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Peripheral Artery Intervention: insights from the XLPAD registry
Subhash Banerjee, MD; FACCChief, Division of Cardiology, VA North Texas Healthcare System
Prof. of Medicine, UT Southwestern Med. Ctr.
Texas FreshAir 2015 Annual Conference
Topics for Discussion Research question:
Peripheral Artery Disease (PAD)
Research infrastructure & methodology: XLPAD registry Core laboratory
Research findings: Key publications Grants
Updated slide kit, February 2006
3
PAD: A Global Epidemic
The global prevalence of PAD increased by 24% from 2000 to 2010, from 164 million to 202 million
32 million peripheral diagnostic & interventional procedures performed annually in the U.S.
55 million
15 million
10 million
45 million
15 million
15 million
42 million
6 million
Fowkes et al. Lancet 2013, volume 382, issue 9901, pages 1329-1340
Long-Term Survival in Patients With PAD
Criqui MH et al. N Engl J Med. 1992;326:381-386.
Normal subjects
Asymptomatic PAD
Symptomatic PAD
Severe symptomatic PAD
100
75
50
25
0 2 4 6 8 10 12
Su
rviv
al (%
)
Year
624 men and women who were residents of a predominantly white, upper-middle-class community in southern CA
Predictive Value of ABI in Patients with Established CAD (XLPAD® Registry)
Banerjee et al. AJC 2013
ABI<0.9(58.4%)
ABI=0.9-1.4(38.7%)
ABI>1.4(2.9%)
Prevalence of Abnormal ABI in Patients with Stable CAD
ABI: ankle-brachial index, CAD: coronary artery disease, Normal ABI (>0.9 and <1.4), Abnormal ABI (<0.9 and >1.4)
n=679
Predictive Value of ABI in Patients with Established CAD (XLPAD® Registry)
Cardiovascular Events Based on ABI values & Diabetes Mellitus
no DM, normal ABI DM, normal ABI no DM, abnormal ABI DM, abnormal ABI0
5
10
15
20
25
1.16
4.483.91
5.524.65
5.977.03
14.29
2.33 2.24
0
4.223.45
4.23
6.15
13.46
7.95
12.4111.45
20.63
1-Y
ear
Eve
nt
Rat
e (%
)
p=0.006
p=0.40
p=0.29
Death Non-fatal myocardial infarction Stroke Repeat coronary revascularization MACE
(n=88) (n=145) (n=131) (n=315)
n=679
Predictive Value of ABI in Patients with Established CAD (XLPAD® Registry)
Banerjee et al. AJC 2013
Freedom form Major Adverse Cardiovascular Events (MACE)
No DM, Normal ABIDM, Normal ABINo DM, Abnormal ABIDM, Abnormal ABI
(n=88)n=679
(n=88)(n=145)(n=131)
(n=315)
No DM, Normal ABI (Reference group)
DM, Normal ABI (HR=1.7, 95% CI: 0.71-4.06, p=0.24)
No DM, Abnormal ABI (HR=2.03, 95% CI: 0.83-4.98, p=0.12)
DM, Abnormal ABI (HR4.85, 95% CI: 2.22-10.61, p=0.0001)
Peripheral Artery Anatomy SFA: superficial femoral
artery
Longest artery, highly dynamic
Repetitive trauma, & prone to atherosclerosis
In a fibromuscular canal
Lack of compensatory expansion, limited collaterals
Site of most frequent endovascular procedures
PAD: highly prevalent in Veterans
Soor GS et al. Pathology 40(4), pp. 385–391
SFA
PAD: Endovascular Intervention, Surgery & Amputation Trends: 1996-2006
100
200
300
400
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
Num
ber o
f pro
cedu
res
/100
,000
Med
icar
e be
nefic
iarie
s
Years J Vascular Surgery 2009; 50:54-60
Total endovascular interventionsRR=3.3; 95% CI 2.9-3.8
Major LE amputationRR=0.71; 95% CI 0.7-0.8
LE bypass surgeryRR=0.58; 95% CI 0.5-0.7
3x growth in endovascular interventions
Ehrin Armstrong, MDMazen Abu-Fadel, MDOsvaldo Gigliotti, MDAnand Prasad, MD
Nicolas Shammas, MDAndrew Klein, MDRobert Dieter, MDM Ishti Ali, MD
Subhash Banerjee, MD (Principal investigator)Tony Das, MDGerardo Rodriguez, MDEdiberto Soto-Cora, MD
Established 2013: Total procedures: 2,500 Total patients: 1,600
The XLPAD website: www.xlpad.org, Clinicaltrials.gov #: NCT01904851
Excellence in Peripheral Artery Disease
http://www.xlpad.org
XLPAD Registry Research infrastructure:
UTSW RedCap (NIH) infrastructure & data servers
Contracts with participating sites through UTSW research office
Data transfer agreements with each site On-site monitoring, audit & data
collection Remote access to EMR & cath lab data
archive through third party vendor Approved by VA & non-VA sites
XLPAD Registry
Scientific value: Multicenter (VA &
non-VA; women, inter-disciplinnary)
>92% data audits Independent, blinded
adjudication of clinical & procedural findings
Publications & presentations
Background data for prospective studies
Participant value: 20 peer-reviewed
publications 2014-15 32 national meeting
presentations Data access to site
investigators & students
Peer-peer education Background data for
grants
LDA analyzer
Source DICOM Files
VA North Texas Cardiovascular Core LaboratoryCoronary and Vascular Quantitative Analyses
PVR
Intervention strategy: SFA CTO
SFA CTO
Crossing
Wire-catheter
Crossing device
Treatment
Balloon Stent
Balloons & stents: bare, non-drug coated or anti-proliferative drug coated
SFA; superficial femoral artery; CTO: Chronic total occlusion
CTO Crossing StrategiesCrossing CTO Lesions
CTO Crossing Device Guidewire and Catheter
CXI
GlideCath
Trailblazer
QuickCros
s
NaviCross
Rubicon
Viance
Frontrunner
Wildcat/Ocelot
Crosser
TruePath
Banerjee et al J Invasive Cardiol 2014 26(8): 363-9
Charalambous et al Cardiovasc Intervent Radiol 2010; 33(1): 25-33Shetty et al J Invasive Cardiol 2013; 25(7):344-7
Banerjee et al J Endovasc Ther 2014; 21(2):281-8Bosiers et al J Endovasc Ther 2014; 21(1):61-70
Joye et al Am J Cardiol 2007; 100(Suppl 1):S24Gandini et al J Endovasc Ther 2009; 16(1):23-7Staniloae et al J Invasive Cardiol 2011; 23(9):359-62
Pigott et al J Vasc Surg 2012; 56(6):1615-21
Selmon et al J Endovasc Ther 2013; 20(6):770-81
0.014’’, 0.018’’, and 0.035’’ guidewires
www.xlpad.org
CTO Crossing: Primary technical success
www.xlpad.org
Procedural Success: Successful revascularization of the CTO with a ≤30% residual diameter stenosisWire-catheter CTO-crossing device
CTO Crossing: Secondary technical success
www.xlpad.org
CTO Crossing: provisional technical success
www.xlpad.org
Results: Technical & Procedural Success
Primary Technical Success (%)
51.9
72.1
Wire-Catheter (n=295)
CTO Device (n=143)
P<0.001
Procedural Success (%)
93.6 90.9
P=0.332
Results: 12-month Adverse Events
Death
Endovascular Revascularization
Surgical Revascularization
Unplanned Amputation
Stent Thrombosis
4.7
19.7
8.8
3.4
4.1
3.5
19.5
2.8
2.1
6.3
%
P=0.343
P=0.560
P=0.025
P=1.000
P=0.626
CTO deviceWire catheter
Results: 12-month Clinical Outcomes
Wire-Catheter CTO Device
Before After
P<0.001
Wire-Catheter CTO Device
P<0.001 P<0.001P<0.001
Ankle-Brachial Index
Rutherford Category
3.31 ± 1.24
2.67 ± 1.51
3.22 ± 1.30
2.46 ± 1.53 0.71
± 0.31
0.81 ± 0.24
0.83 ± 0.26
0.70 ± 0.32
Dual antiplatelet therapy (DAPT) Patient Flow Chart
334 unique patients from XLPAD registry (NCT01904851) followed for up to 12
months after index procedure
27 did not receive DAPT
therapy
176 received DAPT therapy for ≤3 months before
discontinuation OR first occurrence of MAE
131 received DAPT therapy for >3 months before
discontinuation OR first occurrence of MAE
“≤3 months DAPT” (n=203)
“>3 months DAPT” (n=131)
www.xlpad.org
12-m outcome analyses: ‘as treated’ & ‘as treatment prescribed’
