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      Effect of Ischemic Postconditioning During Primary Percutaneous Coronary Intervention for Patients With ST-Segment Elevation Myocardial Infarction : A Randomized Clinical Trial

      research-article
      , MD, DMSc 1 , , , MD, DMSc 2 , , MD, DMSc 1 , , MD, PhD 1 , , RN 1 , , MD, PhD 1 , , MD, DMSc 1 , , MD 1 , , MD, PhD 1 , , MD, DMSc 1 , , MD, DMSc 3 , , MD 1 , , MD 3 , , MD 3 , , MD, PhD 3 , , MD, PhD 3 , , MD, DMSc, PhD 4 , , MD, DMSc, PhD 4 , , MD, PhD 4 , , MD, PhD, MPM 4 , , MD 4 , , MD, DMSc, PhD 5 , , MD 5 , , MD 1 , , MD, DMSc 6 , , MD, PhD 1 , , MD 1 , , DMSc 7 , , MD, PhD 1 , , MD, PhD 1 , , MD 1 , , MD, DMSc 1
      JAMA Cardiology
      American Medical Association

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          Abstract

          This multicenter, randomized clinical trial investigates whether ischemic postconditioning of the infarct-related artery vs conventional percutaneous coronary intervention can improve the clinical outcomes of patients with acute onset of ST-segment elevation myocardial infarction.

          Key Points

          Question

          Does ischemic postconditioning of the heart during primary percutaneous coronary intervention improve clinical outcome?

          Finding

          In a Danish multicenter, randomized clinical trial of 1234 patients with onset of symptoms within 12 hours, ST-segment elevation myocardial infarction, and thrombolysis in myocardial infarction grade 0-1 flow in the infarct-related artery at arrival, all-cause hopitalization or death occurred in 11.2% of 617 patients who underwent percutaneous coronary intervention (including stent implantation) and 10.5% of 617 patients who underwent postconditioning (4 repeated balloon occlusions of 30 seconds followed by 30 seconds of reperfusion immediately after opening of the infarct-related artery and before stent implantation).

          Meaning

          Ischemic postconditioning does not improve clinical outcome in patients with ST-segment elevation myocardial infarction.

          Abstract

          Importance

          Ischemic postconditioning of the heart during primary percutaneous coronary intervention (PCI) induced by repetitive interruptions of blood flow to the ischemic myocardial region immediately after reopening of the infarct-related artery may limit myocardial damage.

          Objective

          To determine whether ischemic postconditioning can improve the clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI).

          Design, Setting, And Participants

          In this multicenter, randomized clinical trial, patients with onset of symptoms within 12 hours, STEMI, and thrombolysis in myocardial infarction (TIMI) grade 0-1 flow in the infarct-related artery at arrival were randomized to conventional PCI or postconditioning. Inclusion began on March 21, 2011, through February 2, 2014, and follow-up was completed on February 2, 2016. Analysis was based on intention to treat.

          Interventions

          Patients were randomly allocated 1:1 to conventional primary PCI, including stent implantation, or postconditioning performed as 4 repeated 30-second balloon occlusions followed by 30 seconds of reperfusion immediately after opening of the infarct-related artery and before stent implantation.

          Main Outcome and Measures

          A combination of all-cause death and hospitalization for heart failure.

          Results

          During the inclusion period, 1234 patients (975 men [79.0%] and 259 women [21.0%]; mean [SD] age, 62 [11] years) underwent randomization in the trial. Median follow-up was 38 months (interquartile range, 24-58 months). The primary outcome occurred in 69 patients (11.2%) who underwent conventional primary PCI and in 65 (10.5%) who underwent postconditioning (hazard ratio, 0.93; 95% CI, 0.66-1.30; P = .66). The hazard ratios were 0.75 (95% CI, 0.49-1.14; P = .18) for all-cause death and 0.99 (95% CI, 0.60-1.64; P = .96) for heart failure.

          Conclusions and Relevance

          Routine ischemic postconditioning during primary PCI failed to reduce the composite outcome of death from any cause and hospitalization for heart failure in patients with STEMI and TIMI grade 0-1 flow at arrival.

