The UK EndoVascular Aneurysm Repair (EVAR) trials: randomised trials of EVAR versus standard therapy

摘要: Objective To assess the efficacy of endovascular aneurysm repair (EVAR) against standard alternative management in patients with large abdominal aortic (AAA). Design Two national, multicentre randomised trials - EVAR 1 and 2. Setting Patients were recruited from 38 out 41 eligible UK hospitals. Participants Men women aged at least 60 years, an AAA measuring 5.5 cm on a computerised tomography scan that was regarded as anatomically suitable for EVAR, assessed fitness open repair. considered fit to or trial unfit no intervention Interventions intervention. Main outcome measures The primary mortality (operative, all-cause related). flagged Office National Statistics centrally coded death certificates by Endpoints Committee. Power calculations based upon indicated 900 280 required 2, respectively. Secondary outcomes graft-related complications reinterventions, adverse events, renal function, health-related quality life costs. Cost-effectiveness analyses performed both trials. Results Recruitment occurred between September 1999 31 August 2004, targets exceeded trials: 1252 into (626 EVAR) 404 2 (197 EVAR). Follow-up closed December 2009 very little loss follow-up (1%). In 1, 30-day operative mortalities 1.8% 4.3% open-repair groups, respectively: adjusted odds ratio 0.39 [95% confidence interval (CI) 0.18 0.87], p = 0.02. During total 6904 person-years follow-up, 524 deaths (76 Overall, there significant difference groups terms mortality: hazard (HR) 1.03 (95% CI 0.86 1.23), 0.72. group did demonstrate early advantage AAA-related mortality, which sustained first few but lost end study, primarily due fatal endograft ruptures: HR 0.92 0.57 1.49), 0.73. procedure more expensive than (mean £1177) not found be cost-effective, model sensitive assumptions. during 1413 305 (78 7.3% group. However, this later demonstrated became apparent only after 4 years: overall 0.53 0.32 0.89), Sadly, result any benefit 0.99 0.78 1.27), 0.97. £10,222) cost-effective. Conclusions offers clear over procedures, is translated long-term survival advantage. Among repair, associated reduction does appear influence mortality. Trial registration Current Controlled Trials ISRCTN 55703451. Funding This project funded NIHR Health Technology Assessment programme will published full Assessment; Vol. 16, No. 9. See HTA website further information.