EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
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Randomized Controlled Trial Multicenter Study Comparative Study
Paclitaxel-eluting balloon angioplasty and cobalt-chromium stents versus conventional angioplasty and paclitaxel-eluting stents in the treatment of native coronary artery stenoses in patients with diabetes mellitus.
Coronary lesions in diabetics (DM) are associated with a high recurrence following percutaneous coronary intervention (PCI), even after drug-eluting stent (DES) deployment. Encouraging clinical data of the drug-eluting balloon catheter (DEB) SeQuent Please warrant its investigation in these patients. ⋯ The clinical and angiographic outcome of the combination of the drug-eluting balloon SeQuent Please with a cobalt chromium stent compared to the drug eluting Taxus stent are similar.
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Randomized Controlled Trial Multicenter Study
Optical coherence tomography (OCT) in PCI for in-stent restenosis (ISR): rationale and design of the SEDUCE (Safety and Efficacy of a Drug elUting balloon in Coronary artery rEstenosis) study.
The optimal treatment of bare metal stent restenosis is still not defined. The most employed contemporary option is the implantation of a drug-eluting stent (DES). However, this procedure implies the addition of a second metal layer in the vessel wall, which is linked to delayed healing. Furthermore, there may be a increased risk of malapposition of both struts of the bare metal and the newly implanted drug-eluting stent. These phenomena may give rise to an increased risk of stent thrombosis in this patient population. Recently, drug-eluting balloons (DEB) have been proposed as a new treatment strategy for bare metal stent restenosis. The initial results of this technique look promising. ⋯ Currently no prospectively collected data on vessel wall healing after treatment of in-stent restenosis, whether with DES or with DEB, are available. Therefore, the SEDUCE trial will yield pivotal insights on this important topic and guide further optimisation of the interventional treatment for this condition.
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There is heterogeneity in the reporting of procedural outcomes and complications following transcatheter aortic valve replacement (TAVR). Recently, new definitions have been proposed by the Valve Academic Research Consortium (VARC) in an effort to standardise these outcomes and improve the quality of future clinical research. The aim of this study is to report the procedural outcomes and complication rates following TAVR in a large sequential patient cohort using a balloon expandable valve according to the new VARC definitions. ⋯ The VARC consensus guidelines provide a standardised reporting framework for clinical endpoints and complications post TAVR. We report the first series to our knowledge of 30-day outcomes using these definitions utilising a balloon expandable valve system.
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Randomized Controlled Trial
USage of chitosan for Femoral (USF) haemostasis after percutaneous procedures: a comparative open label study.
To test the efficacy and safety of a chitosan pad for femoral haemostasis as an adjunct to manual compression. Haemostasis of the femoral artery after coronary angiography by manual compression is time consuming and uncomfortable for the patient. Closure devices are costly and do not reduce vascular complication rate. The HemCon(r) pad is used by the US army to control traumatic bleeding. It consists of chitosan, a positively charged carbohydrate that attracts the negatively charged blood cells and platelets and promotes clotting. ⋯ The HemCon(r) pad significantly decreased time-to-haemostasis compared to the regular pad. The total incidence of haematoma tended to be lower in the HemCon(r) pad compared to the regular pad group.