Essential following BTK - Long-term patency is intervention for limb salvage Thomas Zeller, MD
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Long-term patency is
essential following BTK
intervention for limb salvage
Thomas Zeller, MD
Universitäts-Herzzentrum
Freiburg-Bad Krozingen
Bad Krozingen, Germany
Faculty Disclosure Thomas Zeller, MD For the 12 months preceding this presentation, I disclose the following types of financial relationships: • Honoraria received from: Abbott Vascular, Angioslide, Bard Peripheral Vascular, Biomimics, Biotronik, Boston Scientific Corp., Cook Medical, Cordis Corp., Covidien, ev3, Inc., Gore & Associates, Lutonix, Medrad, Medtronic, Spectranetics, Straub Medical, TriReme, Veryan/Novate, VIVA Physicians, WL Gore • Consulted for: Abbott Vascular, Bard Peripheral Vascular, Boston Scientific Corp., Cook Medical, ev3, Inc., Gore & Associates, IDEV Technologies, Inc., Medtronic, Spectranetics, WL Gore
Faculty Disclosure (continued) Thomas Zeller, MD For the 12 months preceding this presentation, I disclose the following types of financial relationships: • Held common stock in: None • Research, clinical trial, or drug study funds received from: 480 biomedical, Angioslide, Bard Peripheral Vascular, Biomimics, Biotronik, Cook Medical, Cordis Corp., Covidien, ev3, Inc., Gore & Associates, IDEV Technologies, Inc., Medrad, Medtronic, Spectranetics, Terumo, TriReme, Volcano, WL Gore I will be discussing products that are investigational or not labeled for use under discussion.
“BTK Interventions”?
BTK disease = claudication and CLI
BTK interventions = CLI
Main goal of CLI therapy = functional limb preservation
1) Revascularization 2) Extravascular Care 3) Surveillance
All 3 must be optimalCLI: Flow (Entity and Time) Demand
1. A wound to heal requires higher blood flow beyond the basal metabolic need
2. In absence of wounds (or after wounds are healed), blood flow can be suboptimal
3. An incidental trauma triggers an immediate need of incremental blood flow
4. Other factors triggering sustained blood flow: suboptimal wound care, nondirect flow
to the wound related artery
5. Optimal revascularization (and durable patency) represents an insurance policy
against multifactorial and unpredictable CLI triggers of incremental blood flow
F. Vermassen 2010DEFINITIVE LE
Wound Healing in CLI (RCC 5 & 6)
52% 61% 72%
@ 3 months @ 6 months @ 12 monthsDES in Tibial Interventions
12-Month Follow-Up
Drug-Eluting Stent Randomized Trials
YUKON-BTK DESTINY ACHILLES†
SES/BMS EES/BMS SES/PTA
Patients (n)/lesions (n) 161/161 140/154 200/228
Rutherford-Becker class 2 to 5 4 and 5 3 to 5
Mean lesion length (mm) 30±8/31±9‡ 15.9/18.9‡ 26.9±21/27.5±22‡
Follow-up (months) 12 12 12
TLR (%) 9.7/17.5‡ 7.5/34.7* 10/16.5‡
Limb salvage rate (%) 98.4/96.8‡ 98.7/97.1‡ 86.2/80‡
Death (%) 17.1/13.9‡ 18.5/16.3‡ 10.1/11.9‡
† preliminary results
Rastan, et al. EHJ. 2011.
‡ ns
Bosiers, et al. JVS. 2011.
* P≤0.05
Scheinert, et al. JACC 2013YUKON, DESTINY & ACHILLES Trials
Primary Patency
PYUKON-BTK Trial: Event-Free Survival at 24 Months
Survival Free from TVR, Major and Minor Amputation, Myocardial Infarction
and Death Was Compared by Kaplan-Meier Analysis with the Use of the
Mantel-Cox Log-Rank Test
Rastan A, et al. JACC. 2012.MAE and Limb Salvage at 2-Year FU in CLI Patients
DES vs BMS (YUKON Trial)
Sirolimus Stent Bare Metal Stent P
CLI Cohort (N=38) (N=31)
Death 10 (26.3%) 10 (30.3%) 0.60
Major/minor amputation 1/1 (5.3%) 4/3 (22.6%) 0.04
TVR 4 (10.5%) 4 (12.9%) 0.70
Myocardial infraction 0 (0%) 2 (6.4%) 0.20
Limb salvage 37 (97.4%) 27 (87.1%) 0.10
Rastan A, et al. JACC. 2012.DES vs PTA in BTK (RCT)
ACHILLES1-2 trial – Cypher Select vs PTA
– Lesion length 2.7 cm (DES)/2.7 cm (PTA)
– 12-m TLR = 10.0% (DES) vs 16.5% (PTA) (p=0.257)
– 12-m wound heal rate (WHR): 61.7% (DES) vs 41.3%
(PTA) (p=0.0628)
39% TLR 49% WHR
p=0.257 p=0.0628
Scheinert D, et al. J Am Coll Cardiol. 2012;60:2290–5.
