SHERIDAN, WYOMING – November 10, 2024 – Shockwave Medical, a Johnson & Johnson MedTech company, has announced encouraging results from its DISRUPT BTK II study, which investigated the use of Intravascular Lithotripsy (IVL) in patients with calcified peripheral lesions below the knee. The study focused on patients with Critical Limb-Threatening Ischemia (CLTI), a severe form of peripheral artery disease (PAD) that can lead to amputation.
PAD affects over 8 million people over 40 in the United States, with CLTI representing the most serious form. It can lead to a 40% major amputation rate within a year and a 50% mortality rate within five years.
The DISRUPT BTK II study enrolled 250 patients with 305 lesions across 38 sites worldwide. The study population included a high percentage of patients with comorbidities such as diabetes, chronic total occlusions (CTOs), and moderate-to-severe calcium, making them particularly challenging to treat.
Dr. Venita Chandra, a Vascular Surgeon and Clinical Professor at Stanford Health Care, who led the study, highlighted the complexity of these patients: “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. These are the patients typically excluded from other studies.”
The study found that IVL, a procedure that uses sonic pressure waves to break down calcified plaque, was both safe and effective in this challenging patient population. The primary effectiveness endpoint, defined as a reduction in stenosis (narrowing of the artery) without serious complications, was achieved in 97.9% of cases at 30 days. The primary safety endpoint, which measured the absence of major adverse limb events or death within 30 days, was met with a rate of 0.8%.
Dr. Chandra added: “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 Rutherford Category (RC) is a classification system used to assess the severity of PAD. Within 30 days, 49% of treated limbs showed improvement in their RC baseline. Additionally, patients reported a significant improvement in their quality of life, as measured by VascuQol scores.
Dr. Ehrin Armstrong, an Interventional Cardiologist and Medical Director at Adventist Heart & Vascular Institute, who co-led the study, commented on the next steps: “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. 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.”
Shockwave Medical's IVL technology offers a potential breakthrough in the treatment of PAD, particularly in patients with complex cases and comorbidities. The DISRUPT BTK II study provides further evidence of the safety and effectiveness of this innovative approach, offering hope for improved outcomes and quality of life for those suffering from this debilitating condition.