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Coronary angioplasty in octogenarians with emergent coronary syndromes: study protocol for a randomized controlled
Berglind Libungan1, Geir Hirlekar, Per Albertsson
1Department of Cardiology, Sahlgrenska University Hospital, Blå stråket 3, vån 1, SE-413 45 Gothenburg, Sweden. berglind.libungan@vgregion.se.
Insights
This study investigates invasive versus medical treatment for elderly acute coronary syndrome (ACS) patients. Invasive strategies may improve survival and quality of life in older adults with ACS.
Area of Science:
- Cardiology
- Geriatric Medicine
- Clinical Trials
Background:
- Elderly patients with acute coronary syndrome (ACS) are often undertreated with invasive procedures due to perceived risks.
- Medical therapy is the current standard for ACS in the elderly, but its long-term efficacy is debated.
- Previous studies on ACS treatments have under-represented the elderly population.
Purpose of the Study:
- To evaluate the efficacy and safety of invasive treatment versus medical therapy for ACS in patients aged 80 and over.
- To compare outcomes including survival, quality of life, and adverse events between invasive and medical strategies.
- To determine if an invasive approach offers superior benefits in elderly ACS patients.
Main Methods:
- A multicenter, randomized controlled trial involving 200 patients aged 80 years and above with non-ST elevation myocardial infarction or unstable angina.
- Patients were randomized into two parallel arms: medical therapy group and invasive treatment group.
- The primary outcome was major adverse cardiac or cerebrovascular event (MACCE) at one year, with secondary outcomes including quality of life and bleeding events.
Main Results:
- The study is currently recruiting patients.
- Data on the primary and secondary outcomes are not yet available.
- The trial aims to provide definitive results on the benefits and risks of invasive ACS treatment in the elderly.
Conclusions:
- The study will determine if invasive treatment is superior to medical therapy for elderly patients with ACS.
- Findings will inform clinical practice guidelines regarding ACS management in older adults.
- The research addresses a critical gap in understanding treatment benefits for this vulnerable population.
Background:
Invasive 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/Design:
This 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.
Discussion:
This 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 Registration:
ClinicalTrials.gov trial identifier: NCT02126202. Registered on 7 January 2014.
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