Substudy of I-LOVE-IT 2 Supports 6-Month DAPT After Biodegradable SES Implantation

February 16, 2016—Yaling Han, MD, et al published the outcomes of a randomized substudy on the duration of dual-antiplatelet therapy (DAPT) in the prospective I-LOVE-IT 2 trial. The findings are available online ahead of print in Circulation: Cardiovascular Interventions.

The I-LOVE-IT 2 trial is sponsored by Essen Technology Co., Ltd. to evaluate the efficacy and safety of the company’s Tivoli biodegradable polymer sirolimus-eluting stent (SES) compared with its Firebird durable polymer SES for treating coronary revascularization. One-year findings from I-LOVE-IT 2 were reported in September 2014 at the 26th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC, and published by Dr. Han, et al in the Journal of the American College of Cardiology: Cardiovascular Interventions (2014;7:1352–1360).

The background of the substudy is that there are no reports from a large-scale randomized trial exploring optimal DAPT duration after biodegradable polymer SES implantation, noted the investigators.

As summarized in Circulation: Cardiovascular Interventions, the prospective noninferiority randomized I-LOVE-IT 2 trial included 1,829 patients allocated to the biodegradable polymer SES group who were also randomized to receive either 6-month (n = 909) or 12-month DAPT (n = 920).

The primary endpoints of the noninferiority substudy were 12-month target lesion failure (composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization), and the major secondary endpoints were 12-month net adverse clinical and cerebral events (composite of all-cause death, all myocardial infarction, stroke, or major bleeding [Bleeding Academic Research Consortium type ≥ 3]).

The investigators found that the 12-month target lesion failure in the 6-month DAPT group was comparable with the 12-month DAPT group (6.8% vs 5.9%; difference and 95% confidence interval, 0.87% [−1.37% to 3.11%]; P for noninferiority = .0065). Further follow-up at 18 months showed that the incidence of target lesion failure and net adverse clinical and cerebral events were similar between the two groups (7.5% vs 6.3%; log-rank P = .32; and 7.8% vs 7.3%; log-rank P = .6; respectively), as well as their individual endpoint components.

This study indicated noninferiority in safety and efficacy of 6-month versus 12-month DAPT after implantation of the novel biodegradable polymer SES, concluded the investigators in Circulation: Cardiovascular Interventions.