Table 1.

Patient characteristics^A

Study	Year	Design	No.	Age	Male, %	Clinical scenario	Follow- up	Primary outcome	MACE definition	Definition of complication	Cardiogenic shock
RCTs
FARMI²⁵	2007	RCT, single center	57 57	60 ± 12 58 ± 13	86 82	STEMI	In-hospital	Incidence of peripheral arterial complication	NR	TIMI major	No
Gan et al²⁶	2009	RCT, multicenter	90 105	54 ± 12.5 52 ± 12	73 84	STEMI	In-hospital and 6 mo	NR	Death, CABG, MI, and TLR	NR	No
Hou et al²⁷	2010	RCT, single center	100 100	65 ± 8 66 ± 8	72 69	AMI	30 d	NR	Death, recurrent MI, and TVR	Hemoglobin loss of at least 2 mmol/L, administration of blood transfusions, and needing vascular repair	No
Li et al²⁸	2007	RCT, single center	184 186	56.5 ± 11 55 ± 13	76 64	STEMI	In-hospital	NR	NR	Local hematoma	No
Mann et al²⁹	1998	RCT, single center	65 77	63 62	65 68	ACS	In-hospital	NR	NR	Access site complications were defined as a vascular bleeding that prolonged hospitalization	No
OCEAN RACE³⁰	2014	RCT, single center	52 51	61 (50–72) 63 (50–75)	NR	STEMI	12 mo	Major bleeding by the REPLACE-2 scale and minor bleeding by EASY scale (TR arm) or the FEMORAL scale (TF arm)	Cardiovascular death, recurrent MI, stroke, repeat revascularization, and (non-CABG) bleedings	REPLACE-2 scale	No
RADIAL-AMI³¹	2005	RCT, multicenter	25 25	52 (48–60) 58 (49–72)	76 100	STEMI	30 d	Primary efficacy: reperfusion time (time from local anesthesia infiltration to first balloon inflation) Primary safety: major bleeding and access site complications	NR	Intracranial or retroperitoneal bleeding, drop in hemoglobin level >5 g/dL, hematocrit z^B 15%, or bleeding requiring blood transfusion	No
RADIAMI³²	2009	RCT, single center	50 50	60 ± 9 59 ± 9	51.5 48.5	STEMI	In-hospital	NR	Death, MI	Intracranial hemorrhage, fatal bleeding, bleeding requiring blood transfusion, operation, or resulting in drop in hemoglobin count >3 g/dL	No
RADIAMI II³³	2011	RCT, single center	49 59	62 ± 9 58 ± 10	65 63	STEMI	In-hospital	NR	Death, CABG, MI, and TLR	Intracranial hemorrhage, fatal bleeding, bleeding requiring blood transfusion, operation, or resulting in drop in hemoglobin count >3 g/dL	No
RIFLE-STEACS³⁴	2012	RCT, multicenter	500 501	65 (56–75) 65 (55–77)	75 72	STEMI	30 d	(NACEs) Cardiac death, stroke, myocardial infarction, target lesion revascularization, and bleeding	Cardiac death, nonfatal MI, TLR, and stroke	Non-CABG bleeding with 3 g/dL decrease in hemoglobin, leading to increased level of care	No
RIVAL³⁵	2011	RCT, multicenter	3507 3514	62 (12) 62 (12)	74 73	STEMI NSTEMI	30 d	composite of death, myocardial infarction, stroke, or (non-CABG)-related major bleeding	Death, MI, and stroke	TIMI major	No
STEMI-RADIAL³⁶	2014	RCT, multicenter	348 359	63 ± 11 61.5 ± 11	75 79	STEMI	30 d and 6 mo	Cumulative incidence of major bleeding and vascular access site complications	Death, MI, and stroke	HORIZONS-AMI	No
TEMPURA³	2003	RCT, single center	77 72	66 ± 12 67 ± 10	80.5 82	STEMI	In-hospital and 9 mo	MACE	Death, recurrent MI, or TVR	Bleeding requiring blood transfusion and/or surgical repair or cerebral bleeding	No
Wang et al³⁷	2012	RCT, single center	60 59	60 ± 12 60 ± 11	87 83	STEMI	In hospital	NR	Death, recurrent MI, and repeat TLR	TIMI major	No
Yan et al³⁸	2008	RCT, single center	57 46	70 ± 7.5 71 ± 8	75 74	STEMI	30 d	NR	Death, recurrent MI, and repeat TVR	TIMI major	No
Cohorts
Arzamendi et al³⁹	2010	Prospective cohort, single center with propensity-matched analysis	238 251	59 ± 13 64 ± 13	81 59	STEMI	In-hospital, 30 d and 1 y	Time to revascularization and the incidence of major bleeding.	Cardiac death, MI, and TVR	Intracranial or intraocular bleeding, access site hemorrhage requiring intervention, hematoma with diameter of ≥5 cm, a reduction in hemoglobin level of ≥4 g/dL without overt bleeding source or ≥ 3 g/dL with an overt bleeding source, reoperation for bleeding, or transfusion of blood product	Yes
Diaz de la Llera et al⁴⁰	2004	Prospective cohort, single center	103 59	55 ± 11 61 ± 12	90 78	STEMI	30 d	MACE and local complications	Death, new MI, and need for new revascularization	Vascular repair and hemorrhage requiring blood transfusion and hematomas requiring prolonged hospitalization	No
EURO TRANSFER⁴¹	2010	Post hoc analysis of multicenter, multinational EUROTRANSFER registry	169 917	63 ± 13 63 ± 0.512	76 75	STEMI	In-hospital bleeding, death at 1 y	Main outcomes death and in-hospital bleeding	Death, MI, or TLR	Blood transfusion during hospital stay after index PCI procedure and intracranial hemorrhage	No
