Clinical and Industry News for April 2006

St. Jude Medical Launches New Vascular Closure Device; Angio-Seal VIP Seals Arteries in Both Diagnostic and Interventional Procedures

St. Jude Medical, Inc. announced U.S. Food and Drug Administration (FDA) approval and launch of its next generation vascular closure device, the Angio-Seal VIP. The new device is approved for both diagnostic and interventional procedures. The Angio-Seal VIP provides more coverage on the artery surface than previous devices and utilizes a coated suture. If physicians need to access the site a second time, they can safely re-enter with the Angio-Seal VIP device within 1 centimeter of the original site. All components of the Angio-Seal VIP are fully absorbed within 60 to 90 days, so no foreign material permanently remains in the body. These components include a small anchor, collagen and a suture. The anchor is placed in the artery through a small delivery system, where it is pulled against the inside wall of the artery. The anchor and collagen are gently sandwiched together with the suture to form a secure seal.

Philips to Acquire Cardiology Healthcare Company Witt Biomedical Corporation

Royal Philips Electronics and Witt Biomedical Corporation announced Philips will acquire Witt Biomedical Corporation, the largest independent supplier of hemodynamic monitoring and clinical reporting systems used in cardiology catheterization laboratories (cath labs). Subject to receipt of regulatory approval, Philips will acquire Witt Biomedical for approximately USD 165 million. The transaction is expected to close in the second quarter of 2006. Through this acquisition, both companies expect to benefit from being able to offer customers an integrated suite of technologies for the cath lab department, including cardiovascular x-ray, cardiology picture archiving and communication systems (PACS), and hemodynamic monitoring and reporting systems. Based on company estimates, Philips in 2005 held the number-one global position in cardiovascular x-ray and in cardiology PACS. In hemodynamic monitoring and clinical reporting systems, Witt Biomedical was the largest independent supplier in the United States in 2005, and was the number 2 supplier in the global market.

Anti-Thrombotic Medication Significantly Reduces Risk of Death for STEMI Patients

Salim Yusuf, DPhil, FRCPC, FRSC, of McMaster University and Hamilton Health Services, Ontario, Canada, and colleagues with the OASIS-6 Trial conducted a study to evaluate the effect of fondaparinux compared with standard approaches to antithrombotic therapy in patients with ST-elevation myocardial infarction (STEMI) in preventing death or reinfarction at 30 days. These outcomes were also assessed at 9 days and at study end (minimum of 3 and maximum of 6 months). The study included 12,092 patients with STEMI from 447 hospitals in 41 countries who were randomized to receive fondaparinux 2.5 mg once daily for up to 8 days or usual care (placebo in those in whom UFH is not indicated or UFH for up to 48 hours followed by placebo for up to 8 days in patients with STEMI). The researchers found that death or reinfarction at 30 days was significantly reduced from 11.2 percent of 6,056 patients in the control group to 9.7 percent of 6,036 patients in the fondaparinux group, a risk reduction of 14 percent. These benefits were observed at 9 days (8.9 percent) placebo vs. (7.4 percent) fondaparinux, a 17 percent risk reduction; and at study end (14.8 percent) placebo vs. (13.4 percent) fondaparinux, a 12 percent reduction. Risk of death was significantly reduced throughout the study. However, there was no benefit in those undergoing primary PCI. There was a tendency to fewer severe bleeding events in the fondaparinux group. This study was published in the Journal of the American Medical Association and also presented at the American College of Cardiology Scientific Sessions. In summary, fondaparinux reduces mortality and reinfarction early, and this benefit persists long term, the authors write. … results from … OASIS-6 confirm the value and safety of fondaparinux as a simple and widely applicable antithrombotic therapy in a broad group of patients with acute coronary syndrome. In an accompanying editorial, Robert M. Califf, MD, of Duke Clinical Research Institute, Durham, NC, comments on the OASIS-6 Trial results. The results of the OASIS 6 trial are certain to lead to an outburst competitive pronouncements by companies and by leaders in the clinical community about the question of which regimen is truly best. The multiple permutations and combinations of antithrombotic drugs are increasingly confusing to clinicians seeking the best options for their patients. How do physicians find a way out of this maze? Hopefully, the era in which individual clinical trials are considered to be the definitive answer to questions of clinical practice is coming to an end. Rather, clinical practices should be organized in a manner that allows for continuous learning based on observation of practice through collection of data, with randomized trials embedded within observational databases to answer specific questions about pragmatic choices in medical care. Just a few years ago, this would have seemed impossible, but the impending wide-scale availability of electronic health records and professional databases promises to make the data readily available the challenges are no longer technical. The largest advances in STEMI treatment are the findings that reperfusion is beneficial, that direct PCI is superior to lysis, and that treatment with aspirin, beta-blockers, and angiotensin-system modulators in appropriate patients all save lives. Due to the outstanding contributions of the OASIS 6 investigators, another degree of certainty can be added to the understanding that anticoagulation is also an essential element of STEMI care. True knowledge of the best mix of antithrombotics for each patient will come with development of a global network that truly provides an unbiased assessment of multiple medical permutations as part of a continuous learning effort.

