Validation of utility of intravascular lithotripsy in lower limb lesions in late-breaking presentation at VIVA 2024

The favorable results, which met both the primary safety and effectiveness endpoint, were presented in a late-breaking presentation at the annual Vascular InterVentional Advances (VIVA) meeting.

Peripheral artery disease (PAD) affects more than eight million people aged 40 and older in the United States. People suffering from PAD not only have impaired quality of life, but also increased risk of heart attack or stroke.  CLTI is the most advanced and serious form of PAD, impacting nearly two million patients in the U.S. It is associated with 40% major amputations at one year and a 50% mortality rate at five years, worse than most forms of cancer.

DISRUPT BTK II is a post-market, prospective, multicenter, core lab-adjudicated, single-arm study led by Venita Chandra, M.D., Vascular Surgeon and Clinical Professor, Division of Vascular Surgery, Stanford Health Care, and Ehrin Armstrong, M.D., Interventional Cardiologist and Medical Director, Adventist Heart & Vascular Institute. The study enrolled 250 patients with 305 lesions across 38 sites globally, representing a complex patient population with 46% of patients presenting with baseline wounds, 80% with CLTI, 70% with diabetes mellitus, 30% with chronic total occlusions (CTOs) and 85% with moderate-to-severe calcium.

“More and more patients with CLTI also present with end-stage renal disease, CTOs, advanced diabetes, or other comorbidities that impact their overall health and our ability to effectively treat their CLTI,” said Dr. Chandra, who presented the study. “These are the patients typically excluded from other studies. We already knew that IVL can reduce significant dissections and the need for provisional stenting over conventional percutaneous transluminal angioplasty in peripheral vessel beds. DISRUPT BTK II 30-day results add to this body of work with the use of IVL in the most challenging patients and showed that IVL offers a safe and effective treatment option that may improve patients’ quality of life and Rutherford Category (RC).”

The primary effectiveness endpoint of procedural success, defined as ≤50% residual stenosis for all treated target lesions without serious angiographic complications was met with a rate of 97.9% at 30-days. The primary safety endpoint, the absence of major adverse limb events (MALE) or Post-Operative Death (POD) within 30 days of the index procedure, was met with a rate of 0.8%. Angiographic complications were rare, with only 1.9% occurring after IVL and 1.0% at the final procedure. Within 30-days, 49% of treated limbs had already improved from their RC baseline (p<0.001) and patients showed a statistically significant improvement in VascuQol scores (12.1 ± 4.0 at baseline to16.1 ± 5.1 at 30-days, p<0.001).

“Patients will now be followed in the study out to two years to assess the long-term durability of the compelling 30-day data in this difficult-to-treat patient population,” said Dr. Armstrong. “With both new IVL devices at our disposal and new data to interpret, I look forward to the additional analyses and learning about the optimal use of IVL to help improve outcomes in these difficult to treat patients.”