Clinical trial NCT00307047: SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Official title: SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Stents
Angioplasty
Total coronary occlusion
coronary restenosis
stent thrombosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2006-03-27
Enrollment: 3687
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®). The XIENCE V® arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent System (TAXUS®), commercially available from Boston Scientific.

TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

Detailed description: The completion of the SPIRIT IV clinical trial at three years is justified by the consistent long-term clinical evidence supporting the safety and efficacy of the XIENCE V EECSS in complex, real-world patients across multiple geographies. As SPIRIT IV was designed as a continued access trial, completing the clinical follow-up at the three-year visit does not conflict with any FDA requirements. Abbott Vascular is committed to providing clinical outcomes through three years. The clinical evidence provided from across multiple geographies, in complex populations thus supports Abbott Vascular's proposal to complete the SPIRIT IV RCT at the three-year clinical follow-up.

The SPIRIT IV Clinical Trial is a randomized, active-controlled, single-blinded, multicenter clinical trial in the US that will enroll approximately 3,690 subjects (2:1 randomization XIENCE V®: TAXUS®). The trial allows the treatment of up to three de novo native coronary artery lesions, maximum of two lesion per epicardial vessel, with reference vessel diameters (RVD) ≥ 2.5 mm to ≤ 4.25 mm and lesion lengths ≤ 28 mm. (NOTE: RVD ≥ 2.5 mm to ≤ 3.75 mm until 4.0 mm TAXUS® is commercially available). All subjects will be screened per the protocol inclusion and exclusion criteria and enrolled subjects will have clinical follow-up at 30, 180, and 270 days and 1, 2, and 3 years.

Eligibility criteria: General Inclusion Criteria:

* Subject must be at least 18 years of age
* Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving XIENCE V® and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
* Subject 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)
* Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
* Subject must agree to undergo all protocol-required follow-up procedures
* Subject must agree not to participate in any other clinical study for a period of one year following the index procedure

Angiographic Inclusion Criteria:

* Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and treatment of up to a three de novo target lesions, maximum of two de novo target lesions per epicardical vessel. (NOTE: RVD ≥2.5 mm to ≤3.75 mm until 4.0 mm TAXUS® is commercially available)
* Target lesion(s) must measure ≤28 mm in length by visual estimation(≥3 mm of non-diseased tissue on either side of the target lesion should be covered by the study stent)
* If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria
* If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria
* The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1
* Non-study, percutaneous intervention for lesions in a target vessel (including side branches) is allowed if done ≥ 9 months prior to the index procedure
* Non-study percutaneous intervention for lesions in a non-target vessel involving:
* Successful and uncomplicated (visually estimated diameter stenosis \< 50%, TIMI Grade 3 flow, no ECG changes, prolonged chest pain, or angiographic complications) bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 24 hours prior to the index procedure or during (before randomization) the index procedure. For interventions done within 24 to 48 hours prior to the index procedure, CK and CK-MB must be assessed to be \< 2 times the upper limit of normal at the time of the index procedure. NOTE: Procedures within the 24 hour period preceding the index procedure are not permitted
* Unsuccessful or complicated bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 30 days prior to the index procedure
* Drug-eluting stent treatment is allowed if done ≥ 90 days prior to the index procedure
* Non-study, percutaneous interventions for lesion(s) in a target vessel (including side branches) or non-target vessel are allowed if done ≥ 9 months after the index procedure

General Exclusion Criteria:

* Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure
* The subject is currently experiencing clinical symptoms consistent with AMI
* Subject has current unstable arrhythmias
* Subject has a known left ventricular ejection fraction (LVEF) \< 30%
* Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
* Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure
* Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.)
* Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
* Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated
* Elective surgery that will require discontinuing either aspirin or clopidogrel is planned within the first 9 months after the procedure
* Subject 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)
* Subject has known renal insufficiency (e.g., serum creatinine level of \> 2.5 mg/dL or subject on dialysis)
* Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
* Subject has had a significant GI or urinary bleed within the past six months
* Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
* Subject 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 life expectancy of less than one year
* Subject is already participating in another clinical study that has not yet reached its primary endpoint
* Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used up to 1 year following the index procedure)
* Angiographic Exclusion Criteria
* The target lesion(s) meets any of the following criteria:
* Left main coronary artery location including left main ostial location (NOTE: RCA-aorto-ostial lesions are not excluded)
* Located within 2 mm of the origin of the LAD or LCX
* Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and any visually estimated diameter stenosis \> 20%) arterial or saphenous vein graft
* Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium of the side branch is \> 50% stenosed by visual estimation
* Involves a side branch requiring pre-dilatation
* Total occlusion (TIMI flow 0) prior to wire crossing
* Excessive tortuosity proximal to or within the lesion
* Extreme angulation (≥ 90º) proximal to or within the lesion
* Heavy calcification
* Restenotic from previous intervention
* Subject has received brachytherapy in any epicardial vessel (including side branches)
* The target vessel contains thrombus
* Another clinically significant lesion in the target vessel is present that requires or has a high probability of requiring PCI during the index procedure
* Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 9 months after the index procedure

