Table 1
Baseline characteristics of 785 patients with type 2 diabetes undergoing surgery for partial foot amputation.
| BASELINE VARIABLE | TOTAL COHORT, | NON-COMPLIANT/NON-ADHERENT | NON-COMPLIANT/ADHERENT | COMPLIANT/NON-ADHERENT | COMPLIANT/ADHERENT | p-VALUE |
|---|---|---|---|---|---|---|
| n = 785 | n = 184 | n = 101 | n = 68 | n = 432 | ||
| Age, years mean ± SD | 60.9 ± 9.1 | 62.0 ± 10.1 | 61.3 ± 9.0 | 61.7 ± 9.1 | 60.3 ± 8,6 | 0.138 |
| Sex, n (%) | <0.001 | |||||
| Male | 503 (64.1) | 128 (69.5) | 86 (85.1) | 20 (29.4) | 269 (62.3) | |
| Female | 282 (35.9) | 56 (30.4) | 15 (14.8) | 48 (70.6) | 163 (37.7) | |
| HbAC1, % mean ± SD | 11.4 ± 2.7 | 12.3 ± 2.8 | 11.5 ± 2.7 | 11.0 ± 2.5 | 11.2 ± 2.5 | <0.001 |
| Diabetes duration, years, mean ± SD | 7.9 ± 5.9 | 8.5 ± 6.4 | 7.4 ± 5.7 | 9.5 ± 6.2 | 7.6 ± 5.8 | 0.098 |
| New diagnosed diabetes, n (%) | 54 (6.8) | 14 (7.6) | 7 (6.9) | 5 (7.4) | 28 (6.4) | 0.774 |
| Diabetic nephropathy, n (%) | 175 (22.3) | 56 (30.4) | 19 (18.8) | 14 (20.5) | 86 (19.9) | 0.030 |
| Oral anti-diabetes drugs, n (%) | ||||||
| Biguanide monotherapy: metformin | 145 (18.4) | 36 (19.6) | 15 (14.8) | 17 (25.0) | 77 (17.8) | |
| Sulfonylureas monotherapy: gliclazide, glimepiride | 127 (16.2) | 23 (12.5) | 16 (15.8) | 12 (17.7) | 76 (17.6) | |
| Combination of metfomin with sulfonylureas or DDP4 (sitagliptin) | 235 (29.9) | 49 (26.6) | 32 (31.7) | 14 (20.6) | 140 (32.4) | |
| SGLT-2i or GLP-1-mimetics | – | – | – | – | – | |
| Insulin, n (%) | 224 (28.5) | 62 (33.7) | 31 (30.7) | 20 (29.4) | 111 (25.7) | 0.207 |
| Insulin with metformin | 186 (23.7) | 49 (26.6) | 25 (24.8) | 15 (22.1) | 97 (22.5) | |
| BMI, mean ± SD | 28.7 ± 4.1 | 28.6 ± 3.9 | 29.8 ± 8.0 | 28.4 ± 3.1 | 28.8 ± 3,5 | 0.131 |
| Normal weight, n (%) | 101 (12.9) | 26 (14.1) | 14 (13.9) | 16 (23.5) | 45 (10.4) | |
| Overweight n (%) | 427 (54.4) | 104 (56.5) | 56 (55.4) | 33 (48.5) | 234 (54.2) | |
| Obesity, n (%) | 257 (32.7) | 54 (29.3) | 31 (30.7) | 19 (27.9) | 153 (35.4) | |
| Arterial hypertension, n (%) | 498 (63.4) | 112 (60.9) | 73 (72.3) | 38 (55.9) | 275 (63.6) | 0.161 |
| Stage 2, n (%) | 448 (57.1) | 105 (57.1) | 63 (62.4) | 32 (47.1) | 248 (57.4) | |
| Stage 1, n (%) | 50 (6.4) | 7 (3.8) | 10 (9.9) | 6 (8.8) | 27 (6.2) | |
| Elevated, n (%) | 162 (20.6) | 30 (16.3) | 12 (11.9) | 17 (25.0) | 103 (23.8) | |
| Normal, n (%) | 125 (15.9) | 42 (22.8) | 16 (15.4) | 13 (19.1) | 54 (12.5) | |
| Dyslipidemia, n (%) | 560 (71.3) | 132 (71.7) | 65 (64.3) | 48 (70.6) | 315 (72.9) | |
| History statin use, n (%) | 162 (20.6) | 36 (19.5) | 23 (22.8) | 15 (22.1) | 88 (20.4) | 0.732 |
| History aspirin use, n (%) | 408 (51.9) | 69 (37.5) | 54 (53.5) | 31 (45.6) | 254 (58.8) | |
| Smoking, n (%) | 443 (56.4) | 145 (78.8) | 96 (95.0) | 13 (19.1) | 189 (43.7) | <0.001 |
| Never/past smoker, n (%) | 342 (43.6) | 39 (21.2) | 5 (4.9) | 55 (80.9) | 243 (56.2) | 0.137 |
| Occasional | 105 (13.4) | 29 (15.8) | 6 (5.9) | 5 (7.3) | 65 (15.0) | |
| <1 pack/day | 226 (28.8) | 71 (38.6) | 56 (55.4) | 5 (7.3) | 94 (21.7) | |
