Table 4.
Clinical trials of DCB vs PTA in ISR of the SFA
| Femoropopliteal RCT and registry | Italian registry31 | DEBATE ISR35 | FAIR34 | COPA CABANA33 | |||
|---|---|---|---|---|---|---|---|
|
| |||||||
| DCB type used | IN.PACT™ | IN.PACT™ Admiral | IN.PACT™ Admiral | Cotavance® | |||
|
| |||||||
| DCB | DCB | PTA | DCB | PTA | DCB | PTA | |
| Characteristics | |||||||
|
| |||||||
| Number of patients (n) | 39 | 44 | 42 | 62 | 57 | 47 | 41 |
| Diabetics (%) | 49 | 100 | 100 | 45 | 30 | 43 | 46 |
| CLI (%) | 75 | 67 | 4,8 | 10,5 | 8 | 11 | |
| Lesion length (mm)a | 83±39 | 132±86 | 137±82 | 82±71 | 81±66 | 119±96 | 109±78 |
| Lesion type (%) | ISR | ISR | ISR | ISR | ISR | ISR | ISR |
| Total occlusion (%) | 20 | 24 | 33 | 18 | 35 | ||
| Bailout stenting (%) | 10,3 | 15,9 | 26,2 | 1,6 | 7,0 | ||
|
| |||||||
| 12 months | |||||||
|
| |||||||
| Improvement RU | Yes | √ | |||||
| Improvement ABI | √ | √ | |||||
Notes: √ Indicates significant improvement.
Data presented as mean ± standard deviation. IN.PACT™ Admiral DCB (Medtronic GmbH, Meerbusch, Germany); Cotavance™ DCB (Medrad, Bayer Healthcare, Berlin, Germany); DEBATE ISR, Trial Drug Eluting Balloon in Peripheral Intervention for In-Stent Restenosis; FAIR, Drug Eluting Balloon vs PTA for Superficial Femoral Artery In-Stent Restenosis Trial; COPA CABANA trial, Cotavance™ Paclitaxel Coated Balloons vs Uncoated Balloon Angioplasty for Treatment of In-Stent Restenosis in SFA and the Popliteal Arteries. Adapted with permission from Herten M, Schönefeld E, Stahlhoff S, Schwindt A, Torsello GB. Drug-coated balloons in the treatment of femoro- and infra-popliteal lesions. Interv Cardiol. 2015;7(4):353–370.72
Abbreviations: ABI, ankle–brachial index; CLI, critical limb ischemia; DCB, drug-coated balloon; ISR, in-stent restenosis; LLL, late lumen loss; PTA, percutaneous transluminal angioplasty; RCT, randomized controlled trial; RU, Rutherford classification; SFA, superficial femoral artery.