Atherosclerosis, Coronary Artery Disease
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System for the treatment of subjects in China with a single de novo atherosclerotic coronary artery lesion.
Detailed description
A prospective, multi-center, randomized-controlled, single-blind, superiority trial at up to 15 sites in China to enroll 500 subjects (3:1 randomization PROMUS Element to TAXUS Liberté) with a single de novo lesion \<38mm in length (by visual estimate) in a native coronary artery ≥2.50mm to ≤4.00 mm in diameter (by visual estimate).
Interventions
Everolimus-eluting Coronary Stent Drug-eluting Stent (DES) implantation
DEVICETAXUS Liberté Coronary Stent System
Paclitaxel-eluting Coronary Stent Drug-eluting Stent (DES) implantation
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: * Subject must be age 18 - 75 years * Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial- specific tests or procedures are performed * Subject is eligible for percutaneous coronary intervention (PCI) * Subject has symptomatic coronary artery disease or documented silent ischemia * Subject is an acceptable candidate for coronary artery bypass grafting (CABG) * Subject has a left ventricular ejection fraction (LVEF) ≥30% as measured within 60 days prior to enrollment * Subject is willing to comply with all protocol-required follow-up evaluations Angiographic Inclusion Criteria: * Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤ 4.00 mm. * Target lesion length must measure \<38 mm (by visual estimate) * Target lesion must have visually estimated stenosis ≥50% and \<100% with Thrombolysis in Myocardial Infarction (TIMI) flow \>1. * Target lesion must be successfully pre-dilated.
Exclusion criteria
* Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI * Subject with unstable angina or recent MI (within 1 week) must have creatine kinase (CK)/ creatine kinase-myoglobin band(CK-MB) or troponin documented prior to the procedure and are excluded if any of the following criteria are met at the time of the index procedure: * of CK MB \>2× upper limit of normal (ULN), the subject is excluded regardless of the CK Total. * If CK Total \>2× ULN, either CK-MB or troponin must be drawn and the subject is excluded if either CK-MB or troponin is abnormal. * If neither CK Total or CK MB is drawn but troponin is, the subject is excluded if troponin \>1× ULN and the subject has at least one of the following: * Subject has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., \>1 mm stent thrombosis (ST) segment elevation or depression in consecutive leads or new left bundle branch block (LBBB) * Development of pathological Q waves in the ECG or; * Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality Note: Subjects who do not have recent MI or unstable angina must still have CK/CK-MB or troponin drawn prior to the index procedure. However, the results for these subjects do not need to be available prior to the index procedure and there are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 9 Month In-stent Late Loss | 9 Months | The primary endpoint is in-stent late loss measured by quantitative coronary angiography (QCA) at 9 months post-index procedure. |
Secondary
| Measure | Time frame |
|---|---|
| Target Vessel Revascularization (TVR) Rate | In hospital and at 2 years |
| Target Lesion Failure (TLF) Rate | In hospital and at 2 years |
| Major Adverse Cardiac Event (MACE) Rate | In hospital and at 2 years |
| Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate | In hospital and at 2 years |
| Cardiac Death Rate | In hospital and at 2 years |
| Non-cardiac Death Rate | In hospital and at 2 years |
| All Death Rate | In hospital and at 2 years |
| Target Lesion Revascularization (TLR) Rate | In hospital and at 2 years |
| Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions) | In hospital and at 2 years |
| Target Vessel Failure (TVF) Rate | In hospital and at 2 years |
| Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD) | 9 months |
| Periprocedural Endpoints: Technical Success Rate, Clinical Procedural Success Rate | In hospital |
| Angiographic Endpoints: In-stent and In-segment Binary Restenosis Rate, Stent Fracture Rate | 9 month |
| Minimal Lumen Diameter (QCA), Acute Gain (QCA) | In hospital |
| Cardiac Death or MI Rate | In hospital and at 2 years |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PROMUS Element PROMUS Element Everolimus-Eluting Coronary Stent System (PROMUS Element)
PROMUS Element Coronary Stent System: Everolimus-eluting Coronary Stent DES implantation | 373 |
| TAXUS Liberté DES TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (TAXUS Liberté)
TAXUS Liberté Coronary Stent System: Paclitaxel-eluting Coronary Stent DES implantation | 127 |
| Total | 500 |
Baseline characteristics
| Characteristic | PROMUS Element | TAXUS Liberté DES | Total |
|---|---|---|---|
| Age, Continuous | 57.12 years STANDARD_DEVIATION 9.9 | 57.55 years STANDARD_DEVIATION 9.5 | 57.23 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment China | 373 participants | 127 participants | 500 participants |
| Sex: Female, Male Female | 105 Participants | 39 Participants | 144 Participants |
| Sex: Female, Male Male | 268 Participants | 88 Participants | 356 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 86 / 373 | 28 / 127 |
| serious Total, serious adverse events | 57 / 373 | 23 / 127 |
Outcome results
Primary
9 Month In-stent Late Loss
The primary endpoint is in-stent late loss measured by quantitative coronary angiography (QCA) at 9 months post-index procedure.
