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

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 Krucoff

Research output: Contribution to journalArticle

Abstract

Advanced age is directly related to worse outcomes following ST-elevation myocardial infarction (STEMI) and higher complication rates from antithrombotic therapies and primary percutaneous coronary intervention (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, multicenter, unblinded, randomized clinical trial designed to examine the efficacy and safety of instantaneous wave-free ratio–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 study to use a Coordinated Registry Network 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 powered to evaluate 2 independent co-primary end points in a population of older patients with STEMI: (1) third-generation drug-eluting stents for primary PCI and (2) instantaneous wave-free ratio–guided complete revascularization versus infarct-related artery–only revascularization.

Original languageEnglish (US)
Pages (from-to)84-91
Number of pages8
JournalAmerican Heart Journal
Volume218
DOIs
StatePublished - Dec 2019

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Percutaneous Coronary Intervention
Patient Care
Safety
Drug-Eluting Stents
North America
Population
Stents
Registries
ST Elevation Myocardial Infarction
Industry
Randomized Controlled Trials
Clinical Trials
Technology
Costs and Cost Analysis
Equipment and Supplies
Therapeutics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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. / Rymer, Jennifer A.; Mandawat, Aditya; Abbott, J. Dawn; Cohen, Mauricio G.; Davies, Justin E.; Gilchrist, Ian C.; Jolly, Sanjit S.; Popma, Jeffrey J.; Al-Khalidi, Hussein R.; Rao, Sunil V.; Kong, David; Krucoff, Mitchell.

In: American Heart Journal, Vol. 218, 12.2019, p. 84-91.

Research output: Contribution to journalArticle

Rymer, Jennifer A. ; Mandawat, Aditya ; Abbott, J. Dawn ; Cohen, Mauricio G. ; Davies, Justin E. ; Gilchrist, Ian C. ; Jolly, Sanjit S. ; Popma, Jeffrey J. ; Al-Khalidi, Hussein R. ; Rao, Sunil V. ; Kong, David ; Krucoff, Mitchell. / 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. In: American Heart Journal. 2019 ; Vol. 218. pp. 84-91.
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