News Release Details
Shockwave Medical Unveils First One-Year Results of Coronary Intravascular Lithotripsy
First One-Year Outcomes Find Durability of Excellent Procedural Results
The first one-year outcomes from the prospective, multicenter, single-arm, global investigational device exemption (IDE) Disrupt CAD III study demonstrated low rates of major adverse cardiovascular events (MACE, 13.8 percent) and target lesion failure (11.9 percent). The MACE results were primarily driven by the rate of non-Q wave myocardial infarction (9.2 percent), demonstrating durable safety and effectiveness following lesion preparation with IVL prior to stent deployment. The MACE rate included low rates of cardiac death (1.1 percent), myocardial infarction (10.5 percent), and target vessel revascularization (6.0 percent) one year after the index procedure. In addition, target lesion revascularization (TLR), occurred in only 4.3 percent of patients and definite or probable stent thrombosis occurred in 1.1 percent of patients at one year, with only one patient having a definite or probable stent thrombosis beyond 30 days, resulting a late stent thrombosis rate of at 0.3 percent.
“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 one-year report that has been presented on the technology,'' said
OCT Analysis Finds Similar MSA and Stent expansion Across Calcium Morphologies
A pooled analysis of 262 patients enrolled in OCT sub-studies from Disrupt CAD I, II, III, & IV, the largest intravascular imaging analysis of any calcium modification tool to date, confirmed that coronary IVL achieved excellent MSA and stent expansion (SE) consistently in lesions with both eccentric and concentric calcium. MSA and SE at the maximum site of calcification were similar across the four calcium arc quartiles analyzed: ≤180° (6.1mm2 & 104%), 181-270° (6.0mm2 & 101%), 271-359° (6.1mm2 & 98%) and 360° (6.2mm2 & 105%), respectively.
In a separate analysis of calcific nodules, coronary IVL was found to have a notable acute effect on calcific nodules, which were identified in 22 percent of cases, either by flattening or fracturing the nodule, resulting in consistent MSA (6.3mm2 vs 6.0mm2) and SE (101% vs 103%) in lesions with calcified nodules (n=54) or those without (n=194), respectively. The analysis also found that calcific nodules, defined as an accumulation of nodular calcification, or small calcium deposits, with disruption of fibrous cap on the calcified plate, were more commonly associated with concentric calcium and greater overall calcium burden.
“The ability to modify calcium regardless of its morphology, whether eccentric, concentric or nodular, and have MSA and stent expansion still remain consistent shows the versatility of IVL to make a meaningful impact on clinical practice,” said
Coronary IVL Found Equally Safe and Effective in Men and Women
A pooled analysis of the Disrupt CAD I, II, III, & IV studies showed IVL was equally safe and effective in men and women, unlike previous findings with atherectomy.i The analysis of 628 patients stratified outcomes by sex. Women in the analysis, who accounted for 23 percent of total patients, were older and more likely to have hyperlipidemia, renal insufficiency and prior myocardial infarction. Despite more frequent comorbidities and smaller vessel size in women, the primary safety endpoint of 30-day MACE for women and men was similar (8.3 percent vs 7.1 percent, p=0.61). The primary effectiveness endpoint of procedural success for women and men was also similar (91.7 percent vs 92.6 percent, p=0.72). Notably, there were also consistent post-IVL serious angiographic complications between women and men (1.6 percent vs 2.3 percent, p=0.75), which differs from previous atherectomy gender analyses.
“Given the strong safety profile of IVL and the known higher risks of women undergoing PCI, coronary IVL is an attractive option for optimizing outcomes in female patients,” said
Summarizing the totality of the data presented at TCT,
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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Source: Shockwave Medical, Inc.