Use of intravascular lithotripsy (IVL) to treat severe calcifications of peripheral artery disease showed low residual stenosis, marked acute gain, and few complications despite increased disease complexity, according to the initial results of DISRUPT PAD III registry, an ongoing multicenter clinical study in which Main Line Health is participating.
IVL uses sonic pressure waves that pass harmlessly through soft tissue but fracture the calcified blockage. This nonrandomized, single-arm, observational clinical trial is testing the safety and effectiveness of the FDA-approved Shockwave Medical Peripheral Lithoplasty® system used in combination with adjunctive devices in a real-world clinical setting.
The newly published study examined the initial interval of trial enrollment between November 2017 and August 2018. At that time, about 1,300 patients from 18 sites in the United States and Europe were enrolled in the study and followed through hospital discharge. Eligible participants were those who had claudication or chronic limb-threatening ischemia and moderate or severe arterial calcification. To date, Main Line Health has been the second-leading enroller in the study, collecting data on more than 125 participating patients.
During the initial study period, 200 patients and 220 target lesions were treated with IVL in combination with either drug-coated balloon (DCB) catheters or, less frequently, concomitant atherectomy or stenting, as per the treating physicians’ preferences. The calcified lesions were located in the iliac artery, common femoral artery, superficial femoral artery, popliteal artery, and infrapopliteal vessels. Nearly one-third were chronic total occlusions.
Results showed significant lesion reduction and low residual stenosis across all lesion types. Only three angiographic complications in the complex lesion set were reported: two complex dissections and one perforation that occurred after DCB use unrelated to the IVL procedure. No instances of abrupt closure, reflow, distal embolization or thrombotic events were reported.
“This study shows the benefit of IVL in a real-world setting, assisting clinicians who treat complex peripheral artery disease with endovascular therapy,” said Sarang Mangalmurti, MD, a cardiologist at Bryn Mawr Hospital and the Main Line Health principal investigator of the DISRUPT PAD III trial.
William Gray, MD, Main Line Health’s chief of the Division of Cardiovascular Disease, president of Lankenau Heart Institute and one of the study’s authors, noted: “At Main Line Health we remain committed to offering our patients the most advanced treatments available, which is why we participate in important clinical trials such as this. The knowledge gained from these studies can help to expand our therapeutic armamentarium.”
Dr. Gray also serves as a clinical professor of the Lankenau Institute for Medical Research, the research division of Main Line Health.
The initial results of DISRUPT PAD III trial were published in the manuscript “Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study” in the Journal of Endovascular Therapy. Drs. Gray and Mangalmurti coauthored this manuscript along with colleagues from other institutions.
For more on the DISRUPT PAD III clinical trial, which continues to recruit eligible patients, visit www.mainlinehealth.org/research/clinical-trials/disrupt-pad-iii