Background
Methods
Patients
Outcomes
Statistical analysis
Characteristic | DM (-) CKD (-) | DM ( +) CKD (-) | DM (-) CKD ( +) | DM ( +) CKD ( +) |
---|---|---|---|---|
n = 10,513 | n = 3189 | n = 1332 | n = 838 | |
Age, years (SD) | 63.0 (10.2) | 65.0 (9.2) | 71.5 (9.5) | 71.3 (8.8)* |
Male | 8387/10,513 (79.8%) | 2445/3189 (76.7%) | 830/1332 (62.3%) | 518/838 (61.8%)* |
Mean body-mass index, kg/m2 (SD) | 27.65 (4.3) | 29.59 (5.0) | 28.01 (4.5) | 29.91 (5.0)* |
Medical history | ||||
Insulin-dependent diabetes mellitus | 0/10,513 (0.0%) | 869/3155 (27.3%) | 0/1332 (0.0%) | 352/836 (42.0%) |
Hypertension | 7047/10,471 (67.3%) | 2721/3185 (85.4%) | 1118/1329 (84.1%) | 770/838 (91.9%)* |
Hypercholesterolemia | 6771/10,196 (64.4%) | 2421/3085 (75.9%) | 879/1286 (66.0%) | 634/813 (75.7%)* |
Current smoker | 3135/10,513 (29.8%) | 686/3189 (21.5%) | 207/1332 (15.5%) | 110/838 (13.1%)* |
Previous stroke | 209/10,501 (2.0%) | 120/3182 (3.8%) | 48/1330 (3.6%) | 44/838 (5.3%)* |
Previous peripheral vascular disease | 480/10,433 (4.6%) | 273/3158 (8.6%) | 121/1317 (9.1%) | 126/826 (15.0%)* |
Chronic obstructive pulmonary disease | 485/10,474 (4.6%) | 179/3174 (5.6%) | 86/1327 (6.5%) | 69/828 (8.2%)* |
Previous myocardial infarction | 2265/10,487 (21.5%) | 815/3176 (25.6%) | 344/1330 (25.8%) | 269/835 (32.1%)* |
Previous PCI | 3107/10,504 (29.6%) | 1249/3186 (39.2%) | 471/1331 (35.4%) | 372/838 (44.4%)* |
Previous CABG | 477/10,506 (4.5%) | 266/3185 (8.4%) | 91/1331 (6.8%) | 107/838 (12.8%)* |
Previous bleeding | 59/10,504 (0.6%) | 18/3181 (0.6%) | 15/1331 (1.1%) | 6/838 (0.7%) |
Clinical presentation | ||||
Stable coronary artery disease | 5298/10,513 (50.4%) | 1913/3189 (60.0%) | 690/1332 (51.8%) | 514/838 (61.3%) |
Acute coronary syndrome | 5215/10,513 (49.6%) | 1276/3189 (40.0%) | 642/1332 (48.2%) | 324/838 (38.7%) |
Complex PCI | 2976/10,513 (28.3%) | 934/3189 (29.3%) | 377/1332 (28.3%) | 263/838 (31.4%) |
Multivessel PCI | 2216/10,513 (21.1%) | 671/3189 (21.0%) | 282/1332 (21.2%) | 189/838 (22.6%) |
Lesion treated ≥ 3 | 851/10,513 (8.1%) | 266/3189 (8.3%) | 113/1332 (8.5%) | 68/838 (8.1%) |
Stent implanted ≥ 3 | 1793/10,513 (17.1%) | 568/3189 (17.8%) | 235/1332 (17.6%) | 162/838 (19.3%) |
Bifurcation PCI with ≥ 2 stents | 323/10,513 (3.1%) | 88/3189 (2.8%) | 31/1332 (2.3%) | 28/838 (3.3%) |
Total stent length >60 mm | 1346/10,513 (12.8%) | 437/3189 (13.7%) | 180/1332 (13.5%) | 106/838 (12.7%) |
Total Stent Length (SD) | 35.2 (25.1) | 36.0 (25.2) | 35.7 (25.8) | 36.3 (26.2) |
Medications on discharge | ||||
ACE-inhibition and/or ARB | 6346/10,450 (60.4%) | 1986/3162 (62.3%) | 730/1320 (54.8%) | 457/826 (54.5%) |
Beta-blockade | 8194/10,452 (77.9%) | 2577/3163 (80.8%) | 1069/1321 (80.3%) | 669/826 (79.8%) |
Statin | 9718/10,459 (92.4%) | 2916/3168 (91.4%) | 1212/1322 (91.0%) | 764/827 (91.2%) |
Paris bleeding risk score [31] (IQR) | 3 (2,4) | 3 (2,4) | 6 (5,7) | 6 (5,7)* |
Paris thrombotic risk score (IQR) | 2 (0,4) | 3 (2,4) | 4 (2,7) | 5 (4,7)* |
Paris bleeding risk score ≥ 8 | 100/10,039 (1.0%) | 41/3060 (1.3%) | 269/1288 (20.9%) | 189/803 (23.5%)* |
Paris thrombotic risk score ≥ 5 | 140/10,506 (1.3%) | 655/3185 (20.8%) | 243/1331 (18.3%) | 615/838 (73.4%)* |
