Disrupt CAD III: Safety, Efficacy of IVL to Optimize Stent Expansion in Severely Calcified Lesions
Findings from the Disrupt CAD III study presented Oct. 15 during TCT 2020 and simultaneously published in the Journal of the American College of Cardiology suggest coronary intravascular lithotripsy (IVL) can safely and effectively facilitate stent implantation in severely calcified lesions.
The multi-center international study enrolled 431 patients presenting with stable, unstable or silent ischemia and severely calcified de novo coronary artery lesions undergoing PCI. Target lesions were ≤40mm in length with reference vessel diameters of 2.5 to 4.0 mm. Patients with acute myocardial infarction and specific complex lesion features were excluded. The primary safety endpoint was freedom from major adverse cardiovascular events at 30 days. The primary effectiveness endpoint was procedural success.
Overall, the primary safety endpoint was 92.2% and the primary effectiveness endpoint of procedural success was 92.4%. Among other major findings, Jonathan M. Hill, MD, et al., also note that coronary IVL prior to drug-eluting stent implantation was well tolerated with a low rate of major peri-procedural clinical and angiographic complications, and that “transient IVL-induced left ventricular capture occurred frequently, but was benign with no lasting sequelae in any patient.” An optical coherence tomography sub-study also demonstrated multi-plane and longitudinal calcium fractures after IVL in 67.4% of lesions, the researchers said.
Based on the Disrupt CAD III findings, Hill, et al., suggest that future studies “should include more complex patient and angiographic lesion subsets to assess the generalizability of these observations, and clarify the relationships between measures of calcium fracture, stent expansion and long-term clinical outcomes.” They also highlight that “preliminary clinical experience suggests that atheroablative technologies may be required in specific situations to facilitate IVL-balloon placement and that these techniques may be complimentary.”
Keywords: TCT20, Transcatheter Cardiovascular Therapeutics, Percutaneous Coronary Intervention, Coronary Angiography, Coronary Artery Disease
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