Safety and Efficacy of Drug-Eluting and Bare Metal Stents

Abstract

Background-The safety and efficacy of drug-eluting stents (DES) among more generalized "real-world" patients than those enrolled in pivotal randomized controlled trials (RCTs) are controversial. We sought to perform a meta-analysis of DES studies to estimate the relative impact of DES versus bare metal stents (BMS) on safety and efficacy end points, particularly for non-Food and Drug Administration-labeled indications. Methods and Results-Comparative Conclusions-InRCTs, no significant differences were observed in the long-term rates of death or myocardial infarction after DES or BMS use for either off-label or on-label indications. In real-world nonrandomized observational studies with greater numbers of patients but the admitted potential for selection bias and residual confounding, DES use was associated with reduced death and myocardial infarction. Both RCTs and observational studies demonstrated marked and comparable reductions in target vessel revascularization with DES compared with BMS. These data in aggregate suggest that DES are safe and efficacious in both on-label and off-label use but highlight differences between RCT and observational data comparing DES and BMS. (Circulation. 2009;119:3198-3206.)

Downstream coronary effects of drug-eluting stents

“…1,2 Although stents have essentially eliminated vessel reocclusion, restenosis has remained a costly and highly morbid problem. [3][4][5] Mechanical disruption of the endothelium and media appears to trigger intimal and vascular smooth muscle proliferation around the stent surface, and borrowing from the oncologic armamentarium, cell-cycle inhibition has been shown to inhibit this process. 6,7 Coating stents with antiproliferative agents allows targeted delivery to the region of local trauma.…”

Guidelines on myocardial revascularization

“…Subsequent meta-analyses [45] of RCTs comparing DES with BMS reported similar rates of death, cardiac death, and non-fatal MI, but a significant reduction in the need for subsequent or repeat target vessel revascularization (TVR) with DES. In contrast, Kirtane et al [46], in an unadjusted analysis of 182 901 patients in 34 observational studies of BMS and DES, reported a significant reduction in mortality (HR 0.78, 95% CI 0.71 0.86) and MI (HR 0.87, 95% CI 0.78 0.97) with DES. After multivariable adjustment, the benefits of DES were significantly attenuated and the possibility that at least some of the clinical benefit of DES might be due to concomitant dual antiplatelet therapy (DAPT) could not be excluded.…”

“…In native vessels, DES significantly reduce angiographic restenosis and ischaemiadriven TVR [45,215]. In RCTs, no significant differences were observed in the long-term rates of death or MI after DES or BMS use for either off-label or on-label indications [45,46]. In non-randomized large registry studies, DES use may reduce death and MI [46].…”

“…In RCTs, no significant differences were observed in the long-term rates of death or MI after DES or BMS use for either off-label or on-label indications [45,46]. In non-randomized large registry studies, DES use may reduce death and MI [46]. First-generation DES are safe and efficacious for both on-label and off-label use, when implanted in the native circulation, in spite of a slightly increased propensity for late and very late stent thrombosis [215].…”

TWENTE Study: The Real-World Endeavor Resolute Versus Xience V Drug-Eluting Stent Study in Twente: study design, rationale and objectives

“…[1][2][3] However, meta-analyses 4,5 and long-term followup data 6,7 demonstrated that DES improved morbidity but did not reduce mortality (compared with bare metal stents; BMS). Newer generation DES may solve the problems encountered with first-generation DES.…”