NEJM:PCI +更佳药物疗法与单纯更佳药物疗法治疗稳定型冠状动脉疾病的比较

2012-12-04 张永燊 译 NEJM

  背景  稳定型冠脉疾病患者的首选初始治疗是最佳药物治疗。我们假设在根据血流储备分数(FFR)测量确定的冠状动脉功能上明显狭窄的患者中,经皮冠脉介入术(PCI)加最佳药物治疗优于单纯最佳药物治疗。   方法  在考虑进行PCI 的稳定型冠脉疾病患者中,我们通过测量FFR评估了所有狭窄。至少有一处功能上明显狭窄(FFR≤0.80)的患者被随机分为两组,第一组接受FFR指导的P

  背景  稳定型冠脉疾病患者的首选初始治疗是最佳药物治疗。我们假设在根据血流储备分数(FFR)测量确定的冠状动脉功能上明显狭窄的患者中,经皮冠脉介入术(PCI)加最佳药物治疗优于单纯最佳药物治疗。

  方法  在考虑进行PCI 的稳定型冠脉疾病患者中,我们通过测量FFR评估了所有狭窄。至少有一处功能上明显狭窄(FFR≤0.80)的患者被随机分为两组,第一组接受FFR指导的PCI加最佳药物治疗(PCI组),第二组接受单纯最佳药物治疗(药物治疗组)。所有狭窄FFR>0.80 的患者均被纳入一项登记研究并接受最佳药物治疗。主要终点是死亡、心肌梗死或紧急血运重建的复合。

  结果  在纳入1220例患者(888例接受随机分组,332 例被纳入登记研究)后,招募提前终止,因为有主要终点事件的患者百分率有显著组间差异:PCI组为4.3%,药物治疗组为12.7%[PCI风险比为0.32,95%可信区间(CI)0.19~0.53,P<0.001]。差异由PCI 组的紧急血运重建率低于药物治疗组所造成(1.6%对11.1% ,风险比为0.13,95% CI 0.06~0.30,P<0.001)。特别地,在PCI组,心肌梗死或心电图检查的缺血证据引起的紧急血运重建更少(风险比为0.13,95%CI 0.04~0.43,P<0.001)。在登记研究的患者中,3.0%有主要终点事件。

  结论  在冠状动脉功能上明显狭窄的稳定型冠脉疾病患者中,与单纯最佳药物治疗相比,FFR指导的PCI加最佳药物治疗减少了紧急血运重建的需要。在没有缺血的患者中,转归似乎支持单纯最佳药物治疗。


Fractional Flow Reserve–Guided PCI versus Medical Therapy in Stable Coronary Disease

BACKGROUND

The preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone.

METHODS

In patients with stable coronary artery disease for whom PCI was being considered, we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group) or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.

RESULTS

Recruitment was halted prematurely after enrollment of 1220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary end-point event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P<0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30; P<0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P<0.001). Among patients in the registry, 3.0% had a primary end-point event.

CONCLUSIONS

In patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to be favorable with the best available medical therapy alone. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT01132495.)


    

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