Outcomes at 5 Years Reinforce Durability of Stenting for Unprotected Left Main Disease
SAN DIEGO, CA—Long-term data on patients with unprotected left main coronary artery stenosis show similar safety and efficacy outcomes with DES implantation compared with surgery. The study was presented March 15, 2015, at the American College of Cardiology/i2 Scientific Session and published simultaneously in the Journal of the American College of Cardiology.
In the PRECOMBAT trial, 600 patients with unprotected left main coronary artery stenosis were randomized to PCI with the sirolimus-eluting Cypher stent (Cordis; n = 300) or CABG (n = 300) between April 2004 and August 2009. The main analysis, published in 2011, demonstrated noninferiority of PCI to CABG with respect to major adverse cardiac or cerebrovascular events (MACCE) at 1 year.
Mean age of patients was 61.8 years in the PCI group, and 62.7 years in the CABG group (76% and 77% male, respectively), and the mean Syntax scores were 24.4 ± 9.4 and 25.8 ± 10.5, respectively. The use of antiplatelet drugs was significantly higher in PCI patients vs the CABG group throughout the study.
Presenting the 5-year results, Jung-Min Ahn, MD, of Asan Medical Center (Seoul, South Korea), said the new data confirm and extend the prior findings by showing long-term equivalence of the 2 strategies with no difference in MACCE (a composite of death, MI, stroke, and ischemia-driven TVR) or other outcomes. Only the individual endpoint of ischemia-driven TVR occurred more frequently with PCI than CABG (table 1).
According to the study authors, the increased risk of ischemia-driven TVR in the PCI group emerged by the 1-year mark.
Definite or probable stent thrombosis occurred in 2 patients with a 5-year cumulative incidence of 0.3%.
In an interaction analysis, the MACCE results were consistent across multiple subgroups except for those defined according to angiographic left main coronary artery stenosis (> 70% vs 50% to 70%). Additionally, across the 3 subgroups defined by Syntax score tertile, rates of MACCE and the composite of death from any cause, MI, or stroke were not different between the PCI and CABG groups. However, the rate of ischemia-driven TVR was significantly higher in the PCI group than with CABG in those with the highest Syntax scores (P = .024).
A “Feasible” Revascularization Strategy
According to Dr. Ahn and colleagues, the 5-year data support current guideline recommendations that stenting in left main disease is “a feasible revascularization strategy for patients with suitable coronary anatomy.”
They caution, however, that PRECOMBAT was not adequately powered for hard endpoints, such as death, MI, and stroke.
Session co-chair John D. Carroll, MD, of the University of Colorado Denver (Denver, CO), congratulated the researchers on a “well done and unique” study and asked if follow up would continue beyond 5 years.
Dr. Ahn said follow up out to 10 years is likely. Additionally, he responded that more recent patients treated with newer-generation DES could possibly have even better outcomes than those in the PCI arm of PRECOMBAT.
Source:Ahn J-M, MD, Roh J-H, Kim Y-H, et al. Randomized trial of stents versus bypass surgery for left main coronary artery disease: five-year outcomes of the PRECOMBAT study. J Am Coll Cardiol. 2015;Epub ahead of print.
- Dr. Park reports no relevant conflicts of interest.
- Dr. Carroll reports receiving consulting fees/honoraria from Philips Healthcare and research grants from Evalve/Abbott Structural Heart Disease, Philips Healthcare, and St Jude Medical.
- Readmissions Higher with PCI vs CABG for Left Main Disease
- PRECOMBAT: PCI with Sirolimus Stent Equivalent to CABG in Left Main Disease