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Everolimus- vs. novolimus-eluting bioresorbable scaffolds in patients with acute coronary syndrome

Everolimus- vs. Novolimus-freisetzende bioresorbierbare Scaffolds bei Patienten mit akutem Koronarsyndrom

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Abstract

Background

Limited data exist on bioresorbable scaffolds (BRS) in patients with acute coronary syndrome (ACS). The aim of the present study was to evaluate novolimus-eluting BRS (DESolve) as interventional treatment for patients with ACS, and to compare its 12-month outcomes with the everolimus-eluting bioresorbable scaffolds (Absorb).

Methods

In this retrospective study, patients with ACS (including unstable angina pectoris, ST-segment elevation myocardial infarction, or non-ST-segment elevation myocardial infarction) treated with either the Absorb or the DESolve BRS were evaluated in a 1:1 matched-pair analysis. Major adverse cardiac events (MACE), including death, myocardial infarction, and target lesion revascularization, were evaluated as a major endpoint. The occurrence of scaffold thrombosis was also assessed.

Results

A total of 102 patients were eligible for this analysis. The rate of MACE at 12 months was comparable between the Absorb and the DESolve group (8.3% vs. 6.8%, p = 0.738). The occurrence of target lesion revascularization (6.2% vs. 4.7%; p = 0.700) and scaffold thrombosis (4.1% vs. 2.1%; p = 0.580) was comparable as well. All instances of scaffold thrombosis occurred within 30 days of the index procedure.

Conclusion

In this study, similar 12-month event rates were observed for both BRS types after implantation for the treatment of ACS.

Zusammenfassung

Hintergrund

Es gibt nur wenige Daten zur bioresorbierbaren Stents (BRS) bei Patienten mit akutem Koronarsyndrom (ACS). Ziel der vorliegenden Studie war es, Novolimus-freisetzende BRS (DESolve) als interventionelle Behandlung für Patienten mit ACS zu untersuchen und deren 12-Monats-Ergebnisse mit Everolimus-freisetzenden Stents zu vergleichen (Absorb).

Methoden

In der vorliegenden retrospektiven Studie wurden Patienten mit ACS (einschließlich instabiler Angina pectoris; Myokardinfarkt mit ST-Strecken-Erhöhung oder Myokardinfarkt ohne ST-Strecken-Erhöhung) in einer 1:1-Matched-Pair-Analyse untersucht, die entweder mit dem Absorb- oder dem DESolve-BRS behandelt wurden. Schwere kardiale unerwünschte Ereignisse („major adverse cardiac events“, MACE), einschließlich Tod, Myokardinfarkt und Revaskularisierung der Zielläsion, wurden als ein Hauptendpunkt ermittelt. Das Auftreten von Stentthrombosen wurde ebenfalls untersucht.

Ergebnisse

Für die Auswertung waren insgesamt 102 Patienten geeignet. Die Rate an MACE nach 12 Monaten war für die Absorb- und die DESolve-Gruppe vergleichbar (8,3 vs. 6,8 %; p = 0,738). Auch das Vorkommen einer Revaskularisierung der Zielläsion (6,2 vs. 4,7 %; p = 0,700) und von Stentthrombosen (4,1 vs. 2,1 %; p = 0,580) war vergleichbar. Alle Fälle von Stentthrombosen traten innerhalb von 30 Tagen ab dem Indexeingriff auf.

Schlussfolgerung

In dieser Studie wurden ähnliche 12-Monats-Raten unerwünschter Ereignisse für beide BRS-Typen nach Implantation zur Behandlung des ACS ermittelt.

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Funding

Funding

This work was supported in part by a grant from Elixir Corporation.

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Authors and Affiliations

  1. Medizinische Klinik I, Department of Cardiology and Angiology, University of Giessen, Klinikstraße 33, 35392, Giessen, Germany

    H. M. Nef MD, G. Schmidt, N. F. Boeder MD, O. Dörr MD, T. Bauer MD & C. W. Hamm MD

  2. Deutsches Herzzentrum Muenchen, Munich, Germany

    J. Wiebe MD

  3. Department of Cardiology, St. Johannes Hospital, Dortmund, Germany

    H. Möllmann MD

  4. Department of Cardiology, University of Erlangen, Erlangen, Germany

    F. Blachutzik MD

  5. Kerckhoff Heart Center, Bad Nauheim, Germany

    C. Liebetrau MD & C. W. Hamm MD

  6. Department of Cardiology, University of Oldenburg, Oldenburg, Germany

    A. Elsässer MD

  7. Duke-NUS Medical School, National Heart Centre Singapore, Singapore, Singapore

    N. Foin MSc, PhD

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  1. H. M. Nef MD
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Corresponding author

Correspondence to H. M. Nef MD.

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Conflict of interest

H. Möllmann and C.W. Hamm received speaker’s fees from Abbott Vascular. H.M. Nef received speaker’s fees from Abbott Vascular and Elixir Medical and institutional research grants from Abbott Vascular and Elixir Medical. J. Wiebe, G. Schmidt, N.F. Boeder, O. Dörr, T. Bauer, F. Blachutzik, C. Liebetrau, A. Elsässer, and N. Foin declare that they have no competing interests.

All procedures performed in studies involving human participants or on human tissue were in accordance with the ethical standards of the institutional and/or national research committee and with the 1975 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

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Nef, H.M., Wiebe, J., Schmidt, G. et al. Everolimus- vs. novolimus-eluting bioresorbable scaffolds in patients with acute coronary syndrome. Herz 45 (Suppl 1), 95–104 (2020). https://doi.org/10.1007/s00059-019-4822-7

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  • DOI: https://doi.org/10.1007/s00059-019-4822-7

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