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Drug-coated balloon versus drug-eluting stent for treating de novo coronary lesions in large vessels: a meta-analysis of clinical trials

Medikamentenbeschichteter Ballon vs. medikamentenfreisetzender Stent für die Behandlung von De-novo-Koronarläsionen in großen Gefäßen – eine Metaanalyse klinischer Studien

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Abstract

Background

Studies examining the efficiency of drug-coated balloon (DCB) compared to drug-eluting stents (DES) for de novo lesions in large vessels have reported inconsistent results.

Objective

This comprehensive meta-analysis of clinical trials compared the efficacy and safety of DCB and DES for the treatment of de novo coronary lesions.

Methods

The authors formally searched electronic databases before October 2019 to identify randomized and non-randomized clinical trials (RCTs and non-RCTs, respectively). Clinical trials were eligible for inclusion if they compared DCB with DES in patients with coronary lumen diameters >2.5 mm.

Results

Three RCTs and one non-RCT with a total of 321 patients were included in our meta-analysis (DCB group = 152, DES group = 169). The primary endpoint was in-segment late lumen loss (LLL) with a standardized mean difference (SMD) of −0.07 (95% confidence interval [CI]: −0.31, 0.316; P = 0.548) and the secondary endpoint was target lesion revascularization (TLR) with a risk ratio (RR) of 1.17 (95% CI: 0.46, 2.95; P = 0.746).

Conclusion

This meta-analysis indicated that DCB might be non-inferior to DES as evidenced by quantitative coronary angiography (QCA) assessed at 6–9 months after percutaneous coronary intervention in patients presenting with coronary artery disease.

Zusammenfassung

Hintergrund

Die Ergebnisse von Studien zur Wirksamkeit medikamentenbeschichteter Ballons („drug-coated balloons“ [DCB]) im Vergleich zu medikamentenfreisetzenden Stents („drug-eluting stents“ [DES]) bei De-novo-Läsionen in großen Gefäßen sind widersprüchlich.

Ziel

In dieser umfassenden Metaanalyse klinischer Studien wurden die Wirksamkeit und Sicherheit von DCB und DES in der Behandlung von De-novo-Koronarläsionen verglichen.

Methoden

In elektronischen Datenbanken wurde systematisch nach randomisierten und nichtrandomisierten klinischen Studien (RCT bzw. Nicht-RCT) gesucht, die vor Oktober 2019 publiziert worden waren. Klinische Studien wurden eingeschlossen, wenn sie DCB und DES bei Patienten mit einem Koronargefäßinnendurchmesser >2,5 mm verglichen.

Ergebnisse

Drei RCT und eine Nicht-RCT mit insgesamt 321 Patienten wurden in die Metaanalyse eingeschlossen (DCB-Gruppe = 152, DES-Gruppe = 169). Primärer Endpunkt war der späte Lumenverlust im Gefäßsegment („in-segment late lumen loss“) mit einer standardisierten Mittelwertdifferenz von −0,07 (95%-Konfidenzintervall [KI] −0,31, 0,316; P = 0,548), sekundärer Endpunkt war die Revaskularisierung der Zielläsion mit einem relativen Risiko von 1,17 (95%-KI 0,46, 2,95; P = 0,746).

Schlussfolgerung

Gemäß der vorliegenden Metaanalyse könnte eine Nichtunterlegenheit des DCB gegenüber dem DES bestehen, wie in der quantitativen Koronarangiographie 6–9 Monate nach perkutaner Koronarintervention bei Patienten mit koronarer Herzkrankheit gezeigt wurde.

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Funding

This study was supported by Shenzhen Municipal Health Commission (SZFZ2017029).

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Authors and Affiliations

  1. Department of Cardiology, Shenzhen People’s Hospital, Second Clinical Medical College of Jinan University, first affiliated Hospital of South University of Science and Technology, No. 1017, Dongmen Northern Road, 518020, Shenzhen, Guangdong, China

    Yaowang Lin MD, Xin Sun MD, Huadong Liu MD, Xinli Pang MD & Shaohong Dong MD

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  1. Yaowang Lin MD
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  2. Xin Sun MD
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  3. Huadong Liu MD
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Contributions

Yaowang Lin collected, analyzed, and wrote this manuscript. Xin Sun, Huadong Liu, and Xinli Pang assisted in data analysis. Shaohong Dong is the principal investigator.

Corresponding author

Correspondence to Shaohong Dong MD.

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Conflict of interest

Y. Lin, X. Sun, H. Liu, X. Pang, and S. Dong declare that they have no competing interests.

For this article no studies with human participants or animals were performed by any of the authors. All studies performed were in accordance with the ethical standards indicated in each case.

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Lin, Y., Sun, X., Liu, H. et al. Drug-coated balloon versus drug-eluting stent for treating de novo coronary lesions in large vessels: a meta-analysis of clinical trials. Herz 46, 269–276 (2021). https://doi.org/10.1007/s00059-020-04938-8

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  • DOI: https://doi.org/10.1007/s00059-020-04938-8

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