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Original Contribution

Unprotected Left Main Angioplasty in Nonagenarians: Clinical Characteristics, Procedural Features and Outcome (full title below

Sofiene Rekik, MD, Jérôme Brunet, MD, Gilles Bayet, MD, François Xavier Hager, MD, Laurent Meille, MD, Jean Michel Quatre, MD, Joël Sainsous, MD
May 2010

Unprotected Left Main Angioplasty in Nonagenarians: Clinical Characteristics, Procedural Features and Outcome: A Case Series Study

ABSTRACT: Limited information is available on clinical characteristics and outcomes in very old patients with unprotected left main coronary artery disease (ULMCA) undergoing percutaneous coronary intervention (PCI). Methods. From January 2004 and December 2008, 248 patients with ULMCA stenosis underwent coronary revascularization with stent implantation. Among those, 6 were older than 90 years at the time of the procedure and were included in this study. Results. There were 5 males and 1 female; mean age was 91.5 years (range 91–93). All the patients presented with acute coronary syndromes. All of them had multivessel disease with a distal left main stenosis in 4 patients. All were deemed inoperable, with a mean EuroSCORE of 12.66 (range 10–20) and a predicted mortality at 34% (range15.8–86.6%). 5 patients received bare-metal stents and 1 patient a paclitaxel-eluting stent. Rotational atherectomy was required in 2 patients. Provisional side branch T-stenting with final kissing balloons was the technique used in all bifurcation lesions. Angiographic success was obtained in all patients. There were no in-hospital deaths or complications. After a 29.8-month (range 8–59) mean follow up period, a myocardial infarction caused by late stent thrombosis occurred in 1 patient and ischemia-driven target vessel revisualization was required in another; however, all patients were alive. Conclusion. In the very elderly patients at excessively high risk for surgery, PCI for ULMCA disease is a suitable alternative with excellent short-term results and acceptable long-term outcomes. J INVASIVE CARDIOL 2010;22:231–234 Key words: unprotected left main; angioplasty; nonagenarians; outcome; PCI; ULMCA Notwithstanding a continued Class III indication in practice guidelines,1,2 percutaneous coronary intervention (PCI) for unprotected left main coronary artery (ULMCA) disease has recently emerged as a credible alternative to the so-far gold-standard therapy that is coronary artery bypass graft surgery (CABG). The elderly represent a specific subgroup of patients at particularly high risk for surgery. Available data are limited concerning the outcome of unprotected left main angioplasty (ULMA) in this subset of patients, and are even more scarce regarding the very old (> 90 years), found only in a few isolated case reports. 3 In this study, we sought to report our experience of ULMA in nonagenarians, to describe their clinical characteristics, procedural features as well as the short- and long-term outcomes.

Methods

Patients. Between January 2004 and December 2008, 248 patients underwent elective or urgent PCI of ULMCA in a single high-volume institution; among those, 6 were > 90 years of age at the time of the procedure and were included in this study. Definitions. The LMCA was considered unprotected if there were no patent coronary artery bypass grafts to the left anterior descending (LAD) or left circumflex arteries (LCX). Lesions located in the distal LM were defined by quantitative coronary angiography according to the Medina Classification. 4 Angiographic success was defined as the combination of a post-PCI stenosis 5 Stent thrombosis was classified using the Academic Research Council definition as definite, probable, or possible. 6 Major adverse cardiac events (MACE) were defined as the occurrence of death, myocardial infarction (MI) or target lesion revascularization (TLR). Medications. In elective cases, the patients were adequately pre-treated with aspirin and clopidogrel for at least 48 hours prior to the procedure and in urgent cases, a 600 mg clopidogrel loading dose was systematically administered in the catheterization laboratory. The use of glycoprotein (GP) IIb/IIIa inhibitors was at the operator’s discretion. After the procedures, all patients received dual antiplatelet therapy with 150 mg of clopidogrel for 1 month then 75 mg daily (per institution protocol), along with 160 mg of aspirin for at least 1 year. Continuation of dual antiplatelet therapy thereafter was encouraged. Procedures. Arterial access was systematically obtained through a femoral artery approach (6 or 7 French). All procedures were performed with standard interventional techniques. Ostial or shaft lesions were attempted with a single stent placement. For bifurcation lesions, a provisional side branch T-stenting technique (in which a stent was placed across the side branch — usually the LCX artery) was the preferred strategy. The decision to stent the side branch was made in cases of residual side branch stenoses > 50% by visual estimation or in the presence of dissection after final kissing balloon inflation.

