Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction

Zhang, Yao-Jun; Iqbal, Javaid; Windecker, Stephan; Linke, Axel; Antoni, Diethmar; Sohn, Hae Young; Corti, Roberto; van Es, Gerrit-Anne; Copt, Samuel; Eerdmans, Pedro; Saitta, Rana; Morice, Marie-Claude; Di Mario, Carlo; Jüni, Peter; Wijns, William; Buszman, Pawel; Serruys, Patrick W (2015). Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction. Heart (British Cardiac Society), 101(4), pp. 271-8. BMJ Publishing Group 10.1136/heartjnl-2014-306359

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OBJECTIVE

To investigate clinical outcomes of coronary intervention using a biolimus-eluting stent (BES) compared with a sirolimus-eluting stent (SES) in patients with acute myocardial infarction (AMI) in the Limus Eluted from A Durable versus ERodable Stent (LEADERS) coating trial at the final 5-year follow-up.

METHODS

The LEADERS trial is a multicentre all-comer study, where patients (n=1707) were randomised to percutaneous intervention with either BES containing biodegradable polymer or SES containing durable polymer. Out of 1707 patients enrolled in this trial, 573 patients had percutaneous coronary intervention for AMI (BES=280, SES=293) and were included in the current analysis. Patient-oriented composite endpoint (POCE, including all death, all myocardial infarction (MI) and all revascularisations), major adverse cardiac events (MACE, including cardiac death, MI and clinically indicated target vessel revascularisation) and stent thrombosis were assessed at 5-year follow-up.

RESULTS

The baseline clinical, angiographic and procedural characteristics were well matched between BES and SES groups. In all patients with AMI, coronary intervention with a BES, compared with SES, significantly reduced POCE (28.9% vs 42.3%; relative risk (RR) 0.61, 95% CI 0.47 to 0.82, p=0.001) at 5-year follow-up. There was also a reduction in MACE rate in the BES group (18.2% vs 25.9%; RR 0.67, 95% CI 0.47 to 0.95, p=0.025); however, there was no difference in cardiac death and stent thrombosis. In patients with ST-elevation MI (STEMI), coronary intervention with BES significantly reduced POCE (24.4% vs 39.3%; RR 0.55, 95% CI 0.36 to 0.85, p=0.006), MACE (12.6% vs 25.0%; RR 0.47, 95% CI 0.26 to 0.83, p=0.008) and cardiac death (3.0% vs 11.4%; RR 0.25, 95% CI 0.08 to 0.75, p=0.007), along with a trend towards reduction in definite stent thrombosis (3.7% vs 8.6%; RR 0.41, 95% CI 0.15 to 1.18, p=0.088), compared with SES.

CONCLUSIONS

BES, compared with SES, significantly improved safety and efficacy outcomes in patients with AMI, especially those with STEMI, at 5-year follow-up.

TRIAL REGISTRATION NUMBER

NCT 00389220.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM)
04 Faculty of Medicine > Pre-clinic Human Medicine > Department of Clinical Research (DCR)
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan, Jüni, Peter

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

1468-201X

Publisher:

BMJ Publishing Group

Language:

English

Submitter:

Doris Kopp Heim

Date Deposited:

05 Jan 2015 16:41

Last Modified:

20 Feb 2024 14:17

Publisher DOI:

10.1136/heartjnl-2014-306359

PubMed ID:

25423953

Uncontrolled Keywords:

Coronary artery disease inverventional cardiology myocardial ischaemia and infarction (IHD)

BORIS DOI:

10.7892/boris.61444

URI:

https://boris.unibe.ch/id/eprint/61444

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