AIMS: The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of bioresorbable vascular scaffold (BVS). METHODS AND RESULTS: The COMPARE-ABSORB trial was an investigator-initiated, prospective randomized study. Patients at high risk of restenosis were randomly assigned to receive either BVS or everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically-indicated target lesion revascularization at 1 year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS arm. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1 %) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval (CI) -1.2%-3.0%, P non-inferiority < 0.001). Definite or probable device thrombosis (2.0% vs. 0.6%, hazard ratio 3.32, 95% CI 1.22 to 8.99, P=0.012) and TVMI (4.0% vs. 2.1%, hazard ratio 1.96, 95% CI 1.10 to 3.51, P=0.02) were significantly higher in the BVS group than the EES group. CONCLUSIONS: In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at 1 year. BVS carried a higher risk of device thrombosis and TVMI than EES.
RCT Entities:
AIMS: The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of bioresorbable vascular scaffold (BVS). METHODS AND RESULTS: The COMPARE-ABSORB trial was an investigator-initiated, prospective randomized study. Patients at high risk of restenosis were randomly assigned to receive either BVS or everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically-indicated target lesion revascularization at 1 year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS arm. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1 %) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval (CI) -1.2%-3.0%, P non-inferiority < 0.001). Definite or probable device thrombosis (2.0% vs. 0.6%, hazard ratio 3.32, 95% CI 1.22 to 8.99, P=0.012) and TVMI (4.0% vs. 2.1%, hazard ratio 1.96, 95% CI 1.10 to 3.51, P=0.02) were significantly higher in the BVS group than the EES group. CONCLUSIONS: In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at 1 year. BVS carried a higher risk of device thrombosis and TVMI than EES.