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目的对比研究氮氧化钛生物有效性支架(Titan2-BAS)与生物可降解雷帕霉素药物洗脱支架(Excel支架)在冠状动脉血运重建方面的临床疗效。方法 162例冠心病患者,根据植入的支架不同分为A组(Titan2-BAS)88例,B组(Excel)74例,均采用经桡动脉或尺动脉途径冠脉血运重建。A组阿司匹林与氯吡格雷双联抗血小板治疗1~3个月,B组至少6个月,此后长期单用阿司匹林。计算A、B两组支架病变的通过率、早期支架内血栓发生率及随访MACE发生率(指死亡、急性心肌梗死、靶血管重建等)。结果 (1)A组141处>75%狭窄病变共植入Ti-tan2-BAS支架152枚,1枚支架未能通过病变(RCA),通过率99.3%;B组114处病变共植入Excel支架120枚,通过率100%,两组差异无统计学意义(P>0.05)。(2)随访10~18个月,平均13.8个月。两组均无死亡病例;A、B两组均无急、晚期血栓;A组1例术后6个月行靶血管重建,B组无靶血管重建;综合以上,两组MACE发生率差异无统计学意义(P>0.05)。结论在本研究样品量情况下,Titan2-BAS与Excel支架在冠脉血运重建方面的近期及远期疗效相近。
Objective To compare the clinical effects of Titan2-BAS with biodegradable rapamycin-eluting stent (Excel stent) in coronary revascularization. Methods A total of 162 patients with coronary heart disease were divided into two groups: group A (Titan2-BAS), group B, and group B (74 cases). All patients underwent coronary artery revascularization via radial artery or ulnar artery. A group of aspirin and clopidogrel dual antiplatelet therapy for 1 to 3 months, B group at least 6 months, since long-term aspirin alone. The pass rate of stents, the incidence of early stent thrombosis and the follow-up MACE incidence (death, acute myocardial infarction, target vessel reconstruction, etc.) were calculated. Results (1) A total of 152 Ti-tan2-BAS scaffolds were implanted in 141 lesions> 75% of the stenosis in Group A, and one stent failed to pass the lesion (RCA) with a pass rate of 99.3%. Stents 120, the passing rate of 100%, no significant difference between the two groups (P> 0.05). (2) followed up for 10 to 18 months, an average of 13.8 months. There was no death in both groups. There was no acute or advanced thrombosis in group A and B. One case in group A underwent target vessel revascularization at 6 months after operation and no target vessel reconstruction in group B. In summary, the incidence of MACE between the two groups was no significant difference Statistical significance (P> 0.05). Conclusion The short-term and long-term effects of Titan2-BAS and Excel on coronary revascularization are similar in the present study.