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Eur Heart J. 2019 Oct 8. pii: ehz698. doi: 10.1093/eurheartj/ehz698. [Epub ahead of print]

Mortality after use of paclitaxel-based devices in peripheral arteries: a real-world safety analysis.

Author information

1
Department of Cardiology I-Coronary and Peripheral Vascular Disease, Heart Failure, University Hospital Muenster, Albert Schweitzer Campus 1, A1, Muenster, Germany.
2
Institute of Biostatistics and Clinical Research, University of Muenster, Schmeddingstrasse 56, Muenster, Germany.
3
Department of Medicine and Health Services Research, BARMER Health Insurance, Lichtscheider Strasse 89, Wuppertal, Germany.

Abstract

AIMS:

Drug-eluting devices (DED) represent a well-established therapy being widely used for endovascular revascularization (EVR) of peripheral vessels. Recent data indicate a two-fold increased long-term mortality in patients treated with paclitaxel-based DED. The subsequent safety concerns affected international regulatory authorities to enunciate several alerts for further application of DED.

METHODS AND RESULTS:

In 9.2 million insurants of the German BARMER Health Insurance, data on the application of paclitaxel-based drug-eluting stents (DES) and drug-coated balloons (DCB) were retrieved from their introduction on the market in 2007 until present. All patients with first EVR between 2007 and 2015 were indexed and followed until 31 December 2017. Each subsequently applied DES, DCB, bare-metal stent, and uncoated balloon was included in further analyses. Multivariable Cox regression analysis considered potential non-linear time-dependent hazard ratios (HRs) of DES and DCB over 11 years. We identified 64 771 patients who underwent 107 112 EVR procedures using 23 137 DED. Multivariable Cox regression analysis showed paclitaxel-based DES not to be associated with increased long-term mortality for over 11 years past application (all P > 0.057). DCB was associated with decreased long-term mortality for the first year past application (HR 0.92; P < 0.001), and indifferent correlation in the years thereafter (all P > 0.202).

CONCLUSION:

Our real-world analysis showed no evidence for increased mortality associated with paclitaxel-based DED for over 11 years.

KEYWORDS:

Drug-coated balloon; Drug-eluting stent; Endovascular revascularization; Lower extremity artery disease; Paclitaxel device; Patient safety

PMID:
31593987
DOI:
10.1093/eurheartj/ehz698

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