Table 3.
DCB-only angioplasty in general de novo coronary lesions
| Author | DCB used (comparator) | Angiographic outcome (FU, %FU) | Clinical outcome (FU, %FU) |
Duration of DAPT |
|---|---|---|---|---|
| Randomized studies | ||||
| Cortese et al. PICCOLETO Study (2010) [15] | Dior I (1st-Gen DES) | %DS: DCB 43.6% vs. DES 24.3%, p = 0.029 (6 months, 95%) |
MACE: DCB 35.7% vs. DES 13.8%, p = 0.054; TLR: DCB 32.1% vs. DES 10.3%, p = 0.15 (9 months, 95%) |
DCB 1 month, Bailout BMS 3 months, DES 12 months |
| Latib et al. BELLO Study (2012, 2015) [19, 20] | IN.PACT Falcon (1st-Gen DES) | In-stent/balloon LLL: DCB 0.08 ± 0.38 vs. DES 0.29 ± 0.44 p < 0.001 (6 months, 89.6%) |
MACE*: DCB 14.8% vs. DES 25.3%, p = 0.08 TLR: DCB 6.8% vs. DES 12.1%, p = 0.23 (24 months, 98.4%) |
DCB 1 months, bailout BMS 3 months, DES 12 months |
| Nishiyama et al. (2016) [23] | SeQuent Please (2nd-Gen DES) | LLL: DCB 0.25 ± 0.25 vs. DES 0.37 ± 0.40 p = 0.185 (8 months, 100%) |
MACE: DCB 0% vs. DES 6.1% TLR: DCB 0% vs. DES 6.1%, p = 0.193 (8 months, 100%) |
DCB and DES 8 months |
| Funatsu et al. (2017) [28] | SeQuent Please (POBA) | In-balloon LLL: DCB 0.01 ± 0.31 vs. POBA 0.32 ± 0.34), p < 0.01 (6 months, 95%) |
TVF: DCB 3.4% vs. POBA 10.3%, p = 0.2 TLR: DCB 2.3% vs. POBA 10.3%, p = 0.07 (6 months, 95%) |
3 months |
| Comparative observational studies | ||||
| Her et al. (2016) [29] | SeQuent Please (POBA) | LLL: DCB − 0.12 ± 0.30 vs. POBA 0.25 ± 0.50 p < 0.001 (9 months, 100%) | TLR: DCB 0% vs. POBA 4.3%, p = 0.229 (9 months, 100%) | 1.5 months |
| Shin et al. (2016) [24] | SeQuent Please (2nd Gen DES/BMS) | LLL: DCB 0.05 ± 0.27 vs. DES/BMS 0.40 ± 0.54 p = 0.022 (9 months, 79%) |
MACE: DCB 0% vs. DES/BMS 9%, p N.S. TLR: DCB 0% vs. DES/BMS 5%, p N.S. (12 months, 100%) |
DCB 1.5 months, bailout BMS 6 months, DES 12 months |
| Sinaga et al. (2016) [25] | SeQuent Please (2nd/3rd-Gen DES) | NR |
MACE: DCB 11.6% vs. DES 11.7%, p = 1.000 TLR: DCB 5.2% vs. DES 3.7%, p = 0.601 (12 months, 100%) |
DCB 6 months, DES 12 months |
| Giannini et al. (2017) [22] | IN.PACT Falcon (2nd-Gen DES) | NR |
MACE*: DCB 12.2% vs. DES 15.4%, p = 0.538 TLR: DCB 5.6% vs. DES 4.4%, p = 0.720 (12 months, 100%) |
DCB 1 month, Bailout BMS 3 months, DES 12 months |
| Her et al. (2017) [27] | SeQuent Please (1st/2nd Gen DES) | NR |
Pericprocedural MI: DCB 1.9% vs. DES 23.1% p = 0.002 TLR: DCB 1% vs. DES 0%, p = 1.00 (12 months, 100%) |
DCB 1.5 months, DES 12 months |
| Venetsanos et al. (2018) [26] | SeQuent Please, Pantera Lux, IN.PACT Falcon (2nd/3rd-Gen DES) | NR |
TLR: DCB 0.2% vs. DES 1.1%, HR: 1.05; (95% CI 0.72–1.53) TLT: DCB 7.0% vs. DES 6.2%, HR: 0.18 (95% CI 0.04–0.82) (30 months, 100%) |
DCB 1 month, DES 6 months |
| Single-armed observational studies | ||||
| Unverdorben et al. PEPCAD I (2010, 2013) [17, 18] | SeQuent Please | In-Segment LLL: 0.28 ± 0.53 (6 months, 89%) |
MACE: 15.3% TLR: 11.9% (36 months, 100%) |
DCB 1 month, bailout BMS 3 months |
| Cuculi et al. (2012) [44] | IN.PACT Falcon | NR | TLR: 4.8% (12 months, 95%) | 1.5 months |
