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)

0570717 - ÚI 2024 RIV PL eng J - Článek v odborném periodiku
Jakl, M. - Červinka, P. - Kanovský, J. - Kala, P. - Poloczek, M. - Červinková, M. - Bezerra, H. G. - Valenta, Zdeněk - Costa, M. A.
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).
Cardiology Journal. Roč. 30, č. 6 (2023), s. 921-928. ISSN 1897-5593. E-ISSN 1898-018X
Institucionální podpora: RVO:67985807
Klíčová slova: drug-eluting stent * primary percutaneous coronary intervention * stent strut coverage * optical coherence tomography * ST-segment elevation myocardial infarction * clinical trials
Obor OECD: Cardiac and Cardiovascular systems
Impakt faktor: 3.0, rok: 2022
Způsob publikování: Open access
https://dx.doi.org/10.5603/CJ.a2023.0013

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.
Trvalý link: https://hdl.handle.net/11104/0342048