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Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients : A phase 2 randomised clinical trial

Engstrøm, Thomas LU ; Nepper-Christensen, Lars ; Helqvist, Steffen ; Kløvgaard, Lene ; Holmvang, Lene ; Jørgensen, Erik ; Pedersen, Frants ; Saunamaki, Kari ; Tilsted, Hans Henrik and Steensberg, Adam , et al. (2018) In Heart 104(19). p.1593-1599
Abstract

Objectives: Reperfusion immediately after reopening of the infarct-related artery in ST-segment elevation myocardial infarction (STEMI) may cause myocardial damage in addition to the ischaemic insult (reperfusion injury). The gap junction modulating peptide danegaptide has in animal models reduced this injury. We evaluated the effect of danegaptide on myocardial salvage in patients with STEMI. Methods: In addition to primary percutaneous coronary intervention in STEMI patients with thrombolysis in myocardial infarction flow 0-1, single vessel disease and ischaemia time less than 6 hours, we tested, in a clinical proof-of-concept study, the therapeutic potential of danegaptide at two-dose levels. Primary outcome was myocardial salvage... (More)

Objectives: Reperfusion immediately after reopening of the infarct-related artery in ST-segment elevation myocardial infarction (STEMI) may cause myocardial damage in addition to the ischaemic insult (reperfusion injury). The gap junction modulating peptide danegaptide has in animal models reduced this injury. We evaluated the effect of danegaptide on myocardial salvage in patients with STEMI. Methods: In addition to primary percutaneous coronary intervention in STEMI patients with thrombolysis in myocardial infarction flow 0-1, single vessel disease and ischaemia time less than 6 hours, we tested, in a clinical proof-of-concept study, the therapeutic potential of danegaptide at two-dose levels. Primary outcome was myocardial salvage evaluated by cardiac MRI after 3 months. Results: From November 2013 to August 2015, a total of 585 patients were randomly enrolled in the trial. Imaging criteria were fulfilled for 79 (high dose), 80 (low dose) and 84 (placebo) patients eligible for the per-protocol analysis. Danegaptide did not affect the myocardial salvage index (danegaptide high (63.9±14.9), danegaptide low (65.6±15.6) and control (66.7±11.7), P=0.40), final infarct size (danegaptide high (19.6±11.4 g), danegaptide low (18.6±9.6 g) and control (21.4±15.0 g), P=0.88) or left ventricular ejection fraction (danegaptide high (53.9%±9.5%), danegaptide low (52.7%±10.3%) and control (52.1%±10.9%), P=0.64). There was no difference between groups with regard to clinical outcome. Conclusions: Administration of danegaptide to patients with STEMI did not improve myocardial salvage. Trial registration number: NCT01977755; Pre-results.

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publication status
published
subject
keywords
acute myocardial infarction, cardiac magnetic resonance (cmr) imaging, percutaneous coronary intervention
in
Heart
volume
104
issue
19
pages
1593 - 1599
publisher
BMJ Publishing Group
external identifiers
  • pmid:29602883
  • scopus:85049134939
ISSN
1355-6037
DOI
10.1136/heartjnl-2017-312774
language
English
LU publication?
yes
id
d75dfdfd-10cc-4c8b-bc05-3ed7024bf587
date added to LUP
2018-07-17 10:16:35
date last changed
2020-04-07 04:56:06
@article{d75dfdfd-10cc-4c8b-bc05-3ed7024bf587,
  abstract     = {<p>Objectives: Reperfusion immediately after reopening of the infarct-related artery in ST-segment elevation myocardial infarction (STEMI) may cause myocardial damage in addition to the ischaemic insult (reperfusion injury). The gap junction modulating peptide danegaptide has in animal models reduced this injury. We evaluated the effect of danegaptide on myocardial salvage in patients with STEMI. Methods: In addition to primary percutaneous coronary intervention in STEMI patients with thrombolysis in myocardial infarction flow 0-1, single vessel disease and ischaemia time less than 6 hours, we tested, in a clinical proof-of-concept study, the therapeutic potential of danegaptide at two-dose levels. Primary outcome was myocardial salvage evaluated by cardiac MRI after 3 months. Results: From November 2013 to August 2015, a total of 585 patients were randomly enrolled in the trial. Imaging criteria were fulfilled for 79 (high dose), 80 (low dose) and 84 (placebo) patients eligible for the per-protocol analysis. Danegaptide did not affect the myocardial salvage index (danegaptide high (63.9±14.9), danegaptide low (65.6±15.6) and control (66.7±11.7), P=0.40), final infarct size (danegaptide high (19.6±11.4 g), danegaptide low (18.6±9.6 g) and control (21.4±15.0 g), P=0.88) or left ventricular ejection fraction (danegaptide high (53.9%±9.5%), danegaptide low (52.7%±10.3%) and control (52.1%±10.9%), P=0.64). There was no difference between groups with regard to clinical outcome. Conclusions: Administration of danegaptide to patients with STEMI did not improve myocardial salvage. Trial registration number: NCT01977755; Pre-results.</p>},
  author       = {Engstrøm, Thomas and Nepper-Christensen, Lars and Helqvist, Steffen and Kløvgaard, Lene and Holmvang, Lene and Jørgensen, Erik and Pedersen, Frants and Saunamaki, Kari and Tilsted, Hans Henrik and Steensberg, Adam and Fabricius, Søren and Mouritzen, Ulrik and Vejlstrup, Niels and Ahtarovski, Kiril A. and Göransson, Christoffer and Bertelsen, Litten and Kyhl, Kasper and Olivecrona, Göran and Kelbæk, Henning and Lassen, Jens Flensted and Køber, Lars and Lønborg, Jacob},
  issn         = {1355-6037},
  language     = {eng},
  month        = {03},
  number       = {19},
  pages        = {1593--1599},
  publisher    = {BMJ Publishing Group},
  series       = {Heart},
  title        = {Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients : A phase 2 randomised clinical trial},
  url          = {http://dx.doi.org/10.1136/heartjnl-2017-312774},
  doi          = {10.1136/heartjnl-2017-312774},
  volume       = {104},
  year         = {2018},
}