Table 16KQ 3 Strategy 2: Outcomes reported in RCTs evaluating women with stable or unstable angina (PCI vs. CABG)

StudyComposite Outcomea
(Timing)

Anticipated Effect Size
Deatha
(Timing)
MI
(Timing)
CVA
(Timing)
Revascularization
(Timing)
Other (Timing)
ARTS I78,8790Death/CVA/MI/CABG/repeat PCI
(30 days, 1 year, 3 years, 5 years)

Death/CVA
(30 days, 1 year, 3 years)

Death/MI/CVA
(30 days, 1 year, 3 years, 5 years)

MI/CVA/PTCA
(5 years)

Powered to detect 7% difference in favor of CABG
Yes
(30 days, 1 year, 3 years, 5 years)

MACE-free survival
(30 days, 1 year, 3 years)
Yes
(30 days, 1 year, 3 years, 5 years)
Yes
(5 years) (30 days, 1 year, 3 years, 5 years)
Yes
(30 days, 1 year, 3 years, 5 years)
Quality of life
(3 years)

Bleeding
(in hospital)
BARI79,9199Effect size not reportedCumulative survival rate
(5 year, 7 years, 10 years)
Yes
(in hospital)
Yes
(10 years)
Angina status
(4 years, 10 years)

Congestive heart failure
(in hospital)
CABRI80Powered to detect 60% reduction in mortality in PCI groupYes
(1 year)
Angina
(1 year)
CARDia84,100Death/MI/stroke repeat revascularization
(1 year)

Death/MI/CVA
(1 year)

Powered for OR of 0.69 in favor of PCI (upper CI 1.3)
EAST81,101103Powered for 25% reductionSurvival
(3 years, 8 years)
GABI86,104Powered for 15% difference in success rates as therapeutically equivalentYes
(13 years)
Primary outcome was freedom from angina (not reported by sex)
MASS II68,73,74Death/MI/angina requiring revascularization
(10 years)

Powered to detect 2-fold difference
PRECOMBAT85Death/MI/stroke/ischemia-driven target-vessel revascularization
(1 year, 2 years)

Powered to detect 7% difference
SOS82,105,106Powered for event rate of 5% in CABG arm and 10% in PCI armPrimary outcome not reported by sexQuality of life
(6 months, 1 year)

Angina frequency
(6 months, 1 year)

Physical limitation
(6 months, 1 year)
SYNTAX83Death/MI/CVA/repeat revascularization
(1 year)

Powered for clinically relevant difference of 5%

CABG = coronary artery bypass grafting; CVA = cerebrovascular accident; MACE = major adverse cardiovascular event; MI = myocardial infarction; OR = odds ratio; PCI = percutaneous coronary intervention; RRR = relative risk reduction

a

Primary outcome in italics.

From: Results

Cover of Treatment Strategies for Women With Coronary Artery Disease
Treatment Strategies for Women With Coronary Artery Disease [Internet].
Comparative Effectiveness Reviews, No. 66.
Dolor RJ, Melloni C, Chatterjee R, et al.

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