| Woehrle et al. SeQuent Please World Wide Registry (2012) [35] | SeQuent Please | NR |
MACE: 2.6% TLR: 1.0% (9 months, 100%) |
1 month |
| Calé et al. (2013) [40] | SeQuent Please | NR |
MACE: 14.7% TLR: 4.0% (12 months, 100%) |
3 months |
| Waksman et al. Valentines II (2013) [47] | Dior II | In-Balloon LLL: 0.38 ± 0.39 (7.5 months, 34%) |
MACE: 8.7% TLR: 2.9% (6–9 months, 100%) |
DCB 3 months, bailout BMS NR |
| Basavarajah et al. (2014) [45] | IN.PACT Falcon | NR |
MACE*: 16.5% TLR: 17.7% (15 months, 100%) |
DCB 1 month, Bailout BMS 3 months, DES 12 months |
| Toelg et al. DELUX Registry (2014) [49] | Pantera Lux | NR |
MACE*: 9.4% TLR: 3.1% (12 months, 91%) |
DCB 3 months |
| Zeymer et al. SeQuent Please Small Vessel ‘PCB Only’ Registry (2014) [36] | SeQuent Please | NR |
MACE: 4.7% TLR: 3.6% (9 months, 100%) |
1 month |
| Kleber et al. (2015) [30] | SeQuent Please, IN.PACT Falcon | In-balloon MLD: PP 1.73 ± 0.55 vs. FU 1.86 ± 0.5, p = 0.012 (4 months, 100%) |
MACE: 1.8% TLR: 0% (4 months, 100%) |
1 month |
| Vaquerizo et al., Spanish Dior Registry (2015) [48] | Dior I/II | In-stent/balloon LLL: 0.31 ± 0.2 (6–8 months, 84%) |
MACE: 6.7% TLR: 2.9% (12 months, 100%) |
DCB 1 month, bailout BMS NR |
| Cortese et al. (2015) [31] | Restore Elutax SV | Dissection cohort LLL: 0.14 ± 0.28 (6 months, 100%) |
MACE: 7.2. % TLR: 5.3% (9 months, 100%) |
DCB 1 month, bailout stent 6 months |
| Ann et al. FFR and OCT (2016) [33] | SeQuent Please | In-balloon LLL: 0.01 ± 0.21 (9 months, 100%) |
MACE: 0% TLR: 0% (9 months, 100%) |
NR |
| Ann et al. FFR and IVUS (2016) [32] | SeQuent Please | In-balloon LLL: 0.02 ± 0.27 (9 months, 100%) |
MACE: 0% TLR: 0% (9 months, 100%) |
1.5 months |
| Benezet et al. (2016) [41] | SeQuent Please | NR |
MACE*: 8.9% TLR: 5.4% (36 months, 100%) |
DCB 1 months, bailout BMS 6 months |
| Uhlemann et al. Leipzig Registry (2016) [42] | SeQuent Please | NR |
MACE*: 13% TLR: 0% (27 months, 100%) |
3 months |
| Hee et al. (2017) (2017) [43] | SeQuent Please | NR |
MACE*: 1% TLR: 0% (16 months, 100%) |
DCB 3 months, bailout BMS 6 months, bailout DES 12 months |
| Poerner et al. OCTOPUS II (2017) [34] | SeQuent Please | LLL: − 0.13 ± 0.44 (6 months, 85%) |
MACE: 6.5% TLR: 4.3% (12 months, 100%) |
DCB 1 month |
| Zivelonghi et al. (2017) [46] | IN.PACT Falcon | NR |
MACE*: 14.3% TLR: 11.4% (48 months, 100%) |
DCB 1 month, bailout DES 6 months |
| Cortese et al. Italian Elutax SV rEgistry-DCB-RISE (2018) [50] | Elutax SV | NR |
DOCE: 2.6% TLR: 2.6% (13 months, 93.2) |
3 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, %DS percentage diameter stenosis, LLL late luminal loss, TLR target lesion revascularization, MACE major adverse cardiovascular events, MI myocardial infarction, TLT target lesion thrombosis, MLD minimum luminal diameter, DOCE device-orientated adverse cardiovascular events, TVR target vessel revascularization, PP post procedure, HR hazard ratio, 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