Table 1: Baseline characteristics of study population.

Present StudyPROTECT IIEUROpellaUSpella

Number of enrolling centres21121018
Number of enrolled patients86225144175
Age (years), mean±SD72±1068±1172±1070±10
Gender, males/females79/7180/45117/2774/101
Cardiovascular Risk Factors, n()
 Hypertension67 (78)/97 (67)/
 Dyslipidemia53 (62)/93 (65)/
 Diabetes38 (44)117 (52)62 (43)82 (47)
 Smoking16 (19)/61 (42)/
 Family history of CAD16 (19)///
 Renal Failure°27 (31)102 (23)41 (28)58 (33)
Past Cardiac History, n()
 Prior MI30 (35)/76 (53)98 (56)
 Prior PCI14 (16)//84 (48)
 Prior CABG19 (22)85 (38)42 (29)49 (28)
Clinical presentation, n()
 STEMI13 (15)///
 NSTEMI50 (58)55 (37)//
 SA23 (27)93 (63)//
NYHA III-IV, n()60 (70)151 (67)/115 (66)
LVEF, mean±SD ()31±923±6/31±17
LVEF ≤35, n()67 (78)216 (100)92 (64)†121 (69)
EuroSCORE, mean±SD9±39±68±3/
 Lower Tertile (3-7)30 (35)
 Mid Tertile 2 (8-10)30 (35)
 Higher Tertile 3 (11-20)26 (30)
Unsuitable for surgery ‡, n ()86 (100)144 (64)62 (43)98 (56)
Angiographic characteristics
 Multivessel disease, n (%)86 (100)/118 (82)155 (89)
 Left main disease, n (%)38 (44)18 (8)76 (53) §89(51)
 Syntax Score31±1030±13/37±16
 BCIS-JS10±2///

Randomized Impella arm.
† LVEF <40%
‡ On the basis of heart-team discussion.
§PCI on left main coronary artery.
° Abnormalities of kidney function (decreased glomerular filtration rate <60 ml/min/1.73m2) or kidney structure (e.g., kidney transplantation).
CAD=coronary artery disease; MI=myocardial infarction; PCI=percutaneous coronary intervention; CABG=coronary artery bypass graft; STEMI=ST elevation myocardial infarction; NSTEMI=non-ST elevation myocardial infarction; SA= stable angina; NYHA=New York Heart Association; LVEF=left ventricular ejection fraction; BCIS-JS= The British Cardiovascular Intervention Society myocardial Jeopardy Score.