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Dr. Laura Mauri
Presenter report:Windecker, Stephan (SwitzerlandWebcast
Although first generation drug-eluting stents (DES) have profoundly reduced clinical and angiographic measures of restenosis, they have been associated with a small increased risk of very late stent thrombosis, potentially related to the durable polymer component. Slides available
The biolimus-eluting stent (BIOMATRIX) is a new DES releasing biolimus, a sirolimus analogue, from a biodegradable polymer, polylactic acid, which completely degrades into carbon dioxide and water during a period of 6-9 months. This new stent platform was compared against a widely used sirolimus-eluting stent (CYPHER) with durable polymer in 1707 patients with 2472 lesions with both on- and off label characteristics in a randomized, multi-centre, single-blind, non-inferiority trial (LEADERS).
The primary endpoint, a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation within 9 months, occurred in 9.2% of patients treated with biolimus-eluting stents and 10.5% of patients treated with sirolimus-eluting stents, thus establishing non-inferiority (Pnon-inferiority=0.003; rate ratio 0.88, 95%-CI 0.64-1.19, Psuperiority=0.39). Rates of cardiac death (1.6% versus 2.5%, P=0.22), myocardial infarction (5.7% versus 4.6%, P=0.30), and clinically-indicated target vessel revascularisation (4.4% versus 5.5%, P=0.29) were similar for both stent types. Biolimus-eluting stents were also non-inferior to sirolimus-eluting stents in in-stent percent diameter stenosis (20.9% versus 23.3%, Pnon-inferiority=0.001, Psuperiority=0.26), the principal angiographic endpoint of the study.
In summary, biolimus-eluting stents with biodegradable polymer represent a safe and effective alternative to sirolimus-eluting stents with durable polymer in patients with on- and off-label indications. Longer-term follow-up and studies in larger populations will be necessary to determine whether the biodegradable polymer is associated with a reduced risk of late stent thrombosis or different duration of dual antiplatelet therapy.
Discussant report:Mauri, Laura (United States of America)Webcast
The LEADERS study deserves congratulations. The study was well-designed, quick to enroll, and the data collection was independent and adjudicated. The stent platform is unique – with a fully biodegradable polymer releasing the sirolimus analogue, biolimus. The trial design is also unique.
This is the first truly “All-comers” randomized controlled trial of drug-eluting stents, with the only notable exclusion criteria being stent diameters less than 2.25 or greater than 3.5 mm or the inability of patients to take dual antiplatelet therapy for 6 months after the procedure. Such a study design seeks to overcome the main limitations of randomized trials (generalizability) and of observational studies (selection bias), and are a logical extension as drug-eluting stent technologies mature. However, there are still some fundamental limitations to drug-eluting stent studies that apply.
First, regarding generalizability, although myocardial infarction and multivessel stenting were common presentations in this patient population, there is not sufficient power to determine the safety or efficacy in each of these subgroups. Nonetheless, the consistency across the multiple subroups, all either balanced or favoring the biolimus-eluting stent is reassuring. Second, the durability of the clinical results is unknown. A fully biodegradable polymer might have a unique advantage over a durable polymer, particularly once the polymer is no longer present (after 6-9 months). Recent experience has shown the value of following drug-eluting stent patients beyond the restenosis period in randomized trials – with sirolimus-eluting stent trials soon reaching 6 years of follow up. The LEADERS trial reports 9 month follow up. Therefore, the hypothesis that the new biolimus-eluting stent has improved late safety and preserved efficacy compared to sirolimus-eluting stent – remains to be proven in further follow-up.
Hot Line II
This congress report accompanies a presentation given at the ESC Congress 2008. Written by the author himself/herself, this report does not necessarily reflect the opinion of the European Society of Cardiology.
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