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Original Article
Submitted: 2022-08-18
Accepted: 2023-01-27
Published online: 2023-02-27
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Randomized comparison of 9-month stent strut coverage of biolimus and everolimus drug-eluting stents assessed by optical coherence tomography in patients with ST-segment elevation myocardial infarction. Long-term (5-years) clinical follow-up (ROBUST trial)

Martin Jakl12, Pavel Cervinka3, Jan Kanovsky45, Petr Kala4, Martin Poloczek4, Michaela Cervinkova31, Hiram G. Bezerra6, Zdenek Valenta7, Marco Aurelio Costa6
DOI: 10.5603/CJ.a2023.0013
·
Pubmed: 36896638
Affiliations
  1. Department of Military Internal Medicine and Military Hygiene, Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic
  2. Department of Emergency Medicine, University Hospital in Hradec Kralove, Czech Republic
  3. Department of Cardiology, Krajska Zdravotni a.s., Masaryk Hospital and UJEP Usti nad Labem, Czech Republic
  4. Department of Cardiology and Internal Medicine, University Hospital Brno, Czech Republic
  5. Medical Faculty of Masaryk University, Brno, Czech Republic
  6. Harrington Heart and Vascular Institute, University Hospitals Case Medical Center, Cleveland, United States
  7. Department of Statistical Modelling, Institute of Computer Science, Czech Academy of Science, Prague, Czech Republic

open access

Ahead of print
Original articles
Submitted: 2022-08-18
Accepted: 2023-01-27
Published online: 2023-02-27

Abstract

Background: The aim of the study was to compare healing (assessed by optical coherence tomography [OCT]) of biolimus A9 (BES) and everolimus drug-eluting stents (EES) at 9-month follow-up in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (pPCI). Nine-month clinical and angiographic data were also compared in both groups as well as clinical data at 5 years of follow-up. Methods: A total of 201 patients with STEMI were enrolled in the study and randomized either to pPCI with BES or EES implantation. All patients were scheduled for 9 months of angiographic and OCT follow-up. Results: The rate of major adverse cardiovascular events (MACE) was comparable at 9 months in both groups (5% in BES vs. 6% in the EES group; p = 0.87). Angiographic data were also comparable between both groups. The main finding at 9-month OCT analysis was the greatly reduced extent of mean neointimal area at the cost of a higher proportion of uncovered struts in the BES group (1.3 mm2 vs. 0.9 mm2; p = 0.0001 and 15.9% vs. 7.0%; p = 0.0001, respectively). At 5 years of clinical follow-up the rate of MACE was comparable between both groups (16.8% vs. 14.0%, p = 0.74). Conclusions: The study demonstrates a very low rate of MACE and good 9-month stent strut coverage of second-generation BES and EES in patients with STEMI. BES showed greatly reduced extent of mean neointimal hyperplasia area at the cost of a higher proportion of uncovered struts when compared to EES. The rate of MACE was low and comparable in both groups at 5 years.

Abstract

Background: The aim of the study was to compare healing (assessed by optical coherence tomography [OCT]) of biolimus A9 (BES) and everolimus drug-eluting stents (EES) at 9-month follow-up in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (pPCI). Nine-month clinical and angiographic data were also compared in both groups as well as clinical data at 5 years of follow-up. Methods: A total of 201 patients with STEMI were enrolled in the study and randomized either to pPCI with BES or EES implantation. All patients were scheduled for 9 months of angiographic and OCT follow-up. Results: The rate of major adverse cardiovascular events (MACE) was comparable at 9 months in both groups (5% in BES vs. 6% in the EES group; p = 0.87). Angiographic data were also comparable between both groups. The main finding at 9-month OCT analysis was the greatly reduced extent of mean neointimal area at the cost of a higher proportion of uncovered struts in the BES group (1.3 mm2 vs. 0.9 mm2; p = 0.0001 and 15.9% vs. 7.0%; p = 0.0001, respectively). At 5 years of clinical follow-up the rate of MACE was comparable between both groups (16.8% vs. 14.0%, p = 0.74). Conclusions: The study demonstrates a very low rate of MACE and good 9-month stent strut coverage of second-generation BES and EES in patients with STEMI. BES showed greatly reduced extent of mean neointimal hyperplasia area at the cost of a higher proportion of uncovered struts when compared to EES. The rate of MACE was low and comparable in both groups at 5 years.

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Keywords

drug-eluting stent, primary percutaneous coronary intervention, stent strut coverage, optical coherence tomography, ST-segment elevation myocardial infarction, clinical trials

About this article
Title

Randomized comparison of 9-month stent strut coverage of biolimus and everolimus drug-eluting stents assessed by optical coherence tomography in patients with ST-segment elevation myocardial infarction. Long-term (5-years) clinical follow-up (ROBUST trial)

Journal

Cardiology Journal

Issue

Ahead of print

Article type

Original Article

Published online

2023-02-27

Page views

602

Article views/downloads

75

DOI

10.5603/CJ.a2023.0013

Pubmed

36896638

Keywords

drug-eluting stent
primary percutaneous coronary intervention
stent strut coverage
optical coherence tomography
ST-segment elevation myocardial infarction
clinical trials

Authors

Martin Jakl
Pavel Cervinka
Jan Kanovsky
Petr Kala
Martin Poloczek
Michaela Cervinkova
Hiram G. Bezerra
Zdenek Valenta
Marco Aurelio Costa

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