Abstract

Introduction: There is limited data on outcomes of percutaneous endovascular intervention for lower extremity peripheral artery disease (PAD) in patients with diabetes mellitus (DM). We assessed the hypothesis that patients with DM, in comparison to patients without DM, have higher rates of major adverse cardiovascular and limb events after lower extremity PAD stenting. Methods: 1,006 patients with primary stent implant procedures between January 2005 and October 2015 enrolled in the observational XLPAD registry (NCT01904851) were analyzed for 12 month major adverse cardiovascular events (MACE; all-cause death, myocardial infarction, and stroke) and major adverse limb events (MALE; target limb repeated endovascular intervention, surgical revascularization, and major amputation). Cochran-Mantel-Haenszel statistics was used for overall association of categorical baseline characteristics; Cox proportional regressions and Kaplan-Meier curves were used for median time to event analysis. Results: At baseline, patients with DM had higher prevalence of coronary artery disease (74.9% vs. 56.2%; p<0.0001), heart failure (22.9% vs. 10.9%; p<0.001), prior myocardial infarction (27.3% vs. 22.5%; p=0.0076) and prior stroke (10.3% vs. 5.8%; p<0.0001) in comparison to patients without DM. Cox proportional regressions after adjusting for baseline characteristics showed significantly higher MACE (8.5% vs. 4.0%; Hazard ratio (HR) 1.99; 95% CI 1.26-3.50; p=0.003, Figure 1A ) as well as MALE (49.0% vs. 40.9%; HR 1.22; 95% CI 1.01-1.48; p=0.043, Figure 1B ) in patients with DM at 12-months. Conclusion: PAD in patients with DM is associated with significantly higher rates of major adverse cardiovascular and limb events.

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