十年随访的医学、血管成形术或手术研究（MASS II）：多血管冠状动脉疾病 3 种治疗策略的随机对照临床试验。
Ten-year follow-up survival of the Medicine, Angioplasty, or Surgery Study (MASS II): a randomized controlled clinical trial of 3 therapeutic strategies for multivessel coronary artery disease.
机构信息
Heart Institute of the University of São Paulo, São Paulo, Brazil.
出版信息
Circulation. 2010 Sep 7;122(10):949-57. doi: 10.1161/CIRCULATIONAHA.109.911669. Epub 2010 Aug 23.
BACKGROUND
This study compared the 10-year follow-up of percutaneous coronary intervention (PCI), coronary artery surgery (CABG), and medical treatment (MT) in patients with multivessel coronary artery disease, stable angina, and preserved ventricular function.
METHODS AND RESULTS
The primary end points were overall mortality, Q-wave myocardial infarction, or refractory angina that required revascularization. All data were analyzed according to the intention-to-treat principle. At a single institution, 611 patients were randomly assigned to CABG (n=203), PCI (n=205), or MT (n=203). The 10-year survival rates were 74.9% with CABG, 75.1% with PCI, and 69% with MT (P=0.089). The 10-year rates of myocardial infarction were 10.3% with CABG, 13.3% with PCI, and 20.7% with MT (P<0.010). The 10-year rates of additional revascularizations were 7.4% with CABG, 41.9% with PCI, and 39.4% with MT (P<0.001). Relative to the composite end point, Cox regression analysis showed a higher incidence of primary events in MT than in CABG (hazard ratio 2.35, 95% confidence interval 1.78 to 3.11) and in PCI than in CABG (hazard ratio 1.85, 95% confidence interval 1.39 to 2.47). Furthermore, 10-year rates of freedom from angina were 64% with CABG, 59% with PCI, and 43% with MT (P<0.001).
CONCLUSIONS
Compared with CABG, MT was associated with a significantly higher incidence of subsequent myocardial infarction, a higher rate of additional revascularization, a higher incidence of cardiac death, and consequently a 2.29-fold increased risk of combined events. PCI was associated with an increased need for further revascularization, a higher incidence of myocardial infarction, and a 1.46-fold increased risk of combined events compared with CABG. Additionally, CABG was better than MT at eliminating anginal symptoms. Clinical Trial Registration Information- URL: http://www.controlled-trials.com.
REGISTRATION NUMBER
ISRCTN66068876.
背景
本研究比较了经皮冠状动脉介入治疗（PCI）、冠状动脉旁路移植术（CABG）和药物治疗（MT）在多支冠状动脉疾病、稳定型心绞痛和保留心室功能的患者中的 10 年随访结果。
方法和结果
主要终点为全因死亡率、Q 波心肌梗死或需要血运重建的难治性心绞痛。所有数据均根据意向治疗原则进行分析。在一家单中心机构中，611 例患者被随机分为 CABG（n=203）、PCI（n=205）或 MT（n=203）组。CABG、PCI 和 MT 组的 10 年生存率分别为 74.9%、75.1%和 69%（P=0.089）。CABG、PCI 和 MT 组的 10 年心肌梗死发生率分别为 10.3%、13.3%和 20.7%（P<0.010）。CABG、PCI 和 MT 组的 10 年额外血运重建率分别为 7.4%、41.9%和 39.4%（P<0.001）。与复合终点相比，Cox 回归分析显示 MT 组发生主要事件的风险高于 CABG 组（风险比 2.35，95%置信区间 1.78 至 3.11）和 PCI 组高于 CABG 组（风险比 1.85，95%置信区间 1.39 至 2.47）。此外，CABG、PCI 和 MT 组的 10 年无心绞痛生存率分别为 64%、59%和 43%（P<0.001）。
结论
与 CABG 相比，MT 组随后发生心肌梗死、需要进一步血运重建、心脏死亡的风险显著更高，因此联合事件的风险增加 2.29 倍。与 CABG 相比，PCI 组需要进一步血运重建、发生心肌梗死的风险更高，联合事件的风险增加 1.46 倍。此外，CABG 组在消除心绞痛症状方面优于 MT 组。
临床试验注册信息-网址：http://www.controlled-trials.com。
注册号
ISRCTN66068876。
Zotero 插件