Off-label stent use - risky venture

The risk of definitive stent thrombosis is increased after “off-label” stent implantation irrespective of drug-eluting stent or bare-metal stent use

Rainer Hoffmann, Helene Klinker, Malte Kelm and Rüdiger Blindt
Department of Cardiology, University Hospital, Aachen, Germany
Medical Clinic I, University, Aachen, Germany
University Clinic Aachen, Aachen, Germany

Published online: 11 August 2009 Clinical Research in Cardiology

Abstract

Introduction
A limitation of drug-eluting stent (DES) use to FDA-approved indications has been suggested to reduce the risk of stent thrombosis. This study evaluated predictors of stent thrombosis in clinical practice after the use of drug-eluting as well as bare-metal stents (BMS), including adherence to the FDA indications for DES.

Methods
Between July 2002 and October 2006 percutaneous coronary intervention (PCI) was performed on 5,945 patients using BMS (68%) or DES (32%). Patients had 1-year follow-up for definitive stent thrombosis (ARC criteria). 76 patients (1.27%) developed definitive stent thrombosis. Clinical, procedural, and angiographic parameters were related to those of 786 patients without stent thrombosis to define predictors of stent thrombosis. Off-label or on-label implantation of stents according to the FDA-approved indications for DES was included as parameter in the analysis.

Results
In 434 patients, stent implantation was performed within FDA-approved indications and in 428 patients outside of FDA-approved indications for DES. Predictors of stent thrombosis were PCI in acute myocardial infarction (OR = 4.51, P < or =" 4.43,">P < or =" 1.07,">P < or =" 3.67,">P < or =" 6.13,">P < or =" 2.56,">P = 0.014), LV-EF < or =""> P < or =" 3.65,">P = 0.004), stent length in mm (OR = 1.04, P = 0.015), and implantation of multiple stents (OR = 2.64, P = 0.002) remained predictors of stent thrombosis. Off-label stent implantation was no independent additional predictor as it is a combined parameter of the above-mentioned predictors.

Conclusions
Implantation of coronary stents outside of the FDA-approved indications for DES is associated with an increased risk of stent thrombosis using DES and BMS.