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, DELUX investigators, Ralph Toelg, Béla Merkely, Andrejs Erglis, Stefan Hoffman, Huret Bruno, Ran Kornowski, Ton Slagboom, Christoph Naber, Bernhard Witzenbichler, Kristof Graf, Gert Richardt, Christoph Hehrlein, DELUX investigators
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.
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.
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).
Source: PubMed