The Stent or Surgery (SoS) Trial

May 17, 2007 updated by: Royal Brompton & Harefield NHS Foundation Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

988

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rates of repeat coronary revascularisation
Time Frame: median 2 years, range 1-4 years
median 2 years, range 1-4 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Collaborators

Medtronic
British Heart Foundation
Guidant Corporation
Schneider

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1996

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

May 17, 2007

First Submitted That Met QC Criteria

May 17, 2007

First Posted (Estimate)

May 21, 2007

Study Record Updates

Last Update Posted (Estimate)

May 21, 2007

Last Update Submitted That Met QC Criteria

May 17, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MREC/98/2/123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on percutaneous coronary intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe