scholarly journals Polymer ‐free Biolimus‐A9 coated thin strut stents for patients at high bleeding risk 1‐year results from the LEADERS FREE III study

2021 ◽  
Author(s):  
Franz R. Eberli ◽  
Hans‐Peter Stoll ◽  
Philip Urban ◽  
Marie‐Claude Morice ◽  
Philippe Brunel ◽  
...  
Keyword(s):  
Bleeding Risk ◽  
Biolimus A9 ◽  
High Bleeding Risk

P2794Real-world reasons and outcomes for 1-month versus longer dual antiplatelet therapy strategies with a polymer-free biolimus A9-coated stent: insights from the all-comers FREEDOM registry

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G Gallone ◽  
F D'Ascenzo ◽  
M D Di Biasi ◽  
R A Latini ◽  
P Vicinelli ◽  
...  
Keyword(s):  
Composite Endpoint ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Incidence Rates ◽  
Major Surgery ◽  
Target Vessel ◽  
Biolimus A9 ◽  
Landmark Analyses ◽  
High Bleeding Risk

Abstract Background The LEADERS FREE trial established the favourable clinical profile of a new polymer-free biolimus A9-eluting stent (PF-BES) in patients at high bleeding risk when used with a 1-month dual anti-platelet therapy (DAPT) strategy. Purpose This is the first study evaluating real-world reasons and outcomes for a 1-month versus longer DAPT strategies following PF-BES percutaneous coronary intervention (PCI). Methods FREEDOM is an all-comers registry including all patients who underwent PCI with at least one PF-BES at 10 sites, between January 2016 and July 2018. Patients were stratified according to DAPT strategy at discharge (1-month vs >1-month). Baseline features, reasons for PF-BES as reported by the treating physician, and outcomes were compared between groups. Primary outcomes were the 390-day estimates of a patient-oriented composite endpoint (POCE: death, myocardial infarction (MI) or target vessel revascularization) and of a device-oriented composite endpoint (DOCE: cardiac death, target vessel-MI or ischemia-driven target lesion revascularization). Incidence rates were adjusted for clinically relevant factors and outcome predictors. To avoid survival bias, landmark analyses starting from 1-month post-PCI were further carried. Results Following PF-BES PCI, 328 (40.3%) patients were discharged with 1-month DAPT and 485 (59.6%) patients with longer DAPT (median 12 months, IQR 6–12 months). Patients with hypertension or on oral anticoagulation (OAT) were more likely and patients with a previous or an index MI were less likely to be discharged on 1-month DAPT. Patients prescribed with 1-month DAPT were more likely to have had a PF-BES for a LEADERS FREE high bleeding risk criterium than those with longer DAPT (90.2% vs 69.9%, p=0.001). The same association was observed when the reason for PF-BES was a planned major surgery (13.1% vs 6.2%; p=0.001) or OAC to be continued after PCI (38.7% vs 16.5%, p<0.001). Conversely, patients with planned longer DAPT were more likely to have had a PF-BES following the operator preference (2.4% vs 15.5%, p<0.001) or for a reason other than a LEADERS FREE criterium or operator preference (5.2% vs 11.3%, p<0.001). No between-groups differences in the occurrence of the primary outcomes (1-month vs >1-month DAPT: POCE 11.9% vs 13.2%, p=0.747; adj-HR 1.29 [95% CI 0.78–2.10]; DOCE: 4.8% vs 8.1%, p=0.500; adj-HR 1.01 [95% CI 0.50–2.07]) and of bleedings (any: 11.3% vs 9.4%, p=0.472; adj-HR 0.87 [95% CI 0.51–1-50]; BARC 3–5: 4.2% vs 2.2%; p=0.108; adj-HR 1.50 [95% CI 0.58–3.87]) were observed. Landmark analyses showed similar results. Conclusions In a large contemporary all-comers registry, factors reflecting the operator-perceived patient high bleeding risk were the main drivers of a very-short DAPT strategy following PF-BES PCI. We found no interaction of DAPT duration with outcomes following PF-BES PCI, an observation warranting investigation in adequately powered randomised studies.

The Biolimus A9-coated BioFreedom™ stent: from clinical efficacy to real-world evidence

2020 ◽  
Author(s):  
Sarah Mauler-Wittwer ◽  
Philippe Garot
Keyword(s):  
Arterial Wall ◽  
Dual Antiplatelet Therapy ◽  
Bleeding Risk ◽  
Free Trial ◽  
Thrombosis Risk ◽  
Real World Evidence ◽  
Biolimus A9 ◽  
Drug Eluting ◽  
Potential Trigger ◽  
High Bleeding Risk

In this state-of-the-art review, we present the findings and a critical analysis of the Leaders Free trial program, evaluating outcomes of a new stent-generation based on polymer-free technology, in this case the BioFreedom™ (Biosensors Europe, Switzerland), in patients at high bleeding risk (HBR). Polymer-free drug-coated stents were designed to obtain a device with the antirestenotic benefits of drug-eluting stents but without the polymer coating as potential trigger for delayed arterial wall healing and subsequent late ischemic adverse events, causing a prolonged dependence on dual antiplatelet therapy after stenting. This offers therefore the potential of a promising device-based strategy in a complex growing population of patients with combined HBR and high thrombosis risk, due to the possible reduction of antithrombotic duration.

