Supplemental Tables s1
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Supplemental Tables Supplemental Table 1. Baseline Patient Characteristics of the Entire Study Population Comparing Patients With or Without Diabetes Mellitus.
Non-DM DM Variable P value (N = 3507) (N = 2924) Age, years 69.6±1 68.6±9.4 <0.001 Age ≥75 years, n (%) 1223 (35) 824 (28) <0.001 Male gender, n (%) 2691 (77) 2261 (77) 0.57 Body mass index 23.8±3.4 24.7±3.7 <0.001 Hemoglobin A1c, % 5.4±0.4 6.9±1.2 <0.001 Coexisting condition, n (%) Hypertension 2416 (83) 2782 (79) <0.001 Diabetes mellitus Insulin-treated diabetes - 676 (23) - Treated with oral medication only - 1575 (54) - Treated with diet therapy only - 422 (14) - Dyslipidemia 2623 (75) 2297 (79) <0.001 ESRD (eGFR <30 mL/min per 1.73m2) not on hemodialysis 61 (1.8) 93 (3.2) <0.001 Hemodialysis 128 (3.7) 234 (8.0) <0.001 Atrial fibrillation 257 (7.3) 190 (6.5) 0.19 Anemia (hemoglobin <11.0 g/dl) 449 (15) 351 (10) <0.0001 Chronic obstructive pulmonary disease 58 (2.0) 87 (2.5) 0.18 Malignancy 243 (6.9) 209 (7.2) 0.73 Cardiac risk factor, n (%) Current smoker 566 (19) 686 (20) 0.84 Family history of coronary artery disease 454 (17) 547 (17) 0.81 Previous myocardial infarction 897 (31) 983 (28) 0.02 Previous stroke 324 (9.2) 364 (12) <0.001 Heart failure 340 (9.7) 460 (16) <0.001 Peripheral vascular disease 268 (7.6) 353 (12) <0.001 Previous percutaneous coronary intervention 1636 (47) 1567 (54) <0.001 Previous coronary artery bypass grafting 144 (4.1) 179 (6.1) <0.001 Clinical characteristics, n (%) Clinical presentation Stable coronary artery disease 2883 (82) 2446 (84) 0.21 Unstable angina 424 (12) 337 (12) Acute myocardial infarction 200 (5.7) 141 (4.8) Left ventricular ejection fraction <30% 47 (1.6) 66 (2.6) 0.006 Multivessel disease 1569 (45) 1631 (56) <0.001 Target-vessel location, n (%) Left main coronary artery 84 (2.4) 95 (3.3) 0.04 Left anterior descending coronary artery 1390 (48) 1727 (49) 0.17 Left circumflex coronary artery 870 (25) 787 (27) 0.05 Right coronary artery 1138 (32) 949 (32) 0.996 Bypass graft 17 (0.5) 26 (0.9) 0.048 Complexity of coronary artery disease Number of treated lesions per patient 1.23±0.5 1.26±0.54 0.002 SYNTAX score Number of patients analyzed 3102 2535 Median (interquartile range) 9 (5.5-15) 11 (7-17) Tertiles, n (%) Low (<23) 2853 (92) 2225 (88) <0.001 Intermediate (≥23 to <33) 210 (6.8) 241 (9.5) High (≥33) 39 (1.3) 69 (2.7) Medications, n (%) Aspirin 3494 (99.6) 2913 (99.6) 0.97 Thienopyridines 3489 (99.5) 2901 (99.2) 0.17 Clopidogrel 3027 (87) 2466 (85) 0.03 Ticlopidine 440 (13) 421 (15) 0.03 1 Statins 2694 (77) 2236 (2924) 0.74 β-blockers 1278 (36) 1131 (39) 0.06 ACE-I/ARB 2043 (58) 1906 (65) <0.001 Calcium-channel blockers 1559 (44) 1309 (45) 0.80 Nitrates 972 (28) 731 (25) 0.01 Warfarin 280 (8.0) 224 (7.7) 0.63 Pioglitazone - 404 (14) - Data are presented as number (%) or mean ± SD, unless otherwise specified. ACE-I indicates angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blockers; DM, diabetes mellitus; ESRD, end-stage renal disease; eGFR, estimated glomerular filtration rate; G1-DES, first-generation drug-eluting stents; G2-DES, second-generation drug-eluting stents; and SYNTAX, Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery.
2 Supplemental Table 2. Lesion and Procedural Characteristics of the Entire Study Population Comparing Patients With or Without Diabetes Mellitus.
