Lauder Lucas, da Costa Bruno R, Ewen Sebastian, Scholz Sean S, Wijns William, Lüscher Thomas F, Serruys Patrick W, Edelman Elazer R, Capodanno Davide, Böhm Michael, Jüni Peter, Mahfoud Felix
Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Saarland University, Kirrberger Str., Gebäude 41.1, 66421 Homburg/Saar, Germany.
Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, 155 College Street, Toronto, ON M5T 3M6, Canada.
Eur Heart J. 2020 Jul 14;41(27):2556-2569. doi: 10.1093/eurheartj/ehaa495.
The difference in the benefit of invasive cardiovascular interventions compared with placebo controls has not been analysed systematically.
MEDLINE and Web of Science were searched through 29 March 2020. Randomized, placebo-controlled trials of invasive cardiovascular interventions (including catheter-based interventions and pacemaker-like devices) investigating predefined primary outcomes were included. Standardized mean differences (SMD) and odds ratios were calculated for continuous and dichotomous outcomes, respectively. Meta-regression analyses were performed to assess whether estimates of treatment effects were associated with methodological characteristics of trials. Thirty trials, including 4102 patients, were analysed. The overall risk of bias was judged to be low in only 43% of the trials. Ten trials (33%) demonstrated statistically significant superiority of invasive interventions over placebo controls for the respective predefined primary outcomes. In almost half of the 16 trials investigating continuous predefined primary outcomes, the SMD between the active and placebo procedure indicated a small (n = 4) to moderate (n = 3) treatment effect of active treatment over placebo. In contrast, one trial indicated a small treatment effect in favour of the placebo procedure. In the remaining trials, there was no relevant treatment effect of active treatment over placebo. In trials with a protocol-mandated stable and symmetrical use of co-interventions, the superiority of active procedures vs. invasive placebo procedures was significantly larger as compared with trials with frequent or unbalanced changes in co-interventions (P for interaction 0.027).
The additional treatment effect of invasive cardiovascular interventions compared with placebo controls was small in most trials.
与安慰剂对照相比，侵入性心血管干预的获益差异尚未得到系统分析。
检索截至2020年3月29日的MEDLINE和科学网。纳入了调查预定义主要结局的侵入性心血管干预（包括基于导管的干预和类似起搏器的装置）的随机、安慰剂对照试验。分别计算连续和二分结局的标准化均数差（SMD）和比值比。进行Meta回归分析以评估治疗效果估计值是否与试验的方法学特征相关。分析了30项试验，包括4102例患者。仅43%的试验总体偏倚风险被判定为低。10项试验（33%）表明，侵入性干预在各自预定义的主要结局方面在统计学上显著优于安慰剂对照。在16项调查连续预定义主要结局的试验中，近一半试验中，积极治疗与安慰剂治疗之间的SMD表明积极治疗对安慰剂有小（n = 4）到中度（n = 3）的治疗效果。相比之下，一项试验表明安慰剂治疗有小的治疗效果。在其余试验中，积极治疗相对于安慰剂没有相关治疗效果。在方案规定稳定且对称使用联合干预的试验中，与联合干预频繁或不平衡变化的试验相比，积极治疗程序相对于侵入性安慰剂程序的优势显著更大（交互作用P = 0.027）。
在大多数试验中，侵入性心血管干预与安慰剂对照相比的额外治疗效果较小。
