News Release Details
Shockwave IVL Coronary Studies Demonstrate Excellent PCI Outcomes in Both Women and Men at One Year
Unlike previous reports with atherectomy that have shown worse angiographic complications in women versus men,i a pooled analysis of the Disrupt CAD III & IV studies showed that IVL was equally safe and effective in men (n=342) and women (n=106). Despite the smaller vessel size in women (2.8mm vs 3.1mm, p=<0.001), the primary effectiveness endpoint of procedural success for women and men was similar (90.6 percent vs 93.0 percent, p=0.47). The primary safety endpoint of 30-day MACE for women and men was also similar (9.4 percent vs 7.0 percent, p=0.55). Notably, there were also consistently low rates of post-IVL serious angiographic complications in women and men (2.2 percent vs 2.6 percent, p=0.85), which differs from similar analyses in an atherectomy population.
At one year, women and men had similar rates of MACE (12.7 percent vs 13.3 percent, p=0.83) and target lesion failure (10.4 percent vs 11.2 percent, p=0.85), respectively. The components of target lesion revascularization (TLF) were low in both women and men and numerically favored females, including target vessel-myocardial infarction (8.5 percent vs 9.7 percent), target lesion revascularization (2.9 percent vs 4.2 percent) and stent thrombosis (0 percent vs 1.2 percent).
“Given the established safety profile of IVL and the high rates of acute and long-term adverse events in women undergoing PCI, with or without atheroablation of calcified lesions, coronary IVL is an attractive treatment option for optimizing outcomes in our female patients,” said
The presentation follows the recent publication of SCAI’s “Expert Consensus Statement on Sex-Specific Consideration in Myocardial Revascularization” in JSCAI, which referenced the role of IVL in female patients. The SCAI statement concluded, “while additional evidence is needed, these results taken in the context of outcomes with atherectomy devices suggest that IVL may emerge as a first-line therapy for plaque modification of calcified lesions in women specifically.”
“As someone who is dedicating her career to addressing the needs of the most complex patients, I find these results very encouraging,” said
Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. Shockwave aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com.
This press release contains statements relating to our expectations, projections, beliefs, and prospects, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue,” and similar expressions, and the negative of these terms. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware.
Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others: the impact of the COVID-19 pandemic on our operations, financial results, and liquidity and capital resources, including the impact on our sales, expenses, supply chain, manufacturing, research and development activities, clinical trials, and employees; our ability to develop, manufacture, obtain and maintain regulatory approvals for, market and sell, our products; our expected future growth, including the size and growth potential of the markets for our products; our ability to obtain coverage and reimbursement for procedures performed using our products; our ability to scale our organizational culture; the impact of the development, regulatory approval, efficacy and commercialization of competing products; the loss of key scientific or management personnel; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; and our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others. These factors, as well as others, are discussed in our filings with the
Source: Shockwave Medical, Inc.