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)

JAKL, Martin, Pavel CERVINKA, Jan KAŇOVSKÝ, Petr KALA, Martin POLOCZEK, Michaela CERVINKOVA, Hiram G BEZERRA, Zdenek VALENTA and Marco Aurelio COSTA. 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. GDANSK: VIA MEDICA, 2023, vol. 30, No 6, p. 921-928. ISSN 1897-5593. Available from: https://dx.doi.org/10.5603/CJ.a2023.0013.

Basic information

• Original name: 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)
• Authors: JAKL, Martin (203 Czech Republic), Pavel CERVINKA (203 Czech Republic, guarantor), Jan KAŇOVSKÝ (203 Czech Republic, belonging to the institution), Petr KALA (203 Czech Republic), Martin POLOCZEK (203 Czech Republic), Michaela CERVINKOVA (203 Czech Republic), Hiram G BEZERRA, Zdenek VALENTA (203 Czech Republic) and Marco Aurelio COSTA.
• Edition: CARDIOLOGY JOURNAL, GDANSK, VIA MEDICA, 2023, 1897-5593.

Other information

• Original language: English
• Type of outcome: Article in a journal
• Field of Study: 30201 Cardiac and Cardiovascular systems
• Country of publisher: Poland
• Confidentiality degree: is not subject to a state or trade secret
• WWW: URL
• Impact factor: Impact factor: 2.900 in 2022
• RIV identification code: RIV/00216224:14110/23:00133406
• Organization unit: Faculty of Medicine
• Doi: http://dx.doi.org/10.5603/CJ.a2023.0013
• UT WoS: 001116942600001
• Keywords in English: drug-eluting stent; primary percutaneous coronary intervention; stent strut coverage; optical coherence tomography; ST-segment elevation myocardial infarction; clinical trials
• Tags: 14110211, rivok
• Tags: International impact, Reviewed

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. (Cardiol J 2023; 30, 6: 921-928)