Anti-trombotics were one of the main focus with the presentation of two important clinical trials:
- the GRAVITAS study on clopidogrel (Plavix®)
- the ROCKET AF study on rivaroxaban (Xarelto®)
ROCKET AF is a randomized, double-blind, double-dummy study which has enrolled 14,269 patients across 1,100 sites in 45 countries. Patients received 20 mg of oral rivaroxaban (7,081 patients) once daily or dose-adjusted warfarin (7,090 patients).
The study has shown the non inferiority of rivaroxaban compared to warfarin and has also shown a significant reduction of intracranial haemorrhages.
Rivaroxaban should then be shortly the second oral anticoagulant after dabigatran approved for Stroke Prevention in Atrial Fibrillation (SPAF).
GRAVITAS is a double-blind study trial on clopidogrel vs placebo in patients (5,429 patients) who received Drug Eluting Stent (DES) for stable or unstable angina or ACS. The platelet reactivity was determined from the VerifyNow® assay performed 12 to 24 hours after PCI.
With same results in the two arms, the study has not proven that a 150 mg daily dose of clopidogrel is bringing any benefit to patients than the normal dose of 75 mg.
A lot of discussions are now to come to explain why the primary endpoint was not met.
The FDA recommendation to perform genetic tests in patients treated with Platelet Inhibitors is also creating a big debate and the consensus which seems to be shared by cardiologists is that the genotype alone is not enough. Platelet activity is to be also measured.
Next Congress will be held in Orlando (Florida – USA) in November 2011.