IV lithotripsy safe, effective for moderate to severe PAD calcification at 1 year
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ATLANTA — In patients with calcified peripheral artery disease undergoing drug-coated balloon treatment, preparing the vessel with IV lithotripsy conferred better 1-year outcomes vs. preparing it with percutaneous transluminal angioplasty.
Results indicated that use of IV lithotripsy (Shockwave IVL, Shockwave Medical) to facilitate endovascular treatment of patients with moderately to severely calcified femoropopliteal arteries conferred better 1-year freedom from clinically driven target lesion revascularization and restenosis compared with use of percutaneous transluminal angioplasty (PTA).
At the Society for Cardiovascular Angiography and Interventions Scientific Sessions, William A. Gray, MD, FSCAI, chief of cardiovascular services at Main Line Health and co-director of the Lankenau Heart Institute in Wynnewood, Pennsylvania, presented the mid-term results of the DISRUPT PAD III trial.
“[DISRUPT PAD III] reinforces what we're doing today. The 30-day data were proof positive of a beneficial vessel prep adjunct that IV lithotripsy is,” Gray told Healio. “These data with 90% or better patency at 1 year is like icing on the cake. Nobody has seen that in any DCB trial, and nobody has done it in a calcified lesion trial, so there's really no comparator for this. It reinforces the practice and probably elevates it a little bit because now people can say, they have patency data that reinforces my acute result.”
The DISRUPT PAD III trial assessed procedural success in patients who underwent vessel preparation with IV lithotripsy compared with percutaneous transluminal angioplasty prior to DCB treatment with or without stenting in patients with moderately to severely calcified femoropopliteal arteries.
The interim results of the DISRUPT PAD III trial were presented in 2021 at VIVA.
As Healio previously reported, IV lithotripsy was safe and effective patients with PAD and moderate or worse calcification and reduced the mean percent diameter stenosis from 80% at baseline to 24% at final analysis.
The present analysis concerned the secondary effectiveness endpoint of primary patency at 1 year, defined as freedom from clinically driven target lesion revascularization and freedom from restenosis as determined by duplex ultrasound or stenosis of at least 50% on angiogram.
Researchers reported that at 1 year, patients who underwent IV lithotripsy had greater primary patency compared with PTA prior to DCB treatment (80.5% vs. 68%; P = .017), a finding that was primarily driven by more freedom from provisional stenting at index procedure in the lithotripsy group (95.4% vs. 81.7%; P < .0001).
Freedom from clinically driven target lesion revascularization (lithotripsy, 95.7%; PTA, 98.3%; P = .94) and freedom from binary restenosis (lithotripsy, 90%; PTA, 88.8%; P = .48) at 1 year was similar in both treatment groups.
“The original primary endpoint of DISRUPT PAD has already been reported and published, and that primary endpoint was procedural success measured at 30 days ... If you look at the 30-day outcome that was previously reported, IV lithotripsy was superior to percutaneous transluminal angioplasty alone in heavily calcified lesions of an average lesion length of about 10 centimeters,” Gray told Healio. “These data are a follow-on to that ... and found that again, IV lithotripsy was superior; that advantage carried through to 1 year; and was superior to percutaneous transluminal angioplasty for primary patency at 1 year. If we look at elemental things at 1 year, like clinically driven target lesion revascularization and binary restenosis, there were no differences in the two groups.”
References:
- Kereiakes DJ, et al. JACC Cardiovasc Interv. 2021;doi:10.1016/j.jcin.2021.04.015.
- Kereiakes DJ, et al. JACC Cardiovasc Interv. 2021;doi:10.1016/j.jcin.2021.03.036.
- Tepe G, et al. JACC Cardiovasc Interv. 2021;doi:10.1016/j.jcin.2021.04.010.
- Tepe G, et al. J Soc Cardiovasc Angiography Interv. 2022;doi:10.1016/j.jscai.2022.100341.
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Gray WA, et al. Featured Clinical Research: Part 1. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 19-22, 2022; Atlanta.
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