By Liam O’Neill, TCT 2014.
Findings were reported today at the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium revealed that biodegradable polymer sirolimus-eluting stents (BP-SES) were as effective as durable polymer sirolimus-eluting stents (DP-SES) after one year. The study just published in JACC: Cardiovascular Interventions is a first of its kind to compare the safety and efficacy of the two stents.
The prospective, single blinded randomized I-LOVE-IT 2 trial 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)
Lead investigator Xu Bo, MBBS, Director, Catheterization Lab, Fu Wai Hospital National Center for Cardiovascular Diseases and Secretary General, China Interventional Therapeutics (CIT) commented:“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.
“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.”