Results

Clinical features. Baseline clinical and demographic characteristics of the study population are listed in Table 1. Patients were all at very high surgical risk with EuroSCOREs ranging from 10–20 and patient #3 presenting with cardiogenic shock. All of them presented with acute coronary syndromes (5 unstable anginas and 1 non-ST-elevation myocardial infarction [NSTEMI]). Coronary lesions were complex in all the patients with 4 of them having 2-vessel disease and 2 having 3-vessel disease besides the ULMCA stenosis. In all the cases except for patient #3 (urgent intervention for cardiogenic shock), the decision to proceed with PCI was taken by a consensus involving the interventional cardiologist, the cardiac surgeon and the patient and his family. Procedural data. The major angiographic and procedural characteristics are summarized in Table 2. Distal bifurcated lesions were the most frequent location (4 out of 6); in these cases, the preferred PCI technique was stenting of the main vessel (left anterior descending artery in 3 cases and LCX in 1 case) with provisional stenting of the side branch, resulting in single-stenting procedures in 2 cases and a multiple stenting procedures in 2 cases (2 stents in 1 case and 3 stents in another case), both of them having previously required rotational atherectomy with multiple high-pressure balloon inflations prior to stenting. Patients #3 to 6 underwent additional stenting during the same procedure for non-LM lesions according to standard techniques using bare-metal stents (BMS). Angiographic success was obtained in all cases (Figures 1 A through I illustrate the PCI procedure for patient #1). Outcome. No complications occurred during the hospitalization, and patient #3 was successfully weaned from intra-aortic balloon support on day 2. All patients were discharged on dual antiplatelet therapy. Complete follow up was available for all patients, with a mean of 29.8 months (range 8–59). Patient #5 presented 6 months after the stent implantation with an acute MI due to a late definite stent thrombosis in the LCX stent 2 weeks after having interrupted his dual antiplatelet therapy; his index PCI procedure was a provisional side branch (LCX) T-stenting that required kissing balloon inflation after the implantation of a second stent in the circumflex for a significant residual stenosis and additional final kissing balloon inflation, rendering an excellent angiographic result. He successfully underwent primary angioplasty with manual thrombectomy and balloon inflation and was totally asymptomatic at the last follow up 35 months later. Patient #4 also underwent an ischemia-driven repeat revascularization 9 months after stenting due to a diffuse restenosis inside the LM-to-LAD stent and received an additional paclitaxel-eluting stent. No MACE were observed in the remaining 4 patients. At the last follow up, the entire study population was alive: patients #1 and #3 were mildly symptomatic (functional New York Heart Association [NYHA] Class II and Canadian Cardiovascular Society Class II [CCS]), while the remaining 4 patients were totally symptom-free.

Discussion

In this study evaluating the profile and outcomes of PCI for the treatment of ULMCA disease in very old patients traditionally deemed inoperable, the major finding is that stenting is a safe and feasible procedure with excellent short-term and acceptable long-term outcomes. Consistent with prior studies addressing PCI in the elderly, 7,8 surgical risk was particularly high in our population as euroSCOREs exceeded 10 in all the patients. Similar findings were reported by Rodes-Cabeau et al7, as nearly all of the 104 octogenarians in the PCI group in their series had a euroSCORE Value > 6; in another series by Palmerini et al8, the median euroSCORE value was 8 in the 98 patients > 75 years of age undergoing ULMA. Albeit obviously smaller, our series addressed an even more fragile population; indeed, no reports regarding nonagenarians at such a high surgical risk have yet been published. Moreover, this study recruited patients with complex anatomy, as all of them presented with multivessel disease and half had distal bifurcated lesions and heavy calcifications. Despite the complexity of the treated lesions, procedural success was achieved in every patient. We tried to achieve optimal revascularization in order to avoid potentially hazardous staged procedures in such fragile patients. This resulted in stenting of multiple arteries and a relatively high number of stents implanted per procedure (up to 7 in patient #3). Of note, in contrast to most recent series9–11 we prefered to implant BMS, assuming that unplanned non-cardiac surgery or other pathological conditions potentially requiring the interruption of dual antiplatelet therapy are frequent in very elderly patients and may possibly be more easily manageable with BMS rather than drug-eluting stents (DES). Whether this strategy affected our results, particularly in terms of TLR, is difficult to determine because of the modest size of the cohort. Short-term outcomes were excellent, as no in-hospital deaths or complications were recorded, comparing very favorably to the expectable surgical mortality as predicted by the logistic EuroSCORE, standing as high as 34%, even when taking into account the reported overestimation of CABG mortality by logistic EuroSCORE in high-risk patients. 12 Longer-term outcomes were less favorable; indeed, MACE occurred in 1 patient out of 3 after a mean follow up of 30 months. However, these outcomes are still acceptable, as no deaths were recorded despite a late stent thrombosis which occurred due to an unjustified interruption of dual antiplatelet therapy, especially when considering that our patients were denied surgery and that they actually were in a therapeutic “dead end.” Our data compare favorably with those reported in the series by Rodes-Cabau et al in a lower-risk population. 7 Indeed, after 23 months of follow up, the cumulative rate of MACE was 34.6% in the PCI group of octogenarians, very close to the figure we found, but higher than those reported by other series9,13 which, however, addressed much younger and “healthier” populations. Study limitations. The major limitation of this study is obviously the very limited size of the population which prevented any firm conclusions; however, it still remains a valuable study with regard to the paucity of data available concerning very elderly patients, as no series, to our knowledge, specifically addressed ULMCA angioplasty in nonagenarians. The second limitation is the retrospective observational nature of the study, introducing inevitable bias in the selection of patients for PCI treatment. Another potential limitation is the very restrained proportion of DES used, which could partly account for the excess of MACE recorded; this fact is, however, only hypothesis-generating, considering that the number of patients and events are too low to exclude the chance.

