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MY CONFLICTSOF INTEREST ARE
Advisory Board Boston Scientific
Advisory Board Abbott Vascular
Educational Grants Cordis
Educational Grants Boston Scientific
Lesion Complexity
Ellis SG, Vandormael MG, Cowley MJ, DiSciascio G, Deligonul U, Topol EJ, Bulle TM. Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease: implications for patient selection. Circulation. 1990;82:1193–1202
• 10-20mm length
• Eccentric
• Mod tortuosity
• Mod angulation 45-90º
• Irregular contour
• Mod/heavy calcification
• Ostial location
• Bifurcation requiring double wires
• Thrombus
• Total occlusion <3months
Complex: B2/C
• >20mm length
• Excessive tortuosity
• Extremely angulated >90º
• Inability to protect major branch
• Degenerated vein graft
• Total occlusion > 3months
B C
• 10-20mm length
• Eccentric
• Mod tortuosity
• Mod angulation 45-90º
• Irregular contour
• Mod/heavy calcification
• Ostial location
• Bifurcation requiring double wires
• Thrombus
• Total occlusion <3months
Complex: B2/C
• >20mm length
• Excessive tortuosity
• Extremely angulated >90º
• Inability to protect major branch
• Degenerated vein graft
• Total occlusion > 3months
B C
Complex Lesion Subsets
• Type B2/C
• Long Lesions
• Small Vessels
• CTO
• Vein Grafts
• Bifurcation Lesions • LMS
• In-Stent Restenosis
Complexity in DES Trialsmulti-vessel
diseasebifurcated
lesions
ISR
diabeteslong
lesionssmall
vesselswork
-horse
CTO
left maindisease
TRIAL: randomized, multicenter, blinded, actively controlled trial involving an independent core lab and CEC
TRIAL: feasibility studies involving only 1 to 3 centers often not using an independent core lab or CEC
TAXUS V ISR
SYNTAX
TAXUS IV
TAXUS V
REALITY-TAXUS
TAXUS VI
SYNTAX
SYNTAX
SYNTAX
TAXUS VI
TAXUS V
TAXUS V
TAXUS IV
TAXUS V
REALITY-TAXUS
Park LL2
CORPAL-BIF
SISR
ISAR-DESIRE
FREEDOM
ISAR-DIABETES
RIBS II
RAVEL
SES-SMART
SIRIUS
ISAR-SMART
PRISON II
REALITY-CYPHER
DIABETES
CARDIA
Increasing complexity
Data currently all 1st generation DES
Complex LesionsSCANDSTENT: Stenting in non-stress/benestent disease
CTO (36%) /Bifurcation (34%)/Ostial (22%) /Angulated
2
31.9
4.3
29.3
0.63.1
0
5
10
15
20
25
30
35
Restenosis MACE SAT
Cypher
BMS
%N: 322, randomised
Kelbaek et al. JACC 2006; 47:449
P<0.001
p<0.001
6 months outcome
Long LesionsC-Sirius (Sirolimus eluting stent in the treatment of long de-novo lesions)
• Single de novo lesion 15-32mm length
2
52
49
4
18
2 0 2 40
10
20
30
40
50
60
Restenosis TLR MACE CABG MI
Cypher
BMS%
N: 100, randomised
C Sirius Investigators JACC 2004; 43: 1110
p<0.001
p<0.001
9 months outcome
Long LesionsE-Sirius (Sirolimus eluting stents for the treatment of patients with long
atherosclerotic lesions in small coronary arteries)
• Single de novo lesion 15-32mm length, Vessel <3mm
5.9
42.3
4
20.9
8
22.6
1.1 0.64.6
2.30
5
10
15
20
25
30
35
40
45
Restenosis TLR MACE Death MI
Cypher
Bx Velocity%
N: 352, randomised
Schofer et al. Lancet 2003; 362: 1093
p<0.001
p<0.0001
8 months outcome
p<0.002
Small VesselsSES Smart• Single lesion <2.75mm native coronary
12
60
7
21.1
9.3
31.3
0 1.6 1.6
7.8
0
10
20
30
40
50
60
Restenosis TLR MACE Death MI
Cypher
BX Velocity
% N: 257, randomised
Ardissino et al. JAMA 2004; 292: 2727
p<0.002
P<0.001 p<0.001
p<0.04
8 months outcome
Chronic Total Occlusion
PRISON II• Single CTO >2 weeks, crossed and predilated
7
36
4
19
4
20
20
2 3
0
5
10
15
20
25
30
35
40
Restenosis TLR MACE SAT MI
Cypher
BX Velocity
% N: 200, randomised
Suttorp et al. Circulation 2006;114:921
p<0.001
P<0.001 p<0.001
6 months outcome
Chronic Total OcclusionSCANDSTENT Subgroup analysis• CTO, crossed and predilated
0
38
5
35
01.8
0
5
10
15
20
25
30
35
40
Restenosis TVF SAT
Cypher
BMS
%N: 127, randomised
Kelbaek et al; Am Heart J 2006: 152:882
P<0.001 p<0.001 6 months outcome
Saphenous Vein Grafts
RRISC Trial• Lesions in SVG Grafts
11.3
30.6
5.3
21.6
15.8
29.7
2.7
7.9
0
5
10
15
20
25
30
35
Restenosis TLR MACE MI
Cypher
BX Velocity
%N:75pts, 96 lesions, randomised
Vermeersch et al JACC 2006; 48:2423
P=0.012
P=0.024
6 months outcome
Bifurcation Lesions
SCANDSTENT subgroup• Bifurcations: 126 pts randomised
4.9
28.3
14.8
43.4
9
28
0
9
0
5
10
15
20
25
30
35
40
45
Restenosis Restenosis SB MACE SAT
Cypher
BX Velocity
%
Thuesen et al. Am Heart J 2006: 152:1140
P<0.001
6 months outcome
P<0.001 p=0.01