Table 2.
Drug-eluting balloon alone
| Study, year | Design Intervention | Number of patients | Reference mean vessel diameter (mm) | Bailout (%) | Outcome (months of follow-up) Clinical Angiographic |
|---|---|---|---|---|---|
| PEPCAD I [37, 38], 2010/2013 |
Observational SeQuent Please DEB |
118 | 2.35 | 27 |
Intention to treat MACE, %: 15.3 (12, 36), TLR, %: 11.9 (12, 36) Among patients with no bailout MACE, %: 6.1 (12, 36) TLR, %: 4.9 (12, 36) In-segment LLL, mm: 0.28 (12) |
| PICCOLETO [48], 2010 |
Randomized DIOR DEB vs. Taxus Liberté DES |
60 | 2.45 vs. 2.36 | 36 |
MACE, %: 35.7 vs. 13.8 (9) TLR, %: 32.1 vs. 10.3 (9) Diameter stenosis, %: 43.6 vs. 24.3 (6) |
| SeQuent Please World Wide Registry [39], 2012 |
Observational SeQuent Please DEB SeQuent Please DEB + BMS |
390 101 |
2.5 2.8 |
0a 100 |
MACE, %: 2.6 (9) TLR, %: 1.0 (9) MACE, %: 2.4 (9) TLR, %: 2.4 (9) |
| BELLO [49, 51], 2012/2015 |
Randomized IN.PACT Falcon DEB vs. Taxus Liberté DES |
182 | 2.15 vs. 2.25 | 20 |
MACE, %: 10 vs. 16.3 (6) and 14.8 vs. 25.3 (24) TLR, %: 4.4 vs. 7.6 (6) and 6.8 vs. 12.1 (24) In-balloon (in-stent) LLL, mm: 0.08 vs. 0.29 (6) |
| Valentines II trial [10], 2013 |
Observational DIOR II DEB |
103 | 2.40 | 11.9 |
MACE, %: 8.7 (7.5) TLR, %: 2.9 (7.5) In-balloon LLL, mm: 0.38 (7.5) |
|
Calé et al. [40], 2013 |
Observational SeQuent Please DEB |
74 | Not reported | 3 |
MACE, %: 14.7 (12) TLR, %: 6.2 (12) |
| SeQuent Please Small Vessel “PCB Only” Registry [35], 2014 |
Observational SeQuent Please DEB |
447 | 2.14 | 6 |
MACE, %: 4.7 (9) TLR, %: 3.6 (9) |
| DELUX Registry [46], 2015 |
Observational Pantera Lux DEB |
105 | Not reported (69.4% < 2.75) | 22.5 |
MACE, %: 9.4 (12) TLR, %: 3.1 (12) |
| Kleber et al. [52], 2015 |
Observational SeQuent Please DEB/IN.PACT Falcon DEB (pre- vs. post-intervention) |
56 | 2.59 | 0a |
MACE, %: 1.8, TLR, %: 0 (4) Minimal lumen diameter in-lesion, mm: 0.81 vs. 1.75. (4) Diameter stenosis in-lesion, %: 69.2 vs. 33.8 (4) |
| Spanish DIOR Registry [47], 2015 |
Observational DIOR I/DIOR II DEB |
104 | 1.95 | 6.8 |
MACE, %: 4.8 (12) TLR, %: 2.9 (12) LLL, mm: 0.31 (7.5) |
| Shin et al. [54], 2015 |
Observational SeQuent Please DEB vs. DES |
66 | 2.69 vs. 2.92 |
MACE, %: 0 vs. 9.1 (9) TLR, %: 0 vs. 4.5 (9) In-lesion/stent LLL, mm: 0.05 vs. 0.40 (9) |
|
| Leipzig Registry [42], 2016 |
Observational SeQuent Please DEB |
76 | Not reported | 26.3 |
Myocardial infarction, %: 3.9 (27) All-cause mortality, %: 9.2 (27) TLR, %: 0 (27) |
| Her et al. [53], 2016 |
Observational SeQuent Please DEB vs. POBA |
72 | 2.3 vs. 2.1 | 0a | TLR, %: 0 vs. 4.3 (9) |
| Benezet et al. [41], 2016 |
Observational SeQuent Please DEB |
53 | 2.4 | 25 |
MACE, %: 8.9 (36) TLR, %: 5.4 (36) |
| Ann et al. [55], 2016 |
Observational SeQuent Please DEB |
27 | 2.53 | 0a |
MACE, %: 3.7 (9) TLR, %: 0 (9) In-lesion LLL, mm: 0.02 mm (9) |
See Table 1 for abbreviations
aBy design no stent implanted