Effect of Biolimus-Eluting Stents With Biodegradable Polymer vs Bare-Metal Stents on Cardiovascular Events Among Patients With Acute Myocardial Infarction

Räber, Lorenz; Kelbæk, Henning; Ostojić, Miodrag; Baumbach, Andreas; Heg, Dik; Tüller, David; Birgelen, Clemens von; Roffi, Marco; Moschovitis, Aris; Khattab, Ahmed A.; Wenaweser, Peter; Bonvini, Robert F.; Pedrazzini, Giovanni; Kornowski, Ran; Weber, Klaus; Trelle, Sven; Lüscher, Thomas F.; Taniwaki, Masanori; Matter, Christian M.; Meier, Bernhard; Jüni, Peter; Windecker, Stephan; Investigators, for the COMFORTABLE AMI Trial

doi:10.1001/jama.2012.10065

Cited by 285 publications

(163 citation statements)

References 34 publications

Supporting

Mentioning

148

Contrasting

Unclassified

Order By: Relevance

“…Such optimizations have resulted in better clinical outcomes with new‐generation DESs compared with first‐generation DESs9, 10 and, in turn, have led to extended application of DES usage in various clinical settings including patients presenting with acute myocardial infarction 11, 12…”

Section: Introductionmentioning

confidence: 99%

Comparison of Vascular Responses Following New‐Generation Biodegradable and Durable Polymer‐Based Drug‐Eluting Stent Implantation in an Atherosclerotic Rabbit Iliac Artery Model

Nakazawa

Torii

Ijichi

et al. 2016

JAHA

View full text Add to dashboard Cite

BackgroundIncomplete endothelialization is the primary substrate of late stent thrombosis; however, recent reports have revealed that abnormal vascular responses are also responsible for the occurrence of late stent failure. The aim of the current study was to assess vascular response following deployment of biodegradable polymer‐based Synergy (Boston Scientific) and Nobori (Terumo) drug‐eluting stents and the durable polymer‐based Resolute Integrity stent (Medtronic) in an atherosclerotic rabbit iliac artery model.Methods and ResultsA total of 24 rabbits were fed an atherogenic diet, and then a balloon injury was used to induce atheroma formation. Synergy, Nobori, and Resolute Integrity stents were randomly implanted in iliac arteries. Animals were euthanized at 28 days for scanning electron microscopic evaluation and at 90 days for histological analysis. The percentage of uncovered strut area at 28 days was lowest with Synergy, followed by Resolute Integrity, and was significantly higher with Nobori stents (Synergy 1.1±2.2%, Resolute Integrity 2.0±3.9%, Nobori 4.6±3.0%; P<0.001). At 90 days, inflammation score was lowest for Synergy (0.27±0.45), followed by Nobori (0.62±0.59), and was highest for Resolute Integrity (0.89±0.46, P<0.001). Foamy macrophage infiltration within neointima (ie, neoatherosclerosis) was significantly less with Synergy (0.62±0.82) compared with Nobori (0.85±0.74) and Resolute Integrity (1.39±1.32; P=0.034).ConclusionsThe biodegradable polymer‐coated thin‐strut Synergy drug‐eluting stent showed the fastest stent strut neointimal coverage and the lowest incidence of neoatherosclerosis in the current animal model.

show abstract

Section: Introductionmentioning

confidence: 99%

Comparison of Vascular Responses Following New‐Generation Biodegradable and Durable Polymer‐Based Drug‐Eluting Stent Implantation in an Atherosclerotic Rabbit Iliac Artery Model

Nakazawa

Torii

Ijichi

et al. 2016

JAHA

View full text Add to dashboard Cite

show abstract

“…The COMFORTABLE AMI trial was a multicenter, randomized controlled trial (RCT) comparing a biodegradable polymer–based biolimus‐eluting stent with a bare‐metal stent for primary PCI. Main exclusion criteria were mechanical complications of acute MI, use of vitamin‐K antagonists, planned surgery (unless uninterrupted DAPT during the perisurgical period was judged feasible), and history of bleeding diathesis 15. The studies complied with the Declaration of Helsinki and were approved by local institutional ethics committees.…”

Section: Methodsmentioning

confidence: 99%

Incidence, Predictors, and Clinical Impact of Early Prasugrel Cessation in Patients With ST‐Elevation Myocardial Infarction

