

TCT Directors, Gregg W. Stone, MD, and Martin B. Leon, MD, jointly presented the award, given annually at TCT to an interventional operator who has distinguished him or herself as an innovator in the field. Dr. Leon is the Founder of CRF and Professor of Medicine at Columbia University College of Physicians and Surgeons and Director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center. Dr. Stone is Professor of Medicine at Columbia University College of Physicians and Surgeons and Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. Both serve as Co-Directors of the Medical Research and Education Division at CRF, and direct the annual TCT scientific sessions. 

“Dr. Morice is highly deserving of the TCT 2014 Geoffrey O. Hartzler Master Clinical Operator Award,” said Dr. Leon. “Her work inside the cath lab and her devotion to clinical research activities have advanced the field of interventional cardiology and provided physicians with new, more effective ways to treat patients.”

“It is a thrill for us to recognize Dr. Morice with this award,” said Dr. Stone. “Her unparalleled expertise in the cardiac cath laboratory is coupled with charisma and a drive to redefine the stereotype of the interventional cardiologist.”

“She has broken barriers her whole life by setting new standards for the treatment of left main and complex bifurcation disease, educating hundreds of cardiology fellows, and serving as an inspiration to future cardiologists around the world,” Dr. Stone added.

Dr. Morice is currently the Head of Interventional Cardiology at the Institut Cardiovasculaire Paris (Générale de Santé) the highest-volume PCI center in the greater Paris area. Previously, she served as Head of the Interventional Cardiology Department of the CCN in Paris. Dr. Morice is a fellow of the European Society of Cardiology and the American College of Cardiology, as well as an Honorary Professor of the Universidad Del Salvador in Buenos Aires. She is also the President and Medical Director of the European Center for Cardiovascular Research (CERC), founded in 2008. Dr. Morice earned her medical degree at the University of Medicine in Paris.

IVUS-CTO Study: Intravascular Ultrasound-Guided Intervention in Patients With Chronic Total Occlusion

A new study found that intravascular ultrasound (IVUS)-guided intervention in patients with chronic total occlusion (CTO) could improve outcomes compared to a conventional angiography-guided approach during percutaneous coronary intervention (PCI). The IVUS-CTO study is the first randomized trial to examine the clinical impact of IVUS guidance for CTO intervention.

A chronic total occlusion is a complete or nearly complete blockage of a coronary artery that has been present for more than 30 days. PCI of CTO lesions is one of the most challenging forms of PCI, with some of the highest rates of recurrent restenosis due to the complexity of the procedures and lesions. IVUS evaluates coronary arteries using sound waves, and can be used to optimize post-PCI stent results, but whether there is demonstrable efficacy of this technique has not been adequately studied in CTO PCI.

The prospective, multi-center trial randomized 402 patients with CTOs to either the IVUS-guided or angiography-guided groups after successful guide wire crossing. Patients were then additionally randomized to zotarolimus-eluting stents or biolimus-eluting stents. The primary endpoint was the composite of cardiac death, myocardial infarction, and target-vessel revascularization (TVR) at 12 months. Secondary endpoints included a composite rate of cardiac death or myocardial infarction and individual components of the primary endpoint.

After a 12-month follow-up, occurrence of the primary endpoint was significantly lower in the IVUS-guided group compared to the angiography-guided group (2.6 percent vs. 7.1 percent; hazard ratio=0.35, 95% CI=0.13-0.97; p=0.035). Occurrence of the composite of cardiac death and myocardial infarction was also significantly lower in the IVUS-guided group vs. the angiography-guided group (p=0.045). IVUS guidance led to more aggressive balloon inflations during PCI. At follow-up, TVR was non-significantly lower in the IVUS-guided group compared with the angiography-guided group (2.6 percent vs. 5.2 percent; hazard ratio=0.48, 95% CI=0.17-1.42; p=0.186).

Crossover rates were 2.5 percent from IVUS-guided to the angiography-guided group, and 17.4 percent from angiography-guided to the IVUS-guided group (p<0.001). Based on the per-protocol analysis, occurrence of the primary endpoint was lower in the IVUS-guided group than in the angiography-guided group (2.2 percent vs. 8.4 percent; hazard ratio=0.26, 95% CI=0.09-0.71; p=0.005).

“This first-of-its kind trial demonstrates that compared with conventional angiography-guided CTO intervention, IVUS-guided intervention significantly improved 12-month clinical outcomes after new-generation drug-eluting stent implantation,” said lead investigator Yang-Soo Jang, MD, PhD. Dr. Jang is Director of the Research Institute at the Severance Cardiovascular Hospital and Research Institute and Yonsei University Health System in Seoul, Korea. “Findings show that IVUS-guidance for CTO intervention is superior to the conventional approach.”

OCT STEMI Study: Optical Coherence Tomography in Primary Percutaneous Coronary Intervention

The first randomized trial to examine serial optical coherence tomography (OCT) in primary percutaneous coronary intervention (PCI) was reported at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. 

