Table 2. Randomized controlled trials of ISR treatment with DCBs.
| Authors/Literature (time) | Research design | Types of ISR | Follow-up | Key results | |
| Imaging | Clinical | ||||
| BMS: bare-metal stent; BP-SES: biodegradable polymer-coated sirolimus eluting stent; BTHC: trihexylo-butyrylcitrate; DCB: drug-coated balloon; DES: drug-eluting stent; ISR: in-stent restenosis; LLL: late lumen loss; MACE: major adverse cardiac events; MLD: minimum lumen diameter; OCT: optical coherence tomography; TLF: target lesion failure; TLR: target lesion revascularization. | |||||
| PACCOCATH ISR I (2006)[15] | PACCOCATH (26 cases)/Plain balloon (26 cases) | BMS-ISR | 6 months; 12 months |
6 months; 12 months |
6-month LLL: 0.03 ± 0.48 mm vs. 0. 74 ± 0.86 mm (P < 0.002) 6-month restenosis rate: 5% vs. 43% (P < 0.002) 12-month MACE: 4% vs. 31% (P = 0.02) |
| PACCOCATH ISR II (2008)[16] | PACCOCATH (54 cases)/Plain balloon (54 cases) | BMS-ISR & DES-ISR |
6 months | 12 months; 24 months |
6-month LLL: 0.11 ± 0.44 mm vs. 0.8 ± 0.79 mm (P < 0.001) 6-month restenosis rate: 6% vs. 51% (P < 0.001) 24-month MACE: 11% vs. 46% (P < 0.001) |
| PACCOCATH ISR II 5-year follow-up (2012)[17] | PACCOCATH (54 cases)/Plain balloon (54 cases) | BMS-ISR & DES-ISR |
5 years | 5-year TLR: 9.3% vs. 38.9% (P = 0.004) 5-year MACE: 27.8% vs. 59.3% (P = 0.009) |
|
| PEPCAD II (2009)[18] | SeQuent Please (66 cases)/TAXUS stents (65 cases) | BMS-ISR | 6 months | 12 months | 6-month LLL: 0.17 ± 0. 42 mm vs. 0.38 ± 0.61 mm (P = 0.03) 6-month restenosis rate: 7% vs. 20% (P = 0. 06) 12-month MACE: 9% vs. 22% (P = 0.08) |
| PEPCAD II 3-year follow-up (2015)[19] | SeQuent Please (66 cases)/TAXUS stents (65 cases) | BMS-ISR | 3 years | 3-year TLR: 6.2% vs. 15.4% (P = 0.10) 3-year MACE: 7.6% vs. 16.9% (P = 0.11) |
|
| PEPCAD DES (2012)[20] | SeQuent Please (65 cases)/Plain balloon (38 cases) | DES-ISR | 6 months | 6 months | 6-month LLL: 0.43 ± 0.61 mm vs. 1.03 ± 0.77 mm (P < 0.001) 6-month MACE: 16.7% vs. 50.0% (P < 0.001) 6-month restenosis rate: 17.2% vs. 58.1% (P < 0.001) |
| PEPCAD DES 3-year follow-up[21] | SeQuent Please (72 cases)/Plain balloon (38 cases) | DES-ISR | 3 years | 3-year TLR: 19.4% vs. 36.8% (P = 0.046) | |
| Habara, et al. (2011)[22] | SeQuent Please (25 cases)/Plain balloon (25 cases) | DES-ISR | 6 months | 6 months | 6-month LLL: 0.18 ± 0.45 mm vs. 0.72 ± 0.55 mm (P = 0.001) 6-month restenosis rate: 8.7% vs. 62.5% (P = 0.0001) 6-month TLR: 4.3% vs. 42% (P = 0. 003) 6-month MACE: 96% vs. 60% (P = 0. 005) |
| Habara, et al. (2013)[23] | SeQuent Please (137 cases)/Plain balloon (71 cases) | BMS-ISR & DES-ISR |
6 months | 1 month; 3 months; 6 months |
6-month LLL: 0.11 ± 0.33 mm vs. 0.49 ± 0.50 mm (P < 0.001) 6-month MACE: 6.6% vs. 31% (P < 0.001) |
| ISAR-DESIRE III (2013)[24] | SeQuent Please (137 cases)/TAXUS stents (131 cases)/Plain balloon (134 cases) | DES-ISR | 6–8 months | 12 months | 6-month restenosis rate: 39 cases/34 cases/72 cases 12-month TLR: 22.1% vs. 13.5% vs. 43.5% No differences in 12-month MI and mortality among three groups |
| ISAR-DESIRE III 3-year follow-up (2015)[25] | SeQuent Please (137 cases)/TAXUS stents (131 cases)/Plain balloon (134 cases) | DES-ISR | 3 years on average | TLR in 3 years: 33.3% vs. 24.2% vs. 50.8% MI and mortality in 3 years: 10.4% vs. 18.3% vs. 10.9% |
