title: Coronary angioplasty in octogenarians with emergent coronary syndromes: study protocol for a randomized controlled trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov trial identifier: NCT02126202. Registered on 7 January 2014.
authors.affiliation: Department of Cardiology, Sahlgrenska University Hospital, Blå stråket 3, vån 1, SE-413 45 Gothenburg, Sweden. berglind.libungan@vgregion.se.
authors.forename: Berglind
authors.initials: B
authors.lastname: Libungan
authors.forename: Geir
authors.initials: G
authors.lastname: Hirlekar
authors.forename: Per
authors.initials: P
authors.lastname: Albertsson
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D000367:Age Factors; D000369:Aged, 80 and over; D000789:Angina, Unstable / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000401:mortality; D002985:Clinical Protocols; D017023:Coronary Angiography; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000401:mortality; D004630:Emergencies; D006801:Humans; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D011788:Quality of Life; D012107:Research Design; D012307:Risk Factors; D013548:Sweden; D013997:Time Factors; D016896:Treatment Outcome