Pooled Analysis of the CONFIRM Registries: Outcomes in Renal Disease Patients Treated for Peripheral Arterial Disease Using Orbital Atherectomy

Background. Patients with renal disease typically have severely calcified peripheral arterial disease. As a result, this population may have worse clinical outcomes following endovascular intervention compared to patients without renal insufficiency. Clinical trials typically exclude this patient population. Methods. Analysis of the CONFIRM I-III registries revealed 1105 patients with renal disease (1777 lesions) and 1969 patients without renal disease (2907 lesions) who underwent orbital atherectomy. This subanalysis compared the composite procedural complication rate including dissection, perforation, slow flow, vessel closure, spasm, embolism, and thrombus formation in patients with and without renal disease. Results. Patients with renal disease had a higher prevalence of diabetes (P<.001), hypertension (P<.001), hyperlipidemia (P<.001), and coronary artery disease (P<.001), Rutherford 5 or 6 lesions (P<.001), as well as more lesions treated (P<.001), more vessels treated (P<.001), and more below-the-knee lesions (P<.001). The renal disease and non-renal disease groups had similar composite procedural complication rates (21.3% vs 22.4%; P=.46), dissection (11.1% vs 11.5%; P=.83), perforation (0.6% vs 0.8%; P=.55), slow flow (5.0% vs 4.2%; P=.19), spasm (6.7% vs 6.2%; P=.40), embolism (1.7% vs 2.6%; P=.12), and thrombus formation (1.4% vs 1.0%; P=.56). The renal disease group had a trend toward decreased vessel closure (1.1% vs 1.6%; P=.08). Conclusion. Plaque modification with orbital atherectomy resulted in similar low rates of procedural complications in the renal disease group compared with the non-renal disease group despite more unfavorable baseline clinical and lesion characteristics in the renal disease group.