Two-year outcomes of high bleeding risk patients with acute coronary syndrome after Biolimus A9 polymer-free drug-coated stents: a LEADERS FREE substudy

2018 ◽  
Vol 13 (16) ◽  
pp. 1946-1949 ◽  
Author(s):  
Christoph J. Jensen ◽  
Christoph K Naber ◽  
Philip Urban ◽  
Paul J Ong ◽  
Mariano Valdes-Chavarri ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Bleeding Risk ◽  
Free Drug ◽  
Coronary Syndrome ◽  
Biolimus A9 ◽  
Risk Patients ◽  
High Bleeding Risk

P2820Contemporary indications, dual antiplatelet therapy strategies and clinical outcomes for a polymer-free biolimus A9-coated stent: the all-comers FREEDOM registry

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
G Gallone ◽  
F D'Ascenzo ◽  
M D Di Biasi ◽  
R A Latini ◽  
P Vicinelli ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Real World ◽  
Dual Antiplatelet Therapy ◽  
Composite Endpoint ◽  
Bleeding Risk ◽  
Target Vessel ◽  
Biolimus A9 ◽  
History Of ◽  
High Bleeding Risk ◽  
History Of Cancer

Abstract Background The absence of a polymer-coat along with fast drug absorption represent the benchmark counterpart of the favourable clinical profile of a new polymer-free biolimus A9-eluting stent (PF-BES), also when used with a very short dual antiplatelet therapy (DAPT) strategy. Its current use in the real-world setting has not been thoroughly assessed. Purpose We evaluated contemporary patterns of indications, DAPT strategies and outcomes for the PF-BES. Methods FREEDOM is a multicenter registry including all patients who underwent percutaneous coronary intervention (PCI) with at least one PF-BES at 10 italian sites. Reasons for PF-BES PCI and planned antithrombotic regimen at discharge were collected. Primary outcomes were the 390-day Kaplan Meier estimates of a patient-oriented composite endpoint (POCE: death, any myocardial infarction [MI] or any target vessel revascularization [TVR]) and of a device-oriented composite endpoint (DOCE: cardiac death, target vessel-MI or ischemia-driven target lesion revascularization [ID-TLR]). The independent outcomes predictors were assessed through multivariate Cox proportional hazards analysis. Results Between January 2016 and July 2018, 858 patients (age: 74±10 years, 64.6% males, 58.7% acute coronary syndrome presentation) underwent PF-BES PCI. Main reasons for PF-BES physician's choice were advanced age (26.0%), oral anticoagulation (OAT) to be continued after PCI (25.3%), operator preference for PF-BES (9.9%), planned major surgery (8.6%), cancer (8.6%), anemia (7.9%) and recent bleeding (7.0%). Overall, the operator choice to implant a PF-BES reflected a perceived high bleeding risk in 77.7% of patients. At discharge, 99.2% of patients were on DAPT, 19.5% on triple therapy, and 0.8% on single antiplatelet therapy plus OAT. Planned DAPT duration was 1-month in 40.3% of patients, with 33.8% of these being on triple therapy. At 390-day follow-up (median 340 days, interquartile range: 187–390 days) the incident estimate of POCE was 13.1% (any MI 3.7%, any TVR 3.4%) and of DOCE was 7.1% (TV-MI 3.6%, ID-TLR 1.4%); while 390-day estimate of any bleeding event was 11.1% (BARC 3–5 bleeding 3.0%). Independent predictors of 390-day POCE were eGFR≤60 ml/min (HR 1.81; 95% CI 1.09–3.04, p=0.028), a history of cancer (HR 2.62; 95% CI 1.43–4.81, p=0.002) and severely calcified lesion/s (HR 2.05; 95% CI 1.09–3.85, p=0.025). Independent predictors of DOCE were a previous MI (HR 2.06; 95% CI 1.03–4.15, p=0.041), a history of cancer (HR 2.69; 95% CI 1.18–6.13, p=0.019) and bifurcation lesion/s (HR 2.66; 95% CI 1.38–5.13, p=0.004). Conclusions In a large, contemporary all-comers registry, the main reasons for PF-BES use reflected in most cases the operator-perceived high bleeding risk of the patient. Following PF-BES PCI, a very-short DAPT strategy was frequently implemented. The outcomes observed in this registry suggest a favorable safety and efficacy profile for the PF-BES in a real-world clinical setting.

scholarly journals Biolimus A9 polymer-free coated stents in high bleeding risk patients undergoing complex PCI: evidence from the LEADERS FREE randomised clinical trial

2018 ◽  
Vol 14 (4) ◽  
pp. e418-e425 ◽  
Author(s):  
Janusz Lipiecki ◽  
Philippe Brunel ◽  
Marie-Claude Morice ◽  
Christan Roguelov ◽  
Simon J. Walsh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bleeding Risk ◽  
Randomised Clinical Trial ◽  
Biolimus A9 ◽  
Risk Patients ◽  
High Bleeding Risk

Real-world analysis of a Biolimus A9 polymer-free drug-coated stent with very short dual antiplatelet therapy in patients at high bleeding risk

Herz ◽  
2020 ◽  
Author(s):  
Grigorios Chatzantonis ◽  
Georgios Chatzantonis ◽  
Hannes Findeisen ◽  
Matthias Paul ◽  
Alexander Samol ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Real World ◽  
Dual Antiplatelet Therapy ◽  
Bleeding Risk ◽  
Free Drug ◽  
Biolimus A9 ◽  
High Bleeding Risk

scholarly journals Biolimus-A9 polymer-free coated stent in high bleeding risk patients with acute coronary syndrome: aLeaders Free ACSsub-study

2016 ◽  
pp. ehw203 ◽  
Author(s):  
Christoph K. Naber ◽  
Philip Urban ◽  
Paul J. Ong ◽  
Mariano Valdes-Chavarri ◽  
Alexandre A. Abizaid ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Bleeding Risk ◽  
Coronary Syndrome ◽  
Biolimus A9 ◽  
Risk Patients ◽  
High Bleeding Risk
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