Download Présentation PowerPoint - Clinical Trial Results

Three-year results from the multicentre
PROMUS Element European Post-Approval (PEProve) Registry: outcomes in 1010 unselected
patients treated with a platinum-chromium,
everolimus-eluting stent
Andreas Schaefer, MD
Raul Moreno, MD; Gerald S. Werner, MD; Paul Barragan, MD; Rudolf
Berger, MD; Tim Kinnaird, MD; Sarah C. Clarke, MD; Edouard Benit,
MD; Franco Fabbiocchi, MD; Thomas Christen, MD, PhD; Keith D.
Dawkins, MD
For internal use only
Disclosures
Speaker's name: Andreas Schaefer, MD
 I have the following potential conflicts of interest to report:
Consultant:
Employment in industry:
Honorarium:
Institutional grant/research support:
Owner of a healthcare company:
Stockholder of a healthcare company:
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Introduction
• The PROMUS Element platinum chromium everolimus-eluting
stent has demonstrated comparable outcomes to the predicate
XIENCE V everolimus-eluting stent in the randomized controlled
PLATINUM trial1
– Also demonstrated favourable results in substudies of patients with
small diameter vessels and long lesions.2,3
• The PROMUS Element European Post-Approval Surveillance
Study (PE-Prove) is a prospective, open-label, multicenter
observational study
• Study objective: to collect outcomes from an unselected patient
population treated with the PROMUS Element stent
– We have previously reported favourable results from this study at the
primary endpoint of 1 year and at 2 years4,5
1Stone
et al. JACC 2011;57:1700; 2Meredith et al. EuroPCR 2011; 3Teirstein et al. TCT 2011; Moreno et al. EuroPCR 20134;
Thomas et al. EuroPCR 20145.
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Study Design &
Patient Disposition
DESIGN: All-comers registry, single arm,
observational
Analysis Data Set
Patients: 1010
Lesions: 1321
Vessels: 1164
Stents: 1679
Procedures: 1035
PATIENTS: All patients eligible for coronary
artery stenting
FOLLOW-UP: 30 days, 6 & 12 months, and
then annually to 5 years
1° ENDPOINT: 12-month Target Vessel
Failure (cardiac death, target vessel-related
MI, target vessel revascularization)
-Adverse events adjudicated by an
independent Clinical Events Committee
ANALYSIS: Descriptive statistics only; no
predefined comparator. Events were also
categorized by the investigator for
relatedness to PROMUS Element stent.
No 3-Year Follow-up: 62
Withdrew Consent: 6
Lost-to-Follow-up: 7
Missed 3-Year visit: 49
3-Year Clinical Follow-up
93.9% (948/1010)
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Baseline Characteristics
Characteristic
N=1010 patients
Male
75.4% (762/1010)
Age, years
64.7 ± 11.2 (1010)
Current smoker
24.6% (248/1010)
Medically treated diabetes
24.9% (251/1010)
Insulin-dependent
8.2% (83/1010)
Hyperlipidemia
68.2% (689/1010)
Hypertension
70.2% (709/1010)
Stable angina
40.8% (412/1010)
Chronic heart failure
11.6% (117/1010)
Prior PCI
38.8% (392/1010)
Prior MI
34.4% (347/1010)
Values are percent (n/N) or mean ± standard deviation (n)
MI=myocardial infarction; PCI=percutaneous coronary intervention
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Lesion Characteristics
Characteristic
N=1321 lesions
De novo lesion
87.4% (1154/1321)
Reference vessel diameter, mm
Reference vessel diameter ≤2.5 mm
Lesion length, mm
Lesion length >28 mm
Culprit lesion for STEMI
Type B2/C
3.0 ± 0.5 (1264)
26.5% (335/1264)
19.7 ±12.7 (1264)
17.3% (219/1264)
7.3% (96/1321)
50.0% (659/1317)
Chronic total occlusion (>3 months)
6.1% (81/1321)
Left main
3.1% (41/1318)
Bifurcation
14.3% (189/1321)
Thrombus present
7.6% (100/1321)
Values are percent or mean ± standard deviation (n). Lesions may have belonged to more than one category.
STEMI=ST-elevation myocardial infarction
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Procedural Characteristics
Characteristic
Emergent procedure
20.2% (209/1035)
Pre-dilatation
63.4% (838/1321)
Post-dilatation
45.7% (604/1321)
Stents implanted per lesion, n
1.3 ± 0.60 (1321)*
Stented length per patient, mm
34.0 ± 23.7 (1010)*
Patients with multivessel stenting
14.3% (144/1010)
Lesions with overlapping stents
14.5% (192/1321)
Longitudinal stent deformation
0.1% (2/1679)†
Bailout stenting
2.9% (29/1010)
†Both events involved <5% proximal stent compression due to guide catheter interaction with the stent during the index procedure. One
event occurred during attempted retrieval of a fractured guidewire that was jailed during treatment of an LAD/diagonal bifurcation lesion,
and was treated with balloon angioplasty. This patient had a small NQWMI (peak CK-MB 43 U/L, troponin 2.4 ng/ml) associated with the
index procedure. No patient injury was reported for the second event, which was successfully treated with placement of an additional stent.
