Intravascular Lithotripsy for Vessel Preparation in Calcified Coronary Arteries Prior to Stent Placement　― Japanese Disrupt CAD IV Study 1-Year Results ―

Abstract

Background: Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhance vessel compliance, and optimize stent deployment. The Disrupt CAD IV study enrolled patients with severe coronary artery calcification and demonstrated low 30-day major adverse cardiovascular events (MACE) and high procedural success following IVL with no final serious angiographic complications. To date, long-term outcomes have not been reported. This analysis evaluates 1-year outcomes of Disrupt CAD IV. Methods and Results:Disrupt CAD IV was a prospective single-arm multicenter study of IVL performed in a Japanese population with severe coronary artery calcification. Main outcomes included MACE (a composite of cardiac death, myocardial infarction [MI], or target vessel revascularization [TVR]), and target lesion failure (TLF; a composite of cardiac death, target vessel MI, and target lesion revascularization [TLR]) at 1 year. Compliance with patient follow-up at 1 year was 100%. MACE occurred in 9.4% of patients (cardiac death 0.0%, MI 6.3%, TVR 4.7%) and TLF occurred in 6.3% of patients, with both rates driven by non-Q wave MIs (6.3%).The TLR rate at 1 year was 1.6% and no stent thrombosis events were reported. Conclusions:Treatment of severely calcified coronary lesions with IVL was associated with low rates of 1-year MACE and TLR, suggesting durable safety and effectiveness of IVL-facilitated coronary stent implantation in severely calcified lesions in a Japanese population.

Intravascular Lithotripsy for Vessel Preparation in Calcified Coronary Arteries Prior to Stent Placement ― Japanese Disrupt CAD IV Study 2-Year Results ―

“…The J2T Registry was a multicenter registry of rotational atherectomy for calcified coronary lesions that enrolled 1,090 Japanese patients with similar characteristics to those in CAD IV. The 1-year outcomes for MACE (23%), all-cause death (8%), TVR (14%), and TLR (17%) following rotational atherectomy were markedly greater than those observed in CAD IV, 13 with the incidence of MACE continuing to rise to 46.7% during a median follow-up period of 3.8 years. 20 Similar findings were reported in the Coronary Orbital Atherectomy System Study (COAST), which reported 1-year rates of MACE, TVR, and TLR of 22.2%, 9.4%, and 6.3%, respectively.…”

“…10 Secondary endpoints at 1 year, including target lesion failure (TLF; 6.3%), MACE (9.4%), and stent thrombosis (ST; 0.0%), have also been published. 13 The current analysis presents the final outcomes of the Disrupt CAD IV study and evaluated secondary endpoints at 2 years.…”

“…Study design and endpoints have been previously described. 10, 13 Study participants provided written informed consent, and study procedures accorded with the Declaration of Helsinki, Good Clinical Practice guidelines, ISO 14155, applicable national requirements in Japan, and local institutional review boards and ethics committees. Angiographic outcomes were analyzed by an independent core laboratory (Cardiovascular Research Foundation, New York, NY, USA) and adverse events were adjudicated by a Clinical Events Committee (Cardiovascular Research Foundation).…”

An algorithmic approach to balloon undilatable coronary lesions

“…Four prospective, single‐arm, multicenter studies have been conducted to assess the safety and effectiveness of IVL in patients with de novo heavily calcified coronary lesions with encouraging results (Table 1): Disrupt coronary artery disease (CAD) I, 11 Disrupt CAD II, 12 Disrupt CAD III, 13 and Disrupt CAD IV 14 . The Disrupt CAD IV study demonstrated good long‐term (1 year) outcomes (MACE rate = 9.4%).…”

Calcium Fracture After Intravascular Lithotripsy as Assessed With Optical Coherence Tomography

“…Clinical outcomes with IVL have been favorable up to 1 year after PCI. 8 However, it remains unclear whether IVL is time points using anatomic landmarks such as characteristic calcified plaque morphology and side branches.…”