CBRPA News

The Certification Board of Radiology Practitioner Assistants (CBRPA) is happy to announce that 45 applicants sat for the RPA/RA (CBRPA) certification examination on February 24, 2006. All of the candidates passed the exam. The average class score was 86%. The test was developed from the newly revised content specifications. Congratulation to all of the new RPAs/RAs (CBRPA)! There are currently 200 RPA/RA (CBRPA)-certified radiographers practicing in over 45 states as RPAs. For more information on the CBRPA and the RPA, please visit www.cbrpa.org and www.nsrpa.org

Periodontitis Is Linked to Coronary Heart Disease

Periodontal infection, and the pathogen burden in particular, is associated with the presence of coronary heart disease (CHD), according to findings published in the Archives of Internal Medicine. Chronic inflammation from any source is associated with increased cardiovascular risk, Dr. Wolfgang Koenig, of the University of Ulm Medical Center, Germany, and colleagues write. Periodontitis is a possible trigger of chronic inflammation. In examining the association between CHD and periodontitis, the researchers focused on microbial features of the disorder. A total of 789 subjects (263 with stable CHD and 526 matched controls with no history of CHD) were enrolled in the Coronary Event and Periodontal Disease study. DNA-DNA hybridization was used to analyze subgingival biofilm samples for periodontal pathogens. Results of multivariable analyses demonstrated a significant association between total periodontal pathogen burden (log10 of the sum of all pathogens) and the presence of CHD (odds ratio 1.92, p From Arch Intern Med 2006;166:554-559.

Very High-Intensity Statin Therapy Shows Promise for Inducing Regression of Coronary Atherosclerosis

Patients treated with very intensive statin therapy (rosuvastatin) lowered LDL-C levels on average by about 50 percent, increased HDL-C levels by 15 percent, and showed regression of coronary atherosclerosis, according to a study that appeared in the April 5 issue of the Journal of the American Medical Association. This study was also presented at the American College of Cardiology annual conference. Atherosclerosis is generally viewed as a chronic, progressive disease. Prior intravascular ultrasound (IVUS) trials have demonstrated slowing or halting of atherosclerosis progression with statin therapy but have not shown convincing evidence of atherosclerosis regression, as measured using percent atheroma (fatty deposit buildup in an artery) volume (PAV), the most rigorous intravascular ultrasound (IVUS) indicator of disease progression and regression. Steven E. Nissen, MD, of the Cleveland Clinic, and colleagues with the ASTEROID Trial conducted a study to determine the effects of high-intensity statin therapy on IVUS-derived measures of coronary atherosclerosis regression. Rosuvastatin is one of the most recently introduced statins and typically produces greater reductions in low-density lipoprotein cholesterol (LDL-C) and larger increases in high-density lipoprotein cholesterol (HDL-C) than previously available agents. The trial was performed at 53 community and tertiary care centers in the United States, Canada, Europe, and Australia. Coronary atheroma burden was measured at baseline and after 24 months of treatment. Between November 2002 and October 2003, 507 patients had a baseline IVUS examination and received at least 1 dose of study drug, rosuvastatin, 40 mg/d. After 24 months, 349 patients had evaluable serial IVUS examinations. The researchers found that the average baseline LDL-C level of 130.4 mg/dL declined to 60.8 mg/dL, an average reduction of 53.2 percent. Average HDL-C level at baseline was 43.1 mg/dL, increasing to 49.0 mg/dL, an increase of 14.7 percent. For the primary efficacy parameter of change in PAV, the average decrease was -0.98 percent and 63.6 percent of patients showed regression of atherosclerosis. For the second primary efficacy parameter, change in atheroma volume in the 10-mm subsegment with the greatest disease severity, there was a median (midpoint) reduction of 9.1 percent in atheroma volume, and 78.1 percent of patients demonstrated regression of atherosclerosis. The secondary efficacy parameter, change in total atheroma volume, showed a 6.8 percent median reduction. Adverse events were infrequent and similar to other statin trials. Traditional thinking has viewed atherosclerosis as an inexorably progressive disease for which even the most active therapies can merely slow advancement. The current study suggests that there is potential for a more optimistic strategy, in which aggressive lipid-modulating strategies can actually reverse the atherosclerotic disease process. The observed increases in HDL-C in the current study suggest that therapies designed to simultaneously lower LDL-C while raising HDL-C have the potential to substantially reduce lesion burden in patients with established disease, the authors write. The current study supports several conclusions. For secondary prevention patients, very intensive statin therapy using 40 mg/d of rosuvastatin in patients with preexisting coronary disease reduced LDL-C to 60.8 mg/dL while raising HDL-C by 14.7 percent. These changes were larger in magnitude than has been observed in previous statin trials. The very low LDL-C levels and increase in HDL-C levels resulted in significant regression in atheroma burden for all 3 primary and secondary efficacy parameters. This very intensive statin regimen was well tolerated. These observations support the recommendation to administer very intensive statin therapy for high-risk patients with established coronary disease, the researchers conclude. In an accompanying editorial, Roger S. Blumenthal, MD, and Navin K. Kapur, MD, of The Johns Hopkins Ciccarone Preventive Cardiology Center, Baltimore, discussed the findings of Nissen et al. Clearly a multimodality approach to the management of risk factors in patients with coronary artery disease is needed. While IVUS-documented atherosclerotic regression is an intriguing finding, clinicians must remember that this may not be the best measure of the treatment’s effect on hard cardiovascular endpoints. Nevertheless, the pioneering work of Nissen et al has revolutionized the current approach to understanding the anatomy and pathophysiology of coronary atherosclerosis as well as its responsiveness to medical therapy. The results of several ongoing trials will help determine what agent or combination of pharmacologic agents is most efficacious in the long-term management of at-risk patients.