Non-DM DM Variable P value (N = 3507) (N = 2924) Number of lesions treated 4297 3698 Before index procedure Lesion length, mm 17.7±11.6 (3821) 18.9±12.8 (3216) <0.001 Reference vessel diameter, mm 2.64±0.61 (4028) 2.54±0.6 (3388) <0.001 Minimum lumen diameter, mm 0.8±0.45 (4036) 0.77±0.44 (3398) 0.006 Diameter stenosis, % 70±15.4 (4035) 70.2±15.4 (3398) 0.70 Thrombus 147/4036 (3.6) 76/3398 (2.2) <0.001 Chronic total occlusion 254/4297 (5.9) 244/3698 (6.6) 0.21 In-stent restenosis 442/4297 (10) 447/3698 (12) 0.01 Culprit for STEMI 147/4297 (3.4) 91/3698 (2.5) 0.01 Bifurcation 1695/4114 (41) 1418/3482 (41) 0.67 Moderate or heavy calcification 740/4036 (18) 740/3399 (22) <0.001 Small vessel (reference vessel diameter ≤2.75mm) 2440/4028 (61) 2229/3388 (66) <0.001 Long lesion (lesion length >18mm) 1384/3821 (36) 1316/3216 (41) <0.001 After index procedure Number of stents used Per patient 1.51±0.77 (387) 1.59±0.82 (2913) <0.001 Per lesion 1.26±0.55 (4169) 1.3±0.58 (3564) 0.001 Total stent length, mm Per patient 30.9±18.9 (3487) 33.6±20.6 (2912) <0.001 Per lesion 25.9±14.9 (4169) 27.5±16.3 (3563) <0.001 Stent diameter, mm 2.94±0.53 (4236) 2.9±0.55 (3634) 0.001 Multivessel treatment 364/3507 (10) 373/2924 (13) 0.003 Direct stenting 1047/4169 (25) 802/3564 (23) 0.007 Maximum stent inflation pressure, atmosphere 17.0±4.4 (4169) 17.3±4.4 (3564) 0.02 Postdilatation 3028/4236 (71) 2658/3634 (73) 0.10 Bifurcation 2-stent approach 49/2587 (1.9) 35/2153 (1.6) 0.49 Intravascular ultrasound use 2975/3507 (85) 2505/2924 (86) 0.34 Received study stent only 4114/4297 (96) 3518/3698 (95) 0.19 Minimum Lumen diameter, mm In-stent 2.51±0.47 (4008) 2.43±0.47 (3381) <0.001 In-segment 2.11±0.55 (4014) 2.01±0.54 (3387) <0.001 Diameter stenosis, % In-stent 10.2±8.1 (4007) 10.3±8.3 (3379) 0.51 In-segment 21.6±11.7 (4013) 22.8±12 (3385) <0.001 Acute gain, mm In-stent 1.71±0.52 (4008) 1.66±0.51 (3380) <0.001 In-segment 1.31±0.56 (4014) 1.24±0.53 (3386) <0.001 Duration of procedure, min 69.1±42.6 (3507) 71.7±43.8 (2924) 0.02 Successful outcome Lesion success by any treatment modalities 4273/4297 (99.4) 3672/3698 (99.3) 0.41 Lesion success by study stents (acute device success) 4124/4212 (97.9) 3528/3620 (97.5) 0.18 Procedural success (patient level) 3402/3507 (97.0) 2835/2924 (97.0) 0.91 Staged PCI procedures 863/3507 (25) 776/2924 (27) 0.08 Data are presented as number (%) or mean ± SD. PCI indicates percutaneous coronary intervention; and STEMI, ST-segment elevation myocardial infarction. Other abbreviations are same as in Supplemental Table 1.
3 Supplemental Table 3. Baseline Patient Characteristics of the Entire Study Population; Insulin-Treated Versus Non-Insulin-Treated Diabetes Mellitus.
Insulin-Treated DM Non-Insulin-Treated DM Variable P value (n = 676) (n = 2248) Age, years 67.4±9.9 68.9±9.2 <0.001 Age ≥75 years, n (%) 164 (24) 660 (29) 0.01 Male gender, n (%) 480 (71) 1781 (79) <0.001 Body mass index 24.9±4 24.6±3.6 0.053 Hemoglobin A1c, % 7.4±1.4 6.7±1.1 <0.001 Coexisting condition, n (%) Hypertension 570 (84) 2248 (82) 0.19 Dyslipidemia 506 (75) 1791 (80) 0.007 ESRD (eGFR <30 mL/min per 1.73m2) not 36 (5.3) 57 (2.5) <0.001 on hemodialysis Hemodialysis 115 (17) 119 (5.3) <0.0001 Atrial fibrillation 46 (6.8) 144 (6.4) 0.71 Anemia (hemoglobin <11.0 g/dl) 168 (25) 281 (13) <0.001 Chronic obstructive pulmonary disease 11 (1.6) 47 (2.1) 0.45 Malignancy 40 (5.9) 169 (7.5) 0.16 Cardiac risk factor, n (%) Current smoker 120 (18) 446 (20) 0.23 Family history of coronary artery disease 112 (18) 342 (17) 0.35 Previous myocardial infarction 193 (29) 704 (31) 0.17 Previous stroke 86 (13) 278 (12) 0.81 Heart failure 145 (21) 315 (14) <0.001 Peripheral vascular disease 114 (17) 239 (11) <0.001 Previous percutaneous coronary intervention 375 (55) 1192 (53) 0.26 Previous coronary artery bypass grafting 62 (9.2) 117 (5.2) <0.001 Clinical characteristics, n (%) Clinical presentation Stable coronary artery disease 578 (86) 1868 (83) 0.32 Unstable angina 70 (10) 267 (12) Acute myocardial infarction 28 (4.1) 113 (5.0) Left ventricular ejection fraction <30% 17 (2.9) 49 (2.5) 0.57 Multivessel disease 387 (57) 1244 (55) 0.38 Target-vessel location, n (%) Left main coronary artery 26 (3.9) 69 (3.1) 0.32 Left anterior descending coronary artery 313 (46) 1077 (48) 0.46 Left circumflex coronary artery 178 (26) 609 (27) 0.70 Right coronary artery 224 (33) 725 (32) 0.67 Bypass graft 11 (1.6) 15 (0.7) 0.02 Complexity of coronary artery disease Number of treated lesions per patient 1.28±0.56 1.26±0.53 0.38 SYNTAX score Number of patients analyzed 566 1969 Median (interquartile range) 12 (7-17.5) 11 (6.75-17) 0.07 Tertiles, n (%) Low (<23) 487 (86) 1738 (88) 0.13 Intermediate (≥23 to <33) 57 (10) 184 (9.3) High (≥33) 22 (3.9) 47 (2.4) Medications, n (%) Aspirin 671 (99.3) 2242 (99.7) 0.08 Thienopyridines 670 (99.1) 2231 (99.2) 0.73 Clopidogrel 558 (83) 1908 (86) 0.09 Ticlopidine 111 (17) 310 (14) Statins 501 (74) 1735 (77) 0.10 β-blockers 268 (40) 863 (38) 0.56 ACE-I/ARB 456 (67) 1450 (65) 0.17 Calcium-channel blockers 307 (45) 1002 (45) 0.70
4 Nitrates 159 (676) 572 (25) 0.31 Warfarin 59 (8.7) 165 (7.3) 0.23 Pioglitazone 40 (5.9) 364 (16) <0.001 Data are presented as number (%) or mean ± SD, unless otherwise specified. Data are presented as number (%) or mean ± SD. ACE-I indicates angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blockers; DM, diabetes mellitus; ESRD, end-stage renal disease; eGFR, estimated glomerular filtration rate; G1-DES, first-generation drug-eluting stents; G2-DES, second-generation drug- eluting stents; and SYNTAX, Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery.
