tetra randomized european direct stenting study (trends) keith d. dawkins, m. j. suttorp, leif...
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Tetra Randomized European Direct Stenting Study
(TRENDS)
Tetra Randomized European Direct Stenting Study
(TRENDS)Keith D. Dawkins, M. J. Suttorp, Leif Thuesen, Edouard Benit, Armando Bethencourt, Ursula Morjaria, Susan
Veldhof, Bernard Chevalier, on behalf of the TRENDS investigators
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Direct Stenting Trials (n=4297)Direct Stenting Trials (n=4297)
Patients (n) Stent Type
BET 338 Tenax
CONVERTIBLE 202 BeStent 2
DIRECT 107 Multilink Duet
DIRECTO 151 NIR Primo
DIRECTOR I + II 520 R-Stent
DISCO 416 Various
DISTANCE - S7
PREDICT 400 S670SLIDE 362 Multilink DuetSWIBAP 400 NIRTRENDS 1000 Multilink TetraVELVET II 401 Bx Velocity
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Direct Stenting Trials (n=4297)Direct Stenting Trials (n=4297)
Patients (n) Stent Type
BET 338 Tenax
CONVERTIBLE 202 BeStent 2
DIRECT 107 Multilink Duet
DIRECTO 151 NIR Primo
DIRECTOR I + II 520 R-Stent
DISCO 416 Various
DISTANCE - S7
PREDICT 400 S670SLIDE 362 Multilink DuetSWIBAP 400 NIRTRENDS 1000 Multilink TetraVELVET II 401 Bx Velocity
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TRENDSTRENDS
To define the medium term performance of a no pre-dilatation strategy for elective stent implantation using the Multilink Tetra™ Stent
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TRENDSTRENDS
Multicenter, prospective clinical trial1:1 randomization to stent implantation with or without pre-dilatation1000 patient enrolment over a period of one year at 46 sites in Europe and South America
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1000 patients
TRENDS Trial DesignTRENDS Trial Design
Diagnostic catheter(Randomisation 1:1)
Direct Stent(501 pts)
Pre-dilatation(499 pts)
Angiographic follow-up(6 months)
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A Direct stenting strategyA Direct stenting strategy
Possible Advantages Shorter procedure
duration Less radiation Less contrast Reduced resource
utilisation Less embolization Less unprotected
barotrauma
Potential Disadvantages
Failure to cross lesionLoss of stentIncomplete stent deploymentIncrease in guide traumaUndersizing of stent (diameter & length)Poor visualisationError in stent positioning
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117
1327
2
128
14475
52
82
133
116
35
41
35
TRENDSTRENDS
Total Patients:1000
Pre-dilatation: 499Direct stent: 501
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TRENDSTRENDS
Multilink Tetra™ Coronary Stent SystemStent diameters: 2.75, 3.0, 3.5, 4.0 mmStent lengths: 8, 13, 18, 23 mm
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TRENDS Primary EndpointTRENDS Primary Endpoint
Major Adverse Cardiac Events at 30 daysDeath
Myocardial infarction (Q and non-Q)CABG, or re-PCI (TVR)
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TRENDS Secondary EndpointsTRENDS Secondary Endpoints
Use of multiple stents at each target lesionTotal procedure timeRadiographic screening timeContrast volumeTechnical successProcedural resource analysisDuration of hospital stayMACE at 6 monthsBinary angiographic restenosis per lesion at 6 months
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Symptomatic anginaPlanned de novo single lesions, or restenotic lesions (previous POBA) in native coronary arteriesMVD may be treated, one lesion per vesselTarget vessel diameter ≥2.75 mm to ≤4.25 mm, length ≤18 mm (visual)Target lesion ≥70% stenosis, TIMI flow ≥1
TRENDS Inclusion Criteria*TRENDS Inclusion Criteria*
* Selected
