Pooled analysis of the CONFIRM registries: safety outcomes in diabetic patients treated with orbital atherectomy for peripheral artery disease.

PURPOSE: To compare the acute outcomes of orbital atherectomy treatment in diabetic vs. non-diabetic patients with peripheral artery disease (PAD).

METHODS: The CONFIRM registry series contained 1842 diabetic patients (1111 men; mean age 70.6±10.2 years) with 2819 lesions and 1247 non-diabetic patients (732 men; mean age 72.9±10.7 years) with 1885 lesions. The composite rate of procedure-related complications, including dissection, perforation, slow flow, vessel closure, spasm, embolism, and thrombus formation, was analyzed for the diabetic and non-diabetic groups.

RESULTS: Diabetics were younger but had a higher prevalence of coronary artery disease (p<0.001), renal disease (p<0.001), hypertension (p<0.001), hyperlipidemia (p<0.001), and lower ankle-brachial index scores (p=0.007). Diabetics had more severe PAD (Rutherford category 4-6; p<0.001), longer lesions (p<0.001), more infrapopliteal lesions (58% vs. 46%, p<0.001), and more lesions with severe and moderate calcium (86% vs. 78%, p<0.001). Diabetic and non-diabetic patients had the same (21.8%) composite rate of procedure-related complications, as well as similar rates of dissection (11.4% vs. 10.8%, p=0.68), embolism (2.2% vs. 2.4%, p=0.67), and thrombus formation (1.3% vs. 1.1%, p=0.75). However, diabetics had lower rates of perforation (0.5% vs. 1.1%, p=0.03) and spasm (5.5% vs. 7.6%, p=0.005), but a higher rate of slow flow (5.0% vs. 3.5%, p=0.02) and a tendency toward increased vessel closure (1.7% vs. 0.9%, p=0.06).

CONCLUSION: Plaque modification with orbital atherectomy resulted in similar low procedure-related complication rates in both the diabetic and non-diabetic groups, despite diabetics having more unfavorable baseline clinical and lesion characteristics. This study suggests that orbital atherectomy is a safe and effective treatment modality in both the diabetic and the non-diabetic populations.