Table 1. Baseline Characteristics of the Study Population.
| Characteristic | Patients, No./total No. (%) | |||
|---|---|---|---|---|
| All (N = 6641) | With BARC types 3-5 bleeding (n = 381)a | With MI and/or ST (n = 350)a | With neither event (n = 5970) | |
| Baseline characteristics | ||||
| Age, median (IQR), y | 77.9 (70.0-82.6) | 77.9 (70.6-83.0) | 78.1 (69.2-82.5) | 77.9 (70.0-82.6) |
| Female | 2257/6641 (34.0) | 138/381 (36.2) | 107/350 (30.6) | 2032/5970 (34.0) |
| Diabetes (requiring treatment with either insulin or oral medication) | 2327/6634 (35.1) | 146/380 (38.4) | 164/350 (46.9) | 2048/5964 (34.3) |
| BMI, median (IQR) | 26.6 (24.0-29.9) | 26.4 (23.5-30.0) | 26.5 (23.8-29.8) | 26.6 (24.0-30.0) |
| History of hypertension | 5462/6633 (82.3) | 321/381 (84.3) | 292/350 (83.4) | 4901/5962 (82.2) |
| Current smoker | 697/6596 (10.6) | 50/375 (13.3) | 49/349 (14.0) | 609/5932 (10.3) |
| Hypercholesterolemia | 4272/6593 (64.8) | 240/379 (63.3) | 225/345 (65.2) | 3851/5928 (65.0) |
| Previous CABG | 809/6553 (12.3) | 54/379 (14.2) | 58/347 (16.7) | 706/5887 (12.0) |
| Previous MI | 1558/6527 (23.9) | 95/377 (25.2) | 132/347 (38.0) | 1345/5863 (22.9) |
| Congestive heart failure | 608/4162 (14.6) | 57/263 (21.7) | 37/220 (16.8) | 521/3712 (14.0) |
| Peripheral artery disease | 920/5602 (16.4) | 66/347 (19.0) | 62/285 (21.8) | 804/5024 (16.0) |
| COPD | 554/4947 (11.2) | 50/291 (17.2) | 35/280 (12.5) | 476/4416 (10.8) |
| STEMI or NSTEMI at presentation | 1737/6577 (26.4) | 112/377 (29.7) | 139/346 (40.2) | 1499/5914 (25.3) |
| Plasma creatinine, median (IQR), mg/DL | 0.62 (0.47-0.85) | 0.60 (0.43-0.84) | 0.59 (0.43-0.78) | 0.62 (0.47-0.85) |
| Hemoglobin, mean (SD), g/L | 12.6 (1.9) | 11.7 (2.0) | 12.2 (1.9) | 12.7 (1.8) |
| ARC high bleeding risk criteria (adapted)b | ||||
| Aged >75 y | 4259/6641 (64.1) | 237/381 (62.2) | 222/350 (63.4) | 3831/5970 (64.2) |
| Anemia | ||||
| Mild | 1896/6641 (28.5) | 104/381 (27.3) | 119/350 (34.0) | 1696/5970 (28.4) |
| Moderate or severe | 1239/6641 (18.7) | 142/381 (37.3) | 87/350 (24.9) | 1033/5970 (17.3) |
| Platelet count <100 000/mm3 | 198/6641 (3.0) | 10/381 (2.6) | 18/350 (5.1) | 172/5970 (2.9) |
| Hospital admission for bleeding in past 12 mo and/or transfusion for anemia during prior 4 wk | 185/6641 (2.8) | 16/381 (4.2) | 11/350 (3.1) | 160/5970 (2.7) |
| Intracranial bleeding or stroke in the previous 12 mo | 511/6641 (7.7) | 23/381 (6.0) | 23/350 (6.6) | 468/5970 (7.8) |
| eGFR, mL/min | ||||
| 30-59 | 3171/6641 (47.7) | 165/381 (43.3) | 174/350 (49.7) | 2860/5970 (47.9) |
| <30 | 603/6641 (9.1) | 56/381 (14.7) | 52/350 (14.9) | 506/5970 (8.5) |
| Severe liver disease | 57/6641 (0.9) | 5/381 (1.3) | 3/350 (0.9) | 49/5970 (0.8) |
| Cancer in previous 3 yc | 579/6641 (8.7) | 43/381 (11.3) | 30/350 (8.6) | 512/5970 (8.6) |
| Planned major surgery in next 12 mo | 655/6641 (9.9) | 46/381 (12.1) | 37/350 (10.6) | 580/5970 (9.7) |
| Oral anticoagulation planned after PCI | 2086/6641 (31.4) | 153/381 (40.2) | 103/350 (29.4) | 1848/5970 (31.0) |
| Glucocorticoids or NSAIDs planned after PCI | 136/6641 (2.0) | 15/381 (3.9) | 8/350 (2.3) | 115/5970 (1.9) |
| Angiographic and procedural characteristics | ||||
| Multivessel disease | 3115/6362 (49.0) | 194/357 (54.3) | 208/343 (60.6) | 2749/5720 (48.1) |
| BMS implanted | 2290/6641 (34.5) | 133/381 (34.9) | 153/350 (43.7) | 2029/5970 (34.0) |
| No. of stents implanted, mean (SD) | 1.8 (1.1) | 1.9 (1.3) | 2.1 (1.4) | 1.8 (1.1) |
| Complex PCI procedured | 2289/6641 (34.5) | 159/381 (41.7) | 159/350 (45.4) | 2013/5970 (33.7) |
| Multivessel procedure | 2081/6641 (31.3) | 132/381 (34.6) | 145/350 (41.4) | 1831/5970 (30.7) |
| Lesion | ||||
| Left main | 280/6641 (4.2) | 29/381 (7.6) | 28/350 (8.0) | 231/5970 (3.9) |
| Bifurcation | 751/5713 (13.1) | 60/351 (17.1) | 43/288 (14.9) | 659/5128 (12.9) |
| Saphenous vein | 105/6641 (1.6) | 9/381 (2.4) | 12/350 (3.4) | 86/5970 (1.4) |
Abbreviations: ARC, Academic Research Consortium; BARC, Bleeding Academic Research Consortium; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); BMS, bare metal stent; CABG, coronary artery bypass graft; COPD, chronic obstructive pulmonary disease; eGFR, estimated glomerular filtration rate; IQR, interquartile range; MI, myocardial infarction; NSAIDs, nonsteroidal anti-inflammatory drugs; NSTEMI, non–ST-segment elevation MI; PCI, percutaneous coronary intervention; ST, definite or probable stent thrombosis; STEMI, ST-segment elevation MI.
SI conversion factors: To convert creatinine to micromoles per liter, multiply by 88.4; hemoglobin to grams per liter, multiply by 10.0.
Periprocedural events (≤48 hours) excluded.
Adapted ARC high bleeding risk criteria are in eTable 1 in the Supplement.
Excluding nonmelanoma skin cancer.
As defined by Giustino et al.31