Biodegradable stents as good as durable counterparts
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.”