Table 4.
DCB-only angioplasty in primary PCI for de novo lesions
| Author | Design | DCB used | Angiographic outcome (FU, %FU) | Clinical outcome (FU, %FU) |
|---|---|---|---|---|
| Gobic et al. (2017) [51] | Randomized trial, DCB vs. 3rd-Gen DES | SeQuent Please |
LLL: DCB − 0.09 ± 0.09 vs. DES 0.1 ± 0.19, p < 0.05 (6 months, 84%) |
MACE*: DCB 5.3% vs. DES 5.4%, p NS TLR: 0% DCB vs. 5.4% DES, p NS (6 months, 100%) |
| Nijhoff et al. DEB-AMI (2015) [52] | Comparative observational study, DCB only vs. DCB + BMS vs. BMS vs. 1st-Gen DES | Dior II |
In Balloon/Stent LLL: DCB 0.51 ± 0.59 vs. DCB + BMS 0.64 ± 0.56 p = 0.33 vs. BMS 0.74 ± 0.32 p = 0.08 vs. DES 0.2 1 ± 0.32 p < 0.01 (6 months, 90%) |
MACE*: DCB 17.5% vs. DCB + BMS 23.9% vs. BMS 25.0% vs. DES 4.4% p NS TLR: DCB 12.5% vs. DCB + BMS 23.9% vs. BMS 19.1% vs. DES 2.2%, p NS (12 months, 100%) |
| Vos et al. PAPPA (2014) [53] | Single-armed observational study | Pantera Lux | NR |
MACE*: 5% TLR: 3% (12 months, 100%) |
| Ho et al. (2015) [54] | Single-armed observational study | SeQuent Please | NR |
MACE: 4.5% TVR: 0% 1 month (100%) |
DCB drug-coated balloon, DES drug-eluting stent, BMS bare metal stent, Gen generation, FU follow-up, %FU percentage follow-up, LLL late luminal loss, TLR target lesion revascularization, MACE major adverse cardiovascular events, TVR target vessel revascularization, 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