Abstract
BackgroundInvasive treatment (coronary angiography and intervention if feasible) of patients with acute coronary syndrome (ACS) has been shown to lead to better outcomes than medical therapy alone, but the elderly have been under-represented in many of the studies. In the elderly, medical therapy is common in ACS. Fear of complications related to the procedure and unclear benefit in older patients are common reasons for invasive procedures being withheld. Our hypothesis is that invasive treatment of elderly patients with ACS will lead to a better outcome in terms of survival and quality of life than medical therapy alone, with acceptable risk.Methods/DesignThis multicenter, randomized controlled trial of patients 80 years of age and over has two parallel treatment arms, a medical group and an invasive group. In Swedish hospitals, 200 patients with non-ST elevation myocardial infarction or unstable angina will be randomized to medical or invasive treatment strategy. The primary outcome measure is the combined endpoint major adverse cardiac or cerebrovascular event (MACCE) within one year. Secondary outcome measures include quality of life, angina, and adverse events such as bleeding. Assessments will be conducted during hospitalization, at 1 month after allocation, and at 12 months.DiscussionThis study seeks to determine the efficacy and safety of invasive and medical treatment strategies in the elderly with ACS. The study is currently recruiting.Trial registrationClinicalTrials.gov trial identifier: NCT02126202. Registered on 7 January 2014.
Highlights
Invasive treatment of patients with acute coronary syndrome (ACS) has been shown to lead to better outcomes than medical therapy alone, but the elderly have been under-represented in many of the studies
Study objectives and hypothesis This randomized controlled trial (RCT) aims to address a fundamental question: which treatment strategy in elderly patients with myocardial infarction results in a better outcome with acceptable risk? which treatment strategy improves survival and results in less morbidity and better quality of life? important are the adverse events associated with each treatment strategy
We hypothesize that revascularization in elderly patients with ACS will lead to gain in terms of outcome and quality of life compared to medical therapy alone
Summary
This study seeks to determine the efficacy and safety of invasive and medical treatment strategies in elderly patients with ACS. The study will advance our understanding of therapy choice in elderly patients with ACS. The different treatment strategies have the potential to reduce angina pectoris and complications, and improve quality of life and survival. Trial status Recruitment to the study commenced in October 2009 and is still continuing to recruit patients. The recruitment of all patients will hopefully be finished in year 2015. Competing interests The authors declare that there are no competing interests. Authors’ contributions PA is the main author in charge of study design and the principal investigator. All authors read and approved the final manuscript
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