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ARNO TRIAL ( A ntithrombotic R egimens a N d O utcome)

ARNO TRIAL ( A ntithrombotic R egimens a N d O utcome). A RANDOMIZED TRIAL COMPARING BIVALIRUDIN WITH UNFRACTIONED HEPARIN IN PATIENTS UNDERGOING ELECTIVE PCI. David Antoniucci, TCT 2008, Washington DC. ARNO TRIAL.

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ARNO TRIAL ( A ntithrombotic R egimens a N d O utcome)

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  1. ARNO TRIAL(Antithrombotic Regimens aNd Outcome) A RANDOMIZED TRIAL COMPARING BIVALIRUDIN WITH UNFRACTIONED HEPARIN IN PATIENTS UNDERGOING ELECTIVE PCI David Antoniucci, TCT 2008, Washington DC

  2. ARNO TRIAL • The aim of this randomized study is to determine if bivalirudin is still superior to unfractionated heparin plus protamine in patients undergoing elective PCI. • All patients undergoing PCI and pretreated with aspirin (325 mg), and a 600 mg loading dose of clopidogrel at least 6 hours before PCI were considered eligible for enrolment.

  3. ARNO TRIAL • TREATMENTS • Aspirin (325 mg) and clopidogrel (600 mg loading) at least 6 hours • before PCI in all patients. Abciximab on a provisional basis. • Heparin group: 100 IU per kg of body weight with or without • additional boluses to achieve an ACT of 250 to 300 seconds. Protamine 0.5 mg per 100 IU of heparin utilized. • Bivalirudin group: bolus of 0.75 mg/kg followed by infusion of • 1.75 mg/kg per hour for the duration of the procedure. • Immediate post-PCI sheath removal and routine use of closure • devices in all patients.

  4. END POINTS • Primary: in-hospital major bleeding • (REPLACE 2 definition). • Secondary: 1) 30-day composite of death, MI, TVR. • 2) 30-day net clinical outcome (death/MI/TVR or major bleeding). • 3) 30-day minor bleeding. • 4) Vascuular complications. • 5) Six-month outcome. ARNO TRIAL

  5. Study 30-Day End Points Bivalirudin UFH Incidence (%) P = 0.004 P = 0.014 P = 0.043

  6. ARNO TRIAL CONCLUSIONS In this randomized trial of patients undergoing elective PCI and pre-treated with aspirin and clopidogrel, bivalirudin compared to unfractionated heparin plus protamine resulted in a significant reduction of major bleeding, of the composite of death, MI, TVR, and in a better net clinical outcome.

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