I-LOVE-IT-2 Evaluates Safety and Efficacy of Biodegradable Polymer-Coated SES

September 16, 2014—The I-LOVE-IT-2 trial comparing the safety and efficacy of biodegradable polymer sirolimus-eluting stents (BP-SES) to durable polymer sirolimus-eluting stents (DP-SES) found that the biodegradable stents were noninferior to the durable polymer stents after 1 year of follow-up. The findings were reported at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC, and published in JACC: Cardiovascular Interventions.

The TCT announcement noted that no randomized trials have been performed comparing the safety and efficacy of BP-SES versus DP-SES on similar cobalt chromium platforms, thereby isolating the effect of the polymer type. Additionally, the optimal duration of dual-antiplatelet therapy (DAPT) after BP-SES implantation remains undetermined. The trial is sponsored by Essen Technology Co., Ltd. to evaluate the efficacy and safety of the Tivoli BP-SES compared with the Firebird DP-SES for treating coronary revascularization.

As summarized in the TCT press release, the I-LOVE-IT 2 trial was an all-comers, prospective, single-blinded randomized trial that enrolled 2,737 patients eligible for coronary stenting. Patients were randomly treated with BP or DP-SES in a 2:1 ratio. Those allocated to the BP-SES group (n = 1,829) were also randomized to receive 6- or 12-month DAPT. The primary endpoint was target lesion failure (TLF) between the BP-SES and DP-SES groups. Major secondary endpoints were TLF and net adverse clinical events (a composite of death, myocardial infarction, stroke, and major bleeding) between the 6- and 12-month DAPT groups after BP-SES implantation. 

After 1 year, the primary noninferiority endpoint was met with similar TLF rates in both the BP-SES and DP-SES groups (6.3% vs 6.1%, respectively; P = .0002).  Both groups experienced similar rates of cardiac death (0.7% vs 0.6%; P = .62), target vessel myocardial infarction (3.6% vs 4.3%; P = .39), and clinically indicated target lesion revascularization (2.6% vs 2.2%; P = .5). In the BP-SES group, the net adverse clinical event rates were similar among the 6- and 12-month DAPT groups (8% vs 7.4%, respectively; P = .66)

In the TCT press release, Lead Investigator Xu Bo, MD, commented, “The present I-LOVE-IT 2 trial has demonstrated that BP-SES is noninferior in terms of efficacy to DP-SES in clinical practice. Whether BP-SES improves safety with respect to lowering stent thrombosis incidence compared with DP-SES remains to be shown in longer-term follow-up of this trial or in future studies.” Dr. Bo is Director of the Catheterization Lab at Fu Wai Hospital National Center for Cardiovascular Diseases and Secretary General, China Interventional Therapeutics.