Comparison of percutaneous versus cutdown access in patients after endovascular abdominal aortic repair: a randomized controlled trial (SWEET-EVAR trial).

Abstract

Introduction: The optimal choice of either percutaneous or cutdown access for endovascular abdominal aortic repair (EVAR) remains uncertain due to insufficient evidence, particularly regarding patient-centered outcomes (PCOs). This study aimed at comparing both clinician-reported outcomes (ClinROs) and PCOs of percutaneous versus cutdown access in patients after EVAR.

Methods: The study was a single-blind, single-center, non-inferiority, randomized controlled trial. After eligibility screening, patients diagnosed with abdominal aortic diseases were randomly assigned to either the intervention group receiving percutaneous EVAR or the control group receiving cutdown EVAR. Primary ClinRO was access-related complications, and primary PCO was time return to normal life/work.

Results: Overall, 120 patients (containing 240 accesses) were allocated to either intervention group (n = 62) or control group (n = 58). Percutaneous EVAR (10/124, 8.1%) was non-inferior and not superior to cutdown EVAR (17/116, 14.7%) regarding access-related complications (P = 0.110; OR: 0.521, 95% CI: 0.225-1.157). As for PCOs, the recovery time back to normal life or work was superior in percutaneous EVAR compared to cutdown EVAR (16 vs. 28 days, P = 0.025; median difference: 7 days, 95% CI: 0-13 days). Moreover, percutaneous access did better in other PCOs, including a reduction in the duration of access-related pain (4 vs. 8 days, P = 0.001), decreased use of analgesics for access-related pain (0/61, 0% vs. 6/55, 10.9%; P = 0.026), and improved quality of life scores at 2 weeks following EVAR (0.876 vs. 0.782; P = 0.022). Prespecified subgroup analyses demonstrated percutaneous access significantly reduced the incidence of access-related complications compared to cutdown access in patients with thick subcutaneous tissue (1/42, 2.4% vs. 7/32, 21.9%; P = 0.026).

Conclusion: In patients without massive common femoral artery calcification, percutaneous access may accelerate postoperative recovery and enhance patient experience and quality of life following EVAR, but did not provide obvious advantages regarding access-related complications.