Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for Unprotected Coronary Left Main Lesions 2 - ISAR-LEFT MAIN 2
Data from recent trials on left main percutaneous coronary intervention (PCI) have demonstrated promising results. The current trial sought to compare outcomes following left main PCI with two newer-generation drug eluting stents (DES): everolimus-eluting stent (EES) (Xience) versus zotarolimus-eluting stent ZES (Endeavor Resolute).
Left main PCI with ZES would be noninferior to that with EES.
- Unprotected left main PCI
Number of enrollees: 650
Duration of follow-up: 1 year
Mean patient age: 70 years
Percentage female: 25%
Ejection fraction: 53%
- MACE (death, MI, TLR) at 1 year
- Angiographic restenosis on quantitative coronary angiography analysis of angiogram at 6-9 months
- Academic Resource Center (ARC) defined stent thrombosis at 1 year
Patients undergoing unprotected left main PCI were randomized in a 1:1 fashion to PCI with either EES (Xience) or ZES (Endeavor Resolute).
A total of 650 patients were randomized, 324 to ZES and 326 to EES. Baseline characteristics were fairly similar between the two arms. About 29% had diabetes, 36% presented with acute coronary syndrome, and 53% had undergone prior PCI. The mean EuroSCORE was 5.1. Approximately 71% also had right coronary artery stenosis ≥50% (10% had chronic total occlusions). About four-fifths of these lesions were in the distal left main trunk (LMT); 8% were ostial. A single stent strategy was adopted in 64%, Culotte in 28%, and T-stenting in 7%.
The primary endpoint of major adverse cardiac events (MACE) at 1 year met criteria for noninferiority of ZES compared with EES (17.5% vs. 14.3%, relative risk 1.26, 95% confidence interval 0.85-1.85; p for noninferiority = 0.02; p for superiority = 0.25). Other endpoints including death/myocardial infarction (MI) (7.5% vs. 5.9%, p = 0.42), all-cause mortality (5.6% vs. 5.6%, p = 0.98), and definite/probable stent thrombosis (0.9% vs. 0.6%, p > 0.05) were similar between the two arms. Similarly, angiographic restenosis (21.5% vs. 16.8%, p = 0.20) and clinical restenosis/target lesion revascularization (TLR) (11.7% vs. 9.4%, p = 0.35) were similar between the two arms.
The results of the ISAR-LEFT MAIN 2 trial indicate that ZES (Endeavor Resolute) is noninferior to EES (Xience) for unprotected left main PCI at 1 year. Further long-term data and outcomes based on SYNTAX score are awaited. This trial also suggests that DES PCI with either ZES or EES may be a reasonable alternative to coronary artery bypass grafting (CABG) in patients with LMT disease; overall event rates are fairly similar to those noted in the left main subgroup of the SYNTAX trial.
Presented by Dr. Julinda Mehilli at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2012), Miami, FL, October 24, 2012.
Keywords: Risk, Myocardial Infarction, Follow-Up Studies, Coronary Restenosis, Thrombosis, Drug-Eluting Stents, Immunosuppressive Agents, Confidence Intervals, Sirolimus, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Diabetes Mellitus
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