OCT uses light emitted from an intravascular catheter to capture high-resolution cross sectional imaging from within coronary arteries. OCT STEMI is the first randomized multicenter study to examine routine use of OCT guidance during stent implantation in patients with ST-elevation myocardial infarction (STEMI) undergoing primary PCI. The primary endpoints were the rate of major adverse coronary events (MACE) including death, myocardial infarction, and ischemia-driven target lesion revascularization at 30 days and nine months. The number of uncovered struts, area stenosis, and minimal lumen diameter assessed by OCT after nine months was also assessed.

A total of 201 patients were enrolled in the study and pre-treated with aspirin, heparin and clopidogrel. After radial diagnostic angiography, patients were randomly assigned to either primary PCI alone (n=96) or to primary PCI with OCT guidance (n=105). Drug-eluting stents (DES) were used in this trial and dual antiplatelet therapy was recommended for 12 months in both groups.

Baseline demographic and procedural characteristics were well balanced in both groups. Based on the OCT data, more stents were used in the OCT group (likely based upon the intraprocedural OCT findings), and fluoroscopy time was significantly longer in the OCT group.

The rate of MACE was very low and comparable at 30 days and nine-month follow-up in both groups. The rates of stent thrombosis, late lumen loss, and binary restenosis were also similarly low in both groups. Nine-month OCT analysis revealed significantly smaller area stenosis (p=0.001) and a trend toward fewer uncovered struts (p=0.07) in the OCT-guided group.

“The OCT STEMI trial demonstrates the potential merit of OCT guidance during drug-eluting stent implantation in primary PCI,” said lead investigator Pavel Cervinka, PhD, MD. Dr. Cervinka is a Professor from Faculty Hospital Hradee Králové and Masaryk Hospital in the Czech Republic. “The study also indicates that the procedure is safe for STEMI patients, and larger randomized trials with longer-term follow-up are warranted.”

Study Finds Women Underrepresented in Interventional Cardiology Field

Just four percent of interventional cardiologists are women

Women make up just 4 percent of interventional cardiologists and they perform only 3 percent of all percutaneous coronary interventions (PCI), according to a new study conducted through the Society for Cardiovascular Angiography and Interventions (SCAI) Women in Innovations (WIN) initiative and presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2014 conference.

“Women continue to be underrepresented in interventional cardiology,” said WIN Chair Cindy L. Grines, MD, FSCAI. “Today’s study highlights the ongoing gender gap in interventional cardiology and the need to continue to support women interested in joining the profession.”

For the study, researchers reviewed data on nearly 2.5 million PCI procedures at 1,431 U.S. hospitals between 2009 and 2013 in the CathPCI Registry to determine how many procedures were performed by a female operator and outcomes of those procedures.

The study found women were similarly or more likely than male operators to treat high-risk patients, including patients with heart attack (42.2 percent), cardiac arrest (2.5 percent) and cardiogenic shock (2.5 percent). Mortality rates among all female operators was a low 1.8 percent, and the mortality rate for elective PCI cases was just 0.46 percent.

Women also were likely to work in urban (67 percent) and academic (57 percent) settings and have a higher rate of uninsured patients (12 percent). Of female operators in the study, 41 percent worked in an institution where there were no other female interventional cardiologists.

“Women are likely to take challenging cases in challenging settings,” said Dr. Grines. “This study indicates female interventional cardiologists are making significant contributions to the field, and we want to continue to support them and encourage more women to select interventional cardiology as their specialty.”

SCAI’s WIN program has been a leader in supporting women in interventional cardiology, as well as efforts to raise awareness of cardiovascular disease in women and improve treatment of women with heart disease. WIN provides ongoing educational and networking events, leadership opportunities and resources to support career development for female interventional cardiologists.

“It’s important that we encourage women to pursue careers in interventional cardiology,” said WIN Co-founder Roxana Mehran, MD, FSCAI. “Women’s heart disease symptoms can be different than men’s, and women may experience different risk factors – such as the connections between pregnancy complications and heart disease. Female interventional cardiologists can be attuned to these differences, can provide support to women managing heart disease, and can be important advocates in raising awareness of heart disease in women.”

About SCAI. The Society for Cardiovascular Angiography and Interventions is a 4,000-member professional organization representing invasive and interventional cardiologists in approximately 70 nations. SCAI’s mission is to promote excellence in invasive/interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI’s public education program, Seconds Count, offers comprehensive information about cardiovascular disease. For more information about SCAI and Seconds Count, visit www.SCAI.org/or www.SecondsCount.org. 

