Original Title: Coste-efectividad de la colocación aislada de stent frente al stent con angioplastia por balón y protección vascular en la arteriosclerosis carotídea

Authors' objectives: To compare the effectiveness, safety and cost-effective mid-long term of two different therapeutic options against stenosis disease of carotid artery: stent placement with pre and post dilatation using distal protection filters (CAS) versus stenting without pre or post dilation and without use of distal protection filters CASWBAP.

Authors' results and conclusions: RESULTS: The sample size for this study was 377 patients, 177 in CASWBAP group and 200 in CAS group. The populations were not homogeneous, older patients and higher frequency of risk factors occurred in CASWBAP group. The results of effectiveness for both techniques show no statistically significant difference P = 0.1682 for neurological events and P = 0.9196 for survival, although, for frequency of restenosis, the results were statistically significant P <0.0001, occurring greater frequencies in CASWBAP group. The overall incidence of complications in both groups is low. Comparing the incidence of transient ischemic attack statistically significant differences were found (P = 0.038), occurring more frequently in CASWBAP group. There were significant differences in incidence of hypotension P = 0.0018, occurring more frequently in CAS group. According to the results of economic evaluation, taking CASWBAP as base case, incremental cost was € 1,323, with an IC [€ - 4,395, € 7,041], the incremental QALYs were 0.81, with a CI of [- 0.02 QALYs; 1.63 QALYs]. The mean cost-effectiveness ratio of simulations was € 1,633 / QALY. When the willingness to pay is € 30,000 / QALY the probability that CAS is the best alternative is greater than 95%. If the willingness to pay of health authorities is € 15,000 / QALY or more, the annual opportunity cost lost is higher than 0.5 billion of Euros. CONCLUSIONS: - The results of effectiveness of the two treatment options evaluated in this work (CASWBAP or CAS) are similar. There is not security that any alternative is more effective than another due to the lack of statistically significant differences, to demonstrate it. - The restenosis probability is higher in CASWBAP group than in CAS group. However, it should take into account the heterogeneity between samples. - The safety results are similar for both alternatives. There is not security about safety of carotid endovascular treatment will be determined by the treatment technique (CAS or CASWBAP). - On average, the total cost throughout the life of patients undergoing the technique CASWBAP is € 1,323 less than that of patients undergoing CAS technique. Although due to variability of results, these results are not conclusive. - On average, the QALYs of patients undergoing the technique are 0.8 QALYs lower for CASWBAP than for CAS. Although due to variability of results, these results are not conclusive. - It is not the time to make a final decision to establish clinical practice in any of the techniques under study in this report (CASWBAP or CAS) due to high opportunity cost exists because of the uncertainty in the results. - It is time to invest the opportunity cost presented in this work in a new clinical trial to drive away the uncertainty found in this study.

Authors' methods: To meet the objectives of comparing the effectiveness and safety, a retrospective and multicenter cohort study covering from January 2001 to March 2009 has been carried out. This examined the activity logs in four hospitals selected for their experience in endovascular procedures. The information obtained from each of the participating medical centres was recovered and processed by independent researchers. We included all patients suffering carotid artery stenosis disease, which was diagnosed, by means of angiography or Doppler or angioresonance, of stenosis greater than 70% symptomatic or asymptomatic, or who was diagnosed of stenosis higher than 50% symptomatic; who received either of the two types of treatment comparison. In addition to meeting the objective of cost-effectiveness analysis of both techniques, a Markov model which represents the natural history of carotid disease progression after receiving one of the treatments under study was developed. The perspective of the study was the National Health System; the time horizon was 20 years and discount rate was 3% for costs and effects. The measure of effectiveness was quality-adjusted life year (QALY). A probabilistic and multivariate sensitivity analysis was performed using second order Monte Carlo simulation, and acceptability curves and the expected value of perfect information was calculated.

Project Status: Completed

Year Published: 2010

URL for published report: https://sescs.es/coste-efectividad-de-la-colocacion-aislada-de-stent-frente-al-stent-con-angioplastia-por-balon/

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