Brophy James M, Belisle Patrick, Joseph Lawrence
McGill University, Montreal, Quebec, Canada.
Ann Intern Med. 2003 May 20;138(10):777-86. doi: 10.7326/0003-4819-138-10-200305200-00005.
Coronary stents are widely used in interventional cardiology, but a current quantitative systematic overview comparing routine coronary stenting with standard percutaneous transluminal coronary angioplasty (PTCA) and restricted stenting (provisional stenting) has not been published.
To summarize results from all randomized clinical trials comparing routine coronary stenting with standard PTCA.
Electronic databases were searched by using the key words angioplasty and stent. References from identified articles were also reviewed. In addition, several prominent general medical and cardiology journals were searched and agencies known to perform systematic reviews were consulted.
All comparative randomized clinical trials were included, except those involving primary angioplasty for the treatment of acute myocardial infarction.
A specified protocol was followed, and two of the authors independently extracted the data. Outcomes assessed were total mortality, myocardial infarction, angiographic restenosis, coronary artery bypass surgery, repeated PTCA, and freedom from angina.
The results were synthesized by using a Bayesian hierarchical random-effects model. A total of 29 trials involving 9918 patients were identified. There was no evidence for a difference between routine coronary stenting and standard PTCA in terms of deaths or myocardial infarctions (odds ratio, 0.90 [95% credible interval [CrI], 0.72 to 1.11]) or the need for coronary artery bypass surgery (odds ratio, 1.01 [CrI, 0.79 to 1.31]). Coronary stenting reduced the rate of restenosis (odds ratio, 0.52 [CrI, 0.37 to 0.69]) and the need for repeated PTCA (odds ratio, 0.59 [CrI, 0.50 to 0.68]). The trials showed a wide range of crossover rates from PTCA to stenting. By use of a multiplicative model, each 10% increase in crossover rate decreased the need for repeated angioplasty by approximately 8% (odds ratio multiplying factor, 1.08 [CrI, 0.98 to 1.18]). Routine stenting probably reduces the need for repeated angioplasty by fewer than 4 to 5 per 100 treated persons compared with PTCA with provisional stenting. Studies were not blinded and suggest a bias with a possible overestimation of this benefit.
In the controlled environment of randomized clinical trials, routine coronary stenting is safe but probably not associated with important reductions in rates of mortality, acute myocardial infarction, or coronary artery bypass surgery compared with standard PTCA with provisional stenting. Coronary stenting is associated with substantial reductions in angiographic restenosis rates and the subsequent need for repeated PTCA, although this benefit may be overestimated because of trial designs. The incremental benefit of routine stenting for reducing repeated angioplasty diminishes as the crossover rate of stenting with conventional PTCA increases.
冠状动脉支架在介入心脏病学中广泛应用,但目前尚无关于常规冠状动脉支架置入术与标准经皮冠状动脉腔内血管成形术(PTCA)及限制性支架置入术(临时支架置入术)比较的定量系统综述发表。
总结所有比较常规冠状动脉支架置入术与标准PTCA的随机临床试验结果。
使用关键词“血管成形术”和“支架”检索电子数据库。对已识别文章的参考文献也进行了回顾。此外,检索了几本著名的综合医学和心脏病学杂志,并咨询了已知进行系统综述的机构。
纳入所有比较性随机临床试验,但不包括涉及急性心肌梗死的直接血管成形术的试验。
遵循特定方案,由两位作者独立提取数据。评估的结局包括总死亡率、心肌梗死、血管造影再狭窄、冠状动脉旁路移植术、重复PTCA以及无心绞痛。
采用贝叶斯分层随机效应模型合成结果。共识别出29项试验,涉及9918例患者。在死亡或心肌梗死方面(优势比,0.90 [95%可信区间(CrI),0.72至1.11])或冠状动脉旁路移植术的需求方面(优势比,1.01 [CrI,0.79至1.31]),没有证据表明常规冠状动脉支架置入术与标准PTCA之间存在差异。冠状动脉支架置入术降低了再狭窄率(优势比,0.52 [CrI,0.37至0.69])和重复PTCA的需求(优势比,0.59 [CrI,0.50至0.68])。试验显示从PTCA转换为支架置入术的转换率范围很广。使用乘法模型,转换率每增加10%,重复血管成形术的需求就减少约8%(优势比倍增因子,1.08 [CrI,0.98至1.18])。与临时支架置入术的PTCA相比,常规支架置入术可能使每100名接受治疗的患者中重复血管成形术的需求减少不到4至5例。研究未设盲,提示存在偏倚,可能高估了这一益处。
在随机临床试验的受控环境中,常规冠状动脉支架置入术是安全的,但与临时支架置入术的标准PTCA相比,可能不会显著降低死亡率、急性心肌梗死或冠状动脉旁路移植术的发生率。冠状动脉支架置入术与血管造影再狭窄率的大幅降低以及随后重复PTCA的需求相关,尽管由于试验设计,这一益处可能被高估。随着常规支架置入术与传统PTCA的转换率增加,常规支架置入术在减少重复血管成形术方面的增量益处会减少。