GRAVITAS trial - Summary & Results

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A study on gauging responsiveness with a verifynow assay impact on thrombosis and safety (GRAVITAS) with helps of 5429 patients on the regular clopidogrel dose underwent platelet-function tests with the VerifyNow assay 12 to 24 hours after PCI

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GRAVITAS trial - Summary & Results

  1. 1. GRAVITAS (Gauging Responsiveness witha VerifyNow Assay—Impact onThrombosis and Safety)
  2. 2. GRAVITAS (Gauging Responsiveness with a VerifyNowAssay—Impact on Thrombosis and Safety)M Price (Scripps Clinic, La Jolla, CA)American Heart Association 2010 Scientific Sessions• Population and treatment: 5429 patients on the regular clopidogrel dose underwent platelet-function tests with the VerifyNow assay 12 to 24 hours after PCI 2214 (41%) had high residual platelet reactivity (platelet reactivity units [PRU] >230) and were randomized to continue on the 75-mg regular clopidogrel dose or to another 600-mg loading dose and a higher maintenance dose of 150 mg• Primary outcome: Composite end point of CV death/MI/stent thrombosis at six months
  3. 3. GRAVITAS: Results• There was no benefit on CV outcomes or stent thrombosis with the double dose of clopidogrel• There was also no difference in bleeding• The percentage of patients who had persistently high platelet reactivity was significantly reduced at 30 days and at six monthsResults: Primary end point and bleeding outcomes at six monthsOutcome High-dose clopidogrel Standard-dose clopidogrel Hazard ratio (95% CI) p (%) (%)Primary end point 2.3 2.3 1.01 (0.58–1.76) 0.98GUSTO severe/moderate bleeding 1.4 2.3 — 0.10Any GUSTO bleeding 12.0 10.2 — 0.18
  4. 4. GRAVITAS: Commentary*"Many physicians have been using high-dose clopidogrel as a default strategy inpatients who are nonresponsive to the drug. We show that this strategy is probablyineffective." - Dr Matthew Price"This trial does not definitely rule out the benefit of tailoring therapy based onplatelet-function testing, but it suggests that in future we should be looking athigher-risk populations, larger cohorts, and different drugs." - Dr Jessica Mega"Based on this trial, I am looking more favorably toward the genetic approach ratherthan platelet-function testing." - Dr Elliot Antman*All comments from GRAVITAS: No benefit of doubling dose in clopidogrel nonresponders(http://www.theheart.org/article/1150629.do)
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