SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries

Coronary Artery Disease Clinical Trial

— SYNTAX  

Official title:

SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00114972
• Other study ID #: S2024
• Secondary ID: 90169394
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 20, 2005
• Last updated: May 27, 2010
• Start date: March 2005
• Est. completion date: May 2012

Study information

• Verified date: May 2010
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either percutaneous coronary intervention (PCI) with polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).

Description:

Due to the introduction of drug-eluting stents (DESs) and to improvements in therapy for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) patients, PCI is challenging CABG as the gold standard for treatment of three vessel (3VD) and left main (LM) coronary disease.

SYNTAX is a novel, randomized trial with nested registries comparing PCI with paclitaxel-eluting TAXUS stents to CABG for 3VD and LM patients to evaluate the best treatment for these patients with complex coronary disease.

Patients at participating centers will be evaluated by both a cardiothoracic surgeon and by an interventional cardiologist.

Those patients who are determined to be eligible for treatment by both PCI and CABG will be randomized to receive either PCI with a polymer-based paclitaxel-eluting TAXUS stent or CABG.

Patients who are determined to be unsuitable for treatment by PCI will be treated by CABG and will be entered into a CABG registry to help define the patient population in which stenting continues to be an unacceptable treatment option.

Similarly, patients who are determined to be unsuitable for treatment by CABG will be treated by PCI, using any interventional techniques or devices with or without the use of DES, and entered into a PCI registry to help define the patients for whom CABG is considered inappropriate.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1800
• Est. completion date: May 2012
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Three-vessel disease, left main disease or LM equivalent with or without 1, 2 or 3VD (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory)

• De novo lesions with at least 50% stenosis

• Myocardial ischemia (stable, unstable, silent)

Exclusion Criteria:

• Prior PCI or CABG

• Acute myocardial infarction (with creatinine kinase >2x upper limit of normal)

• Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement)

• Participation or planned participation in another cardiovascular clinical study before 1 year follow-up is completed

• Inability to give informed consent due to mental condition, mental retardation, or language barrier

