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Polymer-free biolimus-A9-coated stent for primary percutaneous coronary intervention

  • D. J. H. Lee
  • J. K. K. Loh
  • F. H. Jafary
  • H. H. Ho
  • T. Watson
  • H.-P. Stoll
  • P. J. L. Ong
Original articles
  • 45 Downloads

Abstract

Background

The polymer-free biolimus-A9 drug-coated stent (DCS) was reported to have superior safety and efficacy outcomes compared with a bare metal stent in the LEADERS FREE trial of high-bleeding-risk patients with acute coronary syndrome and on dual antiplatelet treatment (DAPT) for 1 month. The aim of this investigation was to evaluate the DCS in a consecutive cohort of patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI).

Methods

We analyzed data from 164 consecutive STEMI patients who underwent PPCI using the DCS at our institution. The primary efficacy endpoint was clinically indicated target lesion revascularization (ciTLR); the primary safety endpoint was a composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis. Clinical outcomes at 1 year are presented here.

Results

The mean age of the patients was 61.5 ± 15.5 years, and 86.6% were male. The median symptom-to-balloon-time was 55 min. In 57.9% of patients (n = 95), the infarct had an anterior location. PPCI achieved Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow in 163 of 164 patients (99.4%). All patients were prescribed DAPT for 1 year. At 1 year, ciTLR occurred in 1.2% of patients, the primary safety endpoint was reached in 4.3% of patients, and definite stent thrombosis was noted in 0.6% of patients.

Conclusion

In this consecutive real-world cohort of patients, the DCS was safe and efficacious when used for PPCI in patients with STEMI.

Keywords

ST-elevation myocardial infarction Angioplasty Drug-coated stents Antiplatelet agents Bleeding 

Abbreviations

ACS

Acute coronary syndrome

BARC

Bleeding Academic Research Consortium

DAPT

Dual antiplatelet therapy

DCS

Drug-coated stent

DES

Drug-eluting stent

MI

Myocardial infarction

PCI

Percutaneous coronary intervention

STEMI

ST-elevation myocardial infarction

ST

Stent thrombosis

TIMI

Thrombolysis in Myocardial Infarction

TLR

Target lesion revascularization

Polymerfreier Biolimus-A9-beschichteter Stent für die primäre perkutane Koronarintervention

Zusammenfassung

Hintergrund

Der polymerfreie Biolimus-A9-beschichtete Stent („drug-coated stent“, DCS) sei bei Endpunkten in Bezug auf Sicherheit und Wirksamkeit im Vergleich zu einem reinen Metallstent überlegen, wie Berichten über die LEADERS-FREE-Studie an Patienten mit hohem Blutungsrisiko bei akutem Koronarsyndrom unter einmonatiger dualer Thrombozytenaggregationshemmertherapie („dual antiplatelet treatment“, DAPT) zu entnehmen ist. Ziel der vorliegenden Studie war es, den DCS an einer Kohorte aufeinanderfolgender Patienten mit ST-Strecken-Hebungs-Infarkt („ST-elevation myocardial infarction“, STEMI) zu untersuchen, bei denen eine primäre perkutane Koronarintervention (PPCI) durchgeführt wurde.

Methoden

Ausgewertet wurden die Daten von 164 konsekutiven STEMI-Patienten, bei denen in der Klinik der Autoren eine PPCI unter Verwendung des DCS erfolgte. Der primäre Endpunkt in Bezug auf die Wirksamkeit war der klinische Nachweis der Revaskularisierung des Zielgefäßes („clinically indicated target lesion revascularization“, ciTLR); hinsichtlich der Sicherheit handelte es sich um einen zusammengesetzten Endpunkt aus Herztod, Myokardinfarkt und tatsächlicher/wahrscheinlicher Stentthrombose. Hier werden die klinischen Ergebnisse nach einem Jahr dargestellt.

Ergebnisse

Das Durchschnittsalter der Patienten betrug 61,5 ± 15,5 Jahre, 86,6 % waren männlich. Die mittlere Symptom-bis-Ballon-Zeit lag bei 55 min. Bei 57,9 % der Patienten (n = 95) war der Infarkt an der Vorderwand lokalisiert. Mit der PPCI ließ sich ein Durchfluss des Grades 3 gemäß TIMI-Kriterien (Thrombolysis in Myocardial Infarction) bei 163 von 164 Patienten erzielen (99,4 %). Allen Patienten wurde für ein Jahr eine DAPT verordnet. Nach einem Jahr kam es bei 1,2 % der Patienten zur ciTLR, der primäre Endpunkt in Bezug auf die Sicherheit wurde bei 4,3 % der Patienten erreicht, und eine tatsächliche Stentthrombose wurde bei 0,6 % der Patienten diagnostiziert.

Schlussfolgerung

In der untersuchten Kohorte aufeinanderfolgender realer Patienten war der DCS sicher und wirksam, wenn er für eine PPCI bei Patienten mit STEMI eingesetzt wurde.

Schlüsselwörter

ST-Strecken-Hebungs-Infarkt Angioplastie Medikamentenbeschichtete Stents Thrombozytenaggregationshemmer Blutung 

Notes

Compliance with ethical guidelines

Conflict of interest

D.J.H. Lee, J.K.K. Loh, F.H. Jafary, H.H. Ho, T. Watson, and P.J.L. Ong declare that they have no competing interests. H.-P. Stoll is a full-time employee of Biosensors International, the manufacturer of the study stent.

Ethical approval to conduct the study according to the protocol was obtained from our institutional review board. The study was conducted independently of the device manufacturer and without industry funding.

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Copyright information

© Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2018

Authors and Affiliations

  • D. J. H. Lee
    • 1
  • J. K. K. Loh
    • 1
  • F. H. Jafary
    • 1
  • H. H. Ho
    • 1
  • T. Watson
    • 1
    • 2
  • H.-P. Stoll
    • 3
  • P. J. L. Ong
    • 1
  1. 1.Department of CardiologyTan Tock Seng HospitalSingaporeSingapore
  2. 2.Faculty of Medicine and Health ScienceUniversity of AucklandAucklandNew Zealand
  3. 3.Department for Clinical ResearchBiosensors EuropeMorgesSwitzerland

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