Randomized ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2: Design and Rationale of the ISAR-CALC 2 Trial

• Published in: Cardiovascular revascularization medicine Vol. 49; pp. 22 - 27
• Main Authors: Scalamogna, Maria, Abdel-Wahab, Mohamed, Mashayekhi, Kambis, Fusaro, Massimiliano, Leistner, David M., Ayoub, Mohamed, Xhepa, Erion, Joner, Michael, Kastrati, Adnan, Cassese, Salvatore, Rheude, Tobias
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.04.2023
• Subjects: Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - methods; Atherectomy, Coronary - adverse effects; Cardiovascular; Clinical trial; Coronary Angiography; Coronary artery calcification; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - etiology; Coronary Artery Disease - therapy; Drug-Eluting Stents; Humans; Intravascular lithotripsy; Prospective Studies; Super high-pressure balloon; Treatment Outcome; Vascular Calcification - diagnostic imaging; Vascular Calcification - etiology; Vascular Calcification - therapy; OCT; MLD; Coronary artery calcification; Super high-pressure balloon; DES; MACE; SOP; PCI; Clinical trial; TLR; MI; IVL; Intravascular lithotripsy; major adverse cardiac events; standard operating procedures; drug-eluting stent; target lesion revascularization; optical coherence tomography; myocardial infarction; minimal lumen diameter; percutaneous coronary intervention; intravascular lithotripsy
• ISSN: 1553-8389; 1878-0938; 1878-0938
• DOI: 10.1016/j.carrev.2022.12.008

The percutaneous treatment of severely calcified coronary lesions has been associated with lower performance of coronary stents and poor clinical long-term outcomes. Adequate lesion preparation before stent implantation is of paramount importance to minimize the risk of stent failure. Balloon-based techniques for lesion preparation have been the subject of numerous investigations, albeit comparative data from randomized trials are scarce. The ISAR-CALC 2 (ClinicalTrials.gov: NCT05072730) is an investigator-initiated, prospective, randomized, multicentre, assessors-blind, open-label trial designed to compare a lesion preparation strategy with either super high-pressure balloon or intravascular lithotripsy (IVL) before drug-eluting stent (DES) implantation in patients with severely calcified, undilatable coronary lesions. In total, 80 patients are required for trial completion. The primary endpoint will be final angiographic minimal lumen diameter (MLD) after stent implantation. Key secondary endpoints include stent expansion assessed by optical coherence tomography (OCT), procedural and strategy success, need for complementary lesion preparation with rotational atherectomy, acute lumen gain, and major adverse cardiac events up to 30-day follow-up. The ISAR-CALC 2 trial aims to demonstrate the superiority of a lesion preparation strategy with a super high-pressure balloon as compared with intravascular lithotripsy prior to DES implantation in patients with severely calcified undilatable coronary lesions. •The percutaneous treatment of patients with severely calcific coronary artery disease is challenging because of acute complications and poor outcomes.•Optimal lesion preparation and intravascular imaging are key to successful stent implantation in this setting.•The randomized ISAR-CALC 2 trial will compare two balloon-based techniques for preparation of severely calcified coronary lesions amenable to drug-eluting stent implantation.