Table 1. Baseline Patient and Procedural Characteristics.
| No. (%) | ||||
|---|---|---|---|---|
| LOF allele (CYP2C19 *2/*3) carriers | All randomized patients | |||
| Genotype-guided therapy (n = 903) | Conventional therapy (n = 946) | Genotype-guided therapy (n = 2641) | Conventional therapy (n = 2635) | |
| Patient characteristics | ||||
| Age, y | ||||
| Median (range) | 62 (26-95) | 62 (21-93) | 62 (26-95) | 62 (21-93) |
| <50 | 120 (13) | 123 (13) | 327 (12) | 328 (12) |
| 50-59 | 260 (29) | 280 (30) | 737 (28) | 730 (28) |
| 60-69 | 276 (31) | 310 (33) | 867 (33) | 863 (33) |
| 70-74 | 115 (13) | 104 (11) | 333 (13) | 334 (13) |
| 75-79 | 73 (8) | 80 (8) | 216 (8) | 218 (8) |
| ≥80 | 59 (7) | 49 (5) | 161 (6) | 162 (6) |
| Sex | ||||
| Men | 676 (75) | 728 (77) | 1993 (75) | 1990 (76) |
| Women | 227 (25) | 218 (23) | 648 (25) | 645 (24) |
| Race | n = 884 | n = 927 | n = 2578 | n = 2588 |
| White | 442 (50) | 462 (50) | 1750 (68) | 1754 (68) |
| East Asian | 345 (39) | 363 (39) | 595 (23) | 592 (23) |
| South Asian | 62 (7) | 66 (7) | 116 (4) | 120 (5) |
| African American | 17 (2) | 20 (2) | 57 (2) | 67 (3) |
| Othera | 18 (2) | 16 (2) | 60 (2) | 55 (2) |
| Hispanic or Latinx ethnicity | 14/884 (2) | 15/927 (2) | 78/2578 (3) | 70/2588 (3) |
| Country of enrollment | ||||
| US | 345 (38) | 380 (40) | 1359 (51) | 1358 (52) |
| South Korea | 381 (42) | 397 (42) | 654 (25) | 650 (25) |
| Canada | 168 (19) | 161 (17) | 577 (22) | 580 (22) |
| Mexico | 9 (1) | 8 (1) | 51 (2) | 47 (2) |
| BMI, median (IQR)b | 26.9 (24.3-30.9) | 27.0 (24.0-30.6) | 27.9 (24.9-31.8) | 28.1 (24.8-31.9) |
| Comorbidities | ||||
| Hypertension | 531 (59) | 575 (61) | 1636 (62) | 1667 (63) |
| Dyslipidemia | 414 (46) | 416 (44) | 1363 (52) | 1384 (53) |
| Diabetes | 253 (28) | 257 (27) | 733 (28) | 695 (26) |
| Heart failure | 107 (12) | 105 (11) | 225 (9) | 219 (8) |
| Peripheral artery disease | 20 (2) | 18 (2) | 75 (3) | 61 (2) |
| Risk factors | ||||
| Family history of CAD | 279 (31) | 303 (32) | 995 (38) | 1005 (38) |
| Cigarette use | 228 (25) | 239 (25) | 648 (25) | 637 (24) |
| History of PCI | 174 (19) | 188 (20) | 612 (23) | 612 (23) |
| History of MI (excluding index event) | 112 (12) | 111 (12) | 387 (15) | 371 (14) |
| History of CABG surgery | 53 (6) | 53 (6) | 196 (7) | 188 (7) |
| Stroke/TIA | 28 (3) | 27 (3) | 72 (3) | 76 (3) |
| CAD presentation | ||||
| Stable CAD | 127 (14) | 148 (16) | 488 (18) | 484 (18) |
| ACS: unstable angina | 336 (37) | 335 (35) | 830 (31) | 792 (30) |
| ACS: non-STEMI | 250 (28) | 263 (28) | 749 (28) | 785 (30) |
| ACS: STEMI | 190 (21) | 200 (21) | 574 (22) | 574 (22) |
