Cardiovascular DiseasesPhase 3NCT00000465
Emory Angioplasty Versus Surgery Trial (EAST)
A Phase 3 study testing angioplasty, transluminal, percutaneous coronary and coronary artery bypass in people with Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To compare the efficacy of coronary artery bypass graft (CABG) surgery with percutaneous transluminal coronary angioplasty (PTCA) in patients with multiple vessel coronary heart disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- What is being tested?
- angioplasty, transluminal, percutaneous coronary and coronary artery bypass
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 1987to Aug 1998
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Men and women with multivessel coronary artery disease whose symptoms were refractory to medical treatment.
About this study
To compare the efficacy of coronary artery bypass graft (CABG) surgery with percutaneous transluminal coronary angioplasty (PTCA) in patients with multiple vessel coronary heart disease.
Read the detailed description
BACKGROUND:
PTCA is widely practiced as the procedure of choice for revascularization of the myocardium in patients with single-vessel disease who are deemed to need intervention and is probably more widely applied than surgery would be in the same group of patients. No study has shown improved survival by intervention in such patients. The early natural history study by Oberman showed survival experience of patients with single-vessel disease, including the anterior descending, to resemble more closely patients with no coronary artery disease than those with multivessel disease. Quality of life studies including the CASS randomized study, which included 27 percent single-vessel disease patients, showed improved exercise tolerance and less need for medication in patients who received PTCA For single-vessel disease. Balloon angioplasty in single-vessel disease thus appears justified for the treatment of angina pectoris.
In multivessel disease the CASS randomized trial has shown an improved survival at seven years in the subset of patients with three-vessel disease and impaired ventricular function. However, seven years may prove to be the point of widest separation between the medical and surgical survival curves, based on the experience of the VA study which has presented results to 11 years showing convergence of survival experience. Data from the Montreal Heart Institute also indicate accelerated deterioration of venous grafts five to seven years after surgery. The late failure of grafts is a potent argument for delaying CABG as long as possible in the patients with multivessel disease. Should PTCA prove to be only a delaying action in multivessel disease patients, a delay of several years until the first CABG operation would confer an obvious advantage, even if repeat PTCA's were required. Repeat CABG may carry an increased risk and presumably the possibility of inadequate revascularization as autologous graft material is used up.
As long as treatment for coronary artery disease is only palliative, management for the individual patient requires a long-term (a lifetime) strategy, beginning with medical management. PTCA could occupy an intermediate position in the time line of management of multivessel disease patients if its relative efficiency in providing relief of ischemia and ability to avoid or delay CABG were known. Most centers performing PTCA now have expanded the indications for the procedure to patients with multivessel disease. However, its efficacy in those patients has not been proven. Although data from the NHLBI PTCA Registry do include patients with multivessel disease, most of those patients underwent only single PTCA procedures even though they may have had stenoses in other vessels. Hence, a number of questions must be raised concerning the usefulness of PTCA in patients with multivessel disease.
DESIGN NARRATIVE:
Randomized, single-center. A total of 198 patients were randomized to the PTCA group and 194 to the CABG group. As initial treatment, one patient in the CABG group underwent angioplasty and two patients in the PTCA group underwent surgery, but the groups were followed according to an intention-to-treat analysis. Randomization was performed on the basis of four angiographic strata. Data were collected at baseline, and the patients were contacted every six months for follow-up information. Coronary arteriography and thallium stress scanning were performed at one and three years. All patients were followed for the duration of the trial. Repeat angiographic studies were performed in 87 percent of the eligible patients at one year and in 76 percent at three years. Thallium scans were obtained in 88 percent of the patients at one year and in 77 percent at three years. The primary endpoint was a composite of death, Q-wave myocardial infarction within the previous three years, and detection of a large ischemic defect on thallium scanning at three years. Secondary endpoints involved the degree of revascularization at one and three years, ventricular function, exercise performance, the need for subsequent revascularization procedures, the quality of life, and costs. All patients admitted to Emory University Hospital and Crawford Long Memorial Hospital for cardiac catheterization, whether entered into the study or not, were entered into a study registry as were patients who were referred for a revascularization procedure but who had their initial catheterization performed elsewhere. Recruitment ended in April 1990. The trial has been extended through August 1997 to allow a minimum of eight years and a maximum of ten years of followup for the registry patients as well as for the main cohort of randomized patients. Telephone contact is established annually with study participants in order to determine rates of survival, rehospitalization, repeat revascularization procedures, and functional status. The justification for the long-term followup is the evidence that CABG begins to increase its failure rates between five and ten years.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Being tested
- angioplasty, transluminal, percutaneous coronary, coronary artery bypass
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angioplasty, transluminal, percutaneous coronaryProcedure or surgery
coronary artery bypassProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startJun 1987
- Study completionAug 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000465
- Sponsor's protocol ID
- 54
- Other IDs
- R01HL033965
- Status last verified
- Sep 2002
- First submitted
- 27 Oct 1999
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
King SB 3rd, Lembo NJ, Weintraub WS, Kosinski AS, Barnhart HX, Kutner MH, Alazraki NP, Guyton RA, Zhao XQ. A randomized trial comparing coronary angioplasty with coronary bypass surgery. Emory Angioplasty versus Surgery Trial (EAST). N Engl J Med. 1994 Oct 20;331(16):1044-50. doi: 10.1056/NEJM199410203311602.
