achilles-study (des for btk)summitmd.com/pdf/pdf/13-1.schmidt.pdf · achilles: study flowchart ......
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ACHILLES-Study(DES for BTK)
A. Schmidt, MDCenter of Vascular Medicine – Angiology and Vascular Surgery
Park Hospital Leipzig, Germany
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The ACHILLES Study
A Prospective, Randomized, Multicentre Comparison of Balloon Angioplasty and the
CYPHER SELECT® Plus Coronary and Infrapopliteal Stent in the Treatment of
Infrapopliteal Arterial Disease
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The ACHILLES Study
Background
• Several single-centre studies have shown the safety and efficacy of the sirolimus-eluting stent in BTK-lesions.
• The sirolimus-eluting stent (Cypher™, Cordis) has received CE-mark approval in 2006 for use in infrapopliteal arteries.
• ACHILLES was designed to compare for the first time the performance of a drug-eluting stent with balloon angioplasty (PTA) for lesions in infrapopliteal arteries in a randomized trial using an angiographic primary endpoint.
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ACHILLES: Investgators and Study SitesGermany•D. Scheinert, MD,
Leipzig – Coordinating Investigator• V. Geist, MD, Bad Segeberg• P. Huppert, MD, Darmstadt• H. Krankenberg, MD, Hamburg• K. Brechtel, MD, Tübingen• T. Zeller, MD, Bad KrözingenAustria• J. Lammer, MD and R. Koppensteiner, MD, ViennaBelgium• M. Bosiers, MD, Dendermonde• W. Lansink, MD, Genk
Switzerland- I. Baumgartner, MD, BernCzech Republic- J. Peregrin, MD, PragueFrance- P. Commeau, MD, Ollioules- P.E. Magnan, MD, MarseilleGreece- D.Siablis, MD, RionItaly- P. Rubino, MD, MercoglianoUK- P. Sidhu, MD, London
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ACHILLES: Study Design• Design: Prospective, randomized, multicentre trial
• Primary endpoint: in-segment binary restenosis at 12 months by quantitative angiographic analysis
• Secondary endpoints: technical success rates, TLR, TVR, death, amputation, Rutherford status, stent fracture, and wound status
• Clinical follow-up: 6 weeks, 6 months, 12 months
• Event adjudication: independent CEC and DSMB
• Wound analysis: independent clinical reviewer, blinded to treatment assignment
• Anti-platelet regimen: Aspirin/Clopidogrel at least for 6 months
• Sponsor: Cordis, Johnson&Johnson
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Symptomatic CLI (Rutherford 3 - 5) De novo or restenotic (after PTA only) lesion(s)
in the tibial arteries
Target vessel diameter 2.5 and 3.5 mm Target lesion stenosis > 70% DS
Maximum of 2 vessels in 1 limb (each 1 lesion) with a maximum lesion length of 120 mm
Maximum of 4 stents within 1 vessel, or in total for 2 lesions
Additional non-TL in a non-TV could be treated at investigators discretion by PTA (or bailout stenting if needed)
ACHILLES: Inclusion Criteria
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ACHILLES: Study FlowchartTotal Patient PopulationTotal Patient Population
n = 200n = 2001:1 randomization1:1 randomization
CYPHER SELECTCYPHER SELECT®® PlusPlusn = 99 patientsn = 99 patientsn = 113 lesionsn = 113 lesions
Stent(s) implanted (99 patients)Stent(s) implanted (99 patients)Stents/patient: 1.8 on avg.Stents/patient: 1.8 on avg.
