Abstract
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. We identified ambulatory patients in the Vascular Quality Initiative (2011-2019) undergoing 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. There were 16,645 patients who met the criteria (age 65.7 ± 10.1 years, 63.3% male, 83.3% White, 33.5% suprainguinal, and 19.2% open interventions), of which 6507 (39.1%) had complete, 9252 (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 < .01). Complete OMT increased over the course of the study (35.5% to 41.1%; P < .01; Fig 1). One-year patency loss was observed for 243 (3.7%) complete, 489 (5.3%) incomplete, and 50 (5.6%) no OMT (P < .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 < .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 < .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 (Fig 2; Pinteraction < .05). The association of reintervention and MALE with OMT was consistently observed across subgroups. Fewer than half of Vascular Quality Initiative 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.Fig 2Subgroup analysis for association of optimal medical therapy with the outcome of patency loss.View Large Image Figure ViewerDownload Hi-res image Download (PPT)TableMultivariate models for association of optimal medical therapy (OMT) with loss of patency, reintervention, and major adverse limb events (MALE)Loss of patencyReinterventionMALEaOR95% CIaOR95% CIaOR95% CIOMT Complete1Reference1Reference1Reference Incomplete1.321.11-1.561.110.96-1.281.120.97-1.29 No1.340.94-1.931.491.17-1.881.481.16-1.88Age, years 0-591Reference1Reference1Reference 60-690.830.69-1.010.880.75-1.030.880.75-1.03 70-790.610.47-0.80.710.58-0.870.710.58-0.86 ≥800.660.49-0.910.620.46-0.840.630.47-0.84Male sex0.800.68-0.950.720.63-0.820.720.63-0.83Race White1Reference1Reference1Reference Black1.210.96-1.540.810.64-1.020.820.66-1.03 Other1.060.74-1.530.940.67-1.310.930.67-1.29Open revascularization3.442.71-4.370.340.27-0.430.370.29-0.46Risk Analysis Index defined frailty status Robust1Reference1Reference1Reference Normal0.810.56-1.160.700.53-0.930.710.53-0.94 Frail0.830.56-1.240.640.46-0.890.660.48-0.92 Very frail1.000.59-1.690.670.43-1.020.670.44-1.02Infrainguinal revascularization4.973.96-6.242.492.12-2.922.472.1-2.89Coronary artery disease0.850.71-1.010.810.71-0.910.810.72-0.92Diabetes0.970.83-1.141.020.89-1.181.030.9-1.19aOR, Adjusted odds ratio; CI, confidence interval. Open table in a new tab
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