Comparison of biolimus eluted from an erodible stent coating with bare metal stents in acute ST-elevation myocardial infarction (COMFORTABLE AMI trial): rationale and design

Räber, Lorenz; Kelbæk, Henning; Ostoijc, Miodrag; Baumbach, Andreas; Tüller, David; Birgelen, Clemens von; Roffi, Marco; Pedrazzini, Giovanni; Kornowski, Ran; Weber, Klaus; Heg, Dik; Matter, Christian M.; Lüscher, Thomas F.; Taniwaki, Masanori; Meier, Bernhard; Jüni, Peter; Windecker, Stephan

doi:10.4244/eijv7i12a224

Cited by 27 publications

(25 citation statements)

References 29 publications

(19 reference statements)

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“…5,6 Briefly, this is a multicenter, randomized, assessor-blind, superiority trial in patients with STEMI undergoing primary PCI registered at ClinicalTrials.gov (NTC00962416). Consecutive patients ≥18 years with acute ST-segment elevation of ≥1 mm in ≥2 contiguous leads, true posterior myocardial infarction, or new left bundle branch block were eligible for randomization in the presence of ≥1 culprit lesion within the infarct vessel.…”

Section: Methodsmentioning

confidence: 99%

Biolimus-Eluting Stents With Biodegradable Polymer Versus Bare-Metal Stents in Acute Myocardial Infarction

Räber

Kelbæk

Taniwaki

et al. 2014

Circ: Cardiovascular Interventions

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P rimary percutaneous coronary intervention (PCI) is the reperfusion therapy of choice for patients with acute ST-segment-elevation myocardial infarction (STEMI). 1,2Early-generation drug-eluting stents (DES) have been shown more effective than bare-metal stents (BMS), but they were associated with an increased risk of very late stent thrombosis (ST).3 Polymers components applied to the stent surface to enable delayed drug release have been implicated in the pathogenesis of delayed arterial healing and vessel remodeling owing to chronic inflammation. More recently, new-generation DESs with more biocompatible durable and biodegradable polymers have largely overcome this limitation, although the long-term safety profile of these devices particularly among patients with STEMI has not been established to date.Biolimus-eluting stents (BES) are new-generation DES with biodegradable polymer for drug release, which is resorbed Background-This study sought to determine whether the 1-year differences in major adverse cardiac event between a stent eluting biolimus from a biodegradable polymer and bare-metal stents (BMSs) in the COMFORTABLE trial (Comparison of Biolimus Eluted From an Erodible Stent Coating With Bare Metal Stents in Acute ST-Elevation Myocardial Infarction) were sustained during long-term follow-up. Methods and Results-A total of 1161 patients were randomly assigned to biolimus-eluting stent (BES) and BMS at 11 centers, and follow-up rates at 2 years were 96.3%. A subgroup of 103 patients underwent angiography at 13 months. At 2 years, differences in the primary end point of cardiac death, target-vessel myocardial infarction, and target lesion revascularization continued to diverge in favor of BES-treated patients (5.8%) compared with BMS-treated patients (11.9%; hazard ratio=0.48; 95% confidence interval, 0.31-0.72; P<0.001) with a significant risk reduction during the second year of follow-up (hazard ratio 1-2 years=0.45; 95% confidence interval, 0.20-1.00; P=0.049). Differences in the primary end point were driven by a reduction in target lesion revascularization (3.1% versus 8.2%; P<0.001) and targetvessel reinfarction (1.3% versus 3.4%; P=0.023).

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Section: Methodsmentioning

confidence: 99%

Biolimus-Eluting Stents With Biodegradable Polymer Versus Bare-Metal Stents in Acute Myocardial Infarction

Räber

Kelbæk

Taniwaki

et al. 2014

Circ: Cardiovascular Interventions

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“…Methods Both COMFORTABLE AMI and EXAMINATION have been described in detail 28,29 . Briefly, the multicentre COMFORTABLE AMI trial (NCT00962416) randomly assigned 1,161 patients to treatment with biolimus-eluting stents with biodegradable polymer and bare metal stents of otherwise identical design at 11 international sites.…”

Section: Editorial See Page 1566mentioning

confidence: 99%

Selective use of contemporary drug-eluting stents in primary angioplasty for ST-elevation myocardial infarction: pooled analysis of COMFORTABLE AMI and EXAMINATION

