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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

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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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Data availability

The deidentified participant data will be shared on a request basis. Please directly contact the corresponding author to request data sharing.

Code availability

Data analysis was performed using SPSS V.26.0 (IBM Corp., New York, USA).

Abbreviations

BMI :

Body mass index

CABG :

Coronary artery bypass graft

CD-TVR :

Clinically driven target vessel revascularization

CKD :

Chronic kidney disease

DES :

Drug-eluting stent

GFR :

Glomerular filtration rate

IVL :

Intravascular lithoplasty

LVEF :

Left ventricular ejection fraction

MACCE :

Major adverse cardiac and cerebrovascular events

MB :

Modified balloon

MI :

Myocardial infarction

PCI :

Percutaneous coronary intervention

RA :

Rotational atherectomy

SES :

Sirolimus-eluting stent

TLR :

Target-lesion revascularization

TVF :

Target vessel failure

TV-MI :

Target vessel myocardial infarction

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Funding

The PREPARE-CALC trial was financed by the Heart Center, Segeberger Kliniken GmbH, Bad Segeberg, Germany.

Author information

Authors and Affiliations

  1. Cardiology Department, Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany

    Nader Mankerious, Gert Richardt, Volker Geist & Ralph Toelg

  2. Cardiology Department, Zagazig University, Sharkia, Egypt

    Nader Mankerious

  3. Cardiology Department, University Heart Center Lübeck, Lübeck, Germany

    Abdelhakim Allali

  4. Cardiology Department, German Heart Center, Technical University of Munich, Munich, Germany

    Adnan Kastrati & Tobias Rheude

  5. Cardiology Department, DRK Kliniken Berlin Köpenick, Berlin, Germany

    Mohamed El-Mawardy

  6. Cardiology Department, Heart Center Leipzig at University of Leipzig, Leipzig, Germany

    Dmitriy Sulimov & Mohamed Abdel-Wahab

  7. Medical Faculty of the Christian-Albrechts University of Kiel, Kiel, Germany

    Ralph Toelg

  8. Center for Cardiovascular and Diabetes Medicine, Asklepios Clinic Bad Oldesloe, Bad Oldesloe, Germany

    Gert Richardt & Ralph Toelg

Authors
  1. Nader Mankerious
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Contributions

All authors contributed to the study’s conception and design. Material preparation, data collection, and analysis were performed by Nader Mankerious and Gert Richardt. The first draft of the manuscript was written by Nader Mankerious, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Nader Mankerious.

Ethics declarations

Ethics approval

The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments. The present study was approved by the appropriate ethics committee.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Consent for publication

Patients signed informed consent regarding publishing their data.

Conflict of interest

A. Allali is a consultant and proctor for Boston Scientific. G. Richardt has received institutional research grants from St. Jude Medical, Biotronik, and Medtronic. T. Rheude received lecture fees from SIS-Medical AG. M. Abdel-Wahab reports that his hospital receives speaker honoraria and/or consultancy fees on his behalf from Boston Scientific and Medtronic. The other authors have no relevant financial or non-financial interests to disclose.

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Mankerious, N., Richardt, G., Allali, A. et al. 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. Clin Res Cardiol (2024). https://doi.org/10.1007/s00392-024-02434-1

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