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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Paclitaxel- Versus Sirolimus-Eluting Stents for Unprotected Left Main Coronary Artery Disease

Julinda Mehilli, MD^_*,_*, Adnan Kastrati, MD^_*, Robert A. Byrne, MB, MRCPI^_*, Olga Bruskina, MD^_*, Raisuke Iijima, MD^_*, Stefanie Schulz, MD^_*, Jürgen Pache, MD^_*, Melchior Seyfarth, MD^_*, Steffen Maßberg, MD^_*, Karl-Ludwig Laugwitz, MD, Josef Dirschinger, MD, Albert Schömig, MD^_*, for the ISAR-LEFT-MAIN (Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for Unprotected Coronary Left Main Lesions) Study Investigators

^_* Deutsches Herzzentrum, Technische Universität, Munich, Germany
Medizinische Klinik I, Klinikum rechts der Isar, Technische Universität, Munich, Germany

Manuscript received November 20, 2008; revised manuscript received December 16, 2008, accepted January 6, 2009.

^_* Reprint requests and correspondence: Dr. Julinda Mehilli, Deutsches Herzzentrum, Lazarettstrasse 36, 80636 München, Germany (Email: mehilli{at}dhm.mhn.de).

Objectives: The aim of this trial was to compare the safety and efficacy of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) for treatment of unprotected left main coronary artery (uLMCA) disease.

Background: Both PES and SES have reduced the risk of restenosis, particularly in high-risk patient and lesion subsets. However, their comparative performance in uLMCA lesions is not known.

Methods: In this randomized study, 607 patients with symptomatic coronary artery disease undergoing percutaneous coronary intervention for uLMCA were enrolled: 302 were assigned to receive a PES (Taxus, Boston Scientific, Natick, Massachusetts) and 305 assigned to receive a SES (Cypher, Cordis, Johnson & Johnson, New Brunswick, New Jersey). The primary end point was the combined incidence of death, myocardial infarction, and target lesion revascularization (TLR) at 1 year. The secondary end point was angiographic restenosis on the basis of the LMCA area analysis at follow-up angiography.

Results: At 1 year the cumulative incidence of death, myocardial infarction, or TLR was 13.6% in the PES and 15.8% in the SES group (relative risk [RR]: 0.85, 95% confidence interval [CI]: 0.56 to 1.29, p = 0.44). One patient in the PES group (0.3%) and 2 patients in the SES group (0.7%) experienced definite stent thrombosis (p = 0.57). Mortality at 2 years was 10.7% in the PES and 8.7% in the SES group (RR: 1.14, 95% CI: 0.66 to 1.95, p = 0.64). Angiographic restenosis was 16.0% with PES and 19.4% with SES (RR: 0.82, 95% CI: 0.57 to 1.19, p = 0.30).

Conclusions: Implantation of either PES or SES in uLMCA lesions is safe and effective; both of these drug-eluting stents provide comparable clinical and angiographic outcomes. (Drug-Eluting-Stents for Unprotected Left Main Stem Disease [ISAR-LEFT-MAIN]; NCT00133237)

Key Words: coronary artery disease • drug-eluting stents • left main coronary artery • paclitaxel • restenosis • sirolimus

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CABG = aorto-coronary artery bypass graft surgery   CI = confidence interval   CK = creatine kinase   DES = drug-eluting stent(s)   MI = myocardial infarction   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stents(s)   RR = relative risk   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization   uLMCA = unprotected left main coronary artery

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