Primary outcomes:
measure: Ischemia Driven Target Lesion Failure (TLF)
timeFrame: 1 year
Secondary outcomes:
measure: Ischemia Driven Target Vessel Failure (TVF)
timeFrame: 30 days
measure: Ischemia Driven Target Vessel Failure (TVF)
timeFrame: 180 days
measure: Ischemia Driven Target Vessel Failure (TVF)
timeFrame: 270 days
measure: Ischemia Driven Target Vessel Failure (TVF)
timeFrame: 1 year
measure: Ischemia Driven Target Vessel Failure (TVF)
timeFrame: 2 years
measure: Ischemia Driven Target Vessel Failure (TVF)
timeFrame: 3 years
measure: Ischemia Driven Target Lesion Revascularization (TLR)
timeFrame: 30 days
measure: Ischemia Driven Target Lesion Revascularization (TLR)
timeFrame: 180 days
measure: Ischemia Driven Target Lesion Revascularization (TLR)
timeFrame: 270 days
measure: Ischemia Driven Target Lesion Revascularization (TLR)
timeFrame: 1 year
measure: Ischemia Driven Target Lesion Revascularization (TLR)
timeFrame: 2 years
measure: Ischemia Driven Target Lesion Revascularization (TLR)
timeFrame: 3 years
measure: Ischemia Driven Target Vessel Revascularization (TVR)
timeFrame: 30 days
measure: Ischemia Driven Target Vessel Revascularization (TVR)
timeFrame: 180 days
measure: Ischemia Driven Target Vessel Revascularization (TVR)
timeFrame: 270 days
measure: Ischemia Driven Target Vessel Revascularization (TVR)
timeFrame: 1 year
measure: Ischemia Driven Target Vessel Revascularization (TVR)
timeFrame: 2 years
measure: Ischemia Driven Target Vessel Revascularization (TVR)
timeFrame: 3 years
measure: Ischemia Driven Major Adverse Cardiac Events (MACE)
timeFrame: 30 days
measure: Ischemia Driven Major Adverse Cardiac Events (MACE)
timeFrame: 180 days
measure: Ischemia Driven Major Adverse Cardiac Events (MACE)
timeFrame: 270 days
measure: Ischemia Driven Major Adverse Cardiac Events (MACE)
timeFrame: 1 years
measure: Ischemia Driven Major Adverse Cardiac Events (MACE)
timeFrame: 2 years
measure: Ischemia Driven Major Adverse Cardiac Events (MACE)
timeFrame: 3 years
measure: Acute Success (Clinical Device)
timeFrame: Acute: At time of index procedure
measure: Acute Success (Clinical Procedure)
timeFrame: Acute: At time of index procedure
measure: All Myocardial Infarction (MI)
timeFrame: 30 days
measure: All MI
timeFrame: 180 days
measure: All MI
timeFrame: 270 days
measure: All MI
timeFrame: 1 year
measure: All MI
timeFrame: 2 years
measure: All MI
timeFrame: 3 years
measure: All Cause Mortality
timeFrame: 30 days
measure: All Cause Mortality
timeFrame: 180 days
measure: All Cause Mortality
timeFrame: 270 days
measure: All Cause Mortality
timeFrame: 1 year
measure: All Cause Mortality
timeFrame: 2 years
measure: All Cause Mortality
timeFrame: 3 years
measure: Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
timeFrame: 30 days
measure: Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
timeFrame: 180 days
measure: Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
timeFrame: 270 days
measure: Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
timeFrame: 1 year
measure: Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
timeFrame: 2 years
measure: Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
timeFrame: 3 years
measure: Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition
timeFrame: 0-30 days
measure: Definite + Probable Stent Thrombosis Rate Based on ARC Definition
timeFrame: 31-393 days
measure: Definite + Probable Stent Thrombosis Rate Based on ARC Definition
timeFrame: 0 -393 days
measure: Definite + Probable Stent Thrombosis Rate Based on ARC Definition
timeFrame: 0-758 days
measure: Definite + Probable Stent Thrombosis Rate Based on ARC Definition
timeFrame: 0-1123 days
measure: Protocol Defined Stent Thrombosis Rate
timeFrame: 0-30 days
measure: Protocol Defined Stent Thrombosis Rate
timeFrame: 31-393 days
measure: Protocol Defined Stent Thrombosis Rate
timeFrame: 0-393 days
measure: Protocol Defined Stent Thrombosis Rate
timeFrame: 0-758 days
measure: Protocol Defined Stent Thrombosis Rate
timeFrame: 0-1123 days
measure: Cardiac Death or Target Vessel MI Rate
timeFrame: 30 days
measure: Cardiac Death or Target Vessel MI Rate
timeFrame: 180 days
measure: Cardiac Death or Target Vessel MI Rate
timeFrame: 270 days
measure: Cardiac Death or Target Vessel MI Rate
timeFrame: 1 year
measure: Cardiac Death or Target Vessel MI Rate
timeFrame: 2 years
measure: Cardiac Death or Target Vessel MI Rate
timeFrame: 3 years
measure: Ischemia Driven Target Lesion Failure (TLF)
timeFrame: 30 days
measure: Ischemia Driven Target Lesion Failure (TLF)
timeFrame: 180 days
measure: Ischemia Driven Target Lesion Failure (TLF)
timeFrame: 270 days
measure: Ischemia Driven Target Lesion Failure (TLF)
timeFrame: 2 years
measure: Ischemia Driven Target Lesion Failure (TLF)
timeFrame: 3 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: California
city: La Jolla
country: United States
facility: San Diego Cardiovascular Associates
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital - LA
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Santa Rosa
country: United States
facility: Sutter Medical Center of Santa Rosa
state: California
city: Aurora
country: United States
