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Impact of Chronic Kidney Disease on Early (30-Day) and Late (1-Year) Outcomes of Patients With Acute Coronary Syndromes Treated With Alternative Antithrombotic Treatment Strategies

An ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) Substudy

Roxana Mehran, MD^_*,_*, Eugenia Nikolsky, MD, PhD^_*, Alexandra J. Lansky, MD^_*, Ajay J. Kirtane, MD, SM^_*, Young-Hak Kim, MD^_*, Frederick Feit, MD, Steven Manoukian, MD, Jeffrey W. Moses, MD^_*, Ramin Ebrahimi, MD, E. Magnus Ohman, MD^||, Harvey D. White, MD^¶, Stuart J. Pocock, PhD^#, George D. Dangas, MD, PhD^_*, Gregg W. Stone, MD^_*

^_* Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
New York University School of Medicine, New York, New York
The Sarah Cannon Research Institute and The Centennial Heart Center, Nashville, Tennessee
Department of Medicine, University of California Los Angeles, Los Angeles, California
^|| Department of Medicine, Duke University School of Medicine, Durham, North Carolina
^¶ Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
^# London School of Hygiene and Tropical Medicine, London, United Kingdom

^_* Reprint requests and correspondence: Dr. Roxana Mehran, Columbia University Medical Center, 161 Fort Washington Avenue, 5th Floor, New York, New York 10032 (Email: rmehran{at}crf.org).

Objectives: In this substudy of the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial, we investigated the relationship between chronic kidney disease (CKD) and clinical outcomes, and compared the safety and efficacy of bivalirudin monotherapy versus heparin plus a glycoprotein IIb/IIIa inhibitor (GPI).

Background: CKD is an important predictor of prognosis in the general population. The outcomes of patients with CKD and acute coronary syndromes (ACS) have not been well studied.

Methods: In the ACUITY study, 13,819 patients with moderate- and high-risk ACS undergoing an early, invasive strategy were randomly assigned to 1 of 3 antithrombin regimens: a heparin plus a GPI, bivalirudin plus a GPI, or bivalirudin monotherapy. CKD (creatinine clearance <60 ml/min) was present in 2,469 (19.1%) of 12,939 randomized patients with baseline creatinine clearance data.

Results: Patients with CKD had worse 30-day and 1-year clinical outcomes than those with normal renal function. There were no significant differences between bivalirudin monotherapy and heparin plus a GPI in rates of 30-day composite ischemia (11.1% vs. 9.4%, p = 0.27) and net clinical adverse outcomes (16.1% vs. 16.9%, p = 0.65). There was remarkably less major bleeding (6.2% vs. 9.8%, p = 0.008) at 30 days, but no significant difference in 1-year composite ischemia (22.0% vs. 18.9%, p = 0.10) or mortality (7.1% vs. 7.3%, p = 0.96).

Conclusions: In patients with ACS, CKD is associated with higher 30-day and 1-year adverse event rates. Compared with heparin plus a GPI, the use of bivalirudin monotherapy in patients with CKD results in nonstatistically different ischemic outcomes, but significantly less 30-day major bleeding.

Key Words: acute coronary syndromes • chronic kidney disease • anticoagulants • bivalirudin

Abbreviations and Acronyms   ACS = acute coronary syndromes   CABG = coronary artery bypass grafting   CI = confidence interval   CKD = chronic kidney disease   CrCl = creatinine clearance   GPI = glycoprotein IIb/IIIa inhibitor   OR = odds ratio   PCI = percutaneous coronary intervention   UFH = unfractionated heparin

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