Coronary Artery Disease
Conditions
Keywords
Drug Eluting Stents, Interventional Cardiology
Brief summary
The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a real world, all comers study. Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent) system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a real world patient population.
Detailed description
The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a real world, all comers study. Primary objective: to compare the Medtronic Endeavor-Resolute (Zotarolimus-Eluting stent) system with the Abbott XIENCE V (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a real world patient population. Study hypothesis: To determine whether the Zotarolimus-Eluting stent (Medtronic Endeavor-Resolute) is non-inferior to the Everolimus-eluting stent (Abbott XIENCE V) in terms of the primary endpoint at 12 months after stent implantation.
Interventions
DEVICEMedtronic Endeavor Resolute
Medtronic Endeavor Resolute
DEVICEAbbott Xience V
Abbott Xience V
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Medtronic Vascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimal age 18 years * Symptomatic coronary artery disease * Patient acceptable candidate for treatment with drug eluting stent in accordance with applicable guidelines * Presence of one or more coronary artery stenosis \>50% with reference diameter 2.25-4.0mm which can be covered by one or multiple stents * Patient indication, lesion length and vessel diameter according to 'Instructions for Use' of study stents * Patient is willing and able to cooperate with study procedures and required follow up visits and patient or legal representative has been informed and agrees by signing EC approved written informed consent.
Exclusion criteria
* Women of childbearing potential who do not have a negative pregnancy test within 7 days before procedure and women who are lactating * Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel, chromium, molybdenum, polymer coatings, Zotarolimus, Everolimus, or contrast material * Participating in other trial before reaching primary endpoint * Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure | 12 months | Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-Stent Percent Diameter Stenosis | 13 Months | In Stent Percent Diameter Stenosis at thirteen months. In Stent Percent Diameter Stenosis: measured percent of diameter stenosis at the region of the stent (calculated as 100x(RVD-MLD)/RVD using the mean values from 2 orthogonal views by QCA. RVD (Reference Vessel Diameter): average of normal segments within 10mm proximal and distal to target lesion from 2 orthogonal views using QCA. MLD (Minimal Lumen Diameter): average of 2 orthogonal views of the narrowest point wihtin the area of assessment. MLD measured during QCA by the angiographic core laboratory. |
Countries
Switzerland
Participant flow
Recruitment details
Start recruitment: April 30, 2008 \> End recruitment: October 28, 2008 \> Types of location: medical clinic
Participants by arm
| Arm | Count |
|---|---|
| 1. Resolute - 12-13 Months Medtronic Resolute - 12-13 Months | 1,140 |
| 2. XIENCE V - 12-13 Months Abbott Xience V - 12-13 Months | 1,152 |
| Total | 2,292 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missed 12 Months visit | 16 | 19 |
| Overall Study | Withdrawal by Subject | 5 | 7 |
Baseline characteristics
| Characteristic | 1. Resolute - 12-13 Months | 2. XIENCE V - 12-13 Months | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 595 Participants | 589 Participants | 1184 Participants |
| Age, Categorical Between 18 and 65 years | 545 Participants | 563 Participants | 1108 Participants |
| Age, Continuous | 64.4 years STANDARD_DEVIATION 10.9 | 64.2 years STANDARD_DEVIATION 10.8 | 64.3 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment Europe | 1122 participants | 1132 participants | 2254 participants |
| Region of Enrollment Middle East | 18 participants | 20 participants | 38 participants |
| Sex: Female, Male Female | 266 Participants | 263 Participants | 529 Participants |
| Sex: Female, Male Male | 874 Participants | 889 Participants | 1763 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,140 | 59 / 1,152 |
| serious Total, serious adverse events | 435 / 1,140 | 432 / 1,152 |
Outcome results
Primary
Target Lesion Failure
Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year. MI: Q MI if new pathological Q waves and chest pain, non Q MI if CK elevated more than two times normal, troponin elevated more than normal, according to ARC definitions. TLR, clinically indicated if associated with ischemic symptoms and angiographic min lumen diameter bigger than fifty percent by QCA or without symptoms and min lumen diameter bigger than seventy percent. Measure average.
Time frame: 12 months
Population: Analysis per intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1. Resolute - 12-13 Months | Target Lesion Failure | 8.2 percentage of participants |
| 2. XIENCE V - 12-13 Months | Target Lesion Failure | 8.3 percentage of participants |
Secondary
In-Stent Percent Diameter Stenosis
In Stent Percent Diameter Stenosis at thirteen months. In Stent Percent Diameter Stenosis: measured percent of diameter stenosis at the region of the stent (calculated as 100x(RVD-MLD)/RVD using the mean values from 2 orthogonal views by QCA. RVD (Reference Vessel Diameter): average of normal segments within 10mm proximal and distal to target lesion from 2 orthogonal views using QCA. MLD (Minimal Lumen Diameter): average of 2 orthogonal views of the narrowest point wihtin the area of assessment. MLD measured during QCA by the angiographic core laboratory.
Time frame: 13 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1. Resolute - 12-13 Months | In-Stent Percent Diameter Stenosis | 21.65 Percentage diameter stenosis | Standard Deviation 14.42 |
| 2. XIENCE V - 12-13 Months | In-Stent Percent Diameter Stenosis | 19.76 Percentage diameter stenosis | Standard Deviation 14.64 |