facility: The Medical Center of Aurora
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Hospital
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Indianapolis
country: United States
facility: St. Francis Hospital and Health Centers
state: Indiana
city: Indianapolis
country: United States
facility: The Heart Center of Indiana
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center P.C.
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Towson
country: United States
facility: St. Joseph Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: Saint Vincent Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Bay City
country: United States
facility: Bay Regional Medical Center
state: Michigan
city: Dearborn
country: United States
facility: Oakwood Hospital and Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Lansing
country: United States
facility: Ingham Regional Medical Center
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Missoula
country: United States
facility: St. Patrick Hospital
state: Montana
city: Lincoln
country: United States
facility: Nebraska Heart Hospital
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchock Medical Center
state: New Hampshire
city: Buffalo
country: United States
facility: Millard Fillmore Hospital
state: New York
city: New York City
country: United States
facility: New York Presbyterian Hospital-Cornell
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Pomona
country: United States
facility: The Valley Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Hospital and Medical Center
state: New York
city: Syracuse
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital - Charlotte
state: North Carolina
city: Greenville
country: United States
facility: Pitt County Memorial Hospital
state: North Carolina
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Elyria
country: United States
facility: EMH Regional Medical Center
state: Ohio
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Columbia
country: United States
facility: Sisters of Charity Providence Hospitals
state: South Carolina
city: Greenville
country: United States
facility: St. Francis Health System
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Vniversity Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: Plaza Medical Center of Fort Worth
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Norfolk
country: United States
facility: Sentara Norfolk General
state: Virginia
city: Milwaukee
country: United States
facility: St. Luke's Medical Center - Milwaukee
state: Wisconsin
Study officials:
affiliation: Columbia University
name: Gregg W Stone
role: PRINCIPAL_INVESTIGATOR
References:
citation: Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.
citation: Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.
citation: Pervaiz MH, Sood P, Sudhir K, Hermiller JB, Hou L, Hattori K, Su X, Cao S, Wang J, Applegate RJ, Kereiakes DJ, Yaqub M, Stone GW, Cutlip DE. Periprocedural myocardial infarction in a randomized trial of everolimus-eluting and Paclitaxel-eluting coronary stents: frequency and impact on mortality according to historic versus universal definitions. Circ Cardiovasc Interv. 2012 Apr;5(2):150-6. doi: 10.1161/CIRCINTERVENTIONS.111.965566. Epub 2012 Mar 20.
citation: Claessen BE, Smits PC, Kereiakes DJ, Parise H, Fahy M, Kedhi E, Serruys PW, Lansky AJ, Cristea E, Sudhir K, Sood P, Simonton CA, Stone GW. Impact of lesion length and vessel size on clinical outcomes after percutaneous coronary intervention with everolimus- versus paclitaxel-eluting stents pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. JACC Cardiovasc Interv. 2011 Nov;4(11):1209-15. doi: 10.1016/j.jcin.2011.07.016.
citation: Planer D, Smits PC, Kereiakes DJ, Kedhi E, Fahy M, Xu K, Serruys PW, Stone GW. Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials. JACC Cardiovasc Interv. 2011 Oct;4(10):1104-15. doi: 10.1016/j.jcin.2011.06.018.
citation: Kereiakes DJ, Sudhir K, Hermiller JB, Gordon PC, Ferguson J, Yaqub M, Sood P, Su X, Yakubov S, Lansky AJ, Stone GW. Comparison of everolimus-eluting and paclitaxel-eluting coronary stents in patients undergoing multilesion and multivessel intervention: the SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) randomized trials. JACC Cardiovasc Interv. 2010 Dec;3(12):1229-39. doi: 10.1016/j.jcin.2010.09.014.
citation: Kereiakes DJ, Cutlip DE, Applegate RJ, Wang J, Yaqub M, Sood P, Su X, Su G, Farhat N, Rizvi A, Simonton CA, Sudhir K, Stone GW. Outcomes in diabetic and nondiabetic patients treated with everolimus- or paclitaxel-eluting stents: results from the SPIRIT IV clinical trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System). J Am Coll Cardiol. 2010 Dec 14;56(25):2084-9. doi: 10.1016/j.jacc.2010.10.006.
citation: Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010 May 6;362(18):1663-74. doi: 10.1056/NEJMoa0910496.
citation: Nikolsky E, Lansky AJ, Sudhir K, Doostzadeh J, Cutlip DE, Piana R, Su X, White R, Simonton CA, Stone GW. SPIRIT IV trial design: a large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease. Am Heart J. 2009 Oct;158(4):520-526.e2. doi: 10.1016/j.ahj.2009.07.025. Epub 2009 Aug 26.