- early revascularisation
- intra-aortic balloon pump
Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. PMID: 10460813. [Free Fulltext]
- parallel group MC-RCT
- Intention-to-treat analysis
- n = 302
- included patients with cardiogenic shock (clinical and hemodynamic crtieria) and ECG evidence of acute MI
- excluded if not suited to revascularisation, valve disease, DCM or other forms of shock
- emergency revascularisation (PCI or CABG within 12h) vs initial medical stabilisation
— Median time from randomization to revascularization: 1.4 vs. 102.8 hrs
-> no significant difference in 30-day mortality (primary outcome)
-> at 6 months emergency revascularisation did have a survival advantage: 50.3% vs. 63.1% mortality (RR 0.80; 95% CI 0.65-0.98; P=0.027
-> follow-up of the SHOCK trial cohort also demonstrated the benefit or revascularization at 1 and 6 years
— Subgroup analysis suggested benefit of revascularization was limited to patients <75 years, but subsequent studies found that >75y old patients also get the same benefit.
— both arms had high rates of IABP insertion (~85%)
— slightly higher rates of LVAD and cardiac transplantation in intervention group
— study was powered to detect a 10% mortality difference; underpowered to detect smaller more realistic differences
- Bottom line: patients with acute MI and cardiogenic shock have better longterm mortality if they receive emergency revacularisation
INTRA-AORTIC BALLOON PUMP
Thiele H, et al; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26. PubMed PMID: 22920912.
- open-label, parallel group MC-RCT
- Intention-to-treat analysis
- n = 600
- included patients with acute STEMI or NSTEMI complicated by cardiogenic shock (defined by end-organ perfusion, low BP, catecholamine use) who received optimal medical therapy and early reperfusion (PCI ~95% or CABG ~5%)
- excluded >90y, CPR >30 min, coma, non-MI diagnosis, IABP contra-indicated
- intervention: IABP insertion + standard therapy vs standard therapy
- outcome = 30 day mortality -> no difference; no difference in multiple secondary outcomes either
— underpowered: powered to detect a difference of 12% in 30-day survival rates (seems unrealistic), assuming a rate of 56% in the control group
— more of the controls got LVADs: 3.7% vs. 7.4% (P=0.053)
— most IABPs went in post-PCI (86%)
— lower mortality rate (40%) in this trial compared to other registries and RCTs (42-48%) suggests more mild or moderately severe shock cases, precluding generalizability to severe shock.
— 10% cross-over rate from control group to IABP
— long-term follow-up results are pending
— high use of catecholamines and relatively low rate of true hypotension (many had SBP >90 before randomization)
- bottom line: no 30 day mortality benefit from IABP insertion for cardiogenic shock following MI when early revascularisation was planned.
Ranucci M, Castelvecchio S, Biondi A, de Vincentiis C, Ballotta A, Varrica A,Frigiola A, Menicanti L; Surgical and Clinical Outcome Research (SCORE) Group. Arandomized controlled trial of preoperative intra-aortic balloon pump in coronary patients with poor left ventricular function undergoing coronary artery bypass surgery*. Crit Care Med. 2013 Nov;41(11):2476-83. doi:10.1097/CCM.0b013e3182978dfc. PubMed PMID: 23921278.
- prospective SC RCT
- Patients: LVEF < 0.35, haemodynamically stable, undergoing CABG
- n = 110, randomised to IABP or no IABP
– No difference in major morbidity
– No difference in secondary outcomes (MV duration, cardiac output, ICU / hospital LOS)
– Non-signif increase in CI pre-CPB with IABP (associated with an increase in dopamine post CBP in control group that didn’t persist into ICU stay)
– lower MAP in IABP group
- Commentary and criticisms:
– Study stopped after second interim analysis due to futility
– Well matched groups at baseline
Chris is an Intensivist and ECMO specialist at the Alfred ICU in Melbourne. He is also the Innovation Lead for the Australian Centre for Health Innovation at Alfred Health, a Clinical Adjunct Associate Professor at Monash University, and the Chair of the Australian and New Zealand Intensive Care Society (ANZICS) Education Committee. He is a co-founder of the Australia and New Zealand Clinician Educator Network (ANZCEN) and is the Lead for the ANZCEN Clinician Educator Incubator programme. He is on the Board of Directors for the Intensive Care Foundation and is a First Part Examiner for the College of Intensive Care Medicine. He is an internationally recognised Clinician Educator with a passion for helping clinicians learn and for improving the clinical performance of individuals and collectives.
After finishing his medical degree at the University of Auckland, he continued post-graduate training in New Zealand as well as Australia’s Northern Territory, Perth and Melbourne. He has completed fellowship training in both intensive care medicine and emergency medicine, as well as post-graduate training in biochemistry, clinical toxicology, clinical epidemiology, and health professional education.
He is actively involved in in using translational simulation to improve patient care and the design of processes and systems at Alfred Health. He coordinates the Alfred ICU’s education and simulation programmes and runs the unit’s education website, INTENSIVE. He created the ‘Critically Ill Airway’ course and teaches on numerous courses around the world. He is one of the founders of the FOAM movement (Free Open-Access Medical education) and is co-creator of LITFL.com, the RAGE podcast, the Resuscitology course, and the SMACC conference.
His one great achievement is being the father of two amazing children.
On Twitter, he is @precordialthump.