PCI with sirolimus-eluting stents did not significantly differ from CABG in the 10-year incidence of major adverse cardiac or cerebrovascular events (29.8% vs 24.7%; HR 1.25; 95% CI 0.93-1.69).
RCT (n=600)
Yes
Does PCI with sirolimus-eluting stents compared to CABG reduce major adverse cardiac or cerebrovascular events in patients with unprotected left main coronary artery disease?
At 10-year follow-up, PCI with sirolimus-eluting stents did not demonstrate a significant difference in major adverse cardiac or cerebrovascular events compared to CABG for unprotected left main coronary artery disease, though it was associated with higher rates of repeat revascularization.
Hazard Ratio: 1.25 (95% CI 0.93–1.69)
Absolute Event Rate: 29.8% vs 24.7%
BACKGROUND: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents and coronary-artery bypass grafting (CABG) for left main coronary artery disease are highly debated. METHODS: In the PRECOMBAT trial (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease), patients with unprotected left main coronary artery disease were randomly assigned to undergo PCI with sirolimus-eluting stents (n=300) or CABG (n=300) in 13 hospitals in Korea from April 2004 to August 2009. The follow-up was extended to at least 10 years for all patients (median, 11.3 years). The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization). RESULTS: At 10 years, a primary outcome event occurred in 29.8% of the PCI group and in 24.7% of the CABG group (hazard ratio HR with PCI vs CABG, 1.25 95% CI, 0.93-1.69). The 10-year incidence of the composite of death, myocardial infarction, or stroke (18.2% vs 17.5%; HR 1.00 95% CI, 0.70-1.44) and all-cause mortality (14.5% vs 13.8%; HR 1.13 95% CI, 0.75-1.70) were not significantly different between the PCI and CABG groups. Ischemia-driven target-vessel revascularization was more frequent after PCI than after CABG (16.1% vs 8.0%; HR 1.98 [95% CI, 1.21-3.21). CONCLUSIONS: Ten-year follow-up of the PRECOMBAT trial of patients with left main coronary artery disease randomized to PCI or CABG did not demonstrate significant difference in the incidence of major adverse cardiac or cerebrovascular events. Because the study was underpowered, the results should be considered hypothesis-generating, highlighting the need for further research. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03871127 and NCT00422968.
Park et al. (2020) conducted an RCT in Left main coronary artery disease (n=600). PCI with sirolimus-eluting stents vs. CABG was evaluated on Major adverse cardiac or cerebrovascular events (composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) (HR 1.25, 95% CI 0.93-1.69). PCI with sirolimus-eluting stents did not significantly differ from CABG in the 10-year incidence of major adverse cardiac or cerebrovascular events (29.8% vs 24.7%; HR 1.25; 95% CI 0.93-1.69).
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