Table 1.
Clinical and Procedural Characteristics
| Women at HBR (n=821) | Men at HBR (n=1576) | P Value | |
|---|---|---|---|
| Baseline characteristics | |||
| Age, y | 72.7±10.5 (821) | 70.6±11.0 (1576) | <0.0001 |
| Current smoker | 9.6% (75/785) | 19.5% (295/1515) | <0.0001 |
| Diabetes mellitus | 48.7% (399/820) | 42.9% (673/1570) | 0.007 |
| Hypertension | 89.6% (735/820) | 85.1% (1335/1568) | 0.002 |
| Hyperlipidemia | 79.4% (639/805) | 71.0% (1079/1520) | <0.0001 |
| LVEF <30% | 4.4% (27/608) | 4.8% (55/1145) | 0.73 |
| Multivessel disease | 40.7% (334/821) | 45.3% (711/1571) | 0.03 |
| Prior cardiac intervention | 48.1% (379/788) | 49.1% (741/1510) | 0.66 |
| Prior MI | 26.7% (198/741) | 32.4% (471/1453) | 0.006 |
| Clinical presentation | |||
| Acute MI | 17.1% (122/712) | 18.6% (267/1434) | 0.40 |
| Procedural characteristics | |||
| No. of treated lesions per patient | 1.3±0.6 (821) | 1.4±0.7 (1576) | 0.82 |
| No. of treated vessels per patient | 1.1±0.4 (787) | 1.1±0.4 (1483) | 0.21 |
| No. of stents implanted per patient | 1.6±0.8 (821) | 1.6±0.9 (1576) | 0.46 |
| RVD, mm | 2.92±0.48 (983) | 3.00±0.58 (1896) | <0.0001 |
| Lesion length, mm | 17.1±10.5 (972) | 18.7±11.5 (1897) | 0.0003 |
| B2/C lesion | 55.5% (501/902) | 60.0% (1035/1724) | 0.03 |
| Left main | 2.2% (24/1104) | 3.0% (64/2132) | 0.17 |
| Graft | 3.6% (40/1104) | 5.3% (112/2132) | 0.04 |
| Restenosis lesion | 10.8% (119/1103) | 10.4% (221/2123) | 0.74 |
| Bifurcation | 9.7% (105/1085) | 9.6% (198/2073) | 0.91 |
| Ostial lesion | 14.4% (145/1009) | 15.9% (296/1861) | 0.28 |
| No. of HBR criteria | |||
| Major ARC‐HBR | 0.7±0.6 | 0.6±0.6 | |
| Minor ARC‐HBR | 1.4±1.0 | 1.4±1.0 | |
| LEADERS FREE | 1.4±0.6 | 1.3±0.6 | |
Data are reported as percentage and number of patients as well as mean and SD as appropriate. ARC indicates Academic Research Consortium; HBR, high bleeding risk; LEADERS FREE, Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug‐Coated Stent versus the Gazelle Bare‐Metal Stent in Patients at High Bleeding Risk trial; LVEF, left ventricular ejection fraction; MI, myocardial infarction; and RVD, reference vessel diameter.