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Long-term clinical performance of paclitaxel-eluting stents coated with a bioactive polymer (P-5) containing a triflusal derivative: results of the REWAC registry.

AbstractAIMS:
Although drug-eluting stents have dramatically reduced angiographic restenosis and clinical need for repeat revascularization procedures, some adverse effects, such as late stent thrombosis, have been described. We evaluated clinical performance of paclitaxel-eluting stents coated with a new bioactive polymer system (P-5) based on a copolymer of an acrylic derivative of triflusal in patients with coronary artery disease.
METHODS AND RESULTS:
This was a multicenter, observational, prospective study to assess the incidence of target lesion revascularization (TLR) at 6 months and clinical major adverse cardiac events (MACEs) at 1 and 6 months and 1 and 2 years post-stent implantation in 537 patients. After stent implantation, only 1 case of thrombus and acute occlusion was reported in 1 lesion (0.14%). The incidence of new TLR was 0.89% at 6 months, 1.08% at 1 year, and 1.49% at 2 years, with a cumulative incidence of 3.54%. MACEs included cardiac death (0.93%), myocardial infarction (0.37%), and cardiac surgery (0.19%). No cases of late or very late stent thrombosis were recorded.
CONCLUSION:
Under routine clinical practice, the implantation of paclitaxel-eluting stents coated with P-5 is associated with favorable clinical outcomes in both the short and long term (2 years) in patients with coronary artery disease.
AuthorsEulogio García, Antoni Serra, José Javier Zueco, Mariano Larman, José Ramón Rumoroso, José Moreu, Jordi Guarinos, María Rosario Ortas, Basaganyas Puigfel, Adolfo Rincón, Karagounis Ioannidis, Núria Piqué
JournalThe Journal of invasive cardiology (J Invasive Cardiol) Vol. 25 Issue 8 Pg. 391-6 (Aug 2013) ISSN: 1557-2501 [Electronic] United States
PMID23913603 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Observational Study)
Chemical References
  • Polymers
  • Salicylates
  • triflusal
  • Paclitaxel
Topics
  • Aged
  • Coronary Artery Disease (therapy)
  • Coronary Restenosis (prevention & control)
  • Drug-Eluting Stents
  • Female
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Paclitaxel (therapeutic use)
  • Percutaneous Coronary Intervention (methods)
  • Polymers
  • Prospective Studies
  • Registries
  • Salicylates
  • Thrombosis (epidemiology)
  • Treatment Outcome

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