1. 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

2. 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
S670
SLIDE
362
SWIBAP
NIR
TRENDS
1000
Multilink Tetra
VELVET II
401
Bx Velocity

3. 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
S670
SLIDE
362
SWIBAP
NIR
TRENDS
1000
Multilink Tetra
VELVET II
401
Bx Velocity

4. TRENDS
To define the medium term performance of a no pre-dilatation strategy for elective stent implantation using the Multilink Tetra™ Stent

5. TRENDS Multicenter, prospective clinical trial
1:1 randomization to stent implantation with or without pre-dilatation
1000 patient enrolment over a period of one year at 46 sites in Europe and South America

6. Angiographic follow-up
TRENDS Trial Design
1000 patients
Diagnostic catheter
(Randomisation 1:1)
Direct Stent
(501 pts)
Pre-dilatation
(499 pts)
Angiographic follow-up
(6 months)

7. A 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 lesion
Loss of stent
Incomplete stent deployment
Increase in guide trauma
Undersizing of stent (diameter & length)
Poor visualisation
Error in stent positioning

8. TRENDS Total Patients: 1000 Pre-dilatation: 499 Direct stent: 501 11713 27 2
128
144 75 52 82
133
116 35 41
Total Patients: 1000
Pre-dilatation: 499
Direct stent: 501 35

9. TRENDS Top Recruiting Centers
Country
Patients (n)
St Antonius Hospital
Netherlands 95
Skejby Sygehus
Denmark 76
Virga Jesse Ziekenhuis
Belgium 59
Hospital Son Dureta
Spain 58
CHR Citadelle 56
Wessex Cardiac Unit
United Kingdom 52
De Klokkenberg TCI Breda 49
Clinique des Franciscaines
France 40
Casa di Cura Montevergine Spa
Italy
Rigshospitalet

10. TRENDS Multilink Tetra™ Coronary Stent System
Stent diameters: 2.75, 3.0, 3.5, 4.0 mm
Stent lengths: 8, 13, 18, 23 mm

11. TRENDS Primary Endpoint
Major Adverse Cardiac Events at 30 days
Death
Myocardial infarction (Q and non-Q)
CABG, or re-PCI (TVR)

12. TRENDS Secondary Endpoints
Use of multiple stents at each target lesion
Total procedure time
Radiographic screening time
Contrast volume
Technical success
Procedural resource analysis
Duration of hospital stay
MACE at 6 months
Binary angiographic restenosis per lesion at 6 months

13. TRENDS Inclusion Criteria*
Symptomatic angina
Planned de novo single lesions, or restenotic lesions (previous POBA) in native coronary arteries
MVD may be treated, one lesion per vessel
Target vessel diameter ≥2.75 mm to ≤4.25 mm, length ≤18 mm (visual)
Target lesion ≥70% stenosis, TIMI flow ≥1
* Selected

14. TRENDS Exclusion Criteria*
Acute MI within the last 24 hours
Unprotected left main stem lesion
Lesion involving a significant side branch (>2 mm diameter)
Evidence of severe calcification
Use of IVUS before stenting
Chronic total occlusion
* Selected

15. TRENDS Baseline Demographics (I)
Pre-dilatation
n=499 (%)
Direct stent
n=501 (%)
Age (years)
59.4
(range 32-84)
59.9
(range 31-84)
Male 78
Diabetes 18 15
Hypercholesterolemia 58 63
Hypertension 49 53
Family history 36 40
p=ns

16. TRENDS Baseline Demographics (II)
Pre-dilatation
n=499 (%)
Direct stent
n=501 (%)
Current smoker 27 25
Previous smoker 46 43
Previous MI 37 38
Previous CABG/PCI 8
History of angina 97 98
p=ns

17. TRENDS Lesion Characteristics (I)
Pre-dilatation
Direct stent
Procedure:
Single vessel
91%
93%
Two Vessel 8% 7%
Three vessel 1% 0%
p=ns

18. TRENDS Lesion Characteristics (II)
Pre-dilatation
Direct stent
Vessel:
LAD
42%
40%
LCx
20%
25%
RCA
36%
34%
p=ns

19. TRENDS Lesion Characteristics (III)
Pre-dilatation
Direct stent
ACC/AHA Class:
Type A
17%
Type B1
44%
40%
Type B2
38%
42%
Type C 1%
p=ns

20. TRENDS Lesion Characteristics (IV)
Pre-dilatation
Direct stent
TIMI Flow:
Grade 0 0%
Grade 1 2%
Grade 2 5%
Grade 3
93%
p=ns

21. TRENDS Lesion Characteristics (V)
Pre-dilatation
Direct stent
Thrombus at lesion site
2.1%
1.4%
Target site calcification
4.5%
5.3%
Lesion angulation >45o
5.0%
4.7%
Eccentric
63.5%
64.0%
p=ns

22. TRENDS Quantitative Coronary Arteriography
Pre-dilatation
mean ± SD
(n = 472)
Direct stent
(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