5 Supplemental Table 4. Lesion and Procedural Characteristics of the Entire Study Population; Insulin-Treated Versus Non-Insulin- Treated Diabetes Mellitus.
Insulin-Treated DM Non-Insulin-treated DM Variable P value (n = 676) (n = 2248) Number of lesions treated 866 2832 Before index procedure Lesion length, mm 18.7±13.3 (757) 18.9±12.6 (2459) 0.69 Reference vessel diameter, mm 2.47±0.59 (788) 2.56±0.6 (2600) <0.001 Minimum lumen diameter, mm 0.77±0.44 (791) 0.77±0.45 (2607) 0.87 Diameter stenosis, % 69.0±15.7 (791) 70.5±15.3 (2607) 0.02 Thrombus 17/791 (0.85) 59/2607 (2.3) 0.85 Chronic total occlusion 60/866 (6.9) 184/2832 (6.5) 0.65 In-stent restenosis 121/866 (14) 326/2832 (12) 0.052 Culprit for STEMI 18/866 (2.1) 73/2832 (2.6) 0.41 Bifurcation 322/808 (40) 1096/2674 (41) 0.56 Moderate or heavy calcification 195/792 (25) 545/2607 (21) 0.03 Small vessel (reference vessel diameter ≤2.75mm) 546/788 (69) 1683/2600 (65) 0.02 Long lesion (lesion length >18mm) 294/757 (39) 1022/2459 (42) 0.18 After index procedure Number of stents used Per patient 1.64±0.87 (674) 1.58±0.81 (2239) 0.12 Per lesion 1.33±0.62 (833) 1.29±0.57 (2731) 0.20 Total stent length, mm Per patient 34.8±21.7 (674) 33.2±20.3 (2238) 0.09 Per lesion 28.2±17 (833) 27.2±16 (2730) 0.16 Stent diameter, mm 2.87±0.51 (846) 2.90±0.56 (2788) 0.16 Multivessel treatment 87/676 (13) 286/2248 (13) 0.92 Direct stenting 150/833 (18) 652/2731 (24) <0.001 Maximum stent inflation pressure, atmosphere 17.4±4.5 (833) 17.2±4.3 (2731) 0.46 Postdilatation 626/846 (74) 2032/2788 (73) 0.52 Bifurcation 2-stent approach 8/511 (1.6) 27/1642 (1.6) 0.90 Intravascular ultrasound use 566/676 (84) 1939/2248 (86) 0.10 Received study stent only 825/866 (95.3) 2693/2832 (95.1) 0.84 Minimum Lumen diameter, mm In-stent 2.38±0.45 (788) 2.45±0.47 (2593) <0.001 In-segment 1.95±0.52 (790) 2.03±0.54 (2597) <0.001 Diameter stenosis, % In-stent 10.6±8.9 (788) 10.2±8.2 (2591) 0.20 In-segment 23.2±11.8 (790) 22.7±12 (2595) 0.28 Acute gain, mm In-stent 1.6±0.51 (787) 1.67±0.51 (2593) <0.001 In-segment 1.17±0.52 (789) 1.25±0.54 (2597) <0.001 Duration of procedure, min 72.1±2.6 (676) 71.6±44.2 (2248) 0.78 Successful outcome Lesion success by any treatment modalities 860/866 (99.3) 2812/2832 (99.3) 0.97 Lesion success by study stents (acute device 827/852 (97.1) 2701/2768 (97.6) 0.40 success) Procedural success (patient level) 654/676 (96.8) 2181/2248 (97.0) 0.72 Staged PCI procedures 172/676 (25) 604/2248 (27) 0.46 Data are presented as number (%) or mean ± SD. PCI indicates percutaneous coronary intervention; and STEMI, ST-segment elevation myocardial infarction. Other abbreviations are same as in Supplemental Table 1.
6 Supplemental Table 5. Baseline Patient Characteristics in Insulin-Treated and Non-Insulin-Treated Diabetes Mellitus: G1-DES Versus G2-DES.
