TOMAHAWK: Difference between revisions

Jump to navigation Jump to search
845 bytes removed ,  26 May 2022
no edit summary
No edit summary
Line 1: Line 1:
{{info
| title=Angiography after out-of-hospital cardiac arrest without ST-segment elevation
| abbreviation=TOMAHAWK
| expansion=Immediate Unselected Coronary Angiography versus Delayed Triage in Survivors of Out-of-Hospital Cardiac Arrest without ST-segment Elevation
| published=2021-12-30
| author=Desch S, et al
| journal=The New England Journal of Medicine
| year=2021
| volume=385
| issue=27
| pages=2544-2553
| pmid=34459570
| fulltexturl=https://www.nejm.org/doi/10.1056/NEJMoa2101909
| pdfurl=https://www.nejm.org/doi/pdf/10.1056/NEJMoa2101909
| clinicaltrialsgovID=NCT02750462
| status=Reviewable
| statusUsableDate=
| subspecialty=Cardiology
| otherSubspecialty1=
| otherSubspecialty2=
| disease=Cardiac Arrest
| otherDisease1=
| otherDisease2=
| intervention1=
| intervention2=
| briefDesignDescription=
| briefResultsDescription=
| trainingLevel=Resident
}}
==Clinical Question==
==Clinical Question==
<!-- This should be a PICO (Population, Intervention, Comparison, Outcome) style question. As an example, the ACCORD trial's clinical question is shown below, but you should replace it with the clinical question addressed by the trial you're summarizing. -->
In adult patients (30+ years old) with out of hospital cardiac arrest who have been successfully resuscitated but have no ST elevations post-resuscitation, does immediate PCI improve survival?
In adult patients (30+ years old) with out of hospital cardiac arrest who have been successfully resuscitated but have no ST elevations post-resuscitation, does immediate PCI improve survival?


==Bottom Line==
==Bottom Line==
<!-- What is the one thing you would want to take away from this article? Again, the ACCORD's bottom line is shown below, but you should replace it with yours. -->
There is no survival benefit for performing immediate PCI for resuscitated out of hospital arrest who have no post-resuscitation ST elevations
There is no survival benefit for performing immediate PCI for resuscitated out of hospital arrest who have no post-resuscitation ST elevations


==Major Points==  
==Major Points==  
<!-- Now write a succinct paragraph or two describing the major points in the article. Again, ACCORD's major points: -->
Early revascularization has demonstrated benefits in preserving ventricular function in those with an acute myocardial infarction; however this intervention is not risk-free. A RCT in patients with NSTEMI and a shockable rhythm showed no difference in 90-day survival with early vs delated angiography
Early revascularization has demonstrated benefits in preserving ventricular function in those with an acute myocardial infarction; however this intervention is not risk-free. A RCT in patients with NSTEMI and a shockable rhythm showed no difference in 90-day survival with early vs delated angiography


Reference: Dumas F, Bougouin W, Geri G, et al. Emergency percutaneous coronary intervention in post-cardiac arrest patients without ST-segment elevation pattern: insights from the PROCAT II Registry. JACC Cardiovasc Interv 2016;9:1011-8.
Reference: Dumas F, Bougouin W, Geri G, et al. Emergency percutaneous coronary intervention in post-cardiac arrest patients without ST-segment elevation pattern: insights from the PROCAT II Registry. JACC Cardiovasc Interv 2016;9:1011-8.


More than half of out of hospital cardiac arrests are attributable to acute coronary syndrome and ST elevations post-resuscitation suggest an correctable coronary lesion with demonstrated benefit of immediate PCI. Lack of ST elevations post-resuscitation may be secondary to non-cardiac causes, but the value of immediate angiography is unknown.
More than half of out of hospital cardiac arrests are attributable to acute coronary syndrome and ST elevations post-resuscitation suggest an correctable coronary lesion with demonstrated benefit of immediate PCI. Lack of ST elevations post-resuscitation may be secondary to non-cardiac causes, but the value of immediate angiography is unknown.
Reference 5: prior study  Lemkes JS, Janssens GN, van der Hoeven NW, et al. Coronary angiography after cardiac arrest without ST-segment elevation. N Engl J Med 2019;380:1397-407.


