IF06 - Optimal Medical Therapy – Key to Improved Lower Extremity Outcomes Especially Following Endovascular and Infrainguinal Revascularization for Intermittent Claudication

Objectives: Optimal medical therapy (OMT) in patients with systemic atherosclerosis reduces major limb and cardiovascular events. We hypothesized that OMT before intervention is associated with improved 1-year limb outcomes following revascularization for intermittent claudication.

Methods: We identified ambulatory patients in Vascular Quality Initiative (VQI; 2011-2019) receiving initial, elective open or endovascular interventions for claudication, excluding patients with preintervention anticoagulation and incomplete follow-up. Antiplatelet, statin, and non-smoking status defined OMT components and created three groups: complete (all components), incomplete (1-2), and no OMT. Outcomes included 1-year untreated patency loss, reintervention and major adverse limb event (MALE). Patency loss was defined as measured state of patency at follow-up. MALE was defined as major amputation or major reintervention. Multivariate logistic regression generated adjusted odds ratios (aOR) and 95% confidence intervals (95%CI), accounting for pertinent demographic, clinical, and procedural factors, clustered by hospital. Interaction terms evaluated a priori determined subgroup moderation.

Results: 16,645 patients met criteria (age 65.7±10.1 years, 63.3% male, 83.3% White, 33.5% suprainguinal and 19.2% open interventions), of which 6,507 (39.1%) had complete, 9,252 (55.6%) incomplete, and 886 (5.3%) no OMT. Patients with complete OMT were more frequently older, White, and male with more cardiovascular comorbidities (p < 0.01). Complete OMT increased over the course of the study (35.5% to 41.1%; p< 0.01; Figure I).
One-year patency loss was observed for 243 (3.7%) complete, 489 (5.3%) incomplete, and 50 (5.6%) no OMT (p < 0.01). On multivariate modeling, incomplete OMT was associated with reduced patency compared to complete OMT (aOR=1.32 [95%CI,1.11-1.56]). Reintervention at 1-year was observed for 424 (6.5%) complete, 696 (7.5%) incomplete, and 92 (10.4%) no OMT (p < 0.01). No OMT was associated with significantly higher risk of reintervention compared to complete OMT (aOR=1.49 [95% CI, 1.17 – 1.88]). MALE was observed for 428 (6.6%) complete, 705 (7.6%) incomplete, and 92 (10.4%) no OMT (p < 0.01). No OMT was associated with increased MALE (aOR=1.48[95%CI, 1.16-1.88]) (Table).
On subgroup analysis, complete OMT was associated with significantly improved outcomes with greatest association for infrainguinal disease and for endovascular interventions (Figure II; p-interaction < 0.05). The association of reintervention and MALE with OMT was consistently observed across subgroups.

Conclusions: Fewer than half of VQI patients treated for intermittent claudication received complete OMT. Complete OMT was associated with improved patency and reduced MALE, especially for infrainguinal disease and endovascular interventions. In the setting of elective treatment of intermittent claudication, every effort should be made to achieve complete OMT prior to offering revascularization.