Abciximab Reduces Risk of Adverse Events for Patients with ACS Undergoing PCI

Patients with acute coronary syndromes who were pre-treated with the anti-platelet agent clopidogrel before undergoing a procedure such as balloon angioplasty or stent placement had a reduced risk of adverse events if they received the anti-clotting drug abciximab, according to a study appearing in the April 5 issue of the Journal of the American Medical Association. This study was also presented at the American College of Cardiology annual conference. Non-ST-segment elevation acute coronary syndromes (ACS) are associated with an increased risk of death and are a major reason for hospital admissions. Although percutaneous coronary interventions (PCIs) are an established therapeutic approach in high-risk patients presenting with ACS, it is still unclear what the best adjunctive antithrombotic therapies are. There is increasing evidence that treatment with clopidogrel prior to PCI prevents postprocedural ischemic complications. It is not known whether the antiplatelet effect provided by 600 mg of clopidogrel eliminates the need for more potent antiplatelet therapies in patients with ACS undergoing PCI. Adnan Kastrati, MD, of the Deutsches Herzzentrum, Munich, Germany and colleagues with the ISAR-REACT 2 Trial assessed whether abciximab is a useful therapy in patients with non-ST-segment elevation ACS undergoing PCI, even after pretreatment with a 600-mg loading dose of clopidogrel. The randomized, double-blind, placebo-controlled trial included 2,022 patients and was conducted from March 2003 through December 2005. The patients, with non-ST-segment elevation ACS undergoing PCI, were assigned to receive either abciximab or placebo. All patients received clopidogrel, 600 mg, at least two hours prior to the procedure, as well as 500 mg of oral or intravenous aspirin. The primary endpoint of death, heart attack, or urgent target vessel revascularization occurring within 30 days after randomization was reached in 90 patients (8.9 percent) assigned to abciximab vs. 120 (11.9 percent) assigned to placebo. Thus, there was a significant 25 percent relative reduction of the risk with abciximab. Most of the risk reduction caused by abciximab resulted from a reduction in the occurrence of death and heart attack. There was no difference in the incidence of ischemic events between the abciximab group and the placebo group among patients without an elevated troponin level. However, among patients with an elevated troponin level, the incidence of ischemic events was significantly lower (29 percent reduced risk) in the abciximab group (13.1 percent) compared with the placebo group (18.3 percent). There were no significant differences between the two groups regarding the risk of major and minor bleeding as well as need for transfusion. The benefits of abciximab appear to be confined to patients with an elevated troponin level, the authors conclude. In an accompanying editorial, Steven R. Steinhubl, MD, and Richard Charnigo, PhD, of the University of Kentucky, Lexington, commented on the study by Kastrati et al. This brief moment of clarity regarding the optimal antiplatelet therapy in patients undergoing PCI, thanks in part to the ISAR investigators, is an important contribution. Given current evidence, all heparin-treated patients undergoing PCI for treatment of ACS with elevated troponin levels should receive adjunctive GP IIa/IIIb antagonists, irrespective of whether the patient has also received adequate pretreatment with clopidogrel. Whether there is additional clinical benefit to administering clopidogrel in addition to a GP IIa/IIIb antagonist, as has been suggested by previous post hoc analysis, remains to be prospectively studied. Still, the current treatment options of aspirin, clopidogrel, and the GP IIb/IIIa antagonists may soon be joined by new agents. Ongoing or soon-to-begin trials of new [therapies] ¦ may cloud the picture again but at the same time may also lead to continued improvements in the care of patients with acute coronary disease.

Twin-Pass Dual Access Catheter Launched

Vascular Solutions, Inc. recently launched the Twin-Pass dual access catheter. The Twin-Pass is a two-lumen catheter designed to be used in percutaneous cardiology and radiology procedures in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral arterial vasculature and for use during procedures utilizing two guidewires. The Twin-Pass dual access catheter features two 0.014 lumens in one low-profile support catheter. The rapid exchange lumen can be used for catheter placement over an existing 0.014 guidewire and has a 1.9F distal tip. The separate OTW lumen can then be used to confirm position and to deliver a second wire without removal of the original wire. Hydrophilic coating on the distal 20 cm of the catheter allows lubricious delivery. Twin-Pass is available in both the United States and Europe.

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