ShockWave Medical announces new data on one-year outcomes with IVL

Shockwave Medical announced new data demonstrating one-year outcomes with coronary intravascular lithotripsy, IVL, that was consistent in both women and men. The one-year results from Disrupt CAD III and IV trials were recently published in the Journal of the Society for Cardiovascular Angiography & Interventions, JSCAI. In the patient-level pooled analysis, titled “Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Lesions: Long-Term Sex-Specific Outcomes,” use of IVL for lesion preparation of severely calcified lesions had similar safety and effectiveness in women and men at a one-year follow-up. This is in contrast to atheroablative approaches to vessel preparation, where previous reports show that women are more susceptible to adverse procedural outcomes compared with men. The publication reported that despite smaller average reference vessel diameters in women compared with men, post-IVL serious angiographic complications, defined as a composite of severe dissection, perforation, abrupt closure, slow-flow, or no-reflow, were similar between women and men. At one-year, major adverse cardiovascular event rates were not different between women and men and there was no difference between women and men in target lesion failure. Sex was also not an independent predictor of MACE at one year after adjusting for major clinical and angiographic covariates. “The high acute procedural success rate associated with IVL, the infrequent complications and similar one-year clinical outcomes is overall favorable, suggesting that the use of IVL in women is very beneficial in this retrospective analysis,” said Alexandra Lansky, MD, Professor of Medicine (Cardiology), Director of Yale Cardiovascular Clinical Research Program, Yale University School of Medicine, New Haven, CT, USE. “Given these findings, I am even more excited to see the results from the prospective, 400-patient EMPOWER CAD study that has recently started to see how we can better inform interventional cardiologists on the optimal strategy to treat women suffering from coronary artery disease in a ‘real-world’ setting.”