Table 2. Incidence Risk of Ischemic Outcomes and Severe Bleeding at 30 Months, Stratified by High-risk Limb Presentation and Presence of High-risk Comorbidity Among All Patients With Symptomatic Lower Extremity Peripheral Artery Disease (N = 4129).
| Outcome | Patients, No. | MACE | MALE, No. (%) | MACE or MALE, including major amputation, No. (%) | Bleeding | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Patients, No. (%) | Kaplan-Meier incidence risk at 30 mo, % | Patients, No. (%) | Kaplan-Meier incidence risk at 30 mo, % | Patients, No. (%) | Kaplan-Meier incidence risk at 30 mo, % | Fatal or critical organ, No. (%) | Major per modified ISTH, No. (%) | ||||
| Patients, No. (%) | Kaplan-Meier incidence risk at 30 mo, % | Patients, No. (%) | Kaplan-Meier incidence risk at 30 mo, % | ||||||||
| Any high-risk limb presentation | 2040 | 137 (6.7) | 9.2 | 81 (4.0) | 5.1 | 211 (10.3) | 13.7 | 17 (0.8) | 1.0 | 67 (3.3) | 4.7 |
| Amputation | 316 | 32 (10.1) | 13.8 | 23 (7.3) | 9.8 | 54 (17.1) | 22.6 | 2 (0.6) | 0.6 | 3 (0.9) | 1.1 |
| Previous revascularizationa | 1617 | 98 (6.1) | 8.4 | 50 (3.1) | 3.8 | 142 (8.8) | 11.8 | 15 (0.9) | 1.1 | 64 (4.0) | 5.6 |
| Fontaine classificationb | |||||||||||
| III or IV | 107 | 7 (6.5) | 7.1 | 8 (7.5) | 10.7 | 15 (14.0) | 17.6 | 0 | 0.0 | 0 | 0.0 |
| IIa or IIb | 2053 | 109 (5.3) | 7.3 | 22 (1.1) | 1.7 | 128 (6.2) | 8.8 | 15 (0.7) | 1.1 | 40 (1.9) | 3.0 |
| Any high-risk comorbidity | 3481 | 241 (6.9) | 9.5 | 86 (2.5) | 3.4 | 317 (9.1) | 12.4 | 30 (0.9) | 1.2 | 92 (2.6) | 4.0 |
| Polyvascular disease | 2335 | 175 (7.5) | 10.2 | 53 (2.3) | 2.9 | 222 (9.5) | 12.8 | 22 (0.9) | 1.4 | 73 (3.1) | 4.6 |
| History | |||||||||||
| Diabetes | 1940 | 146 (7.5) | 9.8 | 58 (3.0) | 4.1 | 199 (10.3) | 13.4 | 16 (0.8) | 1.0 | 41 (2.1) | 3.0 |
| Heart failure | 686 | 55 (8.0) | 11.1 | 13 (1.9) | 2.8 | 67 (9.8) | 13.5 | 4 (0.6) | 0.9 | 12 (1.7) | 4.0 |
| Kidney insufficiency | 1112 | 93 (8.4) | 11.2 | 26 (2.3) | 3.1 | 118 (10.6) | 14.1 | 10 (0.9) | 1.3 | 35 (3.1) | 5.0 |
| Both high-risk limb presentation and high-risk comorbidity | 1665 | 130 (7.8) | 10.4 | 66 (4.0) | 4.9 | 189 (11.4) | 14.7 | 15 (0.9) | 1.1 | 55 (3.3) | 4.9 |
| Neither high-risk limb presentation nor high-risk comorbidity | 273 | 5 (1.8) | 2.0 | 3 (1.1) | 1.1 | 8 (2.9) | 3.1 | 1 (0.4) | 0.4 | 4 (1.5) | 2.0 |
Abbreviations: ISTH, International Society of Thrombosis and Hemostasis; MACE, major adverse cardiac event; MALE, major adverse limb event.
a
Without prior amputation.
b
Without prior amputation or prior limb revascularization.