1. Lower revascularization rates after high-speed rotational atherectomy compared to modified balloons in calcified coronary lesions: 5-year outcomes of the randomized PREPARE-CALC trial.
- Author
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Mankerious N, Richardt G, Allali A, Geist V, Kastrati A, El-Mawardy M, Rheude T, Sulimov D, Toelg R, and Abdel-Wahab M
- Subjects
- Humans, Male, Female, Aged, Treatment Outcome, Time Factors, Coronary Angiography, Follow-Up Studies, Middle Aged, Coronary Vessels diagnostic imaging, Coronary Vessels surgery, Absorbable Implants, Atherectomy, Coronary methods, Coronary Artery Disease therapy, Coronary Artery Disease diagnosis, Coronary Artery Disease surgery, Drug-Eluting Stents, Vascular Calcification therapy, Vascular Calcification diagnosis, Vascular Calcification surgery, Angioplasty, Balloon, Coronary methods, Angioplasty, Balloon, Coronary instrumentation
- Abstract
Background: In the PREPARE-CALC trial, severely calcified lesion preparation with rotational atherectomy (RA) before biodegradable polymer sirolimus-eluting stent (SES) implantation demonstrated higher procedural success and comparable rates of acute lumen gain and late lumen loss compared to modified balloons (MB) (scoring/cutting). We aimed to analyze the 5-year outcomes of both lesion preparation strategies., Methods: PREPARE-CALC randomly assigned 200 patients 1:1 to MB or RA, followed by SES implantation. The principal endpoint of the current analysis was target vessel failure (TVF) at 5 years., Results: At 5 years, MB had comparable rates of TVF to RA (19% vs. 21%, HR 1.14, 95% CI 0.60-2.16, p = 0.687). Subgroup analysis showed a lesion length treatment interaction, favoring MB for short lesions and RA for long ones (p for interaction = 0.042). Target lesion revascularization (TLR) was significantly less common with RA (12 vs. 3%, HR 0.28, 95% CI 0.08-0.98, p = 0.048). In a multivariate analysis, RA was independently protective against TLR (adj. HR 0.17, 95% CI 0.04-0.78, p = 0.022), while ostial lesions were associated with higher TLR independent of treatment strategy (adj. HR 11.3, 95% CI 2.98-42.6, p < 0.001)., Conclusion: In patients with severely calcified coronary lesions, using MB or RA for lesion preparation followed by biodegradable polymer SES implantation was associated with comparable rates of TVF at 5 years. However, a significant reduction of TLR was observed after RA. PREPARE-CALC is the first randomized trial showing potential clinical advantages of RA over MB during long-term follow-up., Clinical Trial Registration: URL: https://www., Clinicaltrials: gov . Unique identifier: NCT02502851., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)
- Published
- 2024
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