Study shows no significant differences in safety risks between off-label use of drug-eluting stents (DES) and off-label use of bare-metal stents (BMS) and a decreased risk of repeat PCI with use of off-label BMS.
In a new, large database study that evaluated 6,551 patients from the National Heart, Lung, and Blood Institute (NHLBI) Dynamic Registry, the use of drug-eluting stents (DES) for off-label indications was associated with a lower risk of repeat revascularization without any excess risk of death or myocardial infarction (MI) compared with the off-label use of bare-metal stents (BMS). The study was published in the New England Journal of Medicine (NEJM).
Off-label stent use was defined as use in lesions in a bypass graft; left main coronary artery disease; restenotic lesions; or ostial, bifurcated, or totally occluded lesions, and in patients with a reference-vessel diameter <2.5 mm or >3.75 mm or a lesion length >30 mm. Off-label use occurred in 54.7% of registered patients who received BMS and in 48.7% of patients who received DES.
At 1 year, the adjusted risk of repeat percutaneous coronary intervention (PCI) was significantly lower among patients who received off-label DES compared with those who received off-label BMS (adjusted HR=0.75; 95% CI, 0.61–0.93). The adjusted risk of repeat revascularization was also lower among patients who received DES compared with those who received BMS (adjusted HR=0.63; 95% CI, 0.52–0.77). These reduced risks were demonstrated consistently in most subgroups of patients who received off-label DES versus those who received off-label BMS.
The authors stated that these data support off-label use of DES.
In an accompanying editorial, Joseph Carrozza, Jr, MD, emphasized that studies such as this one go a long way towards making the decision to use stents for these off-label indications more evidence based; however, Dr Carrozza cautioned that additional studies, ideally with a randomized trial design, are still needed to definitively support the off-label use of DES.
Marroquin OC, Selzer F, Mulukutla SR, et al. A comparison of bare-metal and drug-eluting stents for off-label indications. N Engl J Med. 2008;358:342–352.
Carrozza JP Jr. Drug-eluting stents - pushing the envelope beyond the labels [editorial]? N Engl J Med. 2008;358:405–407.