Subject(s)
Cardiovascular Agents , Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Absorbable Implants , Cardiovascular Agents/adverse effects , Coronary Artery Disease/drug therapy , Coronary Artery Disease/therapy , Everolimus , Humans , Molecular Weight , Prosthesis Design , Sirolimus/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: RENASCENT is a prospective, multi-center first-in-human clinical study to evaluate the clinical performance of the novel sirolimus-eluting 150-µm strut thickness FORTITUDE® BRS for percutaneous coronary intervention of single de novo coronary lesions. METHODS: FORTITUDE® BRS was tested in a prospective study in Italy and Colombia. Study objectives were in-scaffold angiographic late lumen loss (LLL) measured by quantitative coronary angiography and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction or ischemia driven target lesion revascularization (TLR) at 9- and 24-months with clinical results up to 36-months. RESULTS: A total of 63 patients were enrolled. All patients underwent lesion pre-dilatation and 22 patients (34.9%) underwent post-dilatation. Clinical device and procedural success was 98.4% (62/63 patients) and 96.8% (61/63 patients) respectively. At 9-months, TVF occurred in 3/61 (4.9%) of the patients including 2 peri-procedural MI and one ischemia-driven TLR. Between 9- to 24-months, ischemia-driven TLR occurred in 3 additional patients (4.9%) including 1 patient who presented with very late ST after stopping all medications. There were no further TVF between 24- and 36-months. CONCLUSIONS: In this multi-center prospective study, the FORTITUDE® BRS was shown to be safe and effective in the treatment of single coronary lesions with low levels of TVF and LLL at 9- and 24-months. It was shown to be clinically safe upto 36-months follow-up.
Subject(s)
Cardiovascular Agents , Coronary Artery Disease , Coronary Restenosis , Drug-Eluting Stents , Percutaneous Coronary Intervention , Absorbable Implants , Cardiovascular Agents/therapeutic use , Colombia , Coronary Angiography , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/drug therapy , Coronary Artery Disease/surgery , Coronary Restenosis/drug therapy , Humans , Italy , Molecular Weight , Prospective Studies , Prosthesis Design , Sirolimus , Tomography, Optical Coherence , Treatment OutcomeABSTRACT
A genome-wide association scan in individuals with Crohn's disease by the Wellcome Trust Case Control Consortium detected strong association at four novel loci. We tested 37 SNPs from these and other loci for association in an independent case-control sample. We obtained replication for the autophagy-inducing IRGM gene on chromosome 5q33.1 (replication P = 6.6 x 10(-4), combined P = 2.1 x 10(-10)) and for nine other loci, including NKX2-3, PTPN2 and gene deserts on chromosomes 1q and 5p13.
