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14-03-2024 | Original Paper

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

Authors: Nader Mankerious, Gert Richardt, Abdelhakim Allali, Volker Geist, Adnan Kastrati, Mohamed El-Mawardy, Tobias Rheude, Dmitriy Sulimov, Ralph Toelg, Mohamed Abdel-Wahab

Published in: Clinical Research in Cardiology

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.

Graphical Abstract

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Title: 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
Authors: Nader Mankerious
Gert Richardt
Abdelhakim Allali
Volker Geist
Adnan Kastrati
Mohamed El-Mawardy
Tobias Rheude
Dmitriy Sulimov
Ralph Toelg
Mohamed Abdel-Wahab
Publication date: 14-03-2024
Publisher: Springer Berlin Heidelberg
Published in: Clinical Research in Cardiology
Print ISSN: 1861-0684
Electronic ISSN: 1861-0692
DOI: https://doi.org/10.1007/s00392-024-02434-1

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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

Abstract

Background

Methods

Results

Conclusion

Clinical Trial Registration

Graphical Abstract

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Abstract

Background

Methods

Results

Conclusion

Clinical Trial Registration

Graphical Abstract

Please log in to get access to this content

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page