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      Coronary angioplasty in octogenarians with emergent coronary syndromes: study protocol for a randomized controlled trial

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          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/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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          Most cited references5

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          Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials.

          Many trials have been done to compare primary percutaneous transluminal coronary angioplasty (PTCA) with thrombolytic therapy for acute ST-segment elevation myocardial infarction (AMI). Our aim was to look at the combined results of these trials and to ascertain which reperfusion therapy is most effective. We did a search of published work and identified 23 trials, which together randomly assigned 7739 thrombolytic-eligible patients with ST-segment elevation AMI to primary PTCA (n=3872) or thrombolytic therapy (n=3867). Streptokinase was used in eight trials (n=1837), and fibrin-specific agents in 15 (n=5902). Most patients who received thrombolytic therapy (76%, n=2939) received a fibrin-specific agent. Stents were used in 12 trials, and platelet glycoprotein IIb/IIIa inhibitors were used in eight. We identified short-term and long-term clinical outcomes of death, non-fatal reinfarction, and stroke, and did subgroup analyses to assess the effect of type of thrombolytic agent used and the strategy of emergent hospital transfer for primary PTCA. All analyses were done with and without inclusion of the SHOCK trial data. Primary PTCA was better than thrombolytic therapy at reducing overall short-term death (7% [n=270] vs 9% [360]; p=0.0002), death excluding the SHOCK trial data (5% [199] vs 7% [276]; p=0.0003), non-fatal reinfarction (3% [80] vs 7% [222]; p<0.0001), stroke (1% [30] vs 2% [64]; p=0.0004), and the combined endpoint of death, non-fatal reinfarction, and stroke (8% [253] vs 14% [442]; p<0.0001). The results seen with primary PTCA remained better than those seen with thrombolytic therapy during long-term follow-up, and were independent of both the type of thrombolytic agent used, and whether or not the patient was transferred for primary PTCA. Primary PTCA is more effective than thrombolytic therapy for the treatment of ST-segment elevation AMI.
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            The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.

            To comprehend the results of a randomised controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through total transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by use of a checklist and flow diagram. The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly shows the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have done an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
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              Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial.

              This study sought to determine the risk versus benefit ratio of an early aggressive (EA) approach in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS).
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                Author and article information

                Contributors
                berglind.libungan@vgregion.se
                geir.hirlekar@vgregion.se
                per.albertsson@vgregion.se
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                4 September 2014
                4 September 2014
                2014
                : 15
                : 1
                : 349
                Affiliations
                Department of Cardiology, Sahlgrenska University Hospital, Blå stråket 3, vån 1, SE-413 45 Gothenburg, Sweden
                Article
                2221
                10.1186/1745-6215-15-349
                4164795
                25189626
                9e44e255-0e08-4176-a4b3-c54ac29403ec
                © Libungan et al.; licensee BioMed Central Ltd. 2014

                This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 30 May 2014
                : 22 August 2014
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2014

                Medicine
                elderly,myocardial infarction,conservative therapy,invasive therapy,acute coronary syndrome

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