背景:这是中国冠心病PCI术后个性化抗栓治疗(PATH-PCI)试验的子分析,旨在探讨吸烟与慢性冠状动脉综合征(CCS)患者经皮冠状动脉介入治疗(PCI)患者个性化抗血小板治疗(PAT)后结局之间的关系。
方法:作为单中心,prospective,随机对照和开放标签试验,PATH-PCI试验将接受PCI的CCS患者随机分为标准组或新型血小板功能试验(PFT)指导下的个性化组,从2016年12月到2018年2月。所有患者根据吸烟状况分为吸烟者和非吸烟者。随后,我们进行了180天的随访评估.主要终点是净不良临床事件(NACE)。
结果:无论吸烟状况如何,在NACE的发病率中,PAT降低,但降低无统计学意义.在出血事件的发生率中,我们发现两组之间没有统计学上的显著差异(吸烟者:2.0%vs.1.4%,HR=1.455,95%置信区间[CI]:0.595-3.559,p=.412;非吸烟者:2.2%1.8%,HR=1.228,95%CI:0.530-2.842,p=.632)。在吸烟者中,PAT将主要不良心脑血管事件(MACCE)减少了48.7%(3.0%vs.5.9%,HR=0.513,95%CI:0.290-0.908,p=0.022),与标准抗血小板治疗(SAT)相比。PAT还减少了主要不良心血管事件(MACE),但在减少方面没有统计学差异(p>0.05)。在非吸烟者中,PAT将MACCE和MACE降低了51.5%(3.3%与6.7%,HR=0.485,95%CI:0.277-0.849,p=.011)和63.5%(1.8%vs.4.9%,HR=0.365,95%CI:0.178-0.752,p=.006),分别。当测试相互作用的p值时,我们发现吸烟状况与PAT治疗效果无显著交互作用(pint-NACE=.184,pint-出血=.660).
结论:不管吸烟,PAT减少了MACE和MACCE,出血无显著差异。这表明考虑到缺血和出血风险,PAT是PCI后CCS患者的推荐方案。
BACKGROUND: This is a sub-analysis of the Personalized Antithrombotic Therapy for Coronary Heart Disease after PCI (PATH-PCI) trial in China to explore the relationship between smoking and outcomes following personalized antiplatelet therapy (PAT) in chronic coronary syndrome (CCS) patients undergoing percutaneous coronary intervention (PCI).
METHODS: As a single-center, prospective, randomized controlled and open-label trial, the PATH-PCI trial randomized CCS patients undergoing PCI into standard group or personalized group guided by a novel platelet function test (PFT), from December 2016 to February 2018. All patients were divided into smokers and nonsmokers according to their smoking status. Subsequently, we underwent a 180-day follow-up evaluation. The primary endpoint was the net adverse clinical events (NACE).
RESULTS: Regardless of smoking status, in the incidence of NACE, there was a reduction with PAT but that the reductions are not statistically significant. In the incidence of bleeding events, we found no statistically significant difference between two groups (smokers: 2.0% vs. 1.4%, HR = 1.455, 95% confidence interval [CI]: 0.595-3.559, p = .412; nonsmokers: 2.2% vs. 1.8%, HR = 1.228, 95% CI: 0.530-2.842, p = .632). In smokers, PAT reduced major adverse cardiac and cerebrovascular events (MACCE) by 48.7% (3.0% vs. 5.9%, HR = 0.513, 95% CI: 0.290-0.908, p = .022), compared with standard antiplatelet therapy (SAT). PAT also reduced the major adverse cardiovascular events (MACE) but there was no statistically difference in the reductions (p > .05). In nonsmokers, PAT reduced MACCE and MACE by 51.5% (3.3% vs. 6.7%, HR = 0.485, 95% CI: 0.277-0.849, p = .011) and 63.5% (1.8% vs. 4.9%, HR = 0.365, 95% CI: 0.178-0.752, p = .006), respectively. When testing p-values for interaction, we found there was no significant interaction of smoking status with treatment effects of PAT (pint-NACE = .184, pint-bleeding = .660).
CONCLUSIONS: Regardless of smoking, PAT reduced the MACE and MACCE, with no significant difference in bleeding. This suggests that PAT was an recommendable regimen to CCS patients after PCI, taking into consideration both ischemic and bleeding risk.