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
Drug Eluting Stent

Procedure:
• Coronary Artery Bypass Surgery
Coronary Artery Bypass Surgery

Locations

Country	Name	City	State
Austria	Univ. Klinik für Herzchirurgie Landeskliniken	Salzburg
Austria	Allgemeines Krankenhaus AKH	Vienna
Belgium	Onze Lieve Vrouw Ziekenhuis	Aalst
Belgium	Academisch Ziekenhuis Middelheim	Antwerpen
Belgium	Universitair Ziekenhuis	Gent
Belgium	Centre Hôpital Universitaire Sart Tilman	Liège
Czech Republic	Interni Klinika VFN	Praha
Czech Republic	University Hospital Vinohrady	Praha
Denmark	Skejby Sygehus	Aarhus
Finland	Helsinki University Central Hospital	Helsinki
Finland	University of Helsinki Meilahti Hospital	Helsinki
France	Clinique St Augustin	Bordeaux
France	Institut Cardiovasculaire Paris Sud - Massy	Massy
France	Clinique Saint-Hilaire Rouen	Rouen
France	Centre Hopital Universitaire Rouen - Hopital Charles Nicolle	Rouen Cedex
France	Centre Hôpital Universitaire Rangueil	Toulouse
France	Clinique Pasteur	Toulouse
France	CHU Rangueil	Toulouse Cedex 9
Germany	Herz- und Diabeteszentrum Nordrhein-Westfalen	Bad Oeynhausen
Germany	Campus Virchow Klinikum Herzkatheterlabor	Berlin
Germany	Charite Universitaetsmedizin Berlin, Campus Virchow Klinikum	Berlin
Germany	Universitatsklinik Charite Berlin, Campus Mitte	Berlin
Germany	Universitätsklinik Freiburg	Freiburg
Germany	Universitatsklinikum Hamburg Eppendorf	Hamburg
Germany	Universitätsklinikum Campus Kiel	Kiel
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel	Kiel
Germany	Herzzentrum Universität Leipzig	Leipzig
Germany	Medizinische Universitaet Luebeck	Lübeck
Germany	Klinikum Grosshadern	München
Germany	Krankenhaus der Barmherzigen Brüder	Trier
Hungary	National Medical Center	Budapest
Hungary	University of Debrecen, Medical and Health Science Center	Debrecen
Hungary	Medical School of University PECS	Pecs
Italy	Ospedale Riuniti di Bergamo	Bergamo
Italy	Istituto di Fisiologia Clinica, Stabilimento di Massa Ospedale	Massa
Italy	Ospedale San Raffaele	Milan
Italy	Ospedale Civile di Mirano	Mirano
Italy	IRCCS Policlinico S. Matteo	Pavia
Italy	Policlinico San Matteo	Pavia
Italy	Policlinico Agostino Gemelli	Roma
Italy	Istituto Clinico Humanitas	Rozzano
Latvia	P. Stradins University Hospital	Riga
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	Erasmus MC - University Medical Center Rotterdam	Rotterdam
Netherlands	Isala Klinieken, De Weezenlanden	Zwolle
Norway	Rikshospitalet	Oslo
Poland	Medical University of Silesia - Katowice	Katowice
Poland	Jagiellonian University of Cardiology	Krakow
Poland	John Paul II Hospital	Krakow
Poland	National Institute of Cardiology	Warsaw
Portugal	Hospital de Santa Marta	Lisboa
Spain	Hospital General de Alicante	Alicante
Spain	Hospital General Universitario	Alicante
Spain	Hospital Clinico Y Provincial	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Clinico Salamanca	Salamanca
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Lund University Hospital	Lund
Sweden	University Hospital of Lund	Lund
Sweden	Karolinska Universitets Sjukhuset - Stockholm	Stockholm
Sweden	Akademiska sjukhuset	Uppsala
Sweden	University Hospital Uppsala	Uppsala
United Kingdom	Royal Sussex County Hospital	Brighton	East Sussex
United Kingdom	Western Infirmary	Glasgow
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	University Hospitals of Leicester NHS Trust Glenfield Hospital	Leicester
United Kingdom	King's College Hospital London	London
United Kingdom	London Chest Hospital	London
United Kingdom	St Thomas Hospital	London
United Kingdom	John Radcliffe Infirmary Oxford II	Oxford
United Kingdom	Southampton University Hospital	Southampton
United States	Florida Cardiovascular Research	Atlantis	Florida
United States	Tufts New England Medical Center	Boston	Massachusetts
United States	Baylor University Medical Center	Dallas	Texas
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Evanston Hospital	Evanston	Illinois
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	Spectrum Health	Grand Rapids	Michigan
United States	Cardiovascular and Thoracic Surgeons of Greensboro	Greensboro	North Carolina
United States	LeBauer Cardiovascular Research Foundation	Greensboro	North Carolina
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	Cape Cod Research Institute	Hyannis	Massachusetts
United States	University of Iowa Hospital and Clinics	Iowa City	Iowa
United States	St. Mary's Medical Center	Langhorne	Pennsylvania
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Sentara Norfolk General Hospital 1st Fl	Norfolk	Virginia
United States	Munroe Medical Center	Ocala	Florida
United States	Ocala Heart Institue	Ocala	Florida
United States	Oklahoma Foundation for Cardiovascular Research	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	Cardiac & Vascular Research Center of Northern Michigan	Petoskey	Michigan
United States	Maine Medical Center	Portland	Maine
United States	Wake Medical Center	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Mary's Hospital	Rochester	Minnesota
United States	Rockford Cardiology Research Foundation (St. Anthony's Medical Center)	Rockford	Illinois
United States	Mercy General Hospital	Sacramento	California
United States	San Antonio Endovascular Heart Institue	San Antonio	Texas
United States	SUNY - Stony Brook School of Medicine	Stony Brook	New York
United States	SJH Cardiology Associates	Syracuse	New York
United States	St. Joseph's Hospital Health Center	Syracuse	New York
United States	Washington Hospital Center	Washington	District of Columbia
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Cardialysis BV

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Latvia,  Netherlands,  Norway,  Poland,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Clinical Endpoint of 12-Month Binary MACCE.	Number of participants at primary clinical endpoint of 12-Month binary MACCE. MACCE is defined as: all cause death, cerebrovascular event (stroke), cocumented myocardial infarction, repeat revascularization (PCI and/or CABG).	12 months post enrollment	Yes
Primary	12-month Composite Safety Endpoint.	Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.	12 months after enrollment	Yes
Primary	Repeat Revascularization (PCI and/or CABG).	Number of participants with repeat revascularization (PCI and/or CABG).	12 Months post enrollment	Yes
Secondary	Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.	Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.	1 month after procedure and 6 months, 3 years, and 5 years post allocation	Yes
Secondary	Individual Components of MACCE at 1 Month Post-procedure.	Number of participants with individual components of MACCE at 1 month post-procedure. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.	1 month after procedure	Yes
Secondary	Individual Components of MACCE at 6 Months Post-allocation.	Number of participants with individual components of MACCE at 6 months post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.	6 months post allocation	Yes
Secondary	Individual Components of MACCE at 1 Year Post-allocation.	Number of participants with individual components of MACCE at 1 year post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.	1 year post allocation	Yes
Secondary	Freedom From MACCE and Its Components at 1 Year Post-allocation.	Number of participants with freedom from MACCE and its components at 1 year post-allocation. Freedom from MACCE is defined as no MACCE nor any of the individual components of MACCE (all cause death, stroke, documented myocardial infarction, repeat revascularization).	1 year post allocation	Yes
Secondary	Freedom From MACCE and Its Components at 3 Years Post-allocation		3 years post allocation	Yes
Secondary	Freedom From MACCE and Its Components at 5 Years Post-allocation		5 years post allocation	Yes
Secondary	Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation		1 month after procedure and 6 months, 1, 3 and 5 years post allocation	No
Secondary	Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation		1 year, 3 and 5 years post allocation	No
Secondary	The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible)		5 Years	Yes