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.
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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.
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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.
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Informed consent was obtained from all individual participants included in the study.
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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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DOI: https://doi.org/10.1007/s00392-024-02434-1