Safety and efficacy metrics for primary nitinol stenting in femoropopliteal occlusive disease: A meta-analysis and critical examination of current methodologies

Background The efficacy and safety of primary stenting for superficial femoral artery (SFA) disease have been benchmarked against historically derived performance goals. However, contemporary evidence evaluating SFA stenting is accumulating. The objective of this systematic review and meta‐analysis was to quantitatively assess outcomes after primary SFA stenting with nitinol stents in contemporary practice, to compare these rates with commonly used efficacy and safety goals, and to discuss the clinical and regulatory implications of these findings. Methods and Results We searched MEDLINE, the US Food and Drug Administration (FDA) website, reference lists of qualifying articles, and conference proceedings until October 2012. Studies prospectively assessing primary nitinol stenting for diseased SFA were sought. Data from 11 prospective clinical trials were included. The twelve‐month primary patency (PP) rate was reported in five trials. The meta‐analytic 12‐month PP rate was 71.6% (95% confidence interval [CI] 66.4–76.7%). The meta‐analytic rate of 30‐day freedom from a composite of death, target limb amputation, and reintervention was 99.9% (95% CI 100.0–90.0%). Conclusion Contemporary nitinol‐based bare‐metal stents performed well in controlled settings. Occurrence of the 1‐month composite safety endpoint was extremely uncommon. © 2013 Wiley Periodicals, Inc.