Table 5.
DCB-only angioplasty in de novo coronary bifurcating lesions
| Author | Design | DCB used | Angiographic outcome (FU, %FU) | Clinical outcome (FU, %FU) |
Duration of DAPT |
|---|---|---|---|---|---|
| Kleber et al. PEPCAD-BIF (2016) [55] | Randomized trial, DCB vs. POBA | SeQuent Please | In-Segment LLL: DCB 0.08 ± 0.31 vs. POBA 0.47 ± 0.61 p = 0.006 (9 months, 75%) |
MACE: DCB 3.1% vs. POBA 12.5%, p N.S TLR: DCB 3.1% vs. POBA 9.4%, p N.S (9 months, 100%) |
1 month, bailout BMS/DES 12 months |
| Schulz et al. (2014) [56] | Single-armed observational study | SeQuent Please, IN.PACT Falcon | Binary restenosis: 10% (4 months, 77%) |
MACE: 7.7% TLR: 7.7% (4 months, 100%) |
1 month |
| Bruch et al. (2016) [57] | Single-armed observational study | SeQuent Please | NR |
MACE*: 6.1% TLR: 4.5% (9 months, 100%) |
1 month, bailout BMS 6 months |
| Vaquerizo et al. (2016) [58] | Single-armed observational study | Dior II | In-balloon LLL: 0.32 ± 0.7 (7–8 months, 63%) |
MACE*: 16.3%, TLR: 14.3% (12 months, 82%) |
1 month |
| Her et al. (2016) [59] | Single-armed observational study | SeQuent Please | MB LLL: − 0.01 ± 0.18, SB LLL: − 0.02 ± 0.22 (9 months, 100%) | MACE: 0% (9 months, 100%) | 1.5 months |
DCB drug-coated balloon, DES drug-eluting stent, POBA plain-old balloon angioplasty, BMS bare metal stent, Gen generation, FU follow-up, %FU percentage follow-up, DAPT dual anti-platelet therapy, LLL late luminal loss, TLR target lesion revascularization, MACE major adverse cardiovascular events, MB main branch, SB side branch, NS non-significant, NR not reported
*Indicates studies that adopted a different definition for the composite outcome of MACE and these are elaborated upon in Appendix B