SeQuent Please vs. Pantera Lux drug coated balloon angioplasty in real life: Results from the Düsseldorf DCB registry

Int J Cardiol. 2017 Mar 15:231:68-72. doi: 10.1016/j.ijcard.2016.12.022. Epub 2016 Dec 13.

Abstract

Background: In-stent restenosis (ISR) is still a major concern in interventional cardiology. Drug coated balloon (DCB) angioplasty has been shown to be a promising option in treatment of ISR. However heterogeneity of different DCBs in suppression of neointimal growth has been described in a porcine model of coronary ISR. Therefore, in this registry analysis, we compared two frequently used paclitaxel eluting DCBs, the SeQuent Please and the Pantera Lux DCB.

Methods: 571 patients were treated with DCB angioplasty at the Heinrich-Heine University Düsseldorf between 2009 and 2012. Follow-up was conducted during ambulatory care at our department. Major adverse cardiac events (death, myocardial infarction [MI] and target lesion revascularization) were registered during hospitalization and follow-up.

Results: Patient characteristics, prior diseases, clinical presentation, ejection fraction, procedural success and lost-for-follow-up did not differ between patients treated with the SeQuent Please and. The Pantera Lux DCB. MACE during hospital course were similar as well (Pantera Lux: 6 patients [1.6%] vs. SeQuent®Please: 3 patients [1.5%], relative risk 1.06, 95% confidence interval 0.3-4.2, P=0.93). Event free survival was significantly longer in patients treated with the Pantera Lux DCB as compared to SeQuent Please DCB (Hazard ratio: 0.65, 95% confidence interval 0.43-0.98; P value of log-rank test: 0.0405).

Conclusion: MACE free survival was longer in Pantera Lux DCB treated patients as compared to SeQuent Please treated patients. This finding has to be confirmed in future clinical trials.

Keywords: Coronary intervention; Drug-coated balloon; Drug-eluting balloon; Paclitaxel; Registry.

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / methods*
  • Antineoplastic Agents, Phytogenic / pharmacology
  • Cause of Death / trends
  • Coated Materials, Biocompatible*
  • Coronary Artery Disease / surgery*
  • Coronary Restenosis / epidemiology
  • Coronary Restenosis / prevention & control*
  • Drug-Eluting Stents*
  • Female
  • Germany / epidemiology
  • Humans
  • Incidence
  • Male
  • Paclitaxel / pharmacology*
  • Registries*
  • Retrospective Studies
  • Survival Rate / trends
  • Treatment Outcome

Substances

  • Antineoplastic Agents, Phytogenic
  • Coated Materials, Biocompatible
  • Paclitaxel