Results:

The results demonstrated that the primary safety endpoint of definite/probable device thrombosis was significantly higher in the BVS-treated patients (2.4%, 95% confidence interval [CI]; 1.6-3.7) compared with 0.9% of patients in the EES group (95% CI; 0.3-2.1) (p = 0.01). There was also a higher rate of very late device thrombosis in those treated with BVS (1.4%, 95% CI; 0.08-0.25) compared with those receiving EES (0.5%, 95% CI; 0.2-1.6; odds ratio [OR] 3.04; 95% CI; 1.2-7.68, p = 0.03). Patients who received BVS were also at a higher risk of definite/probable device thrombosis compared with those receiving EES (OR 2.93, 95% CI; 1.37-6.26, p = 0.01). The primary efficacy endpoint was the risk of target lesion failure. This was defined as cardiac death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularization. This occurred in 9.3% of patients in the BVS group (95% CI; 7.5-11.4) compared with 6.6 % in the EES group (95% CI; 4.8-8.8). There was also a trend toward a higher risk of target lesion failure in those treated with BVS compared with EES (OR 1.48 CI; 0.9-2.42, p = 0.09). This result was primarily driven by a higher risk of target vessel myocardial infarction and ischaemia-driven target lesion revascularization. Of note, 92% of late vessel myocardial infarction that occurred in the BVS group occurred in the absence of dual antiplatelet therapy (DAPT). However, there was no difference in the risk of cardiac death between the two groups.