Table 2.
Summary of the patient characteristics of studies investigating the use of DCBs alone in de novo coronary artery disease
| Author | Number of patients | Mean vessel diameter (mm) | Bail out (%) | Mean age | Male N (%) | Diabetes N (%) | Smokers N (%) | HTN N (%) | Dyslip. N (%) |
|---|---|---|---|---|---|---|---|---|---|
| General de novo lesions—randomised studies | |||||||||
| Cortese et al. (2010) [15] | 60 (29 DCB, 31 DES) | 2.54 (DCB), 2.58 (DES) | 36% | 67 | 44 (73%) | 24 (42%) | NR | 41 (72%) | 30 (53%) |
| Latib et al. (2012, 2015) [19, 20] | 182 (90 DCB, 92 DES) | 2.15 (DCB), 2.25 (DES) | 20% | 65 | 143 (79%) | 74 (41%) | 25 (14%) | 147 (81%) | 144 (79%) |
| Nishiyama et al. (2016) [23] | 60 (DCB 27, DES 33) | 2.88 (DCB), 2.72 (DES) | 0%* | 69 | 44 (73%) | 25 (42%) | 36 (60%) | 50 (83%) | 47 (78%) |
| Funatsu et al. (2017) [28] | 133 (DCB 92, POBA 41) | 2.04 (DCB), 1.99 (POBA) | 3% | 68 | 100 (75%) | 57 (43%) | NR | 107 (80%) | 104 (78%) |
| General de novo lesions—comparative observational studies | |||||||||
| Her et al. (2016) [29] | 72 (DCB 49, POBA 23) | 2.3 (DCB), 2.1 (POBA) | 0%* | 63 | 49 (68%) | 25 (35%) | 21 (29%) | 45 (63%) | 43 (60%) |
| Shin et al. (2016) [24] | 66 (DCB 44, BMS/DES 22) | 2.69 (DCB), 2.92 (DES/BMS) | 0%* | 60 | 50 (76%) | 18 (27%) | 25 (38%) | 32 (48%) | 27 (41%) |
| Sinaga et al. (2016) [25] | 335 (172 DCB, 163 DES) | 2.22 (DCB) vs. 2.44 (DES) | 0%* | 57 | 249 (74%) | 168 (50%) | 125 (37%) | 238 (71%) | 238 (71%) |
| Giannini et al. (2017) [22] | 181 (90 DCB, 91 DES) | 2.15 (DCB), DES NR (100% < 2.8) | 20% | 66 | 143 (79%) | 76 (42%) | 69 (38%) | 146 (81%) | 142 (78%) |
| Her et al. (2017) [27] | 104 (DCB 52, DES 52) | 2.3 (DCB), 2.2 (DES) | 0%* | 60 | 34 (33%) | 44 (42%) | 37 (36%) | 60 (58%) | 47 (45%) |
| Venetsanos et al. (2018) [26] | 1648 (DCB 824, 824 DES) | NR (82% < 2.5) | 8% | 68 | 1724 (72%) | 698 (29%) | NR | 1588 (66%) | 1413 (59%) |
| General de novo lesions—observational studies | |||||||||
| Unverdorben et al. (2010, 2013) [17, 18] | 118 | 2.35 | 27% | 68 | 85 (72%) | 51 (43%) | NR | 103 (87%) | 95 (80%) |
| Cuculi et al. (2012) [44] | 79 | 2.8 | 5% | 69 | 63 (80%) | 19 (24%) | 17 (21%) | 56 (71%) | 53 (67%) |
| Woehrle et al. (2012) [35] | 491 | 2.56 | 21% | NR | 379 (77%) | 166 (34%) | 192 (39%) | 408 (83%) | 348 (71%) |
| Calé et al. (2013) [40] | 74 de novo (156 total) | NR (86% < 2.8) | 3% | 66 | 114 (73%) | 68 (44%) | 78 (50%) | 129 (83%) | 120 (77%) |
| Waksman et al. (2013) [47] | 103 | 2.4 | 12% | 63 | 82 (80%) | 29 (28%) | 37 (36%) | 86 (84%) | 61 (60%) |
| Basavarajah et al. (2014) [45] | 79 de novo (184 total) | NR (70% < 2.5) | 22% | 66 | 160 (87%) | 64 (35%) | 99 (54%) | 132 (72%) | 130 (71%) |
| Toelg et al. (2014) [49] | 105 | 2.5 | 23% | 65 | 74 (71%) | 38 (36%) | 71 (68%) | 81 (77%) | 70 (67%) |
| Zeymer et al. (2014) [36] | 447 | 2.14 | 6% | 66 | 324 (73%) | 164 (37%) | 169 (38%) | 360 (80%) | 308 (69%) |
| Kleber et al. (2015) [30] | 56 | 2.58 | 0%* | 67 | 46 (82%) | 19 (34%) | 37 (66%) | 49 (88%) | 46 (82%) |
