Erne Paul, Schoenenberger Andreas W, Burckhardt Dieter, Zuber Michel, Kiowski Wolfgang, Buser Peter T, Dubach Paul, Resink Therese J, Pfisterer Matthias
Division of Cardiology, Kantonsspital Luzern, Luzern, Switzerland.
JAMA. 2007 May 9;297(18):1985-91. doi: 10.1001/jama.297.18.1985.
The effect of a percutaneous coronary intervention (PCI) on the long-term prognosis of patients with silent ischemia after a myocardial infarction (MI) is not known.
To determine whether PCI compared with drug therapy improves long-term outcome of asymptomatic patients with silent ischemia after an MI.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, unblinded, controlled trial (Swiss Interventional Study on Silent Ischemia Type II [SWISSI II]) conducted from May 2, 1991, to February 25, 1997, at 3 public hospitals in Switzerland of 201 patients with a recent MI, silent myocardial ischemia verified by stress imaging, and 1- or 2-vessel coronary artery disease. Follow-up ended on May 23, 2006.
Percutaneous coronary intervention aimed at full revascularization (n = 96) or intensive anti-ischemic drug therapy (n = 105). All patients received 100 mg/d of aspirin and a statin.
Survival free of major adverse cardiac events defined as cardiac death, nonfatal MI, and/or symptom-driven revascularization. Secondary measures included exercise-induced ischemia and resting left ventricular ejection fraction during follow-up.
During a mean (SD) follow-up of 10.2 (2.6) years, 27 major adverse cardiac events occurred in the PCI group and 67 events occurred in the anti-ischemic drug therapy group (adjusted hazard ratio, 0.33; 95% confidence interval, 0.20-0.55; P<.001), which corresponds to an absolute event reduction of 6.3% per year (95% confidence interval, 3.7%-8.9%; P<.001). Patients in the PCI group had lower rates of ischemia (11.6% vs 28.9% in patients in the drug therapy group at final follow-up; P = .03) despite fewer drugs. Left ventricular ejection fraction remained preserved in PCI patients (mean [SD] of 53.9% [9.9%] at baseline to 55.6% [8.1%] at final follow-up) and decreased significantly (P<.001) in drug therapy patients (mean [SD] of 59.7% [11.8%] at baseline to 48.8% [7.9%] at final follow-up).
Among patients with recent MI, silent myocardial ischemia verified by stress imaging, and 1- or 2-vessel coronary artery disease, PCI compared with anti-ischemic drug therapy reduced the long-term risk of major cardiac events.
clinicaltrials.gov Identifier: NCT00387231.
经皮冠状动脉介入治疗（PCI）对心肌梗死（MI）后无症状性心肌缺血患者长期预后的影响尚不清楚。
确定PCI与药物治疗相比是否能改善MI后无症状性心肌缺血患者的长期预后。
设计、地点和参与者：1991年5月2日至1997年2月25日在瑞士3家公立医院进行的随机、非盲、对照试验（瑞士无症状性心肌缺血II型介入研究[SWISSI II]），纳入201例近期发生MI、经负荷成像证实存在无症状性心肌缺血且有单支或双支冠状动脉疾病的患者。随访于2006年5月23日结束。
旨在实现完全血运重建的经皮冠状动脉介入治疗（n = 96）或强化抗缺血药物治疗（n = 105）。所有患者均接受每日100 mg阿司匹林和他汀类药物治疗。
无主要不良心脏事件生存，主要不良心脏事件定义为心源性死亡、非致死性MI和/或症状驱动的血运重建。次要指标包括随访期间运动诱发的缺血和静息左心室射血分数。
在平均（标准差）10.2（2.6）年的随访中，PCI组发生27例主要不良心脏事件，抗缺血药物治疗组发生67例事件（调整后风险比为0.33；95%置信区间为0.20 - 0.55；P <.001），相当于每年绝对事件减少6.3%（95%置信区间为3.7% - 8.9%；P <.001）。PCI组患者的缺血发生率较低（末次随访时为11.6%，而药物治疗组患者为28.9%；P = 0.03），尽管用药较少。PCI患者的左心室射血分数保持稳定（基线时平均[标准差]为53.9%[9.9%]，末次随访时为55.6%[（8.1%]），而药物治疗患者的左心室射血分数显著下降（P <.001）（基线时平均[标准差]为59.7%[11.8%]，末次随访时为48.8%[7.9%]）。
在近期发生MI、经负荷成像证实存在无症状性心肌缺血且有单支或双支冠状动脉疾病的患者中，与抗缺血药物治疗相比，PCI降低了主要心脏事件的长期风险。
clinicaltrials.gov标识符：NCT00387231。