Medtronic Drug-Coated Balloon Shows Strong Clinical and Economic Benefit in Treatment of PAD

IN.PACT global study reports favorable outcomes in real-world patient population and validates key findings from IN.PACT SFA trial

Presented for the first time at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) conference, the latest clinical and economic data on the IN.PACT Admiral drug-coated balloon (DCB) from Medtronic augments an already robust body of evidence that continues to drive a reconsideration of the standard of care for peripheral artery disease (PAD) in leg arteries above the knee.

The IN.PACT Admiral DCB remains an investigational medical device in the United States. No drug-coated balloon has yet received approval from the U.S. Food and Drug Administration.

The new data come from the real-world IN.PACT Global study, the largest and most rigorous post-market evaluation of its kind for any peripheral artery intervention, and from an ongoing economic outcomes analysis of the U.S. phase of the landmark IN.PACT SFA trial.

Together, the results show that the IN.PACT Admiral DCB is not only clinically superior, but also cost-effective for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) or proximal popliteal artery (PPA) at 12 months compared to standard percutaneous transluminal angioplasty (PTA). 

IN.PACT SFA, a randomized controlled trial comparing the IN.PACT Admiral DCB to standard PTA head-to-head, found the lowest 12-month clinically-driven target lesion revascularization (CD-TLR) rate for any peripheral intervention ever studied (2.4 percent vs. 20.6 percent, respectively).

Initial findings from the IN.PACT Global study, which will enroll more than 1,500 patients at 67 sites around the world, characterize the performance of the IN.PACT Admiral DCB in a real-world patient population –– one with more complex and challenging baseline characteristics than the 331 patients enrolled in the IN.PACT SFA trial. Considering the greater complexity of the patients enrolled in IN.PACT Global, 12-month outcomes for the first 655 patients –– including a CD-TLR rate of 8.7 percent –– validate the findings from IN.PACT SFA.

“Based on the exceptionally high quality of this real-world, registry-based evidence, the IN.PACT Admiral drug-coated balloon is demonstrating unparalleled outcomes for atherosclerotic lesions in the femoro-popliteal vessel bed,” said Gary Ansel, MD, System Medical Director for vascular services at OhioHealth/Riverside Methodist Hospital in Columbus, Ohio.  

Interim economic outcomes analysis. In recognition of the traditionally high costs associated with repeat revascularization following PTA, the IN.PACT SFA trial included a pre-specified economic analysis of the trial’s U.S. phase to evaluate the comparative cost-effectiveness of the IN.PACT Admiral DCB in terms of avoiding repeat revascularization.

An interim one-year report on this ongoing analysis, which has a primary two-year endpoint of total PAD-related costs for the target limb, found that treatment with the IN.PACT Admiral DCB is economically attractive, despite higher initial hospital costs.

The follow-up target-limb related medical care costs from discharge to one year were approximately $750 per patient lower in the DCB group than the PTA group, resulting in an incremental cost-effectiveness ratio of about $2,900 per repeat revascularization avoided, which compares favorably to other cardiovascular therapies, including coronary drug-eluting stents.

ACIST Launches HDi High-Definition Intravascular Ultrasound (IVUS)

High-definition resolution, faster pullback, and innovative touch screen display advances IVUS for cardiologists

ACIST Medical Systems, Inc., a Bracco Group company, showcased the first-ever HDi High-Definition Intravascular Ultrasound System in two live cases at the Transcatheter Cardiovascular Therapeutics meeting in Washington, D.C. The cases were presented from Medstar Washington Hospital Center (Washington, D.C.) and New York-Presbyterian Hospital/Columbia University Medical Center (New York, NY). The HDi features an intuitive touch screen with 60MHz image quality, high-speed pullback, a deliverable Kodama HD-IVUS catheter, and the ACIST HDi console. HD-IVUS is a reinvention of intravascular imaging.

The ACIST Medical Systems portfolio has recently expanded beyond the CVi contrast delivery system, to include Rapid Exchange FFR (RXi) and High-Definition IVUS (HDi) technologies. 

The ACIST HDi IVUS system is easier to use and offers detailed insight that physicians can use to optimize treatment choice for their patients. The HDi provides improved image quality over traditional IVUS systems. During one of the live broadcasts from Columbia Medical Center, world-renowned imaging expert Dr. Akiko Maehara noted, “The ability to visualize plaque morphologies and intravascular structures in high definition is a welcome advancement in imaging.”

Additionally, the simple, intuitive touch-screen display features 60MHz image quality, which enables easier identification and interpretation of intravascular structures and disease. The Kodama HD-IVUS catheter is deliverable and offers high-speed pullback that is 20 times faster than currently available IVUS systems—lowering the risk of catheter-induced ischemia by reducing pullback time from minutes to seconds. 

To learn more, visit www.acist.com.

