Table 1.
Baseline characteristics of study population.
| Present Study | PROTECT II | EUROpella | USpella | |
|---|---|---|---|---|
| Number of enrolling centres | 2 | 112 | 10 | 18 |
| Number of enrolled patients | 86 | 225∗ | 144 | 175 |
| Age (years), mean±SD | 72±10 | 68±11 | 72±10 | 70±10 |
| Gender, males/females | 79/7 | 180/45 | 117/27 | 74/101 |
| Cardiovascular Risk Factors, n(%) | ||||
| Hypertension | 67 (78) | / | 97 (67) | / |
| Dyslipidemia | 53 (62) | / | 93 (65) | / |
| Diabetes | 38 (44) | 117 (52) | 62 (43) | 82 (47) |
| Smoking | 16 (19) | / | 61 (42) | / |
| Family history of CAD | 16 (19) | / | / | / |
| Renal Failure° | 27 (31) | 102 (23) | 41 (28) | 58 (33) |
| Past Cardiac History, n(%) | ||||
| Prior MI | 30 (35) | / | 76 (53) | 98 (56) |
| Prior PCI | 14 (16) | / | / | 84 (48) |
| Prior CABG | 19 (22) | 85 (38) | 42 (29) | 49 (28) |
| Clinical presentation, n(%) | ||||
| STEMI | 13 (15) | / | / | / |
| NSTEMI | 50 (58) | 55 (37) | / | / |
| SA | 23 (27) | 93 (63) | / | / |
| NYHA III-IV, n(%) | 60 (70) | 151 (67) | / | 115 (66) |
| LVEF, mean±SD (%) | 31±9 | 23±6 | / | 31±17 |
| LVEF ≤35%, n(%) | 67 (78) | 216 (100) | 92 (64)† | 121 (69) |
| EuroSCORE, mean±SD | 9±3 | 9±6 | 8±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 Score | 31±10 | 30±13 | / | 37±16 |
| BCIS-JS | 10±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.