药物洗脱支架与冠状动脉旁路移植术治疗左主干病变的 10 年结果：PRECOMBAT 试验的扩展随访。
Ten-Year Outcomes After Drug-Eluting Stents Versus Coronary Artery Bypass Grafting for Left Main Coronary Disease: Extended Follow-Up of the PRECOMBAT Trial.
机构信息
Department of Cardiology (D.-W.P., J.-M.A., H.P, D.-Y.K., P.H.L., Y.-H.K., S.-J.P.), Asan Medical Center, Seoul, Korea.
Division of Biostatistics (S.-C.Y.), Asan Medical Center, Seoul, Korea.
出版信息
Circulation. 2020 May 5;141(18):1437-1446. doi: 10.1161/CIRCULATIONAHA.120.046039. Epub 2020 Mar 30.
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.
背景
经皮冠状动脉介入治疗（PCI）与冠状动脉旁路移植术（CABG）治疗左主干冠状动脉疾病的长期对比结果仍存在争议。
方法
在 PRECOMBAT 试验（韩国 13 家医院进行的无保护左主干冠状动脉疾病患者随机接受西罗莫司洗脱支架 PCI 与 CABG 治疗的首要比较试验）中，2004 年 4 月至 2009 年 8 月期间，将 300 例未经保护的左主干冠状动脉疾病患者随机分为接受西罗莫司洗脱支架 PCI 组（n=300）或 CABG 组（n=300）。所有患者的随访时间均延长至至少 10 年（中位随访时间 11.3 年）。主要终点为主要不良心脏或脑血管事件（任何原因导致的死亡、心肌梗死、卒中和缺血驱动的靶血管血运重建的复合终点）发生率。
结果
10 年时，PCI 组中有 29.8%的患者发生主要终点事件，CABG 组中有 24.7%的患者发生主要终点事件（PCI 组与 CABG 组的 HR 为 1.25[95%CI，0.93-1.69]）。10 年时，死亡、心肌梗死或卒中和任何原因死亡（18.2% vs 17.5%；HR 1.00[95%CI，0.70-1.44]）和全因死亡率（14.5% vs 13.8%；HR 1.13[95%CI，0.75-1.70]）的 10 年发生率在 PCI 组和 CABG 组之间无显著差异。PCI 后缺血驱动的靶血管血运重建的发生率高于 CABG 后（16.1% vs 8.0%；HR 1.98[95%CI，1.21-3.21]）。
结论
左主干冠状动脉疾病患者接受 PCI 或 CABG 的 PRECOMBAT 试验 10 年随访结果未显示主要不良心脏或脑血管事件发生率存在显著差异。由于该研究的效能不足，结果应被视为假设产生，这突出表明需要进一步研究。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT03871127 和 NCT00422968。
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