November 5, 2019
DISAPEAR Registry Evaluates Abbott's Absorb BVS in Asian Cohort With CLTI
November 6, 2019—One-year results from the DISAPEAR registry evaluating the Absorb bioresorbable vascular scaffold (BVS; Abbott) were presented by Steven Kum, MD, in a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
The DISAPEAR registry aimed to evaluate the safety and effectiveness of the Absorb BVS in an Asian cohort exclusively with chronic limb-threatening ischemia (CLTI). Previously, the Absorb BVS demonstrated favorable short- and medium-term results in below-the-knee vessels in patients with CLTI or claudication.
As summarized by VIVA, the retrospective analysis was performed in patients with Rutherford class 4 to 6 CLTI with de novo infrapopliteal lesions with angiographic stenosis > 50%. Patients were treated with the Absorb BVS between August 2012 and June 2017 at Changi General Hospital in Singapore. Assessments included technical success, primary patency (duplex ultrasound peak systolic velocity ratio < 2), 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.
The study was composed of 41 patients (41 limbs) with 53 lesions treated with 69 scaffolds during the study period. Approximately 90% of the patients had diabetes, 59% had ischemic heart disease, 12% had dialysis-dependent renal failure, and 93% had Rutherford category 5 or 6 ischemia with tissue loss.
Dr. Kum reported that technical success was achieved in all patients. The mean lesion length was 22.7 ± 17.2 mm, and 24% of lesions were classified as severely calcified according to the PARC classification.
The study found the following at 6 and 12 months, respectively:
- Primary patency, 95% and 86%
- Freedom from CD-TLR, 98% and 93%
- Freedom from major amputation, 98% and 98%
- Amputation-free survival, 93% and 85%
Additionally, complete wound healing occurred in 79.5% of 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.
The investigators concluded that the Absorb BVS demonstrated good patency and clinical outcomes in patients with CLTI, complex infrapopliteal disease, and comorbidities such as diabetes and renal failure. Future prospective controlled studies can further help corroborate the significance of these findings, advised Dr. Kum in the VIVA presentation.