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药物、血管成形术或手术研究(MASS-II):一项针对多支冠状动脉疾病三种治疗策略的随机对照临床试验:一年结果

The medicine, angioplasty, or surgery study (MASS-II): a randomized, controlled clinical trial of three therapeutic strategies for multivessel coronary artery disease: one-year results.

作者信息

Hueb Whady, Soares Paulo R, Gersh Bernard J, César Luiz A M, Luz Protásio L, Puig Luiz B, Martinez Eulógio M, Oliveira Sergio A, Ramires José A F

机构信息

Heart Institute of the University of São Paulo, São Paulo, Brazil.

出版信息

J Am Coll Cardiol. 2004 May 19;43(10):1743-51. doi: 10.1016/j.jacc.2003.08.065.

Abstract

OBJECTIVES

We sought to evaluate the relative efficacies of three possible therapeutic strategies for patients with multivessel coronary artery disease (CAD), stable angina, and preserved ventricular function.

BACKGROUND

Despite routine use of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI), there is no conclusive evidence that either one is superior to medical therapy (MT) alone for the treatment of multivessel CAD.

METHODS

The primary end point was defined as cardiac mortality, Q-wave myocardial infarction (MI), or refractory angina requiring revascularization. All data were analyzed according to the intention-to-treat principle.

RESULTS

A total of 611 patients were randomly assigned to either a CABG (n = 203), PCI (n = 205), or MT (n = 203) group. The one-year survival rates were 96.0% for CABG, 95.6% for PCI, and 98.5% for MT. The rates for one-year survival free of Q-wave MI were 98% for CABG, 92% for PCI, and 97% for MT. After one-year follow-up, 8.3% of MT patients and 13.3% of PCI patients underwent to additional interventions, compared with only 0.5% of CABG patients. At one-year follow-up, 88% of the patients in the CABG group, 79% in the PCI group, and 46% in the MT group were free of angina (p < 0.0001).

CONCLUSIONS

Medical therapy for multivessel CAD was associated with a lower incidence of short-term events and a reduced need for additional revascularization, compared with PCI. In addition, CABG was superior to MT for eliminating anginal symptoms. All three therapeutic regimens yielded relatively low rates of cardiac-related deaths.

摘要

目的

我们试图评估三种可能的治疗策略对多支冠状动脉疾病(CAD)、稳定型心绞痛且心室功能保留患者的相对疗效。

背景

尽管冠状动脉旁路移植术(CABG)和经皮冠状动脉介入治疗(PCI)已常规使用,但尚无确凿证据表明二者在治疗多支CAD方面优于单纯药物治疗(MT)。

方法

主要终点定义为心脏死亡、Q波心肌梗死(MI)或需要血运重建的难治性心绞痛。所有数据均根据意向性治疗原则进行分析。

结果

总共611例患者被随机分配至CABG组(n = 203)、PCI组(n = 205)或MT组(n = 203)。CABG组的一年生存率为96.0%,PCI组为95.6%,MT组为98.5%。CABG组、PCI组和MT组无Q波MI的一年生存率分别为98%、92%和97%。一年随访后,MT组8.3%的患者和PCI组13.3%的患者接受了额外干预,而CABG组仅0.5%的患者接受了额外干预。在一年随访时,CABG组88%的患者、PCI组79%的患者和MT组46%的患者无心绞痛(p < 0.0001)。

结论

与PCI相比,多支CAD的药物治疗与较低的短期事件发生率和减少的额外血运重建需求相关。此外,CABG在消除心绞痛症状方面优于MT。所有三种治疗方案的心脏相关死亡率相对较低。

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