Shockwave’s IVL for “Real-World” Calcium Treatment Supported by Interim Data From DISRUPT PAD III Observational Study

October 6, 2021—Shockwave Medical, Inc., a developer of intravascular lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced that an interim analysis from the company’s DISRUPT PAD III observational study (OS) showed that IVL performs consistently well across challenging peripheral vessels, lesions, and patients.

Findings from the angiographic core lab–adjudicated “real-world” evaluation of IVL in heavily calcified peripheral arteries were presented by Ehrin J. Armstrong, MD, during a late-breaking clinical trials session at the VIVA 2021, the annual Vascular InterVentional Advances meeting held October 4-7 in Las Vegas, Nevada.

DISRUPT PAD III OS is a prospective, multicenter, single-blind study of “real-world” patients that augments the DISRUPT PAD III randomized controlled trial (RCT).

Shockwave Medical stated that the interim analysis looked at results from the first 752 consecutive patients enrolled in the study from November 2017 to June 2019 at 18 global sites. Of the 852 lesions treated in the iliac, common femoral, superficial femoral, popliteal, and infrapopliteal arteries, 88% presented with moderate/severe calcification, with an average calcified length of 127 mm.

The use of IVL in these lesions resulted in a final residual stenosis of 24%, similar to the DISRUPT PAD III RCT finding of 22%. Patients also experienced minimal procedural complications, with 0.9% and 0.1% of patients experiencing final dissections (Type D-F) and perforations, respectively. Notably, there were no instances of embolization, thrombus, no reflow, or abrupt closure.

The DISRUPT PAD III OS completed enrollment in June 2021 with a total of 1,373 patients; analysis of the full data set will be presented in 2022, advised Shockwave Medical.

The company outlined the key findings from the first 752 patients of DISRUPT PAD III OS interim analysis as follows:

• IVL consistently showed its ability to safely and effectively modify superficial and deep calcium across multiple vascular beds, lesion types, and in patients with critical limb ischemia.
• IVL resulted in consistent reduction in the diameter of stenosis with no associated distal embolization, abrupt closure, or thrombotic events at any time.
• IVL outcomes were comparable to the previously reported DISRUPT PAD III RCT outcomes showing minimal procedural complications and consistent reduction in diameter stenosis.
• IVL was successfully used in combination with adjunctive technologies, including specialty balloons and atherectomy, in the treatment of complex calcified lesions.

Dr. Armstrong, who is Medical Director of Adventist Heart and Vascular Institute in St. Helena, California, commented in Shockwave’s press release, “Patients with heavy calcification have traditionally been excluded from endovascular treatment trials, resulting in little available evidence to provide guidance for treating this challenging patient population. The DISRUPT PAD III OS shows that in common clinical situations that physicians encounter daily, peripheral IVL performs consistently well in a variety of peripheral vessels, lesions, and subgroups.”