Biolimus-A9 polymer-free coated stent in high bleeding risk patients with acute coronary syndrome: a Leaders Free ACS sub-study
Eur. heart j
; 38(13): 961-969, 2017. tab, graf
Article
in En
| SES-SP, SESSP-IDPCPROD, SES-SP
| ID: biblio-1062641
Responsible library:
BR79.1
Localization: BR79.1
ABSTRACT
Aims Although a true clinical challenge, high bleeding risk patients with an acute coronary syndrome (ACS) undergoing per cutaneous coronary intervention (PCI) have never been specifically studied. Leaders Free ACS, a pre-specified Leaders Free sub-study, determined efficacy, and safety of a combination of 1-month dual anti-platelet therapy (DAPT) with im plantation of either a polymer-free Biolimus-A9-coated stent (BA9-DCS) or a bare-metal stent (BMS) in these patients. Methods and results Leaders Free included 2466 patients undergoing PCI who had at least 1 of 13 pre-defined factors for an increased bleed ing risk. Of these, 659 ACS patients were included in this analysis (BA9-DCS 330, BMS 329). At 12-month follow-up, treatment with the BA9-DCS was more effective (clinically driven target-lesion revascularization 3.9 vs. 9.0%, P » 0.009) and safer (cumulative incidence of cardiac death, myocardial infarction, or definite or probable stent thrombosis 9.3 vs. 18.5%, P » 0.001), driven by significantly lower rates of cardiac mortality (3.4 vs. 6.9%, P » 0.049) and myocardial infarction (6.9 vs. 13.8%, P » 0.005). Conclusion We believe that the results of this sub-analysis from the Leaders Free trial are likely to significantly impact clinical practice for high bleeding risk patients presenting with an ACS the use of a BMS can, in our view, no longer be recommended, and, given the paucity of available data for second-generation DES with shortened DAPT in these patients, the BA9- DCS should currently be considered as the device with the strongest evidence to support its use for this indication.
Full text:
1
Collection:
06-national
/
BR
Database:
SES-SP
/
SESSP-IDPCPROD
Main subject:
Acute Coronary Syndrome
/
Percutaneous Coronary Intervention
Type of study:
Etiology_studies
/
Risk_factors_studies
Language:
En
Journal:
Eur Heart J
/
Eur. heart j
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European heart journal
Year:
2017
Document type:
Article