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The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: DEFERred stent implantation in connection with primary PCI: DANAMI 3-DEFER. I don’t have any diclosures with regard to this presentation. Investigators & participating sites.

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  1. The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: DEFERred stent implantation in connection with primary PCI: DANAMI 3-DEFER

  2. I don’t have anydiclosures with regard to thispresentation

  3. Investigators & participating sites Henning Kelbæk, Dan Eik Høfsten, Lars Køber, Steffen Helqvist, Lene Kløvgaard, Lene Holmvang, Erik Jørgensen, Frants Pedersen, Kari Saunamäki, Ole De Backer, Lia E Bang, Klaus F Kofoed, Jacob Lønborg, Kiril Ahtarovski, Niels Vejlstrup, Hans E Bøtker, Christian J Terkelsen, Evald H Christiansen, Jan Ravkilde, Hans-Henrik Tilsted, Anton B Villadsen, Jens Aarøe, Svend Eggert Jensen, Bent Raungaard, Lisette Okkels Jensen, Peter Clemmensen, Peer Grande, Jan Kyst Madsen, Christian Torp-Pedersen, Thomas Engstrøm Zealand University Hospital, Roskilde, Denmark Rigshospitalet, University of Copenhagen, Copenhagen, Denmark Skejby Hospital, University of Aarhus, Aarhus, Denmark Aalborg University Hospital, Aalborg, Denmark Odense University Hospital, Odense, Denmark Nykøbing Falster Hospital, Denmark Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark

  4. Contributors Bente Andersen, Bettina Løjmand, Louise Godt, Marie Louise Mahler Sørensen, Karin Møller Pedersen, Kasper Villefranche, Helle Cappelen, Barbara Altman, Lars Romer Krusell, Steen Dalby Kristensen, Michael Mæng, Anne Kaltoft, Karsten T Veien, Jens Flensted Lassen, Knud Nørregaard Hansen, Anders Juncker, Per Thayssen Rigshospitalet, University of Copenhagen, Copenhagen, Denmark Skejby Hospital, University of Aarhus, Aarhus, Denmark Aalborg University Hospital, Aalborg, Denmark Odense University Hospital, Odense, Denmark Clinical Events Committee Kristian Thygesen, Aarhus Anders Galløe, Roskilde Jørgen Jeppesen, Glostrup Data Safety and Monitoring Board Gorm Bøje Jensen, København Gunnar Gislasson, Gentofte David Erlinge, Lund

  5. Background • During PPCI • Distalembolizationoccurs in 7% of cases • Slow-/no-flow occurs in 10% of cases

  6. MACE

  7. Previousstudies of deferred stenting _____________________________________________________ Study n Primary endpoint Results ____________________________________________________________ Non-randomised Meneveau 78 Procedural success* ↑ 18% Isaaz 93 TIMI 3 ↑ 40% Tang 87 TIMI frame count ↓ 22% Cafri 106 thrombotic events ↓ 23% Ke 103 MACE ↓ 20% Pascal 279 MACE-free survival ↑ 15% Randomised DEFER-STEMI 101 no-/slow flow ↓ 23% MIMI 140 MVO (% of LVmass) ↑ 111%** _____________________________________________________ * DS <30%, TIMI 3, no distal embolization**in favor of immediate stenting

  8. Aim of DANAMI-3-DEFER study To evaluate whether the prognosis of STEMI patients treated with pPCI can be improved by deferred stent implantation

  9. Participants Inclusion criteria: chest pain of <12 hours’ duration ST-segment elevation > 0∙1 mV in at least 2 contiguous leads Exclusion criteria Known intolerance of contrast media, anticoagulant or DAPT unconsciousness or cardiogenic shock stent thrombosis indication for acute CABG increased bleeding risk

  10. Flow Chart DANAMI-3 STEMI Angiography TIMI 0-I TIMI 2-3 Randomization PCI PCI TIMI 0-I TIMI 2-3 Excluded Postcon Conv Defer

  11. Flow Chart DANAMI-3 STEMI Angiography TIMI 0-I TIMI 2-3 Randomization PCI PCI TIMI 0-I TIMI 2-3 Excluded Postcon Conv Defer

  12. Primaryendpoint A composite of All causemortality Hospitalization for heartfailure Re-infarction Target vesselrevascularization

  13. Methods DEFER: • Minimal acute manipulation to restore stable flow in IRA • Stent implantation 48 hourslater Conventional PCI: • Immediatestent implantation

  14. Follow up 1207 patients (99.3%) - 8 patients emigrated Median FU 42 months (IQR 33-49 months)

  15. Baseline characteristics

  16. Procedural data * P < 0.001 ** self-reported

  17. Clinical status at discharge

  18. Primaryendpoint

  19. Components of the primary endpoint

  20. Secondaryendpoint

  21. Complications * Requiring blood transfusion or surgical intervention Procedure-related MI, bleeding *, contrast-induced nephropathy or stroke occurred in 28 (5%) patients in the conventional group and 27 (4%) in the DEFER group

  22. Conclusion I Deferred stent implantation in patients with STEMI did not reduce the risk of death, heart failure, or reinfarction compared with standard immediate stent implantation

  23. Conclusion II Routine deferred stenting was associated with an increased rate of target vessel revascularisation, mainly due to premature stent implantation

  24. Conclusion III Left ventricular function is slightly better after deferred stent implantation

  25. Questionsraised • Why did DEFER not improve prognosis ? • If acute TVR’s can be avoided, is there an indication for DEFER ? • Will ∆ LVEF in DEFER patients translate into less heart failure / improved survival ?

  26. The study will be published ….

  27. And now to the disciussion

  28. In order to detect a 25% reduction in the estimated 13% annual event rate of the primary endpoint, with an α of 0∙05 and 80% power, an inclusion period of 2∙5 years, a follow-up of >2 years, and an attrition of 25%, 1,200 patients had to be enrolled in the trial

  29. Flow chart EuroIntervention 2013;8:1126-1133

  30. Angiographicfindings EuroIntervention 2013;8:1126-1133

  31. CMR afterdeferredstent implantation EuroIntervention 2013;8:1126-1133

  32. MACE-freesurvival EuroIntervention 2013;8:1126-1133

  33. Inferior STEMI with complete ST-resolution Baseline 3 dayslater 3 monthslater LVEF 40% LVEF 45% LVEF 60% EuroIntervention 2013;8:1126-1133

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