Routinely ultrasound surveillance improves outcome after endovascular treatment of peripheral arterial disease: propensity-matched comparisons of clinical outcomes after ultrasound or clinical-hemodynamic based surveillance programs.

Background: Endovascular treatment (EVT) has replaced open repair as the first option in intermittent claudication (IC) and chronic limb-threatening ischemia (CLTI) in several centers. However, evidence of the most optimal post-procedural surveillance strategy is sparse. This study aimed to compare two routine surveillance programs after EVT of IC/CLTI: clinical and hemodynamic assessment (CHA) vs. duplex ultrasound (DUS) and clinical/hemodynamic assessment in combination.

Methods: Between February 2012 and December 2015, all patients with EVT of IC/CLTI were allocated to either CHA or DUS-based routine surveillance programs. The allocation-ratio was 1:2 (CHA:DUS), and propensity score matching (PSM) was used to control baseline differences between the groups. Follow-up visits in the CHA group consisted of clinical assessment and ABI at 3, 6, 12 and 24 months. Follow-up visits in DUS group consisted of clinical assessment, ABI, and target vessel DUS at 1, 3, 6, 12, 18 and 24 months.

Results: In total, 340 legs in 305 patients suffering from IC/CLTI were included; 111 (33%) in the CHA-group and 229 (67%) in the DUS group. The two groups were identical except for a significantly lower incidence of diabetes mellitus in the CHA group than the DUS group, 55% vs. 72%, respectively (P=006). Based on PSM, the CHA-group vs. the DUS-group was burdened of an increased risk of amputation (12.5% vs. 8.27%, HR=0.41 [95% CI: 0.17-0.96]), and a higher mortality (21.2% vs. 12.8%, HR=0.37 [95% CI: 0.19-0.72]). The reported differences in reintervention rate (7.5% vs. 12.8%, HR=1.12 [95% CI: 0.44-2.84]) were insignificant. The mean follow-up was 317 days (SD=0.214) in the CHA group and 611 days (SD=0.298) in the DUS group.

Conclusions: Our results suggest that DUS-based routine surveillance after EVT of IC/CLTI is superior to CHA-based routine surveillance in improved amputation rate and mortality.