Opportunities for enhancing the Care of Older Patients with ST-elevation myocardial infarction presenting for primary percutaneous coronary intervention: Rationale and design of the SAFE-STEMI for seniors trial

Publication date: Available online 20 October 2019Source: American Heart JournalAuthor(s): Jennifer A. Rymer, Aditya Mandawat, J. Dawn Abbott, Mauricio G. Cohen, Justin E. Davies, Ian C. Gilchrist, Sanjit S. Jolly, Jeffrey J. Popma, Hussein R. Al-Khalidi, Sunil V. Rao, David Kong, Mitchell KrucoffAbstractAdvanced age is directly related to worse outcomes following STEMI and higher complication rates from anti-thrombotic therapies and primary PCI. Often excluded from clinical trials, seniors presenting with STEMI remain an understudied population despite contributing to 140,000 hospital admissions annually. The SAFE – STEMI for Seniors study is a prospective, multi-center, unblinded, randomized clinical trial designed to examine the efficacy and safety of iFR-guided complete revascularization in multivessel disease, while also investigating other components of STEMI care for patients ≥60 years including the efficacy and safety of zotarolimus-eluting stents for primary PCI and transradial PCI with the Glidesheath Slender and TR band. The SAFE-STEMI trial represents North America's first and only prospective randomized investigational device exemption (IDE) study to use a Coordinated Registry Network (CRN) infrastructure with collaborative partnering across industry manufacturers, promoting both efficiency and reduced cost of evidence development for regulatory decisions related to both diagnostic and therapeutic technologies in a single study design. The study has been...
Source: American Heart Journal - Category: Cardiology Source Type: research