CURRENT OASIS-7 (Clopidogrel Optimal

Loading Dose Usage to Reduce Recurrent

Events/Optimal Antiplatelet Strategy for

Interventions)

CURRENT OASIS-7 (Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent Events/Optimal Antiplatelet Strategy for Interventions)

• Design:

2 x 2 factorial randomized trial studying the optimal dose of clopidogrel and aspirin

in ACS patients scheduled to undergo an early invasive strategy with intent to

perform PCI no later than 72 hours after randomization

• Treatments:

High-dose clopidogrel arm: 600-mg loading dose on day 1 + 150 mg once daily for

seven days + 75 mg once daily until day 30

Standard-dose clopidogrel arm: 300-mg loading dose on day 1 + 75 mg once daily

until day 30

Patients were also assigned open-label aspirin 300–325 mg or 75–100 mg

• Primary outcome:

CV death, MI, or stroke

S Mehta (McMaster University, Hamilton, ON) European Society of Cardiology 2009 Congress

•Efficacy outcomes:

No significant difference in the overall cohort of patients who received the

higher dose of clopidogrel

In the cohort of patients who underwent PCI, there was a significant 15%

reduction in CV death, MI, and stroke (a reduction driven by a significant

22% reduction in the risk of MI)

A significant 42% reduction in the risk of definite stent thrombosis also

occurred in patients who underwent PCI

CURRENT OASIS-7: Results

•Bleeding risk:

No difference with the standard and doubled clopidogrel doses in TIMI major

bleeding

A significant increase in bleeding in CURRENT major and severe bleeding

(driven by an increased need for red blood cell transfusions)

No difference in fatal bleeding, intracranial hemorrhage, or CABG-related

major bleeding

CURRENT OASIS-7: Results

CURRENT OASIS-7: Commentary*

*All comments from CURRENT OASIS-7: Benefit to doubling clopidogrel dose in ACS patients

undergoing PCI (http://www.theheart.org/article/995967.do)

"It's a simple therapy to institute, it's going from one pill to two pills per day, and the

cost implications are virtually negligible and the benefits are large. So this

maneuver could improve patient outcomes in PCI, and it's a fairly simple thing to

institute rapidly."

- Dr Shamir Mehta

"The price to pay in terms of bleeding complications is small and certainly

acceptable."

- Dr Frans Van de Werf

"It is not unreasonable to conclude that the benefit of double-dose clopidogrel does

not outweigh its risk."

- Dr Sanjay Kaul

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