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目的:对中国汉族人群中药物洗脱球囊(DEB)和第二代药物洗脱支架(DES)内再狭窄(ISR)的疗效进行非劣效性比较。方法:连续入选2014年9月至2015年8月,因DES-ISR而接受DEB或第二代DES治疗的患者,根据所接受的治疗策略将患者分别纳入DEB组和第二代DES组。记录两组患者住院期间主要不良心血管事件(MACE)发生率,并于术后12个月通过电话或门诊进行临床随访。结果:共纳入DES-ISR患者183例,包括DEB组74例,DES组109例;根据Mehran分型,非点状病变患者147例。住院期间两组患者均未发生MACE;(12.4±2.9)个月临床随访发现,DEB组共发生MACE 8例,包括心源性死亡1例、非致死性心肌梗死(MI)2例和靶血管血运重建(TVR)6例;第二代DES组MACE 3例,均为TVR。DEB组的MACE发生率高于第二代DES组(11.0%vs.2.8%,P=0.03),并且DEB组的无事件生存率劣于第二代DES组(89.0%vs.97.2%,P非劣效=0.94),而在非点状病变患者中,DEB组患者的无事件生存率仍劣于第二代DES组患者(87.9%vs.96.6%,P非劣效=0.92)。结论:药物洗脱球囊在中国汉族人群中治疗药物洗脱支架内再狭窄的疗效劣于第二代药物洗脱支架,且在非点状病变患者中仍劣于第二代药物洗脱支架。
OBJECTIVE: To compare the efficacy of drug-eluting balloon (DEB) and second-generation drug-eluting stent (DES) restenosis (ISR) in Chinese Han population for non-inferiority comparison. METHODS: Patients enrolled in either DEB or second-generation DES for DES-ISR were enrolled consecutively between September 2014 and August 2015, and were enrolled in DEB and second-generation DES groups, respectively, according to the accepted treatment strategy. The incidence of major adverse cardiovascular events (MACE) during hospitalization was recorded in both groups and was followed up by phone or clinic 12 months after surgery. Results: A total of 183 DES-ISR patients were enrolled, including 74 patients in the DEB group and 109 patients in the DES group. According to the Mehran classification, 147 patients had non-punctate lesions. MACE was not found between the two groups during hospitalization. (12.4 ± 2.9) months clinical follow-up found that 8 cases of MACE occurred in DEB group, including 1 cardiac death, 2 non-fatal myocardial infarction (MI) and target vessel 6 cases of revascularization (TVR); 3 cases of MACE in the second generation of DES group, all of which were TVR. The incidence of MACE in DEB group was higher than that in the second generation DES group (11.0% vs.2.8%, P = 0.03), and the event-free survival rate in DEB group was worse than that in the second generation DES group (89.0% vs.97.2%, P Noninferiority = 0.94). However, in patients with non-point lesions, the event-free survival rate was still lower in patients with DEB than in patients with second-generation DES (87.9% vs.96.6%, P = 0.92). Conclusion: The efficacy of drug-eluting balloon in the treatment of drug-eluting stent restenosis in Chinese Han population is inferior to that of the second-generation drug-eluting stent and is still inferior to the second-generation drug-eluting stent in patients with non-point disease .