HOPE Registry Compares Concept Medical’s MagicTouch Sirolimus DCB and POBA in CLTI

November 1, 2023—The HOPE registry is a single-center prospective registry of patients with chronic limb-threatening ischemia (CLTI). Investigators compared the clinical outcomes of percutaneous transluminal angioplasty (PTA) with the MagicTouch sirolimus-coated balloons (SCB; Concept Medical, Inc.) versus plain old balloon angioplasty (POBA) for patients with CLTI.

Edward Choke, MBBS, PhD, presented the 2-year findings from the HOPE registry during a late-breaking clinical trial session at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on October 30 to November 2 in Las Vegas, Nevada.

The VIVA press release noted that the prospective data captured included preprocedure baseline demographics, angioplasty details, and postprocedure clinical outcomes.

Investigators analyzed consecutive CLTI patients (n = 347) with Rutherford 4, 5, or 6 presentations and de novo infrainguinal artery disease between August 2018 and October 2021. Patients were excluded if they received paclitaxel devices, thrombolysis, or atherectomy devices.

As summarized in the VIVA press release, patients were divided into two groups according to whether they received an SCB in addition to POBA (n = 141) or POBA alone (n = 206). There were no statistically significant differences in the baseline demographics and lesion characteristics between the SCB and POBA groups.

At 2 years, SCBs were associated with statistically significant higher freedom from clinically driven target lesion revascularization (75.2% vs 66.2%; hazard ratio [HR], 0.61; 95% CI, 0.38-0.97; P = .037), higher amputation-free survival (69.5% vs 55.1%; HR, 0.64; 95% CI, 0.46-0.88; P = .007), and higher survival (72.9% vs 64.3%; HR, 0.71; 95% CI, 0.50-0.99; P = .047).

Also, SCBs were numerically but not statistically significantly associated with higher freedom from major amputation at 2 years (93.5% vs 87.1%; HR, 0.63; 95% CI, 0.27-1.45; P = .274).

The study concluded that compared to POBA alone, use of SCBs was associated with improved clinical outcomes at 2 years, and no early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCBs for treatment of CLTI.