RESOLUTE 統合解析

世界規模でのRESOLUTE 臨床試験プログラム

RESOLUTE 臨床試験プログラム
RESOLUTE CEマーク取得のための臨床試験(被験者数:139例)
RESOLUTE All Comers Xience V DESとの比較による大規模なランダム化all-comers試験
(Resolute群:1,140例、Xience V群:1,152例)
RESOLUTE International 複数の大陸にまたがって行われた大規模なall-comers試験
(Resolute群:2,349例)
RESOLUTE US 米国でのピボタル試験
2.25〜4.0 mm サイズを使用した非RCT(Resolute群:1,402例)
米国でのピボタル試験
長さ38 mmサイズを使用した非RCT(Resolute群:114例)
RESOLUTE Japan 日本でのレジストリ試験
2.5〜3.5 mmサイズを使用した非RCT(Resolute 群:100例))

R-FIM、R-AC、R-Int、R-JapanおよびR-US試験データを統合解析し、
Resolute DESの安全性および有効性を示しています。



RESOLUTE Pooled
Baseline and Lesion Characteristics

  R-ZES Pooled1
N = 5130
Age (years, mean ± SD) 63.8 ± 11.0
Females (%) 25.1
Prior MI (%) 26.4
Diabetics (%) 29.9
Unstable angina (%) 25.9
RVD (mm) 2.85 ± 0.51
Lesion length (mm) 16.74 ± 9.91
B2/C lesions (%) 71.1
Complex patients2 (%) 45.8

1 RESOLUTE(5yr), R-AC (2yr), R-Int (2yr), R-US (2yr), R-Japan (2yr)

2 Complex patient definition: bifurcation, bypass grafts, ISR, AMI <72 hr, LVEF <30%, unprotected LM, >2 vessels stented, renal insufficiency or failure (creatinine >140 μmol/L), lesion length >27 mm, >1 lesion per vessel, lesion with thrombus or TO (preprocedure TIMI = 0). Only R-AC and R-INT included complex patients.

J. Belardi ACC2012



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RESOLUTE Pooled
TLF and Components at 2 Years

5つのRESOLUTE臨床試験

TLF (Target Lesion Failure) is defined as Cardiac Death, TVMI, or clinically indicated TLR.

J. Belardi ACC2012



RESOLUTE Pooled
Dual Antiplatelet Therapy (DAPT) Usage

Percent of R-ZES Patients on
DAPT at:
12 Months 24 Months
RESOLUTE (N = 139) 58.1 46.3
RESOLUTE All Comers (N = 1140) 84.1 18.6
RESOLUTE International (N = 2349) 91.1 43.9
RESOLUTE US (N = 1402) 93.5 67.2
RESOLUTE Japan (N = 100) 94.9 89.8
Overall (N = 5130) 89.4 45.6

DAPT = aspirin plus clopidogrel or ticlopidine

J. Belardi ACC2012



RESOLUTE Pooled
Stent Thrombosis ARC Definite/Probable to 2 Years

RESOLUTE Pooled

J. Belardi ACC2012

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