Dual-Prep registry: atherectomy Devices and intravascUlAr Lithotripsy for the PREParation of heavily calcified coronary lesions registry, 1-year Results

Abstract Background Combination therapy with atherectomy and intravascular lithotripsy (IVL) has emerged as a promising strategy for the treatment of severely calcified occlusive coronary lesions, which potentially enhances procedural efficacy without increasing complication risk. Methods The Dual-Prep Registry is a multicenter, prospective registry designed to evaluate the safety and efficacy of IVL after atherectomy in severely calcified lesions. Combined use was selectively applied when the risk of complications was anticipated to be high with a larger atherectomy burr size, or when it was deemed non-beneficial due to unfavorable guidewire bias. All adverse events were adjudicated by a clinical events committee. Kaplan-Meier analysis was performed to evaluate the primary endpoint of major adverse cardiovascular events (MACE; composite endpoint of cardiac death, myocardial infarction, and target vessel revascularization [TVR]) at 1 year. Results A total of 118 cases (120 lesions) were enrolled across 20 facilities. Significant comorbidities included diabetes in 56.8% of patients and hemodialysis-dependence in 25.4%. Calcification score after atherectomy was 4.0 in all cases, and calcified nodules were present in 56.4% (core-lab analysis) of cases. One-year follow-up was complete in 99.2% patients. MACE occurred in 7.6% patients at one year (cardiac death 2.5%, myocardial infarction 5.1%, TVR 5.1%) and stent thrombosis was observed in 1 case. Conclusions Atherectomy followed by IVL resulted in low 1-year rates of MACE, TVR, and stent thrombosis in patients with severely calcified coronary lesions. This approach may be considered for lesions where an “IVL-first” strategy is difficult to apply. Japan Registry of Clinical Trials: jRCT1032230384. URL: https://jrct.mhlw.go.jp A Clinical Perspective 1) What Is New? Elective combined use of IVL and atherectomy resulted in low 1 year MACE and TLR. The incidence of MACE was higher in cases with greater residual stenosis after the procedure and a larger baseline reference vessel diameter. 2) What Are the Clinical Implications? Combining IVL with atherectomy may serve as an effective treatment strategy in cases where IVL-first approaches are difficult to apply. Severe calcified lesions that are presumed to be unresponsive to RA/OA treatment or carry a high risk of RA/OA complications may be good candidates for this strategy.