Grote internationale studie toont belangrijke informatie voor patiënten met acuut coronair syndroom na een percutane coronaire interventie (PCI)
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De CURRENT-OASIS studie is een fase III onderzoek binnen een brede groep patienten met instabiele angina of een hartinfarct (NSTEMI/STEMI) die een vroege invasieve procedure zijn ondergaan. Deze studie is uitgevoerd om te onderzoeken of een hogere dosering Plavix® (clopidogrel) in combinatie met aspirine leidt tot een verdere afname van het risico op ischemische complicaties na een percutane coronaire interventie (PCI), ofwel dotter-procedure. Daarbij is gekeken naar het optreden van cardiovasculair overlijden, hartinfarct of beroerte. Ook is onderzocht of een hogere dosering Plavix even veilig is als de standaarddosering.
Het primaire doel van de studie (cardiovasculair overlijden, hartaanval of beroerte binnen 30 dagen) toont voor de totale studiepopulatie geen statistisch significante resultaten (4.2% vs. 4.4%, HR 0.95, p=0.37). De resultaten binnen klinisch relevante subgroepen die waren gespecificeerd voor eerdere analyses, zoals de PCI-subgroep (70% van de populatie in het onderzoek, 17,232 patienten), tonen wel klinisch relevante verschillen. In deze subgroep werd een verbetering in de resultaten gezien bij de patienten met een hogere dosering Plavix (600 mg start / 150 mg voor dag 2-7 / 75 mg dag 8-30) ten opzichte van de groep met de standaarddosering (300 mg start / 75 mg voor dag 2-30). De resultaten tonen in deze subgroep een reductie op hetzelfde primaire einddoel als voor de gehele populatie op cardiovasculair overlijden, myocardinfarct en beroerte met 15%  (4.5% vs 3.9%, p=0.037). Daarnaast toont de analyse een belangrijke risicoreductie van 42% in stent-trombose (1.2% vs 0.7%, p=0.001) bij een hogere dosering van Plavix in vergelijking met de standaarddosering.
NEW LARGE-SCALE, GLOBAL STUDY PROVIDES ADDITIONAL INFORMATION
ABOUT AN INTENSIFIED DOSE-REGIMEN OF PLAVIX® IN ACUTE CORONARY
SYNDROME PATIENTS UNDERGOING ANGIOPLASTY
-No added benefit on the composite primary end-point with the higher dose
when entire ACS study population considered –
-Important new findings with higher loading dose of Plavix®
for heart patients undergoing coronary angioplasty (PCI)-
Paris, France and Princeton, New Jersey – August 30, 2009 – Today, the OASIS study group
will present initial results of the CURRENT-OASIS 7 clinical trial at the European Society of
Cardiology congress in Barcelona. Sanofi-aventis (EURONEXT: SAN, and NYSE: SNY) and
Bristol-Myers Squibb (NYSE: BMY), co-commercialization and co-development partners for
Plavix® (clopidogrel), were sponsors of the study.
CURRENT-OASIS 7 is the largest clinical trial (25,087 patients) to evaluate different dosing
regimens of Plavix® (clopidogrel) plus aspirin in a broad range of acute coronary syndrome (ACS)
patients (UA/NSTEMI/STEMI). The study was designed to assess the efficacy and safety of an
intensified clopidogrel regimen (600mg loading dose day1/150mg days 2-7/75 mg days 8-30)
versus the approved Plavix dosage (300mg loading dose day1/75mg days 2-30) for patients
managed with an early invasive strategy with an intent for percutaneous coronary intervention
(PCI).
The primary end-point (cardiovascular death, heart attack, or stroke at thirty days) for the entire
study population (including subpopulations of patients that underwent PCI (70%) or not (30%)
examining the difference between the high-dose and standard-dose Plavix® regimens did not reach
statistical significance (4.2% vs. 4.4%, HR 0.95, p=0.37).
For clinically relevant subgroups that were pre-specified for preliminary analyses such as the PCI
subgroup (70% of the trial population, 17,232 patients) potentially medically relevant differences
in patient outcomes were observed. In this subgroup, analysis showed an improvement in outcome
for patients taking the higher dose regimen (600 mg loading / 150 mg for days 2-7/75 mg days
8-30) over the standard dose regimen (300 mg loading/75 mg for days 2-30), as shown by the
reduction of the same composite end-point of cardiovascular death, myocardial infarction and
stroke by 15% (4.5% vs 3.9%, p=0.037). In addition, analysis showed an important 42% relative
risk reduction in definite stent thrombosis (1.2% vs 0.7%, p=0.001) with the higher-dose
regimen of clopidogrel over the standard loading dose.
“An artery opening procedure with stent placement exposes a patient to an increased risk of stent
occlusion and subsequent heart attack,†said Doctor Jean-Pierre Lehner, Chief Medical Officer,
sanofi-aventis. “CURRENT-OASIS 7 provides important new information about a high-dose
regimen of Plavix® in ACS patients planned for PCI. We are pleased to contribute to furthering the
understanding of patient care during the acute phase of coronary intervention.â€
The primary end-point was assessed by the stringent bleeding definition of OASIS and while a
significant increase in the primary safety end-point of major bleeding with the high-dose compared
to the standard-dose Plavix® regimen was observed in the overall trial population (2.5% vs 2.0%,
HR 1.25, p=0.01) and the PCI population (1.6% vs 1.1%, HR 1.44, p=0.006), there was no
statistically significant difference in intracranial bleeding or fatal hemorrhage in the overall
population and the PCI population.
Sanofi-aventis and Bristol-Myers Squibb believe that the CURRENT-OASIS 7 data add to the
broad clinical experience with Plavix®, which has been used in over 90 million patients during the
11 years it has been on the market.
Plavix® is recommended daily for patients who have had a recent heart attack or stroke, or poor
circulation in the legs that may cause pain during exercise, such as walking, and may be relieved
by rest (known as peripheral artery disease, or P.A.D.). Plavix® is also recommended in addition to
aspirin for patients who have been hospitalized with heart-related chest pain (unstable angina) or
had a heart attack.
Please see full prescribing information for the United States by visiting www.plavix.com. For the
most updated Plavix® labelling information in Europe please refer to:
http://www.emea.europa.eu/humandocs/PDFs/EPAR/Plavix/H-174-PI-en.pdf.
Bron: Sanofi Aventis
