COMPARE Clinical Trial
- COMPARE Clinical Trial 12-Month Full Cohort Results presented by Sabine Steiner, MD. LINC 2020.
12-Month full cohort results from COMPARE1, the world’s first head-to-head, prospective, multi-center, randomized controlled Trial (1:1) comparing the low dose paclitaxel RANGER™ DCB (2 µg/mm2) to the higher dose paclitaxel IN.PACT™ DCB (3.5 µg/mm2). Primary endpoints were binary primary patency and freedom from major adverse events.
Presented at LINC 2020 by Sabine Steiner, MD and simultaneously published in European Heart Journal
COMPARE Manuscript
12-Month full cohort results from COMPARE Trial
| PRIMARY ENDPOINTS | RANGER | IN.PACT | p-value |
|---|---|---|---|
| Binary Primary Patency | 83.0% (156/188) |
81.5% (141/173) |
Pnon-inferiority<0.01 |
| Freedom from major adverse events | 91.0% (182/200) |
92.6% (175/189) |
Pnon-inferiority<0.01 |
| Both primary endpoints met. | |||
| TRIAL DETAILS | RANGER (n=207) |
IN.PACT (n=207) |
p-value |
|---|---|---|---|
| Paclitaxel dose density | 2.0 µg/mm2 | 3.5 µg/mm2 | N/A |
| Average total paclitaxel dose per patient in trial | 6,971 µg | 13,035 µg | <0.0001 |
| Excipient | TransPax™ citrate ester |
Urea | N/A |
|
|||
| BASELINE CHARACTERISTICS | RANGER (n=207) |
IN.PACT (n=207) |
p-value |
|---|---|---|---|
| Age (year) | 68.2 | 68.4 | 0.79 |
| Female | 38.2% | 36.2% | 0.68 |
| Current/Former Smoker | 77.3% | 75.3% | 0.63* |
| Total Occlusions | 41% | 43% | 0.62 |
| Total Occlusion Length | 131 mm | 113 mm | 0.23 |
| Target Lesion Length | 124 mm | 128 mm | 0.65 |
| Moderate to Severe Calcification** | 50% | 57% | *** |
| Diabetics | 31% | 37% | 0.18 |
| * p-value based on entire distribution. Never, Former or Current Smokers ** PACSS Grade 3/4 may be considered similar to moderate/severe calcification *** p-value for entire distribution of PACSS Calcium Grades 0, 1, 2, 3, 4 calcium for RANGER vs IN.PACT. p-value was 0.20. |
|||
| 12 MONTH KEY RESULTS | RANGER (n=207) |
IN.PACT (n=207) |
p-value |
|---|---|---|---|
| Mortality: All Cause | 2.5% | 1.6% | 0.73 |
| Mortality: Device or procedure related | 0% | 0% | N/A |
| CD-TLR | 9.0% | 7.4% | 0.59 |
Definitions
Primary safety endpoint — composite of freedom from device and procedure-related death through 30-days and freedom from major target limb amputation and CD-TLR through 12 months post index-procedure.
Primary efficacy endpoint — primary patency at 12 months defined as absence of clinically-driven target lesion revascularization (CD-TLR) or binary restenosis determined as a peak systolic velocity ratio > 2.4 evaluated by duplex ultrasound core laboratory analysis.
CD-TLR — a reintervention performed for ≥ 50% diameter stenosis (confirmed by angiography) within ± 5 mm proximal and/or distal to the target lesion after documentation of recurrent clinical symptoms of PAD (increase of 1 Rutherford class or more) and/or drop of ABI (≥20% or ≥0.15 when compared to maximum early postprocedural level).
CAUTION: Ranger is an Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.
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