Disrupt CAD Demonstrates Consistent Shockwave Coronary IVL Outcomes at 1 Year, Across Calcium Morphologies, and Between Men and Women

November 5, 2021—Data from Shockwave Medical’s Disrupt CAD clinical program demonstrating the safety and effectiveness of Shockwave coronary intravascular lithotripsy (IVL) at 1 year and consistently similar outcomes across calcium morphologies and between men and women were presented in several sessions of TCT 2021 in Orlando, Florida.

Shockwave Medical received FDA premarket approval for their IVL sonic pressure wave therapy to treat severely calcified coronary artery disease in February 2021.

Summarizing the first of three analyses at TCT, Shockwave Medical announced 1-year outcomes from Disrupt CAD III, a prospective, multicenter, single-arm, global, investigational device exemption study.

According to Shockwave, findings at 1 year include the following:

• The major adverse cardiovascular event (MACE) rate was 13.8%, including cardiac death (1.1%), myocardial infarction (MI; 10.5%), and target vessel revascularization (6%) at 1 year post–index procedure.
• The non–Q wave MI rate was 9.2%
• The target lesion failure rate was 11.9%.
• Target lesion revascularization occurred in 4.3% of patients.
• Definite/probably stent thrombosis occurred in 4.3% of patients, with only one case beyond 30 days (late stent thrombosis rate, 0.3%).

“It is very significant that these data show sustained and persistent relative benefit of IVL for lesion preparation prior to coronary stenting, particularly since this is the first robust 1-year report that has been presented on the technology,” remarked Dean Kereiakes, MD. “The achievement of an average stent expansion of 102% and a minimum stent area (MSA) of 6.5 mm² at the index procedure with IVL should have predicted excellent long-term results. We were optimistic that there should be a low rate of late target lesion revascularization and stent thrombosis to 1 year, and that is exactly what we found following IVL.”

Disrupt CAD III Co-Principal Investigator Dr. Kereiakes is Medical Director of The Christ Hospital Heart and Vascular Center and the Christ Hospital Research Institute and Professor of Clinical Medicine at The Ohio State University in Ohio.

Also at TCT, Ziad Ali, MD, presented data from optical coherence tomography (OCT) substudies of Disrupt CAD I to IV.

The pooled analysis of 262 patients enrolled in the substudies confirmed that the use of coronary IVL resulted in MSA and stent expansion (SE) consistent in lesions with both eccentric and concentric calcium. Shockwave’s press release noted that MSA and SE at the maximum site of calcification were similar across the four analyzed calcium arc quartiles: ≤ 180° (6.1 mm², 104%), 181° to 270° (6 mm², 101%), 271°-359° (6.1 mm², 98%) and 360° (6.2 mm², 105%), respectively.

Shockwave also announced that in a separate analysis, coronary IVL acutely affected calcific nodules (present in 22%) via flattening or fracturing the nodule, resulting in MSA (6.3 vs 6 mm²) and SE (101% vs 103%) consistent in lesions with (n = 54) or without (n = 194) calcified nodules, respectively. The analysis also found that calcific nodules were more commonly associated with concentric calcium and greater overall calcium burden.

Dr. Ali, Director of the DeMatteis Cardiovascular Institute and Investigational Interventional Cardiology at St. Francis Hospital & Heart Center in New York, commented to Shockwave, “To date, all OCT analyses of IVL reveal that the greater the calcium burden, the greater the number of fractures. These data now show that evidence of visible fracture by OCT is not necessary to achieve large MSA or adequate stent expansion, particularly in these unique but clinically relevant subgroups of calcification. The take-home message is that IVL liberates vascular compliance in all subgroups, including eccentric lesions and calcified nodules.”

A third analysis stratified 628 patients in a pooled analysis of Disrupt CAD I to IV by sex. The analysis was made up of 23% women, who were older and more likely to have hyperlipidemia, renal insufficiency, and previous MI.

Outcomes comparing the women versus men included:

• A similar primary safety endpoint of 30-day MACE (8.3% vs 7.1%; P = .61).
• A similar primary effectiveness endpoint of procedural success (91.7% vs 92.6%; P = .72).
• Consistent post-IVL serious angiographic complications (1.6 % vs 2.3%; P = .75).

Summarizing the trial for Shockwave Medical, Alexandra Lansky, MD, who is Professor of Medicine (Cardiology) and Director of Yale Cardiovascular Clinical Research Program at Yale University School of Medicine in New Haven, CT, commented, “Given the strong safety profile of IVL and the known higher risks of women undergoing [percutaneous coronary intervention], coronary IVL is an attractive option for optimizing outcomes in female patients.

“While this is the first analysis of its kind for coronary IVL, it is highly suggestive that the technology could potentially serve as first-line therapy for women with calcified lesions, particularly if these findings can be confirmed in a larger patient cohort.”