Everolimus-eluting bioresorbable scaffold versus everolimus-eluting metallic stent in primary percutaneous coronary intervention of ST-segment elevation myocardial infarction: a randomized controlled trial.

Autor:	Eriksen E; Department of Heart Disease, Haukeland University Hospital.; Department of Clinical Science, University of Bergen, Bergen, Norway., Neghabat O; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Saeed S; Department of Heart Disease, Haukeland University Hospital., Herstad J; Department of Heart Disease, Haukeland University Hospital., Nordrehaug JE; Department of Clinical Science, University of Bergen, Bergen, Norway., Tuseth V; Department of Heart Disease, Haukeland University Hospital.; Department of Clinical Science, University of Bergen, Bergen, Norway., Holm NR; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Holck EN; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Sejr-Hansen M; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Maule CF; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Barkholt TØ; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Andreasen LN; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Christiansen EH; Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark., Bleie Ø; Department of Heart Disease, Haukeland University Hospital.
Jazyk:	angličtina
Zdroj:	Coronary artery disease [Coron Artery Dis] 2023 Jan 01; Vol. 34 (1), pp. 1-10. Date of Electronic Publication: 2022 Nov 22.
DOI:	10.1097/MCA.0000000000001202
Abstrakt:	Background: Primary percutaneous coronary intervention with implantation of a metallic drug-eluting stent (DES) is the standard treatment for patients presenting with ST-elevation myocardial infarction (STEMI). Implantation of a bioresorbable scaffold (BRS) during STEMI represents a novel strategy without intravascular metal. Objective: The aim of the study was to investigate 12-month healing response in an STEMI population after implantation of either the Absorb BRS or Xience DES (Abbott Vascular, USA). Methods: The present trial was a prospective, randomized, controlled, nonblinded, noninferiority study with planned inclusion of 120 patients with STEMI. Patients were randomly assigned 1:1 to treatment with Absorb BRS or Xience DES. Implantation result and healing response were evaluated by angiography and optical coherence tomography (OCT) at baseline and 12-month follow-up. The primary endpoint was minimum flow area (MFA) assessed at 12 months. Coronary stent healing index (CSHI) was calculated from OCT images. Results: Out of 66 included patients, 58 had follow-up OCT after 12 months, and 49 entered matched analysis. One death occurred in each group; none were stent-related. MFA was 5.13 ± 1.70 mm2 (95% CI, 4.44-5.82) in the BRS group compared with 6.30 ± 2.49 mm2 (95% CI, 5.22-7.37) (P = 0.06) in the DES group. Noninferiority could not be evaluated. CSHI for both groups had a median score of 3. Conclusion: The DES group performed numerically better in primary and secondary endpoints, but the CSHI showed good stent healing in both groups. (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
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