RT Journal Article
SR Electronic
T1 Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients: a phase 2 randomised clinical trial
JF Heart
JO Heart
FD BMJ Publishing Group Ltd and British Cardiovascular Society
SP 1593
OP 1599
DO 10.1136/heartjnl-2017-312774
VO 104
IS 19
A1 Thomas Engstrøm
A1 Lars Nepper-Christensen
A1 Steffen Helqvist
A1 Lene Kløvgaard
A1 Lene Holmvang
A1 Erik Jørgensen
A1 Frants Pedersen
A1 Kari Saunamaki
A1 Hans-Henrik Tilsted
A1 Adam Steensberg
A1 Søren Fabricius
A1 Ulrik Mouritzen
A1 Niels Vejlstrup
A1 Kiril A Ahtarovski
A1 Christoffer Göransson
A1 Litten Bertelsen
A1 Kasper Kyhl
A1 Göran Olivecrona
A1 Henning Kelbæk
A1 Jens Flensted Lassen
A1 Lars Køber
A1 Jacob Lønborg
YR 2018
UL http://heart.bmj.com/content/104/19/1593.abstract
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.Trial registration number NCT01977755; Pre-results.