Values are percent (n/N) or mean ± standard deviation (n). *Study stents only.
For internal use only
Antiplatelet Medications
100
98.8
97.2
98.2
96.1
Percent
80
96.8
94.4
92.3
79.8
60
40
ASA
20
DAPT
21.0
0
Discharge
6 Months
12 Months
2 years
14.1
3 years
N=1010
Values are percent.
ASA=acetylsalicylic acid; DAPT=dual antiplatelet therapy (ASA plus any P2Y12 inhibitor)
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Primary Endpoint
TVF at 12 Months
Components of TVF at 12 Months
10
10
Percent
15
Percent
15
6.2
5
3.4
5
2.7
1.7
2.1
3.2
2.1
0.4
0
0
Target Vessel Failure
N=1010
Cardiac Death
Overall
TV-MI
TVR
Related to Promus Element Stent
TVF=target vessel failure; TV-MI=target vessel myocardial infarction; TVR=target vessel revascularization.
Binary analysis.
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TVF at 3 years
TVF at 3 years
15
5
15
10.1
10
5.0
Percent
Percent
10
Components of TVF at 3 years
6.4
5
3.2
2.9
3.7
2.5
0.4
0
0
Target Vessel Failure
N=1010
Cardiac Death
Overall
TV-MI
TVR
Related to Promus Element Stent
TVF=target vessel failure; TV-MI=target vessel myocardial infarction; TVR=target vessel revascularization.
Time-to-event analysis.
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TVF at 3 years
PtCr-EES (N=1010)
Patients (%)
15
10.1%
10
5
0
0
No. at risk
PtCr-EES 1010
90
180
270
365
730
1095
Days Since Index Procedure
1000
968
951
935
TLF = cardiac death or MI related to the target vessel or ischemia-driven TLR
908
694
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Other Cardiac Endpoints at
3 years
Time
Period
15
0-1
days
ST Rate 0.1 (1)
2-30
days
31-365
days
1-year
Total
2-year
Total
3-year
Total
0.2 (2)
0.3 (3)
0.6 (6)
0.8 (8)
0.9 (9)
10.9
Percent
10
5.6
4.8
5
4.1
2.5
0
n/a
MACE
N=1010
0.7
n/a
All Death
Overall
2.2
MI
0.9
0.3
QWMI
NQWMI
0.9
ARC ST
(def/prob)
Related to Promus Element Stent
ARC ST (def/prob)=Academic Research Consortium definite/probable stent thrombosis; MACE=major cardiac adverse
For internal u
events (defined as cardiac death, all MI, TVR); MI=myocardial infarction; n/a=not applicable (events defined as regardless
of relationship to stent); QWMI=Q-wave MI; NQWMI=non-Q-wave MI; TVR=target vessel revascularization. Time-to-event rates.
Diabetes Subset
20
17.9
Components of TVF
15
Percent
10.6
10.6
9.4
10
8.1
6.8
5.1
5
3.0
1.7
3.0
0
TVF
N=237
Cardiac Death
Overall
MI
TVR
ARC ST
(def/prob)
Related to Promus Element Stent
ARC ST (def/prob)=Academic Research Consortium definite/probable stent thrombosis; TVF=target vessel failure;
MI=myocardial infarction; TVR=target vessel revascularization. Binary analysis.
For internal use only
Small Vessel Subset
(RVD ≤2.5mm)
15
Components of TVF
12.1
Percent
10
8.0
7.2
7.6
5.3
5
3.8
2.3
1.1
0.4
1.1
0
TVF
N=273
Cardiac Death
Overall
MI
TVR
ARC ST
(def/prob)
Related to Promus Element Stent
ARC ST (def/prob)=Academic Research Consortium definite/probable stent thrombosis; TVF=target vessel failure;
MI=myocardial infarction; TVR=target vessel revascularization. Binary analysis.
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Long Lesion Subset
(Lesion Length >28mm)
15
12.8
Components of TVF
Percent
10
8.2
7.7
7.1
5.6
5
4.1
2.6
1.0
0.5
1.0
0
TVF
N=203
Cardiac Death
Overall
MI
TVR
ARC ST
(def/prob)
Related to Promus Element Stent
ARC ST (def/prob)=Academic Research Consortium definite/probable stent thrombosis; TVF=target vessel failure;
MI=myocardial infarction; TVR=target vessel revascularization. Binary analysis.
For internal use only
Conclusions
• In a large, real-world patient cohort, coronary artery
revascularization with the PROMUS Element everolimuseluting stent provides favourable results
• Low event rates related to PROMUS Element through 3 years
– 0.4% cardiac death
– 3.2% target vessel MI (cardiac enzyme testing required 12-24 hours
post-procedure in all patients)
– 3.7% target vessel revascularization
– 0.9% ARC definite/probable stent thrombosis
• Good results in subsets of patients with small vessels and long
lesions
• Patients will continue to be followed annually for 5 years.
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Thank You
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