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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.
- Source :
-
Clinical research in cardiology : official journal of the German Cardiac Society [Clin Res Cardiol] 2024 Jul; Vol. 113 (7), pp. 1051-1059. Date of Electronic Publication: 2024 Mar 14. - Publication Year :
- 2024
-
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.<br />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.<br />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).<br />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.<br />Clinical Trial Registration: URL: https://www.<br />Clinicaltrials: gov . Unique identifier: NCT02502851.<br /> (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 1861-0692
- Volume :
- 113
- Issue :
- 7
- Database :
- MEDLINE
- Journal :
- Clinical research in cardiology : official journal of the German Cardiac Society
- Publication Type :
- Academic Journal
- Accession number :
- 38483633
- Full Text :
- https://doi.org/10.1007/s00392-024-02434-1