A biodegradable polymer sirolimus-eluting stent (BP-SES) is noninferior to a durable polymer sirolimus-eluting stent (DP-SES) for one-year target lesion failure, according to results from the I-LOVE-IT 2 trial, presented Sept. 16 at TCT 2014, and simultaneously published in JACC: Cardiovascular Interventions. 

Additional Resources TCT 2014 Meeting Coverage I-LOVE-IT 2 Trial Summary

The trial was led by Yaling Han, MD, PhD, FACC, General Hospital of Shenyang Military Region, Shenyang, China, and looked at 2,737 patients in 32 Chinese sites who were eligible for coronary stenting. Patients were treated with BP- or DP-SES in a 2:1 ratio.

Results showed at 12 months, the difference in the primary endpoint (a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization) of target lesion failure between BP-SES (6.3 percent) and DP-SES (6.1 percent) groups was 0.25 percent (95 percent confidence interval: -1.67 percent to 2.17 percent, P for noninferiority=0.0002), demonstrating noninferiority of BP-SES to DP-SES.

Further, individual target lesion failure components 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) were similar, as were low definite/probable stent thrombosis rates (0.4 percent vs. 0.6 percent, P=0.55).

The investigators note that their study is the “first adequately powered trial to compare biodegradable polymer with durable polymer on similar coated cobalt chromium stents eluting the same sirolimus drug.” Moving forward, they add that “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.”

Keywords: Myocardial Infarction, Follow-Up Studies, Coronary Restenosis, Cobalt, Thrombosis, Polymers, Chromium, Confidence Intervals, Sirolimus, Angioplasty, Balloon, Coronary, Stents

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