REPRISE II Data Demonstrate Sustained Safety and Performance Outcomes at One Year for the Boston Scientific Lotus Valve System

No cases of moderate or severe paravalvular aortic regurgitation at one year

New data from the Boston Scientific clinical trial program of the Lotus valve system continue to demonstrate strong performance as a less invasive treatment for patients with severe aortic stenosis who are considered high risk for surgical valve replacement. Data from the REPRISE II clinical trial confirmed safety and effectiveness out to one year, with more than 86 percent of patients exhibiting a complete absence of paravalvular aortic regurgitation and no patients demonstrating moderate or severe paravalvular aortic regurgitation. New data from the REPRISE I and REPRISE II clinical trials were presented at the 26th Transcatheter Cardiovascular Therapeutics (TCT) meeting.

REPRISE II is an ongoing prospective, single-arm, multi-center study designed to evaluate safety and performance of the Lotus valve system for symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement. The study enrolled 120 patients at 14 sites in Australia, France, Germany and the UK.

In REPRISE II, key one-year results include the following:

• Mean aortic valve pressure gradient remained low and stable at 12.6 ± 5.7 mmHg.
• More than 86 percent of patients had no paravalvular aortic regurgitation by independent core lab assessment. In addition, no cases of moderate or severe paravalvular aortic regurgitation occurred. Mild and trace paravalvular aortic regurgitation rates were low at 11.4 and 2.3 percent, respectively.
• Cardiovascular mortality rate was 6.7 percent.
• Disabling stroke rate was 3.4 percent.
• No cases of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolization, valve-in-valve, or ectopic valve placement occurred.

“The one-year REPRISE II data show strong and sustained clinical benefits, excellent valve hemodynamics and remarkably low rates of paravalvular regurgitation and cardiovascular mortality,” said Professor Ian Meredith, director of MonashHeart at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial. “These positive data reinforce the benefits and features of the Lotus valve system, including the ability to achieve precise primary valve placement, reposition or fully retrieve if needed, and minimize if not obliterate paravalvular regurgitation with an effective Adaptive Seal.”

REPRISE II data build on the positive findings from REPRISE I, a prospective, single-arm, feasibility study that evaluated 11 patients. The REPRISE I two-year results also demonstrated no instances of moderate or severe paravalvular leak and no instances of death. Additionally, patients who received the Lotus valve system had durable and significant improvements in valve area, transvalvular pressure gradients, and New York Heart Association classification compared to baseline.

About the Lotus valve system. The Lotus aortic valve system is a differentiated second-generation TAVI technology, consisting of a pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve. The low-profile delivery system and introducer sheath are designed to enable predictable and precise placement associated with early valve function, as well as bi-directional atraumatic repositioning and retrieval at any time prior to release of the aortic valve implant. The device also features a unique Adaptive Seal designed to minimize the incidence of paravalvular regurgitation, which has been identified as a predictor of mortality in multiple clinical trials.^i,ii,iii In the U.S., the Lotus valve system is not available for sale. It is a CE marked device, available for sale in countries where CE marking is the regulation in force. For more information, visit www.bostonscientific.com.

References

i   Kodali SK, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. NEJM. 2012; 366: 1685. Available online at https://www.nejm.org/doi/full/10.1056/NEJMoa1200384. Accessed April 25, 2013.

ii   Tamburino C, et al. Valvular heart disease. Circulation. 2011; 123: 299. Available online at https://circ.ahajournals.org/content/123/3/299.full. Accessed April 25, 2013.

iii  Abdel-Wahab M, et al. Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve implantation registry. Heart. 2011; 97: 899. Available online at https://circ.ahajournals.org/content/123/3/299.full. Accessed April 25, 2013.

EXCITE ISR Proves Superiority in Safety, Efficacy of Laser Atherectomy With PTA vs. PTA Alone

Study proves 93.5% procedural success rate of laser with PTA vs. 82.7% with PTA alone; Turbo-Tandem and Turbo-Elite are the only devices cleared by FDA to treat fempop ISR

The Spectranetics Corporation announced that Eric Dippel, MD, at Transcatheter Cardiovascular Therapeutics (TCT), presented findings from the EXCITE ISR clinical trial proving Spectranetics’ laser atherectomy devices, used with PTA (percutaneous transluminal angioplasty), are clinically superior to PTA alone in both safety and efficacy, triggering a new standard in cardiovascular care.

Eric Dippel, MD, of Genesis Heart Institute in Davenport, Iowa, presented the EXCITE ISR data as part of TCT’s Late-Breaking Clinical Trials. Critical data findings include:

• 93.5% procedural success rate using Turbo-Tandem with PTA vs. 82.7% with PTA alone (p=0.01).
• Primary safety endpoint, major adverse event (MAE) rates at 30 days 5.8% vs. 20.5% with PTA alone (p<0.001).
• Primary efficacy endpoint, 73.5% freedom from target lesion revascularization (TLR) at 6 months vs. 51.8% with PTA alone (p<0.005).
• Excimer laser atherectomy with adjunctive PTA was associated with a 52% reduction in TLR (Hazard Ratio 0.48; 95% CI 0.31 – 0.74).
• Dissection rate of 7.7% vs. 17.2% with PTA alone (p=0.03).
• Bailout stenting 4.1% vs. 11.1% with PTA alone (p=0.05).
• There was no procedurally related stent damage observed in either cohort.
• Visit TreatISR.com/Resources for a copy of the EXCITE ISR presentation.

