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Safety of bailout stenting after paclitaxel-coated balloon angioplasty

Sicherheit der Notfallstenteinlage nach Angioplastie mit paclitaxelbeschichtetem Ballon

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Abstract

Background

Bailout stenting after suboptimal paclitaxel-coated balloon (PCB) angioplasty is required in up to 28% of cases. We sought to compare the safety of bailout stenting with drug-eluting stents (DES) compared with the more established combination of PCB with bare metal stents (BMS).

Methods

We retrospectively evaluated all patients who had stents implanted owing to suboptimal PCB angioplasty results between January 2010 and April 2015. Endpoints analyzed were major adverse cardiac events (MACE) – defined as cardiovascular death, nonfatal myocardial infarction (MI), and target lesion revascularization (TLR) – as well as major and minor bleeding.

Results

Baseline clinical characteristics were comparable with a high proportion of diabetics in both groups (50.0% vs. 45.8%, p = 0.74). BMS and DES sizes were similar (mean diameter 2.72 ± 0.50 mm vs. 2.89 ± 0.56 mm, p = 0.20, length 25.22 ± 13.47 mm vs. 28.08 ± 9.08 mm, p = 0.47). Outcomes were comparable at the end of 1 year (MACE 12.2% vs. 9.5%, p = 1.00, TLR 6.1% vs. 4.8%, p = 1.00, MI 0% vs. 4.8%, p = 0.30). There was no case of stent thrombosis or major bleeding, and the rates of minor bleeding were similar (4.2% vs. 4.8%, p = 1.00).

Conclusion

Our initial experience using DES instead of BMS as a bailout after suboptimal PCB results shows that the procedure is safe and effective at 1 year.

Zusammenfassung

Hintergrund

Eine Notfallstenteinlage nach suboptimaler Angioplastie mit einem paclitaxelbeschichteten Ballon („paclitaxel-coated balloon“, PCB) ist in bis zu 28% der Fälle erforderlich. Ziel der vorliegenden Arbeit war ein Vergleich der Sicherheit der Notfallstentversorgung mit medikamentenfreisetzenden Stents („drug-eluting stents“, DES) gegenüber der etablierten Kombination aus PCB und reinen Metallstents („bare metal stents“, BMS).

Methoden

Dazu wurden die Daten aller Patienten retrospektiv ausgewertet, bei denen zwischen Januar 2010 und April 2015 Stents aufgrund suboptimaler Ergebnisse nach PCB-Angioplastie implantiert wurden. Ausgewertete Endpunkte waren hierbei schwerere unerwünschte kardiale Ereignisse („major adverse cardiac events“, MACE), nichtletaler Myokardinfarkt (MI) und die Revaskularisierung der Zielläsion („target lesion revascularization“, TLR) sowie größere und kleinere Blutungen.

Ergebnisse

Die klinischen Merkmale mit einem hohen Anteil an Diabetikern bei Studienbeginn waren in beiden Gruppen vergleichbar (50,0% vs. 45,8%; p = 0,74). Die Größen der BMS und DES waren ähnlich (durchschnittlicher Durchmesser: 2,72 ± 0,50 mm vs. 2,89 ± 0,56 mm; p = 0,20; Länge: 25,22 ± 13,47 mm vs. 28,08 ± 9,08 mm; p = 0,47). Nach Ende eines Jahren waren die Ergebnisse vergleichbar (MACE: 12,2% vs. 9,5%; p = 1,00; TLR 6,1% vs. 4,8%; p = 1,00; MI 0% vs. 4,8%; p = 0,30). Es gab keinen Fall einer Stentthrombose oder einer schweren Blutung, und die Rate kleinerer Blutungen war in beiden Gruppen ähnlich (4,2% vs. 4,8%; p = 1,00).

Schlussfolgerung

Die anfänglichen Erfahrungen der Autoren mit dem Einsatz von DES anstelle von BMS zur Notfalltherapie nach suboptimalen PCB-Ergebnissen zeigen nach einem Jahr, dass dieses Vorgehen sicher und wirksam ist.

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Authors and Affiliations

  1. Department of Cardiology, Tan Tock Seng Hospital, 11 Jalan Tan Tock Seng, 308433, Singapore, Singapore

    K. H. Mok,  T. Watson, H. H. Ho & P. J. L. Ong

  2. Department of Cardiology, Norwich and Norfolk University Hospital, Norwich, UK

    U. Wickramarachchi & S. Eccleshall

  3. Faculty of Medicine and Health Science, University of Auckland, Auckland, New Zealand

    T. Watson

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  1. K. H. Mok
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  2. U. Wickramarachchi
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  3. T. Watson
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Correspondence to T. Watson.

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K.H. Mok, U. Wickramarachchi, T. Watson, H.H. Ho, S. Eccleshall, and P.J.L. Ong declare that they have no competing interests.

This article is based on retrospective registry data of real-world patients.

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Mok, K.H., Wickramarachchi, U., Watson, T. et al. Safety of bailout stenting after paclitaxel-coated balloon angioplasty. Herz 42, 684–689 (2017). https://doi.org/10.1007/s00059-016-4502-9

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