Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients: A phase 2 randomised clinical trial
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Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients : A phase 2 randomised clinical trial. / Engstrøm, Thomas; Nepper-Christensen, Lars; Helqvist, Steffen; Kløvgaard, Lene; Holmvang, Lene; Jørgensen, Erik; Pedersen, Frants; Saunamaki, Kari; Tilsted, Hans Henrik; Steensberg, Adam; Fabricius, Søren; Mouritzen, Ulrik; Vejlstrup, Niels; Ahtarovski, Kiril A.; Göransson, Christoffer; Bertelsen, Litten; Kyhl, Kasper; Olivecrona, Göran; Kelbæk, Henning; Lassen, Jens Flensted; Køber, Lars; Lønborg, Jacob.
I: Heart, Bind 104, Nr. 19, 2018, s. 1593-1599.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients
T2 - A phase 2 randomised clinical trial
AU - Engstrøm, Thomas
AU - Nepper-Christensen, Lars
AU - Helqvist, Steffen
AU - Kløvgaard, Lene
AU - Holmvang, Lene
AU - Jørgensen, Erik
AU - Pedersen, Frants
AU - Saunamaki, Kari
AU - Tilsted, Hans Henrik
AU - Steensberg, Adam
AU - Fabricius, Søren
AU - Mouritzen, Ulrik
AU - Vejlstrup, Niels
AU - Ahtarovski, Kiril A.
AU - Göransson, Christoffer
AU - Bertelsen, Litten
AU - Kyhl, Kasper
AU - Olivecrona, Göran
AU - Kelbæk, Henning
AU - Lassen, Jens Flensted
AU - Køber, Lars
AU - Lønborg, Jacob
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
KW - acute myocardial infarction
KW - cardiac magnetic resonance (cmr) imaging
KW - percutaneous coronary intervention
U2 - 10.1136/heartjnl-2017-312774
DO - 10.1136/heartjnl-2017-312774
M3 - Journal article
C2 - 29602883
AN - SCOPUS:85049134939
VL - 104
SP - 1593
EP - 1599
JO - Heart
JF - Heart
SN - 1355-6037
IS - 19
ER -
ID: 218668954