Differential outcomes after sirolimus-eluting stent implantation: comparing on-label versus off-label patients in the ‘real world’

Abstract

Among 'real world' patients treated with SES, the incidence of TLR and MACE at 1 year was substantially greater among SIRIUS ineligible patients compared with SIRIUS eligible patients. These findings confirm that pivotal clinical trials of drug-eluting stents tend to enroll low-risk patients and that the estimated rates of TLR and MACE derived from such trials may not reflect subsequent outcomes with unrestricted clinical use.

Predicting Restenosis of Drug-Eluting Stents Placed in Real-World Clinical Practice

“…1 As a result, rapid adoption of DES by the cardiology community has resulted in frequent placement of DES in clinical settings for which efficacy and safety data are limited. These "off-label" patients and lesions have higher rates of adverse events including repeat revascularization, [2][3][4][5] which likely contributes to the continued 5% to 7% incidence of clinical restenosis reported in contemporary registries of percutaneous coronary intervention (PCI). 6,7 Clinical Perspective on p 334…”

Repeat Revascularization After Contemporary Percutaneous Coronary Intervention

“…2 These improvements have led interventional cardiologists to treat increasingly complex coronary anatomy, including frequent PCI in patients with off-label clinical scenarios, 3,4 many of which are associated with higher rates of subsequent revascularization than those reported in randomized trials. [5][6][7][8] In addition, despite increased attention to more intensive medical therapy for patients with established coronary artery disease (CAD), progressive atherosclerosis in sites unrelated to the revascularized segment commonly contributes to the need for repeat revascularization. 1,[9][10][11][12][13] …”

Sirolimus- vs. paclitaxel-eluting stents in patients undergoing off-label percutaneous coronary intervention

“…The dramatic efficacy of drug-eluting stents (DES) in reducing restenosis rates and related target vessel revascularization has prompted interventional cardiologists to extend their use beyond the "on-label" scenario, up to include "off-label" lesions for which evidence of efficacy and safety is still a matter of debate.Recent studies reported increased risk of adverse outcomes and complications associated with DES use in patients with off-label coronary lesions than in those without [1,2]. However, there are few direct comparative data on outcomes of first generation DES in off-label scenarios and these data are somewhat limited by not fully inclusive definitions and/or short follow up.…”

“…Recent studies reported increased risk of adverse outcomes and complications associated with DES use in patients with off-label coronary lesions than in those without [1,2]. However, there are few direct comparative data on outcomes of first generation DES in off-label scenarios and these data are somewhat limited by not fully inclusive definitions and/or short follow up.…”