RIVIERA Registry Identifies Modifiable Predictors of Clinical Outcome in Patients Undergoing Percutaneous Coronary Intervention

Barcelona, Spain (ots/PRNewswire) - Results of the multinational,prospective, observational RIVIERA registry (Registry on IntraVenousanticoagulation In the Elective and primary Real world ofAngioplasty) announced today at the World Congress of Cardiology2006- joint meeting of the European Society of Cardiology & WorldHeart Federation - in Barcelona show that routine PCI appears to be asafe revascularisation procedure with a low rate of clinicalcomplications - death (0.3%), myocardial infarction (1.0%) andbleeding episodes (3.4%). The RIVIERA registry, was performed between2002 and 2005, during which time many technical improvements occurredin percutaneous coronary intervention (PCI) and adjunctive medicaltherapy. RIVIERA identified several factors associated with anincreased risk of adverse clinical outcomes: PCI of the left maintrunk, PCI of coronary bypass grafts, and the clinical features ofthe patients at presentation. RIVIERA also identified severalmodifiable factors that may lead to improved clinical outcome: theuse of thienopyridine treatment (mainly clopidogrel) administeredbefore PCI, and the use of statins, and enoxaparin were associatedwith less ischemic events. Radial access was also associated withless ischemic events and bleeding. Use of GP IIb/IIIa inhibitors andthe use of both enoxaparin and UFH were associated with more bleedingwhereas enoxaparin alone was associated with less bleeding comparedto UFH.

The RIVIERA data were collected in 7962 patients in 144 hospitalsin 23 countries across 4 continents in order to characterise currentpractice patterns in a wide range of clinical settings around theworld. The aims of RIVIERA were to characterise current practicepatterns in modern PCI with a wide representation of countries aroundthe world, to investigate the use of anticoagulation withunfractionated heparin (UFH) or low molecular weight heparin (LMWH)among patients undergoing elective or primary PCI, and to identifyindependent predictors of adverse clinical and angiographiccomplications following the PCI procedure.

Patients in the RIVIERA registry were a high-risk population witha history of myocardial infarction (30%), a recent or ongoingST-segment elevation myocardial infarction (STEMI) (21%) or a recentnon-ST elevation-acute coronary syndrome (NSTE-ACS) (36%). Ninety-twopercent of the population underwent elective PCI and 8% underwentprimary PCI. None of the patients were pre-treated withantithrombotic therapy (UFH or LMWH) before undergoing PCI. Duringthe PCI procedure, most patients received either enoxaparin alone(58%) or UFH alone (36%) and a few patients (6%) received either bothdrugs and a different drug. Other in-hospital treatments includedaspirin in 95% of the patients, clopidogrel in 89%, ticlopidine in12% and GP IIa/IIIb inhibitors in 18%.

"Our results confirm that the advent of new and improved devicesand techniques and the use of adjunctive antithrombotic therapy havenotably reduced the rates of major complications of PCI in theroutine clinical setting" said Gilles Montalescot MD PhD, Professorof Cardiology at the Institut du Coeur, Hopital de laPitie-Salpetriere in Paris and Principal Investigator for the RIVIERAregistry. "It is very encouraging to see that many of the variablesassociated with an increased risk of adverse cardiac outcomesfollowing PCI in the contemporary clinical setting are modifiable andconfirm the results of recent randomised trials; further improvementsin the clinical outcomes of PCI patients should be forthcoming"Gilles Montalescot added.

The results of the RIVIERA registry not only provide data from areal-world perspective but are also timely given the increasing useof PCI in the treatment of acute coronary syndromes. More than 1million PCI procedures are now performed worldwide each year. PCI iscommonly referred to as balloon angioplasty/coronary stentimplementation.

The RIVIERA registry was funded by sanofi-aventis.

More about percutaneous coronary intervention (PCI)

PCI is a treatment procedure that unblocks coronary arteries thathave narrowed due to atherosclerosis or atherothrombosis. Theprocedure is conducted to restore coronary arterial vascularization(or coronary perfusion) in an acutely or subacutely occluded arteryduring acute myocardial infarction, unstable angina or stable angina.PCI includes balloon angioplasty and most often implantation ofintracoronary stent. The main long-term concern of PCI isre-stenosis. However, the use of coated and drug-eluting stents havebeen shown to reduce this risk.

Primary PCI is defined as intervention in the culprit vesselwithin 12 hours after the onset of chest pain or other symptoms ofacute myocardial infarction. Elective PCI is performed in all otherless-urgent cases in patients with coronary artery disease.

ots Originaltext: Hospital Pitie Salpetriere-Institut du coeurIm Internet recherchierbar: http://www.presseportal.de

Contact:Pr G. Montalescot, Professor of Universities, Secretariat: +33-(0)1-42-16-30-07, Telefax: +33-(0)1-42-16-29-31, Email: gilles.montalescot@psl.ap-hop-paris.fr

Hospital Pitie Salpetriere-Institut du coeur

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RIVIERA Registry Identifies Modifiable Predictors of Clinical Outcome in Patients Undergoing Percutaneous Coronary Intervention