Original Title: Efectividad, seguridad y eficiencia de los stents recubiertos de fármacos

Authors' objectives: 1. To assess and synthesize the scientific evidence on the effectiveness and security of the use of DES in PCI in patients with coronary artery disease (CAD) comparing with conventional BMS (DES vs. BMS). 2. To determine the cost-effectiveness of DES compared to BMS. 3. To establish a systematic descriptive map on the effectiveness and security of DES of different design (DES vs. DES)

Authors' results and conclusions: RESULTS: With the search update 39 new RTCs were found and 63 published RTCs were finally included in the systematic review of clinical effects. These included 31 trials of DES vs. BMS and 27 trials of DES vs. DES. Three studies compared two types of DES with BMS in a three-arm study. A range of eluting agents was studied: sirolimus (n = 44), paclitaxel (n = 37), zotarolimus (n = 7), everolimus (n = 6), biolimus A9 (n = 1), tacrolimus (n = 1), novolimus (n = 1), abciximab (n = 1) y 17βestradiol (n = 1). For the in-deep review of DES vs. BMS comparison, a total of 31 ECA were included but only 22 trials contributed to the meta-analysis with at least one outcome: 8 RCT (5,231 patients) for the comparison paclitaxel eluting stent (PES) vs. BMS and 16 RCT (5,909 patients) for sirolimus eluting stent (SES) vs. BMS. No statistically significant differences were found in death and AMI rates neither between SES vs.BMS and PES vs. BMS for the pooled analyses at any of the time points (6-9 months, 1, 2 and 5 years after procedure). However, for both comparisons, rates of TLR, TVR and MACE were significantly higher in the BMS group at 1 and 5 years. The angiographic follow-up of the binary reestenosis rate at 6-9 months indicate significantly superiority of PES and SES over BMS at 95% confidence. No statistically significant difference for the comparisons of PES and SES with BMS in the incidence of stent thrombosis up to 1 year and 2 years post-procedure was identified. Model results for the base case show that the average cost of a patient in the BMS industry is € 20,480.56, while the DES branch is € 16,886.53. The results show that quality of life a patient lives in the BMS arm 11.924 QALYs. However, in the field of DES that patient would live 12.363 QALYs. If we look at a willingness to pay between 20,000 and 30,000 € / QALY, the probability of succeeding in the decision to fund DES versus BMS is over 90%. CONCLUSIONS: Data from RTCs confirm that drug-eluting stents are as safe as baremetal stents. The need for TVR and TLR is substantially decreased after stenting with DES, and current evidence suggests that the incidence of stent trombosis is similar between DES and BMS. Optimization of antiplatelet therapy can probably improve clinical outcome of PCI patients after implantation of DES. According to the results of economic assessment, the use of DES is more efficient compared with the alternative BMS. Furthermore, the DES is an alternative option that dominates the BMS alternative, ie, producing savings for the NHS and better outcomes for patients.

Authors' methods: Objetives 1 and 3: An update of a systematic literature review previously published was performed by searching the following bibliographic databases: MEDLINE, EMBASE, CENTRAL, SCOPUS, Science Citation Index, IBECS, LILACS y SCIELO (February 2011). A comprehensive search strategy combining controlled vocabulary and free text was used. In addition, a manual search was performed with the references of included articles. Randomised controlled trials (RCTs) published in English or Spanish and comparing DES with BMS or comparing the effects of different DES designs were considered for inclusion. For the in-deep review on the effectiveness and security of DES compared with BMS, the methodological quality of included trials was assessed according to the criteria of Scottish Intercollegiate Guidelines Network (SIGN). Trials were combined by meta-analysis for mortality, acute myocardial infarction (AMI), target lesion revascularisation (TLR), target vessel revascularisation (TVR), major adverse cardiac event (MACE), binary reestenosis and stent thrombosis. Data in the form of odds ratios (ORs) and 95% confidence intervals (CIs) were analysed using the Mantel-Haenszel method, fixed-effect model. Objective 2: A Markov model was designed and implemented representing the natural history of steno-occlusive disease of the coronary arteries. The model has two main branches, one representing the use of new technology to evaluate (DES) and another one for teh alternative (BMS). The transition probabilities between health states represented in the model were obtained from the systematic review, while cost data were obtained from the database Oblikue costs and literature when they were not available in the database. Estimates of costs include the costs of the procedure in our environment (direct costs), hospital stay, complications, post-intervention drug treatment and other relevant direct medical costs such as hospital care. Also from the literature was obtained the information on the quality of life related to health of patients operated with either technology for incorporation as a measure of effectiveness of economic analysis.

Project Status: Completed

Year Published: 2012

URL for published report: https://sescs.es/efectividad-seguridad-y-eficiencia-de-los-stents-recubiertos-de-farmacos/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es