Safety and efficacy profile of bioresorbable‐polylactide‐polymer‐biolimus‐A9‐eluting stents versus durable‐polymer‐everolimus‐ and zotarolimus‐eluting stents in patients with acute coronary syndrome

Jaguszewski, Miłosz; Dörig, Manuela; Frangieh, Antonio H.; Ghadri, Jelena-Rima; Cammann, Victoria L.; Diekmann, Johanna; Napp, L. Christian; D’Ascenzo, Fabrizio; Ishizaki, Yoichi; Obeid, Slayman; Maier, Willibald; Lüscher, Thomas F.; Templin, Christian

doi:10.1002/ccd.26617

Cited by 5 publications

(3 citation statements)

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“…1,2) However, Japanese individuals exhibit weaker responses to clopidogrel, a classic P2Y12 receptor inhibitor, owing to an increased incidence of CYP2C19 loss-of-function polymorphisms.…”

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confidence: 99%

Dual Antiplatelet Therapy Guided by CYP2C19 Polymorphisms after Implantation of Second-Generation Drug-Eluting Stents for Management of Acute Coronary Syndrome

et al. 2018

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SummaryPrasugrel, a novel P2Y12 receptor inhibitor, is administered to patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI), but it can increase the risk of bleeding. The Japanese exhibit weaker responses to clopidogrel than other races because of CYP2C19 polymorphisms; thus, it is unclear whether these patients should continue dual antiplatelet therapy (DAPT) using prasugrel or switch to clopidogrel in the chronic phase. Here we evaluated the clinical outcomes of DAPT guided by CYP2C19 polymorphisms after implantation of second-generation drug-eluting stents (DESs) for ACS management. Patients with ACS receiving PCI via DES from November 2011 to March 2015 were divided into two groups: conventional DAPT with clopidogrel (n = 41) and gene-guided DAPT (n = 24). In the gene-guided DAPT group, all patients with ACS were given DAPT using prasugrel as soon as possible; extensive and intermediate metabolizers receiving PCI for the first time were switched to clopidogrel at least 2 weeks after discharge, and intermediate metabolizers with repeated ACS and poor metabolizers continued on DAPT using prasugrel. Notably, geneguided DAPT significantly reduced major adverse cardiovascular/cerebrovascular events (MACCEs; 22.0% versus 4.2%, hazard ratio [HR]: 0.15, 95% confidence interval [CI]: 0.01-0.81; P = 0.0247). Hemorrhagic complications were observed in 3.1% of patients receiving conventional DAPT and absent in the gene-guided group. Moreover, multivariate analysis showed that gene-guided DAPT significantly decreased MACCE incidence (HR: 0.15, 95% CI: 0.01-0.81; P = 0.033). Collectively, these data suggest that CYP2C19 polymorphism analysis may improve treatment decisions in patients with ACS receiving DES-PCI.(Int Heart J 2018; 59: 21-26) Key words: Prasugrel, Clopidogrel, Percutaneous coronary intervention (PCI), Major adverse cardiovascular/ cerebrovascular event (MACCE) P ercutaneous coronary intervention (PCI) is the first-line therapy for acute coronary syndrome (ACS), and drug-eluting stents (DESs) have been widely employed with excellent results in patients with stable coronary artery disease (CAD) or ACS.1,2) However, Japanese individuals exhibit weaker responses to clopidogrel, a classic P2Y12 receptor inhibitor, owing to an increased incidence of CYP2C19 loss-of-function polymorphisms.3) Recent reports have established the efficacy of prasugrel, a novel P2Y12 receptor inhibitor exhibiting strong inhibition of platelet aggregation, in patients with ACS after PCI independent of CYP2C19 function.4) However, prasugrel may increase the risk of bleeding, 5) and it is unknown whether patients with ACS should continue dual antiplatelet therapy (DAPT) using prasugrel or be switched to DAPT using clopidogrel during the chronic phase.In this study, we evaluated 1-year clinical outcomes of patients receiving CYP2C19 polymorphism-guided DAPT after implantation of second-generation DESs for ACS management. Methods Study population:We evaluated consecutive patients with ACS who received ...