Konstantinos K. CIRSE. 2012 Oral Presentation.DES in BTK Lesion Trials
Limitations
• Mean lesion length ranging
from 15.9 to 31mm
– Longest lesions enrolled in
ACHILLES (up to 10cm)
• Unavailability of DES of
appropriate length
– Longest DES 38mm
• Uncertainty about the
performance of DES in
long lesionsDEB in Tibial Interventions
Clinical Reality in CLI Diffuse and Long Lesions
Diffuse & Long Lesions
Infrapopliteal Arteries
Diffuse Lesions
PTA PTA-DCB
Patients (n) 77 104
CLI (%) 100 83
Mean lesion length 18375 mm 17688 mm
Follow-up 460186 days 37865 days
Primary patency @ 3 months 31% 72.6 %
TLR 50% 17.3%
Limb salvage 100 95.6%
Schmidt, et al. CCI 2010.
Schmidt, et al. JACC 2011.POBA of BTK Lesions
Limitations
3-mo re-occlusion
Occlusion ATA, stenosis PA After POBA both arteries
Courtesy A. Schmidt.DEB in BTK Lesions
DEBATE BTK
First published randomized trial to
assess DEB vs PTA in a complex CLI–
diabetic population with 12-month
angiographic endpoint
CLI + Diabetes
150 (Tibial) Lesions
random
(1:1)
DEB Std PTA
(75 lesions) (75 lesions)
• Single-center randomized (1:1)
• CLI, diabetic patients Aspirin + Clopidogrel (1 month)
• IN.PACT Amphirion vs std PTA
12m Angio / Clinical FU
• Primary endpoint: 12-month
(>50%) angiographic RR 24 m Duplex / Clinical FU
Liistro F. LINC. 2013.DEB vs PTA in BTK (RCT)
DEBATE BTK [1] trial - IN.PACT vs PTA
– Lesion length 12.8 cm (DEB)/13.0 cm (PTA)
– 12-m TLR = 18.5% (DEB) vs 43.3% (PTA) (p=0.003)
– 12-m wound heal. rate (WHR) 86% (DEB) vs 67%
(PTA) (p=0.01)
59% TLR 28% WHR
p=0.003 p=0.01
Liistro F et al. Circulation 2013Economic Value Can Be Provided in a Number
of Different Ways in the Interventional Space
• Faster procedure times
• Fewer infections
• Reduced procedure costs
$£€ • Faster recovery times
• Reduction in needed materials
• More durable clinical
outcomesEconomic Value Can Be Provided in a Number
of Different Ways in the Interventional Space
• Faster procedure times: DES
• Fewer infections: DES & DEB
• Reduced procedure costs
•
$£€ Faster recovery times: DES &
DEB
• Reduction in needed materials
• More durable clinical outcomes:
DES & DEBDES vs DEB in BTK Interventions
Conclusion I
• Patency is necessary but not sufficient for wound healing
and ultimately limb salvage
• Durable and sustained blood flow to the wound is an
insurance against the variety of concomitant factors and
unpredictable triggers leading to either wound
persistence, deterioration, or recurrence
• DES in lesions with a length up to 10 cm may be the
solution to achieve the necessary patency levels
• DEB are the preferred revascularization for lesions
longer than 10 cm and foot artery lesionsRole of DES in BTK Interventions
Conclusion II
• The significant TLR reduction and higher
wound healing rates currently observed
with DES and DEB as compared to POBA
and BMS likely position this technology to
demonstrate a high cost-effectiveness
benefit as a general approachYou can also read
