TCT-164 Coronary AtheRectomy and Drug Coated Ballon Intervention in All-comer Calcific lesions: The CARDIAC Trial
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Authors
Benedetto D.
Frazzetto M.
Regazzoli D.
Bezubka J.
Fischetti D.
Jones D.
Khialani B.
Minha S.
Ugo F.
Wanczura P.
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2025
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[Formula presented] Aims: To evaluate the efficacy of DCB after plaque modification strategies (PMS) for severe coronary calcification. CARDIAC is an ambispective multicenter study which analyzed the performance of a solo-DCB strategy in severely calcified coronary lesions after atherectomy or calcium modification. We excluded patients with cardiogenic shock, or stent at the lesion site. Calcified lesions were evaluated by intravascular imaging or detailed angiographic parameters. Primary endpoint was target lesion failure (TLF), a composite of cardiac death, myocardial infarction of the target vessel excluding periprocedural one, ischemia-driven target lesion revascularization, and thrombosis of the segment, assessed at 30 days, 6 and 12 months. Angiographic parameters and Murray-law based quantitative flow ratio (muFR) were assessed by an indipendent core-lab (University Hospital of Ferrara, Italy). A total of 121 patients with de novo coronary artery lesions who underwent solo-DCB treatment were included. All patients received pre-dilatation with normal balloon followed by rotational (37%), orbital atherectomy (17%) or lithotripsy (IVL, 53%). Notably, in 6% of procedures there was a combination between atherectomy and IVL. Intravascular imaging was performed in 43% of patients (IVUS 33%, OCT 10%). Vessel dissection occurred in 21% of cases, with 90% classified as type A or B. Procedural success was 100%. At a median follow-up of 384 days (IQR 185-453), TLF was observed in 8 patients (6.7%). TLF comprised no cardiac death, 2 non-fatal myocardial infarctions (1.7%), and 6 target lesion revascularizations (5%). Furthermore, one patient experienced a non-cardiac death, one had a stroke after one year, and 3 patients (2.5%) reported bleeding events classified as BARC 2-5 during the first three months of follow-up. Core-Lab assessment was available for 108 patients (89%), 13 patients being excluded for poor images quality. All patients demonstrated improvements in MLD and %DS following calcium modifying techniques. Notably, the most substantial improvements were observed in patients with a final muFR >0.80. These patients achieved a mean increase in MLD of 1.36 mm and a mean reduction in %DS of 44%, whereas those with a final muFR <0.80 showed a smaller mean MLD increase of 0.92 mm and a %DS reduction of 31%. Conclusion(s): In severely calcified lesions, a calcium modification approach before solo-DCB use is safe and associated with good clinical performance at mid-term clinical follow up. Copyright © 2025
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Journal of the American College of Cardiology
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Transcatheter Cardiovascular Therapeutics Abstracts.