for morning journal club

1. A Systematic Review and Meta-Analysis of
Randomized Clinical Trials
Seema et al.
Circulation: cardiovascular intervention
(Circ Cardiovasc Interv. 2012;5:1-15.)
© 2012 American Heart Association, Inc.

2. BACKGROUND
• ROLE OF PERCUTANEOUS CORONARY
INTERVENTION
– ST SEGMENT ELEVATION MI
– UNSTABLE ANGINA
– NSTEMI
• FOR STABLE CORONARY ARTERY DISEASE
– OPTIMAL TREATMENT STRATEGY?
• PCI(PERCUTANEOUS CORONARY INTERVENTION)
• OMT(OPTIMAL MEDICAL THERAPY)

3. PERCUTANEOUS CORONARY
CLINICAL TRAILS INTERVENTION VERSUS
OPTIMAL MEDICAL THERAPY
Clinical outcomes utilizing No significant difference in outcomes
Revascularization and aggressive drug
evaluation (COURAGE)
Bypass Angioplasty Revascularization No significant difference in outcomes
Investigation 2 Diabetes (BARI 2D)
Schömig et al ( 2008)Swiss Interventional Improvement in all-cause mortality in the
Study on Silent revascularized group
Ischemia Type II (SWISS-II) and
COURAGE trials

4. OBJECTIVE
whether revascularization
with PCI reduces
cardiovascular outcomes
when compared with
OMT in patients with
stable CAD.

5. METHODS
• PUBMED, EMBASE And CENTRAL Searchs
• Using medical subject heading or keywords
– Diagnosis of stable CAD
– Intervention of PCI
– Comparision with medical therapy

6. Eligible trails
• Cohort enrolled- Stable Coronary Artery
Disease patients
• Comparision of PCI to optimal medical therapy
• Reporting outcomes
– All-cause mortality
– Cardiovascular death
– Nonfatal MI
– Revascularization
– Freedom from angina

7. Selection and quality assesment
Compilation of searches
Duplicates removed
Study screened by title and abstract (by two independent
reviewer)
Qualified study(full text review by(by two independent reviewer)
DATA ABSTRACTION AND ASSESMENT FOR SOURCES OF SYSTEMATIC
BIAS

8. Data extraction
• Two independent reviewer extracted data
• Data abstracted measured
– study characteristics
– patient characteristics
– details regarding the intervention
– comparison group
– outcome measures

9. Statistical Analysis
• RevMan software provided by Cochrane
Collaboration

10. Sensitivity Analyses
• POTENTIAL IMPACT OF INDUSTRY FUNDING
• EVOLUTION OF PCI
– potential differential effect of stenting as opposed
to balloon angioplasty alone.

11. RESULTS

12. STUDY SELECTION

13. • 12 randomized clinical trials
• participants enrolled from all over the world
• 7182 patients
• followed-up - 4.9 years (range 1.5–10.2 years).

14. STUDY YEARS
Characteristics of Included Trials Descrip Secondary
Exclusion Description Primary Follo
OF INCLUSION Criteria
tion of
of Medical Outcome
Outcomes w Up, y
ENROLMENT, Interve
COUNTRY CRITERIA ntion Therapy
70%–99% stenosis in 6 mo exercise Change in
ACME- Not reported PTCA 325 mg
11987–
proximal two thirds of 1
major coronary artery,
Aspirin,
nitrates, β-
stress testing:
length of time
to onset of 1
degree of
stenosis in
index lesion,
3
physical well
1990 stress test with ≥1 mm ST blockers, mm ST
depression, being
depression in at least 1 lead calcium questionnaire,
USA or filling defect on thallium channel
maximal ST
segment employment
status
scan, or MI in past 3 mo blockers depression,
maximal work
product
History of angina, MI Unstable angina PTCA Aspirin plus Primary/seco change in
ACME-2 refractory to ndary exercise 5
within 3 mo, or ≥3 mm individualiz
1987– medical therapy,
ed therapy outcomes duration,
horizontal ST depression prior PCI, primary not time to onset
1990 on exercise testing; cardiac diagnosis of Nitrates, individually of angina,
other than CAD, β-blockers, described maximal
USA ≥70% stenosis in ≥50% left main and Angina rate-pressure
proximal two thirds of 1 stenosis, 3 vessel Calcium frequency, 6 product,
or 2 coronary arteries CAD, LVEF≤30% channel mo exercise percent
tolerance diameter
(data for 1 vessel CAD blockers
testing and stenosis of
previously presented as angiography: index lesions
ACME-1)

15. Baseline Characteristics

21. CLINICAL CHARACTERISTICS OF THE
PARTICIPANTS

28. RESULTS

29. ALL CAUSE MORTALITY
PCI OMT RISK RATIO

32. All Cause Mortality
PCI VS OMT RESULT
longest follow-up duration risk ratio [RR], 0.85; 95% CI, 0.71–
1.01
the ≤1 year RR, 1.34; 95% CI, 0.87–2.08
1 to 5 years RR, 0.97; 95% CI, 0.56–1.69
≥5 years RR, 0.82; 95% CI, 0.65–1.02
• Overall, there was no statistically significant difference in mortality
between the PCI and OMT groups; the point estimate at the longest
follow-up duration notably did favor the PCI group SWISS-2 and
ALKK individually showed the most favorable effects of PCI over
OMT; of note, these 2 trials included those with prior recent MIs.

33. CARDIVASCULAR DEATH
PCI VS OMT CARDIVASCULAR DEATH
longest follow-up duration RR, 0.71; 95% CI, 0.47–1.06
PCI group (RR, 0.71; 95% CI, 0.47– RR, 0.70; 95% CI, 0.46–1.08
1.06)
<5 YEARS RR, 1.53; 95% CI, 0.69–3.38
• The point estimate in the longest follow-up duration
analysis favored the PCI group and this difference was
most apparent in those trials with ≥5 years follow-up
although these were not statistically significant.

34. NONFATAL MI
PCI vs OMT result
overall analysis (RR, 0.93; 95% CI, 0.70–1.24)
≤1 year RR, 0.82; (95% CI, 0.37–1.80)
1 to 5 years RR 1.11(95% CI, 0.47–2.59),
≥5 year RR O.92(95% CI, 0.67–1.27)

35. Revascularization
PCI VS OMT RESULT
overall analysis (RR, 0.93; 95% CI, 0.76–
1.14)
≤1 year RR, 1.49; 95% CI
1–5 years RR 0.98; 95% CI, 0.74–1.30;
≥5 year RR 0.99; 95% CI, 0.75–1.30
time points

36. Freedom From Angina
PCI VS OMT RESULT
OVERALL (RR, 1.20; 95% CI, 1.06–1.37
≤1 year RR, 1.32; 95% CI, 1.13–1.54
1–5 years 1.57; 95% CI, 1.06–2.32
≥5 year 1.06–2.32; RR, 1.17; 95% CI, 1.00–1.38)

37. Study limitations
• Analysis of symptoms driven
revascularization
• Freedom from angina
• Dosage of medication administered
• Evolution of therapy
• Variation in target level

38. Discussion
BUT
Most
updated
analysis to All-cause
date mortality
Greater
No and cardiac
freedom
significant death in trial
from angina-
difference in with longer
PCI
outcome follow up-
PCI

39. ISCHEMIA-STUDY
• International Study of Comparative Health
Effectiveness with Medical and Invasive
Approaches