Insulin-Treated DM Non-Insulin-Treated DM G1-DES G2-DES P G1-DES G2-DES P
(N = 163) (N = 513) value (N = 550) (N = 1698) value Age, years 67.6±10 67.3±9.9 0.80 69±9.4 68.9±9.1 0.79 Age ≥75 years, n (%) 37 (23) 127 (25) 0.59 492 (29) 168 (31) 0.48 Male gender, n (%) 114 (70) 366 (71) 0.73 431 (78) 1350 (80) 0.57 Body mass index 24.8±3.7 25±4.1 0.49 24.7±3.7 24.6±3.6 0.47 Hemoglobin A1c, % 7.5±1.3 7.4±1.4 0.48 6.7±1.1 6.7±1.1 0.67 Coexisting condition, n (%) Hypertension 139 (85) 431 (84) 0.70 450 (82) 1396 (82) 0.83 Dyslipidemia 113 (69) 393 (77) 0.06 430 (78) 1361 (80) 0.32 ESRD (eGFR <30 mL/min per 1.73m2) not on 7 (4.3) 29 (5.7) 0.69 15 (2.7) 42 (2.5) 0.76 hemodialysis Hemodialysis 30 (18) 85 (17) 0.59 23 (4.2) 96 (5.7) 0.18 Atrial fibrillation 11 (6.8) 35 (6.8) 0.97 39 (7.1) 105 (6.2) 0.45 Anemia (hemoglobin <11.0 g/dl) 40 (25) 128 (25) 0.91 73 (13) 208 (12) 0.52 Chronic obstructive pulmonary disease 4 (2.5) 7 (1.4) 0.31 8 (1.5) 39 (2.3) 0.30 Malignancy 12 (7.4) 28 (5.5) 0.37 42 (7.6) 127 (7.5) 0.90 Cardiac risk factor, n (%) Current smoker 26 (16) 94 (18) 0.49 108 (20) 338 (20) 0.89 Family history of coronary artery disease 31 (24) 81 (17) 0.07 91 (19) 251 (16) 0.08 Previous myocardial infarction 54 (33) 139 (27) 0.14 196 (36) 508 (30) 0.01 Previous stroke 19 (12) 67 (13) 0.64 62 (11) 216 (13) 0.37 Heart failure 33 (20) 112 (22) 0.67 83 (15) 232 (14) 0.40 Peripheral vascular disease 29 (18) 85 (17) 0.72 44 (8.0) 195 (11) 0.02 Previous percutaneous coronary intervention 94 (58) 281 (55) 0.52 308 (56) 884 (52) 0.11 Previous coronary artery bypass grafting 15 (9.2) 47 (9.2) 0.99 45 (8.2) 72 (4.2) <0.001 Clinical characteristics, n (%) Clinical presentation Stable coronary artery disease 141 (87) 437 (85) 0.91 450 (82) 1418 (84) 0.006 Unstable angina 16 (9.8) 54 (11) 82 (15) 185 (11) Acute myocardial infarction 6 (3.7) 22 (4.3) 18 (3.3) 95 (5.6) Left ventricular ejection fraction <30% 7 (5.0) 10 (2.3) 0.09 15 (3.1) 34 (2.3) 0.34 Multivessel disease 95 (58) 292 (57) 0.76 293 (53) 951 (56) 0.26 Target-vessel location, n (%) Left main coronary artery 4 (2.5) 22 (4.3) 0.36 16 (2.9) 53 (3.1) 0.89 Left anterior descending coronary artery 79 (48) 234 (46) 0.52 264 (48) 813 (48) 0.96 Left circumflex coronary artery 44 (27) 134 (26) 0.83 141 (26) 468 (28) 0.38 Right coronary artery 51 (31) 173 (34) 0.57 171 (31) 554 (33) 0.50 Bypass graft 4 (2.5) 7 (1.4) 0.34 4 (0.7) 11 (0.7) 0.84 Complexity of coronary artery disease No. of treated lesions per patient 1.31±0.56 1.27±0.56 0.50 1.23±0.48 1.27±0.55 0.06 SYNTAX score No. of patients analyzed 130 436 444 1525 Median (interquartile range) 11.5 (7.75-16.5) 7 (7-18) 0.90 10 (6-16) 11 (7-17.25) 0.02 Tertiles, n (%) Low (<23) 117 (90) 370 (85) 0.03 404 (91) 1334 (87) 0.13 Intermediate (≥23 to <33) 13 (10) 44 (10) 32 (7.2) 152 (10) High (≥33) 0 22 (5.1) 8 (1.8) 39 (2.6) Medications, n (%) Aspirin 161 (98.8) 510 (99.4) 0.40 547 (99.5) 1695 (99.8) 0.15 Thienopyridines 161 (98.8) 509 (99.2) 0.60 542 (98.6) 1689 (99.5) 0.03 Clopidogrel 134 (83) 424 (83) 0.94 468 (86) 1440 (86) 0.80 Ticlopidine 27 (17) 84 (17) 74 (14) 236 (14) Statins 117 (72) 384 (75) 0.44 433 (79) 1302 (77) 0.32 β-blockers 59 (36) 209 (41) 0.30 210 (38) 653 (38) 0.91 ACE-I/ARB 111 (68) 345 (67) 0.84 348 (63) 1102 (65) 0.47 7 Calcium-channel blockers 77 (47) 230 (45) 0.59 248 (45) 754 (44) 0.78 Nitrates 50 (31) 109 (21) 0.01 161 (29) 411 (24) 0.02 Warfarin 16 (9.8) 43 (8.4) 0.57 46 (8.4) 119 (7.0) 0.29 Pioglitazone 6 (3.7) 34 (6.6) 0.16 114 (21) 250 (15) <0.001 Data are presented as number (%) or mean ± SD, unless otherwise specified. ACE-I indicates angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blockers; DM, diabetes mellitus; ESRD, end-stage renal disease; eGFR, estimated glomerular filtration rate; G1-DES, first-generation drug-eluting stents; G2-DES, second-generation drug-eluting stents; and SYNTAX, Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery.
8 Supplemental Table 6. Lesion and Procedural Characteristics in Insulin-Treated and Non-Insulin-Treated Diabetes Mellitus: G1- DES Versus G2-DES.