Baumbach

Heg²,

Räber³

et al. 2017

EuroIntervention

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Aims: Selective use of DES only in patients at higher risk of MACE is common practice, particularly in healthcare systems with a large premium payable for DES. We aimed to identify subgroups of patients in which the use of BMS in primary percutaneous coronary intervention (PPCI) for STEMI can still be justified.Methods and results: We performed a patient-level pooled analysis of COMFORTABLE AMI and EXAMINATION comparing contemporary DES with BMS in PPCI. A risk score was applied using three parameters: lesion length >15 mm, vessel size <3 mm, and diabetes mellitus. Individual data were available for 2,655 patients. The incidence of MACE at one year was incrementally higher in patients with risk scores of 1 or 2/3. MACE rates were lower in patients with a risk score 0 or 1 who were treated with DES (p=0.0073 and p=0.008). No difference in death or reinfarction was seen between DES and BMS in any group. There was a significant reduction in TLR with DES in all three groups.Conclusions: A score comprising vessel size, lesion length, and diabetes did not identify patients at low risk with equivalent or better results from BMS use. The results suggest that the practice of only selective use of DES in primary PCI should be discouraged. KEYWORDS• drug-eluting stents • primary angioplasty • STEMI

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“…Biolimus-eluting stents have showed better clinical outcomes than BMSs in patients with ST-elevation myocardial infarction [54]. In addition, they have reported to have significantly lower rates of very late stent thrombosis compared to sirolimus-eluting durable polymer stents [55,56], and non-inferior clinical outcomes to Synergy (everolimus-eluting), Nobori (biolimus-eluting), Ultimaster (sirolimus-eluting), and Orsiro (sirolimus-eluting) stents [57][58][59][60][61][62][63].…”

Section: Partially-bioresorbable Stentsmentioning

confidence: 99%

The Development of Coronary Artery Stents: From Bare-Metal to Bio-Resorbable Types

Chen

Wang

et al. 2016

Metals

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Abstract:Coronary artery disease is the leading cause of death worldwide. Conventional balloon angioplasty is associated with high rates of complications such as coronary dissection and vessel recoil. The deployment of bare-metal stents (BMSs) can overcome these problems and achieve a better patency rate than simple balloon angioplasty. It has been shown that the stent design including structure platform, size, length, and strut thickness has a major influence on the clinical results. Even though angioplasty with BMS implantation is widely used in coronary interventions, the restenosis rate due to neointimal hyperplasia remains high. Therefore, drug-eluting stents (DESs) coated with anti-proliferative agents and polymers have been developed to reduce the restenosis rate and improve the clinical outcomes. Although the repeat revascularization rate of DESs is lower than that of BMSs, the long-term stent thrombosis rate is higher than for BMSs. Therefore, new and emerging generations of stents, in which, for example, thinner struts and bioresorbable polymers are used, are available for clinical use. However, there are only a limited number of clinical trials, in which these newer stents have been compared with BMSs and first-and second-generation DESs. The purpose of this review was to provide up-to-date information on the evolution of coronary artery stents from BMSs to DESs to bioresorbable stents (BRSs).Keywords: coronary artery disease; stent; bioresorbable; drug; polymer; strut The Evolution of Coronary Stent DevelopmentCoronary artery disease (CAD) is a major cause of mortality and morbidity. One of the treatment options for CAD is a percutaneous coronary intervention. Balloon angioplasty alone, which involves pushing the plaque to the walls of the artery, can achieve a larger luminal diameter in the acute phase. However, arterial recoil, dissection, and late neointimal hyperplasia can result in vessel restenosis. Therefore, bare metal stents (BMSs) made from metallic materials were developed to overcome the dissection and the restenosis complications caused by recoil. Although the restenosis rate can be reduced by stenting, the in-stent restenosis (ISR) rate is still high at around 20%-30% [1,2]. ISR is mostly caused by neointimal hyperplasia.A reduction in restenosis was first achieved with the evolution of the stent platform, including thinner stent struts and new metal compounds. Furthermore, new drug delivery systems and polymer coatings have been developed to achieve better clinical outcomes. The first generation of drug-eluting stents (DESs) with a sirolimus or paclitaxel coating showed better clinical outcomes with lower rates of cardiac death, myocardial infarction, and target vessel revascularization than BMSs [3,4]. However, increased rates of stent thrombosis were reported with first-generation

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Comparison of biolimus eluted from an erodible stent coating with bare metal stents in acute ST-elevation myocardial infarction (COMFORTABLE AMI trial): rationale and design

Cited by 27 publications

References 29 publications

Biolimus-Eluting Stents With Biodegradable Polymer Versus Bare-Metal Stents in Acute Myocardial Infarction

Biolimus-Eluting Stents With Biodegradable Polymer Versus Bare-Metal Stents in Acute Myocardial Infarction

Selective use of contemporary drug-eluting stents in primary angioplasty for ST-elevation myocardial infarction: pooled analysis of COMFORTABLE AMI and EXAMINATION

The Development of Coronary Artery Stents: From Bare-Metal to Bio-Resorbable Types

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