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Calcium: The Achilles Heel of Endovascular Procedures?
Scaffold or remove before drug delivery
Konstantinos Stavroulakis MD
University of Münster and
St. Franziskus Hospital
Germany
Disclosure
K Stavroulakis
I have the following potential conflicts of interest to report:
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
Factors associated with restenosis in peripheral interventions
• Lesion length1
• Diabetes2
• CTOs3
• Calcification4
1. Norgren et al. Eur J Vas Endovasc Surg 33, S1-S75: 2007. 2. DeRubertis et al. J Vasc Surg 2008;47:101-108. 3. Lida et al. Cath and Cardiovasc Interven 2011 Oct 1;78(4):611-7. 4. Cioppa et al. CV Revasc. Med. 2012 Jul-Aug:219-23.
Calcium still a challenge for ET
• Prevalence of vascular calcification in symptomatic PAD is unknown (~30-50% in asymptomatic patients)
• Vessel non-compliance leads to overstretch in non-diseased tissue causing dissection, recoil, excessive injury and poor outcomes
Fully Inflated BalloonElastic Recoil
(Residual High Grade Stenosis)
Impact of Calcium
Okuno et al JEVT, 2016. 23(5) 731–737
The current problems of POBA
Okuno et al JEVT, 2016. 23(5) 731–737
Scaffolds for calcified lesions
Rocha-Singh et al. Catheterization and Cardiovascular Interventions 89:1250–1256 (2017)
Bare Metal Stents
Garcia et al, Catheterization and Cardiovascular Interventions 89:1259–1267 (2017)
Interwoven Nitinol Stents
@ 2
years
Scaffolds for severely calcified lesions
IN.PACT DCB and Calcium Registry Study (n=60) 12 month Results1
1. Fanelli F, et al. Cardiovasc Intervent Radiol, 37: 898-907 (2014).2. Tepe G, et al. J Endovasc Ther. 2015 Oct;22(5):727-33.
• Retrospective analysis of 91 patients2
• Analysed at 6M post DEB• Lesion calcification analysed by core labs
(PACSS score + angiographic calcium score)• Severity of lesion calcification is associated
with LLL after treatment with DCB. • Author conclusion: “One possible approach
to overcome this limitation might be plaque modification or removal prior to DEB usage.”
Drug coated balloons
DCB and Bailout stent rates
LUTONIX Global1ILLUMENATE
Global2
IN.PACT Global Full Clinical
Cohort3
IN.PACT Global Long Lesion4
IN.PACT Global CTO5
IN.PACT Global ISR6
Follow-up
691 subjectsComplete follow-up
Site-reported
InterimCore Lab-
adjudicated
1406 subjectsComplete follow-up
Core Lab-adjudicated
157 subjectsComplete follow-up
Core Lab-adjudicated
126 subjectsComplete follow-up
Core Lab-adjudicated
131 subjectsComplete follow-up
Core Lab-adjudicated
Key Lesion Characteristics
Length (cm)CTO (%)Ca2+ (%)
10.12cm31.2%50.2%
7.2cm28.3%62%
12.1cm35.5%68.7%
26.4cm60.4%71.8%
22.9 cm100.0%71.2%
17.2cm34.0%59.1%
Primary Patency FF TLR/CD-TLR
85.4%94.1%
86.5%93.9%
-92.6%
91.1%94.0%
84.4%88.2%
88.7%92.9%
Bail-out Stent (%) 25.2% 15.0% 25.3% 40.4% 46.8% 14.5%
1. Presented by Benenati, JF. VIVA 2016 BARD Symposium2. Presented by Krishnan, P. NCVH 2016.3. Presented by Jaff M, VIVA Las Vegas 2016.
4. Presented by Scheinert D, PCR Paris 2015.5. Presented by Tepe G, CX London 2016.]6. Presented by Brodmann M, VIVA Las Vegas 2015.
Plaque Modification
Luminal Gain
Less Dissections
Increased Drug Uptake
Less permanent scaffolds
Improved patency
Why debulking?