| Pre-PCI LVEF, median (IQR), % | 60 (53-66) | 60 (53-67) | 60 (51-65) | 59 (52-65) |
| Kidney function, eGFR, mL/minc | ||||
| <60 | 100 (12) | 94 (11) | 243 (10) | 296 (12) |
| ≥60 | 738 (88) | 773 (89) | 2171 (90) | 2105 (88) |
| Multivessel disease | 379 (42) | 343 (36) | 1120 (43) | 1099 (42) |
| Procedural characteristics | ||||
| PCI to randomization, median (IQR), h | 4.5 (1.1-19.7) | 4.8 (1.1-20.1) | 7.0 (1.9-20.7) | 8.3 (1.9-20.6) |
| Antithrombin use | ||||
| Unfractionated heparin | 775 (86) | 828 (88) | 2255 (86) | 2262 (86) |
| Bivalirudin | 91 (10) | 96 (10) | 340 (13) | 329 (13) |
| Low-molecular-weight heparin | 38 (4) | 47 (5) | 130 (5) | 148 (6) |
| GpIIb-IIIa inhibitor use | 55 (6) | 88 (9) | 264 (10) | 270 (10) |
| Loading medication | ||||
| Clopidogrel | 606 (67) | 622 (66) | 1786 (68) | 1792 (68) |
| Ticagrelor | 219 (24) | 238 (25) | 587 (22) | 620 (24) |
| Prasugrel | 19 (2) | 23 (2) | 74 (3) | 53 (2) |
| Ticlopidine | 1 (<1) | 1 (<1) | 1 (<1) | 1 (<1) |
| Other | 4 (<1) | 2 (<1) | 8 (<1) | 5 (<1) |
| None | 52 (6) | 60 (6) | 168 (6) | 160 (6) |
| No. of stents placed, median (IQR) | 1.0 (1.0-2.0) | 1.0 (1.0-2.0) | 1.0 (1.0-2.0) | 1.0 (1.0-2.0) |
| Artery treated | ||||
| Left anterior descending | 456 (51) | 500 (53) | 1356 (52) | 1355 (52) |
| Right coronary | 312 (35) | 329 (35) | 935 (36) | 931 (35) |
| Left circumflex | 239 (26) | 253 (27) | 683 (26) | 727 (28) |
| Left main coronary | 32 (4) | 21 (2) | 71 (3) | 56 (2) |
| First antiplatelet after randomization | ||||
| Clopidogrel | 132 (15) | 932 (99) | 1790 (68) | 2586 (99) |
| Ticagrelor | 764 (85) | 9 (1) | 822 (31) | 35 (1) |
| Prasugrel | 4 (<1) | 2 (<1) | 9 (<1) | 3 (<1) |
| Cilostazol | 1 (<1) | 0 | 1 (<1) | 0 |
| Time from PCI to first postrandomization antiplatelet therapy, median (IQR), h | 21.7 (10.1-26.1) | 21.9 (17.7-25.0) | 21.9 (17.2-28.5) | 21.9 (17.8-27.9) |
Abbreviations: ACS, acute coronary syndrome; BMI, body mass index; CABG, coronary artery bypass graft; CAD, coronary artery disease; eGFR, estimated glomerular filtration rate; GpIIb-IIIa, glycoprotein IIb/IIIa complex; IQR, interquartile range; LOF, loss of function; LVEF, left ventricular ejection fraction; MI, myocardial infarction; PCI, percutaneous coronary intervention; STEMI, ST-segment elevation myocardial infarction; TIA, transient ischemic attack.
a
Other race consists of 130 patients who indicated “other” and 19 who indicated “Native American Indian or Native Alaskan.”
b
Calculated as weight in kilograms divided by height in meters squared.
c
eGFR calculated by Modification of Diet in Renal Disease equation. Equation = 186*([serum creatinine]^(–1.154))*([age, y]^(–0.203))*(0.742^[female])*(1.21^[black]).