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

Untersuchung eines polymerfreien medikamentenbeschichteten Biolimus-A9-Stents mit sehr kurzer dualer Plättchenhemmung unter Realbedingungen bei Patienten mit hohem Blutungsrisiko

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Abstract

Background

Patients at high risk of bleeding requiring percutaneous coronary intervention (PCI) need careful evaluation of both their thrombotic and their bleeding risks. In these patients, a polymer-free metallic stent coated with biolimus-A9 (BA9-DCS) followed by 1‑month dual antiplatelet therapy (DAPT) could be a safe option; however, real-world data are still lacking. We analyzed the performance of the device in a real-world scenario.

Methods

Patients assessed as being at high risk of bleeding with an indication for PCI were treated with BA9-DCS and DAPT consisting of aspirin (100 mg/day) and clopidogrel (75 mg/day) for at least 1 month, followed by either oral anticoagulation or single antiplatelet therapy. No exclusion criteria were used. The primary endpoint was the occurrence of an adverse event after PCI, i.e. severe bleeding requiring hospitalization, ischemic or hemorrhagic stroke, clinically driven stent thrombosis, myocardial infarction or cardiac death.

Results

Overall, 89 patients were enrolled in this study [median age 75 (66–81) years; 27 females (30%)] and 171 interventions were performed. During a median follow-up of 203 (145–273) days the primary endpoint occurred in 20 patients (23%): 12 (13%) had clinically significant bleeding, four (5%) ischemic stroke and four (5%) died from cardiac causes related neither to stent thrombosis nor to acute myocardial infarction. Female gender emerged as the only statistically significant predictor of an adverse event (adjusted hazard ratio (HR) 3.3; 95% confidence interval (CI): 1.2–8.7, p = 0.017).

Conclusion

In real-world patients at high risk of bleeding, implantation of the polymer-free metallic stent coated with Biolimus-A9 (Biofreedom®; Biosensors Europe, Morges, Switzerland) followed by 1 -month DAPT showed encouraging results without any stent thrombosis.

Zusammenfassung

Hintergrund

Patienten mit hohem Blutungsrisiko, bei denen eine perkutane Koronarintervention (PCI) notwendig ist, müssen sorgfältig bezüglich ihres Thrombose- wie auch Blutungsrisikos beurteilt werden. Bei ihnen könnte der Einsatz eines mit Biolimus A9 beschichteten polymerfreien Metallstents (BA9-DCS) mit nachfolgender 1‑monatiger dualer Plättchenhemmung („dual antiplatelet therapy“ [DAPT]) eine sichere Option sein. Es fehlen allerdings immer noch Daten aus der Praxis. Daher haben wir den BA9-DCS unter Realbedingungen untersucht.

Methoden

Patienten mit hohem Blutungsrisiko und Indikation zur PCI wurden mit BA9-DCS und einer DAPT (Acetylsalicylsäure 100 mg/Tag und Clopidogrel 75 mg/Tag für mindestens 1 Monat) behandelt, worauf eine orale Antikoagulation oder einfache Plättchenhemmung folgte. Ausschlusskriterien gab es nicht. Als primärer Endpunkt wurde der Eintritt eines unerwünschten Ereignisses nach PCI definiert (schwere Blutung mit erforderlicher Krankenhausaufnahme, ischämischer oder hämorrhagischer Schlaganfall, klinisch begünstigte Stentthrombose, Myokardinfarkt oder kardial bedingter Tod).

Ergebnisse

Insgesamt 89 Patienten wurden in die Studie eingeschlossen (medianes Alter 75 [66–81] Jahre; 27 weiblich [30 %]); es wurden 171 Interventionen durchgeführt. In einem medianen Follow-up von 203 (145–273) Tagen wurde der primäre Endpunkt bei 20 Patienten (23 %) erreicht: 12 (13 %) hatten eine klinisch relevante Blutung, 4 (5 %) einen ischämischen Schlaganfall und 4 (5 %) verstarben kardial bedingt, wobei die Ursache weder mit einer Stentthrombose noch mit einem akuten Myokardinfarkt zusammenhing. Weibliches Geschlecht erwies sich als einziger statistisch signifikanter Prädiktor für ein unerwünschtes Ereignis (adjustierte Hazard Ratio [HR] 3,3; 95 %-Konfidenzintervall [KI]: 1,2–8,7, p = 0,017).

Schlussfolgerung

Bei Patienten unter Realbedingungen mit hohem Blutungsrisiko lieferte die Implantation des mit Biolimus A9 beschichteten polymerfreien Metallstents (Biofreedom®, Biosensors Europe, Morges, Schweiz) gefolgt von einer 1‑monatigen DAPT vielversprechende Ergebnisse, ohne dass es zu einer Stentthrombose kam.

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Abbreviations

ACS:

Acute coronary syndrome

BA9 DCS:

Biolimus A9TM drug-coated stent

BMS:

Bare metal stent

CABG:

Coronary artery bypass graft

CAD:

Coronary artery disease

CI:

Confidence interval

DAPT:

Dual antiplatelet therapy

DES:

Drug eluting stent

HR:

Hazard ratio

ICB:

Intracranial bleeding

NSTEMI:

Non-ST segment elevation myocardial infarction

OAC:

Oral anticoagulation

OR:

Odds ratio

PCI:

Percutaneous coronary intervention

STEMI:

ST segment elevation myocardial infarction

TT:

Triple therapy

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Author contribution

GrC carried out the data and statistical analysis and wrote the initial draft version of the manuscript. GeC carried out the data and statistical analysis and wrote a number of paragraphs of the initial draft version of the manuscript. HF, MP, AS and FD evaluated all the patients for the use of a BioFreedomTM Stent and performed the percutaneous coronary interventions. TB critically reviewed the manuscript. FD supervised the study, critically reviewed the manuscript and drafted the manuscript. All authors read and approved the final manuscript.

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Authors and Affiliations

  1. Department of Cardiology I—Coronary and Peripheral Vascular Disease, Heart Failure, University Hospital Münster, Albert-Schweitzer-Campus 1, Building A1, 48149, Münster, Germany

    Grigorios Chatzantonis, Hannes Findeisen, Matthias Paul & Dieter Fischer

  2. Department of Vascular Surgery, Klinikum Ludwigshafen, Ludwigshafen, Germany

    Georgios Chatzantonis

  3. Department of Cardiology and Critical Care Medicine, Johannes Wesling University Hospital, Ruhr University Bochum, 32429, Minden, Germany

    Alexander Samol

  4. Clinic of Advanced Endovascular Services, Athens Medical Centre, Athens, Greece

    Theodosios Bisdas

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  1. Grigorios Chatzantonis
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  2. Georgios Chatzantonis
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Correspondence to Grigorios Chatzantonis.

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Conflict of interest

Gr. Chatzantonis, Ge. Chatzantonis, H. Findeisen, M. Paul, A. Samol, T. Bisdas and D. Fischer declare that they have no competing interests.

The study protocol complies with the Declaration of Helsinki. Written informed consent was obtained from all patients.

Additional information

The authors Grigorios Chatzantonis and Georgios Chatzantonis contributed equally to the manuscript.

Availability of data and materials

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

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Chatzantonis, G., Chatzantonis, G., Findeisen, H. et al. 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 46, 242–249 (2021). https://doi.org/10.1007/s00059-019-04882-2

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