SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)

Phase 4

Completed

Conditions: Coronary Artery Disease
Coronary Disease
Coronary Restenosis

Interventions: Device: TAXUS® Liberté™
Device: XIENCE V® EECSS

Registration Number: NCT01171820

Lead Sponsor: Abbott Medical Devices

Brief Summary: The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).

Detailed Description: The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic sub-study and the Registry.

The SPIRIT V Diabetic sub-study is a prospective, randomized, active-controlled, single blind, parallel two-arm multi-center study comparing the XIENCE V® EECSS to the TAXUS® Liberté™ in the treatment of diabetic patients with coronary artery lesions who will fulfill the eligibility criteria. Approximately 300 patients will be randomized (2:1) against the TAXUS® Liberté™ coronary stent system. These patients will be recruited in up to 40 selected sites.

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 observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results.

The post approval SPIRIT V 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 SPIRIT V Diabetic study after 1 year.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 324

Inclusion Criteria

at least 18 years
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
diagnosed with diabetes, as documented by medical history.
evidence of myocardial ischemia
acceptable candidate for coronary artery bypass grafting (CABG) surgery
agree to undergo all clinical investigation plan (CIP)-required follow-up examinations
artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned stents
maximum of one, de novo, target lesion per native major epicardial vessel or side branch
target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
target lesion ≤ 28 mm in length by visual estimate
target lesion must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% and a TIMI flow > 1

Exclusion Criteria

known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure
current unstable arrhythmias
Left ventricular ejection fraction < 30%
received a heart or any other organ transplant or is on a waiting list for any organ transplant
receiving or scheduled to receive chemotherapy or radiation therapy within 30 days prior to or after the procedure.
receiving immunosuppression therapy or has known immunosuppressive or autoimmune disease
known hypersensitivity or contraindication to specific agents
elective surgery is planned within the first 9 months after the procedure that will require discontinuing either aspirin or clopidogrel
platelet count limits, white blood cell limits or documented or suspected liver disease
renal insufficiency
history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Cerebrovascular accident or transient ischemic attack within the past 6 months
significant GI or urinary bleed within the past 6 months
history of other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse that may cause non-compliance with the CIP, confound the data interpretation or is associated with a limited life expectancy (i.e. less than one year)

Target lesion meets any of the following criteria:

In-stent restenotic
aorto-ostial location (within 3 mm)
left main location
located within 2 mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX)
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)
lesion involving a side branch ≥ 2.5 mm in diameter
lesion involving a side branch with > 50% stenosis by visual estimation Lesion involving a side branch requiring predilatation
located in a major epicardial vessel that has been previously treated with brachytherapy
located in a major epicardial vessel or a side branch that has been previously treated with any type of percutaneous intervention (e.g., balloon angioplasty, cutting balloon, atherectomy), < 9 months prior to the index procedure
total occlusion (TIMI flow 0), prior to wire crossing
excessive tortuosity proximal to or within the lesion
extreme angulation (≥ 90%) proximal to or within the lesion
heavy calcification

The target vessel contains visible thrombus

Patient has a high probability that a procedure other than pre-dilatation, stenting and post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. brachytherapy)

Patient has additional clinically significant lesion(s) (> 50% diameter stenosis) in a target vessel or side branch for which an intervention within 9 months after the index procedure may be required

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAXUS® Liberté™	TAXUS® Liberté™	-
XIENCE V® EECSS	XIENCE V® EECSS	-

Primary Outcome Measures

Name	Time	Method
In-stent Late Loss (LL)	270 days	In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up

Secondary Outcome Measures

Name	Time	Method
Clinical Device Success (Per-lesion)	immediately post-procedure	Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy.
Clinical Procedure Success (Per-patient)	immediately post-procedure	Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success.
In-segment Late Loss	270 days	In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up
Proximal Late Loss	270 day	Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up
Distal Late Loss	270 days	Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up
In-stent Angiographic Binary Restenosis Rate	270 days	Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.
In-segment Angiographic Binary Restenosis Rate	270 days	Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.
In-stent Percent Diameter Stenosis (% DS)	270 days	This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 \* (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
In-segment Percent Diameter Stenosis (% DS)	270 days	This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)	365 days	The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death \>30 days after stent placement.
Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.	393 days	TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs.
Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)	393 days	Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR \>=70% in the absence of the above signs.
Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)	393 days	Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.
Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR)	37 days	Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR
Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)	393 days	Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR

Trial Locations

Locations (28): Herzzentrum Siegburg GmbH
🇩🇪
Siegburg, Germany
CHU Lille - Hôpital Cardiologique
🇫🇷
Lille, France
Herzzentrum
🇩🇪
Bernau, Germany
Azienda Ospedaliera Riuniti
🇮🇹
Bergamo, Italy
Hospital Puerta de Hierro
🇪🇸
Madrid, Spain
Hospital General de Valencia
🇪🇸
Valencia, Spain
King's College Hospital
🇬🇧
London, United Kingdom
Wessex Cardiac Unit
🇬🇧
Southampton, United Kingdom
Institute Jantung Negara
🇲🇾
Kuala Lumpur, Malaysia
Maasstad Ziekenhuis
🇳🇱
Rotterdam, Netherlands
King Chulalongkorn Memorial Hospital
🇹🇭
Bangkok, Thailand
Ospedale Civile
🇮🇹
Mirano, Italy
Azienda Ospedaliera di Padova
🇮🇹
Padova, Italy
IRCCS Policlinico San Matteo
🇮🇹
Pavia, Italy
Salzburger Landeskliniken
🇦🇹
Salzburg, Austria
Universitätsklinikum
🇩🇪
Heidelberg, Germany
Lukas Krankenhaus Neuss
🇩🇪
Neuss, Germany
C.H.U. - Hopital Michallon
🇫🇷
Grenoble, France
Sheba Medical Center
🇮🇱
Ramat Gan, Israel
Azienda Ospedaliera S. Gdi Dio Salerno
🇮🇹
Salerno, Italy
Medisch Centrum Alkmaar
🇳🇱
Alkmaar, Netherlands
Medical University of Bydgoszcz
🇵🇱
Bydgoszcz, Poland
General De Alicante
🇪🇸
Alicante, Spain
Hospital Belvigte de Barcelona
🇪🇸
Barcelona, Spain
Hospital Santa Creu I Sant Pau
🇪🇸
Barcelona, Spain
La Paz
🇪🇸
Madrid, Spain
Hospital Virgen de la Arrixaca
🇪🇸
Murcia, Spain
Clinico San Carlos
🇪🇸
Madrid, Spain