对无保护左主干狭窄采用西罗莫司洗脱支架经皮冠脉介入术和冠脉旁路移植术的随机比较

OBJECTIVES: The purpose of this randomized study was to compare sirolimus-eluting stenting with coronary artery bypass grafting (CABG) for patients with unprotected left main (ULM) coronary artery disease.

BACKGROUND: CABG is considered the standard of care for treatment of ULM. Improvements in percutaneous coronary intervention (PCI) with use of drug-eluting stents might lead to similar results. The effectiveness of drug-eluting stenting versus surgery has not been established in a randomized trial.

METHODS: In this prospective, multicenter, randomized trial, 201 patients with ULM disease were randomly assigned to undergo sirolimus-eluting stenting (n = 100) or CABG using predominantly arterial grafts (n = 101). The primary clinical end point was noninferiority in freedom from major adverse cardiac events, such as cardiac death, myocardial infarction, and the need for target vessel revascularization within 12 months.

RESULTS: The combined primary end point was reached in 13.9% of patients after surgery, as opposed to 19.0% after PCI (p = 0.19 for noninferiority). The combined rates for death and myocardial infarction were comparable (surgery, 7.9% vs. stenting, 5.0%; noninferiority p < 0.001), but stenting was inferior to surgery for repeat revascularization (5.9% vs. 14.0%; noninferiority p = 0.35). Perioperative complications including 2 strokes were higher after surgery (4% vs. 30%; p < 0.001). Freedom from angina was similar between groups (p = 0.33).

CONCLUSIONS: In patients with ULM stenosis, PCI with sirolimus-eluting stents did not show noninferiority [corrected] to CABG at 12-month follow-up with respect to freedom from major adverse cardiac events, which is mainly influenced by repeated revascularization, whereas for hard endpoints,corrected] PCI results are favorable. A longer follow-up is warranted. [corrected]