Gloria Oliva1, Mireia Espallargues, Juan M V Pons. 1. Agència d'Avaluació de Tecnologia i Recerca Mèdiques, Servei Català de la Salut (CatSalut), Departament de Sanitat i Seguretat Social, Barcelona, Spain. goliva@aatrm.catsalut.net
Abstract
INTRODUCTION AND OBJECTIVES: Antiproliferative drug-coated stents are a possible solution for post-angioplasty coronary restenosis. Here we analyze their efficacy, effectiveness and safety, and estimate the economic impact of their use in Spain. MATERIAL AND METHOD: Systematic review (meta-analysis) of the scientific evidence available up to January 2004, and analysis of hospital costs within a 1-year time horizon. RESULTS: We identified 12 published studies (5 clinical series and 7 RCTs) comparing coated stents (sirolimus or paclitaxel) with conventional stents in patient with de novo single lesions < 30 mm in 2.5-3.5 mm vessels. In nearly all cases the rates of angiographic restenosis and major adverse cardiac events were lower in the coated stent group after 6-12 months. Meta-analysis showed a 69% decrease in revascularization rate (RR=0.31; 95%CI, 0.19-0.51). For every 1000 patients with de novo lesions, the use of a coated stent involved an additional average cost of Euro 818718. The estimated neutral price of a new stent was Euro 1448 at a market price per unit of Euro 2000. CONCLUSIONS: At 12-month follow-up, sirolimus- or paclitaxel-eluting stents were effective and safe in patients with de novo lesions and low or medium risk of restenosis. At current market prices, the widespread use of these stents would involve an increase in health care expenditure for the different sensitivity scenarios we evaluated. More studies are needed to specify the type of patients and lesions likely to obtain the greatest clinical benefit.
INTRODUCTION AND OBJECTIVES: Antiproliferative drug-coated stents are a possible solution for post-angioplasty coronary restenosis. Here we analyze their efficacy, effectiveness and safety, and estimate the economic impact of their use in Spain. MATERIAL AND METHOD: Systematic review (meta-analysis) of the scientific evidence available up to January 2004, and analysis of hospital costs within a 1-year time horizon. RESULTS: We identified 12 published studies (5 clinical series and 7 RCTs) comparing coated stents (sirolimus or paclitaxel) with conventional stents in patient with de novo single lesions < 30 mm in 2.5-3.5 mm vessels. In nearly all cases the rates of angiographic restenosis and major adverse cardiac events were lower in the coated stent group after 6-12 months. Meta-analysis showed a 69% decrease in revascularization rate (RR=0.31; 95%CI, 0.19-0.51). For every 1000 patients with de novo lesions, the use of a coated stent involved an additional average cost of Euro 818718. The estimated neutral price of a new stent was Euro 1448 at a market price per unit of Euro 2000. CONCLUSIONS: At 12-month follow-up, sirolimus- or paclitaxel-eluting stents were effective and safe in patients with de novo lesions and low or medium risk of restenosis. At current market prices, the widespread use of these stents would involve an increase in health care expenditure for the different sensitivity scenarios we evaluated. More studies are needed to specify the type of patients and lesions likely to obtain the greatest clinical benefit.