| ≥1 pack/day | 112 (14.3) | 45 (24.5) | 34 (33.7) | 3 (4.4) | 30 (6.9) | |
| Coronary artery disease, n (%) | 516 (65.7) | 134 (72.8) | 60 (59.4) | 46 (67.6) | 276 (63.9) | 0.083 |
| Congestive heart failure | 260 (33.1) | 87 (47.2) | 25 (24.7) | 24 (35.3) | 124 (28.7) | 0.003 |
| Previous myocardial infarction, n (%) | 178 (22.7) | 75 (40.8) | 24 (23.8) | 19 (27.9) | 60 (13.9) | 0.145 |
| Revised cardiac risk index, n (%) | 0.029 | |||||
| II | 169 (21.5) | 26 (14.1) | 28 (27.7) | 12 (17.6) | 103 (23.8) | |
| III | 224 (28.5) | 49 (26.6) | 25 (24.7) | 24 (35.3) | 126 (29.2) | |
| IV | 392 (49.9) | 109 (59.3) | 48 (47.5) | 32 (47.1) | 203 (47.0) |
Table 2
Clinical outcomes across categories of medication adherence and lifestyle recommendations compliance in 785 patients with type 2 diabetes after partial foot amputation.
| VARIABLE, n (%) | NON-COMPLIANT/NON-ADHERENT n = 184 | NON-COMPLIANT/ADHERENt n = 101 | COMPLIANT/NON-ADHERENT n = 68 | COMPLIANT/ADHERENT n = 432 | TOTAL COHORT, n = 785 |
|---|---|---|---|---|---|
| Postoperative all-cause mortality, n (%) | |||||
| 30 days | 27 (14.7) | 0 | 1 (1.5) | 4 (0.9) | 32 (4.1) |
| 1-year | 79 (42.9) | 20 (19.8) | 12 (17.6) | 22 (5.1) | 133 (16.9) |
| Postoperative major adverse cardiovascular events, n (%) | |||||
| 30 days | 51 (27.7) | 8 (7.9) | 3 (4.4) | 8 (1.8) | 70 (8.9) |
| 1-year | 116 (63.0) | 28 (27.7) | 19 (27.9) | 37 (8.6) | 200 (25.5) |
Table 3
Multivariable adjusted Cox regression analysis for the association of persistent compliance and adherence with the risk of all-cause mortality and major adverse cardiovascular events in type 2 diabetes patients undergoing partial foot amputations.
| ALL-CAUSE MORTALITY | HR | 95.0% CI | |||
|---|---|---|---|---|---|
| LOWER | UPPER | p-VALUE | |||
| Group adherence and compliance (reference) | 0.000 | ||||
| Compliance/adherence (ref) | 1 | ||||
| Non-compliance/adherence | 3.807 | 2.033 | 7.127 | <0.001 | |
| Compliance/non-adherence | 3.138 | 1.521 | 6.145 | 0.002 | |
| Non-compliance/non-adherence | 8.670 | 5.299 | 14.187 | <0.001 | |
| Major adverse cardiovascular events | |||||
| Compliance/adherence (ref) | 1 | <0.001 | |||
| Non-compliance/adherence | 3.479 | 2.097 | 5.772 | <0.001 | |
| Compliance/non-adherence | 3.350 | 1.899 | 5.910 | <0.001 | |
| Non-compliance/Non-adherence | 9.663 | 6.554 | 14.245 | <0.001 | |
[i] Analyses were adjusted for age, gender, history of diabetes and diabetes-associated complications, severity of PAD, level of PFA, cardiovascular comorbidities, arterial hypertension, obesity, revised cardiac risk index, Charlson comorbidity score.
Figure 1
Unadjusted all-cause mortality free and major adverse cardiovascular events (MACE) – free Kaplan-Meier survival curves in patients with type 2 diabetes undergoing partial foot amputation A) all-cause mortality B) MACE. Patients were divided into 4 groups: persistently adherent/compliant (n = 432), adherent/non-compliant (n = 101), compliant/non-adherent (n = 68), non-adherent/non-compliant (n = 184).