Johnson & Johnson (J&J) MedTech has reported one-year outcomes from the DISRUPT BTK II trial of the Shockwave Peripheral intravascular lithotripsy (IVL) System to treat calcified lesions below the knee (BTK) in individuals with peripheral artery disease (PAD).
The multi-centre, prospective, single-arm, post-market trial included a significant proportion of those diagnosed with chronic limb-threatening ischaemia (CLTI).
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According to the full cohort results, 94.8% of subjects remained free from major target limb amputation at one year, with no amputations recorded among those who did not have CLTI at baseline.
Additionally, 84.5% of participants avoided clinically driven target revascularisation within a year.
Durable vessel patency was identified in 67.1% of subjects one year after treatment. Improvement by at least one Rutherford Class was seen in 75.5% of cases, and nearly half of the subjects were asymptomatic at the one-year mark.
Moreover, wound healing or improvement was noted in 61.3% of subjects.
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By GlobalDataWithin the cohort of patients diagnosed with CLTI, which represented 80% of those enrolled, 8.1% experienced an amputation by one year.
The proportion of subjects classified as having CLTI based on Rutherford criteria showed improvements from 80.1% at baseline to 25.1% among those who completed follow-up after one year.
In CLTI subjects, 82.7% were free from clinically driven target lesion revascularisation after a year, and primary patency was maintained in 64% at the same interval.
DISRUPT BTK II is spearheaded by Stanford Health Care Division of Vascular Surgery clinical professor and vascular surgeon Venita Chandra, and Adventist Heart & Vascular Institute medical director and interventional cardiologist Ehrin Armstrong.
The trial recruited 250 subjects with a total of 305 lesions across 38 global sites. The patient group included 200 who had CLTI; 58.5% presented with wounds; 70% had diabetes mellitus; 30% had chronic total occlusions; and 85% had moderate-to-severe arterial calcification.
Chandra said: 鈥淲e will continue tracking patient outcomes through two years to evaluate the long-term durability of these compelling results, and we look forward to the additional analyses to continue to optimise outcomes in this complex, real-world patient population.鈥�
In September 2025, J&J announced the European launch of its Shockwave Javelin Peripheral IVL Catheter, designed to treat calcium deposits in severely narrowed blood vessels.