Time frame: 9 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | 9 Month In-stent Late Loss | 0.11 percentage of Intent-to-treat patients |
| TAXUS Liberté DES | 9 Month In-stent Late Loss | 0.40 percentage of Intent-to-treat patients |
Comparison: H0: μt - μc = 0 H1: μt - μc ≠ 0 where μt and μc are the mean 9-month in-stent late loss values for the subjects in the PROMUS Element test and TAXUS Liberté control treatment groups, respectively.p-value: 0.0595% CI: [-0.37, -0.21]t-test, 2 sided
Secondary
All Death Rate
Time frame: In hospital and at 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | All Death Rate | 0.0 percentage of participants |
| TAXUS Liberté DES | All Death Rate | 1.6 percentage of participants |
Secondary
Angiographic Endpoints: In-stent and In-segment Binary Restenosis Rate, Stent Fracture Rate
Time frame: 9 month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PROMUS Element | Angiographic Endpoints: In-stent and In-segment Binary Restenosis Rate, Stent Fracture Rate | In-stent binary restenosis rate | 2.1 percentage of participants |
| PROMUS Element | Angiographic Endpoints: In-stent and In-segment Binary Restenosis Rate, Stent Fracture Rate | in-segment binary restenosis rate | 3.0 percentage of participants |
| PROMUS Element | Angiographic Endpoints: In-stent and In-segment Binary Restenosis Rate, Stent Fracture Rate | Stent fracture rate | 0.0 percentage of participants |
| TAXUS Liberté DES | Angiographic Endpoints: In-stent and In-segment Binary Restenosis Rate, Stent Fracture Rate | In-stent binary restenosis rate | 5.2 percentage of participants |
| TAXUS Liberté DES | Angiographic Endpoints: In-stent and In-segment Binary Restenosis Rate, Stent Fracture Rate | in-segment binary restenosis rate | 7.8 percentage of participants |
| TAXUS Liberté DES | Angiographic Endpoints: In-stent and In-segment Binary Restenosis Rate, Stent Fracture Rate | Stent fracture rate | 0.0 percentage of participants |
Secondary
Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD)
Time frame: 9 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PROMUS Element | Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD) | in-segment percent diameter stenosis | 21.51 percentage | Standard Deviation 12.17 |
| PROMUS Element | Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD) | In-stent minimum lumen diameter | 2.52 percentage | Standard Deviation 0.53 |
| PROMUS Element | Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD) | In-segment late loss | 0.06 percentage | Standard Deviation 0.36 |
| PROMUS Element | Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD) | in-segment minimum lumen diameter | 2.24 percentage | Standard Deviation 0.52 |
| PROMUS Element | Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD) | In-stent percent diameter stenosis | 11.06 percentage | Standard Deviation 13.86 |
| TAXUS Liberté DES | Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD) | in-segment minimum lumen diameter | 2.07 percentage | Standard Deviation 0.56 |
| TAXUS Liberté DES | Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD) | In-stent percent diameter stenosis | 22.20 percentage | Standard Deviation 16 |
| TAXUS Liberté DES | Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD) | in-segment percent diameter stenosis | 28.42 percentage | Standard Deviation 14.92 |
| TAXUS Liberté DES | Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD) | In-segment late loss | 0.27 percentage | Standard Deviation 0.45 |
| TAXUS Liberté DES | Angiographic Endpoints: In-stent and In-segment Percent Diameter Stenosis (%DS), In-segment Late Loss , In-stent and In-segment Minimum Lumen Diameter (MLD) | In-stent minimum lumen diameter | 2.24 percentage | Standard Deviation 0.57 |
Secondary
Cardiac Death or MI Rate
Time frame: In hospital and at 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Cardiac Death or MI Rate | 0.3 percentage of participants |
| TAXUS Liberté DES | Cardiac Death or MI Rate | 3.1 percentage of participants |
Secondary
Cardiac Death Rate
Time frame: In hospital and at 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Cardiac Death Rate | 0 percentage of participants |
| TAXUS Liberté DES | Cardiac Death Rate | 0 percentage of participants |
Secondary
Major Adverse Cardiac Event (MACE) Rate
