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Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years
Franz R Eberli1, Keith G Oldroyd2, Philip Urban3
1Municipal Hospital Triemli, Zurich, Switzerland.
Insights
The LEADERS FREE III trial shows the next-generation cobalt-chromium biolimus-coated stent is safe and effective for high bleeding-risk patients after 3 years. This stent demonstrated lower rates of target lesion revascularization compared to older models.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Previous trials (LEADERS FREE and II) established safety and efficacy of stainless steel polymer-free biolimus-coated stents (SS-BCS) in high bleeding-risk (HBR) patients with 30 days of dual antiplatelet treatment (DAPT).
- The LEADERS FREE III (LF III) trial evaluated a next-generation cobalt-chromium thin-strut polymer-free biolimus-coated stent (CoCr-BCS) in HBR patients undergoing percutaneous coronary intervention (PCI).
Purpose of the Study:
- To report the final 3-year clinical outcomes from the LF III trial.
- To compare the 3-year outcomes of the CoCr-BCS stent in LF III with the SS-BCS stent from the LF II trial using propensity-matched analysis.
Main Methods:
- LF III was a prospective, multicenter, open-label, single-arm study assessing the safety and efficacy of the CoCr-BCS stent.
- Primary safety endpoint: composite of cardiac death (CD), myocardial infarction (MI), or definite/probable stent thrombosis (ST).
- Primary efficacy endpoint: clinically driven target lesion revascularization (cd-TLR). Propensity-matched comparison to LF II 3-year outcomes was performed.
Main Results:
- At 3 years, the cumulative incidence of CD/MI/ST was 15% and cd-TLR was 6.2% in the LF III trial.
- In propensity-matched comparison, CoCr-BCS (LF III) and SS-BCS (LF II) showed similar rates of CD (6.6% vs 7.8%), MI (7.1% vs 8.3%), and definite/probable ST (1.1% vs 2%).
- The CoCr-BCS group demonstrated a significantly lower rate of cd-TLR compared to the SS-BCS group (5.3% vs 9.8%, p=0.03).
Conclusions:
- The LF III trial confirms the long-term safety and efficacy of the next-generation cobalt-chromium polymer-free biolimus-coated stent (CoCr-BCS).
- This stent is suitable for high bleeding-risk patients treated with one month of dual antiplatelet therapy (DAPT).
- The CoCr-BCS shows a potential benefit in reducing target lesion revascularization compared to previous generation SS-BCS.
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.
