Table 2.
Recent clinical trials of DCB vs PTA and registries of DCB use in the SFA
| Femoropopliteal RCT | IN.PACT SFA20 | LEVANT II19 | ILLUMENATE FIH21 | ||
|---|---|---|---|---|---|
|
| |||||
| DCB type used | IN.PACT™ Admiral | Lutonix® | Stellarex™ | ||
|
| |||||
| DCB | PTA | DCB | PTA | DCB | |
| Characteristics | |||||
|
| |||||
| Number of patients (n) | 220 | 111 | 316 | 160 | 50/58 |
| Diabetics (%) | 41 | 49 | 43 | 43 | 34 |
| CLI (%) | 5 | 5 | 8 | 8 | 2 |
| Lesion length (mm)a | 89±49 | 88±51 | 63±41 | 63±40 | 72±47 |
| De novo lesion (%) | 95 | 95 | 100 | ||
| Total occlusion (%) | 26 | 20 | 21 | 22 | 12 |
| Calcified lesion (%) | 59 | 57 | 62 | ||
| Severe calcification (%) | 8 | 6 | |||
| Bailout stenting (%) | 8 | 13 | 3 | 7 | 8 |
|
| |||||
| 12 months | |||||
|
| |||||
| Improvement RU | √ | √ | Yes | √ | |
| Improvement ABI | Yes | √ | |||
Notes: √ Indicates significant improvement.
Data presented as mean ± standard deviation. IN.PACT™ Admiral DCB (Medtronic GmbH, Meerbusch, Germany); Lutonix® DCB (BARD Peripheral Vascular, Inc, Tempe, AZ, USA); Stellarex DCB™ (Spectranectrics, Colorado Springs, CO, USA); IN.PACT SFA, Randomized Trial of IN.PACT Admiral™ Drug Eluting Balloon vs Standard PTA for the Treatment of Superficial Femoral and/or Popliteal Peripheral Artery Disease; LEVANT II, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropoliteal Restenosis; ILLUMENATE FIH, Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions With A Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon. 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; LLL, late lumen loss; PTA, percutaneous transluminal angioplasty; RCT, randomized controlled trial; RU, Rutherford classification; SFA, superficial femoral artery.