TY - JOUR
T1 - Late thrombotic events after bioresorbable scaffold implantation: a systematic review andmeta-analysis of randomized clinical trials
AU - Collet, Carlos
AU - Asano, Taku
AU - Miyazaki, Yosuke
AU - Tenekecioglu, Erhan
AU - Katagiri, Yuki
AU - Sotomi, Yohei
AU - Cavalcante, Rafael
AU - de Winter, Robbert J.
AU - Kimura, Takeshi
AU - Gao, Runlin
AU - Puricel, Serban
AU - Cook, Stéphane
AU - Capodanno, Davide
AU - Onuma, Yoshinobu
AU - Serruys, Patrick W.
PY - 2017
Y1 - 2017
N2 - Aims To compare the long-term safety and efficacy of bioresorbable vascular scaffold (BVS) with everolimus-eluting stent (EES) after percutaneous coronary interventions. Methods and results A systematic review and meta-analysis of randomized clinical trials comparing clinical outcomes of patients treated with BVS and EES with at least 24 months follow-up was performed. Adjusted random-effect model by the Knapp-Hartung method was used to compute odds ratios (OR) and 95% confidence intervals (CI). The primary safety outcome of interest was the risk of definite/probable device thrombosis (DT). The primary efficacy outcome of interest was the risk of target lesion failure (TLF). Five randomized clinical trials (n=1730) were included. Patients treated with Absorb BVS had a higher risk of definite/probable DT compared with patients treated with EES (OR 2.93, 95% CI 1.37-6.26, P=0.01). Very late DT (VLDT) occurred in 13 patients [12/996 (1.4%, 95% CI: 0.08-2.5) Absorb BVS vs. 1/701 (0.5%, 95% CI: 0.2-1.6) EES; OR 3.04; 95% CI 1.2-7.68, P=0.03], 92% of the VLDT in the BVS group occurred in the absence of dual antiplatelet therapy (DAPT). Patients treated with Absorb BVS had a trend towards higher risk of TLF (OR 1.48, 95% CI 0.90-2.42, P=0.09), driven by a higher risk of target vessel myocardial infarction and ischaemia-driven target lesion revascularization. No difference was found in the risk of cardiac death. Conclusion Compared with EES, the use of Absorb BVS was associated with a higher rate of DT and a trend towards higher risk of TLF. VLDT occurred in 1.4% of the patients, the majority of these events occurred in the absence of DAPT
AB - Aims To compare the long-term safety and efficacy of bioresorbable vascular scaffold (BVS) with everolimus-eluting stent (EES) after percutaneous coronary interventions. Methods and results A systematic review and meta-analysis of randomized clinical trials comparing clinical outcomes of patients treated with BVS and EES with at least 24 months follow-up was performed. Adjusted random-effect model by the Knapp-Hartung method was used to compute odds ratios (OR) and 95% confidence intervals (CI). The primary safety outcome of interest was the risk of definite/probable device thrombosis (DT). The primary efficacy outcome of interest was the risk of target lesion failure (TLF). Five randomized clinical trials (n=1730) were included. Patients treated with Absorb BVS had a higher risk of definite/probable DT compared with patients treated with EES (OR 2.93, 95% CI 1.37-6.26, P=0.01). Very late DT (VLDT) occurred in 13 patients [12/996 (1.4%, 95% CI: 0.08-2.5) Absorb BVS vs. 1/701 (0.5%, 95% CI: 0.2-1.6) EES; OR 3.04; 95% CI 1.2-7.68, P=0.03], 92% of the VLDT in the BVS group occurred in the absence of dual antiplatelet therapy (DAPT). Patients treated with Absorb BVS had a trend towards higher risk of TLF (OR 1.48, 95% CI 0.90-2.42, P=0.09), driven by a higher risk of target vessel myocardial infarction and ischaemia-driven target lesion revascularization. No difference was found in the risk of cardiac death. Conclusion Compared with EES, the use of Absorb BVS was associated with a higher rate of DT and a trend towards higher risk of TLF. VLDT occurred in 1.4% of the patients, the majority of these events occurred in the absence of DAPT
U2 - https://doi.org/10.1093/eurheartj/ehx155
DO - https://doi.org/10.1093/eurheartj/ehx155
M3 - Review article
C2 - 28430908
SN - 0195-668X
VL - 38
SP - 2559-2564B
JO - European Heart journal
JF - European Heart journal
IS - 33
ER -