Impact of Calcified Lesion Complexity on the Success of Percutaneous Coronary Intervention With Upfront High-Speed Rotational Atherectomy or Modified Balloons - A Subgroup-Analysis From the Randomized PREPARE-CALC Trial.


Journal

Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551

Informations de publication

Date de publication:
12 2021
Historique:
received: 19 11 2020
revised: 04 01 2021
accepted: 05 01 2021
pubmed: 17 1 2021
medline: 1 1 2022
entrez: 16 1 2021
Statut: ppublish

Résumé

In the randomized PREPARE-CALC trial, lesion preparation of calcified lesions with upfront rotational atherectomy (RA) prior to drug-eluting stent (DES) implantation resulted in higher acute success as compared to a provisional modified balloon (MB) strategy. We aimed to investigate the impact of calcified lesion complexity on the treatment effect with either MB or RA. Two hundred patients were randomized to lesion preparation with either MB or RA. The study population was stratified according to lesion complexity into at least one type-C lesion or into exclusively non-type-C lesions. Endpoints were strategy success, need for bail-out RA, acute lumen gain, and late lumen loss (LLL) at 9 months. In total, 143 patients were graded as type-C (45% patients were allocated to MB), whereas 57 patients were graded as non-type-C (61% patients were allocated to MB). In patients with at least one type-C lesion, strategy success with RA was higher than with MB (97% vs 72%, p < 0.001), but superiority of RA was not observed in patients with non-type-C lesions (100% vs 97%, p = 1.00; p In patients with calcified non-type-C lesions, the treatment strategy with RA or MB before DES implantation results in comparable success rates, whereas in type-C lesions upfront RA appears to be the superior upfront strategy.

Sections du résumé

BACKGROUND/PURPOSE
In the randomized PREPARE-CALC trial, lesion preparation of calcified lesions with upfront rotational atherectomy (RA) prior to drug-eluting stent (DES) implantation resulted in higher acute success as compared to a provisional modified balloon (MB) strategy. We aimed to investigate the impact of calcified lesion complexity on the treatment effect with either MB or RA.
METHODS/MATERIALS
Two hundred patients were randomized to lesion preparation with either MB or RA. The study population was stratified according to lesion complexity into at least one type-C lesion or into exclusively non-type-C lesions. Endpoints were strategy success, need for bail-out RA, acute lumen gain, and late lumen loss (LLL) at 9 months.
RESULTS
In total, 143 patients were graded as type-C (45% patients were allocated to MB), whereas 57 patients were graded as non-type-C (61% patients were allocated to MB). In patients with at least one type-C lesion, strategy success with RA was higher than with MB (97% vs 72%, p < 0.001), but superiority of RA was not observed in patients with non-type-C lesions (100% vs 97%, p = 1.00; p
CONCLUSIONS
In patients with calcified non-type-C lesions, the treatment strategy with RA or MB before DES implantation results in comparable success rates, whereas in type-C lesions upfront RA appears to be the superior upfront strategy.

Identifiants

pubmed: 33451925
pii: S1553-8389(21)00005-1
doi: 10.1016/j.carrev.2021.01.002
pii:
doi:

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

26-31

Informations de copyright

Copyright © 2021 Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest Dr. Hemetsberger reports speaker's honoraria from Boston Scientific. Drs. Toelg and Richardt report speaker's honoraria from Boston Scientific, Abbott Vascular, and Biotronik. Dr. Byrne reports Research funding to the institution of prior employment from Celonova Biosciences. Dr. Allali reports being a proctor for Boston Scientific. The other authors report no conflicts of interest.

Auteurs

Rayyan Hemetsberger (R)

Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany.

Ralph Toelg (R)

Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany.

Nader Mankerious (N)

Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany.

Abdelhakim Allali (A)

Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany.

Hussain Traboulsi (H)

Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany.

Dmitriy S Sulimov (DS)

Heart Center Leipzig at University of Leipzig, Leipzig, Germany.

Mohamed El-Mawardy (M)

Vivantes Wenckebach Hospital, Berlin, Germany.

Robert A Byrne (RA)

Cardiovascular Research Institute (CVRI) Dublin, Mater Private Hospital, Dublin, Ireland; School of Pharmacy and Biomolecular Sciences, RCSI University of Medicine and Health Sciences, Dublin, Ireland.

Derek R Robinson (DR)

Department of Mathematics, University of Sussex, Brighton, United Kingdom.

Adnan Kastrati (A)

Deutsches Herzzentrum München, Technical University of Munich, Munich, Germany.

Mohamed Abdel-Wahab (M)

Heart Center Leipzig at University of Leipzig, Leipzig, Germany.

Gert Richardt (G)

Heart Center Bad Segeberg, Segeberger Kliniken GmbH, Bad Segeberg, Germany. Electronic address: gert.richardt@segebergerkliniken.de.

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