Notably, the study’s average lesion length was approximately 20 cm as compared to various stent IDE studies with average lesion lengths of 4 to 6 cm. Additionally, a high number of complex or advanced disease-state patients were enrolled in the trial, indicative of success in treating many types of ISR lesions, including the most complex cases.

The EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis (EXCITE ISR) is the first large multi-center, prospective randomized trial ever conducted for the treatment of fempop ISR. In July, Spectranetics received a U.S. Food and Drug Administration (FDA) 510(k) indication of its peripheral atherectomy products, Turbo-Tandem and Turbo-Elite, to treat ISR. Other products are not indicated or contraindicated to treat ISR.

Once ISR develops, there is a 65% chance of recurrence after treatment with PTA. Each year, up to 250,000 people suffer from ISR globally.

Lead EXCITE ISR investigator Eric Dippel, MD, said, “When it comes to patient care, physicians demand proven results that exhibit superior outcomes, with safety and efficacy as a priority. With 73.5% freedom from TLR at six months versus 51.8% with PTA alone, the data tells the story. The EXCITE results demonstrate that Spectranetics has set a new standard of care for ISR.”

About EXCITE ISR. The EXCITE ISR trial was designed to enroll a maximum of 318 subjects at up to 40 sites, randomized 2:1 treatment to control with predetermined statistical analyses at 200, 250 and 300 enrolled patients. Earlier this year, Spectranetics announced success of the trial based on achieving highly significant statistical superiority in both safety and efficacy among 250 patients. The treatment arm is laser atherectomy combined with PTA and the control arm is PTA alone. The primary efficacy endpoint is freedom from TLR through six months. The primary safety endpoint is freedom from major adverse events (MAEs) at 30 days. MAEs include all-cause mortality, major amputation in the target limb, or TLR. For more information, visit www.spectranetics.com.

Clinical Trial Results for Impella RP Right Ventricular Heart Failure Trial, RECOVER RIGHT, Released at TCT 2014

Abiomed Inc. announced clinical trial results from RECOVER RIGHT, an Investigational Device Exemption (IDE) study of the Impella RP (Right Percutaneous) System. RECOVER RIGHT was an FDA-approved, prospective, multicenter, single-arm study designed to evaluate the safety and probable benefit of the Impella RP in patients with right ventricular failure (RVF) refractory to medical treatment and deemed to require hemodynamic support. The clinical trial results demonstrated a survival rate of 73% in the overall patient population.

The 30 patients enrolled in the RECOVER RIGHT trial were categorized into two patient cohorts. Cohort A included patients who developed RVF within 48 hours after implantation of a left ventricular assist device (LVAD). Cohort B examined patients who developed RVF within 48 hours of post-cardiotomy shock or post acute myocardial infarction (AMI) shock. The primary endpoint was patient survival at 30 days, hospital discharge, or bridge to the next therapy.

Overall, the survival rate was 73% in the entire population at 30 days. Cohort A showed a survival rate of 83.3% and Cohort B had a 58.3% survival rate at 30 days.

“Right-side heart failure carries a high risk of mortality, and historically has been difficult for physicians to treat minimally invasively.  The data from this trial is encouraging, and demonstrates that the Impella RP may play a pivotal role in the treatment of RVF patients in need of hemodynamic support in the future here in the U.S.,” said William O’Neill, MD, co-principal investigator for the RECOVER RIGHT trial and medical director of structural heart disease at Henry Ford Hospital.

“The Impella RP is the first percutaneous, single vascular access pump designed for right heart support. The pump is designed to be used concurrently with other left ventricle pumps in the Impella platform, which in the future may offer physicians the option of percutaneous biventricular support for acute patients,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed.

 “The trial results were favorable and the 30-day outcomes appear promising compared with clinical data from surgical RV assist devices; however our study was not designed for a statistical comparison. Overall, the results show that the percutaneous approach with Impella RP potentially offers significant advantages to patients,” said Mark Anderson, MD, co-principal investigator for the RECOVER RIGHT trial and chair of the division of cardiothoracic surgery at Einstein Medical Center.

The trial results, “A Prospective, Multicenter Study to Evaluate a New Percutaneous Ventricular Assist Device for Right Ventricular Failure: The RECOVER Right Study,” were presented by Dr. O’Neill at Transcatheter Cardiovascular Therapeutics (TCT) 2014 in Washington, D.C.

The Company also announced last week that it has completed its FDA submission of RECOVER RIGHT trial data for the Human Device Exemption (HDE) submission. Please visit www.abiomed.com for more information.

