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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 IntraVenous anticoagulation In the Elective and primary Real world of Angioplasty) announced today at the World Congress of Cardiology 2006- joint meeting of the European Society of Cardiology & World Heart Federation - in Barcelona show that routine PCI appears to be a safe revascularisation procedure with a low rate of clinical complications - death (0.3%), myocardial infarction (1.0%) and bleeding episodes (3.4%). The RIVIERA registry, was performed between 2002 and 2005, during which time many technical improvements occurred in percutaneous coronary intervention (PCI) and adjunctive medical therapy. RIVIERA identified several factors associated with an increased risk of adverse clinical outcomes: PCI of the left main trunk, PCI of coronary bypass grafts, and the clinical features of the patients at presentation. RIVIERA also identified several modifiable factors that may lead to improved clinical outcome: the use of thienopyridine treatment (mainly clopidogrel) administered before PCI, and the use of statins, and enoxaparin were associated with less ischemic events. Radial access was also associated with less ischemic events and bleeding. Use of GP IIb/IIIa inhibitors and the use of both enoxaparin and UFH were associated with more bleeding whereas enoxaparin alone was associated with less bleeding compared to UFH.
The RIVIERA data were collected in 7962 patients in 144 hospitals in 23 countries across 4 continents in order to characterise current practice patterns in a wide range of clinical settings around the world. The aims of RIVIERA were to characterise current practice patterns in modern PCI with a wide representation of countries around the world, to investigate the use of anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH) among patients undergoing elective or primary PCI, and to identify independent predictors of adverse clinical and angiographic complications following the PCI procedure.
Patients in the RIVIERA registry were a high-risk population with a history of myocardial infarction (30%), a recent or ongoing ST-segment elevation myocardial infarction (STEMI) (21%) or a recent non-ST elevation-acute coronary syndrome (NSTE-ACS) (36%). Ninety-two percent of the population underwent elective PCI and 8% underwent primary PCI. None of the patients were pre-treated with antithrombotic therapy (UFH or LMWH) before undergoing PCI. During the PCI procedure, most patients received either enoxaparin alone (58%) or UFH alone (36%) and a few patients (6%) received either both drugs and a different drug. Other in-hospital treatments included aspirin in 95% of the patients, clopidogrel in 89%, ticlopidine in 12% and GP IIa/IIIb inhibitors in 18%.
"Our results confirm that the advent of new and improved devices and techniques and the use of adjunctive antithrombotic therapy have notably reduced the rates of major complications of PCI in the routine clinical setting" said Gilles Montalescot MD PhD, Professor of Cardiology at the Institut du Coeur, Hopital de la Pitie-Salpetriere in Paris and Principal Investigator for the RIVIERA registry. "It is very encouraging to see that many of the variables associated with an increased risk of adverse cardiac outcomes following PCI in the contemporary clinical setting are modifiable and confirm the results of recent randomised trials; further improvements in the clinical outcomes of PCI patients should be forthcoming" Gilles Montalescot added.
The results of the RIVIERA registry not only provide data from a real-world perspective but are also timely given the increasing use of PCI in the treatment of acute coronary syndromes. More than 1 million PCI procedures are now performed worldwide each year. PCI is commonly referred to as balloon angioplasty/coronary stent implementation.
The RIVIERA registry was funded by sanofi-aventis.
More about percutaneous coronary intervention (PCI)
PCI is a treatment procedure that unblocks coronary arteries that have narrowed due to atherosclerosis or atherothrombosis. The procedure is conducted to restore coronary arterial vascularization (or coronary perfusion) in an acutely or subacutely occluded artery during acute myocardial infarction, unstable angina or stable angina. PCI includes balloon angioplasty and most often implantation of intracoronary stent. The main long-term concern of PCI is re-stenosis. However, the use of coated and drug-eluting stents have been shown to reduce this risk.
Primary PCI is defined as intervention in the culprit vessel within 12 hours after the onset of chest pain or other symptoms of acute myocardial infarction. Elective PCI is performed in all other less-urgent cases in patients with coronary artery disease.
ots Originaltext: Hospital Pitie Salpetriere-Institut du coeur
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