The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: Ischemic postconditioning or deferred stent implantation versus conventional primary angioplasty and complete revascularization versus treatment of culprit lesion only: Rationale and design of the DANAMI 3 trial program

Dan Eik Høfsten; Henning Kelbæk; Steffen Helqvist; Lene Kløvgaard; Lene Holmvang; Peter Clemmensen; Christian Torp-Pedersen; Hans-Henrik Tilsted; Hans Erik Bøtker; Lisette Okkels Jensen; Lars Køber; Thomas Engstrøm; DANAMI-3 Investigators

doi:10.1016/j.ahj.2015.02.004

The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: Ischemic postconditioning or deferred stent implantation versus conventional primary angioplasty and complete revascularization versus treatment of culprit lesion only: Rationale and design of the DANAMI 3 trial program

Dan Eik Høfsten, Henning Kelbæk, Steffen Helqvist, Lene Kløvgaard, Lene Holmvang, Peter Clemmensen, Christian Torp-Pedersen, Hans-Henrik Tilsted, Hans Erik Bøtker, Lisette Okkels Jensen, Lars Køber, Thomas Engstrøm, DANAMI-3 Investigators

Department of Clinical Medicine

55 Citations (Scopus)

Abstract

BACKGROUND: In patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction, ischemic postconditioning has been shown to reduce infarct size, but the effect on clinical outcome has not been tested in a large randomized trial. In addition, deferring stent implantation in the infarct-related lesion 1 to 3 days after acute opening of the infarct-related artery could have protective effects, by reducing the risk of injury caused by distal embolization and microvascular obstruction. Finally, a considerable fraction of patients present with lesions in other coronary artery branches than the infarct-related artery. Whether a strategy of complete or partial revascularization of these patients should be preferred remains uncertain.

STUDY DESIGN: The DANAMI 3 trial program was designed to investigate 3 different randomized treatment strategies in patients with ST-segment elevation myocardial infarction: (1) ischemic postconditioning versus conventional treatment with a primary end point of death and hospitalization for heart failure; (2) deferring stent implantation in the infarct-related lesion versus conventional treatment with a primary end point of death, hospitalization for heart failure, reinfarction, and repeat revascularization; and (3) treatment of the culprit lesion only versus fractional flow reserve-guided complete revascularization in patients with multivessel disease, with a primary end point of death, reinfarction, and repeat revascularization.

SUMMARY: The DANAMI 3 trial program will determine whether either of 2 approaches to reduce reperfusion injury and distal microvascular obstruction with postconditioning or deferred stent implantation will translate into improved clinical outcome and whether patients with multivessel disease undergoing primary percutaneous coronary intervention will benefit from a strategy of complete or partial revascularization.

Original language	English
Journal	American Heart Journal
Volume	169
Issue number	5
Pages (from-to)	613-21
Number of pages	9
ISSN	0002-8703
DOIs	https://doi.org/10.1016/j.ahj.2015.02.004
Publication status	Published - 1 May 2015

Keywords

Adult
Angioplasty, Balloon, Coronary
Heart Failure
Hospitalization
Humans
Ischemic Postconditioning
Myocardial Infarction
Recurrence
Research Design
Stents

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Høfsten, D. E., Kelbæk, H., Helqvist, S., Kløvgaard, L., Holmvang, L., Clemmensen, P., Torp-Pedersen, C., Tilsted, H-H., Bøtker, H. E., Jensen, L. O., Køber, L., Engstrøm, T., & DANAMI-3 Investigators (2015). The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: Ischemic postconditioning or deferred stent implantation versus conventional primary angioplasty and complete revascularization versus treatment of culprit lesion only: Rationale and design of the DANAMI 3 trial program. American Heart Journal, 169(5), 613-21. https://doi.org/10.1016/j.ahj.2015.02.004

The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction : Ischemic postconditioning or deferred stent implantation versus conventional primary angioplasty and complete revascularization versus treatment of culprit lesion only: Rationale and design of the DANAMI 3 trial program. / Høfsten, Dan Eik; Kelbæk, Henning; Helqvist, Steffen et al.

In: American Heart Journal, Vol. 169, No. 5, 01.05.2015, p. 613-21.