==Guidelines==
==Guidelines==


==Design==
==Design==
<!-- This section provides a bulleted-list summary of your trial's design. Use the ACCORD trial as a template. Don't worry about the asterisks; they're just bullets for a bulleted list. -->
* Multicenter, open-label, 1:1 randomized, controlled trial
* Multicenter, open-label, 1:1 randomized, controlled trial
** Investigator initiated
** Investigator initiated
* N= 554
* N=554
** Immediate Angiography (n= 281)
** Immediate Angiography (n=281)
*** 13 did not received intervention (6 secondary to death, 7 secondary to other causes)
** Delayed Angiography (n=273)
** Delayed Angiography (n= 273)
* Setting: 31 centers in Germany and Denmark
*** 22 received early angiography by protocol violation
* Enrollment: 2016-2019
* Setting: 31 centers in  
* Enrollment: November 2016 to September 2019
* Mean follow-up: 30 days
* Mean follow-up: 30 days
* Analysis: Intention-to-treat
* Analysis: Intention-to-treat
Line 43: Line 58:
==Population==
==Population==
===Inclusion Criteria===
===Inclusion Criteria===
<!-- Jot down a quick bulleted list of inclusion criteria. Here are the ones from the ACCORD trial, but as before you should just replace them with the ones from the trial you're summarizing. -->
* 30 years or older, with out of hospital resuscitation of cardiac arrest of possible cardiac etiology, without ST elevation post-resuscitation
* 30 years or older, with out of hospital resuscitation of cardiac arrest of possible cardiac etiology, without ST elevation post-resuscitation
* Shockable and unshockable rhythms included
* Shockable and unshockable rhythms included


===Exclusion Criteria===
===Exclusion Criteria===
<!-- Ditto for exclusion criteria! -->
* ST elevation or LBBB
* ST elevation or LBBB
* No ROSC
* No ROSC
Line 59: Line 69:
* pregnancy
* pregnancy
* participation in another intervention trial that may interfere with TOMAHAWK participation
* participation in another intervention trial that may interfere with TOMAHAWK participation


===Baseline Characteristics===
===Baseline Characteristics===
<!-- Now summarize what the patients looked like at randomization. An example is shown below, but replace it with the baseline characteristics from the study you're summarizing. -->
''From the immediate angiography group''
 
* Demographics: Age 69 years, 30% female
* Mean age: 70 years
* Anthropometrics: BMI 26.5
* Female: 30.4%
* Comorbidities: DM 29%, HTN 67%, smoker 30%, dyslipidemia 35%, CAD 34%, prior MI 19%, prior PCI 18%, prior CABG 80%
* Known CAD: 37.6%
* Arrest details: Witnessed 91%, shockable rhythm 52%, bystander CPR 58%, duration from arrest to BLS 2 min, duration from arrest to ROSC 15 min, prehospital ECMO 1%
* Mean time to ROSC: 15 minutes
* Admission details: GCS 3, SBP 110, LVEF 45%
* Shockable arrest rhythm: 55.5%
** Labs (since this was a European study, the authors reported in SI units): Blood pH (presumably arterial) 7.22, lactate 5 mmol/L, creatinine 118 umol/L, troponin T 0.09 ug/L, troponin I 0.40 uG/L, blood glucose 11.5 mmol/L
* Median GCS: 3


==Interventions==
==Interventions==
<!-- What were the study's interventions? A bulleted list is a nice way to describe these, hence the asterisks in the ACCORD example below. You should replace that with the relevant interventions from the study you're summarizing. -->
* Randomized to immediate coronary angiography vs delayed angiography
* Randomized to immediate coronary angiography vs delayed angiography
* Immediate angiography were taken as soon as possible to cath lab
* Immediate angiography were taken as soon as possible to cath lab
Line 86: Line 92:


==Outcomes==
==Outcomes==
<!-- The outcomes are where the magic is! Read on for more details. -->
<!-- Because we're comparing experimental and control groups, we usually start the outcomes section with a sentence like this one from ACCORD, just to be clear. The two single-quotes on each side make italics. -->
''Comparisons are immediate angiography vs. delayed angiography.''
''Comparisons are immediate angiography vs. delayed angiography.''


