Disrupt PAD BTK II Evaluates Shockwave IVL System to Treat Calcified Lesions

November 4, 2024—The Disrupt PAD BTK II study’s 30-day outcomes were revealed. The core lab–adjudicated, prospective, multicenter, single-arm study is evaluating patients with moderately to severely calcified below-the-knee (BTK) lesions treated with the Shockwave peripheral intravascular lithotripsy (IVL) system (Shockwave Medical).

Venita Chandra, MD, presented the findings in the first late-breaking clinical trials session at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.

According to the VIVA24 press release, BTK lesions in peripheral artery disease (PAD) may be particularly challenging to treat owing to length, diffuse disease, and extent of calcification. Disrupt PAD BTK II enrolled 250 patients with calcified infrapopliteal lesions and Rutherford category 3 to 5 presentation from 38 sites in the United States and Europe.

The study’s primary safety endpoint was major adverse limb events (MALE) or postoperative death at 30 days. The primary effectiveness endpoint was procedural success, defined as ≤ 50% residual stenosis for all treated target lesions without serious core lab–adjudicated serious angiographic complications. Follow-up is planned through 2 years.

As summarized in the press release, investigators treated a total of 305 lesions in 250 patients with a procedural success of 97.9%. Mean target lesion length was 76.3 ± 65.2 mm, diameter stenosis was 77.7% ± 17.9%, and 84.8% had moderate or severe calcification as assessed by an independent angiographic core lab.

The study findings included the following:

• After IVL, residual stenosis was reduced to 29% and to 25.5% after optional postdilatation and/or stent implantation.
• At 30 days, there were no deaths, the MALE rate was 0.8%, and mean improvement in VascuQoL scores was 4 ± 5 (P < .0001).
• Of the patients with baseline wounds, 15.8% healed and 53.4% were improved at 30 days.

IVL treatment of patients with moderately to severely calcified BTK lesions resulted in high procedural success, significant reduction in residual stenosis, and improvements in patient quality of life and wound healing, with minimal adverse events at 30-day follow-up.

These outcomes support the safety and effectiveness of IVL in the treatment of patients with complex calcified BTK lesions, concluded the study investigators in the VIVA24 press release.