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12-12-2007 | Cardiology | Article

Dangers of off-label drug-eluting stent use 'overstated'


Free abstract

MedWire News: Off-label use of drug-eluting stents (DES) appears to be feasible, study findings indicate.

Off-label DES implantation has been shown to reduce neointimal hyperplasia and clinical stenosis. Nevertheless, recently safety concerns with DES have been raised, chiefly with respect to an increased risk for late stent thrombosis (ST) and other procedural complications.

These have led the US Food and Drug Administration to declare that their use should be restricted to improving coronary luminal diameters and reducing restenosis in symptomatic ischemic de novo lesions and lesions in native coronary arteries, and to treating abrupt or threatened closure with failed interventional therapy.

To determine the safety of on- and off-label DES implantations, Asif Qasim, from the EMO Centro Cuore Columbus Hospital in Milan, Italy, and team examined 1044 consecutive patients over a 4-year period. Of these, 364 received on-label DES implantation and 680 received off-label DES for left main artery lesions, acute myocardial infarction (MI), ostial disease, bifurcation lesions, chronic total occlusions, restenotic lesions, left ventricular ejection fraction (LVEF) <30%, and internal mammary artery or saphenous vein graft lesions.

Endpoints included procedural complications, in-hospital MI, and acute ST, and at follow-up, subacute ST, late ST, target vessel revascularization, MI, death, and major adverse clinical events (MACE).

The two groups had similar rates of procedural complications, at 2.5% for the on-label group and 2.9% with off-label use, as well as in-hospital MI, at 3.3% and 4.7%, respectively. Also, no significant differences were observed in ST rates or late ST. Follow-up revealed similar all-cause mortality with on- and off-label use, at 4.9% and 4.1%, respectively.

Less frequent target lesion revascularization rates and MACE in the on-label compared with the off-label group were found to be due to previous coronary artery bypass surgery, diabetes mellitus, and treatment for bare metal stent restenosis, and not off-label DES.

"This study demonstrates that DES implantation in common off-label situations is not associated with increased procedural complications and MI, nor increased mortality on follow-up, MI, or late ST," conclude the researchers in The American Journal of Cardiology.

Nevertheless, they caution that the small number of patients treated with off-label DES for LVEF, acute MI, and internal mammary artery graft lesions limit conclusions in these subgroups.

By Liz Scherer

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