Apposition IV
© STENTYS June 2014, all rights reserved
Apposition
IV
RAndomized comParison between a Self-APpOsing SIrolimus-Eluting Coronary STent
and a balloon-expandable stent in Acute MyocardIal InfarctiON
Final results
Data presented by:
Robert-Jan van Geuns, MD, PhD, Thoraxcenter, Erasmus MC, Rotterdam,
The Netherlands.
Tuesday 20th 13:12-13:20 - Room Maillot, EuroPCR Paris.
2
Apposition
IV
Design and Population
Double Randomisation:
Patients were randomised to either arm
(STENTYS or Resolute) and randomised to follow
up period (4 month or 9 month)
Primary Endpoint
% malapposed and uncovered struts by OCT at 9
months follow-up
Secondary Endpoint
% malapposed and uncovered struts by OCT at 4
months follow-up
Inclusion criteria
•STEMI caused by a de novo lesion in a native coronary
artery
•Reference vessel diameter between 2.5 and 4.0mm
•Lesion length ≤25mm
Exclusion criteria
•Cardiogenic shock; LVEF < 30%
•Unprotected left main coronary artery stenosis >30%
•Chronic Total Occlusion; Aneurysm
•3-Vessel disease
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Apposition
IV
OCT Outcomes
OCT Images at 4 Months
Total Stent Coverage
4 Month Cohort
40%
P=0.02
35%
30%
25%
20%
STENTYS SES
Control
Control
15%
% Malapposed Struts
1.4%
1.2%
1.0%
0.8%
0.6%
0.4%
0.2%
0.0%
10%
5%
0%
STENTYS SES
N=21
N=26
STENTYS SES
Control
P=0.02
P=0.55
SES
N=21
Control
N=26
4 Month Cohort
SES
N=40
4
N=21
9 Month Cohort
Earlier Complete Apposition and Healing
Note:- 4 month and 9 Month data is from separate patient cohorts and therefore it is
not possible to compare the 2 groups
Control
Apposition
IV
QCA Outcomes
Best in Class
Late Lumen Loss
Larger Lumen Gain
Note:- 4 month and 9 Month data is from separate patient cohorts and therefore it is not possible to compare the 2 groups i.e. it is
not possible to say that the STENTYS SES group shows a decrease in either Mean Lumen Diameter or Late Lumen Loss between 4
months and 9 months
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Apposition
IV
Clinical Outcomes
There is no significant difference in any of the measured
clinical outcomes
STENTYS
Stent
Control
Stent
Hazard Ratio
(95% CI)
pvalue
8.0%
4.9%
1.66 (0.43-6.43)
0.46
0.0%
-
-
3.3%
0.35 (0.03-3.86)
0.39
1.7%
2.84 (0.32-25.40)
0.35
3.4%
1.8%
-
-
Acute (≤24 h)
3.4%
0.0%
-
-
Late
0.0%
1.8%
-
-
MACE
Cardiac death
2.3%
Recurrent MI
1.1%
TLR, clinically-driven
4.7%
Stent thrombosis,
definite /probable
TLR rate includes patients with
ST (3.4%) so the TLR rate
driven by restenosis is 1.3%
v
v
3 Early Sent Thrombosis in the STENTYS
SES arm
• 1 due to Distal Dissection
• 1 due to an under expanded stent
• 1 was in a patient with 2 vessels
stented (Protocol Violation)
6
2 Cardiac Death in the STENTYS Arm
• 1 procedural death: result of a very
difficult procedure leading to tamponade
and pericardial effusion
• 1 death at 48 days for unknown reason:
by definition classified as cardiac death if
there is no autopsy done
Apposition
IV
Conclusions
Sirolimus-eluting STENTYS stent shows
• excellent apposition immediately and over time
• better stent apposition at 4 months than drug-eluting
balloon-expandable stents
• faster strut coverage than drug-eluting balloonexpandable stents
• significantly larger lumens than balloon-expandable
stents at 4 and 9 months, with stabilized stent expansion
• best-in-class Lumen Loss at 9 months