Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies.

ABSTRACT Aims The clinical outcomes of intravascular lithotripsy (IVL) to optimize target lesion preparation in severely calcified de novo coronary stenoses have been examined in four prospective studies (Disrupt CAD I, II, III, and IV). The aim of this pooled analysis was to assess the cumulative safety and effectiveness of coronary IVL. Methods Patient data were pooled from the Disrupt CAD studies which shared uniform study criteria, endpoint definitions and adjudication, and procedural follow-up. The primary safety endpoint was freedom from MACE (composite of cardiac death, all MI, or TVR) at 30 days. The primary effectiveness endpoint was procedural success, defined as stent delivery with a residual stenosis ≤30% by QCA without in-hospital MACE. Secondary outcomes included serious angiographic complications, target lesion failure (TLF), cardiac death (CD) and stent thrombosis (ST) at 30 days. Results Between December 2015 and April 2020, 628 patients were enrolled at 72 sites from 12 countries. Presence of severe calcification was confirmed in 97.0% of target lesions with an average calcified segment length of 41.5 ± 20.0 mm. The primary safety and effectiveness endpoints were achieved in 92.7% and 92.4% of patients, respectively. At 30 days, the rates of TLF, CD, and ST were 7.2%, 0.5%, and 0.8%. Post-IVL and final serious angiographic complications were 2.1% and 0.3% with no IVL-associated perforations, abrupt closure or episodes of no-reflow. Conclusions In the largest cohort of patients treated with coronary IVL assessed to date, coronary IVL safely facilitated successful stent implantation in severely calcified coronary lesions with a high rate of procedural success.