Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years.
Open Heart
; 11(1)2024 Jun 18.
Article
in En
| MEDLINE
| ID: mdl-38890129
ABSTRACT
BACKGROUND:
For high bleeding-risk patients (HBR) undergoing percutaneous coronary intervention (PCI), the LEADERS FREE (LF) and LEADERS FREE II (LF II) trials established the safety and efficacy of a stainless steel polymer-free biolimus-coated stent (SS-BCS) with 30 days of dual antiplatelet treatment (DAPT). The LEADERS FREE III (LF III) trial investigated clinical outcomes after PCI with the next-generation cobalt-chromium thin-strut polymer-free biolimus-coated stent (CoCr-BCS) in HBR patients.AIMS:
To report the final 3-year results of the LF III trial and compare them to LF II.METHODS:
LF III was a prospective, multicentre, open-label single-arm study to evaluate the safety and efficacy of the CoCr-BCS stent. The primary safety endpoint was the composite of cardiac death (CD), myocardial infarction(MI) or definite/probable stent thrombosis (ST). The primary efficacy endpoint was clinically driven target lesion revascularisation (cd-TLR). We performed a propensity-matched comparison to the 3-year outcomes of LF II.RESULTS:
After 3 years, CD/MI/ST had occurred in 57 patients (15%, 95% CI 11.8% to 19%) and cd-TLR in 23 (6.2%, 95% CI 4.1% to 9.2%) patients. In a propensity-matched comparison of patients treated with the CoCr-BCS versus the SS-BCS, there were similar rates of CD (6.6% vs 7.8%, p=0.50), MI (7.1% vs 8.3%, p=0.47) and definite/probable ST (1.1% vs 2%, HR 0.56, 95% CI 0.16 to 1.93, p=0.35). The rates of cd-TLR were 5.3% with CoCr-BCS versus 9.8% with SS-BCS (HR 0.54, 95% CI 0.31 to 0.96, p=0.03).CONCLUSION:
LF III confirms the long-term safety and efficacy of the CoCr-BCS in HBR patients treated with 1 month of DAPT. TRIAL REGISTRATION NUMBER NCT02843633, NCT03118895.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Prosthesis Design
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Coronary Artery Disease
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Sirolimus
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Drug-Eluting Stents
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Percutaneous Coronary Intervention
Limits:
Aged
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Female
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Humans
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Male
/
Middle aged
Language:
En
Journal:
Open Heart
Year:
2024
Document type:
Article
Affiliation country:
Country of publication: