Coronary Artery DiseaseNCT00475449
The Stent or Surgery (SoS) Trial
A study testing percutaneous coronary intervention and coronary artery bypass grafting in people with Coronary Artery Disease, run by Royal Brompton & Harefield NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- percutaneous coronary intervention and coronary artery bypass grafting
- Type of treatment
- Surgery or procedure
- How many people
- 988 participants
- Where
- No sites listed yet
- Study dates
- Nov 1996to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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.
Read more
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.
- Conditions
- Coronary Artery Disease
- Being tested
- percutaneous coronary intervention, coronary artery bypass grafting
- Keywords
- percutaneous coronary intervention, Stent, coronary artery bypass grafting
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionProcedure or surgery
coronary artery bypass graftingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
rates of repeat coronary revascularisation
Measured: median 2 years, range 1-4 years
Secondary outcomes (6)
i. Myocardial infarction free survival
Measured: median 2 years, range 1-4 years
ii. Death
Measured: median 2 and 6 years
iii. Myocardial infarction. (Fatal and non-fatal)
Measured: median 2 years, range 1-4 years
iv. Left ventricular function as assessed by 2D echocardiography
Measured: median 2 years, range 1-4 years
vi. Functional capacity - subjective by NYHA class
Measured: median 2 years, range 1-4 years
vii. Anti-anginal medication requirements
Measured: median 2 years, range 1-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startNov 1996
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 988 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Guidant Corporation, Schneider, British Heart Foundation
- Investigators
- Rodney H Stables, Study chair, Liverpool Cardiothoracic CentreUlrich Sigwart, Study chair, University Hospital, GenevaSpencer King, Principal investigator, Fuqua Heart Centre of Atlanta Piedmont HospitalJohn Pepper, Principal investigator, Royal Brompton & Harefield NHS Foundation TrustPeter Wahrborg, Principal investigator, Institute of Stress MedicineWilliam Weintraub, Principal investigator, Christiana Centre for Outcomes ResearchJacobus Lubsen, Principal investigator, Erasmus Medical Centre RotterdamPetros Nihoyannopolous, Principal investigator, Hammersmith Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475449
- Sponsor's protocol ID
- MREC/98/2/123
- Status last verified
- May 2007
- First submitted
- 17 May 2007
- Last updated
- 21 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Booth J, Clayton T, Pepper J, Nugara F, Flather M, Sigwart U, Stables RH; SoS Investigators. Randomized, controlled trial of coronary artery bypass surgery versus percutaneous coronary intervention in patients with multivessel coronary artery disease: six-year follow-up from the Stent or Surgery Trial (SoS). Circulation. 2008 Jul 22;118(4):381-8. doi: 10.1161/CIRCULATIONAHA.107.739144. Epub 2008 Jul 7.
PubMed 18606919
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00475449
- Acronym / sponsor ID
- MREC/98/2/123
- Conditions
- Coronary Artery Disease
- Keywords
- percutaneous coronary intervention, Stent, coronary artery bypass grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 988 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Medtronic, Guidant Corporation, Schneider, British Heart Foundation
- Study start
- Nov 1996
- Study completion
- Feb 2006 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous coronary intervention | Procedure or surgery | – |
| coronary artery bypass grafting | Procedure or surgery | – |
Primary outcome
rates of repeat coronary revascularisation
Time frame: median 2 years, range 1-4 years
6 secondary outcomes
i. Myocardial infarction free survival
Time frame: median 2 years, range 1-4 years
ii. Death
Time frame: median 2 and 6 years
iii. Myocardial infarction. (Fatal and non-fatal)
Time frame: 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
vi. Functional capacity - subjective by NYHA class
Time frame: median 2 years, range 1-4 years
vii. Anti-anginal medication requirements
Time frame: median 2 years, range 1-4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2007.
- Derived from this study: PubMed 18606919Booth J, Clayton T, Pepper J, Nugara F, Flather M, Sigwart U, Stables RH; SoS Investigators. Randomized, controlled trial of coronary artery bypass surgery versus percutaneous coronary intervention in patients with multivessel coronary artery disease: six-year follow-up from the Stent or Surgery Trial (SoS). Circulation. 2008 Jul 22;118(4):381-8. doi: 10.1161/CIRCULATIONAHA.107.739144. Epub 2008 Jul 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney H Stables study chair
Liverpool Cardiothoracic Centre
Ulrich Sigwart study chair
University Hospital, Geneva
Spencer King principal investigator
Fuqua Heart Centre of Atlanta Piedmont Hospital
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous coronary intervention and coronary artery bypass grafting in people with Coronary Artery Disease, run by Royal Brompton & Harefield NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rates of repeat coronary revascularisation (time frame: median 2 years, range 1-4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00475449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2007.