ABSTRACT
BACKGROUND: Drug-coated balloon (DCB) angioplasty with paclitaxel-eluting devices is an established treatment for coronary in-stent restenosis (ISR). Biolimus A9™ (BA9), a sirolimus analogue with enhanced lipophilicity, may facilitate enhanced local drug delivery into vascular tissue. A novel DCB coated with Biolimus A9™ represents an alternative to traditional paclitaxel- and sirolimus-coated devices. Hence, we sought to investigate the safety and efficacy of this novel DCB in the treatment of coronary ISR. METHODS AND DESIGN: REFORM (NCT04079192) is a prospective, multicenter, single blind, randomized controlled trial comparing the BA9-DCB (Biosensors Europe SA, Morges, Switzerland) to the paclitaxel-coated SeQuent® Please DCB (Braun Melsungen AG, Germany) in the treatment of coronary ISR. A total of 201 patients with coronary artery disease and an indication for interventional treatment of ISR in a bare-metal stent (BMS) or drug-eluting stent (DES) have been randomized 2:1 to receive treatment with the BA9- or the paclitaxel-DCB comparator. Patients were enrolled across 24 investigational centers in Europe and Asia. The primary endpoint is percent diameter stenosis (%DS) of the target segment as assessed by quantitative coronary angiography (QCA) at 6 months. Key secondary endpoints are in-stent late lumen loss, binary restenosis, target lesion failure, target vessel failure, myocardial infarction and death at 6 months. Subjects will be followed for 24 months from enrolment. IMPLICATIONS: The REFORM trial will seek to prove that the BA9-DCB is non-inferior to the standard paclitaxel-DCB comparator in the treatment of coronary ISR with respect to %DS at 6 months and has similar safety characteristics.
Subject(s)
Cardiovascular Agents , Coronary Restenosis , Drug-Eluting Stents , Humans , Pharmaceutical Preparations , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/etiology , Coronary Restenosis/therapy , Constriction, Pathologic , Prospective Studies , Single-Blind Method , Treatment Outcome , Cardiovascular Agents/adverse effects , Coronary Angiography , Sirolimus/adverse effects , Paclitaxel/adverse effects , Coated Materials, BiocompatibleABSTRACT
Purple urine bag syndrome (PUBS) is a rare and striking manifestation associated with urinary tract infection involving bright purple discoloration of the lining and tubing of a urinary catheter bag. We present the interesting case of a 90-year-old female patient who developed PUBS and include a review of the relevant literature to date. Uniquely, in this case, PUBS acts as an important clinical sign in supporting the diagnosis of urinary tract infection in a high-risk patient.