Research output: Contribution to journal › Journal article › Research › peer-review

Høfsten, DE, Kelbæk, H, Helqvist, S, Kløvgaard, L, Holmvang, L, Clemmensen, P, Torp-Pedersen, C, Tilsted, H-H, Bøtker, HE, Jensen, LO, Køber, L, Engstrøm, T & DANAMI-3 Investigators 2015, 'The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: Ischemic postconditioning or deferred stent implantation versus conventional primary angioplasty and complete revascularization versus treatment of culprit lesion only: Rationale and design of the DANAMI 3 trial program', American Heart Journal, vol. 169, no. 5, pp. 613-21. https://doi.org/10.1016/j.ahj.2015.02.004

Høfsten DE, Kelbæk H, Helqvist S, Kløvgaard L, Holmvang L, Clemmensen P et al. The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: Ischemic postconditioning or deferred stent implantation versus conventional primary angioplasty and complete revascularization versus treatment of culprit lesion only: Rationale and design of the DANAMI 3 trial program. American Heart Journal. 2015 May 1;169(5):613-21. doi: 10.1016/j.ahj.2015.02.004

Høfsten, Dan Eik ; Kelbæk, Henning ; Helqvist, Steffen et al. / The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction : Ischemic postconditioning or deferred stent implantation versus conventional primary angioplasty and complete revascularization versus treatment of culprit lesion only: Rationale and design of the DANAMI 3 trial program. In: American Heart Journal. 2015 ; Vol. 169, No. 5. pp. 613-21.

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abstract = "BACKGROUND: In patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction, ischemic postconditioning has been shown to reduce infarct size, but the effect on clinical outcome has not been tested in a large randomized trial. In addition, deferring stent implantation in the infarct-related lesion 1 to 3 days after acute opening of the infarct-related artery could have protective effects, by reducing the risk of injury caused by distal embolization and microvascular obstruction. Finally, a considerable fraction of patients present with lesions in other coronary artery branches than the infarct-related artery. Whether a strategy of complete or partial revascularization of these patients should be preferred remains uncertain.STUDY DESIGN: The DANAMI 3 trial program was designed to investigate 3 different randomized treatment strategies in patients with ST-segment elevation myocardial infarction: (1) ischemic postconditioning versus conventional treatment with a primary end point of death and hospitalization for heart failure; (2) deferring stent implantation in the infarct-related lesion versus conventional treatment with a primary end point of death, hospitalization for heart failure, reinfarction, and repeat revascularization; and (3) treatment of the culprit lesion only versus fractional flow reserve-guided complete revascularization in patients with multivessel disease, with a primary end point of death, reinfarction, and repeat revascularization.SUMMARY: The DANAMI 3 trial program will determine whether either of 2 approaches to reduce reperfusion injury and distal microvascular obstruction with postconditioning or deferred stent implantation will translate into improved clinical outcome and whether patients with multivessel disease undergoing primary percutaneous coronary intervention will benefit from a strategy of complete or partial revascularization.",

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AU - Høfsten, Dan Eik

AU - Kelbæk, Henning

AU - Helqvist, Steffen

AU - Kløvgaard, Lene

AU - Holmvang, Lene

AU - Clemmensen, Peter

AU - Torp-Pedersen, Christian

AU - Tilsted, Hans-Henrik

AU - Bøtker, Hans Erik

AU - Jensen, Lisette Okkels

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AU - DANAMI-3 Investigators

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N2 - BACKGROUND: In patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction, ischemic postconditioning has been shown to reduce infarct size, but the effect on clinical outcome has not been tested in a large randomized trial. In addition, deferring stent implantation in the infarct-related lesion 1 to 3 days after acute opening of the infarct-related artery could have protective effects, by reducing the risk of injury caused by distal embolization and microvascular obstruction. Finally, a considerable fraction of patients present with lesions in other coronary artery branches than the infarct-related artery. Whether a strategy of complete or partial revascularization of these patients should be preferred remains uncertain.STUDY DESIGN: The DANAMI 3 trial program was designed to investigate 3 different randomized treatment strategies in patients with ST-segment elevation myocardial infarction: (1) ischemic postconditioning versus conventional treatment with a primary end point of death and hospitalization for heart failure; (2) deferring stent implantation in the infarct-related lesion versus conventional treatment with a primary end point of death, hospitalization for heart failure, reinfarction, and repeat revascularization; and (3) treatment of the culprit lesion only versus fractional flow reserve-guided complete revascularization in patients with multivessel disease, with a primary end point of death, reinfarction, and repeat revascularization.SUMMARY: The DANAMI 3 trial program will determine whether either of 2 approaches to reduce reperfusion injury and distal microvascular obstruction with postconditioning or deferred stent implantation will translate into improved clinical outcome and whether patients with multivessel disease undergoing primary percutaneous coronary intervention will benefit from a strategy of complete or partial revascularization.

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KW - Angioplasty, Balloon, Coronary

KW - Heart Failure

KW - Hospitalization

KW - Humans

KW - Ischemic Postconditioning

KW - Myocardial Infarction

KW - Recurrence

KW - Research Design

KW - Stents

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JF - American Heart Journal

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