CLINICAL OUTCOMES IN.PACT Admiral Drug-Coated Balloon

IN.PACT ADMIRAL SFA TRIAL

The IN.PACT SFA Trial demonstrates superior safety and effectiveness of IN.PACT Admiral as compared to standard PTA.  Patient and Lesion characteristics are comparable to other SFA pivotal trials.

Durable Patency Outcomes

IN.PACT™ Admiral™ drug-coated balloon (DCB) shows durable outcomes in primary patency out to 3 years, relative to the PTA control arm.*

Durable Patency Outcomes for IN.PACT Admiral DCB

* Primary Patency: Freedom from clinically driven TLR or freedom from restenosis as determined by Duplex ultrasound peak systolic velocity ratio ≤2.4 at 12 months and reported again at 24 and 36 months. Primary patency was calculated based on Kaplan-Meier estimates.

Durable Outcomes, Low Reintervention

IN.PACT Admiral DCB had a low reintervention rate of 15.2%, half that found in the PTA control arm at 3 years.*

Target Lesion Revascularization: 

  • 1-year: 2.4% DCB  vs. 20.6% PTA
  • 2-year: 9.1%  DCB vs. 28.3% PTA
  • 3-year: 15.2% DCB vs. 31.1% PTA

Clinically-driven TLR adjudicated by an independent Clinical Event Committee, blinded to the assigned treatment based on any re-intervention at the target lesion due to symptoms or drop of ABI of ≥20% or >0.15 when compared to post-procedure baseline ABI.

Consistent Outcomes, Low TLR

IN.PACT Admiral DCB demonstrates positive, consistent outcomes across trials, complex patients, and lesion subgroups. IN.PACT Admiral provides high primary patency and consistently low TLR rates for ISR at 12 months.

IN.PACT Global Study: ISR Imaging Cohort1

  • Lesion Length: 17.2cm
  • Occluded Lesions: 34.0%
  • 12 Month TLR: 7.3% 

1  M. Brodmann, VIVA 2015. CD-TLR Rate.

Consistent Outcomes in Complex Patients

IN.PACT Admiral DCB performs consistently across a range of complex patient types at 12 months.

Consistent Outcomes Complex Patients for IN.PACT Admiral DCB

TLR and Mean Lesion Length may be calculated differently, and therefore may not be directly comparable; chart is for illustration only.

Overlap exists between the patient populations in the IN.PACT Global ISR Imaging Cohort and the IN.PACT Global ISR Cohort.

3-Year Safety Outcomes

IN.PACT Admiral DCB has an excellent safety profile with superior results relative to PTA.

IN.PACT Admiral
(n = 220)
PTA
(n = 111)
p-value†

Primary Safety Composite*

81.2% (160/197)

64.1% (66/103)

< 0.001**

Device- and Procedure-Related Deaths

0.0% (0/197)

0.0% (0/103)

N/A
Target Limb Major Amputation

0.0% (0/197)

0.0% (0/103)

N/A
Thrombosis

2.0% (4/197)

4.9% (5/103)

0.283

* Freedom from 30-day device- and procedure-related death and target limb major amputation and clinically driven TVR within 36 months

p values are based on Fisher exact test for superiority with significance level of 0.05.

** 10% Non-inferiority Test Margin with one-sided 97.5005% CI


IN.PACT GLOBAL

The IN.PACT Global Study confirms safety and effectiveness of IN.PACT Admiral in a complex, real-world patient population and reinforces the market-leading outcomes from IN.PACT SFA Trial.

IN.PACT Global: Study Design

IN.PACT Global: Study Design

1 Syntactx Clinical Events Committee,  New York, NY, US

2 VasCore DUS Core Lab, Boston, MA, US

3 SynvaCor Angiographic Core Lab, Springfield, IL, US

IN.PACT Global: Study Architecture

This presentation includes outcome data on the 1406 ITT subjects who compose the IN.PACT Global Clinical Cohort.

IN.PACT Global: Study Architecture

*  1406 ITT subjects comprised the IN.PACT Global Clinical Cohort

1  Primary endpoint CD-TLR defined as TLR due to symptoms or drop of ABI/TBI of >20% or >0.15 when compared to post-procedure baseline ABI/TBI.

2  Primary endpoint is primary patency defined as freedom from CD-TLR and DUS-derived restenosis (PSVR  ≤2.4) at 12m. IN.PACT Global Study: Only imaging cohorts Core Lab Adjudicated (Long lesions, CTO, ISR).

IN.PACT Global Clinical Cohort:
Primary Endpoint: Freedom from CD-TLR through 1 Year

IN.PACT global clinical cohort: Primary endpoint: freedom from CD-TLR through 1 year

1  Number at risk represents the number of evaluable subjects at the beginning of each 30-day window.

PRIMARY SUSTAINED CLINICAL IMPROVEMENT

  N = 1406 Subjects

Clinically driven TLR*

7.5% (98/1311)

Any TLR

7.8% (102/1311)

Primary sustained clinical improvement**

80.6% (953/1183)

* Clinically driven TLR adjudicated by an independent Clinical Event Committee, blinded to the assigned treatment based on any re-intervention at the target lesion due to symptoms or drop of ABI of >20% or >0.15 when compared to post-procedure baseline ABI.

 Any TLR includes clinically-driven and incidental or duplex driven TLR.

** Primary sustained clinical improvement defined as freedom from target limb amputation, freedom from target vessel revascularization, and increase in Rutherford class at 12 months.

IN.PACT GLOBAL CLINICAL COHORT: 1-YEAR SAFETY OUTCOMES

  N = 1406 Subjects

Primary safety composite*

92.1% (1207/1311)

Major adverse events†

12.0% (157/1311)

All-cause death

3.5% (46/1311)

Device- or procedure-related death (@ 30 days)

0.2% (3/1394)

CD-TVR

8.1% (106/1311)

Major target limb amputation

0.2% (3/1311)

Thrombosis

2.9% (38/1311)

* Safety composite endpoint consists of: Freedom from device- and procedure-related to 30 days, freedom from target limb amputation within 12 months; and freedom from clinically-driven TVR within 12 months.

 Major Adverse Events (MAE) defined as all-cause death, clinically-drive TVR, major target limb amputation, thrombosis at the target lesion site at 360 days.

IN.PACT ADMIRAL DCB STUDIES:
COMPARISON OF 12-MONTH OUTCOMES IN.PACT GLOBAL CLINICAL COHORT: 1-YEAR SAFETY OUTCOMES

 
IN.PACT SFA
(DCB ARM)
(N = 220)
IN.PACT Global
ISR Imaging Cohort
(N = 131)
Lesion Length 
(Mean + SD, cm)
8.94 +  4.89 17.2 +  10.4
Primary Patency
(KM @ 360 days)

87.5%

88.7%
CD-TLR

2.4%

7.3%

Thrombosis 1.4% 0.8%
Major Amputation Target Limb 0.0% 0.0%

Clinical Data and Journal Articles

pdf 3-Year Results from IN.PACT SFA Trial (.pdf)

Drug-coated balloons showed superior 3-year outcomes versus angioplasty: results from IN.PACT SFA randomized trial.

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pdf 1-Year Results from IN.PACT Global Study (.pdf)

Drug-coated balloon treatment for patients with intermittent claudication: insights from the IN.PACT global full clinical cohort.

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