Table 2.
Angiographic and Procedural Characteristics
| Patients, No | Patients With DM | Patients Without DM | Interaction P Value | ||||||
|---|---|---|---|---|---|---|---|---|---|
| All | BP‐SES | DP‐EES | P Value | All | BP‐SES | DP‐EES | P Value | ||
| N=486 | n=257 | n=229 | N=1633 | n=806 | n=827 | ||||
| Lesions, No. | 727 | 396 | 331 | 2412 | 1198 | 1214 | |||
| Target vessel location per lesion, No. (%) | 0.68 | 0.38 | 0.45 | ||||||
| Left main coronary artery | 19 (2.6) | 10 (2.5) | 9 (2.7) | 37 (1.5) | 19 (1.6) | 18 (1.5) | |||
| Left anterior descending artery | 274 (37.7) | 141 (35.6) | 133 (40.2) | 1054 (43.7) | 508 (42.4) | 546 (45.0) | |||
| Left circumflex artery | 162 (22.3) | 96 (24.2) | 66 (19.9) | 549 (22.8) | 274 (22.9) | 275 (22.7) | |||
| Right coronary artery | 236 (32.5) | 127 (32.1) | 109 (32.9) | 721 (29.9) | 378 (31.6) | 343 (28.3) | |||
| Bypass graft | |||||||||
| Saphenous vein graft | 31 (4.3) | 19 (4.8) | 12 (3.6) | 0.44 | 47 (1.9) | 19 (1.6) | 28 (2.3) | 0.20 | <0.001 |
| Arterial graft | 5 (0.7) | 3 (0.8) | 2 (0.6) | 0.80 | 4 (0.2) | 0 (0.0) | 4 (0.3) | 0.12 | 0.53 |
| No. of treated lesions per patient¶ | 1.50±0.74 | 1.54±0.78 | 1.45±0.69 | 0.39 | 1.48±0.77 | 1.49±0.79 | 1.47±0.74 | 0.76 | 0.53 |
| No. of treated lesions per patient, No. (%) | 0.68 | 0.68 | 0.46 | ||||||
| 1 | 305 (62.8) | 155 (60.3) | 150 (65.5) | 1066 (65.3) | 528 (65.5) | 538 (65.1) | |||
| 2 | 132 (27.2) | 73 (28.4) | 59 (25.8) | 401 (24.6) | 193 (23.9) | 208 (25.2) | |||
| 3 | 39 (8.0) | 22 (8.6) | 17 (7.4) | 131 (8.0) | 62 (7.7) | 69 (8.3) | |||
| ≥4 | 10 (2.1) | 7 (2.7) | 3 (1.3) | 35 (2.1) | 23 (2.9) | 12 (1.5) | |||
| Type of intervention per lesion, No. (%)** | 0.07 | 0.71 | 0.84 | ||||||
| PCI | 699 (96.1) | 376 (94.9) | 323 (97.6) | 2301 (95.4) | 114 (95.2) | 1160 (95.6) | |||
| Balloon angioplasty | 28 (3.9) | 20 (5.1) | 8 (2.4) | 101 (4.2) | 49 (4.1) | 52 (4.3) | |||
| CABG | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (0.1) | 2 (0.2) | 1 (0.1) | |||
| Failed PCI | 0 (0.0) | 0 (0.0) | 0 (0.0) | 7 (0.3) | 6 (0.5) | 1 (0.1) | |||
| Baseline TIMI flow per lesion, No. (%) | 0.08 | 0.32 | <0.001 | ||||||
| 0 or 1 | 107 (15.0) | 54 (13.8) | 53 (16.4) | 496 (20.9) | 258 (22.1) | 238 (19.8) | |||
| 2 | 94 (13.1) | 43 (11.0) | 51 (15.7) | 352 (14.9) | 177 (15.1) | 175 (14.6) | |||
| 3 | 514 (71.9) | 294 (75.2) | 220 (67.9) | 1520 (64.2) | 734 (62.8) | 786 (65.6) | |||
| TIMI flow postintervention per lesion, No. (%) | 0.56 | 0.58 | 0.60 | ||||||
| 0 or 1 | 3 (0.4) | 1 (0.3) | 2 (0.6) | 7 (0.3) | 3 (0.3) | 4 (0.3) | |||
| 2 | 4 (0.6) | 3 (0.8) | 1 (0.3) | 29 (1.2) | 17 (1.4) | 12 (1.0) | |||
| 3 | 715 (99.0) | 388 (99.0) | 327 (99.1) | 2357 (98.5) | 1163 (98.3) | 1194 (98.7) | |||
| Restenotic lesion per lesion, No. (%) | 55 (7.6) | 35 (8.8) | 20 (6.0) | 0.16 | 125 (5.2) | 71 (5.9) | 54 (4.5) | 0.10 | 0.06 |
| Total occlusion per lesion, No. (%) | 98 (13.5) | 60 (15.2) | 38 (11.5) | 0.15 | 433 (18.0) | 218 (18.2) | 215 (17.8) | 0.79 | 0.19 |
| Thrombus aspiration per lesion, No. (%) | 24 (3.3) | 14 (3.5) | 10 (3.0) | 0.70 | 247 (10.3) | 132 (11.0) | 115 (9.5) | 0.21 | <0.001 |
| Thrombus aspiration (only STEMI) per lesion, No. (%) | 18 (22.2)* | 11 (26.8)# | 7 (17.5)¶¶ | 0.32 | 190 (40.1)‖‖‖ | 105 (42.2)§§§§ | 85 (37.8)***** | 0.33 | 0.07 |
| No. of stents per lesion, mean (SD) | 1.30±0.61 | 1.32±0.64 | 1.28±0.57 | 0.71 | 1.33±0.63 | 1.30±0.60 | 1.36±0.66 | 0.28 | 0.86 |