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Acute MI within the last 24 hoursUnprotected left main stem lesionLesion involving a significant side branch (>2 mm diameter)Evidence of severe calcificationUse of IVUS before stentingChronic total occlusion
TRENDS Exclusion Criteria*TRENDS Exclusion Criteria*
* Selected
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TRENDS Baseline Demographics (I)TRENDS Baseline Demographics (I)
Pre-dilatationn=499 (%)
Direct stentn=501 (%)
Age (years) 59.4(range 32-84)
59.9(range 31-84)
Male 78 78
Diabetes 18 15
Hypercholesterolemia
58 63
Hypertension 49 53
Family history 36 40
p=ns
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TRENDS Baseline Demographics (II)TRENDS Baseline Demographics (II)
Pre-dilatationn=499 (%)
Direct stentn=501 (%)
Current smoker 27 25
Previous smoker 46 43
Previous MI 37 38
Previous CABG/PCI 8 8
History of angina 97 98
p=ns
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TRENDS Lesion Characteristics (I)TRENDS Lesion Characteristics (I)
Pre-dilatation Direct stent
Procedure:
Single vessel 91% 93%
Two Vessel 8% 7%
Three vessel 1% 0%
p=ns
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TRENDS Lesion Characteristics (II)TRENDS Lesion Characteristics (II)
Pre-dilatation Direct stent
Vessel:
LAD 42% 40%
LCx 20% 25%
RCA 36% 34%
p=ns
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TRENDS Lesion Characteristics (III)TRENDS Lesion Characteristics (III)
Pre-dilatation Direct stent
ACC/AHA Class:
Type A 17% 17%
Type B1 44% 40%
Type B2 38% 42%
Type C 1% 1%
p=ns
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TRENDS Lesion Characteristics (IV)TRENDS Lesion Characteristics (IV)
Pre-dilatation Direct stent
TIMI Flow:
Grade 0 0% 0%
Grade 1 2% 2%
Grade 2 5% 5%
Grade 3 93% 93%
p=ns
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TRENDS Quantitative Coronary ArteriographyTRENDS Quantitative Coronary Arteriography
Pre-dilatationmean ± SD
(n = 472)
Direct stentmean ± SD
(n = 469)
Pre-procedure DS (%) 63.9 ± 11.2 64.7 ± 10.4
Pre-procedure MLD (mm) 1.07 ± 0.36 1.06 ± 0.36
Pre-procedure reference vessel diameter (mm)
2.99 ± 0.50 3.03 ± 0.56
Lesion length (mm) 12.4 ± 4.87 12.3 ± 4.89
Post-procedure MLD (mm) 2.95 ± 0.44 2.91 ± 0.49
Post-procedure DS (%) 7.95 ± 8.30 8.93 ± 9.73
p=ns
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0
10
20
30
40
50
Predilatation Direct Stent
TRENDS Stent Deployment PressureTRENDS Stent Deployment Pressure
<10 10-12 13-14 15-16 17-18 19-20 >20
Perc
ent
(%)
Maximum pressure (Atm)
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TRENDS Procedural Data (I)TRENDS Procedural Data (I)
Pre-dilatation Direct stentMaximum pressure 13.0 Atm 13.7 AtmBalloon-Artery Ratio 1.14 ± 0.51 1.14 ± 0.55Post implant dilatation
13.3% 15.9%
Additional stent implant
6.4% 6.7%
p=ns
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TRENDS Procedural Data (II)TRENDS Procedural Data (II)
Pre-dilatation Direct stentAdditional Stent implant:
Inflow dissection 13 11
Outflow dissection 8 10
Failure to cover original target lesion
7 10
Lesion at distant site 6 3
Thrombotic lesion 0 1
Unknown 0 1
p=ns
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TRENDS Procedural Data (III)TRENDS Procedural Data (III)
Pre-dilatation Direct stentScreening time (mins)
8.7 8.6
Procedure time (mins)
37.5 34.3*
Contrast volume (mls)
186 175#
Hospital stay (days) 3.6 3.4
*p=0.01, #p=0.05 (Fisher’s Exact Test)
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TRENDS Procedural Data (IV)TRENDS Procedural Data (IV)
Pre-dilatation Direct stent
Technical Success 100% 100%
p=ns
Technical Success: Ability to access the lesion, deploy the stent or remove the delivery system in the event of failure to cross the lesion without stent loss, balloon rupture or general device failure.
