Author + information
- Received November 20, 2008
- Revision received December 16, 2008
- Accepted January 6, 2009
- Published online May 12, 2009.
- 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*,†,
- ISAR-LEFT-MAIN (Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for Unprotected Coronary Left Main Lesions) Study Investigators
- ↵*Reprint requests and correspondence:
Dr. Julinda Mehilli, Deutsches Herzzentrum, Lazarettstrasse 36, 80636 München, Germany
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)
The ISAR-LEFT-MAIN study was supported in part by an unrestricted grant from Cordis. Dr. Mehilli has received lecture fees from Lilly Germany and Daiichi Sankyo. Dr. Kastrati has received lecture fees from Bristol-Myers Squibb, Cordis, GlaxoSmithKline, Lilly Germany, Medtronic, Novartis, and Sanofi-Aventis. Dr. Seyfarth has received lecture fees from Bristol-Myers Squibb, Lilly Germany, and Sanofi-Aventis. Dr. Byrne acknowledges receipt of a research fellowship in atherothrombosis from the European Society of Cardiology.
- Received November 20, 2008.
- Revision received December 16, 2008.
- Accepted January 6, 2009.
- American College of Cardiology Foundation