*The Impella RP is the subject of an investigational device exemption (IDE) clinical study and is limited by federal law to investigational use. The Impella RP currently is not available for sale in the United States.

Medtronic CoreValve Data Demonstrate Favorable Cost Effectiveness Compared to Open-Heart Surgery in High-Risk Patients

Cost effectiveness of self-expanding valve driven by improved quality of life benefit and superior one-year survival rates over surgical aortic valve replacement

In the first-ever in-trial cost effectiveness analysis of transcatheter aortic valve replacement (TAVR) for patients at high risk for surgery, investigators revealed new data demonstrating the cost effectiveness of the CoreValve system from Medtronic, Inc. for high-risk patients with severe aortic stenosis. The economic analysis used data from the CoreValve U.S. Pivotal Trial’s study of high-risk patients, which is the only head-to-head study to show the superiority of TAVR to traditional surgical aortic valve replacement (SAVR) at one year.

The new data were presented during a late-breaking session at Transcatheter Cardiovascular Therapeutics (TCT) 2014.

In this analysis, TAVR patients used fewer healthcare resources related to the procedure time, ICU time, hospital length-of-stay and need for rehabilitation services at discharge (p≤0.001 for all measures, including:

•     Procedure time of 61+/-35 minutes TAVR versus 221+/-85 minutes SAVR; 

•     ICU time of 3.1 days TAVR versus 4.7 days SAVR; 

•     Hospital length-of-stay of 8.1 days TAVR versus 12.5 days SAVR; and 

•     23 percent TAVR vs. 44 percent SAVR for rehab services at discharge). 

While quality of life (QOL) was similar for TAVR and SAVR patients at 6 months and 1 year, TAVR patients reported improved QOL at 1-month.

Initial hospital costs were higher with TAVR by approximately $11,000 per patient, largely driven by the higher cost for a TAVR valve compared to a SAVR valve, which was not fully offset by cost savings due to reduced length-of-stay, more efficient procedures, and reduced use of rehab services. However, TAVR with the CoreValve system added 0.24 life years and 0.20 quality-adjusted life years (QALY) per patient at a lifetime incremental cost of approximately $13,700. Across all access routes, the incremental cost effectiveness ratio for the CoreValve system was $57,000 per life year gained and $67,000 per QALY. Specific to the iliofemoral access route, used in 85 percent of patients in this analysis, the CoreValve System was associated with an ICER of $48,330 per life year gained and $55,534 per QALY.

“It’s encouraging to see that for patients at high risk for surgery, TAVR with the CoreValve System provides a greater chance for a longer and higher quality of life, likely due to faster recovery from the procedure, at a reasonable cost,” said Matthew Reynolds, MD, of Lahey Hospital and Medical Center, Burlington, Mass., who presented the results. “In an age where healthcare costs are under increased scrutiny, it is especially important and reassuring to know that this new self-expanding valve also is cost effective for the U.S. healthcare system. And we can expect costs associated with length-of-stay, complications and ICU days to decrease as this therapy transitions into commercial use and implanters gain greater experience.”

The cost effectiveness analysis examined total one-year costs for all patients randomized in the High Risk Study (n=795) (from the perspective of the U.S. healthcare system), including medical resource utilization for all patients, hospital bills and health state utilities measured at one, six and 12 months. These data were then combined with patient-level survival and quality of life data to estimate the incremental cost effectiveness ratio of TAVR versus SAVR, in terms of cost per year of life gained and cost per QALY, gained over a lifetime horizon. The investigational sites in this analysis did not have prior TAVR experience, but did have extensive SAVR experience.

The CoreValve system was approved by the U.S. Food and Drug Administration (FDA) in June 2014 for patients at high risk for surgery based on data that showed the CoreValve system was associated with improved survival over surgery (85.8 percent vs. 80.9 percent), with no increased risk of stroke at one year.

TRUTH Study Demonstrates Orbital Atherectomy’s Effectiveness at Reducing and Modifying Calcified Lesions with Low Procedural Complications

Cardiovascular Systems, Inc. (CSI), unveiled new data about the treatment of arterial calcification at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington D.C. Arterial calcium is a common occurrence for the millions of patients suffering from peripheral artery disease (PAD) and it can lead to significant complications. Calcified plaque is estimated to be present in approximately 65 percent of the population treated annually for PAD. 

Results from the company’s Tissue Removal Assessment with Ultrasound of the SFA and Popliteal (TRUTH) study, a prospective, single-arm, non-randomized feasibility study of 25 patients were featured. TRUTH evaluated the removal of plaque with CSI’s Peripheral Orbital Atherectomy System (OAS) by analyzing changes in plaque volume and composition via an independent virtual histology (VH) - intravascular ultrasound (IVUS) core laboratory. 

