CLINICAL OUTCOMES IN.PACT Admiral Drug-Coated Balloon

QUICK LINKS TO IN.PACT ADMIRAL CLINICAL DATA

The IN.PACT clinical program covers multiple trials and patient populations with varying disease states. The data collected is robust and demonstrates the durability, consistency, and safety of IN.PACT™ Admiral™ drug-coated balloon (DCB) as a proven therapy for patients with peripheral artery disease.


IN.PACT SFA TRIAL

The outcomes from the IN.PACT SFA Trial demonstrate long-term safety and effectiveness.1

Clinical trial design

Study Type

Prospective, multicenter, randomized, controlled pivotal trial

Primary Endpoints

Effectiveness : primary patency*

Safety: safety composite

Rigor + Quality

  • Independent and blinded duplex ultrasound core lab, angiographic core lab, and clinical events committee
  • Independent data safety monitoring board
  • External monitoring with 100% source data verification

Patients

331 patients

Sites

57 sites

(U.S., EU)

Key Eligibility Criteria

  • SFA + proximal popliteal
  • Lesions ≥ 4 cm and ≤ 18 cm
  • RCC 2-4
  • No ISR, severe Ca++

LINKS TO PUBLICATIONS and presentation 

CD-TLR AND SAFETY OUTCOMES THROUGH 5 YEARS5

 

IN.PACT SFA
(N = 220 Subjects)

PTA
(N = 111 Subjects)

p-value

Clinically Driven TLR§

  

25.5% 
(47/184)

35.6% 
(37/104)

0.080

Primary Safety Composite||

70.7% 
(130/184)

59.6% 
(62/104)

0.068

Major Adverse Events

42.9% 
(79/184)

48.1% 
(50/104)

0.459

All-cause Death

15.8% 
(29/184)

9.6% 
(10/104)

0.156

Device- or Procedure-related Death through 5 Years#

0.0% 
(0/184)

0.0% 
(0/104)

N/A

CD-TVR

29.3% 
(54/184)

40.4% 
(42/104)

0.068

Major Target Limb Amputation

0.5% 
(1/184)

0.0% 
(0/104)

1.000

Thrombosis

2.2% 
(4/184)

4.8% 
(5/104)

0.292 

PRIMARY PATENCY THROUGH 3 YEARS4

IN.PACT SFA Trial Graph, Primary Patency vs. Time after index procedure in months

IN.PACT SFA JAPAN TRIAL

The IN.PACT SFA Japan trial continues to demonstrate the durability, consistency, and safety of IN.PACT Admiral DCB compared to PTA. 

Clinical trial design

Study Type

Prospective, multicenter, randomized, controlled pivotal trial

Primary Endpoints

Effectiveness : primary patency*

Safety: safety composite

Rigor + Quality

  • Independent and blinded duplex ultrasound core lab, angiographic core lab, and clinical events committee
  • Independent data safety monitoring board
  • External monitoring with 100% source data verification

Patients

100 patients

Sites

11 sites

(Japan)

Key Eligibility Criteria

  • SFA + proximal popliteal
  • Lesions ≥ 4 cm and ≤ 20 cm
  • RCC 2-4
  • No ISR, severe Ca++

LINKS TO PUBLICATIONS AND PRESENTATION

 

CD-TLR and Safety outcomes through 3 years8

 

MDT-2113 DCB
(N = 68 Subjects)

PTA
(N = 32 Subjects)

 p-value

Clinically Driven TLR  

14.9%
(10/67)

20.7%
(6/29)

0.554

Primary Safety Composite††

 

83.6%
(56/67)

75.9%
(22/29)

0.402

30-day Device- & Procedure-related Death

0.0%
(0/68)

0.0%
(0/32)

> 0.999

Major Adverse Event‡‡

20.9%
(14/67)

31.0%
(9/29)

0.306

Major Target Limb Amputation

0.0%
(0/67)

0.0%
(0/29)

> 0.999

Clinically Driven TVR

16.4%
(11/67)

24.1%
(7/29)

0.402

All-cause Death

6.0%
(4/67)

6.9%
(2/29)

1.000

Thrombosis

1.5%
(1/67)

0.0%
(0/29)

1.000

PRIMARY PATENCY THROUGH 3 YEARS8

IN.PACT Japan Trial Graph, Primary Patency vs. Time after index procedure in months

IN.PACT GLOBAL STUDY

The IN.PACT Global study was a real-world registry of 1,535 patients from 64 sites across the globe. This study proved the durability, consistency, and safety of the IN.PACT Admiral DCB in complex patients and lesion types. 