Banerjee et al. SCAI 2014
www.xlpad.org
≤3 months DAPT (n=203)
>3 months DAPT (n=131)
Results: Major adverse event (MAE)-free survival with ≤3m & >3m DAPT
Hazard ratio*: 1.60 95% Confidence Interval: 1.08-2.43; p=0.019
10
1.0
0.8
0.6
0.4
0.2
0.0
2 4 6 8 12
Months of follow-up
MA
E F
ree S
urv
ival
*Adjusted for age, diabetes, hypertension, hyperlipidemia, smoking, ankle-brachial index, Rutherford category, prior lower-extremity procedure, and coronary artery disease
59.7%
70.3%
p=0.002
a b c d
Figure 1: Case of definite stent thrombosis
Banerjee et al. Circulation 2015 (in review)
Stent-based femoropopliteal peripheral artery intervention (n=724)
Peripheral artery stent thrombosis(n=29; 4.0%)
No peripheral artery stent thrombosis(n=695; 96.0%)
Definite stent thrombosis
(n=23; 3.2%)
Probable stent thrombosis(n=1; 0.1%)
Possible stent thrombosis(n=5; 0.7%)
Timing of stent thrombosis (days)Median=30; 25%-75% IQR=[7-150]
Very late stent/vessel thrombosis(n=2; 0.3%)
Late stent/vessel thrombosis
(n=12; 1.7%)
Early stent/vessel thrombosis
(n=15; 2.1%)
Acute stent/vessel thrombosis(n=5; 0.7%)
Sub-acute stent/vessel thrombosis
(n=10; 1.4%)
Figure 2: Flowchart describing stent thrombosis
Events
At risk
0
717
19
523
23
410
25
285
29
154
Kap
lan
-Mei
er F
ailu
re (
%)
6.3%
0 2 6 10 12Months
4 8
20
40
0
Figure 3: 12-month stent thrombosis rate
Banerjee et al. Circulation 2015 (in review)
BMS (n=541) DCS (n=74) Supera™ (n=57) Viabahn™ (n=52)0
2
4
6
8
10
12
14
3.1
4.1
5.3
11.5
Sten
t Thr
ombo
sis
(%)
Figure 4a: Rate of stent thrombosis by stent type
p=0.011
p=0.72
p=0.43
Figure 5a: 12-month MALE for patients with and without stent thrombosis
Non-stent thrombosis
Stent thrombosis
aAdjusted for age, ABI, diabetes mellitus, CAD, CLI, smoking
aHR=3.04, 95% CI=[1.62-5.25], p=0.001
Kap
lan
-Mei
er F
ailu
re (
%)
Months
27.2%
58.0%
P<0.0001
0 2 4 6 8 10 12
20
40
60
80
100
Figure 5b: 12-month MACE for patients with and without stent thrombosis
Non-stent thrombosis
Stent thrombosisaHR=1.10, 95% CI=[0.69-1.64], p=0.675
aAdjusted for age, ABI, diabetes mellitus, CAD, CLI, smoking
Kap
lan
-Mei
er F
ailu
re (
%)
Months
7.8%
7.7%
P=0.781
0 2 4 6 8 10 120
20
40
Banerjee et al. Circulation 2015 (in review)
Endovascular Intervention Procedural Cost Analysis
Heakyung et al. ACC 2016 Submission
1. Comparative Assessment of Guidewire and Microcatheter versus a Crossing Device–Based Strategy to Traverse Infrainguinal Peripheral Artery Chronic Total Occlusions. Banerjee S, Sarode K, Patel A, Mohammad A, Parikh R, Armstrong EJ, Tsai S, Shammas NW, Brilakis ES. J Endovasc Ther 2015
2. Drug Coated Balloon and Stent Therapies for Endovascular Treatment of Atherosclerotic Superficial Femoral Artery Disease. Banerjee S, Sarode K, Mohammad A, Brilakis ES. Curr Cardiol Rep 2015
3. Optimal Dual Antiplatelet Therapy after Infrainguinal Endovascular Endovascular Revascularization. Sarode K, Mohammad A, Das S, Vinas A, Banerjee A, Brilakis ES, Banerjee S. Ann Vasc Surg 2015
4. Recanalization of Popliteal and Infrapopliteal Chronic Total Occlusions using Viance and CrossBoss Crossing Catheters: a Multicenter Experience from the XLPAD Registry. Sethi S, Mohammad A, Ahmed H, Germanwala S, Sarode K, Ortiz-Lopez C, Banerjee S, Prasad A. J Inv Cardiol. 2015
5. Stent and Non-stent Based Outcomes of Infrainguinal Peripheral Artery Interventions From the Multicenter XLPAD Registry. Banerjee S, Pershwitz G, Sarode K, Mohammad A, Abu-Fadel MS, Baig MS, Tsai S, Little BB, Gigliotti OS, Soto-Cora E, Foteh MI, Rodriguez G, Klein A, Addo T, Luna M, Shammas NW, Prasad A, Brilakis E. J Inv Cardiol. 2015
