Im Eui, Kim Gwang-Sil, Shin Dong-Ho, Kim Jung-Sun, Kim Byeong-Keuk, Ko Young-Guk, Choi Donghoon, Jang Yangsoo, Hong Myeong-Ki
Yongin Severance Hospital, Yonsei University Health System, Yongin, Korea.
Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.
J Interv Cardiol. 2016 Apr;29(2):162-7. doi: 10.1111/joic.12283. Epub 2016 Mar 1.
To investigate the long-term clinical outcomes of biolimus-eluting stents with biodegradable polymers in real-world clinical practice.
Long-term clinical outcomes of biolimus-eluting stents have not been clearly established.
A total of 824 all-comer patients (971 lesions) treated with unrestricted implantation of a biolimus-eluting stent with a biodegradable polymer were prospectively enrolled. Patients were divided into complex (413 patients) versus noncomplex (411 patients) groups according to the complexity of coronary lesions. Long-term clinical outcomes for stent efficacy (target lesion revascularization) and safety (composite of cardiac death, target lesion-related myocardial infarction, and definite or probable stent thrombosis) were compared between the two groups during 5 years of follow-up.
The complex group showed higher rates of decreased left ventricular ejection fraction, impaired renal function, previous history of myocardial infarction, and diabetes mellitus compared to the noncomplex group. In the overall population, the 5-year cumulative rate of target lesion revascularization was 4.8% (8.3% in the complex group vs 1.6% in the noncomplex group, P < 0.001). For stent safety, the 5-year cumulative rate for a composite of cardiac death, target lesion-related myocardial infarction, and stent thrombosis was 2.5% overall (3.9% in the complex group vs 1.1% in the noncomplex group, P = 0.010). Overall 5-year cumulative rate of stent thrombosis was 0.4% (0.5% in the complex vs 0.2% in the noncomplex group, P = 0.561) with no very late stent thrombosis (VLST).
Biodegradable polymer-based biolimus-eluting stents showed favorable efficacy and safety in all-comer patients during 5 years of follow-up.
在真实世界临床实践中研究含可生物降解聚合物的生物雷帕霉素洗脱支架的长期临床结局。
生物雷帕霉素洗脱支架的长期临床结局尚未明确确立。
前瞻性纳入824例接受含可生物降解聚合物的生物雷帕霉素洗脱支架无限制植入治疗的所有患者（971处病变）。根据冠状动脉病变的复杂程度将患者分为复杂组（413例患者）和非复杂组（411例患者）。在5年随访期间比较两组在支架疗效（靶病变血运重建）和安全性（心源性死亡、靶病变相关心肌梗死以及明确或可能的支架血栓形成的复合终点）方面的长期临床结局。
与非复杂组相比，复杂组左心室射血分数降低、肾功能受损、既往心肌梗死病史和糖尿病的发生率更高。在总体人群中，靶病变血运重建的5年累积发生率为4.8%（复杂组为8.3%，非复杂组为1.6%，P<0.001）。对于支架安全性，心源性死亡、靶病变相关心肌梗死和支架血栓形成复合终点的5年累积发生率总体为2.5%（复杂组为3.9%，非复杂组为1.1%，P=0.010）。支架血栓形成的总体5年累积发生率为0.4%（复杂组为0.5%，非复杂组为0.2%，P=0.561），无极晚期支架血栓形成（VLST）。
在5年随访期间，含可生物降解聚合物的生物雷帕霉素洗脱支架在所有患者中显示出良好的疗效和安全性。
