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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

The Influence of Peripheral Arterial Disease on Outcomes

A Pooled Analysis of Mortality in Eight Large Randomized Percutaneous Coronary Intervention Trials

Jacqueline Saw, MD, FRCPC^_*, Deepak L. Bhatt, MD, FACC^,_*, David J. Moliterno, MD, FACC, Sorin J. Brener, MD, FACC, Steven R. Steinhubl, MD, FACC, A. Michael Lincoff, MD, FACC, James E. Tcheng, MD, FACC, Robert A. Harrington, MD, FACC, Maarten Simoons, MD, FACC^||, TingFei Hu, MS, Mobeen A. Sheikh, MD, Dean J. Kereiakes, MD, FACC^¶ and Eric J. Topol, MD, FACC

^_* Department of Medicine, Division of Cardiology, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada
Department of Cardiovascular Medicine, the Cleveland Clinic Foundation, Cleveland, Ohio
Department of Cardiovascular Medicine, University of Kentucky, Lexington, Kentucky
Division of Cardiology, Duke University Medical Center, Durham, North Carolina
^|| Department of Cardiology, Erasmus University, Rotterdam, the Netherlands
^¶ Lindner Center and the Ohio Heart and Vascular Center at the Christ Hospital, Cincinnati, Ohio

Manuscript received October 15, 2005; revised manuscript received February 27, 2006, accepted March 21, 2006.

^_* Reprint requests and correspondence: Dr. Deepak L. Bhatt, Department of Cardiovascular Medicine, Cleveland Clinic Foundation, 9500 Euclid Avenue, Desk F25, Cleveland, Ohio 44195 (Email: bhattd{at}ccf.org).

OBJECTIVES: We aimed to evaluate clinical outcomes among peripheral arterial disease (PAD) patients following percutaneous coronary intervention (PCI).

BACKGROUND: A significant proportion of patients with coronary artery disease undergoing PCI have concomitant PAD, which may be associated with worse outcomes.

METHODS: We performed a pooled analysis of 8 randomized PCI trials. We included multicenter PCI trials that compared antiplatelet therapies (EPIC, EPILOG, EPISTENT, RAPPORT, CAPTURE, IMPACT-II, TARGET, and CREDO) and had baseline PAD status recorded. Multivariable analyses were performed with stepwise logistic regression for 7- and 30-day outcomes and Cox regression for 6-month and 1-year events.

RESULTS: In our pooled analysis of 19,867 patients undergoing PCI, 1,602 (8.1%) were previously diagnosed with PAD. Patients with PAD had higher incidences of 7-day death (1.0% vs. 0.4%; p < 0.001) or myocardial infarction (MI) (6.8% vs. 5.6%; p = 0.047), 30-day death (1.7% vs. 0.7%; p < 0.001) or MI (7.4% vs. 6.1%; p = 0.05), 6-month death (4.2% vs. 1.5%; p < 0.001) or MI (9.1%, vs. 7.7%; p = 0.048), and 1-year death (5.0% vs. 2.1%; p < 0.001). There was a trend toward higher major bleeding risk with PAD (4.8% vs. 3.9%; p = 0.06). With multivariable analyses, PAD remains a significant predictor of mortality at 30 days (hazard ratio [HR] 1.67, 95% confidence interval [CI] 1.03 to 2.70; p = 0.039), 6 months (HR 1.76, 95% CI 1.31 to 2.37; p < 0.001), and 1 year (HR 1.46, 95% CI 1.08 to 1.96; p = 0.013).

CONCLUSIONS: The presence of PAD is associated with higher rates of post-PCI death and MI, and is an independent predictor of short- and long-term mortality.

Abbreviations and Acronyms   CAD = coronary artery disease   CI = confidence interval   GPIIb/IIIa = glycoprotein IIb/IIIa   HR = hazard ratio   MI = myocardial infarction   OR = odds ratio   PAD = peripheral arterial disease   PCI = percutaneous coronary intervention   TVR = target vessel revascularization

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