PubMed 8090163King SB 3rd, Lembo NJ, Weintraub WS, Kosinski AS, Barnhart HX, Kutner MH. Emory Angioplasty Versus Surgery Trial (EAST): design, recruitment, and baseline description of patients. Am J Cardiol. 1995 Mar 23;75(9):42C-59C.
PubMed 7892822Zhao XQ, Brown BG, Stewart DK, Hillger LA, Barnhart HX, Kosinski AS, Weintraub WS, King SB 3rd. Effectiveness of revascularization in the Emory angioplasty versus surgery trial. A randomized comparison of coronary angioplasty with bypass surgery. Circulation. 1996 Jun 1;93(11):1954-62. doi: 10.1161/01.cir.93.11.1954.
PubMed 8640968Weintraub WS, Mauldin PD, Becker E, Kosinski AS, King SB 3rd. A comparison of the costs of and quality of life after coronary angioplasty or coronary surgery for multivessel coronary artery disease. Results from the Emory Angioplasty Versus Surgery Trial (EAST). Circulation. 1995 Nov 15;92(10):2831-40. doi: 10.1161/01.cir.92.10.2831.
PubMed 7586249King SB 3rd, Barnhart HX, Kosinski AS, Weintraub WS, Lembo NJ, Petersen JY, Douglas JS Jr, Jones EL, Craver JM, Guyton RA, Morris DC, Liberman HA. Angioplasty or surgery for multivessel coronary artery disease: comparison of eligible registry and randomized patients in the EAST trial and influence of treatment selection on outcomes. Emory Angioplasty versus Surgery Trial Investigators. Am J Cardiol. 1997 Jun 1;79(11):1453-9. doi: 10.1016/s0002-9149(97)00170-7.
PubMed 9185632Hodakowski GT, Craver JM, Jones EL, King SB 3rd, Guyton RA. Clinical significance of perioperative Q-wave myocardial infarction: the Emory Angioplasty versus Surgery Trial. J Thorac Cardiovasc Surg. 1996 Dec;112(6):1447-53; discussion 1453-4. doi: 10.1016/S0022-5223(96)70002-8.
PubMed 8975835King SB 3rd. The impact of performing a clinical trial on patient outcomes: lessons from the Emory Angioplasty vs. Surgery Trial. Trans Am Clin Climatol Assoc. 1996;107:68-77; discussion 77-8. No abstract available.
PubMed 8725561Alazraki NP, Krawczynska EG, Kosinski AS, DePuey EG 3rd, Ziffer JA, Taylor AT Jr, Pettigrew RI, Vansant JP, Shaw LJ, Weintraub WS, King SB 3rd. Prognostic value of thallium-201 single-photon emission computed tomography for patients with multivessel coronary artery disease after revascularization (the Emory Angioplasty versus Surgery Trial [EAST]). Am J Cardiol. 1999 Dec 15;84(12):1369-74. doi: 10.1016/s0002-9149(99)00578-0.
PubMed 10606106King SB 3rd, Kosinski AS, Guyton RA, Lembo NJ, Weintraub WS. Eight-year mortality in the Emory Angioplasty versus Surgery Trial (EAST). J Am Coll Cardiol. 2000 Apr;35(5):1116-21. doi: 10.1016/s0735-1097(00)00546-5.
PubMed 10758949King SB 3rd. The Emory Angioplasty vs Surgery Trial (EAST). Semin Interv Cardiol. 1999 Dec;4(4):185-90. doi: 10.1006/siic.1999.0099.
PubMed 10738351Weintraub WS, Becker ER, Mauldin PD, Culler S, Kosinski AS, King SB 3rd. Costs of revascularization over eight years in the randomized and eligible patients in the Emory Angioplasty versus Surgery Trial (EAST). Am J Cardiol. 2000 Oct 1;86(7):747-52. doi: 10.1016/s0002-9149(00)01074-2.
PubMed 11018194Becker ER, Mauldin PD, Culler SD, Kosinski AS, Weintraub WS, King SB. Applying the resource-based relative value scale to the Emory angioplasty versus surgery trial. Am J Cardiol. 2000 Mar 15;85(6):685-91. doi: 10.1016/s0002-9149(99)00841-3.
