Ocala Heart Institute, Munroe Regional Medical Center, 1221 SE 5th St, Ocala, FL 34471, USA.
Circulation. 2013 Jun 4;127(22):2177-85. doi: 10.1161/CIRCULATIONAHA.112.000646. Epub 2013 May 14.
Several randomized clinical trials support the use of coronary artery bypass grafting (CABG) for patients with unprotected left main coronary artery disease. Studies suggesting the equivalence of percutaneous coronary intervention (PCI) with CABG for this indication indirectly support the 2011 American College of Cardiology Foundation/American Heart Association Class IIa recommendation for PCI to improve survival in patients with unprotected left main coronary artery disease. We tested whether bayesian approaches uphold the new recommendation.
We performed a bayesian cross-design and network meta-analysis of 12 studies (4 randomized clinical trials and 8 observational studies) comparing CABG with PCI (n=4574 patients) and of 7 studies (2 randomized clinical trials and 5 observational studies) comparing CABG with medical therapy (n=3224 patients). The odds ratios of 1-year mortality after PCI compared with CABG using bayesian cross-design meta-analysis were not different among randomized clinical trials (odds ratio, 0.99; 95% bayesian credible interval, 0.67-1.43), matched cohort studies (odds ratio, 1.10; 95% bayesian credible interval, 0.76-1.73), and other types of cohort studies (odds ratio, 0.93; 95% bayesian credible interval, 0.58-1.35). A network meta-analysis suggested that medical therapy is associated with higher 1-year mortality than the use of PCI for patients with unprotected left main coronary artery disease (odds ratio, 3.22; 95% bayesian credible interval, 1.96-5.30).
Bayesian methods support the current guidelines, which were based on traditional statistical methods and have proposed that PCI, like CABG, improves survival for patients with unprotected left main coronary artery disease compared with medical therapy. An integrated approach using both direct and indirect evidence may yield new insights to enhance the translation of clinical trial data into practice.
多项随机临床试验支持对无保护左主干冠状动脉疾病患者行冠状动脉旁路移植术（CABG）。一些研究提示经皮冠状动脉介入治疗（PCI）与 CABG 治疗该适应证的等效性，这间接支持 2011 年美国心脏病学会基金会/美国心脏协会 IIa 类推荐，即 PCI 可改善无保护左主干冠状动脉疾病患者的生存。我们检验了贝叶斯方法是否支持这一新推荐。
我们对 12 项研究（4 项随机临床试验和 8 项观察性研究）进行了贝叶斯交叉设计和网络荟萃分析，比较了 CABG 与 PCI（n=4574 例患者），以及对 7 项研究（2 项随机临床试验和 5 项观察性研究）进行了贝叶斯交叉设计和网络荟萃分析，比较了 CABG 与药物治疗（n=3224 例患者）。采用贝叶斯交叉设计荟萃分析，PCI 与 CABG 相比 1 年死亡率的比值比在随机临床试验（比值比，0.99；95%贝叶斯可信区间，0.67-1.43）、匹配队列研究（比值比，1.10；95%贝叶斯可信区间，0.76-1.73）和其他类型的队列研究（比值比，0.93；95%贝叶斯可信区间，0.58-1.35）中均无差异。网络荟萃分析提示，与 PCI 相比，药物治疗与无保护左主干冠状动脉疾病患者 1 年死亡率较高相关（比值比，3.22；95%贝叶斯可信区间，1.96-5.30）。
贝叶斯方法支持当前的指南，这些指南基于传统的统计学方法，并提出与药物治疗相比，PCI 可改善无保护左主干冠状动脉疾病患者的生存。采用直接证据和间接证据相结合的综合方法可能会产生新的见解，以增强临床试验数据向实践的转化。
