Predictors of outcome in patients undergoing PCI. Results of the RIVIERA study☆☆☆
Received 26 February 2007; received in revised form 7 June 2007; accepted 7 July 2007. published online 06 December 2007.
Abstract
Background
Limited information is available about clinical outcomes following routine percutaneous coronary intervention (PCI) in the current era. This study aimed to identify predictors of adverse clinical or angiographic complications following PCI in patients from many different countries.
Methods
RIVIERA is a multinational, prospective, observational study in patients undergoing elective or primary PCI. Consecutive patients (n=7962) were enrolled in 144 hospitals from 23 countries in four different continents. Primary outcome was death or myocardial infarction (MI).
The mean age of the patients was 59 years and 77% were men; 92% of patients underwent elective and 8% primary PCI.
Results
The rate of in-hospital outcomes was low: death 0.3%, MI 1%, any bleeding 3.4%. Angiographic complications occurred in 8.7% of patients, mainly coronary dissection (3.7%) and no reflow (2%). After multivariable analysis, the strongest independent predictors of death or MI were clinical presentation with non-ST-segment elevation acute coronary syndrome or ST-segment elevation myocardial infarction and administration of a glycoprotein (GP) IIb/IIIa inhibitor. Radial access, thienopyridine pretreatment and anticoagulation with enoxaparin were associated with a lower risk of death or MI. Female gender, PCI of coronary artery bypass graft, administration of a GP IIb/IIIa inhibitor and combined use of enoxaparin and unfractionated heparin were significantly associated with more bleeding. Radial access was the only variable associated with less bleeding.
Conclusions
Routine PCI appears to be a relatively safe revascularization procedure. Many of the variables identified as predictors of adverse cardiac outcomes confirm results obtained in recent randomized PCI trials and are modifiable, suggesting that further improvements can be made.
hUnité de Recherche Clinique, Hôpital Lariboisière, Paris, France
Corresponding author. Gilles Montalescot, Institut de Cardiologie, Bureau 2-236, Centre Hospitalier Universitaire Pitié-Salpêtrière, 47 Blvd de l'Hôpital, 75013, Paris, France. Tel.: +33 1 42 16 30 06; fax: +33 1 42 16 29 31.
☆Grant support: The RIVIERA study is funded by sanofi-aventis, Paris, France.
☆☆ The authors all served on the advisory board of the RIVIERA registry. In addition, Gilles Montalescot has received research grants from sanofi-aventis, Eli Lilly and Guerbet; honoraria from sanofi-aventis, Eli-Lilly, GSK, MSD, The Medicine's Company, and Pfizer, and has been consulted/on advisory boards for sanofi-aventis, Eli-Lilly, GSK, MSD, The Medicine's Company, Schering Plough, and Pfizer; Andre Pellois was an employee of sanofi-aventis; Amanda Sousa had received enoxaparin.