===Primary Outcomes===
===Primary Outcomes===
<!-- What were the primary outcomes of the study? Be careful with how stats are written. The name of the outcome starts with a semicolon (;) and the actual statistics for that outcome start with a colon (:), for example: -->
; 30 day all cause mortality
 
; 30 day all cause mortality:
: 54.0% vs. 46.0% (HR 1.28; 95% CI 1.00-1.63)
: 54.0% vs. 46.0% (HR 1.28; 95% CI 1.00-1.63)


===Secondary Outcomes===
===Secondary Outcomes===
<!-- Ditto for secondary outcomes -->
''95% CIs not adjusted for multiplicity. HLE is Hodges-Lehmann estimator.''


; Myocardial infarction:
; Myocardial infarction
: 0% vs. 0.8% (RR 0; 95% CI 0-1.93)
: 0% vs. 0.8% (RR 0; 95% CI 0-1.93)


; Severe neurological deficit:
; Severe neurological deficit
: ''Defined as Cerebral Performance Category scale of 3 (severe neurologic disability), 4 (persistent vegetative state), or 5 (brain death)''
: 18.8% vs. 12.7% (RR 1.48; 95% CI 0.82-2.67)
: 18.8% vs. 12.7% (RR 1.48; 95% CI 0.82-2.67)


; Death from any cause or severe neurological deficit:
; All-cause mortality or severe neurological deficit
: 64.3% vs. 55.6% (RR1.16; 95% CI 1.00-1.34)
: 64.3% vs. 55.6% (RR 1.16; 95% CI 1.00-1.34)
 
; Median length of ICU stay (days):
: 7 vs. 8 (HLE -1; -2 to 0)


; Median Peak SAPS II:
; Median length of ICU stay
: 70 vs. 69 (HLE 0; -4 to 4)
: 7 vs. 8 days (HLE -1; 95% CI -2 to 0)


; Rehospitalization for congestive heart failure:
; Median Peak SAPS II
: 0.4% vs. 0.4% (RR 1.00; 0.19-1.85)
: 70 vs. 69 (HLE 0; 95% CI -4 to 4)


; Median peak Troponin T (µg/L):
; Rehospitalization for heart failure
: 0.39 vs. 0.34 (HLE 0.04; -0.03 to 0.49)
: 0.4% vs. 0.4% (RR 1.00; 95% CI 0.19-1.85)


; Median peak Troponin I (µg/L):
; Median peak Troponin T (µg/L)
: 1.46 vs. 1.10 (HLE 0.06; -0.37 to 0.49)
: 0.39 vs. 0.34 (HLE 0.04; 95% CI -0.03 to 0.11)


; Median peak creatinine (µmol/L):
; Median peak Troponin I (µg/L)
: 133 vs. 133 (HLE 2.08; -8.6 to 12.22)
: 1.46 vs. 1.10 (HLE 0.06; 95% CI -0.37 to 0.49)


; Moderate Bleeding:
; Median peak creatinine (µmol/L)
: 4.6% vs. 3.4% (RR 1.34; 0.57-3.14)
: 133 vs. 133 (HLE 2.08; 95% CI -8.6 to 12.22)


; Stroke:
; Moderate Bleeding
: 1.6% vs. 2.1% (RR 1.13; 0.33-3.84)
: 4.6% vs. 3.4% (RR 1.34; 95% CI 0.57-3.14)


; Acute renal failure requiring renal replacement therapy:
; Stroke
: 18.9% vs. 15.8% (RR 1.14; 0.78-1.68)
: 1.6% vs. 2.1% (RR 1.13; 95% CI 0.33-3.84)


; Acute renal failure requiring renal replacement therapy
: 18.9% vs. 15.8% (RR 1.14; 95% CI 0.78-1.68)


===Subgroup Analysis===
===Subgroup Analysis===
<!-- Was there a subgroup analysis? If so, include a summary of it here. -->
The primary outcome was similar by age of 65 years, diabetes, type of first rhythm, use of TTM. The WJC editors note the following patterns by specific subgroups.  
 
