Patients with complex calcified peripheral artery stenosis who underwent intravascular lithotripsy had minimal vessel injury and minimal use of adjunctive stents, according to results from DISRUPT PAD II study published in Catheterization and Cardiovascular Interventions.
Marianne Brodmann, MD, of the clinical division of angiology in the department of internal medicine at Medical University Graz in Austria, and colleagues analyzed data from 60 patients (mean age, 72 years; 78% men) with calcified peripheral artery stenosis. Patients also had claudication or rest pain, target zone length 150 mm or less, diameter stenosis of at least 70%, a minimum of one vessel run-off and a reference vessel diameter between 3.5 mm and 7 mm.
Enrollment into the study was considered once insertion of an intravascular lithotripsy catheter (Peripheral IVL System, Shockwave Medical) was performed.
The primary efficacy endpoint was patency at 12 months. The primary safety endpoint was major adverse events at 30 days. A key secondary endpoint was clinically driven target lesion revascularization.
Final residual stenosis in the study was 24.2%, and 3 mm was the average acute gain.
The major adverse event rate was 1.7% at 30 days. One grade D dissection occurred, which was resolved after a stent was placed, Brodmann and colleagues wrote.
At 12 months, primary patency was 54.5% for the intention-to-treat group vs. 62.9% who underwent the optimal technique, which was defined as correct balloon sizing and avoiding therapeutic miss. Clinically driven TLR at 12 months was 20.7% for patients in the intention-to-treat group compared with 8.6% in the optimal-technique group.
“Treatment with [intravascular lithotripsy] is associated with minimal vascular complications, a large acute gain and minimal use of stent implants,” Brodmann and colleagues wrote. “[Intravascular lithotripsy] technique can be optimized to improve patency at 12 months and can be easily adopted by peripheral interventionalists.” – by Darlene Dobkowski
Disclosures: The study was funded by Shockwave Medical. Brodmann reports she received institutional grants for this study and has participated in physician advisory meetings for Shockwave Medical. Please see the study for all other authors’ relevant financial disclosures.