Phase 4
N=200
EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease
Coronary Disease · Coronary Artery Disease · Coronary Artery Stenosis · Coronary Artery Restenosis
Bottom Line
View on ClinicalTrials.gov: NCT00531011 ↗Enrolled (actual)
200
Serious AEs
20.8%
Results posted
Aug 2011
Primary outcome: Primary: In-stent Late Loss (LL) — 0.052; 0.238 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- XIENCE V® Everolimus Eluting Coronary Stent System (Device); TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-stent Late Loss (LL) |
0.052; 0.238 | — |
| SECONDARY In-stent Binary Restenosis Rate |
5.8; 3.6 | — |
| SECONDARY In-segment Binary Restenosis Rate |
6.2; 4.6 | — |
| SECONDARY In-segment Late Loss (LL) |
-0.100; 0.037 | — |
| SECONDARY Composite Rate of Cardiac Death, Myocardial Infarction (MI, Both Q-wave and Non Q-wave), and Ischemia-driven Target Lesion Revascularization (TLR) . |
1; 2.1 | — |
| SECONDARY Composite Rate of All Death, MI (Q-wave and Non Q-wave), and Target Vessel Revascularization (TVR). |
1; 2.1 | — |
| SECONDARY Lesion Success |
99.2; 99.6 | — |
| SECONDARY Procedural Success |
98.1; 97 | — |
| SECONDARY Device Success |
97.7; 98.2 | — |
| SECONDARY Adjudicated Stent Thrombosis. |
0; 0 | — |
| SECONDARY Adjudicated Stent Thrombosis. |
0; 0 | — |
| SECONDARY Revascularizations |
5.8; 11.3 | — |
| SECONDARY Revascularizations |
5.8; 11.3 | — |
| SECONDARY Composite Endpoint of Cardiac Death, MI (Q-wave and Non Q-wave), and Ischemia-driven TLR . |
4.9; 7.2 | — |
| SECONDARY Composite Endpoint of All Death, MI (Q-wave and Non Q-wave), and TVR. |
6.8; 12.4 | — |
| SECONDARY In-stent Minimum Lumen Diameter (MLD). |
2.29; 2.17 | — |
| SECONDARY In-segment Minimum Lumen Diameter (MLD). |
2.10; 2.04 | — |
| SECONDARY Proximal Minimum Lumen Diameter (MLD). |
2.67; 2.61 | — |
| SECONDARY Distal Minimum Lumen Diameter (MLD). |
2.28; 2.25 | — |
Summary
The purpose of this two part study is the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific setting of patients with Multi-Vessel Coronary Artery Disease (MVD).
Eligibility Criteria
Inclusion Criteria
- Patient must be at least 18 years of age
- Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site
- Patient has been diagnosed a MVD, as documented by coronary angiography, i.e. presenting a severe stenosis (>50%) amenable to PCI in at least 2 major epicardial vessels or their principal bifurcation branches (diagonal or obtuse marginal)
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram -ECG- consistent with ischemia)
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
- Patient must agree to undergo all protocol-required follow-up examinations.
Angiographic Inclusion Criteria
- Patients may receive up to 4 planned XIENCE V® EECSS stents, depending on the number of vessels treated and their respective lesion length. When multiple lesions are present in one or more main coronary branches, complete revascularization should be attempted with the implantation of a maximum of 4 planned stents
- Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy)
- Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
- Target lesion or = 50%
- Two lesions in a single main coronary artery or its branches do not constitute a MVD situation, therefore this type of patient must not be enrolled
Exclusion Criteria
- Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (non-procedural/spontaneous MI, CK-MB > or = to 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure
- Patient has current unstable arrhythmias
- Patient has a known left ventricular ejection fraction (LVEF) 700,000 cells/mm3, a WBC of 20% stenosed lesion by visual estimation)
- Heavy calcification
- The patient may need more than 4 planned stents. Bailout stents are allowed but must be of the same type as randomization stent.
Data sourced from ClinicalTrials.gov (NCT00531011). 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.