One-Year Results of the DISAPEAR Registry Positive for Absorb Stent – Diagnostic and Interventional Cardiology

November 8, 2019 The Absorb bioresorbable stent (BVS) demonstrated good patency and clinical outcomes in patients with chronic limb-threatening ischemia (CLTI) in the DISAPEAR Registry. This included complex infrapopliteal disease and comorbidities such as diabetes and renal failure, said Steven Kum, M.D., who presented the trial at the 2019 Vascular Interventional Advances (VIVA) annual meeting.

Future prospective controlled studies can further help corroborate the significance of these findings, Kum said.

The Abbott Absorb BVS has demonstrated favorable short- and medium-term results in below-the-knee vessels in patients with CLTI or claudication. The DISAPEAR registry aimed to evaluate the safety and effectiveness of the Absorb BVS in an Asian cohort exclusively with CLTI.

A retrospective analysis was performed in patients with Rutherford class 4 to 6 CLTI with de novo infrapopliteal lesions with angiographic stenosis > 50 percentwho were treated with Absorb BVS between August 2012 and June 2017 at Changi General Hospital, Singapore. Assessments included technical success, primary patency (duplex ultrasound peak systolic velocity ratio < 2.0), freedom from clinically driven target lesion revascularization (CD-TLR), amputation-free survival, limb salvage, and wound healing at 6 and 12 months after the index intervention.

Forty-one patients (41 limbs) with 53 lesions were treated with 69 scaffolds during the study period. About 90 percentof the patients had diabetes, 59 percenthad ischemic heart disease, 12 percenthad dialysis-dependent renal failure, and 93 percenthad Rutherford category 5/6 ischemia with tissue loss.

Technical success was achieved in all patients. The mean lesion length was 22.7 17.2 mm. Twenty-four percent of lesions were classified as severely calcified according to the PARC classification. The primary patency rates at 6 and 12 months were 95 percentand 86 percent, respectively. The corresponding rates of freedom from CD-TLR were 98 percentand 93 percent. Freedom from major amputation was 98 percentat both time points and amputation-free survival was 93 percentand 85 percentat 6 months and 1 year after the index procedure. Complete wound healing occurred in 79.5 percentof patients with Rutherford 5 and 6 ischemia by the end of 12 months after the index procedure. There were no deaths within 30 days of the index intervention.

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One-Year Results of the DISAPEAR Registry Positive for Absorb Stent - Diagnostic and Interventional Cardiology