纳米表面聚烯F与药物洗脱支架在急性冠状动脉综合征患者1个月双重抗血小板治疗中的比较研究:即时和1年临床结果

Hazem Arnous, Mamdouh Eltahhan, T. Ahmad, A. Fahmy, M. Sallam
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摘要

背景和目的:目前的临床实践提倡支架血栓形成(ST)段抬高型心肌梗死(STEMI)后一年的双重抗血小板治疗(DAPT),主要是由于持续的血栓形成风险。新型COBRA PzF冠状动脉支架的研制是为了降低ST的风险。本研究的主要目的是比较新型纳米涂层PzF支架在STEMI患者和单支冠状动脉疾病(CAD)患者中使用1个月DAPT与使用现有药物洗脱支架(DES)后12个月DAPT的有效性和安全性。患者和方法:一项前瞻性观察研究纳入了100例STEMI和单血管CAD患者。将符合条件的患者分为两组;第一组包括50例使用COBRA PzF支架的患者,他们接受了一个月的DAPT。第二组为50例DES患者,接受为期一年的DAPT治疗。ST的发生是我们的主要终点。次要终点是靶血管重建术和全年主要的脑血管不良事件。结果:ⅰ组无明显ST例,ⅱ组3例,差异无统计学意义(P < 0.094)。ⅰ组和ⅱ组靶血管重建术发生率(6%比10%)、死亡发生率(2%比4%)、卒中发生率(0比2%)、大出血发生率(0%比4%)差异无统计学意义(P < 0.094)。结论:COBRA Polyzene-F支架配合1个月DAPT满足STEMI合并单血管CAD患者ST的性能目标,优于市售的DES配合1年DAPT。
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Comparative study between Nano-surface Polyzene F and drug eluting stents in acute coronary syndrome patients with one-month dual antiplatelet therapy: Immediate and one-year clinical outcome.
Background and objectives : The current clinical practice advocates dual antiplatelet therapy (DAPT) for a year after stent thrombosis (ST) segment elevation myocardial infarction (STEMI), primarily owing to persistent thrombotic risk. The novel COBRA PzF coronary stent was developed to reduce ST risk. The primary goal of the current research was to compare the ef fi cacy and safety of the novel nanocoated PzF stenting with one-month DAPT against 12-month DAPT after the current drug-eluting stent (DES) in STEMI patients and single-vessel coronary artery disease (CAD). Patients and methods : A prospective observational study enrolled 100 cases presented with STEMI and single vessel CAD. Eligible patients were allocated into 2 groups; group I consisted of 50 patients managed with the COBRA PzF stent who received one-month DAPT. Group II consisted of 50 patients treated with DES who received one-year DAPT. The occurrence of ST was our primary endpoint. The secondary endpoints were target vessel revascularization and major adverse cerebro-cardiovascular occurrences throughout the year. Results : There were no observed cases of de fi nite ST in group I against three in group II, however, it did not reach statistical signi fi cance ( P ¼ 0.094) The incidence of target vessel revascularization (6% against 10%), death (2% versus 4%), stroke (0 versus 2%) and major bleeding (0% versus 4%) observed in group I and II, respectively, however, it did not reach statistical signi fi cance. Conclusion : The COBRA Polyzene-F stent with one-month DAPT met the performance goals for ST in patients presenting with STEMI with single vessel CAD and compared favorably with the commercially available DES with one-year DAPT.
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