SAN FRANCISCO, Calif.—The biolimus A9-eluting stent with a bioabsorbable polymer was found noninferior to the sirolimus-eluting stent with a durable polymer in patients with stable angina and/or ACS, according to two-year follow-up results of the LEADERS trial.
Volker Klauss, MD, from the department of cardiology at University Hospital Munich in Germany, presented the late-breaking trial results on Wednesday. Klauss said the noninferiority of the biolimus A9-eluting stent (BES) when compared with the sirolimus-eluting stent (SES) was sustained in all subgroups of the study population.
“There were similar outcomes for the biolimus-eluting stent and the sirolimus-eluting stent with respect to the primary endpoints of MACE, cardiac death or MI, and clinically-indicated target-vessel revascularization,” Klauss said (see Table).
Klauss noted that inclusion criteria for the trial “were broad, reflecting routine clinical practice. We set no limits for the number of treated lesions, vessels or lesion length, and excluded no patients on the basis of comorbid disorders or age.”
The LEADERS trial included 1,700 patients with stable angina and/or ACS. Patients were randomized in a 1:1 ratio to one of the two stent types.
The two treatment groups were well-matched for age, gender and risk factors such as family history, smoking, diabetes, hypercholesterolemia, chronic angina, previous MI, previous CABG and previous PCI. The average patient age was 65 years.
In a subanalysis of patients with STEMI, there was an improved rate of MACE in patients treated with a BES compared with a SES (8.1% vs. 19.3%; P<.01). Very late stent thrombosis events were rare in both groups (0.2% for BES and 0.5% for SES; P=.73).
“No very late stent thrombosis events were observed in patients treated with a biolimus-eluting stent after discontinuation of dual antiplatelet therapy,” Klauss added. Dual antiplatelet therapy was recommended for a 12-month period for all patients.
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