NCT Number: NCT00475449
The Stent or Surgery (SoS) Trial
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.
Looking for future studies?
Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Coronary artery bypass grafting
ProcedurePrimary outcomes
-
rates of repeat coronary revascularisation
Time frame: median 2 years, range 1-4 years
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
Sponsors and collaborators
Lead sponsor
Royal Brompton & Harefield NHS Foundation Trust
Other
Collaborators
- British Heart Foundation
- Guidant Corporation
- Medtronic
- Schneider
Registry information
Official study 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
Important dates
- Study start
- 1996
- Study completion
- 2006
- First posted
- May 21, 2007
- Registry last updated
- May 21, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
CES1 Carriers in the PAPI Study
NCT03188705
Arterial Occlusive Diseases, Arteriosclerosis
Lancaster, Pennsylvania, United States
View Trial DetailsImpact of Cardiac Rehabilitation on Patient Outcomes
NCT07468955
Arterial Occlusive Diseases, Arteriosclerosis
Kütahya, Center, Turkey (Türkiye)
View Trial DetailsA Sugar-Sweetened Beverage Reduction Intervention for Native American Men
NCT06029517
Arterial Occlusive Diseases, Arteriosclerosis
Buffalo, New York, United States
View Trial DetailsSafety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)
NCT04058990
Arterial Occlusive Diseases, Arteriosclerosis
Kitakyushu, Fukuoka, Japan
View Trial Details