In a poster presentation on Saturday, Sept. 13, 2014, at the Walter E. Washington Convention Center, physicians Anvar Babaev, MD, PhD, NYU Medical Center, New York City, Susanna Zavlunova, MD, NYU Langone Medical Center, New York City, Michael J. Attubato, MD, New York University School of Medicine, New York City, and Akiko Maehara, MD, Cardiovascular Research Foundation and Columbia University Medical Center, New York City, highlighted TRUTH study results demonstrating that OAS treatment is effective at reducing and modifying calcium from lesions, resulting in low acute complications and improved Rutherford Classification — the scale which measures arterial blockage severity. 

Key TRUTH results included: 

•    All patients were asymptomatic two weeks after OAS treatment (Rutherford Classification (RC) of 0 (100% asymptomatic) compared to a baseline RC of 3 (96.0%); 

•    100% freedom from recoil, slow flow/no reflow, flow-limiting dissections or perforations after OAS treatment; 

•    At the treated lesion site, the minimum lumen area increased significantly from 4.0 mm² to 9.1 mm² post-treatment (p<0.0001), accompanied by a decrease in area stenosis; 

•    At the site of maximum calcium removal, calcium reduction was responsible for 86% of the lumen area increase; and 

•    Calcium modification was directly related to OAS usage. 

David L. Martin, CSI’s President and Chief Executive Officer, said, “TRUTH demonstrates that by using CSI’s peripheral atherectomy systems, physicians can improve procedural success in calcified lesions.” 

The Stealth 360 and Diamondback 360 Peripheral Orbital Atherectomy Systems are minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue — a critical factor in preventing reoccurrences. Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results. The U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System for the treatment of PAD in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. For more information, visit www.csi360.com. 

Product Disclosure: The Stealth 360 PAD System, Diamondback 360 PAD System and Predator 360 PAD System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The systems are contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation and distal. 

Twelve-Month Data from St. Jude Medical EnligHTN Renal Denervation System Show Continued Safety and Efficacy for PatientsData for patients with drug-resistant uncontrolled hypertension presented at TCT 2014

St. Jude Medical, Inc. announced 12-month outcome data from the EnligHTN III study, which demonstrated a continuation of safe, rapid, and effective treatment with the next-generation EnligHTN Renal Denervation System for patients with drug-resistant, uncontrolled hypertension. The results were presented during the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. 

Renal denervation is a specialized ablation procedure that has demonstrated a reduction in blood pressure for patients with hypertension, or high blood pressure, that is resistant to medical therapy. The EnligHTN system delivers radiofrequency (RF) energy from an ablation catheter to create lesions along the renal nerves – a network of nerves in the walls of the renal arteries thought to help control blood pressure. The intentional disruption of the nerve supply has been found to help reduce systolic and diastolic blood pressure. The system catheter has a unique, non-occlusive basket design with multiple electrodes, which help physicians deliver a predictable treatment pattern while allowing for continuous blood flow to the kidney throughout the procedure. The next-generation EnligHTN system, CE Mark approved in 2013, delivers simultaneous ablations via a multi-electrode catheter, reducing total ablation time by more than 80 percent in comparison to the first generation system, from approximately 24 minutes to four minutes. 

“The twelve-month data for EnligHTN III continues to show the benefits of the EnligHTN Renal Denervation System and merits for its potential to change the way hypertension is treated,” said Prof. Stephen Worthley of St. Andrew’s Hospital in Adelaide, Australia, a principal investigator of the EnligHTN III study. “These data continue to demonstrate that the multi-electrode system from St. Jude Medical provides a safe and effective alternative for patients with drug-resistant and uncontrolled hypertension.” 

The EnligHTN III study is an international, non-randomized clinical trial that followed device performance and assessed outcomes at six centers through twelve months of follow-up for 37 eligible patients. 

Twelve-month EnligHTN III data showed: 

• An average office systolic blood pressure reduction of 23 mmHg points;
• An average ambulatory systolic blood pressure reduction of 10 mmHg points;
• 78 percent of patients responded to the therapy, which is defined as a blood pressure reduction of at least 10 mmHg when measured during an office visit.

Dr. Mark D. Carlson, chief medical officer for St. Jude Medical, said, “Our innovative EnligHTN technology with its multiple electrode basket design allows for consistent lesion creation that we believe minimizes variability during the procedure.” 

The EnligHTN III study expands upon the research conducted in the EnligHTN I trial of the first-generation EnligHTN system, which demonstrated that patients with drug-resistant hypertension had a safe drop in blood pressure. 

About EnligHTN I. New data from the EnligHTN I trial, which was presented at EuroPCR 2014, confirmed the fast, early reduction in blood pressure remains sustained at 24 months, further demonstrating the long-term benefits of this procedure when using the EnligHTN technology. 77 percent of patients were responders at 24 months, with a blood pressure reduction of at least 10 mmHg. 