PubMed 12004793
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emory Angioplasty Versus Surgery Trial (EAST)
- ClinicalTrials.gov ID
- NCT00000465
- Acronym / sponsor ID
- 54
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jun 1987
- Study completion
- Aug 1998 (actual)
- First posted
- 28 Oct 1999 (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.
To compare the efficacy of coronary artery bypass graft (CABG) surgery with percutaneous transluminal coronary angioplasty (PTCA) in patients with multiple vessel coronary heart disease.
Detailed description
BACKGROUND:
PTCA is widely practiced as the procedure of choice for revascularization of the myocardium in patients with single-vessel disease who are deemed to need intervention and is probably more widely applied than surgery would be in the same group of patients. No study has shown improved survival by intervention in such patients. The early natural history study by Oberman showed survival experience of patients with single-vessel disease, including the anterior descending, to resemble more closely patients with no coronary artery disease than those with multivessel disease. Quality of life studies including the CASS randomized study, which included 27 percent single-vessel disease patients, showed improved exercise tolerance and less need for medication in patients who received PTCA For single-vessel disease. Balloon angioplasty in single-vessel disease thus appears justified for the treatment of angina pectoris.
In multivessel disease the CASS randomized trial has shown an improved survival at seven years in the subset of patients with three-vessel disease and impaired ventricular function. However, seven years may prove to be the point of widest separation between the medical and surgical survival curves, based on the experience of the VA study which has presented results to 11 years showing convergence of survival experience. Data from the Montreal Heart Institute also indicate accelerated deterioration of venous grafts five to seven years after surgery. The late failure of grafts is a potent argument for delaying CABG as long as possible in the patients with multivessel disease. Should PTCA prove to be only a delaying action in multivessel disease patients, a delay of several years until the first CABG operation would confer an obvious advantage, even if repeat PTCA's were required. Repeat CABG may carry an increased risk and presumably the possibility of inadequate revascularization as autologous graft material is used up.
As long as treatment for coronary artery disease is only palliative, management for the individual patient requires a long-term (a lifetime) strategy, beginning with medical management. PTCA could occupy an intermediate position in the time line of management of multivessel disease patients if its relative efficiency in providing relief of ischemia and ability to avoid or delay CABG were known. Most centers performing PTCA now have expanded the indications for the procedure to patients with multivessel disease. However, its efficacy in those patients has not been proven. Although data from the NHLBI PTCA Registry do include patients with multivessel disease, most of those patients underwent only single PTCA procedures even though they may have had stenoses in other vessels. Hence, a number of questions must be raised concerning the usefulness of PTCA in patients with multivessel disease.
DESIGN NARRATIVE:
Randomized, single-center. A total of 198 patients were randomized to the PTCA group and 194 to the CABG group. As initial treatment, one patient in the CABG group underwent angioplasty and two patients in the PTCA group underwent surgery, but the groups were followed according to an intention-to-treat analysis. Randomization was performed on the basis of four angiographic strata. Data were collected at baseline, and the patients were contacted every six months for follow-up information. Coronary arteriography and thallium stress scanning were performed at one and three years. All patients were followed for the duration of the trial. Repeat angiographic studies were performed in 87 percent of the eligible patients at one year and in 76 percent at three years. Thallium scans were obtained in 88 percent of the patients at one year and in 77 percent at three years. The primary endpoint was a composite of death, Q-wave myocardial infarction within the previous three years, and detection of a large ischemic defect on thallium scanning at three years. Secondary endpoints involved the degree of revascularization at one and three years, ventricular function, exercise performance, the need for subsequent revascularization procedures, the quality of life, and costs. All patients admitted to Emory University Hospital and Crawford Long Memorial Hospital for cardiac catheterization, whether entered into the study or not, were entered into a study registry as were patients who were referred for a revascularization procedure but who had their initial catheterization performed elsewhere. Recruitment ended in April 1990. The trial has been extended through August 1997 to allow a minimum of eight years and a maximum of ten years of followup for the registry patients as well as for the main cohort of randomized patients. Telephone contact is established annually with study participants in order to determine rates of survival, rehospitalization, repeat revascularization procedures, and functional status. The justification for the long-term followup is the evidence that CABG begins to increase its failure rates between five and ten years.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| angioplasty, transluminal, percutaneous coronary | Procedure or surgery | – |
| coronary artery bypass | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 18 Feb 2016.
