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

12-Month Results Published in European Heart Journal 

 Kaplan-Meier Primary Patency Results

Target Lesion Length = ~126 mm Total Occlusions = ~42% Moderate to Severe Calcium = ~54%

1. COMPARE Clinical Trial 12-Month Results presented by Sabine Steiner, MD. LINC 2020. 12-Month Primary Endpoints: Binary Primary Patency = 83.0% for Ranger DCB and 81.5% for IN.PACT DCB (Pnon-inferiority <0.01). Freedom from Major Adverse Events = 91.0% for Ranger DCB and 92.6% for IN.PACT DCB (Pnon-inferiority <0.01).
2. Based on total drug dose for 4mmx60mm or averages for full size matrix per the IN.PACT™ Admiral™ Drug-Coated Balloon Instructions for Use, http://www.medtronic.com, and the Ranger™ Paclitaxel-Coated PTA Balloon Catheter Instructions for Use.
* Log-rank p-value compares the entire K-M curves from time zero to full one year follow-up window.
12-MONTH 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
 
24 MONTH KEY RESULTS RANGER
(n=207)
IN.PACT
(n=207)
p-value
Mortality: All Cause 3.6% 1.1% 0.6
Mortality: Device or procedure related 0% 0% N/A
CD-TLR 17.3% 13.0% 0.3
 

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).

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