Forty-six patients were treated with the EnligHTN system in the EnligHTN I multicenter study. To be considered for enrollment, patients were required to have a systolic blood pressure above 160 mmHg (150 mmHg for patients with type II diabetes) and take at least three antihypertensive medications, including a diuretic. Notably, the EnligHTN I study reports the longest term follow-up to date on a multi-electrode ablation catheter. For more info, visit sjm.com. 

Results of DKCRUSH-VI Trial Reported at TCT 2014

First-of-its-kind study compares outcomes of fractional flow reserve-guided and angiography-guided provisional side branch stenting

A new study found that fractional flow reserve (FFR)-guided provisional side branch (SB) stenting of true coronary bifurcation lesions yields similar outcomes to the current standard of care. The DKCRUSH-VI clinical trial is the first study to compare FFR-guided and angiography-guided stenting. Findings were reported at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. 

Angiography alone is most commonly used to guide the decision whether and how to treat SBs of a coronary bifurcation lesion. Previous studies have demonstrated that this approach is effective for the majority of these lesions. However, there is little data regarding outcomes after FFR-guided provisional bifurcation stenting. FFR integrates both lesion severity and the area of the myocardium supplied by the specific coronary artery, and has become the gold standard for assessing the functional significance of a coronary lesion. 

The DKCRUSH-VI trial examined a total of 320 patients at eight centers with true coronary bifurcation lesions (Medina 1,1,1, or 0,1,1) undergoing stenting with a provisional SB approach. Patients were randomly assigned 1:1 to an angiography-guided and FFR-guided method. The primary endpoint was the one-year composite rate of major adverse cardiac events (MACE) including cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization (TVR). 

Comparing the angiography and FFR groups, treatment of the SB (balloon or stenting) was performed in 63.1 percent vs. 56.3 percent of cases, respectively (p=0.07). Stenting of the side branch was attempted in 38.1 percent vs. 25.9 percent, respectively (p=0.01). Among attempted cases, stenting was successful in 83.6 percent and 77.3 percent respectively (p=0.01). While fewer SB stents were used in the FFR group, the one-year composite MACE rate was 18.1 percent in both groups (p=1.0). 

“Given the nearly identical one-year MACE rates with both approaches, either the angiography-guided or FFR-guided technique may be recommended for provisional side branch stenting of true bifurcation lesions,” said lead investigator Shao-Liang Chen, MD. Dr. Chen is Director of Cardiology and Cath Lab at Nanjing First Hospital and Professor of Internal Medicine and Cardiology at Nanjing Medical University in China. “The FFR technique may result in somewhat fewer stents being implanted and a slightly lower long-term restenosis rate, but may be technically challenging and require the upfront cost of a pressure wire in all patients.”

The DKCRUSH-VI trial was funded by the Jiangsu Provincial Special Program of Medical Science. Dr. Chen reported no disclosures.

Results of RIBS IV Trial Reported at TCT 2014

New study finds everolimus-eluting stents provide superior clinical outcomes compared to drug-eluting balloons in patients with drug-eluting stent restenosis

A new clinical trial comparing the use of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in treating in-stent restenosis (ISR) from drug-eluting stents found that EES provided superior late angiographic results and better late clinical outcomes. Findings were reported at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. 

Treatment of patients with ISR remains a challenge, especially in patients presenting with drug-eluting stent (DES) ISR. In this setting, DEB appear to be as effective as first-generation DES. However, the relative value of DEB compared to new generation DES with DES-ISR remains unknown. 

RIBS IV was a multicenter, prospective, randomized trial that compared the efficacy of DEB with that of EES in patients with DES-ISR. The primary endpoint was minimal lumen diameter (MLD) at late angiographic follow-up. Secondary endpoints including diameter stenosis, angiographic late lumen loss, and binary restenosis were also analyzed at nine months. 

A total of 309 patients with DES-ISR were randomized to receive either EES (n=155) or DEB (n=154). Late angiographic follow-up was obtained in 90 percent of eligible patients. At nine months, the EES group reported a larger in-segment MLD than the DEB group (2.03 vs. 1.80, respectively; p=0.004). After one year, the EES group also reported higher rates of freedom from target lesion revascularization (96 percent vs. 87 percent, p=0.008) and freedom from major adverse coronary events, including cardiac death, myocardial infarction, and target vessel revascularization (90 percent vs. 82 percent, p=0.044). 

“In patients with DES-ISR, our study found that EES provides superior late angiographic results and better late clinical outcomes compared to DEB,” said lead investigator Fernando Alfonso, MD, PhD. Dr. Alfonso is the Head of the Cardiac Department at the Hospital Universitario de La Princesa in Madrid, Spain. “Treatment of DES-ISR remains challenging and associated with poorer clinical and angiographic results than treatment of bare metal stent ISR. Further studies with more patients and longer follow-up are warranted in this adverse setting.”

The RIBS IV trial was an investigator driven initiative funded by unrestricted grants from B. Braun and Abbot Vascular. Dr. Alfonso reported no disclosures.