The subgroup analysis (values list below) did not show any significant differences
 
;Age greater that 65 years old
: 63% vs 54% (HR 1.29, CI 0.97 - 1.73)
 
; Age less than 65 years old
: 40% vs 31% (HR 1.37, CI 0.84 - 2.23)
 
;History of diabetes
: 69% vs 62% (HR 1.19, CI 0.78 - 1.18
 
:No diabetes
: 47% vs 39% (HR 1.32, CI 0.95 - 1.83)
 
:Non-shockable rhythm
: 73% vs 68% (HR 1.24, CI 0.88 - 1.75)
 
;Shockable rhythm
: 39% vs 30% (HR 1.44, CI 0.95 - 2.19


;OHCA triggered MI
; Out of hospital cardiac arrest confirmed as MI
: 50 % vs 40% (HR 1.34, CI 0.95 - 1.89)
: '''No''': 50% vs 40% (HR 1.34, 95% CI 0.95-1.89)
: '''Yes''': 38% vs 42% (HR 0.97, 95% CI 0.50-1.90)


;Non-OHCA triggered MI
; Sex
: 38% vs 42% (HR 0.97, CI 0.50 - 1.90)
: '''Females''': 62% vs 46% (HR 1.64, 95% CI 1.06-2.54)
: '''Males''': 51% vs 47% (HR 1.14, 95% CI 0.84-1.53)


;Male sex
; Duration of time until ROSC
: 51% vs 47% (HR 1.14, CI 0.84 - 1.53)
: '''&ge;15 min''': 58% vs 57% (HR 1.02, 95% CI 0.76-1.36)
: '''<15 min''': 34% vs 30% (HR 1.52, 95% CI 0.78-2.93) <!-- PICK UP HERE--->


;Female sex
===Additional Measures===
: 62% vs 46% (HR 1.64, CI 1.06 - 2.54)
; Coronary angiography performed
: 96% vs. 62%
: '''PCI''': 37% vs. 43%


;TTM
; Median (IQR) duration from arrest to angiography
: 56% vs 47% (HR 1.26, CI 0.96 - 1.67)
: 2.9 (2.2-3.9) vs. 47 (26-117) hours


;No TTM
; Disease
: 47% vs 45% (HR 1.34, CI 0.77 - 2.33)
: '''None''': 39% vs. 28%
: '''1 Vessel''': 15% vs. 13%
: '''2 Vessel''': 13% vs. 16%
: '''3 Vessel''': 33% vs. 44%


;Time greater than 15 min to ROSC
; Culprit lesion identified
: 58% vs 57% (HR 1.02, CI 0.76 - 1.36)
: 38% vs. 43%
 
;Time less than 15 min to ROSC
: 34% vs 30% (HR 1.52, CI 0.78 - 2.93)


===Adverse Events===
===Adverse Events===
<!-- Were there significant adverse events recorded other than those listed in the secondary outcomes? If so, list them here -->


==Criticisms==  
==Criticisms==  
<!-- What criticisms exist about the paper? -->


==Funding==
==Funding==
* German Center For Cardiovascular Research [clinicaltrials.gov NCT02750462]
* German Center For Cardiovascular Research [clinicaltrials.gov NCT02750462]


==Further Reading==
==Further Reading==
<references/>
<references/>
Bureaucrats, editor, reviewer, Administrators
6,385

edits

Navigation menu