1. Three-year results from the multicentre PROMUS Element European Post-Approval (PE-Prove) 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
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2. 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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3. 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
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4. Study Design & Patient Disposition
DESIGN: All-comers registry, single arm, observational
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.
Analysis Data Set Patients: 1010 Lesions: 1321 Vessels: 1164 Stents: 1679
Procedures: 1035
3-Year Clinical Follow-up 93.9% (948/1010)
No 3-Year Follow-up: 62
Withdrew Consent: 6
Lost-to-Follow-up: 7
Missed 3-Year visit: 49
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5. Baseline Characteristics
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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6. Lesion Characteristics
N=1321 lesions
De novo lesion
87.4% (1154/1321)
Reference vessel diameter, mm
3.0 ± 0.5 (1264)
Reference vessel diameter ≤2.5 mm
26.5% (335/1264)
Lesion length, mm
19.7 ±12.7 (1264)
Lesion length >28 mm
17.3% (219/1264)
Culprit lesion for STEMI
7.3% (96/1321)
Type B2/C
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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7. Procedural Characteristics
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.
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8. Antiplatelet Medications
Percent
N=1010
Values are percent. ASA=acetylsalicylic acid; DAPT=dual antiplatelet therapy (ASA plus any P2Y12 inhibitor)
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9. Components of TVF at 12 Months
Primary Endpoint
TVF at 12 Months
Components of TVF at 12 Months
Percent
Percent
N=1010
TVF=target vessel failure; TV-MI=target vessel myocardial infarction; TVR=target vessel revascularization. Binary analysis.
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10. Components of TVF at 3 years
Percent
Percent
N=1010
TVF=target vessel failure; TV-MI=target vessel myocardial infarction; TVR=target vessel revascularization. Time-to-event analysis.
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11. Days Since Index Procedure
TVF at 3 years
PtCr-EES (N=1010) 15 10 5
10.1%
Patients (%) 90
180
270
365
730
1095
Days Since Index Procedure
1010
1000
968
951
935
908
694
No. at risk
PtCr-EES
TLF = cardiac death or MI related to the target vessel or ischemia-driven TLR
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12. Other Cardiac Endpoints at 3 years
Time Period
0-1
days
2-30 days
days
1-year Total
2-year Total
3-year Total
ST Rate
0.1 (1)
0.2 (2)
0.3 (3)
0.6 (6)
0.8 (8)
0.9 (9)
Percent
n/a
n/a
N=1010
ARC ST (def/prob)=Academic Research Consortium definite/probable stent thrombosis; MACE=major cardiac adverse 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.
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13. Diabetes Subset N=237 Components of TVF Percent
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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14. Small Vessel Subset (RVD ≤2.5mm)
Components of TVF
Percent
N=273
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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15. Long Lesion Subset (Lesion Length >28mm)
Components of TVF
Percent
N=203
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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16. Conclusions
In a large, real-world patient cohort, coronary artery revascularization with the PROMUS Element everolimus-eluting 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 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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17. Thank You
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