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- Engstrøm, Thomas, et al.
(författare)
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Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients : A phase 2 randomised clinical trial
- 2018
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Ingår i: Heart. - : BMJ. - 1355-6037 .- 1468-201X. ; 104:19, s. 1593-1599
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Tidskriftsartikel (refereegranskat)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 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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| 2. |
- Erlinge, David, et al.
(författare)
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Therapeutic Hypothermia for the Treatment of Acute Myocardial Infarction-Combined Analysis of the RAPID MI-ICE and the CHILL-MI Trials
- 2015
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Ingår i: Therapeutic Hypothermia and Temperature Management. - : Mary Ann Liebert Inc. - 2153-7658 .- 2153-7933. ; 5:2, s. 77-84
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Tidskriftsartikel (refereegranskat)abstract
- In the randomized rapid intravascular cooling in myocardial infarction as adjunctive to percutaneous coronary intervention (RAPID MI-ICE) and rapid endovascular catheter core cooling combined with cold saline as an adjunct to percutaneous coronary intervention for the treatment of acute myocardial infarction CHILL-MI studies, hypothermia was rapidly induced in conscious patients with ST-elevation myocardial infarction (STEMI) by a combination of cold saline and endovascular cooling. Twenty patients in RAPID MI-ICE and 120 in CHILL-MI with large STEMIs, scheduled for primary percutaneous coronary intervention (PCI) within <6 hours after symptom onset were randomized to hypothermia induced by rapid infusion of 600-2000mL cold saline combined with endovascular cooling or standard of care. Hypothermia was initiated before PCI and continued for 1-3 hours after reperfusion aiming at a target temperature of 33 degrees C. The primary endpoint was myocardial infarct size (IS) as a percentage of myocardium at risk (IS/MaR) assessed by cardiac magnetic resonance imaging at 4 +/- 2 days. Patients randomized to hypothermia treatment achieved a mean core body temperature of 34.7 degrees C before reperfusion. Although significance was not achieved in CHILL-MI, in the pooled analysis IS/MaR was reduced in the hypothermia group, relative reduction (RR) 15% (40.5, 28.0-57.6 vs. 46.6, 36.8-63.8, p=0.046, median, interquartile range [IQR]). IS/MaR was predominantly reduced in early anterior STEMI (0-4h) in the hypothermia group, RR=31% (40.5, 28.8-51.9 vs. 59.0, 45.0-67.8, p=0.01, median, IQR). There was no mortality in either group. The incidence of heart failure was reduced in the hypothermia group (2 vs. 11, p=0.009). Patients with large MaR (>30% of the left ventricle) exhibited significantly reduced IS/MaR in the hypothermia group (40.5, 27.0-57.6 vs. 55.1, 41.1-64.4, median, IQR; hypothermia n=42 vs. control n=37, p=0.03), while patients with MaR<30% did not show effect of hypothermia (35.8, 28.3-57.5 vs. 38.4, 27.4-59.7, median, IQR; hypothermia n=15 vs. control n=19, p=0.50). The prespecified pooled analysis of RAPID MI-ICE and CHILL-MI indicates a reduction of myocardial IS and reduction in heart failure by 1-3 hours with endovascular cooling in association with primary PCI of acute STEMI predominantly in patients with large area of myocardium at risk. (ClinicalTrials.gov id NCT00417638 and NCT01379261).
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| 4. |
- Råmunddal, Truls, et al.
(författare)
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Prognostic Impact of Chronic Total Occlusions : A Report From SCAAR (Swedish Coronary Angiography and Angioplasty Registry)
- 2016
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Ingår i: JACC: Cardiovascular Interventions. - : Elsevier BV. - 1936-8798. ; 9:15, s. 1535-1544
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Tidskriftsartikel (refereegranskat)abstract
- Objectives The aim of this study was to determine the prognostic impact of chronic total occlusion (CTO) on long-term mortality in a large prospective cohort. Background CTO is present in many patients with coronary artery disease and is difficult to treat with percutaneous coronary intervention. Methods The study population consisted of all consecutive patients who underwent coronary angiography in Sweden between January 1, 2005 and January 1, 2012, who were registered in SCAAR (Swedish Coronary Angiography and Angioplasty Registry). The patient population was heterogeneous with regard to indication for angiography (stable angina, ST-segment elevation myocardial infarction [STEMI], unstable angina or non-STEMI, and other) and treatment options. The long-term mortality rates of patients with and without CTO were compared by using shared frailty Cox proportional hazards regression adjusted for confounders. Tests were conducted for interactions between CTO and several pre-specified characteristics: indication for angiography and percutaneous coronary intervention (stable angina, STEMI, unstable angina or non-STEMI, and other), severity of coronary artery disease (1-, 2-, and 3-vessel and/or left main coronary artery disease), age, sex, and diabetes. Results During the study period, 14,441 patients with CTO and 75,431 patients without CTO were registered in SCAAR. CTO was associated with higher mortality (hazard ratio: 1.29; 95% confidence interval: 1.22 to 1.37; p < 0.001). In subgroup analyses, the risk attributable to CTO was lowest in patients with stable angina and highest in those with STEMI. In addition, CTO was associated with highest risk in patients under 60 years of age and with lowest risk in octogenarians. There was no interaction between CTO and either diabetes or sex, suggesting an equally adverse effect in both groups. Conclusions In this large prospective observational study of patients with coronary artery disease, CTO was associated with increased mortality. This association was most prominent in younger patients and in those with acute coronary syndromes.
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