Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for Unprotected Coronary Left Main Lesions 2 - ISAR-LEFT MAIN 2

Oct 24, 2012
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Presented:
01/01/2012
Date Updated:
10/24/2012
Original Posted Date:
10/24/2012
References

Description:

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).

Hypothesis:

Left main PCI with ZES would be noninferior to that with EES.

Study Design

  • Randomized
  • Blinded
  • Parallel

Patient Populations:

  • 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%

Primary Endpoints:

  • MACE (death, MI, TLR) at 1 year

Secondary Endpoints:

  • Angiographic restenosis on quantitative coronary angiography analysis of angiogram at 6-9 months
  • Academic Resource Center (ARC) defined stent thrombosis at 1 year

Drug/Procedures Used:

Patients undergoing unprotected left main PCI were randomized in a 1:1 fashion to PCI with either EES (Xience) or ZES (Endeavor Resolute).

Principal Findings:

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.

Interpretation:

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.

References:

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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