Effects of study design and trends for EVAR versus OSR

PURPOSE To investigate if study design factors such as randomization, multi-center versus single center evidence, institutional surgical volume, and patient selection affect the outcomes for endovascular repair (EVAR) versus open surgical repair (OSR). Finally, we investigate trends over time in EVAR versus OSR outcomes. METHODS Search strategies for comparative studies were performed individually for: OVID's MEDLINE, EMBASE, CINAHL, HAPI, and Evidence Based Medicine (EBM) Reviews (including Cochrane DSR, ACP Journal Club, DARE and CCTR), limited to 1990 and November 2006. RESULTS Identified literature: 84 comparative studies pertaining to 57,645 patients. These include 4 randomized controlled trials (RCTs), plus 2 RCTs with long-term follow-up. The other 78 comparative studies were nonrandomized with 75 reporting perioperative outcomes, of which 16 were multi-center, and 59 single-center studies. Of the single-center studies 31 were low-volume and 28 were high-volume centers. In addition, 5 studies had all patients anatomically eligible for EVAR, and 8 studies included high-risk patients only. Finally, 25 long term observational studies reported outcomes up to 3 years. OUTCOMES Lower perioperative mortality and rates of complications for EVAR versus OSR varied across study designs and patient populations. EVAR adverse outcomes have decreased in recent times. CONCLUSION EVAR highlights the problem of performing meta-analysis when the experience evolves over time.