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The Stent or Surgery (SoS) Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00475449
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : May 21, 2007
Guidant Corporation
British Heart Foundation
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust

Brief Summary:

This study compared two different methods of restoring blood flow to the heart when there has been a narrowing or blockage in the blood vessels that supply the heart. Currently there are two different ways of restoring blood flow. One is heart surgery where a surgeon operates directly on the heart, through an incision in the breast bone (sternum) and takes segments of the patient’s (non-essential) veins or arteries and then uses these to bypass blocked or narrowed segments in the coronary arteries. This way additional blood can be “piped” into the heart muscle wall. The second method is coronary angioplasty with stent implantation. Coronary angioplasty is a non-surgical method performed under a local anaesthetic. During angioplasty a special balloon is advanced to the site of a coronary narrowing, then inflated to make it expand and this action removes the narrowing. This is a more simple and less invasive than surgery but its value has been limited by a tendency for narrowings to reoccur(restenosis) in the six months following the treatment. When this happens a repeat procedure is often performed. To reduce the incidence of restenosis coronary stents are implanted. These are tubular metal scaffold devices that are placed inside a coronary artery at the site of a previous narrowing to help keep the artery open. These devices are usually delivered on an angioplasty balloon and expanded into place.

Both treatments are equally effective at preventing death and subsequent myocardial infarction and most doctors are happy to recommend either option. Angioplasty offers a more simple initial procedure but with a chance of needing a repeat performance. Bypass surgery represents a more significant initial undertaking with a longer recovery and convalescent period but in most cases, provides good relief of symptoms. Patient preference plays an important part in the decision process.

Bypass grafting is currently the therapy most frequently performed world-wide. Angioplasty has a number of important advantages but the need for repeat procedures currently limits its appeal.

Since these trials were performed there have been important advances in angioplasty techniques. Prominent amongst these has been the development and use of Coronary Stents which has been shown (in clinical trials) to reduce the need for repeat procedures after an initial angioplasty. Consequently stent implantation is now in routine use world wide.

If angioplasty is performed with coronary stent implantation then this may reduce the need for repeat procedures and address the principal factor currently limiting the value of this approach. If the results were found to be as good as with bypass grafting then patients could benefit from a shorter hospital stay, a less traumatic operation and a shorter recovery period. We therefore wish to compare the outcomes in patients treated with a) bypass grafting or b) angioplasty with coronary stent implantation.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: percutaneous coronary intervention Procedure: coronary artery bypass grafting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 988 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Compare Coronary Artery Bypass Grafting With Percutaneous Transluminal Coronary Angioplasty and Primary Stent Implantation in Patients With Multi-Vessel Coronary Artery Disease
Study Start Date : November 1996
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. rates of repeat coronary revascularisation [ Time Frame: median 2 years, range 1-4 years ]

Secondary Outcome Measures :
  1. i. Myocardial infarction free survival [ Time Frame: median 2 years, range 1-4 years ]
  2. ii. Death [ Time Frame: median 2 and 6 years ]
  3. iii. Myocardial infarction. (Fatal and non-fatal) [ Time Frame: median 2 years, range 1-4 years ]
  4. iv. Left ventricular function as assessed by 2D echocardiography [ Time Frame: median 2 years, range 1-4 years ]
  5. vi. Functional capacity - subjective by NYHA class [ Time Frame: median 2 years, range 1-4 years ]
  6. vii. Anti-anginal medication requirements [ Time Frame: median 2 years, range 1-4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent.
  • Patient has typical angina pectoris - stable or unstable symptoms.
  • Atherosclerotic coronary artery disease demonstrated with selective coronary angiography with a significant lesion present in at least two of the principal epicardial vessel systems.
  • Revascularisation procedure clinically indicated.
  • Nominated trial surgeon accepts the patient for CABG.
  • Nominated trial interventionist accepts the patient for PTCA and stent.
  • At least one identified lesion suitable and targeted for primary stent implantation.
  • A procedure for the completion of either revascularisation strategy can be performed within 6 weeks of randomisation.

Exclusion Criteria:

  • Previous CABG procedure or other thoracotomy.
  • Previous coronary interventional procedure (of any type).
  • Intervention on any cardiac valve scheduled for the index revascularisation procedure.
  • Excision or other intervention on the myocardium scheduled for the index revascularisation procedure.
  • Intervention on the great vessels, carotid arteries or aorta scheduled for the index revascularisation procedure.
  • Absent autologous graft material.
  • Non-cardiac disease influencing survival.
  • Acute myocardial infarction in the 48 hours preceding the proposed revascularisation procedure.
  • Participation in any other study that would involve deviation from the routine local management of a revascularisation procedure.
  • Allergy to anti-platelet agents in local use.
  • Language or other communication barrier.
  • Follow-up for two years not possible / Patient unreliable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00475449

Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Guidant Corporation
British Heart Foundation
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Study Chair: Rodney H Stables Liverpool Cardiothoracic Centre
Study Chair: Ulrich Sigwart University Hospital, Geneva
Principal Investigator: Spencer King Fuqua Heart Centre of Atlanta Piedmont Hospital
Principal Investigator: John Pepper Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: Peter Wahrborg Institute of Stress Medicine
Principal Investigator: William Weintraub Christiana Centre for Outcomes Research
Principal Investigator: Jacobus Lubsen Erasmus Medical Centre Rotterdam
Principal Investigator: Petros Nihoyannopolous Hammersmith Hospitals NHS Trust

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00475449     History of Changes
Other Study ID Numbers: MREC/98/2/123
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
percutaneous coronary intervention
coronary artery bypass grafting
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases