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
About
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.
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i https://onlinelibrary.wiley.com/doi/10.1002/ccd.28373
Source: Shockwave Medical, Inc.