Insulin-Treated DM Non- Insulin-Treated DM P G1-DES G2-DES G1-DES G2-DES P valu (N = 163) (N = 513) (N = 550) (N = 1698) value e Number of lesions treated 213 653 674 2158 Before index procedure 19.2±13.9 16.6±10.5 Lesion length, mm 17±10.9 (178) 0.02 18±11.9 (2888) <0.001 (579) (933) Reference vessel diameter, mm 2.44±0.56 (187) 2.48±0.6 (601) 0.37 2.6±0.65 (985) 2.65±0.59 (3043) 0.04 0.76±0.43 0.81±0.46 Minimum lumen diameter, mm 0.81±0.45 (189) 0.19 0.8±0.45 (3050) 0.41 (602) (986) 69.8±15.3 69.2±16.1 Diameter stenosis, % 66.7±16.8 (189) 0.03 70.3±15.1 (3049) 0.049 (602) (986) Thrombus 15/602 (2.5) 2/189 (1.1) 0.39 102/3050 (3.3) 45/986 (4.6) 0.08 Chronic total occlusion 17/213 (8.0) 43/653 (6.6) 0.49 43/674 (6.4) 141/2158 (6.5) 0.89 In-stent restenosis 26/213 (12) 95/653 (15) 0.39 90/674 (13) 236/2158 (11) 0.09 Culprit for STEMI 3/213 (1.4) 15/653 (2.3) 0.58 9/674 (1.3) 64/2158 (3.0) 0.02 Bifurcation 245/619 (40) 77/189 (41) 0.78 390/986 (40) 1305/3128 (42) 0.23 Moderate or heavy calcification 39/189 (21) 156/603 (26) 0.14 119/608 (20) 426/1999 (21) 0.36 Small vessel (reference vessel diameter ≤2.75mm) 137/187 (73) 409/601 (68) 0.18 622/985 (63) 1818/3043 (60) 0.06 Long lesion (lesion length >18mm) 231/579 (40) 63/178 (35) 0.28 296/933 (32) 1088/2888 (38) 0.001 After index procedure Number of stents used 1.66±0.89 1.49±0.69 Per patient 1.56±0.76 (162) 0.13 1.61±0.84 (1693) 0.002 (512) (546) 1.35±0.65 1.25±0.51 Per lesion 1.24±0.49 (204) 0.006 1.31±0.59 (2078) 0.01 (629) (653) Total stent length, mm 31.8±18.2 Per patient 34.2±20.1 (162) 35±22.2 (512) 0.67 33.7±20.9 (1692) 0.04 (546) 28.5±17.6 26.6±15.4 Per lesion 27.2±14.9 (204) 0.29 27.5±16.2 (2077) 0.20 (629) (653) 2.95±0.37 Stent diameter, mm 2.9±0.37 (204) 2.87±0.55 0.26 2.89±0.61 (2135) <0.001 (653) Multivessel treatment 21/163 (13) 66/513 (13) 0.995 60/550 (11) 226/1698 (13) 0.14 Direct stenting 42/204 (21) 108/629 (17) 0.27 149/653 (23) 503/2078 (24) 0.47 Maximum stent inflation pressure, atmosphere 18.1±4.2 (204) 17.1±4.6 (629) 0.005 18.1±3.8 (653) 17.0±4.4 (2078) <0.001 Postdilatation 151/204 (74) 475/642 (74) 0.99 487/653 (75) 1545/2135 (72) 0.27 Bifurcation 2-stent approach 1/213 (0.5) 7/298 (2.4) 0.15 5/674 (0.7) 22/968 (2.3) 0.02 Intravascular ultrasound use 131/163 (80) 435/513 (85) 0.18 459/550 (83) 1480/1698 (87) 0.03 Received study stent only 201/213 (94) 624/653 (96) 0.48 637/674 (95) 2056/2158 (95) 0.42 Minimum Lumen diameter, mm 2.38±0.45 2.48±0.46 In-stent 2.35±0.48 (188) 0.42 2.52±0.48 (3031) 0.03 (600) (977) 1.95±0.52 2.08±0.54 In-segment 1.95±0.51 (188) 0.96 2.12±0.55 (3037) 0.10 (602) (977) Diameter stenosis, % In-stent 11.2±8.9 (188) 10.5±8.8 (600) 0.34 10.6±8.2 (977) 10±8.1 (3030) 0.049 23.1±12.2 In-segment 23.6±10.6 (188) 0.53 22.6±11.6 (977) 21.3±11.7 (3036) 0.003 (602) Acute gain, mm 1.62±0.48 1.67±0.52 In-stent 1.54±0.59 (188) 0.09 1.72±0.53 (3031) 0.007 (599) (977) 1.27±0.57 In-segment 1.13±0.56 (188) 1.19±0.5 (601) 0.25 1.32±0.56 (3037) 0.02 (977) 71.1±42.7 70.1±44.1 Duration of procedure, min 75.4±42.4 (163) 0.26 72.1±44.3 (1698) 0.34 (513) (550) Successful outcome Lesion success by any treatment modalities 211/213 (99.1) 649/653 (99.4) 0.62 666/674 (98.8) 2146/2158 (99.4) 0.11 Lesion success by study stents (acute device 201/213 (94) 623/639 (98.0) 0.007 640/674 (95) 2061/2094 (98.4) <0.001 success) Procedural success (patient level) 158/163 (96.9) 496/513 (96.7) 0.88 533/550 (96.9) 1648/1698 (97.1) 0.86
9 Staged PCI procedures 40/163 (25) 132/513 (26) 0.76 143/550 (26) 461/1698 (27) 0.60 Data are presented as number (%) or mean ± SD. Stent implantation was not attempted in 17 patients (G1-DES: 9 patients and G2-DES: 8 patients) because of guidewire failure, undilatable lesions, or complications. Non-study stents were attempted without attempt of the study stent in 19 patients (G1-DES: 7 patients and G2-DES: 12 patients; protocol violation). PCI indicates percutaneous coronary intervention; and STEMI, ST-segment elevation myocardial infarction. Other abbreviations are same as in Table 1.
10 Supplemental Table 7. Angiographic Results at 8-month in Patients Enrolled in the Angiographic Substudy: G1-DES versus G2-DES.
Non-DM DM G1-DES G2-DES P G1-DES G2-DES P
145 411 103 285 Number of patients 165 505 120 362 Number of lesions
8-month 280±51 (165) 268±54 (503) 0.01 278±58 (120) 271±57 (361) 0.28 Study interval, days 2.7±0.43 (165) 2.66±0.5 (503) 0.25 2.66±0.24 (118) 2.59±0.53 (360) 0.24 Reference vessel diameter, mm
Minimum lumen diameter, mm 2.39±0.44 (165) 2.36±0.5 (502) 0.43 2.26±0.57 (118) 2.27±0.55 (360) 0.92 In-stent 2.08±0.46 (165) 2.04±0.54 (503) 0.31 1.97±0.56 (118) 1.94±0.57 (361) 0.57 In-segment
Percent diameter stenosis, % 13.6±10.6 (165) 14±12 (502) 0.63 17.1±16.1 (118) 14.9±13.8 (360) 0.19 In-stent 23±11.8 (165) 23.3±14.4 (503) 0.80 25.4±16.8 (118) 25.3±16.9 (361) 0.95 In-segment
Late loss, mm 0.11±0.33 (165) 0.14±0.35 (501) 0.37 0.17±0.45 (118) 0.18±0.38 (360) 0.81 In-stent 0.04±0.5 (118) 0.06±0.44 (503) 0.27 0.04±0.5 (118) 0.06±0.44 (361) 0.80 In-segment Data are presented as number (%) or mean ± SD, unless otherwise specified. DM indicates diabetes mellitus; G1-DES, first-generation drug-eluting stents; and G2-DES, second-generation drug-eluting stents.