|
| SEDUCE (2014)[26] | SeQuent Please (20 cases)/Xience stents (20 cases) | BMS-ISR | 9 months (OCT) | 12 months | 9-month MLD: 2.13 mm vs. 2.54 mm (P = 0.006) 9-month LLL: 0.28 mm vs. 0.07 mm (P = 0.1) No differences in in-stent thrombosis, TLR or mortality in 1 year |
| PEPCAD China (2014)[27] | SeQuent Please (110 cases)/TAXUS stents (110 cases) | DES-ISR | 9 months | 9 months; 12 months |
9-month LLL: 0.46 ± 0.51 mm vs. 0.55 ± 0.61 mm (Pnon-inferiority = 0.0005) 12-month TLR: 14.5% vs. 13.6% (P = 0.84) |
| PEPCAD China 2-year follow-up (2016)[28] | SeQuent Please (110 cases)/TAXUS stents (110 cases) | DES-ISR | 24 months | 24-month TLR: 15.9% vs. 13.7% (P = 0.66) | |
| RIBS V (2014)[29] | SeQuent Please (95 cases)/Xience stents (94 cases) | BMS-ISR | 6 months; 9 months |
12 months | 9-month MLD: 2.01 ± 0.6 mm vs. 2.36 ± 0.6 mm (P < 0.001) 9-month LLL: 0.14 ± 0.5 mm vs. 0.04 ± 0.5 mm No obvious differences in 12-month MACE |
| RIBS V 3-year follow-up (2016)[30] | SeQuent Please (95 cases)/Xience stents (94 cases) | BMS-ISR | 3 years | 3-year TLR: 8% vs. 2% (P = 0.04) | |
| RIBS IV (2015)[31] | SeQuent Please (154 cases)/Xience stents (155 cases) | DES-ISR | 6–9 months | 6–9 months; 1 year |
6–9-month min. lumen diameter: 1.80 ± 0.6 mm vs. 2.03 ± 0.7 mm (P < 0.01) 6–9-month restenosis rates: 19% vs. 11% (P = 0.06) 1-year MACE: 18% vs. 10% (P = 0.04) |
| TIS (2016)[32] | SeQuent Please (68 cases)/Promus stents (68 cases) | BMS-ISR | 12 months (± 2 months) | 6 months; 12 months |
12-month LLL: 0.09 ± 0.44 mm vs. 0.44 ± 0.73 (P = 0.0004) 12-month restenosis rates: 8.7% vs. 19.12% (P = 0.078) 12-month MACE: 10.29% vs. 19.12% (P = 0.213) |
| ISAR DESIRE IV (2017)[33] | Scoring balloon + Pantera Lux drug balloon (125 cases)/Pantera Lux drug balloon (127 cases) | DES-ISR | 6–8 months | 12 months | 6-8-month LLL: 0.31 ± 59 mm vs. 0.41 ± 0.74 mm (P = 0.27) 12-month MACE: 18.4% vs. 23.3% (P = 0.35) 12-month TLR: 16.2% vs. 21.8% (P = 0.26) |
| RESTORE (2018)[34] | SeQuent Please (86 cases)/Xience stents (86 cases) | DES-ISR | 9 months | 12 months | 9-month LLL: 0.15 ± 0.49 mm vs. 0.19 ± 0.41 mm (P = 0.54) 12-month MACE: 7% vs. 4.7% (P = 0.51) 12-month TLR: 5.8% vs. 1.2% (P = 0.1) |
| BIOLUX (2018)[35] | BTHC-based DCB (157 cases)/BP-SES (72 cases) | MIXED-ISR | 6 months | 12 months | 6-month LLL: 0.03 ± 0.40 mm vs. 0.20 ± 0.70 mm (P = 0.40) 12-month TLF: 16.9% vs. 14.2% (P = 0.65) 12-month TLR: 12.5% vs. 10.1% (P = 0.82) |
| DARE (2018)[36] | SeQuent Please (141 cases)/Xience stents (137 cases) | MIXED-ISR | 6 months | 12 months | 6-month MLD: 1.71 ± 0.51 mm vs. 1.74 ± 0.61 mm (Pnon-inferiority < 0.0001) 12-month TLR: 8.8% vs. 7.1% (P = 0.65) |
| RESTORE ISR China (2018)[37] | SeQuent Please (120 cases)/Restore DCB (120 cases) | MIXED-ISR | 9 months | 12 months | 9-month LLL: 0.35 ± 0.47 mm vs. 0.38 ± 0.50 mm 12-month TLF: 12.6% vs. 13.3% (P = 0.87) |
| FIM LIMUS DCB (2019)[7] | Sequent SCB (25 cases)/SeQuent Please Neo (25 cases) | DES-ISR | 6 months | 12 months | 6-month LLL: 0.17 ± 0.55 mm vs. 0.21 ± 0.54 mm (P = 0.794) No differences in 12-month clinical events |
| Zhu, et al. (2021)[38] | SeQuent Please (108 cases)/Swide (108 cases) | MIXED-ISR | 9 months | 12 months | 9-month LLL: 0.30 ± 0.46 mm vs. 0.29 ± 0.43 mm (P = 0.002) 12-month TLF: 15.09% vs. 10.91% (P = 0.42) |