From the Disrupt CAD IV study, vessel preparation of calcified lesions in coronary arteries using intravascular lithotripsy (IVL) by Japanese cardiologists was associated with a high procedural success rate and good 1-year safety and efficacy, according to a presentation by Dr.Shigeru Saito of Shonan Kamakura General Hospital at the Oral Presentation Session at the 86th Annual Meeting of the Japanese Circulation Society (JCS).
Intravascular Lithotripsy for Vessel Preparation in Calcified Coronary Arteries Prior to Stent Placement: Japanese Disrupt CAD IV Study 1-Year Results
The Disrupt CAD IV study of IVL for coronary artery disease in Japan enrolled 72 patients treated with IVL for highly calcified lesions of coronary arteries de novo from 8 centers in Japan from November 2019 to April 2020, with 64 patients included in the intention-to-treat analysis after excluding the first patient enrolled at each center.
The mean age of eligible patients was 75 years old. In the study, 75% were male, 62.5% had a history of smoking, 48.4% had diabetes, 46.9% had a history of PCI, and 20.3% had a history of MI.
The mean total procedure time was 63 minutes; radial artery access was selected in 84%; anterior dilation was performed in 20.3%; the mean number of IVL catheters used was 1.6; the mean IVL pulse was 104; the maximum IVL dilation pressure was 6.0 atm; and post-IVL dilation was performed in 1.6% of the cases. The mean lesion length was 27.5 mm, while the mean number of stents implanted was 1.1, with stent delivery successful in all patients. In addition, post-stenting dilation was performed in all patients, recording a procedural success rate of 93.8%.
An acute gain of 1.7 mm was recorded, stent I.D. stenosis rate was 9.9%, and no complications were noted from the final contrast; OCT evaluation showed a mean minimal lumen area of 5.7 mm² and a stent expansion rate of 99.5% at the site of maximum calcification.
The Kaplan-Meier analysis showed MACE (cardiac death, MI, TVR) rates of 6.3% at 30 days and 9.4% at 1-year; at 1-year follow-up, no cardiac deaths were reported, 4 non-Q-wave MI cases during hospitalization but no MI after discharge (overall 6.3%), and 4.7% TVR. The 1-year rates of TLF (cardiac death, MI related to target vessel, and TLR of ischemic origin) were 6.3%, MI related to target vessel, and 1 TLR of ischemic origin (1.6%); and there were no cases of definite/probable stent thrombosis. After 1-year, CCS angina scores showed marked improvement with 85.9% for class 0, 14.1% for class I, and zero for II-IV.
Dr. Saito summarized, "In Japanese patients with highly calcified lesions, the 1-year MACE and TLR rates were low and stent thrombosis was zero after treatment with vessel preparation using IVL before DES implantation."
The 86th Japan Circulation Society Academic Assembly (2022)