Azzalini Lorenzo, Giustino Gennaro, Ojeda Soledad, Serra Antonio, La Manna Alessio, Ly Hung Q, Bellini Barbara, Benincasa Susanna, Chavarría Jorge, Gheorghe Livia L, Longo Giovanni, Miccichè Eligio, D'Agosta Guido, Picard Fabien, Pan Manuel, Tamburino Corrado, Latib Azeem, Carlino Mauro, Chieffo Alaide, Colombo Antonio
From the Interventional Cardiology Unit, Cardio-Thoraco-Vascular Department, San Raffaele Scientific Institute, Milan, Italy (L.A., B.B., S.B., A.L., M.C., A. Chieffo, A. Colombo); Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (G.G.); Department of Cardiology, Reina Sofía Hospital, University of Córdoba (IMIBIC), Spain (S.O., J.C., M.P.); Interventional Cardiology Unit, Division of Cardiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (A.S., L.L.G.); Division of Cardiology, Ferrarotto Hospital and Policlinico Vittorio Emanuele University Hospitals, Catania, Italy (A.L.M., G.L., E.M., G.D., C.T.); and Interventional Cardiology Division, Department of Medicine, Montreal Heart Institute, University of Montreal, QC, Canada (H.Q.L., F.P.).
Circ Cardiovasc Interv. 2016 Oct;9(10). doi: 10.1161/CIRCINTERVENTIONS.116.004284.
There is little evidence regarding the efficacy and safety of bioresorbable scaffolds (BRS) for the percutaneous treatment of chronic total occlusions.
We performed a multicenter registry of consecutive chronic total occlusion patients treated with BRS (Absorb; Abbott Vascular) and second-generation drug-eluting stents (DES) at 5 institutions. Long-term target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target-lesion revascularization) was the primary end point. Inverse probability of treatment weight-adjusted Cox regression was used to account for pretreatment differences between the 2 groups. A total of 537 patients (n=153 BRS; n=384 DES) were included. BRS patients were younger and had lower prevalence of comorbidities. Overall mean Japan-Chronic Total Occlusion (J-CTO) score was 1.43±1.16, with no differences between groups. Procedural success was achieved in 99.3% and 96.6% of BRS- and DES-treated patients, respectively (P=0.07). At a median follow-up of 703 days, there were no differences in target-vessel failure between BRS and DES (4.6% versus 7.7%; P=0.21). By adjusted Cox regression analysis, there were still no significant differences between BRS and DES (hazard ratio, 1.54; 95% confidence interval, 0.69-3.72; P=0.34). However, secondary analyses suggested a signal toward higher ischemia-driven target-lesion revascularization with BRS.
Implantation of BRS versus second-generation DES in chronic total occlusion was associated with similar risk of target-vessel failure at long-term follow-up. However, a signal toward increased ischemia-driven target-lesion revascularization with BRS was observed. Large randomized studies should confirm these findings.
关于生物可吸收支架（BRS）用于经皮治疗慢性完全闭塞病变的疗效和安全性，证据较少。
我们在5家机构进行了一项多中心登记研究，纳入连续接受BRS（Absorb；雅培血管）和第二代药物洗脱支架（DES）治疗的慢性完全闭塞患者。长期靶血管失败（包括心源性死亡、靶血管心肌梗死和缺血驱动的靶病变血运重建的复合终点）是主要终点。采用治疗权重的逆概率Cox回归分析来解释两组之间的预处理差异。共纳入537例患者（BRS组153例；DES组384例）。BRS组患者更年轻，合并症患病率更低。总体日本慢性完全闭塞（J-CTO）评分平均为1.43±1.16，两组之间无差异。BRS组和DES组患者的手术成功率分别为99.3%和96.6%（P=0.07）。在中位随访703天时，BRS组和DES组的靶血管失败无差异（4.6%对7.7%；P=0.21）。通过校正Cox回归分析，BRS组和DES组之间仍无显著差异（风险比，1.54；95%置信区间，0.69 - 3.72；P=0.34）。然而，二次分析提示BRS组有缺血驱动的靶病变血运重建增加的趋势。
在慢性完全闭塞病变中植入BRS与第二代DES相比，长期随访时靶血管失败风险相似。然而，观察到BRS组有缺血驱动的靶病变血运重建增加的趋势。大型随机研究应证实这些发现。
