Endpoint | Period (days) | Diabetic patients | Adjusted HR* (95% CI) | P value | Non diabetic patients | Adjusted HR* (95% CI) | P value | ||
---|---|---|---|---|---|---|---|---|---|
(no(no/person year)) | Endeavour | Cypher | Endeavour | Cypher | |||||
Patient level analysis* | N = 342 | N = 602 | N = 1936 | N = 3207 | |||||
Death | 0-823 | 31 (9.9) | 36 (4.6) | 2.03 (1.21-3.42) | 0.0076 | 102 (5.6) | 122 (3.2) | 1.20 (0.90-1.60) | 0.20 |
0-30 | 12 (43.9) | 10 (20.5) | 2.13 (0.88-5.15) | 0.0942 | 43 (27.5) | 40 (15.3) | 1.52 (0.96-2.42) | 0.077 | |
31-365 | 15 (6.9) | 18 (3.9) | 1.69 (0.80-3.58) | 0.1701 | 47 (3.7) | 51 (2.1) | 1.09 (0.71-1.68) | 0.70 | |
Cardiac death | 0-823 | 17 (5.4) | 12 (1.5) | 3.54 (1.59-7.90) | 0.0020 | 38 (2.1) | 46 (1.2) | 0.97 (0.60-1.58) | 0.91 |
0-30 | 8 (29.3) | 4 (8.2) | 3.71 (1.03-13.4) | 0.0449 | 22 (14.1) | 25 (29.6) | 1.09 (0.58-2.03) | 0.79 | |
31-365 | 8 (3.7) | 7 (1.5) | 3.38 (1.10-10.4) | 0.0341 | 13 (1.0) | 15 (0.6) | 0.70 (0.29-1.72) | 0.44 | |
Noncardiac death | 0-823 | 12 (3.8) | 14 (1.8) | 1.65 (0.72-3.79) | 0.2347 | 41 (2.3) | 52 (1,3) | 1.19 (0.77-1.83) | 0.44 |
0-30 | 4 (14.6) | 6 (12.3) | 1.22 (0.32-4.61) | 0.7678 | 12 (7.7) | 14 (5.4) | 1.30 (0.56-3.02) | 0.55 | |
31-365 | 7 (3.2) | 7 (1.5) | 1.67 (0.51-5.44) | 0.3984 | 24 (1.9) | 27 (1.1) | 1.18 (0.66-2.10) | 0.57 | |
Myocardial infarction | 30-823 | 54 (19.6) | 86 (12.7) | 1.24 (0.86-1.79) | 0.2522 | 319 (20.4) | 543 (16.4) | 0.98 (0.85-1.13) | 0.79 |
0-30 | 41 (168) | 68 (155) | 1.24 (0.82-1.86) | 0.3032 | 279 (206) | 473 (210) | 0.99 (0.85-1.16) | 0.92 | |
31-365 | 10 (5.2) | 14 (3.5) | 0.89 (0.33-2.40) | 0.8195 | 35 (3.2) | 49 (2.4) | 0.93 (0.56-1.55) | 0.79 | |
Composite safety end point† | 30-823 | 31 (11.1) | 48 (6.8) | 1.45 (0.87-2.40) | 0.1507 | 105 (6.5) | 168 (4.7) | 1.00 (0.76-1.31) | 0.98 |
Target lesion revascularization | 0-823 | 29 (9.8) | 14 (1.8) | 3.64 (1.10-12.1) | 0.0350 | 81 (4.6) | 76 (2.0) | 2.14 (1.29-3.54) | 0.003 |
In-stent restenosis | 0-823 | 24 (8.0) | 11 (1.4) | 7.18 (1.59-32.4) | 0.0103 | 60 (3.4) | 56 (1.4) | 1.97 (1.11-3.48) | 0.020 |
Stent thrombosis | 0-823 | 5 (1.6) | 4 (0.5) | - | - | 21 (1.2) | 20 (0.5) | 2.92 (0.95-8.93) | 0.060 |
0-30 | 4 (14.7) | 1 (2.0) | - | - | 17 (10.9) | 12 (4.6) | 5.61 (1.14-27.6) | 0.034 | |
31-365 | 1 (0.5) | 1 (0.2) | - | - | 3 (0.2) | 4 (0.2) | 1.74 (0.23-13.2) | 0.59 | |
366-823 | 0 (0.0) | 2 (0.8) | - | - | 1 (0.3) | 4 0.3) | - | - | |
Lesion level analysis | |||||||||
Target lesion revascularization | 0-823 | 29 (7.3) | 15 (1.4) | 5.06 (2.65-9.69) | <.0001 | 86 (3.5) | 80 (1.5) | 2.08 (1.53-2.85) | <0.0001 |
In-stent restenosis | 0-823 | 24 (6.0) | 12 (1.1) | 5.06 (2.48-10.3) | <.0001 | 63 (2.5) | 60 (1.2) | 2.08 (1.45-2.99) | <0.0001 |
Stent thrombosis | 0-823 | 5 (1.2) | 4 (0.4) | 4.33 (1.02-18.4) | 0.047 | 23 (0.9) | 20 (0.4) | 2.03 (1.10-3.76) | 0.0234 |
0-30 | 4 (11.2) | 1 (1.5) | 11.6 (1.10-122) | 0.0413 | 19 (9.0) | 12 (3.5) | 2.40 (1.15-4.99) | 0.0194 | |
31-365 | 1 (0.4) | 1 (0.2) | 1.84 (0.11-30.5) | 0.6693 | 3 (0.2) | 4 (0.1) | 1.34 (0.29-6.08) | 0.7074 | |
366-823 | 0 (0.0) | 2 (0.5) | - | - | 1 (0.2) | 4 (0.2) | 1.68 (0.17-16.4) | 0.66 |