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(Circulation. 2006;113:1434-1441.)
© 2006 American Heart Association, Inc.

Interventional Cardiology

Safety of Coronary Sirolimus-Eluting Stents in Daily Clinical Practice

One-Year Follow-Up of the e-Cypher Registry

Philip Urban, MD, FESC; Anthony H. Gershlick, MD; Giulio Guagliumi, MD, FESC; Philippe Guyon, MD; Chaim Lotan, MD; Joachim Schofer, MD; Ashok Seth, MD, MBBS, DSc; J. Eduardo Sousa, MD, PhD; William Wijns, MD, PhD, FESC; Claude Berge, MSc; Monika Deme, MD; Hans-Peter Stoll, MD, on behalf of the e-Cypher Investigators

From La Tour Hospital (P.U.), Geneva, Switzerland; University Hospitals of Leicester (A.H.G.), Leicester, England; Azienda Ospedaliera Ospedali Riuniti di Bergamo (G.G.), Bergamo, Italy; Centre Cardiologique Du Nord (P.G.), Paris, France; Hadassah–Hebrew University Medical Center (C.L.), Jerusalem, Israel; Hamburg University Cardiovascular Center (J.S.), Hamburg, Germany; Max Heart and Vascular Institute (A.S.), New Delhi, India; Institute Dante Pazzanese de Cardiologia (J.E.S.), Sao Paulo, Brazil; OLV Ziekenhuis (W.W.), Aalst, Belgium; Hesperion Ltd (C.B.), Allschwill, Switzerland; and Cordis Clinical Research Europe (M.D., H.-P.S.), Waterloo, Belgium.

Correspondence to Philip Urban, MD, Cardiovascular Department, La Tour Hospital, 1 Avenue JD Maillard, 1217 Geneva, Switzerland. E-mail philip.urban{at}latour.ch

Received December 27, 2004; revision received December 8, 2005; accepted January 9, 2006.

Background— The expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice.

Methods and Results— Between April 2002 and September 2005, data were collected on 15 157 patients who underwent implantation of 1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7±11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18 295 lesions were treated (20 503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade <3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months.

Conclusions— This analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials.

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CLINICAL PERSPECTIVE

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