COMPARE is the world’s first head-to-head prospective, RCT (1:1) comparing low dose Ranger DCB (2 μg/mm2) to higher dose IN.PACT DCB (3.5 μg/mm2).
Ranger demonstrated similar primary patency1 with half the total drug dose.2
Presented at LINC 2020 by Sabine Steiner, MD and simultaneously published in European Heart Journal
COMPARE Manuscript
Primary endpoints were binary primary patency and freedom from major adverse events.
| 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 |
|---|---|---|---|
| Excipient | TransPax™ citrate ester |
Urea | N/A |
| 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 |
|
|||
| 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).
Ranger is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners.
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