12 months follow12 months follow--up:up:Pts. Comp. clinical f/u: n=80 (79.2%)Pts. Comp. clinical f/u: n=80 (79.2%)
-- Deceased (n = 12)Deceased (n = 12)-- Withdrew consent (n = 3)Withdrew consent (n = 3)-- Lost to FU (n = 6)Lost to FU (n = 6)
Lesions eval. angio f/u : n=74 (64.3%)Lesions eval. angio f/u : n=74 (64.3%)
Balloon AngioplastyBalloon Angioplastyn = 101 patientsn = 101 patientsn = 115 lesionsn = 115 lesions
PTA (93 patients)PTA (93 patients)CCrossross--over to Stent (8 patients)over to Stent (8 patients)
12 months follow12 months follow--up:up:Pts. comp. clinical f/u: n=74 (74.7%)Pts. comp. clinical f/u: n=74 (74.7%)
-- Deceased (n = 11)Deceased (n = 11)-- Withdrew consent (n = 4)Withdrew consent (n = 4)-- Lost to FU (n = 10)Lost to FU (n = 10)
Lesions eval. angio f/u : n=67 (59.3%)Lesions eval. angio f/u : n=67 (59.3%)
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ACHILLES: Patient Demographics - ITT
CYPHER CYPHER SELECTSELECT®® PlusPlus(99 Patients)(99 Patients)
PTAPTA(101 Patients)(101 Patients)
pp--valuevalue
Age, yearsAge, years 72.4 72.4 ±± 9.49.4 74.3 74.3 ±± 8.28.2 0.1170.117Male, %Male, % 67.767.7 75.275.2 0.2740.274History of CAD, %History of CAD, % 45.545.5 44.644.6 1.0001.000History of PVD, %History of PVD, % 66.766.7 63.463.4 0.6580.658Diabetes, %Diabetes, % 64.664.6 64.464.4 1.0001.000Hyperlipidemia, %Hyperlipidemia, % 77.677.6 68.368.3 0.1540.154Hypertension, %Hypertension, % 89.989.9 91.191.1 0.8130.813Smoker, %Smoker, % 38.438.4 26.326.3 0.0940.094
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CYPHER CYPHER SELECTSELECT®® PlusPlus(113 Lesions)(113 Lesions)
PTAPTA(115 (115
Lesions)Lesions)
pp--valuevalue
Total Lesion Length, mmTotal Lesion Length, mm 26.9 26.9 ±± 20.920.9 26.8 26.8 ±± 21.321.3 0.9900.990
Total Occlusion, %Total Occlusion, % 81.381.3 75.475.4 0.3340.334
Total Length of Occlusion, Total Length of Occlusion, mmmm
6.7 6.7 ±± 19.319.3 11.0 11.0 ±± 22.422.4 0.1350.135
Reference Vessel Diameter, Reference Vessel Diameter, mmmm
2.6 2.6 ±± 0.50.5 2.6 2.6 ±± 0.60.6 0.9910.991
Restenotic Lesions, %Restenotic Lesions, % 5.35.3 1.81.8 0.1710.171
Calcification Calcification (moderate, severe), %(moderate, severe), %
15.115.1 15.215.2 1.0001.000
ACHILLES: Lesion Characteristics - ITT
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Balloon AngioplastyBalloon AngioplastyCYPHER SELECTCYPHER SELECT®® PlusPlus
P = NSP = NS
ACHILLES: Lesion Location - ITT
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CYPHER CYPHER SELECTSELECT®®
113 Lesions113 Lesions
PTAPTA115 Lesions115 Lesions
pp--valuevalue
PrePre--procedure Stenosis, %procedure Stenosis, % 68.8 68.8 ±± 19.319.3 74.0 74.0 ±± 19.019.0 0.0560.056
PostPost--procedure Stenosis, %procedure Stenosis, % 13.3 13.3 ±± 14.314.3 25.9 25.9 ±± 15.215.2 < 0.001< 0.001
Device Success, %Device Success, %residual stenosis < 30% withresidual stenosis < 30% withAssigned treatmentAssigned treatment
95.595.5 58.258.2 < 0.001< 0.001
Lesion Success, %Lesion Success, %residual stenosis < 50% with residual stenosis < 50% with any treatmentany treatment
100100 96.996.9 0.1030.103
Procedure Success, %Procedure Success, %residual stenosis < 50% with residual stenosis < 50% with any treatment without any SAEany treatment without any SAE
94.894.8 92.992.9 0.7580.758
ACHILLES: Procedural Parameters - ITT
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22,4
41,9
0
10
20
30
40
50
CYPHER SELECT PLUS (n = 67)
PTA (n = 74)
The ACHILLES StudyPrimary Endpoint
12M In-Segment Binary Restenosis by QA*
P=0.019
21.3
45.5
0
10
20
30
40
50
CYPHER SELECT PLUS (n = 75)
PTA (n = 66)
P=0.004
%
* lesion-based analysis
n = 15/67 n = 31/74 n = 16/75 n = 30/66
Intention to Treat (ITT): As Treated:
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17.6
53,2
0
10
20
30
40
50
60
Diabetic Patients
CYPHER SELECT PLUS (n = 51)
PTA (n = 47)
The ACHILLES Study12M In-Segment Binary Restenosis by QA
in Diabetic Patients* - Lesion based analysis
P<0.001
*Post-hoc analysis
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The ACHILLES Study
Safety Endpoints at 12M Follow-up - ITT
CYPHER SELECT®
PTA p-value
Death 10.1% 11.9% 0.822
TLR, clinically driven 10.0% 16.5% 0.257
TVR, non TLR 6.4% 2.4% 0.263
Index Limb Amputations 13.8% 20.0% 0.307
Stent fractures 0.9% - -
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The ACHILLES StudyChange in Rutherford Classification – ITT
CYPHER SELECT® PTA p-value
Baseline (mean ± sd) 4.1 ± 0.9 4.0 ± 0.9 0.641
At 6 weeks
∆ vs baseline
2.6 ± 1.9
-1.5 ± 1.6
2.7 ± 2.0
-1.3 ± 1.6
0.701
0.548
At 6 months
∆ vs baseline
2.0 ± 1.8
-2.0 ± 1.7
2.5 ± 2.0
-1.5 ± 1.9
0.180
0.098
At 12 months
∆ vs baseline
1.9 ± 1.7
-2.2 ± 1.7
2.3 ± 1.8
-1.6 ± 1.8
0.189
0.077
There was a significant difference in the change from baseline to 12 months in the “As Treated” population: -2.2±1.6 vs. -1.6±1.8, p=0.044
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The ACHILLES Study
P=0.431 P=0.295 P=0.101
*Any amputation (major or minor) considered as wound failure
Closed Wound By Visit* - Independent Blinded Evaluation
Stent n=53 wounds n=49 wounds n=49 woundsPTA n=57 wounds n=51 wounds n=46 wounds
18.9%
12.3%
40.8%
29.4%
57.1%
39.1%
*Preliminary Data
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The ACHILLES Study - Summary
• The Achilles study achieved its primary endpoint and documented superiority of the Cypher™ sirolimus eluting stents in reducing rates of angiographic restenosis compared to PTA in infrapopliteal arteries at 12 months follow-up.
