TRIALS

 BARI - BYPASS ANGIOPLASTY REVASCULARIZATION

INVESTIGATION
 ARTS
 ARTS11
 FREEDOM
 SOS
 SYNTAX
 EXCEL
 NOBLE
BARI – POBA VS CABG IN MVD
Patient Populations:
• Clinically severe angina or objective evidence of ischemia that requires revascularization
• Angiographically documented multivessel coronary disease
• Suitability for both PTCA and CABG
• Informed consent for random assignment.

Study Design:
Patients Screened: Not given
Patients Enrolled: 1,829
Mean Follow Up: 5.4 years
Mean Patient Age: 61
Female: 26
Mean Ejection Fraction: 57.1-57.6
.

Exclusions:
• Absence of significant CAD: Insufficient angina or objective evidence of ischemia.
• Primary congenital heart disease.
• Primary valvular heart disease (including a ventricular aneurysm, which requires
surgery).
• Prior PTCA or CABG.
• Single-vessel CAD.
• Age < 17 years or > 80 years.
• Geographically inaccessible or unable to return for follow-up.
• Unstable angina or acute MI, which requires emergency revascularization.
• Left main stenosis > 50% or of a character that precludes angioplasty.
• Noncardiac illness that is expected to limit survival.
• Extensive ascending aortic calcification.
• Primary coronary spasm.
Primary Endpoint:
Mortality at 5 yeaRS

Secondary Endpoints:
MI
Angina (stable or unstable)
Myocardial ischemia
Subsequent revascularization
Resource use (subsequent hospitalization)
Quality of life
Angiographic assessment at 5 years
Left ventricular function (ejection fraction) at 5 yearrs .
Principal Findings:
Over 5 years of follow-up, there were 111 deaths in the CABG group and 131 in the PTCA
group, not a statistically significant difference. Cumulative survival was 89.3% for CABG
patients and 86.3% for PTCA patients

Freedom from Q-wave MI occurred at similar rates in both groups: 80.4% for CABG,
78.7% for PTCA.

The median hospital stay after CABG was 7 days, vs 3 days for PTCA. The median total
hospital stay was 12 days with CABG vs 7 days with PTCA.

In-hospital event rates were similar in the two groups: 1.3% with CABG, 1.1% with PTCA.
CABG patients were more likely to have Q-wave MIs than PTCA patients (4.5% vs 2.1%, p
= 0.01). The rate of stroke for CABG patients was 0.8%; for PTCA patients, 0.2%.

PTCA patients were more likely to need a repeat revascularization procedure in the hospital
than CABG patients: 6.3% of PTCA patients underwent emergency CABG .
During the 5-year follow-up, 8% of CABG patients underwent repeat revascularization, vs.
54% for PTCA patients.

69% of patients assigned to PTCA did not subsequently undergo CABG.

The survival rate for diabetics was significantly lower than patients without diabetes. In
addition, the survival rate of diabetics was much worse with PTCA than with CABG (65.5%
vs 80.6%).

At 5 years, differences in angina-free rates between patients assigned to PTCA and CABG
decreased from 73% vs 95% at 4 to 14 weeks (P<.001) to 79% vs 85% at 5 years (P=.007).
Similar patterns were observed for exercise-induced angina and ischemia, except 5-year
differences were not significant. Among patients angina-free at 5 years, 52% of patients who
had PTCA required revascularization after the initial procedure vs 6% of patients who had
CABG.

At follow-up of 1 year and later, quality of life, return to work, modification of smoking and
exercise behaviors, and cholesterol levels were similar for the 2 treatments.
CONCLUSION:

-5-year cardiac mortality in patients with multivessel disease was significantly greater
after initial treatment with PTCA than with CABG.

- For treated diabetics, 5-year survival was significantly better after CABG than after
PTCA.

