CENTURY II

Overview

  • Comparable clinical outcomes of Ultimaster™ stent with bioresorable polymer coating versus Xience stent with durable polymer coating are maintained up to five years.
  • Particularly remarkable was the low rate of very late stent thrombosis (0.2%) in both arms.
  • These data supports the long term safe use and good performance of the Ultimaster™ DES.

Study Design

clinical_evidence_century_ll_study_design

Study Outline

Patient Background

  Ultimaster N=551 pts Xience N=550 pts P
Age, years (mean ±SD) 65.2+10.5 65.5+10.6 0.61
Gender - male, % 78.6 82.4 0.11
DM, % 31.9 30.9 0.71
 IDDM, % 16.5 14.7 0.65
Hypertension, % 73.3 67.8 0.05
Current Smoker, % 22.2 23.9 0.50
Previous smaker, % 46.7 42.0 0.12
Previous MI, % 28.3 27.6 0.80
Previous PCI, % 37.2 35.0 0.45
Previous CABG, % 4.5 3.7 0.46
Peripheral vascular discase, % 9.6 6.6 0.06
High risk ACS, % 22.5 24.7 0.39
  Ultimaster N=551 pts Nlesions=711 Xience N-550 pts Nlesions=716 P
Multi-vessel disease, % 39.6 41.3 0.56
Lesions detected ,n 2.0±1.3 2.0±1.3 0.67
Lesions treated,n 1.3±0.6 1.3±0.6 0.62
Bifurcation/lesion, % 13.8 14.4 0.74
Ostial/lesion, % 6.0 8.4 0.08
Moderate/severe calcification, % 21.5 17.7 0.70
Access site, %
 Radial
 Femoral

71.7
26.7

73.1
25.6
0.55
N° of stents implanted/pt 1.5±0.8 1.6±0.9 0.94
Total implanted stent length/pt 29.5±17.0 29.6±18.1 0.66
Delivery success, % 99.1 99.5 0.23
Procedure success/pt, % 98.0 98.2 0.83

Result

5-year clinical outcomes

 

clinical_evidence_century_ll_clinical_outcomes_1clinical_evidence_century_ll_clinical_outcomes_2

Reference