Thirty-Day Outcomes From the Disrupt PAD BTK II Study
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NYU Langone Medical Center, New York
At ISET 2025 on Tuesday, Anvar Babaev, MD, PhD, director of endovascular interventions at NYU Langone Medical Center in New York, presented findings from the Disrupt PAD BTK II study, a prospective, multicenter trial assessing the efficacy and safety of Shockwave intravascular lithotripsy (IVL) in treating calcified below-the-knee (BTK) peripheral artery disease (PAD). This study is particularly relevant for patients with chronic limb-threatening ischemia (CLTI), who often experience severe BTK disease, characterized by small vessels, long lesions, and moderate-to-severe calcification.
Dr Babaev outlined the challenges of BTK treatment disease, which is complex due to small vessel size and diffuse lesions, severe calcification (both superficial and deep), and a high risk of procedural complications. Conventional therapies such as balloon angioplasty and stenting often show limited long-term success in these cases.
Discussing the design of the Disrupt PAD BTK II, Dr Babaev described the study as a prospective, multicenter, single-arm clinical trial to evaluate the Shockwave IVL system. The study was closely monitored by an independent clinical events committee, the Angiographic Core Lab (Yale Cardiovascular Research Group), and the Duplex Ultrasound Core Lab (VasCore). Key inclusion criteria included least moderate calcification, Rutherford category (RC) 3 to 5 (indicating rest pain or tissue loss), and up to 2 BTK lesions (≤200 mm in length). Key exclusion criteria include planned use of cutting/scoring balloons, re-entry devices, or atherectomy; in-stent restenosis; severe renal disease (unless on dialysis). The primary safety endpoint was major adverse limb events (MALE) or postoperative death (POD) at 30 days, and the primary effectiveness endpoint was procedural success defined as ≤50% residual stenosis without major complications. The study enrolled 250 patients with 305 lesions, and 30-day follow-up was achieved in 242 patients (97.9% compliance).
Dr Babaev then described the key findings of the study. Procedural success was high, with significant stenosis reduction in treated lesions. Safety outcomes were favorable, with low MALE rates, no major device-related complications, and minimal angiographic complications, including perforations or embolization. Of the 250 patients, 48.9% showed improvement in Rutherford category (P<0.001). VascuQoL scores significantly improved, indicating better quality of life for patients.
In conclusion, the Disrupt PAD BTK II Study highlights the potential of Shockwave IVL as an effective and safe alternative for treating calcified BTK lesions in CLTI patients.
