Clinical impact of off-label use of contemporary drug-eluting stents in the randomized TWENTE trial

Purpose: Drug-eluting stents (DES) were initially used in simple lesions and low-risk patients ("on-label" indications). Nowadays, DES are mostly implanted "off-label", however, there is limited knowledge about potential differences in outcome between indication groups. Methods: We assessed this issue in the 1-year clinical outcome data of the randomised TWENTE trial, which evaluated second-generation DES (Xience V and Resolute) in 1387 patients. Off-label indications included: renal insufficiency; ejection fraction 27 mm; acute myocardial infarction (MI); >1 lesion/vessel or >2 vessels treated; bifurcation, graft, in-stent restenotic, left main, thrombotic, and totally occluded lesions. Primary endpoint was target vessel failure, a composite of cardiac death, target-vessel related MI, or target-vessel revascularization. Periprocedural MI was defined as MI ≤48 hours after PCI. Results: Patients with off-label DES (n=1033; 74.5%) had more diabetes mellitus (22.9% vs. 17.5%; p=0.03), previous MI (35.9% vs. 22.3%; p<0.001), complex lesions (76.1% vs. 60.7%; p<0.001), and acute coronary syndromes (57.8% vs. 33.3%; p<0.001). Outcome was similar except for more target vessel-related MI in off-label DES (5.6% vs. 1.7%; p<0.001), which reflected more periprocedural MI (5.0% vs. 1.4%; p=0.003) that resulted in a higher target vessel failure rate (p=0.004; Fig.). However, logistic regression analysis demonstrated absence of an independent association between off-label DES use and target vessel failure (adjusted HR 1.11, 0.95% CI: 0.62-2.00; p=0.73). ![Figure][1] Conclusion: Despite significant differences in baseline data between patients with off-label and on-label DES use, 1-year clinical outcome was similar except for more periprocedural MI in patients with off-label DES use. [1]: pending:yes