11 Supplementary Figure legend
Supplemantary Figure 1. Cumulative 3-year incidences of TLR in the non-DM and DM strata and in the ITDM and non-ITDM patients: SES versus EES versus BES.
BES, biolimus-eluting stent; DM, diabetes mellitus; EES, everolimus-eluting stent; PCI, percutaneous coronary intervention; SES, sirolimus-eluting stent: and TLR, target-lesion revascularization.
12 Supplementary Figure 1(A)
13 Supplementary Figure 1(B)
14 Supplementary Figure 1(C)
15 Supplementary Figure 1(D)
16 Supplemental Appendix
Supplemental Appendix A. List of the participating centers and the investigators of RESET trial
Caress Sappro Tokeidai Memorial Hospital: Kazushi Urasawa, Ryoji Koshida
Teine Keijinkai Hospital: Mitsugu Hirokami
Cardio-vascular Center Hokkaido Ohno Hospital: Takehiro Yamashita, Masato Nagashima
Caress Sappro Hokko Memorial Hospital: Yoichi Nozaki
Hokkaido Social Insurance Hospital: Keiichi Igarashi, Jungo Furuya
Aomori Prefectural Central Hospital: Fuminobu Yoshimachi, Yukinori Sakamoto
Iwate Prefectural Central Hospital: Akihiro Nakamura, Shigefumi Fukui
Iwate Medical University Hospital: Tomonori Itoh
Sendai Kosuei Hospital: Naoto Inoue, Kaname Takizawa
Tohoku Kousei Nenkin Hospital: Yoshiaki Katahira, Takao Nakano
Sendai Open Hospital: Atsushi Kato
Iwaki Kyoritsu General Hospital: Yoshito Yamamoto, Tomohiro Tada
Fukushima Medical University Hospital: Yasuchika Takeishi, Kazuhiko Nakazato
Hoshi General Hospital: Mikihiro Kijima, Yuichi Ujiie
Ohta Nishinouchi Hospital: Nobuo Komatsu, Goro Ishida
Saiseikai Kurihashi Hospital: Yoshimi Ota, Atsushi Honda
Saitama Cardiovascular And Respiratory Center: Makoto Muto, Tetsuya Ishikawa
Dokkyo Medical University Koshigaya Hospital: Takaaki Komatsu
Jikei University Kashiwa Hospital: Mitsuyuki Shimizu, Yoshiki Uehara
Juntendo University Hospital: Hiroyuki Daida, Katsumi Miyauchi
Sakakibara Memorial Hospital: Tetsuya Sumiyoshi, Ryuta Asano
NTT Medical Center Tokyo: Masao Yamasaki
The Cardiovascular Institute Hospital: Junji Yajima, Ryuichi Funada
Mitsui Memorial Hospital: Kengo Tanabe, Masanori Taniwaki
Tokyo Medical University Hospital: Nobuhiro Tanaka, Masashi Ogawa
Teikyo University Hospital: Akiyoshi Miyazawa, Ken Kozuma, Nobuaki Suzuki
Tokyo Women's Medical University Hospital: Nobuhisa Hagiwara, Fumiaki Mori
The Jikei University Hospital: Takayuki Ogawa, Kazuo Ogawa
Juntendo University Nerima Hospital: Masataka Sumiyoshi, Shinya Okazaki
Tokyo Metropolitan Hiroo General Hospital: Tamotsu Tejima, Yasuhiro Tanabe
St. Luke's International Hospital: Yutaro Nishi
Itabashi Chuo General Hospital: Hiroshi Ohta
Saiseikai Yokohama-city Eastern Hospital: Toshiya Muramatsu, Hiroshi Ishimori
Yokohama Rosai Hospital: Kenichi Kato, Kazuhiko Yumoto
17 Tokai University Hospital: Yoshihiro Morino
Yokohama City University Medical Center: Kazuo Kimura, Kiyoshi Hibi
Kitasato University Hospital: Taiki Tojo, Takao Shimohama
Kanazawa Cardiovascular Hospital: Masanobu Namura, Yuki Horita
University of Fukui Hospital: Jong-Dae Lee, Akira Nakano
Fukui Cardio Vascular Center: Sumio Mizuno, Katsushi Misawa
Juntendo University Shizuoka Hospital: Satoru Suwa
Shizuoka City Shizuoka Hospital: Tomoya Onodera, Ryosuke Takeuchi
Shizuoka General Hospital: Osamu Doi, Satoshi Kaburagi
Okamura Memorial Hospital: Yasuhiro Tarutani
Seirei Hamamatsu General Hospital: Hisayuki Okada
Hamamatsu Medical Center: Masakazu Kobayashi, Yohei Takayama
Toyohashi Heart Center: Takahiko Suzuki, Masashi Kimura
Aichi Medical University Hospital: Takayuki Ito, Hiroaki Takashima
Tosei General Hospital: Hiroshi Asano
Nagoya Daini Red Cross Hospital: Haruo Hirayama, Mamoru Nanasato, Yasushi Tatematsu
Toyota Memorial Hospital: Hisashi Umeda
Nagoya Kyoritsu Hospital: Toru Aoyama
Fujita Health University Hospital: Yukio Ozaki, Hiroyuki Naruse
Matsusaka Chuo General Hospital: Masatoshi Miyahara
Nagai Hospital: Kozo Hoshino
Mie University Hospital: Takashi Tanigawa
Mie Heart Center: Hideo Nishikawa, Hiroyuki Suzuki
Yokkaichi Social Insurance Hospital: Masaki Kawamura
Koto Memorial Hospital: Teruki Takeda
Shiga University of Medical Science Hospital: Takashi Yamamoto
Kyoto University Hospital: Takeshi Kimura, Hiroki Shiomi
