Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: Clinical results of the international real-world DELUX registry

Ralph Toelg, Béla Merkely, Andrejs Erglis, Stefan Hoffman, Huret Bruno, Ran Kornowski, Ton Slagboom, Christoph Naber, Bernhard Witzenbichler, Kristof Graf, Gert Richardt, Christoph Hehrlein

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Aims: Safety and efficacy of percutaneous coronary interventions using the Pantera Lux paclitaxel-coated balloon have been demonstrated in the PEPPER first-in-man trial. This prospective, multicentre, clinical registry aims to evaluate its safety and efficacy in an international real-world setting in a larger cohort of patients.

Conclusions: Safety and efficacy of the Pantera Lux paclitaxel-coated balloon was confirmed in a real-world setting with low major adverse cardiac event rates in patients with in-stent restenosis or de novo lesions. (ClinicalTrials.gov: NCT01081366).

Methods and results: Between April 2010 and April 2011, 1,064 patients were treated for predominantly diffuse and proliferative in-stent restenosis of bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR), or for de novo lesions. Clinical device success was obtained in 98.2% of the patients. The study endpoint was major adverse cardiac events (MACE), defined as a composite of all-cause mortality, non-fatal myocardial infarction and clinically driven target vessel revascularisation, and was 8.5% in the overall, 6.0% in the BMS-ISR, 11.5% in the DES-ISR and 7.0% in the de novo population at six months, and 15.1%, 11.6%, 20.6% and 9.4% at 12 months, respectively. Definitive stent thrombosis occurred in 0.4% of the patients within 12 months.

Original languageEnglish
Pages (from-to)591-599
Number of pages9
JournalEuroIntervention
Volume10
Issue number5
DOIs
Publication statusPublished - Sep 1 2014

Keywords

  • BTHC
  • Coronary artery disease
  • De novo lesions
  • Drug-coated balloon
  • In-stent restenosis
  • Paclitaxel

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Toelg, R., Merkely, B., Erglis, A., Hoffman, S., Bruno, H., Kornowski, R., Slagboom, T., Naber, C., Witzenbichler, B., Graf, K., Richardt, G., & Hehrlein, C. (2014). Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: Clinical results of the international real-world DELUX registry. EuroIntervention, 10(5), 591-599. https://doi.org/10.4244/EIJV10I5A102