Table 1.
Design Characteristics of the Included Randomized Controlled Trialsa
| Study and Sources | Year and Study Design | Allocation in Study Arms | Paclitaxel‐Coated Device | Primary Study End Point | Maximum Follow‐Up Period | Study Registration | Dual Antiplatelet Therapy |
|---|---|---|---|---|---|---|---|
| ZILVER PTX9, 19, 23 |
2011 Multi‐center Open label (1:1) |
DES (n=241) vs PTA (n=238) | ZILVER‐PTX Stent by Cook Medical | Primary patency at 1 y | 5 y | NCT00120406 | >2 mo |
| THUNDER28, 57 |
2008 Multi‐center Single‐blind (1:1:1) |
DCB (n=48) vs PTA (n=54) | Cotavance Balloon by Bavaria Medizin | Late lumen loss at 6 mo | 5 y | NCT00156624 | 1 mo |
| INPACT SFA10, 11, 25, 56, 82 |
2015 Multi‐center Single‐blind (2:1) |
DCB (n=220) vs PTA (n=111) | IN.PACT Admiral by Medtronic | Primary patency at 1 y | 3 y |
NCT01175850 NCT01566461 |
1 mo (3 mo if bail‐out stenting) |
| FEMPAC29 |
2008 Multicenter Single‐blind (1:1) |
DCB (n=45) vs PTA (n=42) | Paccocath Balloon by Bavaria Medizin | Late lumen loss at 6 mo | 2 y | NCT00472472 | Long‐term (not specified) |
| LEVANT I27 |
2012 Multicenter Single‐blind (1:1) |
DCB (n=49) vs PTA (n=52) | Lutonix by CR Bard | Late lumen loss at 6 mo | 2 y | NCT00930813 | 1 mo (3 mo if bailout stenting) |
| LEVANT II24, 26, 31, 33 |
2015 Multi‐center Single‐blind (2:1) |
DCB (n=316) vs PTA (n=160) | Lutonix by CR Bard | Primary patency at 1 y | 2 y | NCT01412541 | 1 mo |
| ILLUMENATE EU32, 35 |
2017 Multicenter Single‐blind (3:1) |
DCB (n=222) vs PTA (n=72) | Stellarex by Spectranetics | Primary patency at 1 y | 2 y | NCT01858363 | 1 mo (3 mo if bailout stenting) |
| CONSEQUENT30, 36 |
2017 Multicenter Single‐blind (1:1) |
DCB (n=78) vs PTA (n=75) | SeQuent Please by B. Braun | Late lumen loss at 6 mo | 2 y | NCT01970579 | 2 mo |
| ISAR‐STATH51 |
2017 Two‐center Open label (1:1:1) |
DCB+BMS (n=48) vs PTA+BMS (n=52) | IN.PACT Admiral by Medtronic | Diameter Stenosis at 6 mo | 2 y | NCT00986752 | 6 mo |
| ISAR‐PEBIS55 |
2017 Two‐center Open label (1:1) for ISR |
DCB (n=36) vs PTA (n=34) | IN.PACT Admiral by Medtronic | Diameter stenosis at 6 to 8 mo | 2 y | NCT01083394 | >6 mo |
| IN.PACT SFA JAPAN34, 41 |
2018 Multi‐center Single‐blind (2:1) |
DCB (n=68) vs PTA (n=32) | IN.PACT Admiral by Medtronic | Primary patency at 1 y | 2 y | NCT01947478 | 1 mo (3 mo if bailout stenting) |
| ACOART I40, 42 |
2016 Multicenter Single‐blind (1:1) |
DCB (n=100) vs PTA (n=100) | Orchid by Acotec Scientific | Late lumen loss at 6 mo | 2 y | Not registered | 6 mo |
| FINN‐PTX18 |
2018 Multi‐center Open label (2:1) |
DES (n=28) vs PTFE (n=18) | ZILVER‐PTX Stent by Cook Medical | Secondary Patency at 2 y | 2 y | NCT01450722 | 3 mo (Aspirin in control group) |
| BATTLE20, 21 |
2018 Multicenter Open label (1:1) |
DES (n=86) vs BMS (n=85) | ZILVER‐PTX Stent by Cook Medical | In‐stent binary restenosis at 1 y | 1 y | NCT02004951 | >2 mo (clopidogrel to continue for 2 y) |
| DEBATE in SFA22 |
2018 Multi‐center Open label (1:1:1) |
DES (n=85) vs BMS (n=170) | ZILVER‐PTX Stent by Cook Medical | In‐stent binary restenosis at 1 y | 1 y | UMIN000010071 | >2 mo (Aspirin to continue lifelong) |
| DEBELLUM38, 39 |
2014 Single‐center Open (1:1) |
DCB (n=25) vs PTA (n=25) | IN.PACT Admiral by Medtronic | Late lumen loss at 6 mo | 1 y | Not registered | 1 mo |
| PACIFIER45 |
