Table 2.

The incidence rates of major bleeding and vascular complications in select study population of acute myocardial infarction complicated by cardiogenic shock.

	IABP vs TANDEMHEART	IABP-SHOCK II TRIAL	IMPRESS TRIAL	va-ECMO	CATHPCI CHEST PAIN-MI	CULPRIT-SHOCK SUBANALYSIS
Author (year)	Thiele (2005)	Thiele (2012)	Ouweneel (2017)	Cheng (2014)	Dhurva (2020)	Freund (2020)
Study Arms	TandemHeart vs IABP	IABP vs OPT	Impella CP vs IABP	va-ECMO	LVAD vs IABP	Culprit-only vs complete revascularization
Study Population	AMI-CS†	AMI-CS†	AMI-CS	AMI-CS	AMI-CS	AMI-CS‡
Sample Size	41	300	48	1,866	1,680	684
Study Design	RCT	RCT	RCT	Meta-analysis	Retrospective cohort study	RCT‡
Definitions
Bleeding	Transfusion*	GUSTO criteria	Hgb ↓ ≥ 5 g/dL Transfusion* Surgery to control bleeding	Variable	Hgb ↓ ≥ 3 g/dL Transfusion Surgery to control bleeding Retroperitoneal GI or GU bleed	BARC 3b-5 GUSTO criteria TIMI bleeding§
Vascular Complications	Lower extremity ischemia requiring surgical or interventional action	Peripheral ischemic vascular complications requiring surgical or interventional therapy	Device extraction Thrombotic occlusion of CFA ALI Surgery	Lower extremity ischemia Fasciotomy or compartment syndrome Amputation	-	-
Major Findings
Bleeding	↑↑↑ *TandemHeart 90% vs. 40%, p=0.002	No Difference IABP vs. Control: 3.3% vs. 4.4%, p =0.51	↑↑↑ *Impella Retroperitoneal bleeding (n=1) Puncture site bleeding (n=2)	↑↑↑ * va-ECMO Major bleeding = 40.8% (95% CI 26.8%-56.6%)	↑↑↑ *LVAD (LVAD vs IABP: 31.3% vs 16.0, P<0.001)	↑↑↑ *va-ECMO *Impella Estimate = 21.5%
Vascular Complication	↑↑ Limb ischemia *TandemHeart 33% vs. 0%, p=0.009	No Difference IABP vs. Control: 4.3% vs. 3.4%, p =0.53	↑↑ *Impella Vascular repair for retroperitoneal bleeding (n=1)	↑↑ *va-ECMO ALI = 16.9% (95% CI 12.6%-22.6%); Amputation = 4.7% (95%CI 2.3%-9.3%)	-	Among bleeding group=14.3%
Other outcomes	Improved hemodynamics *TandemHeart Cardiac Power Index: 0.37 vs. 0.28, p=0.004	-	↑↑ hemolysis ↑retroperitoneal bleeding *Impella	↑↑ fasciotomy compartment syndrome ↑Amputation *va-ECMO	-	Dialysis among bleeding group Estimate = 25.2%

Abbreviations: AMI = Acute Myocardial Infarction; OPT = optimal medical therapy; BARC = Bleeding Academic Research Consortium; CFA = Common Femoral Artery; CABG = coronary artery bypass graft surgery; CS = cardiogenic shock; GUSTO = Global Use of Strategies to Open Occluded Coronary Arteries; Hgb = hemoglobin; IABP=intra-aortic balloon pump; LVAD = left ventricular assist device; PCI = percutaneous coronary intervention; RCT=randomized clinical trial; TIMI = Thrombolysis in Myocardial Infarction.

^†Intended to undergo revascularization (PCI or CABG); va-ECMO = venoarterial-Extracorporeal Membrane Oxygenation; CI = Confidence Interval.

^‡Pre-defined sub-analysis of the CULPRIT-SHOCK trial.

^*Major bleeding requiring transfusion.

^§In case of > 1 bleeding event, only the most severe was counted.