![]() Low primary patency and increased repeat intervention rates, mainly due to vascular restenosis by means of intimal hyperplasia and negative vessel wall remodelling, has orientated modern cardiovascular research toward new alternative techniques, such as atherectomy, laser-assisted angioplasty, covered stent-grafts, brachytherapy, and cryoplasty. ĭespite their safety and versatility, current results of minimally invasive endovascular techniques for atherosclerotic lesions in the superficial femoral (SFA) and popliteal (PA) arteries remain mediocre, with reported 2-year patency rates between 40 and 60%. Interestingly, DM has been identified as an independent risk factor of recurrent occlusive disease symptoms, and there is a trend toward decreased vascular patency and higher rates of repeat intervention procedures after percutaneous or surgical revascularization of the infrainguinal arteries. Of note, almost half of all amputees suffer from DM. Owing to a higher prevalence of diabetic foot ulcers and critical limb ischemia (CLI), diabetic patients demonstrate a 5 times higher risk of amputation and a 10 times higher risk of mortality after percutaneous treatment of peripheral arterial occlusive disease (PAOD) compared with normoglycemic patients. DM is a well-recognized independent risk factor of atherosclerosis and peripheral arterial disease, inducing multilevel, mainly small-vessel disease of the coronary and infrapopliteal arteries. Cryoplasty was associated with lower primary patency and more clinically driven repeat procedures after long-term follow-up compared with conventional balloon angioplasty.ĭiabetes mellitus (DM) is developing into a worldwide epidemic with an estimated prevalence of 5.4%, and >300 million people will be affected by the year 2025. Significantly more repeat intervention events because of recurrent symptoms were required in group CRYO (HR 2.5 95% CI 1.2–5.3, p = 0.01). Primary patency was significantly lower in group CRYO compared with group COBA (HR 2.2 95% CI 1.1–4.3, p = 0.02). There was a nonsignificant trend of increased binary restenosis in group CRYO (hazard ratio 1.3 95% CI 0.6–2.6, p = 0.45). 92.1% in groups CRYO and COBA, respectively, p = 0.60). 87.0% in group COBA, p = 0.54) and limb salvage (95.8 vs. According to 3-year Kaplan–Meier estimates, there were no significant differences with regard to patient survival (86.8% in group CRYO vs. Immediate technical success rate was 58.0% in group CRYO versus 64.0% in group COBA ( p = 0.29). More than 70% of the lesions were Transatlantic Inter-Society Consensus (TASC) B and C in both groups, and 41.4% of the patients in group CRYO and 38.7% in group COBA suffered from critical limb ischemia. In total, 61.3% (19 of 31) in group CRYO and 52.9% (18 of 34) in group COBA were de novo lesions. Cox proportional hazards regression analysis was performed to adjust for confounding factors of heterogeneity. Technical success was defined as 50%), and freedom from target lesion recanalization. Fifty diabetic patients (41 men, mean age 68 years) were randomized to cryoplasty (group CRYO 24 patients with 31 lesions) or conventional balloon angioplasty (group COBA 26 patients with 34 lesions) of the femoropopliteal artery. The purpose of this study was to investigate the immediate and long-term results of cryoplasty versus conventional balloon angioplasty in the femoropopliteal artery of diabetic patients.
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