Intravascular lithotripsy safe, effective in complex patients with PAD
In the interim results of the observational DISRUPT PAD III study, intravascular lithotripsy was safe and effective in patients with peripheral artery disease and calcified lesions, researchers reported at VIVA 21.
Ehrin Armstrong, MD, medical director at Adventist Heart and Vascular Institute in St. Helena, California, presented results of 752 consecutive patients (mean age, 72 years; 71% men) with PAD and moderate or worse calcification treated with the peripheral intravascular lithotripsy system (Shockwave IVL, Shockwave Medical) between November 2017 and June 2019. Results were adjudicated by an independent core laboratory.
“Patients with moderate-to-severe calcification are often excluded from endovascular treatment trials, resulting in little available evidence to provide treatment guidance in this challenging patient population,” Armstrong said during a presentation.
All patients were Rutherford class 2 to 6, and adjunctive therapy could be used at the operator’s discretion.
Mean percent diameter stenosis was 80% at baseline and 24% at final analysis, Armstrong said, noting the final complication rate was low, with 0.9% having grade D to F dissections, 0.1% having perforation and no patients having distal emboli, slow flow/no reflow, abrupt closure or thrombus. He also said those results were consistent with data from the DISRUPT PAD III randomized controlled trial.
He said the outcomes were consistent across vessel beds: iliac artery, common femoral artery, superficial femoral artery, popliteal artery and below the knee.
Outcomes were also consistent in complex lesions and complex patients, including lesions at least 15 cm, eccentric lesions, chronic total occlusion, severe calcification and critical limb ischemia, Armstrong said.
Use of adjunctive therapy (atherectomy or special balloon) ranged from 4% in iliac lesions to 37% in common femoral artery lesions and from 22% in patients with CLI to 33% in patients with lesions 15 cm or greater, he said.
“Periprocedural safety and effectiveness with IVL were excellent across vessel beds, complex calcified lesions and CLI patients,” Armstrong said during the presentation. “The DISRUPT PAD III randomized controlled trial will assess long-term durability in IVL treatment of calcified PAD.”
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Armstrong E, et al. Late-Breaking Clinical Trials. Presented at: VIVA 21; Oct. 4-7, 2021; Las Vegas (hybrid meeting).
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