September 26, 2014 — A first-of-its kind study 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 non-inferior to the durable polymer stents after one year of follow-up.
Findings were reported at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Results of the trial were simultaneously published today in JACC: Cardiovascular Interventions.
To date no randomized trials have been performed comparing the safety and efficacy of BP-SES vs. DP-SES on similar cobalt-chromium platforms, thereby isolating the effect of the polymer type. Furthermore optimal duration of dual antiplatelet therapy (DAPT) after BP-SES implantation remains undetermined.
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 six or 12 month DAPT. The primary endpoint was target lesion failure (TLF) between BP and DP-SES groups. Major secondary endpoints were TLF and net adverse clinical events (NACE), a composite of death, myocardial infarction, stroke and major bleeding, between the six and 12-month DAPT groups after BP-SES implantation.
After one year, the primary non-inferiority endpoint was met with similar TLF rates in both the BP and DP-SES groups (6.3 percent vs. 6.1 percent, respectively, p=0.0002). Both groups experienced similar rates of cardiac death (0.7 percent vs. 0.6 percent, p=0.62), target vessel myocardial infarction (3.6 percent vs. 4.3 percent, p=0.39) and clinically indicated target lesion revascularization (2.6 percent vs. 2.2 percent, p=0.50). In the BP-SES group, NACE rates were similar among the six-month and 12-month DAPT groups (8.0 percent vs. 7.4 percent, respectively, p=0.66)
“The present I-LOVE-IT 2 trial has demonstrated that BP-SES is non-inferior in terms of efficacy to DP-SES in clinical practice,” said lead investigator Xu Bo, MBBS, director, catheterization lab, Fu Wai Hospital, National Center for Cardiovascular Diseases and Secretary General, China Interventional Therapeutics (CIT). “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.”
The I-LOVE-IT 2 trial was funded by Essen Technology. It was also supported by the National Key Technology R&D program in the 12th Five Year Plan of China and the Key Project of National 12th Five-Year Research Program of China. Xu Bo reported no disclosures.
For more information: www.crf.org, www.tctconference.com