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

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

September 05, 2006

    BARCELONA, Spain, Sept. 5 /Xinhua-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.

    For more information, please contact:

     Pr G. Montalescot
     Professor of Universities, Secretariat 
     Tel:   [phone]
     Fax:   [phone]
     Email: [e-mail]  

SOURCE  Hospital Pitie Salpetriere-Institut du coeur