Trading Restenosis for Thrombosis? New Questions about Drug-Eluting Stents

Shuchman, Miriam

doi:10.1056/nejmp068234

Cited by 110 publications

(84 citation statements)

References 3 publications

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“…In light of stent thrombosis, there have been great concerns about the long-term safety of DES associated with late stent thrombosis. 17,18 The primary stenting for STEMI was associated with a higher risk of stent thrombosis in registry data, 19,20 even though meta-analysis of randomized trials has not shown an increased risk of stent thrombosis in the DES group compared with bare metal stents (BMS) in the primary PCI. 21 Delayed healing characterized by persistent fibrin deposition, poorer endothelialization, and local hypersensitivity reaction are some of the mechanisms put forward for the explanation of the late occurrence of thrombosis-related events with DES.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Sirolimus‐ and Paclitaxel‐Eluting Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST‐Elevation Myocardial Infarction: A Meta‐analysis of Randomized Trials

Zheng

Lu³

et al. 2010

Clinical Cardiology

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Background: It has been reported that sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) have been more effective than bare-metal stents in reducing restenosis and cardiac events in a broad range of patients with coronary artery disease. However, it is unknown whether there might be differences between these two drug-eluting stents in terms of efficacy and safety in the setting of acute ST-segment elevation myocardial infarction (STEMI). Hypothesis: The aim of the present study was to compare SES with PES in patients with acute STEMI undergoing primary percutaneous coronary intervention (PCI). Methods: The published research was scanned by formal searches of electronic databases (PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials) from January 2001 to February 2010. Internet-based sources of information on the results of clinical trials in cardiology were also searched. Results: A total of 4 randomized trials were included in the present meta-analysis, involving 1105 patients (550 in the SES group, 555 in the PES group). SES were significantly more effective in the reduction of angiographic binary (≥50%) restenosis (4.0% vs 9.6%, odds ratio 0.38, 95% confidence interval 0.19 to 0.74, P = 0.004) compared to PES. The differences between SES and PES were not statistically significant with respect to target vessel revascularization (TVR), stent thrombosis, cardiac death, and myocardial infarction. Conclusions: SES are superior to PES in reducing the incidence of restenosis in patients undergoing primary PCI for STEMI, with nonsignificant differences in terms of TVR, cardiac death, myocardial infarction, and stent thrombosis. IntroductionPrimary angioplasty has become the standard of care for acute ST-segment elevation myocardial infarction (STEMI); however, its long-term success is limited by the occurrence of restenosis. 1,2 The introduction of drugeluting stents (DES) has greatly alleviated this problem, 3 and their use in coronary intervention has markedly increased. DES decreases angiographic and clinical measurements of restenosis compared with bare metal stents 4,5 in elective patients and those with STEMI. A meta-analysis in a broad population has shown that sirolimus-eluting stents (SES) are superior to paclitaxel-eluting stents (PES) in terms of late loss and target lesion revascularization (TLR). 6 However, the relative efficacy and safety of SES and PES in STEMI patients remains unclear. We therefore performed a meta-analysis of randomized

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Section: Discussionmentioning

confidence: 99%

Comparison of Sirolimus‐ and Paclitaxel‐Eluting Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST‐Elevation Myocardial Infarction: A Meta‐analysis of Randomized Trials

Zheng

Lu³

et al. 2010

Clinical Cardiology

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“…Increased risk of late in-stent thrombosis resulting in acute coronary syndrome (unstable angina, acute myocardial infarction and death) after the use of drug-eluting stent (DES) devices has become a major safety concern [1][2][3] . These adverse effects are thought to result mainly from the anti-healing effects of the drugs (sirolimus and paclitaxel) on endothelial cells, leading to impaired re-endothelialization, excessive inflammation, proliferation and fibrin deposition [4][5][6] .…”

Section: Introductionmentioning

confidence: 99%

Pitavastatin-Incorporated Nanoparticle-Eluting Stents Attenuate In-Stent Stenosis without Delayed Endothelial Healing Effects in a Porcine Coronary Artery Model

Tsukie

Nakano

Matoba

et al. 2013

JAT

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Aim:The use of currently marketed drug-eluting stents presents safety concerns including increased late thrombosis, which is thought to result mainly from delayed endothelial healing effects (impaired re-endothelialization resulting in abnormal inflammation and fibrin deposition). We recently developed a bioabsorbable polymeric nanoparticle (NP)-eluting stent using a novel cationic electrodeposition technology. Statins are known to inhibit the proliferation of vascular smooth muscle cells (VSMC) and to promote vascular healing. We therefore hypothesized that statin-incorporated NPeluting stents would attenuate in-stent stenosis without delayed endothelial healing effects. Methods: Among six marketed statins, pitavastatin (Pitava) was found to have the most potent effects on VSMC proliferation and endothelial regeneration in vitro. We thus formulated a Pitava-NP-eluting stent (20 μg Pitava per stent). Results: In a pig coronary artery model, Pitava-NP-eluting stents attenuated in-stent stenosis as effectively as polymer-coated sirolimus-eluting stents (SES). At SES sites, delayed endothelial healing effects were noted, whereas no such effects were observed in Pitava-NP-eluting stent sites. Conclusion: Pitava-NP-eluting stents attenuated in-stent stenosis as effectively as SES without the delayed endothelial healing effects of SES in a porcine coronary artery model. This nanotechnology platform could be developed into a safer and more effective device in the future.

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“…These results, controversial as they are and as yet unpublished, are a major cause for concern and should prompt re-evaluation of everyday practice. (29) The necessity of prolonged dual antiplatelet therapy to prevent stent thrombosis is problematic at best in an older patient population who may require non-cardiac surgery in the weeks and months after PCI.…”

Section: Drug-eluting Stentsmentioning

confidence: 99%

The management of patients with stable coronary syndromes

Commerford

2017

SAHJ

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Trading Restenosis for Thrombosis? New Questions about Drug-Eluting Stents

Cited by 110 publications

References 3 publications

Comparison of Sirolimus‐ and Paclitaxel‐Eluting Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST‐Elevation Myocardial Infarction: A Meta‐analysis of Randomized Trials

Comparison of Sirolimus‐ and Paclitaxel‐Eluting Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST‐Elevation Myocardial Infarction: A Meta‐analysis of Randomized Trials

Pitavastatin-Incorporated Nanoparticle-Eluting Stents Attenuate In-Stent Stenosis without Delayed Endothelial Healing Effects in a Porcine Coronary Artery Model

The management of patients with stable coronary syndromes

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