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Original Investigation |

Percutaneous Coronary Intervention Outcomes in Patients With Stable Obstructive Coronary Artery Disease and Myocardial Ischemia:  A Collaborative Meta-analysis of Contemporary Randomized Clinical Trials

Kathleen Stergiopoulos, MD, PhD1; William E. Boden, MD2; Pamela Hartigan, PhD3; Sven Möbius-Winkler, MD4; Rainer Hambrecht, MD5; Whady Hueb, MD, PhD6; Regina M. Hardison, MS7; J. Dawn Abbott, MD8; David L. Brown, MD1
[+] Author Affiliations
1Division of Cardiovascular Medicine, Department of Medicine, State University of New York–Stony Brook School of Medicine, Stony Brook
2Samuel S Stratton VA Medical Center, Albany Medical Center, Albany, New York
3VA Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, West Haven
4Universität Leipzig, Leipzig, Germany
5Klinikum, Links der Weser GmbH, Chefarzt Klinik für Kardiologie und Angiologie, Bremen, Germany
6Heart Institute of the University of Săo Paolo, Săo Paolo, Brazil
7Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania
8Warren Alpert Brown University School of Medicine, Providence, Rhode Island
JAMA Intern Med. 2014;174(2):232-240. doi:10.1001/jamainternmed.2013.12855.
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Importance  Myocardial ischemia in patients with stable coronary artery disease (CAD) has been repeatedly associated with impaired survival. However, it is unclear if revascularization with percutaneous coronary intervention (PCI) to relieve ischemia improves outcomes compared with medical therapy (MT).

Objective  The objective of this study was to compare the effect of PCI and MT with MT alone exclusively in patients with stable CAD and objectively documented myocardial ischemia on clinical outcomes.

Data Sources  MEDLINE, Cochrane, and PubMed databases from 1970 to November 2012. Unpublished data were obtained from investigators.

Study Selection  Randomized clinical trials of PCI and MT vs MT alone for stable coronary artery disease in which stents and statins were used in more than 50% of patients.

Data Extraction  For studies in which myocardial ischemia diagnosed by stress testing or fractional flow reserve was required for enrollment, descriptive and quantitative data were extracted from the published report. For studies in which myocardial ischemia was not a requirement for enrollment, authors provided data for only those patients with ischemia determined by stress testing prior to randomization. The outcomes analyzed included death from any cause, nonfatal myocardial infarction (MI), unplanned revascularization, and angina. Summary odds ratios (ORs) were obtained using a random-effects model. Heterogeneity was assessed using the Q statistic and I2.

Results  In 5 trials enrolling 5286 patients, myocardial ischemia was diagnosed in 4064 patients by exercise stress testing, nuclear or echocardiographic stress imaging, or fractional flow reserve. Follow-up ranged from 231 days to 5 years (median, 5 years). The respective event rates for PCI with MT vs MT alone for death were 6.5% and 7.3% (OR, 0.90 [95% CI, 0.71-1.16); for nonfatal MI, 9.2% and 7.6% (OR, 1.24 [95% CI, 0.99-1.56]); for unplanned revascularization, 18.3% and 28.4% (OR, 0.64 [95% CI, 0.35-1.17); and for angina, 20.3% and 23.3% (OR, 0.91 [95% CI, 0.57-1.44]).

Conclusions and Relevance  In patients with stable CAD and objectively documented myocardial ischemia, PCI with MT was not associated with a reduction in death, nonfatal MI, unplanned revascularization, or angina compared with MT alone.

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Figures

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Figure 1.
Study Selection

Flow diagram depicts study selection for inclusion in the meta-analysis according to the PRISMA statement for reporting systematic reviews and meta-analyses.19

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Figure 2.
Comparison of Percutaneous Coronary Intervention (PCI) and Medical Therapy (MT) vs Medical Therapy Alone in Patients With Documented Myocardial Ischemia

Each graph illustrates an outcome. A, Death; B, nonfatal myocardial infarction; C, unplanned revascularization; and D, angina during follow-up. All included studies are listed by name along with point estimates of the odds ratios (ORs) and respective 95% CIs. The sizes of the squares denoting the point estimate in each study are proportional to the weight of the study. The diamonds represent the overall findings in each plot.

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Figure 3.
Assessment of Publication Bias

This funnel plot is a plot of a measure of study size on the vertical axis as a function of effect size on the horizontal axis for mortality. Large studies appear toward the top of the graph and tend to cluster near the mean effect size. Smaller studies appear toward the bottom of the graph and (since there is more sampling variation in effect size estimates in the smaller studies) will be dispersed across a range of values. In the absence of publication bias, as demonstrated in this funnel plot, the studies, represented by pale dotted circles, are distributed symmetrically about the combined effect size. The dashed diamond appearing below the x-axis represents the summary effect.

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