-In nondiabetic patients with multivessel coronary disease, coronary artery bypass surgery
is associated with a better quality of life for three years than coronary angioplasty, after the
initial morbidity caused by the procedure.
SURGERY OR STENT –SOS
this study was to assess the safety and efficacy of stent-based percutaneous coronary
intervention (PCI) compared with coronary artery bypass grafting (CABG) in the
management of patients with multivessel coronary artery disease (CAD).

Hypothesis:
CABG will be more effective than stent-based PCI in the management of multivessel CAD.

Study Design
Randomized
Patients Enrolled: 988
Mean Follow Up: 6 years
Mean Patient Age: 61 years
Female: 21%
Mean Ejection Fraction: 57%
Patient Populations:
Symptomatic multivessel CAD that could be managed by either a percutaneous or surgical
approach

Exclusions:
Previous thoracotomy
Previous coronary revascularization
Need for surgery on the aorta, great vessels, or valves
Primary Endpoints:
Rate of repeat revascularization after the index procedure
Secondary Endpoints:
Death or nonfatal myocardial infarction
All-cause mortality
Symptoms of angina
Medication requirement
Cost and cost-effectiveness at 1 year
Psychological outcomes
Principal Findings:

Severe angina was present in 46% of patients, an acute coronary syndrome was present in
24%, and three-vessel disease was present in 42%.
Among the PCI group, 94% of attempted lesions were successfully revascularized (mean of
2.7 lesions per patient).
In the CABG group, the mean number of bypass grafts was 2.8 per patient (internal
mammary artery was used in 81%).

At a median follow-up of 6 years, the incidence of mortality was 10.9% in the PCI group
versus 6.8% in the CABG group . In the PCI group, there were 22 cardiovascular deaths and
25 noncardiovascular deaths. In the CABG group, there were 17 cardiovascular deaths and
11 noncardiovascular deaths. There was no change in mortality according to baseline angina
or severity of CAD. Among diabetics, CABG was favored, and among nondiabetics, PCI
CONCLUSION

At a median follow-up of 6 years, CABG was superior to bare-metal PCI

by conferring a survival advantage.

The same result was observed at the 2-year reporting of SoS. This
finding is in contrast to the long-term (5-year) results of the ARTS,
ERACI II, and MASS II trials, which found no difference in
mortality between PCI and CABG.
FREEDOM (Future Revascularization Evaluation in
Patients with Diabetes Mellitus: Optimal Management
of Multivessel Disease)
Demonstrated that for patients with diabetes mellitus (DM) and multivessel
coronary disease (MVD), coronary artery bypass grafting (CABG) is superior
to percutaneous coronary intervention with drug-eluting stents (PCI-DES) in
reducing the rate of major adverse cardiovascular and cerebrovascular events
after a median follow-up of 3.8 years. It is not known, however, whether
CABG confers a survival benefit after an extended follow-up period.
STUDY DESIGN
-PATIENT POPULATION 1900
-mean age was 63
- 29% of the patients were women
-The mean hemoglobin A1c was 7.8%
-mean ejection fraction was 66%
- mean SYNTAX score, which defines the anatomic complexity of lesions,
was26
- mean EURO score, whichdefines surgical risk, was 2.7

INCLUSION :diabetics and angiographically confirmed

multivessel coronary artery disease (83% with
three-vessel disease) with stenosis of more
than 70% in two or more major epicardial vessels involving at least two
separate coronaryartery territories.
Exclusion criteria

-Severe left main coronary artery stenosis(≥ 50% stenosis)

-Class III or IV congestive heart failure
-Previous CABG or valve surgery
RESULT:
Death, nonfatal myocardial infarction, nonfatal stroke, repeat revascularization at 30 days
or 12months) had occurred significantly more often in the PCI group than in the CABG
group with most of the difference attributable to a higher repeat revascularization rate in the
PCI group(12.6% vs 4.8%, P < .001).

CONCLUSION
FREEDOM was a landmark trial that confirmed that CABG provides significant benefit
compared witH PCI with
drug-eluting stents in patients with diabetes and multi essel coronary artery disease,