• There was a significant difference in device success and residual stenosis in favor of the Cypher™ arm, supporting the feasibility of stent implantation in the infrapopliteal territory.
• Rates of TLR, amputation or death were similar, however, the study was not powered for clinical endpoints.
• The rate of healed wounds – as assessed by an independent reviewer blinded to treatment allocation – showed a trend in favor of the stent arm at any follow-up time point.
• Implantation of sirolimus-eluting stents are a potentially promising therapeutic option to enhance interventional treatment of infrapopliteal arteries.
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Randomized Trials DES BTK
- YUKON:- Yukon BMS vs. Sirolimus coated stent (no polymer)
- DESTINY:- BMS (Multilink Vision) vs. Xience V (Everolimus)
- ACHILLES:- Balloon vs. Cypher Select (Sirolimus)
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DESTINY-Trial DES vs. BMS
Bosiers et al. LINC 2011
Primary patency (angiographical at 12 months)
85.2% for DES85.2% for DES(Xience V)(Xience V)
54.3% for BMS(Multilink Vision)54.3% for BMS54.3% for BMS(Multilink Vision)(Multilink Vision)
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Standard-Treatment BTK
- Standard-treatment BTK is plane balloon-angioplas
not BMS-implantation.
- If improvement of patency is the goal, comparison o
DES to standard-treatment (POBA) is reasonable.
- The Achilles-trial design is therefore the appropria
concept, not the Destiny- and Yukon-design.
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Drug-Eluting Stents Below-The-KneeDrugDrug--Eluting Stents BelowEluting Stents Below--TheThe--KneeKnee
52 years, DM, Rutherford 5 Cypher 3,5/33mmCypher 3,5/33mm
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Angioplasty with Uncoated Balloons (POBA)
Occlusion ATA, Stenosis PAOcclusion ATA, Stenosis PA 3-mo re-occlusion3-mo re-occlusionAfter POBA both arteriesAfter POBA both arteries
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Leipzig Experience with DEB BTK
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Leipzig Experience with DEB BTK
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Leipzig Experience with DEB BTK
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Leipzig Experience with DEB BTK
3-months follow-up angiography
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Leipzig Experience with DEB BTK
61% restenosis reduction
POB BTK DEB BTK
Lesion-length 183 mm 173 mm
Restenosis >50 % @ 3 Mo 69 % 27 %
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Use of Cypher BTK in Daily Practice
- Short BTK lesions
- Younger patients
- When long wound-healing time is expected
- Calcified lesions
Is dual anticoagulation for 6 mo possible ?
Always full-lesion coverage !
Often as primary treatment, not only for bailout
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Residual stenosis
Balloon-angioplasty
Focal stenting with DES
Problem of Long BTK-LesionsProblem of Long BTK-Lesions
Follow-up
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Long-Term Patency Cypher BTKLong-Term Patency Cypher BTK
Patients 150
Treated limbs 158
Mean clinical follow up 30,1 months
Deaths 26 (21%)
Limb amputations 3 (2%)
Mean angiographical follow up 21,9 months
Patients available for FU 100 (67%)
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Long-Term Patency Cypher BTKLong-Term Patency Cypher BTK
6 12 24 36 60
Patency 96,9% 87,0% 87,0% 83,8% 83,8%
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Clear Case forCypher-StentsClear Case forCypher-Stents
• 54 years, male pat.• Severe claudication left calf• Walking-capacity 100m• Sustained reliefe of symptoms
after DES-implantation
• 54 years, male pat.• Severe claudication left calf• Walking-capacity 100m• Sustained reliefe of symptoms
after DES-implantation