Department of Epidemiology, Baylor Scott & White Health, Dallas, Tex; Robbins Institute for Health Policy and Research, Baylor University, Waco, Tex; Department of Statistics, Southern Methodist University, Dallas, Tex.
Department of Cardiothoracic Surgery, Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, Tex.
J Thorac Cardiovasc Surg. 2018 Jan;155(1):172-179.e5. doi: 10.1016/j.jtcvs.2017.08.026. Epub 2017 Sep 1.
Despite many studies comparing on- versus off-pump coronary artery bypass graft (CABG), there is no consensus as to whether one of these techniques offers patients better outcomes.
We searched PubMed from inception to June 30, 2015, and identified additional studies from bibliographies of meta-analyses and reviews. We identified 42 randomized controlled trials (RCTs) and 31 rigorously adjusted observational studies (controlling for the Society of Thoracic Surgeons-recognized risk factors for mortality) reporting mortality for off-pump versus on-pump CABG at specified time points. Trial data were extracted independently by 2 researchers using a standardized form. Differences in probability of mortality (DPM) were estimated for the RCTs and observational studies separately and combined, for time points ranging from 30 days to 10 years.
RCT-only data showed no significant differences at any time point, whereas observational-only data and the combined analysis showed short-term mortality favored off-pump CABG (n = 1.2 million patients; 36 RCTs, 26 observational studies; DPM [95% confidence interval (CI)], -44.8% [-45.4%, -43.8%]) but that at 5 years it was associated with significantly greater mortality (n = 60,405 patients; 3 RCTs, 5 observational studies; DPM [95% CI], 10.0% [5.0%, 15.0%]). At 10 years, only observational data were available, and off-pump CABG showed significantly greater mortality (DPM [95% CI], 14.0% [11.0%, 17.0%]).
Evidence from RCTs showed no differences between the techniques, whereas rigorously adjusted observational studies (with >1.1 million patients) and the combined analysis indicated that off-pump CABG offers lower short-term mortality but poorer long-term survival. These results suggest that, in real-world settings, greater operative safety with off-pump CABG comes at the expense of lasting survival gains.
尽管有许多研究比较了非体外循环冠状动脉旁路移植术(CABG)与体外循环 CABG,但对于这两种技术中哪一种能为患者带来更好的结果,尚无共识。
我们从 1966 年 1 月至 2015 年 6 月 30 日在 PubMed 上进行了检索,并从荟萃分析和综述的参考文献中确定了其他研究。我们确定了 42 项随机对照试验(RCT)和 31 项严格调整的观察性研究(控制胸外科医师协会认可的死亡率风险因素),报告了非体外循环与体外循环 CABG 在特定时间点的死亡率。两名研究人员使用标准化表格独立提取试验数据。分别对 RCT 和观察性研究以及合并分析进行了死亡率差异(DPM)估计,时间范围从 30 天到 10 年。
仅 RCT 数据在任何时间点均无显著差异,而仅观察性数据和合并分析显示,短期死亡率有利于非体外循环 CABG(n=120 万患者;36 项 RCT,26 项观察性研究;DPM[95%置信区间(CI)],-44.8%[-45.4%,-43.8%]),但 5 年后,非体外循环 CABG 与死亡率显著增加相关(n=60405 例患者;3 项 RCT,5 项观察性研究;DPM[95%CI],10.0%[5.0%,15.0%])。10 年后,只有观察性数据可用,且非体外循环 CABG 显示死亡率显著增加(DPM[95%CI],14.0%[11.0%,17.0%])。
来自 RCT 的证据表明两种技术之间没有差异,而严格调整的观察性研究(超过 110 万例患者)和合并分析表明,非体外循环 CABG 可降低短期死亡率,但长期生存率较差。这些结果表明,在实际环境中,非体外循环 CABG 的手术安全性更高,但其长期生存获益却降低了。