Table 1.
Drug-eluting balloon in combination with bare metal stent
| Study, year | Design Intervention | Number of patients | Reference mean vessel diameter (mm) | Outcome (months of follow-up) Clinical Angiographic |
|---|---|---|---|---|
| LOCAL-TAX [21], 2009 |
Randomized BMS + Genie DEB vs. BMS vs. Taxus DES |
202 | 2.48 |
MACE, %: 13.4 vs. 26.8 vs. 14.9 (6) TLR, %: 13.4 vs. 22.1 vs. 13.4 (6) In-stent LLL, mm: 0.61 vs. 0.98 vs. 0.44 (6) |
| PERfECT [24, 25], 2011/2016 |
Randomized SeQuent Please DEB + EPC stent vs. EPC stent |
120 | 2.65 vs. 2.74 |
MACE, %: 4.8 vs. 17.2 (6) TLR, %: 4.8 vs. 15.5 (6) MACE, %: 23.5 vs. 30.4 (60) TLR, %: 15 vs. 23.2 (60) In stent LLL, mm: 0.34 vs. 0.88 (6) |
| De novo pilot study [32], 2011 |
Randomized Moxy DEB + BMS vs BMS + Moxy DEB |
26 | 2.81 vs. 2.41 |
MACE, %: 15.4 vs. 30.8 (6) TLR, %: 15.4 vs. 15.4 (6) In-stent LLL, mm: 0.34 vs. 0.88 (6) In-stent neointimal volume obstruction, %: 25.5 vs. 24.9 (6) |
| IVUS study [30], 2012 (PEPCAD III substudy) |
Randomized Coroflex DEBlue + BMS vs. Cypher DES |
55 | Not reported |
Clinical outcomes not reported Stent malapposition, %: 6.9 vs. 15.4 (9) In-stent restenosis, %: 19.7 vs. 11.0 (9) In-stent neointimal hyperplasia, mm2: 1.08 vs. 0.69 (9) |
| PEPCAD CTO [67], 2012 | Observational BMS + SeQuent Please DEB vs. Taxus DES | 96 | 2.98 vs. 2.95 (post-procedure) |
MACE, %: 14.6 vs. 18.8 (12) TLR, %: 14.6 vs. 14.6 (12) In-stent LLL, mm: 0.64 vs. 0.43 (6) |
| Liistro et al. [31], 2013 |
Randomized Elutax DEB + BMS vs. Xience DES |
125 | 2.85 vs. 2.77 |
MACE, %: 29 vs. 6 (9) TLR, %: 25 vs. 4 (9) In-stent LLL, mm: 1.14 vs. 0.34 (9) Binary in-stent restenosis, %: 17 vs. 3 (9) |
| INDICOR [33], 2013 |
Randomized SeQuent Please DEB + BMS vs. BMS + SeQuent Please DEB |
97 | 2.8 vs. 2.8 |
MACE, %: 16.3 vs. 8.4 (12) Target lesion related MACE, %: 10.2 vs. 4.2 (12) In-stent LLL, mm: 0.52 vs. 0.46 (6) |
| PEGASUS [26], 2013 |
Observational IN.PACT Falcon DEB + EPC Stent |
40 | 2.78 |
MACE, %: 18; TLR, %: 10 (9) In-stent LLL, mm: 0.38 (6) Diameter stenosis, %: 25.3 (6) |
| Clever et al. [22], 2014 (PEPCAD III substudy) |
Randomized BMS vs. Coroflex DEBlue vs. Cypher DES |
77 | 3.3 vs. 2.8 vs. 2.9 |
MACE, %: 16 vs. 0 vs. 8 (9) TLR, %: 12 vs. 0 vs. 8 (9) In-stent LLL, mm: 0.85 vs. 0.36 vs. 0.25 |
| OCTOPUS [28], 2014 |
Randomized BMS + SeQuent Please DEB vs. Xience V DES |
90 | 2.59 vs. 2.61 |
MACE, %: 9.8 vs. 10.4(6) TLR, %: 2 vs. 4.2 (6) In-stent LLL, mm; 0.24 vs. 0.16 (6) Uncovered stent struts, %: 5.64 vs. 4.93 (6) |
| IN-PACT CORO [23], 2015 |
Randomized BMS vs. IN.PACT Falcon DEB + BMS vs. BMS + IN.PACT Falcon DEB |
30 | 2.78 vs. 3.03 vs. 2.86 |
Both DEB groups combined: MACE, %: 30 vs. 20 (12) TLR, %: 30 vs. 20 (12) In-stent LLL, mm: 0.85 vs. 0.50 vs. 0.64 (6) Mean neointimal area, mm2: 3.03 vs. 1.96 vs. 2.06 (6) Area obstruction, %: 37.5 vs. 19.5 vs. 29.1 (6) |
| Żurakowski et al. [27], 2015 |
Randomized BMS + SeQuent Please DEB vs. Coroflex Please DES |
202 | 2.52 vs. 2.62 |
MACE, %: 7.0 vs. 6.9 (9) TLR, %: 6.9 vs. 5.0 (9) In-stent, LLL, mm: 0.21 vs. 0.30 (9) |
|
Otto et al. [29], 2016 (substudy [28]) |
Observational BMS + SeQuent Please DEB |
21 | Not reported |
Incomplete stent strut apposition, %: 11.4 at 2 months and 1.8 at 6 months Uncovered stent struts, %: 14.5 at 2 months and 2.0 at 6 months Positive vessel remodelling 4.9 at 2 months and 2.0 at 6 months |
LLL late lumen loss—reflects the loss of lumen in the treated segment usually measured by subtracting the lumen diameter at follow-up from the lumen diameter just after the PCI procedure; MACE major adverse cardiac event—not consistently defined among the different studies, but most frequently including the combination of either death, myocardial infarct, target lesion revascularization, or target vessel revascularization; TLR target lesion revascularization—revascularization within the treated/stented area, usually including 5 mm of the proximal and distal segment adjacent to the treated/stented area