- Background: PubMed 8090163King SB 3rd, Lembo NJ, Weintraub WS, Kosinski AS, Barnhart HX, Kutner MH, Alazraki NP, Guyton RA, Zhao XQ. A randomized trial comparing coronary angioplasty with coronary bypass surgery. Emory Angioplasty versus Surgery Trial (EAST). N Engl J Med. 1994 Oct 20;331(16):1044-50. doi: 10.1056/NEJM199410203311602.
- Background: PubMed 7892822King SB 3rd, Lembo NJ, Weintraub WS, Kosinski AS, Barnhart HX, Kutner MH. Emory Angioplasty Versus Surgery Trial (EAST): design, recruitment, and baseline description of patients. Am J Cardiol. 1995 Mar 23;75(9):42C-59C.
- Background: PubMed 8640968Zhao XQ, Brown BG, Stewart DK, Hillger LA, Barnhart HX, Kosinski AS, Weintraub WS, King SB 3rd. Effectiveness of revascularization in the Emory angioplasty versus surgery trial. A randomized comparison of coronary angioplasty with bypass surgery. Circulation. 1996 Jun 1;93(11):1954-62. doi: 10.1161/01.cir.93.11.1954.
- Background: PubMed 7586249Weintraub WS, Mauldin PD, Becker E, Kosinski AS, King SB 3rd. A comparison of the costs of and quality of life after coronary angioplasty or coronary surgery for multivessel coronary artery disease. Results from the Emory Angioplasty Versus Surgery Trial (EAST). Circulation. 1995 Nov 15;92(10):2831-40. doi: 10.1161/01.cir.92.10.2831.
- Background: PubMed 9185632King SB 3rd, Barnhart HX, Kosinski AS, Weintraub WS, Lembo NJ, Petersen JY, Douglas JS Jr, Jones EL, Craver JM, Guyton RA, Morris DC, Liberman HA. Angioplasty or surgery for multivessel coronary artery disease: comparison of eligible registry and randomized patients in the EAST trial and influence of treatment selection on outcomes. Emory Angioplasty versus Surgery Trial Investigators. Am J Cardiol. 1997 Jun 1;79(11):1453-9. doi: 10.1016/s0002-9149(97)00170-7.
- Background: PubMed 8975835Hodakowski GT, Craver JM, Jones EL, King SB 3rd, Guyton RA. Clinical significance of perioperative Q-wave myocardial infarction: the Emory Angioplasty versus Surgery Trial. J Thorac Cardiovasc Surg. 1996 Dec;112(6):1447-53; discussion 1453-4. doi: 10.1016/S0022-5223(96)70002-8.
- Background: PubMed 8725561King SB 3rd. The impact of performing a clinical trial on patient outcomes: lessons from the Emory Angioplasty vs. Surgery Trial. Trans Am Clin Climatol Assoc. 1996;107:68-77; discussion 77-8. No abstract available.
- Background: PubMed 10606106Alazraki NP, Krawczynska EG, Kosinski AS, DePuey EG 3rd, Ziffer JA, Taylor AT Jr, Pettigrew RI, Vansant JP, Shaw LJ, Weintraub WS, King SB 3rd. Prognostic value of thallium-201 single-photon emission computed tomography for patients with multivessel coronary artery disease after revascularization (the Emory Angioplasty versus Surgery Trial [EAST]). Am J Cardiol. 1999 Dec 15;84(12):1369-74. doi: 10.1016/s0002-9149(99)00578-0.
- Background: PubMed 10758949King SB 3rd, Kosinski AS, Guyton RA, Lembo NJ, Weintraub WS. Eight-year mortality in the Emory Angioplasty versus Surgery Trial (EAST). J Am Coll Cardiol. 2000 Apr;35(5):1116-21. doi: 10.1016/s0735-1097(00)00546-5.
- Background: PubMed 10738351King SB 3rd. The Emory Angioplasty vs Surgery Trial (EAST). Semin Interv Cardiol. 1999 Dec;4(4):185-90. doi: 10.1006/siic.1999.0099.
- Background: PubMed 11018194Weintraub WS, Becker ER, Mauldin PD, Culler S, Kosinski AS, King SB 3rd. Costs of revascularization over eight years in the randomized and eligible patients in the Emory Angioplasty versus Surgery Trial (EAST). Am J Cardiol. 2000 Oct 1;86(7):747-52. doi: 10.1016/s0002-9149(00)01074-2.
- Background: PubMed 12004793Becker ER, Mauldin PD, Culler SD, Kosinski AS, Weintraub WS, King SB. Applying the resource-based relative value scale to the Emory angioplasty versus surgery trial. Am J Cardiol. 2000 Mar 15;85(6):685-91. doi: 10.1016/s0002-9149(99)00841-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing angioplasty, transluminal, percutaneous coronary and coronary artery bypass in people with Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Feb 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000465, which also lists 12 linked publications.
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 18 Feb 2016.