Biolimus-A9-Eluting Stent Comparable With Sirolimus-Eluting Stent for Percutaneous Coronary Intervention: Presented at ESC

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Title: Biolimus-A9-Eluting Stent Comparable With Sirolimus-Eluting Stent for Percutaneous Coronary Intervention: Presented at ESC
URL: http://www.pslgroup.com/dg/22AC7E.htm
Doctor's Guide
September 4, 2008

By Chris Berrie

MUNICH, Germany -- September 4, 2008 -- Use of an abluminal biodegradable polymer with biolimus, a semisynthetic sirolimus analogue, is noninferior to a sirolimus-eluting stent with durable polymer for safety, efficacy, and angiographic outcome at 9 months in an all-comers population of patients with stable angina, silent ischaemia, and acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI).

Principal investigator Stephan Windecker, MD, Department of Cardiology, Berne University Hospital, Berne, Switzerland, presented these findings from a randomised, noninferiority trial on behalf of the Limus Eluted From a Durable Versus Erodable Stent Coating (LEADERS) investigators on September 1 here at the European Society of Cardiology 2008 Congress (ESC).

The study was published simultaneously in The Lancet on September 1 (DOI:10.1016/S0140-6736(08)61244-1).

Biolimus has a 10-fold greater lipophilicity and similar potency compared with its analogue sirolimus. The Biolimus-A9-eluting stent is formed by absorption of biolimus (15.6 mcg/mm) into a biodegradable polylactic acid polymer, which is coreleased with biolimus over 6 to 9 months.

Dr. Windecker and colleagues investigated the safety and efficacy of the biolimus stent compared with the sirolimus stent in patients encountered in routine clinical practice. They enrolled patients with stable angina, silent ischaemia, or ACS, with at least 1 lesion with a stenosis diameter of 50% or more and a reference vessel diameter of 2.25 to 3.5 mm.

The primary clinical endpoint was the composite of cardiac death, myocardial infarction (MI), or clinically indicated target-vessel revascularisation at 9 months. Patients underwent angiographic studies for in-stent percent diameter stenosis, late loss, and binary restenosis.

A total of 850 patients were randomised to sirolimus stenting and 857 patients to biolimus stenting. Each stenting group was further randomised in a 3:1 design for clinical or clinical-plus-angiographic follow-up. The 2 treatment groups had the same mean age (65 years) and proportion of men (75%). The sirolimus stent group had a total of 1,215 lesions and the biolimus stent group had a total of 1,257 lesions.

Patient demographics and clinical parameters in the 2 groups were well balanced, with a high incidence of ACS (>55%) and 1.5 lesions per patient.

Procedural characteristics were also very similar, with 1.3 stents per lesion, 3.0-mm maximal stent diameter, and 24.7-mm stent length per lesion. Direct stenting was performed in 40% of patients, with 95% device success and 98% lesion success.

For the composite of cardiac death, MI, or clinically indicated target-vessel revascularisation at 9 months, there was a 1.3% risk difference in favour of biolimus stenting (P for noninferiority, .003; risk ratio [RR], 0.88).

Efficacy endpoints all showed trends for biolimus stenting (RR, 0.76-0.90), while safety endpoints showed no significant differences between treatment groups (RR, 0.56-1.25).

Stratified analysis of the primary endpoint was largely nonsignificant, and there was only a small beneficial trend for the impact of angiographic follow-up (clinical only, RR = 0.90; clinical plus angiographic, RR = 0.80).

The angiographic follow-up endpoint of percent diameter stenosis showed no significant differences according to stenting (risk difference, 2.2%; P for noninferiority, .001).

Thus, Dr. Windecker concluded, noninferiority for this biodegradable biolimus stent over the durable sirolimus stent was reached, although he noted, "Longer-term follow-up will be necessary to determine potential differences in late stent thrombosis related to biodegradable as opposed to durable polymer for drug release."

Funding for this study was provided by Biosensors Europe S.A.

[Presentation title: LEADERS - Limus Eluted From a Durable Versus Erodable Stent Coating (Randomised Comparison of a Biolimus-A9-Eluting Stent With a Sirolimus-Eluting Stent for Percutaneous Coronary Intervention). Abstract 1696]

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