Clinical Effectiveness of the ABSORB

Bioresorbable Scaffold in Patients with

Complex Infrapopliteal Disease

Atman P. Shah MD FACC FSCAI

Abdul Dia, Joseph M. Venturini, Jonathan Paul, John Blair, Janet Friant, Sandeep Nathan

Co-Director, Hans Hecht Cardiac Catheterization Laboratory

Clinical Director, Section of Cardiology

Associate Professor of Medicine

The University of Chicago

Disclosures

Affiliation/Financial Relationship Company

• Grant / Research Support NIH RO1HL076671

Medtronic

• Consulting / Advisory Panel / Honoraria

Abbott Cardiovascular

Maquet

Medtronic

AstraZeneca

Physio-Control

St. Jude Medical

Edwards

Zoll

• Intellectual Property Rights None

• Other Financial Benefit None

• July 5th 2016 FDA approves ABSORB BVS Scaffold

• September 14th, 2017: Abbott stops commercial sales of

the ABSORB BVS

• WHAT Happened?

• Compared to XIENCE stent, more stent thrombosis, more

TVR

History

3ABSORB 12 Months Infrapopliteal

• In the coronary trials, a 1st generation BVS system was compared against a mature,

well studied and developed 7th generation coronary DES system

• Proper implant technique was not fully elucidated

• If the benefit from improved vascular function was to be seen, how best to measure,

and is the coronary system the best?

• Varcoe et al have presented 4 year data demonstrated 71% primary patency in

infrapopliteal disease

• Could the periphery, with all its needs, be the optimal landing zone for ABSORB BVS?

Are Peripheral Arteries Different?

4ABSORB 12 Months Infrapopliteal

3M 6M 12M 18M 24M 30M 36M 42M 48M

Histology

OCT

IVUS-GS

IVUS-Echogenicity

Comprehensive imaging of Bioresorption and Integration process: Histology, OCT, IVUS-greyscale and IVUS echogenicity (preclinical)

• At a single academic, quatenary care center we performed a retrospective review of

patients who presented with chronic limb ischemia or non-healing wounds with complex

infrapopliteal disease.

• CLI RC 3-6, life expectancy >12 months

• These patients were treated with the ABSORB BVS

• Clinical and imaging assessment was performed at 12 months

Methods

6ABSORB 12 Months Infrapopliteal

Lappas et al 2012

2211

16

• Clinical endpoints included stent thrombosis, primary patency (defined as freedom from

target vessel occlusion and clinically driven target lesion revascularization evaluated at

12 months), limb salvage (defined as freedom from major amputation above the ankle),

and ultrasound designated patency (cutoff velocity of 2m/sec).

• In patients with a wound, WIfI classification was assessed

• Data expressed as continuous variables within this prespecified population will be

analyzed with a Mann Whitney test with presentation being median +/- standard

deviation. Primary patency wasassessed using Kaplan Meier analysis and utilizing

SPSS software

• Clinically-driven TLR must satisfy all of the following:

(1) Recurrent symptoms (worsening ankle-brachial index (ABI) or toe-brachial index

(TBI)) related to the target lesion

(2) Loss of Rutherford class related to the target lesion

(3) Angiographically-demonstrated lesion of > 70%

Clinical Endpoints

7ABSORB 12 Months Infrapopliteal

8ABSORB 12 Months Infrapopliteal

9ABSORB 12 Months Infrapopliteal

• 31 patients were enrolled, 48 scaffolds were used to treat 39 lesions

• 79% of lesions were TASC C/D

• 88% were RB >/=4

Results

10ABSORB 12 Months Infrapopliteal

StentThrombosis

Primary Patency

Limb Salvage U/S Defined Patency

(>2m/sec)

12 Months 0 (0) 96.7% (30) 100 (31) 96.7 % (30)

RB Classification at Baseline and at 12 Months

11ABSORB 12 Months Infrapopliteal

0

2

4

6

8

10

12

14

16

1 2 3 4 5 6

PreRB

PostRB

Change in RB Classification at 12 Months

12ABSORB 12 Months Infrapopliteal

0

1

2

3

4

5

6

7

8

9

1 0 -1 -2 -3 -4 -5 -6

• Infrapopliteal arterial disease presents unique revascularization challenges

• Compared to the coronaries, the distal vascular beds subtend a large muscular territory

• Having a BVS, which theoretically preserves distal vasomotor function, may have

greater benefit in the peripheral compared to the coronary tree

• This single center, retrospective study demonstrated clinical safety and efficacy of the

ABSORB BVS for the treatment of infrapopliteal disease

• REVA system has CE Mark

• Further studies with more patients and longer term follow up is needed

Conclusions

13ABSORB 12 Months Infrapopliteal

Thank You