CTO angioplasty
Role of DES for CTO angioplaty Improve the prognosis?
Recent concepts and techniques Can we treat a patient smartly?
Himeji Cardiovascular Center
10
9% 0
SICCO GISSOC STOP TOSCA Nakamura Hoye
3% 9% 2%
Ge Nakamura
BMS
DES(SES)
Himeji Cardiovascular Center
SES for CTO lesions: CTO vs Non-CTO
Cypher Post Marketing Study (PMS) in Japan
Lesion Characteristics
No of lesions RVD, mm Lesion Length, mm ACC/AHA TypeB2/C* De novo ISR Bifurcation Osital Moderato/Severe Calcification
CTO 109(105pts) 2.28±0.70 26.9±17.1 109 (100.0)
90 (82.6) 14 (12.8) 30 (27.5) 11 (10.1)
Non-CTO P Value 2,350(1946pts) －
2.57±0.60 <0.001 17.2±9.9 <0.001 1,872 (80.0) <0.001 1,856 (79.0) 0.367 342 (14.6) 0.620 779 (33.1) 0.222 400 (17.0) 0.058
(%)
10
P=0.132
P=0.453
P=0.806
0.40
0.31mm
0.22mm 10
0.20
11.2%
8.9%
5 3.9% 3.9%
0.00
Late Loss (8 Months)
0
0
Binary Restenosis
TLR
(8 Months)
(12 Months)
Himeji Cardiovascular Center
201 Total Occlusion(CTO) Case Presentation:
Key Concepts and Techniques
Takatoshi Hayashi MD Himeji Cardiovascular Center, Japan
Himeji Cardiovascular Center
Method
Prospective Non-randomized Registry
Inclusion Criteria
Consecutive patients treated with the Cypher stent(including off ｌabel use
Follow-up
In-Hospital,3,8 months and 1,2,3,4,5 years clinical follow-up data ：Angiographic follow-up is mandated at 8 months（Analysis:Core lab)
Himeji Cardiovascular Center
Study Design (Cypher PMS in Japan)
Background
Post market evaluation to fulfill a Regulatory Approval Condition
Purpose
To evaluate the safety and efficacy of the Cypher Sirolimus-eluting coronary stent in routine daily practice in the Japanese population
23 (21.1)
403 (17.1) 0.287
Values are n (%). *:Excluding Unevaluated 10 lesion in Non-CTO
Himeji Cardiovascular Center
Efficacy Evaluation
(mm
(%)
)
0.60
20
：CTO ：Non-CTO
Target Enrollment
2,000 patients (1st year=1,000 patients, 2nd year =1,000patients)
No of Sites
50 sites (Select sites on basis of balanced population density, hospitals distribution as well as scale of hospitals)
Delivery Success Rate: 99.8%
Follow up Rate： 85.4％
90.5％
1,752 cases 1,857 cases
Intent-totreat
Actual Enrollment
8M
12M
Angiographic F/U Clinical F/U
Himeji Cardiovascular Center
Himeji Cardiovascular Center
Study Profile of Cypher PMS in Japan
Enrollment Period 1st Year: 9/1/04～3/31/05 2nd Year: 4/1/05～9/30/05
2,054 cases
2,051 cases
Role of DES for CTO angioplaty
Himeji Cardiovascular Center
CTO angioplasty in DES era
(%)
60
Restenosis
50
8%
Re-occlusion
47%
40
8%
6%
30 12%
8%
34%
32%
20
24%
20%
3%
MACE to 12 Months Follow-up
No of patients MACE Death MI