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. 2018 Oct 27;7(2):127–149. doi: 10.1007/s40119-018-0121-2

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