Intravascular Lithotripsy Eases Stent Implantation In Severe
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Coronary calcification hinders stent delivery and expansion and is associated with adverse outcomes. Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhancing vessel compliance and optimizing stent deployment.

This study aimed to assess the safety and effectiveness of IVL in severely calcified de novo coronary lesions.

Disrupt CAD III was a prospective, single-arm multicenter study designed for regulatory approval of coronary IVL. The primary safety endpoint was freedom from major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success. Both endpoints were compared to a pre-specified performance goal (PG). The mechanism of calcium modification was assessed in an optical coherence tomography (OCT) sub-study.

-- 431 patients were enrolled at 47 sites in four countries. The primary safety endpoint of the 30-day freedom from MACE was 92.2%; the lower bound of the 95% confidence interval (CI) was 89.5% which exceeded the PG of 84.4%.

-- The primary effectiveness endpoint of procedural success was 92.4%; the lower bound of the 95% CI was 90.2% which exceeded the PG of 83.4%.

-- Mean calcified segment length was 47.9±18.8 mm, calcium angle was 292.5±76.5° and calcium thickness was 0.96±0.25 mm at the site of maximum calcification.

-- OCT demonstrated multi-plane and longitudinal calcium fractures after IVL in 67.4% of lesions.

-- Minimum stent area was 6.5 ± 2.1mm2 and was similar regardless of demonstrable fractures on OCT.

Conclusively, Coronary IVL safely and effectively facilitated stent implantation in severely calcified lesions.