6. Blunt microdissection for endovascular treatment of infra-inguinal peripheral arterial chronic total occlusions: featured case series, outcomes and comparative description of crossing devices. Banerjee S, Hadidi OF, Mohammad A, Alsamarah A, Thomas R, Sarode K, Garg P, Baig MS, Brilakis ES. J Endovasc Ther. 2014
7. Endovascular treatment of infra-inguinal peripheral arterial chronic total occlusions with the TruePath device: featured case series, device features, handling and procedural outcomes. Banerjee S, Sarode K, Das T, Hadidi OF, Thomas R, Vinas A, Garg P, Mohammad A, Baig MS, Shammas N, Brilakis E. J Endovasc Ther. 2014
8. Significance of an abnormal ankle-brachial index in patients with established coronary artery disease with and without associated diabetes mellitus. Banerjee S, Vinas A, Mohammad A, Hadidi OF, Thomas R, Sarode K, Banerjee A, Garg P, Weideman R, Little B, Brilakis ES. Am J Cardiol. 2014
9. Crossing of Infra-inguinal Peripheral Arterial Chronic Total Occlusion with Viance™ Blunt Microdissection Catheter. Banerjee S, Thomas R, Sarode K, Das T, Hadidi OF, Vinas A, Garg P, Mohammad A, Baig MS, Abu-Fadel M, Shammas NW, Prasad A, Brilakis ES. J Invasive Cardiol. 2014
10. Drug Delivering Technologies for Endovascular Management of Infrainguinal Peripheral Artery Disease. Sarode K, Spelber D, Bhatt D, Mohammad A, Prasad A, Brilakis ES, Banerjee S. J Am Coll Cardiol Intv. 2014
11. Protected PTA in the lower limbs: a step forward in preventing distal embolization. Banerjee S, Sarode K, Brilakis ES. J Endovasc Ther. 201312. Commentary: embolic capture angioplasty with the 300-mm long proteus balloon. Banerjee S, Garg P, Brilakis ES. J Endovasc Ther. 201213. Embolic capture angioplasty in peripheral artery interventions. Hadidi OF, Mohammad A, Zankar A, Brilakis ES, Banerjee S. J Endovasc Ther.
2012
XLPAD Key Publicationswww.xlpad.org
VA Cooperative Clinical Trial (VA CCTA0002)
4 centers ($2.0M)
Translational research
3 industry grants for PAD intervention & atherosclerosis imaging
Real-world device use, efficacy & safety
Interaction of device & drug therapies
Participant QOL & health-economic analysis
Grantswww.xlpad.org
PAD is highly prevalent and is associated with worse cardiovascular and limb outcomes
XLPAD registry provides a unique platform to conduct large-scale multicenter outcomes research in patients with PAD
Findings from the XLPAD registry has provided important scientific data & supported successful grant applications
XLPAD registry could potentially serve as a template for building diverse investigational collaborations
Conclusionswww.xlpad.org
Acknowledgements
Emmanouil S. Brilakis, MD, PhD
Clark Gregg, MD
Richard Miller, MD
Joseph Hill, MD, PhD
Scott Grundy, MD
Anand Prasad, MD
Nicolas Shammas, MD
Osvaldo S. Gigliotti, MD
Mazen Abu Fadel, MD
Tayo Addo, MD
Michael Luna, MD
Dharam Kumbhani, MD
Jeffry Hastings, MD
Gerold Grodin, MD
Shuaib Abdullah, MD
Joseph Garcia, MD
Laura Collins, MD
Nicole Minniefield, MD
Knyugen Kytai, PhD
Xu Hao, PhD
Atif Mohammad MD
Preeti Kamath, BDS
Michele Lytal, RN
Evaster Bennett, LVN
Puja Garg, PhD
Swagata Das, MBBS
Karan Sarode, BS
Bertis Little, PhD
Rick Weideman, PharmD
Kevin Kelly, PharmD
Cheryl Webb-Singh
Donald Haagan, RVT
Teresa Jeong, RN
Susan Droughty, RN
Lauren Makke, RVT
Dwaine William
Tina Terry, RN
Smitha Thomas, RN
Diana Lacey, RN
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