Time frame: In hospital and at 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Major Adverse Cardiac Event (MACE) Rate | 3.0 percentage of participants |
| TAXUS Liberté DES | Major Adverse Cardiac Event (MACE) Rate | 7.1 percentage of participants |
Secondary
Minimal Lumen Diameter (QCA), Acute Gain (QCA)
Time frame: In hospital
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PROMUS Element | Minimal Lumen Diameter (QCA), Acute Gain (QCA) | Proximal Edge MLD | 2.84 mm |
| PROMUS Element | Minimal Lumen Diameter (QCA), Acute Gain (QCA) | In-Stent Acute gain (QCA) | 1.73 mm |
| PROMUS Element | Minimal Lumen Diameter (QCA), Acute Gain (QCA) | Distal Edge MLD | 2.44 mm |
| PROMUS Element | Minimal Lumen Diameter (QCA), Acute Gain (QCA) | In Segment Acute gain (QCA) | 1.41 mm |
| PROMUS Element | Minimal Lumen Diameter (QCA), Acute Gain (QCA) | In-Stent MLD | 2.64 mm |
| TAXUS Liberté DES | Minimal Lumen Diameter (QCA), Acute Gain (QCA) | In Segment Acute gain (QCA) | 1.46 mm |
| TAXUS Liberté DES | Minimal Lumen Diameter (QCA), Acute Gain (QCA) | In-Stent MLD | 2.65 mm |
| TAXUS Liberté DES | Minimal Lumen Diameter (QCA), Acute Gain (QCA) | Proximal Edge MLD | 2.94 mm |
| TAXUS Liberté DES | Minimal Lumen Diameter (QCA), Acute Gain (QCA) | Distal Edge MLD | 2.43 mm |
| TAXUS Liberté DES | Minimal Lumen Diameter (QCA), Acute Gain (QCA) | In-Stent Acute gain (QCA) | 1.77 mm |
Secondary
Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate
Time frame: In hospital and at 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate | 0.3 percentage of participants |
| TAXUS Liberté DES | Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate | 1.6 percentage of participants |
Secondary
Non-cardiac Death Rate
Time frame: In hospital and at 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Non-cardiac Death Rate | 0.0 percentage of participants |
| TAXUS Liberté DES | Non-cardiac Death Rate | 1.6 percentage of participants |
Secondary
Periprocedural Endpoints: Technical Success Rate, Clinical Procedural Success Rate
Time frame: In hospital
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PROMUS Element | Periprocedural Endpoints: Technical Success Rate, Clinical Procedural Success Rate | Technical success rate | 99.5 percentage of participants |
| PROMUS Element | Periprocedural Endpoints: Technical Success Rate, Clinical Procedural Success Rate | Clinical procedural success rate | 100.00 percentage of participants |
| TAXUS Liberté DES | Periprocedural Endpoints: Technical Success Rate, Clinical Procedural Success Rate | Clinical procedural success rate | 100.00 percentage of participants |
| TAXUS Liberté DES | Periprocedural Endpoints: Technical Success Rate, Clinical Procedural Success Rate | Technical success rate | 99.2 percentage of participants |
Secondary
Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions)
Time frame: In hospital and at 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions) | 0.3 percentage of participants |
| TAXUS Liberté DES | Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions) | 0.8 percentage of participants |
Secondary
Target Lesion Failure (TLF) Rate
Time frame: In hospital and at 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Target Lesion Failure (TLF) Rate | 2.4 percentage of participants |
| TAXUS Liberté DES | Target Lesion Failure (TLF) Rate | 4.7 percentage of participants |
Secondary
Target Lesion Revascularization (TLR) Rate
Time frame: In hospital and at 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Target Lesion Revascularization (TLR) Rate | 2.4 percentage of participants |
| TAXUS Liberté DES | Target Lesion Revascularization (TLR) Rate | 4.7 percentage of participants |
Secondary
Target Vessel Failure (TVF) Rate
Time frame: In hospital and at 2 years
Population: Per Protocol Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Target Vessel Failure (TVF) Rate | 3.0 percentage of participant |
| TAXUS Liberté DES | Target Vessel Failure (TVF) Rate | 5.5 percentage of participant |
Secondary
Target Vessel Revascularization (TVR) Rate
Time frame: In hospital and at 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS Element | Target Vessel Revascularization (TVR) Rate | 3.0 percentage of participants |
| TAXUS Liberté DES | Target Vessel Revascularization (TVR) Rate | 5.5 percentage of participants |