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“…1,2) However, Japanese individuals exhibit weaker responses to clopidogrel, a classic P2Y12 receptor inhibitor, owing to an increased incidence of CYP2C19 loss-of-function polymorphisms.…”

mentioning

confidence: 99%

Dual Antiplatelet Therapy Guided by CYP2C19 Polymorphisms after Implantation of Second-Generation Drug-Eluting Stents for Management of Acute Coronary Syndrome

et al. 2018

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“…In a study consisting of 1899 patients, the rates were reported for TLR (3.0%), MI (2.4%), all-cause death (7.4%), and definite or probable stent thrombosis (1.6%) [ 13 ]. On the contrary, these very favorable results appeared to be worse than those found with thin-strut-durable-polymer-everolimus- and zotarolimus-eluting stents at 5 years in a study consisting of 1547 patients with very low TLR rate (2.0%), MI (5.3%), all-cause death (4.8%), and definite and probable stent thrombosis (2.1%) [ 14 ].…”

Section: Discussionmentioning

confidence: 99%

In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease

Landolff,

Quillot,

Picard

et al. 2023

Journal of Interventional Cardiology

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Objectives. The aim of this postmarket clinical study was to assess the safety and efficacy of the latest generation polymer-free sirolimus-eluting stents (PF-SES) in an all-comers population comparing outcomes in stable coronary artery disease (CAD) versus acute coronary syndrome (ACS) in France. Background. The efficacy and safety of the first-generation PF-SES have already been demonstrated by randomized controlled trials and “all-comers” observational studies. Methods. For this all-comers observational, prospective, multicenter study, 1456 patients were recruited in 22 French centers. The primary endpoint was target lesion revascularization (TLR) rate at 12 months and secondary endpoints included major adverse cardiac events (MACE) and bleeding. Results. 895 patients had stable CAD and 561 had ACS. At 12 months, 2% of patients had a TLR, with similar rates between stable CAD and ACS (1.9% vs 2.2%, p = 0.7). The overall MACE rate was 5.2% with an expected higher rate in patients with ACS as compared to those with stable CAD (7.3% vs 3.9%, p = 0.007). The overall bleeding event rate was 4.5%, with similar rates in stable CAD as compared to ACS patients (3.8% vs 5.6%, p = 0.3). Dual antiplatelet therapy (DAPT) interruptions prior to the recommended duration occurred in 41.7% of patients with no increase in MACE rates as compared to patients who did not prematurely interrupt DAPT (3.9% vs 6.1%, p = 0.073). Conclusions. The latest generation PF-SES is associated with low clinical event rates in these all-comers patients. There was a high rate of prematurely terminated DAPT, without any effect on MACE at 12 months. This trial is registered with NCT03809715.

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“…Advances in interventional techniques, and the improvement in DES design by decreasing strut thickness, using more biocompatible polymers, or reducing drug load have improved the outcomes of patients with acute coronary syndromes treated by PCI . Even if the current permanent DES are associated with a high clinical performance even in STEMI patients , all they have shortcomings related to the permanent caging of the coronary wall at the original “culprit” site.…”

Section: Discussionmentioning

confidence: 99%

A prospective evaluation of a standardized strategy for the use of a polymeric everolimus‐eluting bioresorbable scaffold in ST‐segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY‐IT study

Ielasi

Varricchio²,

Campo

et al. 2016

Cathet Cardio Intervent

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Safety and efficacy profile of bioresorbable‐polylactide‐polymer‐biolimus‐A9‐eluting stents versus durable‐polymer‐everolimus‐ and zotarolimus‐eluting stents in patients with acute coronary syndrome

Abstract: Long-term safety and efficacy of bioresorbable-polymer-BES and durable-polymer-EES/ZES appear comparable in patients with ACS. © 2016 Wiley Periodicals, Inc.

Cited by 5 publications

References 35 publications

Dual Antiplatelet Therapy Guided by <i>CYP2C19</i> Polymorphisms after Implantation of Second-Generation Drug-Eluting Stents for Management of Acute Coronary Syndrome

Dual Antiplatelet Therapy Guided by <i>CYP2C19</i> Polymorphisms after Implantation of Second-Generation Drug-Eluting Stents for Management of Acute Coronary Syndrome

In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease

A prospective evaluation of a standardized strategy for the use of a polymeric everolimus‐eluting bioresorbable scaffold in ST‐segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY‐IT study

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