Randomized Comparison of Everolimus- and Paclitaxel-Eluting Stents

Stone, Gregg W.; Rizvi, Ali A.; Sudhir, Krishnankutty; Newman, William; Applegate, Robert J.; Cannon, Louis; Maddux, James T.; Cutlip, Donald E.; Simonton, Charles A.; Sood, Poornima; Kereiakes, Dean J.

doi:10.1016/j.jacc.2011.02.022

Cited by 206 publications

(21 citation statements)

References 12 publications

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“…Across almost all subjects and lesion types, continued thienopyridine was associated with reductions in the risk of both co-primary end points. Different stents 20,21 and P2Y12 inhibitors 22 have been associated with varied rates of stent thrombosis and myocardial infarction in previous reports, yet in this study, thienopyridine use beyond one year reduced the risks of both outcomes across all stent and drug types. Although results from prior studies vary with regard to risk of thienopyridine discontinuation after 6 months, 10-13,23,24 the current study detected an increased risk of myocardial infarction (both stent- and non-stent related) during the first three months after discontinuation in both treatment groups.…”

Section: Discussionmentioning

confidence: 50%

Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents

et al. 2014

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Background Dual antiplatelet therapy is recommended after coronary stenting to prevent thrombotic complications, yet the benefits and risks of treatment beyond 1 year are uncertain. Methods Subjects were enrolled after a drug-eluting coronary stent procedure. After 12 months of thienopyridine (clopidogrel bisulfate [Plavix] or prasugrel [Effient/Efient]) with aspirin, subjects were randomized to continued thienopyridine or placebo for another 18 months; all continued aspirin. The co-primary effectiveness end points were stent thrombosis and major adverse cardiovascular and cerebrovascular events (a composite of death, myocardial infarction, or stroke) at 12 to 30 months. The primary safety end point was moderate or severe bleeding. Results Subjects (N=9,961) were randomized to continued thienopyridine or placebo. Continued thienopyridine reduced stent thrombosis (0.4% vs. 1.4%, hazard ratio 0.29, 95% confidence interval [CI] 0.17-0.48, P<0.001) and major adverse cardiovascular and cerebrovascular events (4.3% vs. 5.9%, hazard ratio 0.71, 95% CI 0.59-0.85, P<0.001). Myocardial infarction was reduced (2.1% vs. 4.1%, hazard ratio 0.47, P<0.001). Rates of all-cause mortality in the continued thienopyridine and placebo groups were 2.0 and 1.5%, respectively (hazard ratio 1.36, 95% CI 1.00-1.85, P=0.052). Moderate or severe bleeding was increased with continued thienopyridine (2.5% vs. 1.6%, P=0.001). An elevated hazard for stent thrombosis and myocardial infarction was observed in both groups during the 3 months following thienopyridine discontinuation. Conclusion Dual antiplatelet therapy beyond one year after drug-eluting stent placement significantly reduced the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events compared with aspirin alone, but was associated with increased bleeding.

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Section: Discussionmentioning

confidence: 50%

Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents

et al. 2014

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“…When we look at the current generation of DES that are either commercially available or at the clinical research stage, the initial 50:50 split has shifted significantly in favor of sirolimus and its derivatives to the point where P-DES appear almost “exotic” [77, 78]. This trend appears to be driven by clinical evidence which often ranks first- and second-generation S-DES ahead of their P-DES counterparts [1, 3, 79–81]. Another explanation may be the robustness of sirolimus alluded to above.…”

Section: Discussionmentioning

confidence: 99%

Optimization of Drug Delivery by Drug-Eluting Stents

et al. 2015

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Drug-eluting stents (DES), which release anti-proliferative drugs into the arterial wall in a controlled manner, have drastically reduced the rate of in-stent restenosis and revolutionized the treatment of atherosclerosis. However, late stent thrombosis remains a safety concern in DES, mainly due to delayed healing of the endothelial wound inflicted during DES implantation. We present a framework to optimize DES design such that restenosis is inhibited without affecting the endothelial healing process. To this end, we have developed a computational model of fluid flow and drug transport in stented arteries and have used this model to establish a metric for quantifying DES performance. The model takes into account the multi-layered structure of the arterial wall and incorporates a reversible binding model to describe drug interaction with the cells of the arterial wall. The model is coupled to a novel optimization algorithm that allows identification of optimal DES designs. We show that optimizing the period of drug release from DES and the initial drug concentration within the coating has a drastic effect on DES performance. Paclitaxel-eluting stents perform optimally by releasing their drug either very rapidly (within a few hours) or very slowly (over periods of several months up to one year) at concentrations considerably lower than current DES. In contrast, sirolimus-eluting stents perform optimally only when drug release is slow. The results offer explanations for recent trends in the development of DES and demonstrate the potential for large improvements in DES design relative to the current state of commercial devices.

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“…In the randomized Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions (SPIRIT) IV trial comparing EES with PES, the overall risk of definite ST at 2 years was also lowered by 64% in favor of EES, whereas the risk of VLST was nonsignificantly reduced by 24% during the very late period (Ͼ1 year). 26 The latter observation is most likely related to differences in patient populations because the phenomenon of VLST emerged among more complex patients and lesions. Although the duration of dual antiplatelet therapy was longer in SPIRIT IV compared with COMPARE and may have influenced outcomes, it remains to be shown whether prolonged dual antiplatelet therapy effectively prevents VLST.…”

Section: Discussionmentioning

confidence: 99%

Very Late Coronary Stent Thrombosis of a Newer-Generation Everolimus-Eluting Stent Compared With Early-Generation Drug-Eluting Stents

Räber

Magro²,

Stefanini³

et al. 2012

Circulation

354

182

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Background-Early-generation drug-eluting stents releasing sirolimus (SES) or paclitaxel (PES) are associated with increased risk of very late stent thrombosis occurring Ͼ1 year after stent implantation. It is unknown whether the risk of very late stent thrombosis persists with newer-generation everolimus-eluting stents (EES). Methods and Results-We assessed the risk of stent thrombosis in a cohort of 12 339 patients with unrestricted use of drug-eluting stents (3819 SES, 4308 PES, 4212 EES). Results are incidence rates per 100 person-years after inverse probability of treatment weighting to adjust for group differences. During follow-up of up to 4 years, the overall incidence rate of definite stent thrombosis was lower with EES (1.4 per 100 person-years) compared with SES (2.9; hazard ratio, 0.41; 95% confidence interval, 0.27-0.62; PϽ0.0001) and PES (4.4; hazard ratio, 0.33; 95% confidence interval, 0.23-0.48; PϽ0.0001). The incidence rate per 100 person-years of early (0 -30 days), late (31 days-1 year), and very late stent thrombosis amounted to 0.6, 0.1, and 0.6 among EES-treated patients; 1.0, 0.3, and 1.6 among SES-treated patients; and 1.3, 0.7, and 2.4 among PES-treated patients. Differences in favor of EES were most pronounced beyond 1 year, with a hazard ratio of 0.

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Randomized Comparison of Everolimus- and Paclitaxel-Eluting Stents

Abstract: In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, the benefits of EES compared with those of PES present at 1 year were sustained at 2 years.

Cited by 206 publications

References 12 publications

Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents

Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents

Optimization of Drug Delivery by Drug-Eluting Stents

Very Late Coronary Stent Thrombosis of a Newer-Generation Everolimus-Eluting Stent Compared With Early-Generation Drug-Eluting Stents

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