Drug uptake after vessel prep
Tzafriri et al, J Control Release. 2017; 264: 203–210
Roberts, Catheterization and Cardiovascular Interventions 84:236–244 (2014)
Directional atherectomy
Minko et al, Cardiovasc Intervent Radiol (2014) 37:1165–1170
Directional atherectomy as standalone therapy
Directional atherectomy with anti-restenotic therapy (DAART)
Severe calcified lesions
Mean lesion length: 115 mm
CTOs: 13.3%
Bailout Stent: 6.7%
12 M PPR: 90%
12 M TLR: 10%
Amputation Rate: 0%
A. Cioppa et al. / Cardiovascular Revascularization Medicine 13 (2012) 219–223
DAART for popliteal disease
DCB DAART P Wert
Primary patency 65% 82% 0.021
Freedom from TLR 82% 94% 0.7
Stavroulakis et al JEVT. 2017;24(2):181-188
DEFINITIVE AR – Study design
Inclusion Criteria• RCC Score of 2, 3 or 4
• 70% stenosis, restenosis or occlusion in the SFA and/or popliteal artery
• Target lesion(s) length is 7-15 cm
• Target vessel diameter is 4 mm and ≤ 7 mm
Exclusion Criteria• In-stent restenosis
• Aneurysmal target vessel
• 2 or more lesions that require treatment in the target limb
Zeller et al, Circ Cardiovasc Interv. 2017;10:e004848.
DEFINITIVE AR – Baseline Demographics
* p-value for DA+DCB RCT and DCB groups
Baseline DemographicsDA+DCB(N=48)
DCB (N=54) p-Value*DA+DCB Severe
Ca++(N=19)
Lesion Length (cm) 11.2 9.7 0.05 11.9
Diameter Stenosis 82% 85% 0.35 88%
Reference vessel diameter (mm) 4.9 4.9 0.48 5.1
Minimum lumen diameter (mm) 1.0 0.8 0.34 0.7
Calcification 70.8% 74.1% 0.82 94.7%
Severe calcification 25.0% 18.5% 0.48 89.5%
Zeller et al, Circ Cardiovasc Interv. 2017;10:e004848.
DEFINITIVE AR – Peri-procedural Outcomes
Higher Technical Success and Lower Incidence of Flow-Limiting Dissection in DA+DCB RCT Arm
Technical success defined as achieving ≤30% residual stenosis following protocol-defined treatment and before adjunctive therapy (ie post-dilatation). No surgical interventions were required for any patient.
* p-value for DA+DCB RCT and DCB groups
OutcomesDA+DCB(N=48)
DCB (N=54) p-Value*DA+DCB Severe
Ca++(N=19)
Technical Success 89.6% 64.2% 0.004 84.2%
Distal Embolization 6% (3/48) 0% (0/54) 0.101 5.3% (1/19)
Bail-Out Stent 0% (0/48) 3.7% (2/54) 0.50 5.3% (1/19)
Dissection (flow limiting, Grade C/D)
2% (1/48) 19% (10/54) 0.01 0% (0/19)
Perforation 4% (2/48) 0% (0/54) 0.22 0% (0/19)
Zeller et al, Circ Cardiovasc Interv. 2017;10:e004848.
DEFINITIVE AR – 12 Month OutcomesAngiographic Patency
Perc
en
t A
ng
iog
rap
hic
Pate
ncy
Results for all patients who returned for angiographic follow-up
Per Core Lab Assessment. “All Severe Ca++ “ group includes all patients treated with DA+DCB therapy including randomized and non-randomized patients with severe calcium.
Zeller et al, Circ Cardiovasc Interv. 2017;10:e004848.
The value of Luminal gain after DAART
Zeller et al, Circ Cardiovasc Interv. 2017;10:e004848.
After Atherectomy After DAARTLong-Severely Calcified Lesion
DAART for calcified lesion
Treatment Algorithm for severely calcified lesions
Scaffolds
• CKD patients
• Long CTOs
• CLI (?)
• Subintimal (?)
Vessel Prep + DCBs
• Younger patients
• Claudicants
• ‘No-stenting-zones’
• Benefit from the use of scaffolds
• DCB angioplasty is associated with increased LLL and
loss of patency
• Vessel Prep can improve the outcomes of ‘leave-
nothing-behind’
• Debulking:
- Less permanent scaffolds
- Increased Drug Uptake
- Improved patency
Calcium: The Achilles Heel of Endovascular Procedures?
Scaffold or remove before drug delivery
Konstantinos Stavroulakis MD
University of Münster and
St. Franziskus Hospital
Germany