| Total stent length per lesion, mm | 26.61±16.44 | 26.65±17.22 | 26.56±15.51 | 0.87 | 26.69±16.01 | 25.67±14.75 | 27.70±17.11 | <0.001 | 0.27 |
| Maximum stent diameter per lesion, mm | 3.02±0.50 | 3.03±0.48 | 3.01±0.53 | 0.52 | 3.05±0.49 | 3.05±0.49 | 3.04±0.48 | 0.34 | 0.32 |
| Left main coronary artery | 3.51±0.44† | 3.50±0.47** | 3.53±0.44## ** | 0.89 | 3.67±0.38¶¶¶ | 3.59±0.42† | 3.76±0.31††††† | 0.58 | 0.51 |
| Left anterior descending artery | 2.93±0.45‡ | 2.96±0.44†† | 2.89±0.46*** | 0.21 | 2.97±0.42### | 3.00±0.44‖‖‖‖ | 2.94±0.41‡‡‡‡‡ | 0.020 | 0.86 |
| Left circumflex artery | 2.80±0.41§ | 2.80±0.40‡‡ | 2.80±0.43††† | 0.98 | 2.85±0.44**** | 2.84±0.45¶¶¶¶ | 2.86±0.43§§§§§ | 0.67 | 0.85 |
| Right coronary artery | 3.21±0.50‖ | 3.22±0.46§§ | 3.21±0.55‡‡‡ | 0.75 | 3.25±0.50†††† | 3.24±0.50#### | 3.26±0.50‖‖‖‖‖ | 0.63 | 0.60 |
| Bypass graft | 3.13±0.57¶ | 3.10±0.53‖‖ | 3.18±0.65§§§ | 0.81 | 3.35±0.53‡‡‡‡ | 3.22±0.55† | 3.44±0.52¶¶¶¶¶ | 0.21 | 0.55 |
| Maximum pressure per lesion, atm. | 14.00±3.46 | 13.92±3.61 | 14.11±3.29 | 0.55 | 13.69±3.41 | 13.71±3.46 | 13.66±3.35 | 0.69 | 0.26 |
| Overlapping stents per lesion, No. (%) | 145 (20.7) | 81 (21.5) | 64 (19.8) | 0.57 | 521 (22.6) | 234 (20.5) | 287 (24.7) | 0.02 | 0.60 |
| Direct stenting per lesion, No. (%) | 184 (26.3) | 90 (23.9) | 94 (29.1) | 0.18 | 683 (29.7) | 338 (29.6) | 345 (29.7) | 0.72 | 0.05 |
| Bifurcation treatment per lesion, No. (%) | 105 (14.5) | 46 (11.6) | 59 (17.8) | 0.04 | 417 (17.4) | 216 (18.2) | 201 (16.6) | 0.31 | 0.004 |
| Type of stent per lesionⱡ, No. (%) | 0.58 | 0.41 | 0.97 | ||||||
| Study stent BP‐SES | 372 (53.2) | 369 (98.1) | 3 (0.9) | 1138 (49.5) | 1132 (99.2) | 6 (0.5) | |||
| Study stent DP‐EES | 327 (46.8) | 7 (1.9) | 320 (99.1) | 1160 (50.4) | 6 (0.5) | 1154 (99.5) | |||
| Other drug‐eluting stent | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (0.1) | 2 (0.2) | 0 (0.0) | |||
| Bare‐metal stent | 1 (0.1) | 0 (0.0) | 1 (0.3) | 4 (0.2) | 3 (0.3) | 1 (0.1) | |||
| IABP per patient, No. (%) | 2 (0.4) | 1 (0.4) | 1 (0.4) | 0.93 | 3 (0.2) | 2 (0.2) | 1 (0.1) | 0.56 | NA |
| Vasopressors per patient, No. (%) | 4 (0.8) | 3 (1.2) | 1 (0.4) | 0.39 | 8 (0.5) | 6 (0.7) | 2 (0.2) | 0.17 | 0.92 |
Data are expressed as number (percentage) or mean±SD. P values from ¶Poisson regression and ǂchi‐square test for per‐patient analyses, otherwise P values from mixed models for the per‐lesion analyses, accounting for lesions nested within patients. General linear mixed models for continuous variables and generalized linear mixed models for counts numbers. ⱡ Two patients randomized to biodegradable polymer sirolimus‐eluting stents (BP‐SES) with both BP‐SES and another drug‐eluting stent within the same lesion; 1 patient randomized to durable polymer everolimus‐eluting stents (DP‐EES) with DP‐EES and BP‐SES within the same lesion; 1 patient randomized to DP‐EES with DP‐EES and bare‐metal stents within the same lesion. P value for any nonrandomized stent implanted per patient. CABG indicates coronary artery bypass grafting; DM, diabetes mellitus; IABP, intra‐aortic balloon pump; NA, not applicable; PCI, percutaneous coronary intervention; STEMI, ST‐segment–elevation myocardial infarction; TIMI, Thrombolysis in Myocardial Infarction. *N=81; †N=19; ‡N=262; §N=156; ‖N=228; ¶N=34; #N=396; **N=10; ††N=133; ‡‡N=90; §§N=123; ‖‖N=20; ¶¶N=40; ##N=9; ***N=129; †††N=66; ‡‡‡N=105; §§§N=14; ‖‖‖N=474; N=36; ###N=1002; ****N=521; ††††N=692; ‡‡‡‡N=50; §§§§N=249; ‖‖‖‖N=483; ¶¶¶¶N=259; ####N=361; *****N=225; †††††N=17; ‡‡‡‡‡N=519; §§§§§N=262; ‖‖‖‖‖N=331; ¶¶¶¶¶N=31.