EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease

Phase 4

Completed

Conditions: Coronary Disease
Coronary Artery Disease
Coronary Artery Restenosis
Coronary Artery Stenosis

Interventions: Device: XIENCE V® Everolimus Eluting Coronary Stent System
Device: TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System

Registration Number: NCT00531011

Lead Sponsor: Abbott Medical Devices

Brief 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).

Detailed Description: This is a clinical evaluation of the XIENCE V® everolimus eluting coronary stent system as a revascularization treatment of patients with multi-vessel coronary artery disease (MVD-CAD).

The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were consistently lower than the comparator arm of each study.

The post approval EXECUTIVE study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria.

Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the EXECUTIVE trial.

The study is composed of two parts:

A Registry, outlined in a separate posting and the Randomized Control Trial (RCT) portion of this study, which is as follows:

-A randomized group of patients aimed at assessing the angiographic efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) compared to the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

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 = 28 mm in length by visual estimation
Target lesions must be in a major artery or its principal branches (diagonal or obtuse marginal) with a visually estimated stenosis of > 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) <30%
Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
Patient is receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
Patient is receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
Patient is receiving chronic anticoagulation therapy (e.g. coumadin)
Patient has a known hypersensitivity or contraindication to aspirin, paclitaxel, either heparin or bivalirudin, clopidogrel or ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated
Elective surgery is planned within the first 9 months (+/- 14 days) after the procedure that will require discontinuing either aspirin or clopidogrel
Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dl, patient on dialysis)
Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
Patient has had a significant GI or urinary bleed within the past six months
Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)
Patient is already participating in another investigational use device or drug study or has completed the follow-up phase of another study within the last 30 days.

Angiographic Exclusion Criteria

Target lesion meets any of the following criteria:
- Left main location
- Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft (defined as vessel irregularity per angiogram and >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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XIENCE V	XIENCE V® Everolimus Eluting Coronary Stent System	Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
TAXUS® Liberté™	TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System	Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System

Primary Outcome Measures

Name	Time	Method
In-stent Late Loss (LL)	at 270 days	Full Analysis Set (FAS). LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In stent is measured within the confines of the stent edges.

Secondary Outcome Measures

Name	Time	Method
Composite Rate of Cardiac Death, Myocardial Infarction (MI, Both Q-wave and Non Q-wave), and Ischemia-driven Target Lesion Revascularization (TLR) .	at 30 days	This measure is a calculation of the percentage of participants who experience any of the components of this composite measure.
Composite Endpoint of Cardiac Death, MI (Q-wave and Non Q-wave), and Ischemia-driven TLR .	9 months	ITT
Distal Minimum Lumen Diameter (MLD).	at 9 months.	Distal refers to the immediate 5 mm outside of the distal end of the stent.
In-stent Binary Restenosis Rate	at 9 months	This measures the percentage of patients who have \> 50% diameter stenosis of the assessed vessel, within the stent edges.
Device Success	at the time of PCI	defined as achievement of a final residual in-stent diameter stenosis of \< 30% (visual assessment) using the assigned device only.
Adjudicated Stent Thrombosis.	9 months
In-stent Minimum Lumen Diameter (MLD).	at 9 months.
In-segment Late Loss (LL)	at 9 months	LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In segment LL is measured within the confines of the stent edges and within 5 mm of those edges.
Composite Rate of All Death, MI (Q-wave and Non Q-wave), and Target Vessel Revascularization (TVR).	at 30 days
Revascularizations	9 months	(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.
Composite Endpoint of All Death, MI (Q-wave and Non Q-wave), and TVR.	9 months
In-segment Minimum Lumen Diameter (MLD).	at 9 months.
Proximal Minimum Lumen Diameter (MLD).	at 9 months.	Proximal refers to the immediate 5 mm outside of the proximal end of the stent.
In-segment Binary Restenosis Rate	at 9 months	This measures the percentage of patients who have \> 50% diameter stenosis of the assessed vessel, within the stent edges In-segment is measured within the confines of the stent edges plus within 5 mm on either side of the stent.
Lesion Success	at the time of PCI	defined as attainment of \< 30% residual in-stent stenosis (by visual assessment) using any percutaneous method.
Procedural Success	at the time of PCI	defined as: residual in-stent %DS of \< 30% using a percutaneous method, without cardiac death, Q-wave MI, non Q-wave MI, or repeat revasc of the target during hospitalization.

Trial Locations

Locations (24): A.O. San Giovanni di Dio
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Agrigento, Italy
Ospedale Maggiore Bologna
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Bologna, Italy
Policlinico S. Orsola - Malpighi
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Bologna, Italy
A.O. Cannizzaro
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Catania, Italy
A.O. Università Mater Domini c/o Campus Università Magna Grecia
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Catanzaro, Italy
E.O. Ospedali Galliera
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Genova, Italy
A.O. Universitaria OO.RR Foggia
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Foggia, Italy
A.O. Carlo Poma
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Mantova, Italy
Centro Cardiologico Monzino
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Milano, Italy
Ospedale Loreto Mare
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Napoli, Italy
A. O. Sant'Andrea
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Roma, Italy
Ospedale Generale Madre Vannini
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Roma, Italy
A.S.O. Molinette San Giovanni Battista di Torino
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Torino, Italy
Ospedale Sandro Pertini
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Roma, Italy
Ospedale Maria Vittoria
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Torino, Italy
San Giovanni Battista - Ospedale Molinette
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Torino, Italy
Ospedale Civile
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Vicenza, Italy
P.O. San Giovanni Bosco
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Torino, Italy
Ospedale Civile Maggiore - Università di Verona
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Verona, Italy
A.O. Universitaria - Ospedale Riuniti Umberto I - G.M. Lancisi - G. Salesi
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Torrette Di Ancona, Italy
Ospedale Civile di Vigevano
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Vigevano, Italy
A.O. Della Provincia di Pavia
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Voghera, Italy
Policlinico San Marco
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Zingonia, Italy
A.O. Universitaria Vittorio Emanuele - Ferrarotto - S. Bambino
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Catania, Italy