Koskinas

Zanchin

Klingenberg

et al. 2018

JAHA

Self Cite

View full text Add to dashboard Cite

BackgroundEarly withdrawal of recommended antiplatelet treatment with clopidogrel adversely affects prognosis following percutaneous coronary interventions. Optimal antiplatelet treatment is essential following ST‐segment elevation myocardial infarction (STEMI) given the increased risk of thrombotic complications. This study assessed the frequency, predictors, and clinical impact of early prasugrel cessation in patients with STEMI undergoing primary percutaneous coronary interventions.Methods and ResultsWe pooled patients with STEMI discharged on prasugrel in 2 prospective registries (Bern PCI Registry [NCT02241291] and SPUM‐ACS (Inflammation and Acute Coronary Syndromes) [NCT01000701]) and 1 STEMI trial (COMFORTABLE‐AMI (Comparison of Biomatrix Versus Gazelle in ST‐Elevation Myocardial Infarction) [NCT00962416]). Prasugrel treatment status at 1 year was categorized as no cessation; crossover to another P2Y12‐inhibitor; physician‐recommended discontinuation; and disruption because of bleeding, side effects, or patient noncompliance. In time‐dependent analyses, we assessed the impact of prasugrel cessation on the primary end point, a composite of cardiac death, myocardial infarction, and stroke. Of all 1830 included patients (17% women, mean age 59 years), 83% were treated with new‐generation drug‐eluting stents. At 1 year, any prasugrel cessation had occurred in 13.8% of patients including crossover (7.2%), discontinuation (3.7%), and disruption (2.9%). Independent predictors of any prasugrel cessation included female sex, age, and history of cerebrovascular event. The primary end point occurred in 5.2% of patients and was more frequent following disruption (hazard ratio 3.04, 95% confidence interval,1.34–6.91; P=0.008), without significant impact of crossover or discontinuation. Consistent findings were observed for all‐cause death, myocardial infarction, and stent thrombosis following prasugrel disruption.ConclusionsIn this contemporary study of patients with STEMI, early prasugrel cessation was not uncommon and primarily involved change to another P2Y12‐inhibitor. Disruption was the only type of early prasugrel cessation associated with statistically significant excess in ischemic risk within 1 year following primary percutaneous coronary interventions.

show abstract

“…The details and primary results of the COMFORTABLE AMI and EXAMINATION trials have been described previously 15,16 . In summary, 1,161 STEMI patients undergoing primary PCI at 11 sites in Europe and Israel between September 2009 and January 2011 were randomly assigned to treatment with biolimus-eluting stents with biodegradable polymer coating (BioMatrix™; Biosensors Europe SA, Morges, Switzerland), or bare metal stents (Gazelle™; Biosensors Europe SA) in the COMFORTABLE AMI trial.…”

Section: Patient Populationmentioning

confidence: 99%

“…However, these findings were based on studies without systematic use of P2Y12 receptor inhibitors, thrombus aspiration and stent implantation, which have significantly improved clinical outcomes [9][10][11][12][13]14 . In addition, the results of two large-scale randomised clinical trials have recently suggested that the use of new-generation drug-eluting stents (DES) among STEMI patients undergoing primary PCI is associated with a lower risk of repeat revascularisation, reinfarction and stent thrombosis (ST) compared with bare metal stents through to one year 15,16 . The purpose of the present study was therefore to identify predictors of all-cause death or any reinfarction and definite ST, target lesion revascularisation (TLR) among patients with STEMI undergoing primary PCI in a pooled analysis of two contemporary primary PCI trials (EXAMINATION and COMFORTABLE AMI) 15,16 .…”

Section: Introductionmentioning

confidence: 99%

Predictors of adverse events among patients undergoing primary percutaneous coronary intervention: insights from a pooled analysis of the COMFORTABLE AMI and EXAMINATION trials

Taniwaki¹,

Räber²,

Brugaletta³

et al. 2015

EuroIntervention

Self Cite

View full text Add to dashboard Cite

Aims: The aim of this study was to identify predictors of adverse events among patients with ST-elevation myocardial infarction (STEMI) undergoing contemporary primary percutaneous coronary intervention (PCI).Methods and results: Individual data of 2,655 patients from two primary PCI trials (EXAMINATION, N=1,504; COMFORTABLE AMI, N=1,161) with identical endpoint definitions and event adjudication were pooled. Predictors of all-cause death or any reinfarction and definite stent thrombosis (ST) and target lesion revascularisation (TLR) outcomes at one year were identified by multivariable Cox regression analysis. Killip class III or IV was the strongest predictor of all-cause death or any reinfarction (OR 5.11, 95% CI: 2.48-10.52), definite ST (OR 7.74, 95% CI: 2.87-20.93), and TLR (OR 2.88, 95% CI: 1.17-7.06). Impaired left ventricular ejection fraction (OR 4.77, 95% CI: 2.10-10.82), final TIMI flow 0-2 (OR 1.93, 95% CI: 1.05-3.54), arterial hypertension (OR 1.69, 95% CI: 1.11-2.59), age (OR 1.68, 95% CI: 1.41-2.01), and peak CK (OR 1.25, 95% CI: 1.02-1.54) were independent predictors of all-cause death or any reinfarction. Allocation to treatment with DES was an independent predictor of a lower risk of definite ST (OR 0.35,) and any TLR (OR 0.34, 95% CI: 0.21-0.54).Conclusions: Killip class remains the strongest predictor of all-cause death or any reinfarction among STEMI patients undergoing primary PCI. DES use independently predicts a lower risk of TLR and definite ST compared with BMS. The COMFORTABLE AMI trial is registered at:

show abstract

Effect of Biolimus-Eluting Stents With Biodegradable Polymer vs Bare-Metal Stents on Cardiovascular Events Among Patients With Acute Myocardial Infarction

Abstract: clinicaltrials.gov Identifier: NCT00962416.

Cited by 285 publications

References 34 publications

Comparison of Vascular Responses Following New‐Generation Biodegradable and Durable Polymer‐Based Drug‐Eluting Stent Implantation in an Atherosclerotic Rabbit Iliac Artery Model

Comparison of Vascular Responses Following New‐Generation Biodegradable and Durable Polymer‐Based Drug‐Eluting Stent Implantation in an Atherosclerotic Rabbit Iliac Artery Model

Incidence, Predictors, and Clinical Impact of Early Prasugrel Cessation in Patients With ST‐Elevation Myocardial Infarction

Predictors of adverse events among patients undergoing primary percutaneous coronary intervention: insights from a pooled analysis of the COMFORTABLE AMI and EXAMINATION trials

Contact Info

Product

Resources

About