| Vaquerizo et al. (2015) [48] | 104 | 1.95 | 7% | 65 | 78 (75%) | 45 (43%) | 34 (33%) | 74 (71%) | 68 (65%) |
| Cortese et al. (2015) [31] | 156 | 2.83 | 3% | 61 | 106 (68%) | 55 (35%) | NR | 91 (58%) | 95 (61%) |
| Ann et al., FFR and OCT (2016) [33] | 20 | 2.68 | 0%* | 59 | 13 (65%) | 4 (20%) | 7 (35%) | 11 (55%) | 9 (45%) |
| Ann et al., FFR and IVUS (2016) [32] | 27 | 2.53 | 0%* | 59 | 18 (64%) | 7 (25%) | 9 (32%) | 15 (54%) | 13 (46%) |
| Benezet et al. (2016) [41] | 53 | 2.4 | 25% | 66 | 35 (63%) | 28 (50%) | 24 (43%) | 41 (73%) | 30 (54%) |
| Uhlemann et al. (2016) [42] | 76 | NR (100% < 2.5) | 4% | 70 | 60 (79%) | 33 (45%) | 15 (20%) | 73 (96%) | 55 (72%) |
| Hee et al. (2017) [43] | 65 | NR | 10% | 66 | 56 (86%) | 24 (37%) | 30 (46%) | NR | NR |
| Poerner et al. (2017) [34] | 46 | 2.32 | 6% | 67 | 29 (63%) | 18 (39%) | 17 (37%) | 40 (87%) | 14 (30%) |
| Zivelonghi et al. (2017) [46] | 35 de novo (143 total) | 2.28 | 12% | 67 | 120 (84%) | 56 (39%) | 29 (20%) | 120 (84%) | 118 (83%) |
| Cortese et al. DCB-RISE (2018) [50] | 238 de novo (544 total) | 2.84 | 12% | 67 | 388 (71%) | 177 (32%) | 217 (40%) | 413 (76%) | NR |
| Primary PCI (de novo lesions) | |||||||||
| Gobic et al. (2017) [51] | 75 (DCB 38, DES 37) | 2.6 (DCB), 3.04 (DES) | 0%* | 55 | 54 (72%) | 6 (8%) | 37 (49%) | 19 (25%) | 11 (14%) |
| Nijhoff et al. (2015) [52] | 190 (DCB 40, BMS 51, DCB + BMS 50, DES 49) | 2.83 (DCB), 2.84 (DCB + BMS), 2.84 (BMS), 2.78 (DES) | 10% | 58 | 150 (79%) | 16 8%) | 87 (46%) | 64 (34%) | 47 (25%) |
| Ho et al. (2015) [53] | 89 | 2.4 | 4% | 59 | 74 (83%) | 25 (28%) | 50 [56] | 49 (55%) | 25 (28%) |
| Vos et al. (2014) [54] | 100 | 3.02 | 41% | 60 | 74 (74%) | 11 (11%) | 51 (51%) | 29 (29%) | 10 (10%) |
| Bifurcating lesions | |||||||||
| Kleber et al. (2016) [55] | 64 (DCB 32, POBA 32) | DCB 2.38, POBA 2.41 | 9% | 67 | 47 (73%) | 23 (36%) | 36 (56%) | NR | 23 (36%) |
| Schulz et al. (2014) [56] | 38 | NR | 13% | 71 | 23 (61%) | 17 (45%) | NR | 35 (92%) | 20 (53%) |
| Bruch et al. (2016) [57] | 127 | MB: 2.98, SB: 2.34 | 45% | 66 | 102 (80%) | 40 (32%) | 43 (34%) | 116 (91%) | 96 (76%) |
| Vaquerizo et al. (2016) [58] | 49 | 2.18 | 14% | 62 | 38 (78%) | 20 (41%) | 22 (45%) | 26 (53%) | 30 (61%) |
| Her et al. (2016) [59] | 16 | MB: 2.72, SB: 1.25 | 0% | 60 | 11 (68%) | 4 (25%) | 6 (38%) | 7 (44%) | 8 (50%) |
| Other clinical scenarios (calcifications and chronic total occlusions) | |||||||||
| Ito et al. (2017) [60] | 81 (calcified 46, non-calcified 35) | 2.22 calcified, 2.22 non-calcified | 0%* | 70 | 59 (73%) | 49 (60%) | 11 (14%) | 60 (74%) | 61 (75%) |
| Rissanen et al. (2017) [61] | 65 | NR | 10% | 72 | 44 (68%) | 24 (37%) | 25 (38%) | 49 (75%) | 58 (89%) |
| Köln et al. (2017) [62] | 34 | 2.27 | 0%* | 59 | 26 (73%) | 8 (24%) | 5 (15%) | 25 (74%) | 19 (56%) |
DCB drug-coated balloon, DES drug-eluting stent, POBA plain-old balloon angioplasty, BMS bare metal stent, HTN hypertension, Dyslip. dyslipidemia, N number of patients, NR not reported, MB main branch, SB side branch
*Indicates studies were 0% bailout by design, i.e., they excluded patients receiving a bailout stent