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TRENDS Procedural Data (V)TRENDS Procedural Data (V)
Pre-dilatation Direct stentResource utilization:
Guide wiresGuiding cathetersIVUS cathetersPTCA cathetersIABP cathetersTETRATM stentsOther stents
540554
9548
156819
543
586*
7 115#
155922
IIb/IIIa Inhibitor use 19.3% 18.8%
*p=0.02, #p=0.001 (Fisher’s Exact Test)
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TRENDS Cross-over to pre-dilatationTRENDS Cross-over to pre-dilatation
Direct stent (n=541)
Cross-over to pre-dilatation:
31 (5.7%)
Stent did not cross lesion 25
Guide catheter dissection 1
Ostial location 1
Lesion occluded 1
Fear of dissection 1
Stent placement not feasible 1
Unknown 1
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TRENDS QCA Analysis (6 months)TRENDS QCA Analysis (6 months)
Pre-dilatation
(n=395)
Direct stent(n=379)
Binary Restenosis (≥50%): In-stent
11.4%[95% CI 8.4%, 14.9%]
11.6%[95% CI 8.6%, 15.3%]
In-segment(stent ± 5mm)
12.2%[95% CI 9.1%, 15.8%]
13.4%[95% CI 10.1%, 17.2%]
Late Loss (In-stent) (mm) 0.88 ± 0.52[95% CI 0.83, 0.93]
0.83 ± 0.50[95% CI 0.78, 0.88]
p=ns
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TRENDS MACE at 180 days*TRENDS MACE at 180 days*
Pre-Dilatation
Direct stent Difference [95% CI]
TVF (Death, MI, TLR, TVR)
11.4% 10.8% 0.64% [0.25%, 1.04%]
MACE (Death, MI, TLR) 10.8% 9.8% 1.04% [0.66%, 1.43%]
Death 1.0% 1.0% 0.00% [-0.12%, 0.13%]
Q-wave MI 0.4% 0.4% 0.00% [-0.08%, 0.08%]
Non-Q wave MI
3.0% 2.0% 1.01% [0.80%, 1.22%]
* Hierarchical Ranking
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TRENDS MACE at 180 days*TRENDS MACE at 180 days*
Pre-Dilatation
Direct stent
Difference [95% CI]
TLR CABG 0.6% 0.2% 0.40% [0.31%, 0.50%]
TLR PCI 5.8% 6.2% -0.38% [-0.67%, -0.09%]
TVR CABG 0.0% 0.0% 0.00% [0.00%, 0.00%]
TVR PCI 0.6% 1.0% -0.04% [-0.49%, -0.30%]
Stent thrombosis 0.2% 0.2% 0.00% [-0.05%, 0.06%]
Bleeding ComplicationVascular Complication
2.8%0.4%
2.0%0.4%
0.81% [0.60%, 1.01%]0.00% [-0.08%, 0.08%]
* Hierarchical Ranking
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95
96
97
98
99
100
0 7 14 30 60 90 120 150 180
Direct Stent
Predilatation
TRENDS SurvivalTRENDS Survival
Days
Perc
ent
Surv
ivin
g
99.0%
99.0%
Difference [95% CI] = 0.00% [-0.12%, 0.13%]
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90
92
94
96
98
100
0 7 14 30 60 90 120 150 180
Direct Stent
Predilatation
TRENDS Major Adverse Cardiac Events*TRENDS Major Adverse Cardiac Events*
Days
Freedom
fro
m M
AC
E (
%)
92.94%
91.21%Difference [95% CI] = 1.04% [0.66%, 1.43%]
*MACE: Death, MI, TLR
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TRENDS Diabetic statusTRENDS Diabetic status
Diabetic Diabetic (n=128)(n=128)
Non-Diabetic Non-Diabetic (n=872)(n=872)
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0
5
10
15
20
25
TRENDS Diabetic subgroup (n=128)TRENDS Diabetic subgroup (n=128)Targ
et
Vess
el Fa
ilure
(%
)
Pre-Dilatation Direct Stent
*95% CI 3.92 [2.52, 5.33]TVF = Death, MI, TLR, TVR
19%19%
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0
5
10
15
20
25
TRENDS Diabetic subgroup (n=128)TRENDS Diabetic subgroup (n=128)M