PRECISE DAPT score [15] (IQR) | 14 (9,19) | 15 (10,20) | 27 (23,32) | 29 (24,34)* |
PRECISE DAPT score ≥ 25 | 731/9849 (7.4%) | 323/3007 (10.7%) | 846/1266 (66.8%) | 567/799 (71.0%)* |
Antiplatelet therapy | ||||
Reference treatment strategy | 5297/10,513 (50.4%) | 1575/3189 (49.4%) | 662/1332 (49.7%) | 410/838 (48.9%) |
Experimental treatment strategy | 5216/10,513 (49.6%) | 1614/3189 (50.6%) | 670/1332 (50.3%) | 428/838 (51.1%) |
Results
Patients and outcomes according to DM and CKD status
DM (-) CKD (-) | DM ( +) CKD (-) | DM (-) CKD ( +) | DM ( +) CKD ( +) | Ptrend | ||||
---|---|---|---|---|---|---|---|---|
n = 10,513 | HR (95% CI) | HR (95% CI) | n = 1332 | HR (95% CI) | n = 838 | HR (95% CI) | ||
All-cause mortality or New Q-wave MI | 330 (3.1%) | 1.00 (Ref) | 1.32 (1.07–1.61) | 92 (6.9%) | 1.54 (1.21–2.49) | 80 (9.5%) | 1.91 (1.47–2.49) | < 0.001 |
All-cause mortality | 226 (2.1%) | 1.00 (Ref) | 1.37 (1.08–1.75) | 74 (5.6%) | 1.67 (1.27–2.81) | 67 (8%) | 2.09 (1.55–2.81) | < 0.001 |
New Q-wave MI | 108 (1%) | 1.00 (Ref) | 1.29 (0.9–1.86) | 19 (1.4%) | 1.19 (0.72–2.3) | 13 (1.6%) | 1.26 (0.69–2.3) | 0.257 |
Stroke | 78 (0.7%) | 1.00 (Ref) | 1.86 (1.28–2.71) | 18 (1.4%) | 1.17 (0.68–3.48) | 19 (2.3%) | 2.04 (1.19–3.48) | 0.013 |
MI | 273 (2.6%) | 1.00 (Ref) | 1.48 (1.18–1.85) | 52 (3.9%) | 1.61 (1.18–3.49) | 53 (6.3%) | 2.54 (1.85–3.49) | 0.001 |
Any Revascularization | 917 (8.7%) | 1.00 (Ref) | 1.26 (1.11–1.43) | 129 (9.7%) | 1.17 (0.96–1.91) | 113 (13.5%) | 1.55 (1.26–1.91) | < 0.001 |
TVR | 466 (4.4%) | 1.00 (Ref) | 1.5 (1.27–1.78) | 71 (5.3%) | 1.28 (0.99–2.37) | 67 (8.0%) | 1.8 (1.38–2.37) | < 0.001 |
Definite stent thrombosis | 82 (0.8%) | 1.00 (Ref) | 1.08 (0.69–1.7) | 13 (1.0%) | 1.43 (0.78–2.23) | 6 (0.7%) | 0.94 (0.4–2.23) | 0.569 |
MACE | 394 (3.7%) | 1.00 (Ref) | 1.43 (1.19–1.71) | 101 (7.6%) | 1.4 (1.11–2.42) | 93 (11.1%) | 1.9 (1.49–2.42) | < 0.001 |
POCE | 1242 (11.8%) | 1.00 (Ref) | 1.3 (1.17–1.45) | 219 (16.4%) | 1.3 (1.12–2.06) | 194 (23.2%) | 1.75 (1.49–2.06) | < 0.001 |
NACE | 1360 (12.9%) | 1.00 (Ref) | 1.27 (1.15–1.41) | 245 (18.4%) | 1.29 (1.12–2.03) | 213 (25.4%) | 1.74 (1.49–2.03) | < 0.001 |
BARC 3 or 5 bleeding | 188 (1.8%) | 1.00 (Ref) | 1.05 (0.78–1.41) | 44 (3.3%) | 1.18 (0.83–2.39) | 37 (4.4%) | 1.64 (1.12–2.39) | 0.02 |
BARC 5 bleeding | 27 (0.3%) | 1.00 (Ref) | 0.51 (0.2–1.3) | 8 (0.6%) | 1.16 (0.5–2.09) | 5 (0.6%) | 0.71 (0.24–2.09) | 0.704 |
BARC 3 bleeding | 173 (1.6%) | 1.00 (Ref) | 1.12 (0.83–1.52) | 41 (3.1%) | 1.22 (0.85–2.71) | 35 (4.2%) | 1.84 (1.25–2.71) | 0.005 |
BARC 3a bleeding | 77 (0.7%) | 1.00 (Ref) | 1.31 (0.85–2.01) | 25 (1.9%) | 1.64 (1.02–2.63) | 13 (1.6%) | 1.42 (0.76–2.63) | 0.054 |
BARC 3b bleeding | 74 (0.7%) | 1.00 (Ref) | 1.01 (0.62–1.64) | 17 (1.3%) | 1.29 (0.73–3.71) | 14 (1.7%) | 2.02 (1.1–3.71) | 0.043 |
BARC 3c bleeding | 38 (0.4%) | 1.00 (Ref) | 0.78 (0.37–1.65) | 3 (0.2%) | 0.38 (0.11–4.56) | 10 (1.2%) | 2.11 (0.98–4.56) | 0.524 |
BARC 2 bleeding | 489 (4.7%) | 1.00 (Ref) | 1 (0.83–1.21) | 82 (6.2%) | 1.07 (0.84–1.52) | 54 (6.4%) | 1.14 (0.85–1.52) | 0.388 |
BARC 2, 3 or 5 bleeding | 647 (6.2%) | 1.00 (Ref) | 1.01 (0.86–1.19) | 118 (8.9%) | 1.11 (0.9–1.62) | 84 (10%) | 1.27 (1–1.62) | 0.063 |