Stents eluting biolimus from a biodegradable polymer represent a safe and effective alternative to a stent eluting sirolimus from a durable polymer in patients with chronic stable coronary artery disease or acute coronary syndromes. These are the conclusions of authors of an Article published early Online and in an upcoming edition of The Lancet, authored by Professor Stephan Windecker, Department of Cardiology, Bern University Hospital, Switzerland. The Article is being presented at the European Society of Cardiology Meeting in Munich.
In this randomised study, 1707 patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes were assigned to treatment with either biolimus-eluting (857 patients) or sirolimus-eluting stents (850). Following this, 427 patients were randomly allocated to angiographic follow-up.The primary endpoint of the study was a combination of cardiac death, heart attack, or clinically indicated repeat revascularisation of the treated vessel within nine months.
The researchers found that biolimus-eluting stents were as effective as sirolimus stents for the primary endpoint at nine months — 9% of patients reached the primary endpoint in the biolimus group versus 11% in the sirolimus group. When each part of the primary endpoint was looked at separately, there were no significant differences with respect to cardiac death (1.6% vs. 2.5%), myocardial infarction (5.7% vs. 4.6%) and repeat revascularisation of the treated vessel (4.4% vs. 5.5%) between the biolimus and sirolimus group In the patients given angiographic follow-up, effectiveness of each stent was measured by in-stent percentage diameter stenosis, ie, the percentage of the diameter of the stented vessel that had closed-up again. This percentage was similar in the biolimus group (20.9%) compared with the sirolimus group (23.3%).
The authors conclude: "The present study establishes the non-inferiority of a new-generation drug-eluting stent releasing biolimus from biodegradable polymer versus a stent releasing sirolimus from a durable polymer as used in routine clinical practice."
In an accompanying Comment, Dr Ron Waksman, Washington Hospital Center, Washington, DC, USA, says: "Before we become overly enthused with new-generation drug-eluting stents, we should call for new-generation trial designs that will enable us to assess whether or not these new stents are necessarily better."
Note to editors:
Repeat revascularisation: repeat intervention after renarrowing of the treated vessel
Professor Stephan Windecker, Department of Cardiology, Bern University, Switzerland T) +41-31-632 44 97 (office) / +41-79-208 82 55 (cell) E) stephan.windecker@insel.ch
Dr Ron Waksman, Washington Hospital Center, Washington, DC, USA T) +1 202 253 0240 E) Ron.Waksman@Medstar.net
full study: http://press.thelancet.com/escstentsfinal.pdf
Journal
The Lancet