Shockwave’s Peripheral IVL System Evaluated in Disrupt PAD III Observational Study

November 4, 2022—Ehrin J. Armstrong, MD, presented results from the Disrupt PAD III observational study of intravascular lithotripsy (IVL) for the treatment of peripheral artery calcification using the Shockwave IVL system (Shockwave Medical).

Disrupt PAD III is a prospective, multicenter, single-arm, independent core lab–assessed study designed to evaluate the acute safety and effectiveness of the Shockwave peripheral IVL system. Multivariate analysis was performed to assess independent predictors of stenosis reduction and angiographic complications.

The findings were presented in the first of three Late-Breaking Clinical Trials sessions at the VIVA Foundation’s VIVA22 conference held October 31 to November 3 in Las Vegas, Nevada.

According to the VIVA Foundation press release, the multivariate analysis confirmed the importance of proper IVL balloon sizing, and use of peripheral IVL demonstrated excellent procedural safety and effectiveness in complex lesions across multiple vascular beds. This full cohort analysis of the Disrupt PAD III observational study represents the largest analysis of periprocedural outcomes following IVL treatment, noted the press release.

As summarized by the VIVA Foundation, a total of 1,373 patients with 1,677 lesions were enrolled in the study between November 2017 and June 2021. Of these lesions, 91.3% (1,531/1,677) were evaluable. Diameter stenosis, lesion length, and Peripheral Academic Research Consortium–defined moderate-severe calcification at baseline were 80.6% ± 7.6%, 93.5 ± 74.3 mm, and 89.9%, respectively.

Treated vessels included femoropopliteal (60.7%), iliac (15.8%), common femoral (10.7%), and infrapopliteal arteries (12.8%). Target lesions included 31% chronic total occlusions (CTOs), 19.3% long lesions (≥ 15 cm), and 20.1% eccentric lesions. Concomitant use of atherectomy and/or specialty balloon technology was observed in 22.1% of lesions.

Dr. Armstrong reported that residual stenosis immediately following IVL treatment and at the end of the procedure was 32.5% ± 16.3% and 23.8% ± 11.3%, respectively.

After final treatment, there were 0.9% serious angiographic complications (0.7% flow-limiting dissections, 0.2% perforations) with zero abrupt closures, distal embolizations, no flows, or thrombotic events.

Independent predictors for final residual stenosis ≤ 30% were:

• Lesion length ≥ 15 cm (odds ratio [OR], 0.384; 95% CI, 0.283-0.521)
• Female sex (OR, 1.850; 95% CI, 1.376-2.489)
• Age ≤ 75 years (OR, 1.625; 95% CI, 1.247-2.117)
• IVL balloon–to-artery ratio ≥ 1.0 (OR, 1.538; 95% CI, 1.189-1.989)
• CTO (OR, 0.638; 95% CI, 0.482-0.844)

Finally, lesion length ≥ 15 cm was an independent predictor for angiographic complications (OR, 16.076; 95% CI, 3.394-76.152), noted the VIVA Foundation press release.