Mitsubishi Kyoto Hospital: Shinji Miki, Tetsu Mizoguchi
National Hospital Organization Kyoto Medical Center: Mitsuru Abe
Kyoto Second Red Cross Hospital: Hiroshi Fujita
Sakurabashi Watanabe Hospital: Kenji Fujii
Osaka City General Hospital: Akira Itoh, Kazuhiro Osawa
Osaka Saiseikai Noe Hospital: Shunsuke Take, Shiho Koyama
Osaka City University Hospital: Minoru Yoshiyama, Satoshi Nishimura
Osaka Red Cross Hospital: Tsukasa Inada, Fujio Hayashi
National Cerebral and Cardiovascular Center: Hiroshi Nonogi, Eiji Tada
18 Sumitomo Hospital: Yuji Yasuga, Nobuhiro Mitsusada
Higashisumiyoshi Morimoto Hospital: Yuji Sakanoue
Kansai Denryoku Hospital: Katsuhisa Ishii, Kazuaki Kataoka
Kobe City Medical Center General Hospital: Makoto Kinoshita
Kobe University Hospital: Junya Shite, Hirotoshi Hariki
Kansai Rosai Hospital: Masaaki Uematsu, Masaki Awata
Hyogo Prefectural Amagasaki Hospital: Yoshiki Takatsu, Ryoji Taniguchi
Hyogo College of Medicine Hospital: Motomaru Masutani
Tenri Hospital: Yoshihisa Nakagawa, Hirokazu Kondo
Nara Medical University Hospital: Shiro Uemura, Kenichi Ishigami
Japanese Red Cross Society Wakayama Medical Center: Takashi Tamura, Hiroki Sakamoto
Wakayama Medical University Hospital: Takashi Akasaka, Hironori Kitabata
Tottori University Hospital: Masahiko Kato, Yoshiyuki Furuse
Matsue Red Cross Hospital: Kinya Shirota, Asao Mimura
The Sakakibara Heart Institute of Okayama: Keizou Yamamoto, Hiroyuki Takinami
Kurashiki Central Hospital: Kazushige Kadota, Hiroyuki Tanaka
Kawasaki Medical School Hospital: Hiroyuki Okura, Yoji Neishi
Okayama University Hospital: Hiroshi Ito, Yoshiki Hata
Hiroshima City Hospital: Masaharu Ishihara, Kazuoki Dai
Fukuyama Cardiovascular Hospital: Seiichi Haruta, Hideo Takebayashi
Tsuchiya General Hospital: Mamoru Toyofuku
Chikamori Hospital: Kazuya Kawai, Shuichi Seki
University Of Occupational And Environmental Health Japan: Shinjo Sonoda, Yoshitaka Muraoka
Kurume University Hospital: Takafumi Ueno, Seiji Kanaya
Kokura Memorial Hospital: Masashi Iwabuchi, Shinichi Shirai
Kouseikai Hospital: Yoshihiro Iwasaki
Saiseikai Kumamoto Hospital: Koichi Nakao
Kumamoto Rousai Hospital: Toshiyuki Matsumura, Sei Nakata
Miyazaki Medical Association Hospital: Yoshisato Shibata, Nehiro Kuriyama
Kagoshima Medical Center: Hitoshi Nakashima, Yasuhisa Iriki
19 Supplemental Appendix B. List of the participating centers and the investigators of NEXT trial
Caress Sapporo Tokeidai Memorial Hospital: Kazushi Urasawa, Ryoji Koshida
Oji General Hospital: Katsuhisa Ishii, Nobuo Kato
Hokkaido Junkanki Hospital: Daisuke Hotta, Masaru Yamaki
Teine Keijinkai Hospital: Mitsugu Hirokami
Cardio-vascular Center Hokkaido Ohno Hospital: Takehiro Yamashita, Masato Nagashima
Caress Sapporo Hokko Memorial Hospital: Yoichi Nozaki
Hokkaido Social Insurance Hospital: Keiichi Igarashi, Jungo Furuya
Aomori Prefectural Central Hospital: Fuminobu Yoshimachi, Dai Miura, Yoshihisa Aida, Yukinori Sakamoto
Iwate Prefectural Central Hospital: Akihiro Nakamura, Shigefumi Fukui
Iwate Medical University Hospital: Tetsuya Fusazaki
Tohoku Kousei Nenkin Hospital: Yoshiaki Katahira, Takao Nakano
Sendai Open Hospital: Atsushi Kato, Toru Takii
Iwaki Kyoritsu General Hospital: Yoshito Yamamoto, Tomohiro Tada
Fukushima Medical University Hospital: Yasuchika Takeishi, Kazuhiko Nakazato
Saiseikai Kurihashi Hospital: Yoshimi Ota, Atsushi Honda
Saitama Cardiovascular and Respiratory Center: Tetsuya Ishikawa, Takuro Fujii
Dokkyo Medical University Koshigaya Hospital: Takaaki Komatsu
New Tokyo Hospital: Sunao Nakamura, Naoyuki Kurita
Juntendo University Hospital: Hiroyuki Daida, Katsumi Miyauchi
Sakakibara Memorial Hospital: Itaru Takamisawa
NTT Medical Center Tokyo: Masao Yamasaki
The Cardiovascular Institute Hospital: Junji Yajima, Shingo Tanaka, Ryuichi Funada
Mitsui Memorial Hospital: Kengo Tanabe, Yoshifumi Nakajima
Tokyo Medical University Hospital: Nobuhiro Tanaka, Masashi Ogawa
Teikyo University Hospital: Ken Kozuma, Nobuaki Suzuki
Tokyo Women's Medical University Hospital: Nobuhisa Hagiwara, Fumiaki Mori
Juntendo University Nerima Hospital: Masataka Sumiyoshi, Kenji Inoue, Shinya Okazaki
Itabashi Chuo Medical Center: Hiroshi Ohta