Conclusion

Our study demonstrates that angioplasty is a safe and suitable procedure for the revascularization of ULMCA disease in nonagenarians, yielding excellent short-term and acceptable long-term results, with 100% survival after a nearly 30-month mean follow up period. It adds on to the growing body of evidence supporting the routine use of PCI in ULMCA lesions, regardless of the severity of the terrain.

References

1. Patel MR, Dehmer GJ, Hirshfeld JW, et al. JAACC/SCAI/STS/AATS/AHA/ASNC 2009 appropriateness criteria for coronary revascularization. J Am Coll Cardiol 2009;53:530–553. 2. King SB 3rd, Smith SC Jr, Hirshfeld JW Jr, et al. 2007 focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: A report of the American College of Cardiology/American Heart Association Task Force on Practice guidelines. J Am Coll Cardiol. 2008 Jan 15;51:172–209. 3. Sillano D, Moretti C, Biondi-Zoccai G, Sheiban I. Percutaneous unprotected left main angioplasty with drug-eluting stents in a nonagenarian: Feasible and safe despite recurrent restenosis. Minerva Cardioangiol 2008;56:167–170. 4. Medina A, Suarez de Lezo J, Pan M. A new classification of coronary bifurcation lesions. Rev Esp Cardiol 2006;59:183–184. 5. Roques F, Michel P, Goldstone AR, Nashef SA. The logistic euroSCORE. Eur Heart J 2003;24:881–882. 6. Cutlip DE, Windecker S, Mehran R, et al. Academic Research Consortium. Clinical end points in coronary stent trials: A case for standardized definitions. Circulation 2007;115:2344–2351. 7. Rodés-Cabau J, Deblois J, Bertrand OF, et al. Nonrandomized comparison of coronary artery bypass surgery and percutaneous coronary intervention for the treatment of unprotected left main coronary artery disease in octogenarians. Circulation 2008;118:2374–2381. 8. Palmerini T, Barlocco F, Santarelli A, et al. A comparison between coronary artery bypass grafting surgery and drug eluting stent for the treatment of unprotected left main coronary artery disease in elderly patients (aged > or = 75 years). Eur Heart J 2007;28:2714–2719. 9. Vaquerizo B, Lefèvre T, Darremont O, et al. Unprotected left main stenting in the real world: two-year outcomes of the French left main Taxus registry. Circulation 2009;119:2349–2356. 10. Seung KB, Park DW, Kim YH, et al. Stents versus coronary-artery bypass grafting for left main coronary artery disease. N Engl J Med 2008;358:1781–1792. 11. Chieffo A, Park SJ, Valgimigli M, et al. Favorable long-term outcome after drug-eluting stent implantation in nonbifurcation lesions that involve unprotected left main coronary artery: A multicenter registry. Circulation 2007;116:158–162. 12. Gummert JF, Funkat A, Osswald B, et al. EuroSCORE overestimates the risk of cardiac surgery: Results from the national registry of the German Society of Thoracic and Cardiovascular Surgery. Clin Res Cardiol 2009;98:363–369. 13. Mehilli J, Kastrati A, Byrne RA, et al. LEFT-MAIN intracoronary stenting and angiographic results: Drug-eluting stents for unprotected coronary left main lesions study Investigators. Paclitaxel- versus sirolimus-eluting stents for unprotected left main coronary artery disease. J Am Coll Cardiol 2009;53:1760–1768.

_________________________________________________________________ From the Cardiovascular Department, Clinique Rhône Durance, Avignon, France. The authors report no conflicts of interest regarding the content herein. Manuscript submitted October 7, 2009, provisional acceptance given November 16, 2009, final version accepted December 7, 2009. Address for correspondence: Sofiene Rekik, MD, Cardiovascular department, Clinique Rhône Durance, 1750, chemin du Lavarin, 84082, Avignon, France. E-mail: sofienerek@yahoo.fr


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