Nationwide Study of the Outcome of Treatment of Lower Extremity Atherosclerotic Lesions With Endovascular Surgery With or Without Drug Eluting Methods in Patients With Diabetes

Abstract

Paclitaxel eluting balloons and stents reduce the development of intimal hyperplasia and restenosis rate after endovascular treatment for peripheral arterial disease (PAD) in the lower extremities. As diabetes mellitus (DM) worsens the prognosis in PAD patients after invasive endovascular treatment, we assessed the effects of drug eluting technology for PAD with special focus on effects in patients with and without DM. All Swedish patients registered in the Swedish vascular registry Swedvasc after vascular or endovascular surgery for intermittent claudication, IC; (n=1948) or chronic limb threatening ischemia, CLTI (n=3353) in 2013 to 2015 were followed up regarding a composite of either major amputation and/or mortality during median 607 days and for reinterventions for PAD during median 522 days. Patients with DM registered in the Swedish National Diabetes Registry (NDR) and patients without DM were evaluated separately. The 201 CLTI patients with DM treated with drug eluting methods had a lower adjusted risk for amputation or mortality after adjustment than the 1476 CLTI patients with DM treated without drug eluting methods (hazard ratio [HR] 0.712 [0.562-0.901], P=.005). There were no differences among IC patients. Regarding the need for reinterventions for PAD, there were no differences between patients treated with and without drug eluting methods, irrespectively of the presence or absence of DM. In conclusion, this nationwide follow-up study indicated potential benefits of drug eluting treatment in CLTI patients with diabetes. The results need to be evaluated and confirmed in prospective randomized studies. Clinical Impact This retrospective observational registry trial combines national registries for vascular surgical procedures and diabetes mellitus to clarify results of drug eluting technology in treating diabetic subjects with intermittent claudication or chronic limb threatening ischemia compared to treatment of non-diabetic subjects. As earlier proposed and showed in this trial, there may be an implication for a beneficial treatment efficacy with drug eluting therapy in the diabetic population with PAD compared to the non-diabetic population. A finding worth further exploration.