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.
SOURCES
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.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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