- DISRUPT BTK II study involved 250 patients with 305 lesions across 38 sites globally.
- Key findings: 94.8% freedom from major limb amputation, 84.5% freedom from revascularization.
- 67.1% durable patency and 75.5% RC class improvement observed at one year.
- 80% of trial patients had chronic limb-threatening ischemia.
Study Overview
Johnson & Johnson MedTech announced the one-year results of the DISRUPT BTK II study, assessing the Shockwave Peripheral IVL System's safety and effectiveness for treating calcified lesions below the knee in peripheral artery disease (PAD) patients. The study included 250 patients with 305 lesions across 38 sites globally, focusing on complex cases, including those with chronic limb-threatening ischemia (CLTI).
Key Findings
The study reported 94.8% freedom from major target limb amputation and 84.5% freedom from clinically driven target revascularization at one year. Durable patency was observed in 67.1% of patients, and 75.5% achieved RC class improvement, with nearly 50% becoming asymptomatic. Wound healing or improvement was noted in 61.3% of patients.
CLTI Cohort Results
Within the CLTI cohort, which comprised 80% of trial patients, 8.1% experienced amputation. The proportion of patients with a CLTI Rutherford classification improved from 80.1% at baseline to 25.1% at one-year follow-up. Significant symptomatic and VascuQoL improvements were documented, with a more than 5-point increase from baseline.
Implications and Future Research
The results highlight IVL's role in wound healing and limb preservation, reducing amputations and improving mobility for severe PAD patients. The study will continue tracking outcomes over two years to evaluate long-term durability. The findings set a new standard for treating complex below-the-knee lesions, offering a frontline strategy for high-risk patients.
