Phase 4
Completed N=2,681
PROMUS Element Plus US Post-Approval Study
Source: ClinicalTrials.gov NCT01589978 ↗Enrolled (actual)
2,681
Serious AEs
29.1%
Results posted
May 2016
Primary outcomePrimary: Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients — 1.78 percentage of patients — p=<.0001
◆ Published Evidence
Emerging
16citations · ~2 / year
One-Year Outcomes in "Real-World" Patients Treated With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study [PE-Plus PAS]).
Summary
This study is designed to observe clinical outcomes in patients receiving the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Patients will have symptomatic heart disease or documented silent ischemia. This is a prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5 years. Approximately 2,689 patients are to be enrolled in up to 65 centers in the United States.
Linked Publications (3)
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One-Year Outcomes in "Real-World" Patients Treated With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study [PE-Plus PAS]).
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Does study subject diversity influence cardiology research site performance?: Insights from 2 U.S. National Coronary Stent Registries.
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Percutaneous Coronary Intervention in Men, Women, and Minorities With a Previous Coronary Artery Bypass Graft Surgery (from the Pooled PLATINUM Diversity and PROMUS Element Plus Registries).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients |
1.78 | <.0001 sig |
| SECONDARY Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients |
0.3 | — |
| SECONDARY Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients |
0.7 | — |
| SECONDARY Rate of Longitudinal Stent Deformation |
2 | — |
| SECONDARY Major Adverse Cardiac Event Rate (MACE) |
6.9 | — |
| SECONDARY Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent |
4.7 | — |
| SECONDARY Myocardial Infarction (MI) Rate |
1.1 | — |
| SECONDARY Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent |
0.7 | — |
| SECONDARY Cardiac Death Rate |
1.4 | — |
| SECONDARY Rate of Cardiac Death Events Related to the PROMUS Element Stent |
1.3 | — |
| SECONDARY Target Vessel Revascularization (TVR) Rate |
5.6 | — |
| SECONDARY Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent |
3.5 | — |
| SECONDARY Cardiac Death or Myocardial Infarction (MI) Rate |
2.3 | — |
| SECONDARY Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent |
1.8 | — |
| SECONDARY Target Vessel Failure (TVF) Rate |
6.7 | — |
| SECONDARY Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent |
4.7 | — |
| SECONDARY All Death Rate |
2.3 | — |
| SECONDARY Non-cardiac Death Rate |
0.9 | — |
| SECONDARY All Death or Myocardial Infarction Rate |
3.2 | — |
| SECONDARY Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients |
3.26 | — |
| SECONDARY ARC ST Rate in PLATINUM-like Population. |
0.0023 | <.0001 sig |
Eligibility Criteria
Inclusion Criteria
- The population will include consecutive, consented patients.
Exclusion Criteria
- There are no exclusion criteria in this all-comers study.
Data sourced from ClinicalTrials.gov (NCT01589978) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.