Intravascular lithotripsy improves stenosis in real-world cohort of calcified PAD
In a real-world observational study, intravascular lithotripsy was associated with improvement in stenosis in patients with calcified peripheral artery disease, researchers reported at VIVA 22.
Ehrin J. Armstrong, MD, MSc, FACC, FSCAI, FSVM, medical director at Adventist Heart and Vascular Institute in St. Helena, California, and colleagues conducted the single-arm DISRUPT PAD III Observational Study to determine the procedural safety and effectiveness of intravascular lithotripsy (Shockwave IVL, Shockwave Medical) in a real-world cohort of patients with calcified PAD.
The cohort included 1,262 patients (mean age, 72 years; 70% men; 36% with critical limb ischemia) with 1,531 lesions that were treated with intravascular lithotripsy and underwent core laboratory assessment.
“Calcified PAD complicates endovascular treatment,” Armstrong said during a presentation. “Moderate to severe calcification is often excluded from trials, resulting in a paucity of data to guide treatment in this challenging population.”
Use of adjunctive therapies was common, with 8% receiving a scoring/cutting balloon, 16% receiving atherectomy, 54% receiving a drug-coated balloon and 32% receiving a stent, Armstrong said.
Mean percent diameter stenosis fell from 81% before the procedure to 33% immediately after intravascular lithotripsy and 24% at the end of the procedure, Armstrong said, noting the results were similar to those assigned intravascular lithotripsy in the DISRUPT PAD III randomized controlled trial.
Grade D through F dissections occurred in 2.2% of patients after intravascular lithotripsy and 0.7% at the end of the procedure, and there were few or no cases of perforation, distal emboli, slow or no reflow, abrupt closure or thrombus, he said.
The results were consistent across subgroups of challenging patient/lesion types, including long lesions (at least 15 cm), eccentric lesions, chronic total occlusion, severe calcification and below-the-knee lesions, according to the researchers.
In a multivariable analysis, the odds of achieving residual stenosis less than 30% were lower in patients with lesions with 15 cm or more (OR = 0.384; 95% CI, 0.283-0.521; P < .0001) and in those with CTO (OR = 0.638; 95% CI, 0.482-0.844; P = .0017), but higher in women (OR = 1.85; 95% CI, 1.376-2.489; P < .0001), patients aged 75 years or younger (OR = 1.625; 95% CI, 1.247-2.117; P = .0003) and patients who had a procedure where the intravascular lithotripsy balloon-to-artery ratio was at least 1 (OR = 1.538; 95% CI, 1.189-1.989; P = .001).
“Proper IVL balloon sizing is an independent predictor of stenosis reduction,” Armstrong said.
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Armstrong EJ, et al. Late-Breaking Clinical Trials. Presented at: VIVA 22; Oct. 31-Nov. 3, 2022; Las Vegas (hybrid meeting).
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