Results of I-LOVE-IT-2 Trial Reported at TCT 2014; Findings Simultaneously Published in JACC: Cardiovascular Interventions
WASHINGTON, DC – September 16, 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 today at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine. 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. Dr. Xu Bo reported no disclosures.