Author + information
To compare safety and effectiveness of different duration of DAPT(6 months versus 12 months) after implantation of biodegradable polymer sirolimus-eluting stent(BP-SES) in diabetic patients.
In the I-LOVE-IT 2 Trial, 414 diabetic patients received 6 months (211) or 12 months (203) after implantation of BP-SES. The primary endpoint of was 12-month target lesion failure(TLF) rate (composite of cardiac death, target vessel myocardial infarction or clinically indicated target lesion revascularization). Secondary endpoints was 12-month net adverse clinical events (composite of all-cause death, all myocardial infarction, stroking or major bleeding defined as Bleeding Academic Research Consortium type ≥ 3).
The 12-month TLF in 6-month DAPT group was comparable with the 12-month DAPT group (9.0% versus 9.4%; difference and 95% confidence interval, 0.40% [−5.92% to 5.12%], P=0.92). Cardiac deaths (0.5% vs 1.5%, log-rank P=0.29), target vessel myocardial infarction (8.1% vs 5.9%, log-rank P = 0.40), and clinically driven target lesion revascularization (2.4% vs 3%, log-rank P=0.71) in two groups were also similar. 12 months net clinical adverse events in two groups (NACE) showed no significant difference (11.4% vs 11.3%, log rank P = 0.98). All -course death(0.5% vs 2.0%, log rank P = 0.16), all MI (9.0% vs 6.9%, log rank P = 0.44),stroking (1.4% vs 0%, log-rank P=0.09) and major bleeding (0.5% vs 0.5%, log rank P = 0.97) in two groups were similar, too.
The present study indicated that there is no significant difference on effectiveness and safety of 6-month versus 12-month DAPT after implantation of a novel biodegradable polymer sirolimus-eluting stent in diabetic patients.