2012 Multicenter Single‐blind (1:1) |
DCB (n=41) vs PTA (n=44) | IN.PACT Pacific by Medtronic | Late lumen loss at 6 mo | 1 y | NCT01083030 | >2 mo |
| FAIR54 |
2015 Multicenter Single‐blind (1:1) for ISR |
DCB (n=62) vs PTA (n=57) | IN.PACT Admiral by Medtronic | 6‐mo binary restenosis | 1 y | NCT01305070 | >6 mo |
| BIOLUX P‐I44 |
2015 Multicenter Single‐blind (1:1) |
DCB (n=30) vs PTA (n=30) | Passeo‐18 Lux by Biotronik | Late lumen loss at 6 mo | 1 y | NCT01056120 | 1 mo (3 mo if bailout stenting) |
| RANGER‐SFA37 |
2018 Multicenter Single‐blind (2:1) |
DCB (n=71) vs PTA (n=34) | Ranger by Boston Scientific | Primary patency at 1 y | 1 y | NCT02013193 | >1 mo |
| ILLUMENATE pivotal43 |
2017 Multicenter Single‐blind (2:1) |
DCB (n=200) vs PTA (n=100) | Stellarex by Spectranetics | Primary patency at 1 y | 1 y | NCT01858428 & NCT01912937 | 1 mo |
| DEBATE‐SFA50 |
2013 Single‐center Open (1:1) |
DCB+BMS (n=53) vs PTA+BMS (n=51) | IN.PACT Admiral by Medtronic | 1‐y binary restenosis | 1 y | NCT01556542 | 3 mo |
| LUTONIX JAPAN48 |
2018 Multicenter Japan (1:1) |
DCB (n=71) vs PTA (n=38) | Lutonix by CR BARD | Primary patency at 1 y | 1 y | Not registered | 1 mo |
| RAPID49 |
2017 Multicenter Double‐blind (1:1) |
DCB+BMS (n=80) vs PTA+BMS (n=80) | LegFlow by Cardionovum | Primary patency at 1 y | 1 y | ISRCTN47846578 | 3 mo |
| EFFPAC47 |
2018 Multicenter Single‐blind (1:1) |
DCB (n=85) vs PTA (n=86) | Luminor by iVascular | Late lumen loss at 6 mo | 1 y | NCT02540018 | >1 mo |
| PACUBA53 |
2016 Dual‐center Single‐blind (1:1) for ISR |
DCB (n=85) vs PTA (n=86) | FREEWAY by Eurocor | Primary patency at 1 y | 1 y | NCT01247402 | 3 mo |
| FREEWAY52 |
2017 Multi‐center Single‐blind (1:1) |
DCB+BMS (n=105) vs PTA+BMS (n=99) | FREEWAY by Eurocor | Target lesion revascularization | 1 y | NCT01960647 | Not specified |
| DRECOREST46 |
2018 Single‐center Open (1:1) |
DCB (n=30) vs PTA (n=30) | IN.PACT by Medtronic for failing bypass | Target lesion revascularization | 1 y | NCT03023098 | 3 mo |
BMS indicates bare metal stent; DCB, drug‐coated balloon; DES, drug‐eluting stent; ISR, in‐stent restenosis; PTA, percutaneous transluminal angioplasty; PTFE, polytetrafluoroethylene.
The design of the ZILVER PTX study included a primary randomization (optimal PTA vs primary DES) and a secondary randomization in the case of PTA failure (bailout BMS vs bail‐out DES)—results of the 2 randomization levels were pooled for the purposes of the present meta‐analysis. For the Thunder trial (3‐arm trial), the arm of paclitaxel dissolved in the contrast medium was excluded. For the ISAR‐STATH trial (3‐arm trial), the arm of directional atherectomy was excluded from the present analysis. For the DEBATE in SFA trial, the 2 BMS arms (with or without cilostazol) were pooled against the ZILVER PTX arm. For the DEBELLUM trial, only femoropopliteal lesions were analyzed. In the LEVANT I trial, randomization between plain BA and PCB was performed after provisional stent placement in a quarter of the cases (26 of 101). In the RAPID study, the Supera biomimetic nitinol stent was used in both arms. Data extraction was supplemented by online archived material from international meetings or regulatory authority filings as cited (US Food and Drug Administration—Japan Pharmaceuticals and Medical Devices Agency).