Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Am Heart J. 2018 Oct;204:128-138. doi: 10.1016/j.ahj.2018.05.018. Epub 2018 Aug 10.
The objective was to compare patients with ischemic heart disease (IHD) undergoing percutaneous coronary intervention (PCI) who were included in randomized controlled trials (RCTs) (trial participants) with patients who were not included (nonparticipants) on a trial-by-trial basis and according to indication for PCI.
In this cohort study, we compared patients with IHD who were randomized in RCTs in relation to undergoing PCI in Denmark between 2011 and 2015 were considered as RCT-participants in this study. The RCT-participants were compared with contemporary nonparticipants with IHD undergoing PCI in the same period, and they were identified using unselected national registry data. The primary end point was all-cause mortality.
A total of 10,317 (30%) patients were included in 10 relevant RCTs (trial participants), and a total of 23,644 (70%) contemporary patients did not participate (nonparticipants). In all the included RCTs, nonparticipants had higher hazard ratios for mortality compared to trial participants (P < .001). Among all patients treated with PCI, the pooled estimates showed a significantly higher mortality rate for nonparticipants compared to trial participants (hazard ratio: 2.03, 95% CI: 1.88-2.19) (P < .001). When patients were stratified according to indication for PCI, the pooled estimates showed a significantly lower mortality rate for trial participants compared to nonparticipants in all strata (P for all < .001).
Trial participants in recently performed RCTs including patients undergoing PCI were not representative of the general population of patients with IHD treated with PCI according to clinical characteristics and mortality. The difference in mortality was found irrespective of the indication for PCI. Thus, results from RCTs including patients undergoing PCI should be extrapolated with caution to the general patient population.
本研究旨在比较入选随机对照试验（RCT）的接受经皮冠状动脉介入治疗（PCI）的缺血性心脏病（IHD）患者与未入选的患者，并根据 PCI 指征进行逐例比较。
在这项队列研究中，我们比较了 2011 年至 2015 年在丹麦接受 RCT 随机分组并接受 PCI 的 IHD 患者，将这些患者视为本研究中的 RCT 参与者。将这些 RCT 参与者与同期接受 PCI 的 IHD 未参与者进行比较，未参与者是通过未选择的全国登记数据确定的。主要终点是全因死亡率。
共有 10317 名（30%）患者入选了 10 项相关 RCT（RCT 参与者），共有 23644 名（70%）同期患者未参与（非参与者）。在所有纳入的 RCT 中，非参与者的死亡率风险比高于参与者（P<0.001）。在所有接受 PCI 治疗的患者中，汇总估计显示非参与者的死亡率明显高于参与者（危险比：2.03，95%CI：1.88-2.19）（P<0.001）。当根据 PCI 指征对患者进行分层时，在所有分层中，与非参与者相比，参与者的死亡率明显较低（P<0.001）。
根据临床特征和死亡率，最近进行的包括接受 PCI 的患者的 RCT 中的参与者并不能代表接受 PCI 治疗的一般 IHD 患者人群。死亡率的差异是在所有 PCI 指征下发现的。因此，包括接受 PCI 的患者的 RCT 结果应谨慎外推至一般患者人群。
