Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Circ Cardiovasc Interv. 2012 Aug 1;5(4):476-90. doi: 10.1161/CIRCINTERVENTIONS.112.970954. Epub 2012 Aug 7.
The role of percutaneous coronary intervention (PCI) in the management of stable coronary artery disease remains controversial. Given advancements in medical therapies and stent technology over the last decade, we sought to evaluate whether PCI, when added to medical therapy, improves outcomes when compared with medical therapy alone.
We performed a systematic review and meta-analysis, searching PubMed, EMBASE, and CENTRAL databases, until January 2012, for randomized clinical trials comparing revascularization with PCI to optimal medical therapy (OMT) in patients with stable coronary artery disease. The primary outcome was all-cause mortality, and secondary outcomes included cardiovascular death, nonfatal myocardial infarction, subsequent revascularization, and freedom from angina. Primary analyses were based on longest available follow-up with secondary analyses stratified by trial duration, with short-term (≤1 year), intermediate (1-5 years), and long-term (≥5 years) time points. We identified 12 randomized clinical trials enrolling 7182 participants who fulfilled our inclusion criteria. For the primary analyses, when compared with OMT, PCI was associated with no significant improvement in mortality (risk ratio [RR], 0.85; 95% CI, 0.71-1.01), cardiac death (RR, 0.71; 95% CI, 0.47-1.06), nonfatal myocardial infarction (RR, 0.93; 95% CI, 0.70-1.24), or repeat revascularization (RR, 0.93; 95% CI, 0.76-1.14), with consistent results over all follow-up time points. Sensitivity analysis restricted to studies in which there was >50% stent use showed attenuation in the effect size for all-cause mortality (RR, 0.93; 95% CI, 0.78-1.11) with PCI. However, for freedom from angina, there was a significant improved outcome with PCI, as compared with the OMT group (RR, 1.20; 95% CI, 1.06-1.37), evident at all of the follow-up time points.
In this most rigorous and comprehensive analysis in patients with stable coronary artery disease, PCI, as compared with OMT, did not reduce the risk of mortality, cardiovascular death, nonfatal myocardial infarction, or revascularization. PCI, however, provided a greater angina relief compared with OMT alone, larger studies with sufficient power are required to prove this conclusively.
经皮冠状动脉介入治疗(PCI)在稳定型冠状动脉疾病治疗中的作用仍存在争议。鉴于过去十年间医学治疗和支架技术的进步,我们研究评估了在稳定型冠状动脉疾病患者中,PCI 联合药物治疗与单纯药物治疗相比是否能改善预后。
我们进行了系统的文献检索,检索了 PubMed、EMBASE 和 CENTRAL 数据库,截至 2012 年 1 月,纳入比较经皮冠状动脉介入治疗与最佳药物治疗(OMT)在稳定型冠状动脉疾病患者中的随机临床试验。主要终点为全因死亡率,次要终点包括心血管死亡、非致死性心肌梗死、再次血运重建和心绞痛缓解。主要分析基于最长随访时间,次要分析根据试验持续时间分层,分为短期(≤1 年)、中期(1-5 年)和长期(≥5 年)。共纳入 12 项随机临床试验,共 7182 名符合纳入标准的患者。主要分析结果显示,与 OMT 相比,PCI 并未显著降低死亡率(风险比[RR],0.85;95%置信区间,0.71-1.01)、心脏性死亡(RR,0.71;95%置信区间,0.47-1.06)、非致死性心肌梗死(RR,0.93;95%置信区间,0.70-1.24)或再次血运重建(RR,0.93;95%置信区间,0.76-1.14),各随访时间点结果一致。敏感性分析限制在支架使用率>50%的研究中,全因死亡率的效应值(RR,0.93;95%置信区间,0.78-1.11)降低。然而,PCI 组在缓解心绞痛方面明显优于 OMT 组(RR,1.20;95%置信区间,1.06-1.37),各随访时间点均有显著差异。
在这项纳入稳定型冠状动脉疾病患者的最严格、最全面的分析中,与 OMT 相比,PCI 并未降低死亡率、心血管死亡、非致死性心肌梗死或血运重建风险。然而,与单纯 OMT 相比,PCI 能更有效地缓解心绞痛,需要进一步进行具有足够效力的大型研究来证实这一结论。