Improved Safety and Reduction in Stent Thrombosis Associated With Biodegradable Polymer-Based Biolimus-Eluting Stents Versus Durable Polymer-Based Sirolimus-Eluting Stents in Patients With Coronary Artery Disease

Serruys, Patrick W.; Farooq, Vasim; Kalesan, Bindu; Vries, Ton de; Buszman, Paweł; Linke, Axel; Ischinger, Thomas; Klauß, Volker; Eberli, Franz R.; Wijns, William; Morice, Marie Claude; Mario, Carlo Di; Corti, Roberto; Antoni, Diethmar; Sohn, Hae Young; Eerdmans, Pedro; Rademaker‐Havinga, Tessa; Es, Gerrit‐Anne van; Meier, Bernhard; Jüni, Peter; Windecker, Stephan

doi:10.1016/j.jcin.2013.04.011

Cited by 306 publications

(193 citation statements)

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“…In the LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial 15 , which compared biodegradable polymer biolimus-eluting stents (BP-BES) with early-generation DP-SES, a lower rate of the primary endpoint MACE among BP-BES treated patients was documented in the subgroup of STEMI at nine months, a finding which was maintained during e 1350 long-term follow-up throughout five years 16 . The present study may extend the potential benefit of biodegradable polymerbased DES among STEMI patients observed with early-generation thick-strut stainless steel DES to newer-generation thin-strut cobalt-chromium DES.…”

Section: Bp-ses Vs Ees In Stemimentioning

confidence: 99%

Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for primary percutaneous coronary revascularisation of acute myocardial infarction

Pilgrim

Piccolo²,

Heg³

et al. 2016

EuroIntervention

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Aims: Our aim was to compare the safety and efficacy of a novel, ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP-SES) with a thin strut, durable polymer everolimus-eluting stent (DP-EES) in a pre-specified subgroup of patients with acute ST-segment elevation myocardial infarction (STEMI) enrolled in the BIOSCIENCE trial. Methods and results:The BIOSCIENCE trial is an investigator-initiated, single-blind, multicentre, randomised non-inferiority trial (NCT01443104). Randomisation was stratified according to the presence or absence of STEMI. The primary endpoint, target lesion failure (TLF), is a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation within 12 months. Between February 2012 and May 2013, 407 STEMI patients were randomly assigned to treatment with BP-SES or DP-EES. At one year, TLF occurred in seven (3.4%) patients treated with BP-SES and 17 (8.8%) patients treated with DP-EES (RR 0.38, 95% CI: 0.16-0.91, p=0.024). Rates of cardiac death were 1.5% in the BP-SES group and 4.7% in the DP-EES group (RR 0.31, 95% CI: 0.08-1.14, p=0.062); rates of target vessel myocardial infarction were 0.5% and 2.6% (RR 0.18, 95% CI: 0.02-1.57, p=0.082), respectively, and rates of clinically indicated target lesion revascularisation were 1.5% in the BP-SES group versus 2.1% in the DP-EES group (RR 0.69, 95% CI: 0.16-3.10, p=0.631). There was no difference in the risk of definite stent thrombosis.Conclusions: In this pre-specified subgroup analysis, BP-SES was associated with a lower rate of target lesion failure at one year compared to DP-EES in STEMI patients. These findings require confirmation in a dedicated STEMI trial. KEYWORDS• acute myocardial infarcation • biodegradable polymer • durable polymer • everolimus-eluting stents • sirolimus-eluting stents

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Section: Bp-ses Vs Ees In Stemimentioning

confidence: 99%

Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for primary percutaneous coronary revascularisation of acute myocardial infarction

Pilgrim

Piccolo²,

Heg³

et al. 2016

EuroIntervention

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“…Studies assessing BP-DES presented non-inferiorly to durable polymer DES, with a hope for decreased inflammatory response post stent implantation, and thus with a hope for faster vessel healing [13][14][15][16]. Moreover, BP-SES implantation in patients with more severe coronary artery disease was characterised by improved clinical outcomes, as compared to implantation of durable DES [17].…”

Section: Discussionmentioning

confidence: 99%

Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective registry

et al. 2016

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A b s t r a c tBackground: Data from clinical trials suggested that biodegradable-polymer-based drug-eluting stents (DES) might improve long-term clinical outcomes. PROLIM (Balton, Warsaw, Poland) DES is based on a stainless steel platform with a closed cell design releasing sirolimus from biodegradable copolymer (lactic and glycolic acid) in eight weeks. Aim:In the present study the safety and the efficacy of a PROLIM stent was assessed in patients with de novo coronary lesions in 12-month clinical follow-up. Methods:It was a single-centre, observational, prospective registry to assess the safety and efficacy of a PROLIM stent implantation in all consecutive patients with de novo coronary artery lesions treated with percutaneous coronary intervention (PCI). The primary study endpoint was a composite safety (cardiac death, non-fatal myocardial infarction), and the second study endpoint was the efficacy of PROLIM implantation-clinically driven target vessel revascularisation (TVR) assessed at 12-month follow-up. Results:One hundred patients were enrolled into the study and 118 PROLIM stents were implanted. Thirty-two (32%) patients had diabetes, 46 (46%) patients were prior PCI, and 17 (17%) patients had coronary artery bypass grafting. 67% of stented lesions were complex ones (B2/C) and 17% were bifurcations. During the 12-month follow-up primary study endpoints occurred in five (5%) patients. Two (2%) cardiac deaths were reported and three (3%) TVRs were performed, of which one was related to in-PROLIM stent restenosis.Conclusions: PCI with biodegradable-polymer PROLIM DES seems to be safe and effective in 12-month follow-up. A larger trial is warranted to assess clinical outcomes post PROLIM stent implantation.

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“…It is important to note that improved clinical outcomes with the everolimus-eluting stent --the most used stent in Nfor et al's study (~59% 32 ) --in multivessel disease, 37 coupled with similarly reported data from the French Left Main Taxus and LEMAX registries that investigated left main stenting with everolimus-eluting stents 38,39 and the known reductions in stent thrombosis of newer-generation DES, [40][41][42][43][44][45][46][47] implies that if newergeneration DES had been used in the SYNTAX trial, there would have been a significant reduction in repeat revascularization and myocardial infarction. It is also plausible that reductions in mortality would have been seen with the newer-generation DES.…”

Section: Syntax In the Contemporary Eramentioning

confidence: 94%

A Tale of Two Techniques: Demystifying the Myth

Jan¹

2015

Journal of Patient-Centered Research and Reviews

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Improved Safety and Reduction in Stent Thrombosis Associated With Biodegradable Polymer-Based Biolimus-Eluting Stents Versus Durable Polymer-Based Sirolimus-Eluting Stents in Patients With Coronary Artery Disease

Abstract: The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).

Cited by 306 publications

References 49 publications

Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for primary percutaneous coronary revascularisation of acute myocardial infarction

Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for primary percutaneous coronary revascularisation of acute myocardial infarction

Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective registry

A Tale of Two Techniques: Demystifying the Myth

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