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The risk of definitive stent thrombosis is increased after off-label stent implantation irrespective of drug-eluting stent or bare-metal stent use
Clinical Research in Cardiology, 08/21/09

Hoffmann R et al. – Implantation of coronary stents outside of the FDA-approved indications for drug-eluting stent (DES) is associated with an increased risk of stent thrombosis using DES and bare-metal stents (BMS).

Methods

Study of predictors of stent thrombosis in clinical practice after use of drug-eluting and bare-metal stents (BMS), including adherence to FDA indications for DES
Percutaneous coronary intervention (PCI) for 5,945 pts using BMS (68%) or DES (32%) July 2002-October 2006
1-yr follow-up for definitive stent thrombosis (ARC criteria)
Stent thromosis defined for 76 pts (1.27%)
Clinical, procedural, and angiographic parameters for 786 pts without stent thrombosis to define predictors of stent thrombosis
Analysis parameter: off-/on-label implantation of stents by FDA-approved indications for DES

Results

Stent implantation for 434 pts within FDA-approved indications and for 428 pts outside of FDA-approved indications for DES
Predictors of stent thrombosis: PCI in acute myocardial infarction, treatment of bifurcation lesions, stent length per mm, implantation of multiple stents, and stent implantation outside of FDA indications
Risk increased for DES as well as BMS
Multivariate analysis: PCI in acute myocardial infarction, LV-EF < 30%, treatment of bifurcation lesion, stent length in mm, and implantation of multiple stents remained predictors of stent thrombosis
Off-label stent implantation was no independent additional predictor as a combined parameter of other predictors

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