Clinical trial design

Study Type

Prospective, multicenter, single-arm study

Primary Endpoints

Effectiveness : freedom from CD-TLR (all subjects)§§

Effectiveness : primary patency (imaging cohort)

Safety: safety composite

Rigor + Quality

  • Independent and blinded duplex ultrasound core lab, angiographic core lab, and clinical events committee
  • Independent data safety monitoring board
  • External monitoring with 100% source data verification

Patients

1,535 patients

Sites

64 sites

(EU, Middle East, Latin America, Asia)

Key Eligibility Criteria

  • SFA + full popliteal
  • Lesions ≥ 2 cm
  • RCC 2-4
  • ISR, severe Ca++

LINKS TO PUBLICATIONS

SAFETY AND EFFECTIVENESS IN complex REAL-WORLD PATIENTS9-13

 

Lesion Length  
(Mean + SD, cm)

Primary Patency 
(KM @ 360 days)

CD-TLR

Thrombosis

Major Target Limb Amputation

IN.PACT Global
(DCB ARM)

(N = 1,406)

12.09
± 9.54

N/A

7.5%

2.9%

0.2%

IN.PACT 
Global 
Long Lesion 
Imaging 
Cohort 

(N = 157)

26.40
± 8.61

91.1%

6.0%

3.7%

0.0%

IN.PACT 
Global 
ISR Imaging 
Cohort 

(N = 131)

17.17
± 10.47

88.7%

7.3%

0.8%

0.0%

IN.PACT 
Global 
CTO Imaging 
Cohort 

(N = 126)

22.83
± 9.76

85.3%

11.3%

4.3%

0.0%

IN.PACT Global Complex Lesion Sub-cohort

(N = 227)13

28.74
± 7.11

89.1%

7.1%

3.3%

0.0%

*

Freedom from CD-TLR and DUS-derived restenosis (PSVR ≤ 2.4) at 12 months.

Composite 30-day freedom for device- and procedure-related mortality and 12-month freedom from major target limb amputation and CD-TVR.

Unless otherwise indicated, all tests were for superiority using the Fisher’s exact test for binary variables and t-test for continuous variables.

§

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

||

Safety Composite Endpoint consists of: Freedom from device- and procedure-related death through 30 days post-index procedure and freedom from target limb major amputation and clinically-driven target vessel revascularization (TVR)1 within 12 months post-index procedure.

Composite of death, clinically driven TVR, target limb major amputation, and thrombosis.

#

All deaths adjudicated by the CEC.

**

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

††

Primary safety composite is defined as freedom from device- and procedure-related 30-day death and freedom from target limb major amputation and clinically driven TVR through 36 months.

‡‡

MAE is defined as composite of death, clinically driven TVR, target limb major amputation, and thrombosis within 36 months.

§§

Defined as TLR due to symptoms or drop of ABI/TBI of > 20% or > 0.15 when compared to post-procedure baseline ABI/TBI.

1

Laird J. IN.PACT SFA 5-year Results. Presented at VIVA 2018; Las Vegas, NV.

2

Tepe G, Laird J, Schneider P, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation. February 3, 2015;131(5):495-502.

3

Laird J, Schneider PA, Tepe G, et al. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. December 1, 2015;66(21):2329-2338.

4

Schneider PA, Laird J, Tepe G, et al. Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial. Circ Cardiovasc Interv. January 2018;11(1):e005891.

5

Laird J, et al. Circ Cardiovasc Interv. 2019;12:e007702.

6

Iida O, Soga Y, Urasawa K, et al. Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial. J Endovasc Ther. February 2018;25(1):109-117.

7

Iida O, Soga Y, Urasawa K et al. Drug-coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan randomized trial. Catheter Cardiovasc Interv. March 1, 2019;93(4):664-672.

8

Iida O. 3-Year Results from the MDT-2113 SFA Japan Trial. DCB vs. standard PTA for the treatment of atherosclerotic lesions in the SFA/PPA. Presented at LINC 2019; Leipzig, Germany.

9

Ansel GM, Brodmann M, Keirse K, et al. Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study. J Endovasc Ther. December 2018;25(6):673-682.

10

Scheinert D, Micari A, Brodmann M, et al. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease. Circ Cardiovasc Interv. October 2018;11(10):e005654.

11

Brodmann M, Keirse K, Scheinert D, et al. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort. JACC Cardiovasc Interv. October 23, 2017;10(20):2113-2123.

12

Tepe G, Micari A, Keirse K, et al. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. March 11, 2019;12(5):484-493.

13

Reijnen MMPJ, van Wijck I, Zeller T, et al. Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study. J Endovasc Ther. June 2019;26(3):305-315.