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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

The CIAO (Coronary Interventions Antiplatelet-based Only) Study

A Randomized Study Comparing Standard Anticoagulation Regimen to Absence of Anticoagulation for Elective Percutaneous Coronary Intervention

Eugenio Stabile, MD, PhD, FESC, FAHA^_*,_*, Wail Nammas, MD^_*, Luigi Salemme, MD^_*, Giovanni Sorropago, MD^_*, Angelo Cioppa, MD^_*, Tullio Tesorio, MD^_*, Vittorio Ambrosini, MD^_*, Esther Campopiano, MD^_*, Gregory Popusoi, MD^_*, Giuseppe Biondi Zoccai, MD and Paolo Rubino, MD^_*

^_* Laboratory of Invasive Cardiology, Division of Cardiology, Clinica Montevergine, Mercogliano, Italy
Interventional Cardiology, Division of Cardiology, S. Giovanni Battista-Molinette Hospital, University of Turin, Turin, Italy

Manuscript received March 26, 2008; revised manuscript received June 23, 2008, accepted July 11, 2008.

^_* Reprints requests and correspondence: Dr. Eugenio Stabile, Cardiac Catheterization Laboratories, Division of Cardiology, Clinica Montevergine, 83013 Mercogliano, Italy (Email: geko50{at}hotmail.com).

Objectives: We sought to evaluate, in a double-blind, randomized, prospective study, safety and efficacy of elective percutaneous coronary intervention (PCI), with pharmacotherapy consisting of antiplatelet therapy and no anticoagulation therapy.

Background: Available guidelines recommend systemic anticoagulation agent use during PCI. Significant debate remains, however, with regard to the correlation between the effects of systemic anticoagulation therapy and ensuing ischemic and hemorrhagic complications.

Methods: From June 2005 to January 2007, 700 patients undergoing elective PCI of an uncomplicated lesion have been prospectively enrolled in the protocol. Patients should have been on aspirin and thienopyridine therapy and were assigned either to the control arm (70 to 100 UI/kg unfractionated heparin) or to the no-heparin arm. A clinical assessment was obtained before hospital discharge and at 30 days after PCI.

Results: Procedural success was obtained in 100% of the cases. No acute or subacute thrombosis was observed. The absence of anticoagulation therapy was associated with a significant decrease in post-procedural myocardial damage (p = 0.03) and bleeding events (p = 0.048). At 30 days, the primary end point (death, myocardial infarction, or urgent target vessel revascularization) was more frequent in the control arm than in the no-heparin arm (2.0% vs. 3.7%, respectively; absolute risk reduction 1.7% [95% confidence interval: –0.1% to 4.5%], p for superiority = 0.17, p for noninferiority <0.001).

Conclusions: In the treatment of uncomplicated lesions and in the presence of dual antiplatelet therapy, elective PCI can be safely performed without systemic anticoagulation and is associated with a reduced incidence of bleeding complications.

Key Words: percutaneous coronary intervention • no anticoagulation • bleeding

Abbreviations and Acronyms   ACT = activated clotting time   CABG = coronary artery bypass graft surgery   CK-MB = creatine kinase-myocardial band   GPI = glycoprotein IIb/IIIa inhibitor   PCI = percutaneous coronary intervention   UFH = unfractionated heparin

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