Registry on Intra-Venous Anticoagulation in the Elective and Primary Real World of Angioplasty - RIVIERA Registry

Description:

The goal of the registry was to characterize current percutaneous coronary intervention (PCI) practice patterns and outcomes in an international setting.

Study Design

Study Design:

Mean Follow Up: Index hospitalization
Mean Patient Age: Mean age 59 years
Female: 23

Patient Populations:

Centers: >100 cases/year, balance between use of UFH and enoxaparin
Patients: admitted for elective or primary PCI, age ≥21 years

Exclusions:

Therapeutic dose of anticoagulant before PCI

Drug/Procedures Used:

The first 10 consecutive, eligible patients undergoing PCI at each center each month were included in the registry. Patients were evaluated for angiographic complications and clinical outcomes through hospital discharge, including death, myocardial infarction (MI), and bleeding.

Principal Findings:

Patients were enrolled in Asia (52%), Europe (27%), Africa (11%), and South America (10%). Presenting syndrome was stable angina (45%), non-ST elevation acute coronary syndrome (36%), and ST elevation MI within 12 hours (9%). Femoral approach was used in 89% of cases and radial approach in 11%. Most cases used one (67%) or two (22%) stents, with an average stent length of 27 mm. Anticoagulation therapy was unfractionated heparin (UFH) in 36%, and enoxaparin in 58%. Clopidogrel was used in 89% of cases, ticlopidine in 12%, and glycoprotein (GP) IIb/IIIa inhibitors in 18%. The average clopidogrel loading dose was 310 mg.

Among the in-hospital events, death occurred in 0.3% of patients, MI in 1.0%, major bleeding in 0.3%, and minor bleeding in 3.1% of patients. The composite of death or MI was 1.3%. Multivariate correlates of death or MI included ST elevation MI within 12 hours, femoral access, non-left anterior descending coronary disease, absence of thienopyridine before PCI, GP IIb/IIIa inhibitor use, absence of nitrate use, and UFH use. Multivariate correlates of death included female gender, presentation with syndrome other than stable angina, left-main PCI, absence of thienopyridine before PCI, absence of nitrate use, and absence of statin use. Multivariate correlates of bleeding included female gender, femoral access, PCI of bypass grafts, number of stents used, GP IIb/IIIa inhibitor use, beta-blocker use, angiotensin-converting enzyme inhibitor/angiotensin-receptor blocker use, and use of anticoagulant other than enoxaparin alone or UFH alone.

Any angiographic complications occurred in 8.7% of patients, including coronary dissection (3.7%), no reflow (2.0%), distal embolization (0.7%), abrupt vessel closure (0.3%), and coronary rupture (0.1%).

Interpretation:

Among patients undergoing PCI, in-hospital clinical events were relatively low. Correlates of clinical complications included left main PCI associated with a higher mortality rate, PCI of grafts associated with a higher bleeding rate, and clinical presentation other than stable angina associated with increased angiographic and ischemic complications. The impact of the effect of medications on outcomes is not possible to evaluate in this registry study, since with a registry, the direction of causality is unknown (i.e., it is unknown if certain medications were given due to a higher risk of an event or if the medications caused the increase in events).

References:

Presented by G. Montalescot, European Society of Cardiology Scientific Congress, September 2006.

Keywords: Myocardial Infarction, Acute Coronary Syndrome, Angina, Stable, Coronary Disease, Heparin, Ticlopidine, Platelet Membrane Glycoprotein IIb, Percutaneous Coronary Intervention, Stents, Registries, Enoxaparin, Platelet Glycoprotein GPIIb-IIIa Complex


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