Coronary Angiography after Cardiac Arrest without ST-Segment Elevation: the COACT trial
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1 Coronary Angiography after Cardiac Arrest without ST-Segment Elevation: the On behalf of the COACT investigators Jorrit Lemkes, MD, Interventional cardiologist Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands
2 Disclosure statement of financial interest I, Jorrit Lemkes, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation. The was supported by unrestricted research grants from the Netherlands Heart Institute, Biotronik, and AstraZeneca.
3 Background OHCA is a leading cause of death in Europe and the United States. Despite advances in the field of resuscitation and intensive care management, the outcome in patients after OHCA remains poor. Among patients with ROSC a mortality of 40% has been reported. 1 The most frequent cause of cardiac arrest is ischemic heart disease, and coronary artery disease has been reported in up to 70% of patients after OHCA Patel N, et al. JAMA Cardiol, 2016; 2. Spaulding CM, et al. N Engl J Med, 1997.
4 Background Guidelines recommend immediate coronary angiography with PCI in patients who present with STEMI and cardiac arrest (class 1 LOE B). 1,2 In patients with cardiac arrest without ST-elevation, guidelines also recommend emergency angiography (weak recommendation, very-low-quality evidence). 3 This is based on observational data and no randomized trials have been performed. 1. Ibanez B, et al. EHJ, 2018; 2. O Gara PT, et al. J Am Coll Cardiol, 2013; 3. Welsford M, et al. Circulation, COACT 2015 trial
5 Observational studies favor early CAG Khan M, et al. Resuscitation, 2017
6 Study hypothesis We therefore hypothesize that immediate coronary angiography will improve survival. We calculated that 251 patients would need to be enrolled in each group to give the trial 85% power to detect a 40% difference between the immediate and delayed angiography group in terms of survival. The sample size was increased by 10% to a total of 552 patients to account for loss of patients to follow-up.
7 Trial design Randomization 1:1 552 OHCA patients with ROSC, without STE Immediate coronary angiography ICU 90-day survival Delayed coronary angiography
8 Trial organization Steering committee Niels van Royen (chair), Jorrit Lemkes, Heleen Oudemans-van Straaten, Lucia Jewbali, Michiel Voskuil, Martijn Meuwissen. Data safety monitoring board Freek Verheugt (chair), Eric Boersma (statistician), Ruud Koster. Trial statistician Peter van de Ven. Study coordinators Gladys Janssens, Nina van der Hoeven.
9 Key in- and exclusion criteria Inclusion criteria Age >18 years. Comatose patients (Glasgow coma score <8) with ROSC after OHCA. Ventricular tachycardia or ventricular fibrillation as initial arrest rhythm. Including patients treated with an AED. Exclusion criteria Signs of STEMI on the ECG at the emergency department. Hemodynamic instability unresponsive to medical therapy. Refractory ventricular arrhythmia. An obvious or suspected non-coronary cause of the arrest. Suspected or confirmed acute intracranial bleeding or acute stroke.
10 End points Primary endpoint: Survival at 90 days Secondary endpoints: Survival at 90 days with good cerebral performance or moderate disability TIMI major bleeding Recurrence of ventricular tachycardia Occurrence of acute kidney injury and need for renal-replacement therapy Time to target temperature Duration of inotropic/catecholamine support Duration of mechanical ventilation Myocardial injury Markers of shock
11 Trial flow diagram Allocation Immediate coronary angiography (n=280) 267 patients with immediate CAG (95.4%) 13 patients with delayed CAG (4.6%) Logistical reason (n=3) Physician decision (n=6) Protocol violation (n=4) Informed consent Informed consent (n=273) 273 patients with full informed consent 7 patients/families refused informed consent 3-month follow-up Additional patients lost to follow-up (n=0) 552 patients with OHCA and ROSC without signs of ST-elevation were randomized (1:1) Allocation Delayed coronary angiography (n=272) 269 patients with delayed CAG (98.9%) Urgent CAG due to symptoms (n=38) 3 patients with immediate CAG (1.1%) Logistical reason (n=1) Physician decision (n=1) Protocol violation (n=1) Informed consent Informed consent (n=265) 265 patients with full informed consent 7 patients/families refused informed consent 3-month follow-up Additional patients lost to follow-up (n=0) Primary end point analysis Analyzed (n=273, 97.5%) 0 patients excluded from intention to treat analysis. Analyzed (n=265, 97.4%) 0 patients excluded from intention to treat COACT analysis. trial Primary end point analysis
12 Baseline characteristics
13 Baseline characteristics
14 Baseline characteristics
15 Baseline characteristics
16 Baseline characteristics
17 Procedures, treatments and characteristics of coronary artery disease 38 of these patients received urgent intervention because of cardiac deterioration, * 95% of patients who survived until hospital discharge. Six of these patients received urgent intervention because of cardiac deterioration.
18 Procedures, treatments and characteristics of coronary artery disease 38 of these patients received urgent intervention because of cardiac deterioration, * 95% of patients who survived until hospital discharge. Six of these patients received urgent intervention because of cardiac deterioration.
19 Procedures, treatments and characteristics of coronary artery disease 38 of these patients received urgent intervention because of cardiac deterioration, * 95% of patients who survived until hospital discharge. Six of these patients received urgent intervention because of cardiac deterioration.
20 Procedures, treatments and characteristics of coronary artery disease 38 of these patients received urgent intervention because of cardiac deterioration, * 95% of patients who survived until hospital discharge. Six of these patients received urgent intervention because of cardiac deterioration.
21 Procedures, treatments and characteristics of coronary artery disease 38 of these patients received urgent intervention because of cardiac deterioration, * 95% of patients who survived until hospital discharge. Six of these patients received urgent intervention because of cardiac deterioration.
22 Procedures, treatments and characteristics of coronary artery disease 38 of these patients received urgent intervention because of cardiac deterioration, * 95% of patients who survived until hospital discharge. Six of these patients received urgent intervention because of cardiac deterioration.
23 Procedures, treatments and characteristics of coronary artery disease 38 of these patients received urgent intervention because of cardiac deterioration, * 95% of patients who survived until hospital discharge. Six of these patients received urgent intervention because of cardiac deterioration.
24 Procedures, treatments and characteristics of coronary artery disease 38 of these patients received urgent intervention because of cardiac deterioration, * 95% of patients who survived until hospital discharge. Six of these patients received urgent intervention because of cardiac deterioration.
25 Procedures, treatments and characteristics of coronary artery disease 38 of these patients received urgent intervention because of cardiac deterioration, * 95% of patients who survived until hospital discharge. Six of these patients received urgent intervention because of cardiac deterioration.
26 Medical treatment during hospitalization
27 Medical treatment during hospitalization
28 Medical treatment during hospitalization
29 Primary end point
30 Primary end point
31 Overall survival
32 Secondary end points * The delayed angiography group is used as the reference group for odds ratios and mean differences.
33 Secondary end points * The delayed angiography group is used as the reference group for odds ratios and mean differences.
34 CK, CK-MB and troponin
35 Lactate and creatinin
36 Subgroup analysis Favors immediate Favors delayed
37 Subgroup analysis Favors immediate Favors delayed
38 Conclusion In patients with ROSC after OHCA without signs of STEMI, immediate coronary angiography was not found to improve survival at 90 days compared to delayed coronary angiography. Patients allocated to immediate coronary angiography reached their target temperature later as compared to delayed coronary angiography. There was no significant difference in myocardial injury between the two treatment groups.
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