Saiseikai Yokohama-City Eastern Hospital: Toshiya Muramatsu, Hiroshi Ishimori
Kanto Rosai Hospital: Atsuo Namiki
Yokohama Rosai Hospital: Kenichi Kato, Kazuhiko Yumoto
Tokai University Hospital: Nobuhiko Ogata, Shou Torii
Yokohama City University Medical Center: Kazuo Kimura, Kiyoshi Hibi
Kitasato University Hospital: Taiki Tojo, Takao Shimohama
Kanazawa Cardiovascular Hospital: Masanobu Namura, Yuki Horita
20 University of Fukui Hospital: Jong-Dae Lee, Hiroyasu Uzui, Akira Nakano
Fukui Cardiovascular Center: Sumio Mizuno, Katsushi Misawa
Ogaki Municipal Hospital: Hiroaki Mukawa, Yohei Shibata
Juntendo University Shizuoka Hospital: Satoru Suwa
Shizuoka General Hospital: Osamu Doi, Hideaki Moriwaki
Okamura Memorial Hospital: Yasuhiro Tarutani
Seirei Hamamatsu General Hospital: Hisayuki Okada
Hamamatsu Medical Center: Masakazu Kobayashi, Terumori Sato, Yohei Takayama
Aichi Medical University Hospital: Hiroaki Takashima, Takayuki Ito
Tosei General Hospital: Masayoshi Ajioka, Yosuke Murase
Toyota Memorial Hospital: Hisashi Umeda, Kazutaka Hayashi
Fujita Health University Hospital: Yukio Ozaki, Hiroyuki Naruse
Japanese Red Cross Nagoya Daini Hospital: Haruo Hirayama, Yasushi Tatematsu
Chubu Rosai Hospital: Tetsuya Amano, Tomohiro Yoshida
Nagai Hospital: Kozo Hoshino
Mie University Hospital: Takashi Tanigawa
Mie Heart Center: Hideo Nishikawa, Hiroyuki Suzuki
Yokkaichi Social Insurance Hospital: Masaki Kawamura, Takashi Yamanaka
Koto Memorial Hospital: Teruki Takeda
Shiga University of Medical Science Hospital: Takashi Yamamoto
Kyoto University Hospital: Takeshi Kimura, Masahiro Natsuaki
Mitsubishi Kyoto Hospital: Shinji Miki, Tetsu Mizoguchi
National Hospital Organization Kyoto Medical Center: Masaharu Akao, Mitsuru Abe
Kyoto Second Red Cross Hospital: Hiroshi Fujita
Osaka University Hospital: Shinsuke Nanto, Masahiro Kumada
Sakurabashi Watanabe Hospital: Kenji Fujii
Osaka City General Hospital: Akira Itoh
Osaka Saiseikai Noe Hospital: Shunsuke Take, Yoshihiro Kato, Shiho Koyama
Osaka City University Hospital: Takao Hasegawa, Tomokazu Iguchi
Osaka Red Cross Hospital: Tsukasa Inada, Fujio Hayashi
National Cerebral and Cardiovascular Center: Hiroki Sakamoto
Sumitomo Hospital: Yuji Yasuga, Nobuhiro Mitsusada
Higashisumiyoshi Morimoto Hospital: Yuji Sakanoue
Kobe City Medical Center General Hospital: Natsuhiko Ehara
Kobe University Hospital: Toshihiro Shinke, Takumi Inoue, Junya Shite
Kansai Rosai Hospital: Masaki Awata
21 Hyogo Prefectural Amagasaki Hospital: Yoshiki Takatsu, Ryoji Taniguchi
Hyogo College of Medicine Hospital: Motomaru Masutani
Tenri Hospital: Yoshihisa Nakagawa, Toshihiro Tamura
Japanese Red Cross Society Wakayama Medical Center: Takashi Tamura, Yuichi Kawase
Wakayama Medical University Hospital: Takashi Akasaka, Yasushi Ino, Hironori Kitabata
Tottori University Hospital: Masahiko Kato, Yoshiyuki Furuse
Matsue Red Cross Hospital: Kinya Shirota
The Sakakibara Heart Institute of Okayama: Atsushi Hirohata, Eiki Hirose
Kurashiki Central Hospital: Kazushige Kadota, Seiji Habara
Kawasaki Medical School Hospital: Hiroyuki Okura, Yoji Neishi
Hiroshima City Hospital: Masaharu Ishihara, Yasuharu Nakama
Fukuyama Cardiovascular Hospital: Hideo Takebayashi, Kenji Goto
Tsuchiya General Hospital: Nobuo Shiode, Masaya Otsuka, Mamoru Toyofuku
Iwakuni Clinical Center: Satoru Sakuragi
Chikamori Hospital: Kazuya Kawai, Shuichi Seki
University of Occupational and Environmental Health Japan: Shinjo Sonoda
Fukuoka Wajiro Hospital: Taro Saito, Yoritaka Otsuka
Kurume University Hospital: Takafumi Ueno, Yoshiaki Mitsutake
Kokura Memorial Hospital: Masashi Iwabuchi, Shinichi Shirai
Kouseikai Hospital: Yoshihiro Iwasaki
Saiseikai Kumamoto Hospital: Koichi Nakao, Shinzo Miyamoto
National Hospital Organization Kumamoto Medical Center: Kazuteru Fujimoto
Kumamoto Rousai Hospital: Toshiyuki Matsumura, Takuo Tsurugi
Miyazaki Medical Association Hospital: Yoshisato Shibata, Nehiro Kuriyama
Tenyokai Central Hospital: Hiroshi Yamaguchi, Junichiro Takaoka
National Hospital Organization Kagoshima Medical Center: Hitoshi Nakashima, Tetsuro Kataoka
Bell Land General Hospital: Toru Kataoka
Sponsor: Abbott Vascular and Terumo.
22