Taglieri Nevio, Bacchi Reggiani Maria Letizia, Ghetti Gabriele, Saia Francesco, Dall'Ara Gianni, Gallo Pamela, Moretti Carolina, Palmerini Tullio, Marrozzini Cinzia, Marzocchi Antonio, Rapezzi Claudio
Istituto di Cardiologia, Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Alma Mater Studiorum Università di Bologna, Bologna, Italy.
PLoS One. 2016 Jul 8;11(7):e0158769. doi: 10.1371/journal.pone.0158769. eCollection 2016.
Stroke is a rare but serious adverse event associated with percutaneous coronary intervention (PCI). However, the relative risk of stroke between stable patients undergoing a direct PCI strategy and those undergoing an initial optimal medical therapy (OMT) strategy has not been established yet. This study sought to investigate if, in patients with stable coronary artery disease (SCAD), an initial strategy PCI is associated with a higher risk of stroke than a strategy based on OMT alone.
We performed a meta-analysis of 6 contemporary randomized control trials in which 5673 patients with SCAD were randomized to initial PCI or OMT. Only trials with stent utilization more than 50% were included. Study endpoint was the rate of stroke during follow up.
Mean age of patients ranged from 60 to 65 years and stent utilization ranged from 72% to 100%. Rate of stroke was 2.0% at a weighted mean follow up of 55.3 months. On pooled analysis, the risk of stroke was similar between patients undergoing a PCI plus OMT and those receiving only OMT (2.2% vs. 1.8%, OR on fixed effect = 1.24 95%CI: 0.85-1.79). There was no heterogeneity among the studies (I2 = 0.0%, P = 0.15). On sensitivity analysis after removing each individual study the pooled effect estimate remains unchanged.
In patients with SCAD an initial strategy based on a direct PCI is not associated with an increased risk of stroke during long-term follow up compared to an initial strategy based on OMT alone.
中风是经皮冠状动脉介入治疗(PCI)相关的一种罕见但严重的不良事件。然而,接受直接PCI策略的稳定患者与接受初始优化药物治疗(OMT)策略的患者之间中风的相对风险尚未确定。本研究旨在调查在稳定型冠心病(SCAD)患者中,初始PCI策略是否比单纯基于OMT的策略具有更高的中风风险。
我们对6项当代随机对照试验进行了荟萃分析,其中5673例SCAD患者被随机分配至初始PCI或OMT组。仅纳入支架使用率超过50%的试验。研究终点为随访期间的中风发生率。
患者的平均年龄在60至65岁之间,支架使用率在72%至100%之间。在加权平均随访55.3个月时,中风发生率为2.0%。汇总分析显示,接受PCI加OMT的患者与仅接受OMT的患者中风风险相似(2.2%对1.8%,固定效应OR = 1.24,95%CI:0.85 - 1.79)。各研究之间无异质性(I2 = 0.0%,P = 0.15)。在逐一剔除每项研究后的敏感性分析中,汇总效应估计值保持不变。
在SCAD患者中,与单纯基于OMT的初始策略相比,基于直接PCI的初始策略在长期随访期间与中风风险增加无关。