AC
E (%
)
*95% CI 5.59 [4.18, 6.99]MACE = Death, MI, TLR
27%27%
Pre-Dilatation Direct Stent
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0
5
10
15
20
25
TRENDS Diabetic subgroup (n=128)TRENDS Diabetic subgroup (n=128)Targ
et
Lesi
on R
evasc
ula
risa
tion (%
)
*95% CI 9.31 [7.99, 10.64]TLR = CABG, Re-PCI
53%53%
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0
5
10
15
20
25
TRENDS Diabetic subgroup (n=128)TRENDS Diabetic subgroup (n=128)M
AC
E (%
)
*95% CI 5.59 [4.18, 6.99]MACE = Death, MI, TLR
27%27%
Pre-Dilatation Direct Stent
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J Am Coll Cardiol 2002;39:15-21
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0
5
10
15
20
25
30
Direct Stenting in AMI (n=206)Direct Stenting in AMI (n=206)C
om
posi
te A
ngio
gra
phic
Endpoin
t*
(%)
*Composite angiographic endpoint = distal embolization, slow flow, no reflow
Pre-Dilatation Direct Stent
p=0.01
J Am Coll Cardiol 2002;39:15-21
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0
10
20
30
40
Direct Stenting in AMI (n=206)Direct Stenting in AMI (n=206)ST-s
egm
ent
Reso
luti
on
(%)
Pre-Dilatation Direct Stent
p=0.01
J Am Coll Cardiol 2002;39:15-21
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Restenosis RatesSelected Trials (uncoated stents)Restenosis RatesSelected Trials (uncoated stents)
30
25
20
15
10
5
Sirius
Music
Elutes
West II
Benestent I
Taxus I
Benestent II
Ravel
Trends
Bin
ary
Rest
enosi
s R
ate
(%
)*
Finesse II
*QCA at six month angiographic follow-upTaxus II
Taxus II
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1. Direct stenting, without balloon pre-dilatation, is technically feasible in the majority of patients
2. Failure to deploy the Multilink Tetra™ stent using a direct stenting strategy in a wide variety of lesions is uncommon, occurring in only 5.8% of patients in this study
3. Resource utilization is significantly less with a direct stent approach
4. Six month QCA results were comparable between groups with a low (11.5%) in-stent binary restenosis rate
5. At six month follow-up, a direct stenting strategy resulted in a lower target vessel failure (TVF) rate, and a lower major adverse cardiac event (MACE) rate than in the balloon pre-dilatation group
6. Direct stenting may have a significant impact on the late results when using a drug eluting stent
TRENDS ConclusionsTRENDS Conclusions
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A Direct stenting strategyA Direct stenting strategy
Possible Advantages Shorter procedure
duration Less radiation Less contrast Reduced resource
utilisation Less embolization Less unprotected
barotrauma
Potential Disadvantages
Failure to cross lesionLoss of stentIncomplete stent deploymentIncrease in guide traumaUndersizing of stent (diameter & length)Poor visualisationError in stent positioning
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A Direct stenting strategyA Direct stenting strategy
Possible Advantages Shorter procedure
duration
Less contrast Reduced resource
utilisation? Less embolization Less unprotected
barotrauma
Potential Disadvantages
Failure to cross lesion 5.8%