XIENCE V: SPIRIT WOMEN Sub-study

A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions

The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Arteriosclerosis; Stent Thrombosis; Vascular Disease; Coronary Artery Stenosis; Total Coronary Occlusion; Coronary Artery Restenosis
• Intervention / Treatment: Device: XIENCE V®/ XIENCE PRIME™; Device: CYPHER SELECT

Detailed Description

SPIRIT Women Randomized Sub-study is a prospective, single-blind, double arm, randomized multi-center sub-study comparing the XIENCE V® EECSS and XIENCE PRIME™ EESS to the CYPHER SELECT™ PLUS Sirolimus-eluting Coronary Stent in the treatment of female patients with coronary artery lesions.

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 Women study after 2 years.

• Study Type: Interventional
• Enrollment (Actual): 455
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1181
    • Hosital Italiano de Buenos Aires - Cardiologia
  • Buenos Aires, Argentina, 1428
    • Instituto Cardiovascular de Buenos Aires-ICBA
• Austria
  • Wien, Austria, 1090
    • Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II
• Belgium
  • Roeselare, Belgium, 8800
    • Heilig Hart Ziekenhuis Roeselare
• Brazil
  • Sao Paulo, Brazil, 04012-180
    • Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
• France
  • Massy, France, 91300
    • Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Kardiologische Klinik Herz- und Diabeteszentrum
  • Bad Segeberg, Germany, 23795
    • Segebergerkliniken
  • Dresden, Germany, 01307
    • Technische Universität Dresden, Medizinische Klinik II - Kardiologie
• Hungary
  • Budapest, Hungary
    • Semmelweis University, Department of Cardiovascular Surgery
• Italy
  • Milan, Italy, 20138
    • Centro Cardiologico Monzino
  • Milano, Italy, 20149
    • Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO
  • Modena, Italy, 41100
    • Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena
  • Pisa, Italy, 56127
    • Ospedale Cisanello
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
• Latvia
  • Riga, Latvia, 1002
    • Latvian Center of Cardiology, P. Stradina University Hospital
• Netherlands
  • Amsterdam, Netherlands, 1105
    • AMC
  • Nieuwegein, Netherlands, 3430
    • St. Antonius Ziekenhuis
• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital
• Poland
  • Warsaw, Poland, 04-628
    • Institute of Cardiology
• Spain
  • Alicante, Spain, 3010
    • Hospital General de Alicante
  • Barcelona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern, Kardiologie
  • Lugano, Switzerland, 6900
    • Cardiocentro Ticino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

General Inclusion Criteria:

• Patient must be female.
• Patient must be at least 18 years of age.
• Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives and she or 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 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.
• Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.

Angiographic Inclusion Criteria:

• Patients' artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned study 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. The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.
• Target lesion greater than or equal to 28 mm in length by visual estimate.

General Exclusion Criteria:

• 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 clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
• Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
• Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
• Patient who is judged to have a lesion that prevents complete inflation of an angioplasty balloon.
• Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) within the target vessel(s)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XIENCE V® / XIENCE PRIME™	Device: XIENCE V®/ XIENCE PRIME™; Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
Active Comparator: CYPHER SELECT	Device: CYPHER SELECT; XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).	This measure adds together all subjects who were determined by an expert panel to have died, had MI or had TVR as a result of their procedure.	at 1 year
In-stent Late Loss (LL) (Main Secondary Endpoint)	In-stent Minimal Lumen Diameter (MLD)post-procedure - in-stent MLD at follow-up.	at 270 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Device Success	Successful delivery and deployment of the study stent at the intended target lesion and successful withdrawal of the stent delivery system.	Intra-operative
Clinical Procedure Success	Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system without adverse cardiac events.	Intra-operative
Adjudicated Stent Thrombosis (Definite, Probable)		< 1 day (Acute)
Adjudicated Stent Thrombosis (Definite, Probable)		1 to 30 days (Sub-Acute)
Adjudicated Stent Thrombosis (Definite, Probable)		30 days to 1 year (Late)
Adjudicated Stent Thrombosis (Definite, Probable, Possible)		30 days to 1 year (Late)
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).		at 30 days
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.		at 240 days
Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.		at 1 year
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).		at 30 days
Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).		at 240 days
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).		at 30 days
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).		at 240 days
Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).		at 1 year
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).		at 30 days
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).		at 240 days
Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).		at 1 year
In-segment Late Loss (LL)	LL = Minimal Lumen Diameter (MLD) post-procedure minus MLD at follow-up	at 270 days
In-stent Angiographic Binary Restenosis Rates	Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).	at 270 days
In-segment Angiographic Binary Restenosis Rates	Only a certain number of patients were required to have angiographic follow-up. Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA).	at 270 days
In-stent Percent Diameter Stenosis		at 270 days
In-segment Percent Diameter Stenosis		at 270 days
Adjudicated Revascularization (TLR/TVR/All Revascularizations)	Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations	at 30 days
Adjudicated Revascularization (TLR/TVR/All Revascularizations)	Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations	at 240 days
Adjudicated Revascularization (TLR/TVR/All Revascularizations)	Composite of Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), all revascularizations	at 1 year
Aneurysm	All subjects with aneurysm of the target lesion up to the 270 day follow-up visit	at 270 days
Thrombus	All subjects with thrombus of the target lesion up to the 270 day follow-up visit	at 270 days
Persisting Dissection	All subjects with persisting dissection of the target lesion up to the 270 day follow-up visit	at 270 days

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Publications and helpful links

General Publications

• Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439.
• Franzone A, Zaugg S, Piccolo R, Modena MG, Mikhail GW, Ferre JM, Strasser R, Grinfeld L, Heg D, Juni P, Windecker S, Morice MC. A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study. PLoS One. 2017 Aug 10;12(8):e0182632. doi: 10.1371/journal.pone.0182632. eCollection 2017.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 13, 2010
• First Submitted That Met QC Criteria: August 12, 2010
• First Posted (Estimate): August 16, 2010

Study Record Updates

• Last Update Posted (Estimate): August 7, 2012
• Last Update Submitted That Met QC Criteria: July 23, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Stents; Everolimus; Angioplasty; Stent thrombosis; Coronary restenosis; Total coronary occlusions
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Embolism and Thrombosis; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Vascular Diseases; Ischemia; Thrombosis; Arteriosclerosis; Coronary Occlusion; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: 07-377 sub-study