23. TRENDS Stent Deployment Pressure
Percent (%)
< >20
Maximum pressure (Atm)

24. TRENDS Procedural Data (I)
Pre-dilatation
Direct stent
Maximum pressure
13.0 Atm
13.7 Atm
Balloon-Artery Ratio
1.14 ± 0.51
1.14 ± 0.55
Post implant dilatation
13.3%
15.9%
Additional stent implant
6.4%
6.7%
p=ns

25. TRENDS Procedural Data (II)
Pre-dilatation
Direct stent
Additional Stent implant:
Inflow dissection 13 11
Outflow dissection 8 10
Failure to cover original target lesion 7
Lesion at distant site 6 3
Thrombotic lesion 1
Unknown
p=ns

26. TRENDS Procedural Data (III)
Pre-dilatation
Direct stent
Screening 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)

27. TRENDS Procedural Data (IV)
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.
Pre-dilatation
Direct stent
Technical Success
100%
p=ns

28. TRENDS Procedural Data (V)
Pre-dilatation
Direct stent
Resource utilization:
Guide wires
Guiding catheters
IVUS catheters
PTCA catheters
IABP catheters
TETRATM stents
Other stents
540
554 9
548 1
568 19
543
586* 7
115#
559 22
IIb/IIIa Inhibitor use
19.3%
18.8%
*p=0.02, #p=0.001 (Fisher’s Exact Test)

29. TRENDS 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
Lesion occluded
Fear of dissection
Stent placement not feasible
Unknown

30. 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

31. TRENDS MACE at 180 days* TVF (Death, MI, TLR, TVR) 11.4% 10.8%
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)
9.8%
1.04% [0.66%, 1.43%]
Death
1.0%
0.00% [-0.12%, 0.13%]
Q-wave MI
0.4%
0.00% [-0.08%, 0.08%]
Non-Q wave MI
3.0%
2.0%
1.01% [0.80%, 1.22%]
* Hierarchical Ranking

32. TRENDS MACE at 180 days* TLR CABG 0.6% 0.2% TLR PCI 5.8% 6.2% TVR CABG
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%
0.00% [0.00%, 0.00%]
TVR PCI
1.0%
-0.04% [-0.49%, -0.30%]
Stent thrombosis
0.00% [-0.05%, 0.06%]
Bleeding Complication
Vascular Complication
2.8%
0.4%
2.0%
0.81% [0.60%, 1.01%]
0.00% [-0.08%, 0.08%]
* Hierarchical Ranking

33. TRENDS Survival Days Percent Surviving 99.0% 99.0%
Difference [95% CI] = 0.00% [-0.12%, 0.13%]
Days

34. TRENDS Major Adverse Cardiac Events*
Freedom from MACE (%)
92.94%
91.21%
Difference [95% CI] = 1.04% [0.66%, 1.43%]
Days
*MACE: Death, MI, TLR

35. TRENDS Diabetic status
Non-Diabetic (n=872)
Diabetic (n=128)

36. TRENDS Diabetic subgroup (n=128)
19%
Target Vessel Failure (%)
Pre-Dilatation Direct Stent
TVF = Death, MI, TLR, TVR
*95% CI 3.92 [2.52, 5.33]

37. TRENDS Diabetic subgroup (n=128)
27%
MACE (%)
Pre-Dilatation Direct Stent
MACE = Death, MI, TLR
*95% CI 5.59 [4.18, 6.99]

38. TRENDS Diabetic subgroup (n=128)
53%
Target Lesion Revascularisation (%)
TLR = CABG, Re-PCI
*95% CI 9.31 [7.99, 10.64]

39. TRENDS Diabetic subgroup (n=128)
27%
MACE (%)
Pre-Dilatation Direct Stent
MACE = Death, MI, TLR
*95% CI 5.59 [4.18, 6.99]

40. J Am Coll Cardiol 2002;39:15-21

41. Direct Stenting in AMI (n=206)
p=0.01
Composite Angiographic Endpoint* (%)
Pre-Dilatation Direct Stent
*Composite angiographic endpoint =
distal embolization, slow flow, no reflow
J Am Coll Cardiol 2002;39:15-21

42. Direct Stenting in AMI (n=206)
p=0.01
ST-segment Resolution (%)
Pre-Dilatation Direct Stent
J Am Coll Cardiol 2002;39:15-21

43. Restenosis Rates Selected Trials (uncoated stents) Sirius 30 Taxus I25 20 15 10 5
Taxus I
Ravel
Benestent I
Elutes
Finesse II
Taxus II
Binary Restenosis Rate (%)*
Trends
West II
Benestent II
Music
Taxus II
*QCA at six month angiographic follow-up

44. TRENDS Conclusions
Direct stenting, without balloon pre-dilatation, is technically feasible in the majority of patients
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
Resource utilization is significantly less with a direct stent approach
Six month QCA results were comparable between groups with a low (11.5%) in-stent binary restenosis rate
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
Direct stenting may have a significant impact on the late results when using a drug eluting stent

45. A 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 lesion
Loss of stent
Incomplete stent deployment
Increase in guide trauma
Undersizing of stent (diameter & length)
Poor visualisation
Error in stent positioning

46. A 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%