          Trial Registration

          clinicaltrials.gov Identifier: NCT01435408

          Related collections

          Author and article information

          Journal
          JAMA Cardiol
          JAMA Cardiol
          JAMA Cardiol
          JAMA Cardiology
          American Medical Association
          2380-6583
          2380-6591
          1 March 2017
          May 2017
          : 2
          : 5
          : 490-497
          Affiliations
          [1 ]Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
          [2 ]Department of Cardiology, Roskilde Hospital, Roskilde, Denmark
          [3 ]Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark
          [4 ]Department of Cardiology, Skejby University Hospital, Skejby, Denmark
          [5 ]Department of Cardiology, Odense University Hospital, Odense, Denmark
          [6 ]Department of Clinical Epidemiology, Aalborg University Hospital, Aalborg, Denmark
          [7 ]Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark
          Author notes
          Article Information
          Group Information: The DANAMI-3–iPOST Investigators are listed at the end of the article.
          Corresponding Author: Thomas Engstrøm, MD, Department of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, Copenhagen 2100, Denmark ( thomas.engstroem@ 123456regionh.dk ).
          Accepted for Publication: January 4, 2017.
          Published Online: March 1, 2017. doi:10.1001/jamacardio.2017.0022
          Open Access: This article is published under the JN-OA license and is free to read on the day of publication.
          Author Contributions: Dr Engstrøm had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
          Study concept and design: Engstrøm, Kelbæk, Helqvist, Clemmensen, Holmvang, S. E. Jensen, Treiman, Lønborg, Køber.
          Acquisition, analysis, or interpretation of data: Engstrøm, Kelbæk, Helqvist, Høfsten, Kløvgaard, Clemmensen, Jørgensen, Pedersen, Saunamaki, Ravkilde, Tilsted, Villadsen, Aarøe, S. E. Jensen, Raungaard, Bøtker, Terkelsen, Maeng, Kaltoft, Krusell, L. O. Jensen, Veien, Kofoed, Torp-Pedersen, Kyhl, Nepper-Christensen, Vejlstrup, Ahtarovski, Lønborg, Køber.
          Drafting of the manuscript: Engstrøm, Helqvist, Kløvgaard, Aarøe.
          Critical revision of the manuscript for important intellectual content: Engstrøm, Kelbæk, Helqvist, Høfsten, Clemmensen, Holmvang, Jørgensen, Pedersen, Saunamaki, Ravkilde, Tilsted, Villadsen, S. E. Jensen, Raungaard, Bøtker, Terkelsen, Maeng, Kaltoft, Krusell, L. O. Jensen, Veien, Kofoed, Torp-Pedersen, Kyhl, Nepper-Christensen, Treiman, Vejlstrup, Ahtarovski, Lønborg, Køber.
          Statistical analysis: Engstrøm, Helqvist, Høfsten, Nepper-Christensen, Lønborg, Køber.
          Obtained funding: Engstrøm, Kelbæk, Køber.
          Administrative, technical, or material support: Engstrøm, Kelbæk, Helqvist, Høfsten, Kløvgaard, Clemmensen, Holmvang, Villadsen, S. E. Jensen, Raungaard, Bøtker, Krusell, Veien, Kofoed, Kyhl, Nepper-Christensen, Vejlstrup, Ahtarovski, Køber.
          Study supervision: Engstrøm, Kelbæk, Helqvist, Clemmensen, Holmvang, Jørgensen, Saunamaki, Villadsen, S. E. Jensen, Terkelsen, Lønborg, Køber.
          Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Engstrøm reports receiving fees from Boston Scientific, St Jude Medical, AstraZeneca, and Bayer. Dr Clemmensen reports fees/grants from Medtronic, Eli Lilly, Daiichi-Sankyo, AstraZeneca, Bayer, Boehringer-Ingelheim, Sanofi, Pfizer, and BMS. Dr L.O. Jensen reports fees/grants from St Jude Medical, Biotronic, and Biosensors. Dr Pedersen reports fees/grants from Novo, Biotronic, Bristol-Myers Squibb, Sanofi, and Bayer. Dr Køber reports receving fees from Servier. No other disclosures were reported.
          Funding/Support: This study was supported by grant 09-066994 from the Danish Agency for Science, Technology, and Innovation and Danish Council for Strategic Research.
          Role of the Funder/Sponsor: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
          Group Information: The following investigators participated in the Third Danish Study of Optimal Acute Treatment of Patients With ST Elevation Myocardial Infarction–Ischemic Postconditioning (DANAMI-3–iPOST): Kristian Thygesen, DMSc, Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark (chairman); Jørgen Jeppesen, DMSc, Department of Medicine, Copenhagen University Hospital Glostrup, Copenhagen, Denmark; Anders Galløe, PhD, Department of Cardiology, Roskilde Hospital, Roskilde, Denmark (clinical events committee); Gorm Boje Jensen, DMSc, Department of Cardiology, Hvidovre Hospital, Hvidovre, Denmark (chairman); Gunnar Gislasson, PhD, Department of Cardiology, Gentofte Hospital, Cohenhagen, Denmark; and David Erlinge, DMSc, Department of Cardiology, Lund University, Lund, Sweden (data safety monitoring board).
          Additional Contributions: We thank our patients for their willingness to participate in the trial despite their acute condition at inclusion and the coinvestigators, our colleagues, and the staff of the participating centers, including our dedicated research nurses.
          Article
          PMC5814983 PMC5814983 5814983 hoi170002
          10.1001/jamacardio.2017.0022
          5814983
          28249094
          71683b9b-2aae-4d53-b976-81146327f9c2
          Copyright 2017 American Medical Association. All Rights Reserved.

          This article is published under the JN-OA license and is free to read on the day of publication.

          History
          : 20 October 2016
          : 2 January 2017
          : 4 January 2017
          Funding
          Funded by: Danish Agency for Science, Technology, and Innovation
          Funded by: Danish Council for Strategic Research
          Categories
          Research
          Research
          Original Investigation
          Online First

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