Hamon et al⁴²	2011	Post hoc analysis of multicenter, multinational OASIS-5 trial with propensity-matched analysis	1,398 12,761	64 ± 11 65 ± 11	71 65	UA NSTEMI	9 d, 30 d, and 6 mo	Death, myocardial infarction and refractory ischemia	Death, MI, and TVR	Fatal bleeding, intracranial, retroperitoneal, intraocular, drop in hemoglobin ≥3 g/dL or requiring transfusion ≥2 U RBC	NR
Hetherington et al⁴³	2009	Prospective cohort, single center	571 480	62 ± 13 65 ± 13	75 66	STEMI	In-hospital	Procedural success, major vascular complication and failed initial access strategy	Death, stroke, CABG, MI, or TVR	Access site hemorrhage/hematoma requiring transfusion or delaying hospital discharge or proved false aneurysm formation	No
HORIZONS-AMI⁴⁴	2011	Post hoc analysis of multicenter, multinational HORIZONS-AMI trial	200 3134	59^a (52–68) 60^a (53–67)	73 77	STEMI	30-d and 1 y	NACE (MACE or major bleeding)	Death, MI, stroke, or TVR	Intracranial or intraocular hemorrhage, hematomas ≥5 cm in diameter, access site hemorrhage requiring intervention, reoperation for bleeding, clinically overt bleeding with decrease in hemoglobin by ≥3 g/dL, reduction in hemoglobin concentration of ≥4 g/dL without an overt source of bleeding, or need for any blood product transfusion	Yes
Ibebuogu et al⁴⁵	2012	Prospective cohort, single center	46 104	62 ± 12 65 ± 14	76 72	STEMI	In-hospital	NR	NR	Hematoma and vascular complications	Yes
Kajiya et al⁴⁶	2012	Prospective cohort, single center with propensity-matched analysis, ACUITY trial	350 693	56 ± 11 57 ± 12	87 85	STEMI	30 d	DTB time, major and minor bleeding, and MACE	Death, MI, and TVR	Intracranial or intraocular bleeding, hemorrhage at access site requiring intervention, hematoma with diameter of at least 5 cm, reduction in hemoglobin levels of at least 4 g/dL without an overt bleeding source or at least 3 g/dL with such a source, reoperation for bleeding, or transfusion of blood product	Yes
Klutstein et al⁴⁷	2013	Post hoc analysis of multicenter, multinational RCT EARLY-ACS trial with propensity-matched analysis	1230 7896	65^a (56–73) 68^a (60–75)	74 68	NSTEMI	30-d death/MI 1−y death	Bleeding occurring within 120 h of the catheterization procedure	Death, MI, and TVR at 3 d	TIMI major	Yes
Philippe et al²	2004	Prospective cohort, single center	64 55	59 ± 20 60 ± 10	75 72	ACS	30 d	Major access site bleeding and major cardiac events	Death, MI, CABG, or TVR	TIMI major	No
Qin et al⁴⁸	2013	Prospective cohort, single center	298 314	66 ± 10 65 ± 12	72 74	STEMI	30 d	MACE	Death, MI, or TLR	Fatal bleeding, resulted in transfusion of ≥2 U of blood; caused substantial hypotension with need for inotropes; required surgical intervention; caused severely disabling sequelae; was intracranial and symptomatic or intraocular and led to significant visual loss or led to decrease in hemoglobin of at least 5 g/dL	No
Secco et al⁴⁹	2013	Prospective cohort, single center	177 106	82 ± 4 83 ± 4	57 42.5	STEMI	In-hospital	Main outcome of interest was time to dilatation	NR	TIMI criteria	Yes
TRAP-AMI⁵⁰	2013	Prospective cohort, single center	425 41	61 ± 14 62 ± 19	76 49	STEMI	In-hospital	NR	NR	Bleeding necessitating blood transfusion	No
Valsecchi et al⁵¹	2003	Prospective cohort, single center	163 563	61.5± 12 61.5 ±13	87 86	STEMI	30 d	MACE	Death, MI, ventricular arrhythmias, heart failure, or TLR	TIMI major	No
Weaver et al⁵²	2010	Prospective cohort, single center	124 116	60 ± 12 61 ± 13	82 79	STEMI	In-hospital	NR	NR	TIMI major	No
Yip et al⁵³	2009	Prospective cohort, single center	506 810	61 ± 12 62 ± 12	82 84	STEMI	30 d	NR	NR	Bleeding related to the procedure with fall in hemoglobin >3 g/dl requiring blood transfusion	No

CABG, coronary artery bypass grafting; DTB, door-to-balloon; MACE, major adverse cardiac events; MI, myocardial infarction; NACE,^C; NR, no result^D; PCI, percutaneous coronary interventions; RBC, red blood cell count; RCT, randomized controlled trial; STEMI, ST-elevation myocardial infarction; TIMI, thrombolysis in myocardial infarction; TF, femoral; TLR, target lesion revascularization; TR, radial; TVR, target vessel revascularization.

Median distribution.

No title provided as originally received. Insertion OK?

What does z mean?

Pls define NACE.

Correct expansion of NR?