BACKGROUND: The COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization. OBJECTIVE: We analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score. METHODS: MASCOT was an international registry of all-comers undergoing attempted COMBO stent implantation. We stratified patients as low bleeding-risk (LBR) for PARIS score ≤ 3 and intermediate-to-high (IHBR) for score > 3 based on baseline age, body mass index, anemia, current smoking, chronic kidney disease and need for triple therapy. Primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a non-target vessel or clinically-driven target lesion revascularization (TLR). Bleeding was adjudicated using the Bleeding Academic Research Consortium (BARC) definition. Dual antiplatelet therapy (DAPT) cessation was independently adjudicated. RESULTS: The study included 56% (n = 1270) LBR and 44% (n = 1009) IHBR patients. Incidence of 1-year TLF was higher in IHBR patients (4.1% vs. 2.6%, p = 0.047) driven by cardiac death (1.7% vs. 0.7%, p = 0.029) with similar rates of MI (1.8% vs. 1.1%, p = 0.17), TLR (1.5% vs. 1.6%, p = 0.89) and definite/ probable stent thrombosis (1.2% vs. 0.6%, p = 0.16). Incidence of 1-year major BARC 3 or 5 bleeding was significantly higher in IHBR patients (2.3% vs. 0.9%, p = 0.0094), as was the incidence of DAPT cessation (29.3% vs. 22.8%, p < 0.01), driven by physician-guided discontinuation. CONCLUSIONS: Patients with intermediate-to-high PARIS bleeding risk in the MASCOT registry experienced greater incidence of 1-year TLF, major bleeding and DAPT cessation than LBR patients, without significant differences in stent thrombosis.

• Klíčová slova
• COMBO stent, Dual therapy stent, Endothelial progenitor cell capture, NCT02183454, PARIS bleeding risk score,
• Publikační typ
• časopisecké články MeSH

OBJECTIVES: The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population. METHODS: Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel. RESULTS: For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis. CONCLUSION: Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.

• Klíčová slova
• Clopidogrel, Dual antiplatelet therapy, Polymer-free, Sirolimus-eluting stent, Ticagrelor,
• MeSH
• časové faktory MeSH
• dodržování směrnic MeSH
• duální protidestičková léčba * škodlivé účinky   mortalita   MeSH
• hodnocení rizik MeSH
• inhibitory agregace trombocytů aplikace a dávkování   škodlivé účinky   MeSH
• kardiovaskulární látky aplikace a dávkování   škodlivé účinky   MeSH
• koronární angioplastika škodlivé účinky   přístrojové vybavení   mortalita   MeSH
• koronární trombóza etiologie   prevence a kontrola   MeSH
• krvácení chemicky indukované   MeSH
• lékařská praxe - způsoby provádění MeSH
• lidé středního věku MeSH
• lidé MeSH
• multicentrické studie jako téma MeSH
• nemoci koronárních tepen diagnostické zobrazování   mortalita   terapie   MeSH
• pozorovací studie jako téma MeSH
• protézy - design MeSH
• rizikové faktory MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• sirolimus aplikace a dávkování   škodlivé účinky   MeSH
• směrnice pro lékařskou praxi jako téma MeSH
• stenty uvolňující léky * MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• inhibitory agregace trombocytů MeSH
• kardiovaskulární látky MeSH
• sirolimus MeSH

Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population.Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible.In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%).PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.

• MeSH
• akutní koronární syndrom diagnóza   mortalita   chirurgie   MeSH
• antibakteriální látky terapeutické užití   MeSH
• cévy - implantace protéz metody   MeSH
• diabetes mellitus epidemiologie   MeSH
• infarkt myokardu bez ST elevací komplikace   epidemiologie   MeSH
• infarkt myokardu s elevacemi ST úseků komplikace   epidemiologie   MeSH
• koronární angioplastika přístrojové vybavení   MeSH
• lékařská praxe - způsoby provádění normy   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nemoci koronárních tepen diagnóza   mortalita   chirurgie   MeSH
• okluze cévního štěpu epidemiologie   MeSH
• polymery MeSH
• prospektivní studie MeSH
• protézy - design MeSH
• rizikové faktory MeSH
• senioři MeSH
• sirolimus terapeutické užití   MeSH
• stenty uvolňující léky škodlivé účinky   trendy   MeSH
• vstřebatelné implantáty škodlivé účinky   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH
• pozorovací studie MeSH
• Názvy látek
• antibakteriální látky MeSH
• polymery MeSH
• sirolimus MeSH

BACKGROUND: The objective of this study was to assess regional and ethnic differences in an unselected patient population treated with polymer-free sirolimus-eluting stents (PF-SES) in Asia and Europe. METHODS: Two all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined for data analysis to assure sufficient statistical power. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 9-12 months. RESULTS: Of the total population of 7243 patients, 44.0% (3186) were recruited in the Mediterranean region and 32.0% (2317) in central Europe. The most prominent Asian region was South Korea (17.6%, 1274) followed by Malaysia (5.7%, 413). Major cardiovascular risk factors varied significantly across regions. The overall rates for accumulated TLR and MACE were low with 2.2% (140/6374) and 4.4% (279/6374), respectively. In ACS patients, there were no differences in terms of MACE, TLR, MI and accumulated mortality between the investigated regions. Moreover, dual antiplatelet therapy (DAPT) regimens were substantially longer in Asian countries even in patients with stable coronary artery disease as compared to those in Europe. CONCLUSIONS: PF-SES angioplasty is associated with low clinical event rates in all regions. Further reductions in clinical event rates seem to be associated with longer DAPT regimens.

• MeSH
• etnicita statistika a číselné údaje   MeSH
• imunosupresiva terapeutické užití   MeSH
• incidence MeSH
• infarkt myokardu epidemiologie   prevence a kontrola   MeSH
• koronární angioplastika metody   MeSH
• lidé středního věku MeSH
• lidé MeSH
• následné studie MeSH
• nemoci koronárních tepen terapie   MeSH
• polymery MeSH
• prognóza MeSH
• prospektivní studie MeSH
• senioři MeSH
• sirolimus terapeutické užití   MeSH
• stenty uvolňující léky * MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Evropa epidemiologie   MeSH
• Korejská republika epidemiologie   MeSH
• Malajsie epidemiologie   MeSH
• Středomoří epidemiologie   MeSH
• Názvy látek
• imunosupresiva MeSH
• polymery MeSH
• sirolimus MeSH

Patients with atrial fibrillation (AF) are at an approximately 0.5% to 3% increased risk of thromboembolism during and immediately after catheter ablation. Treatment guidelines recommend periprocedural oral anticoagulation plus unfractionated heparin during ablation. Rivaroxaban and dabigatran are the only non-vitamin K oral anticoagulants for which there are randomized controlled trials assessing uninterrupted anticoagulation in patients undergoing catheter ablation of AF. Edoxaban, a direct factor Xa inhibitor, is noninferior vs warfarin for the prevention of stroke or systemic embolism with less major bleeding in patients with nonvalvular AF. The ELIMINATE-AF (Evaluation of Edoxaban Compared With VKA in Subjects Undergoing Catheter Ablation of Nonvalvular Atrial Fibrillation) trial is a multinational, multicenter, prospective, randomized, open-label, parallel-group, blinded-endpoint evaluation (PROBE) study to assess the safety and efficacy of once-daily edoxaban 60 mg (30 mg in patients indicated for a dose reduction) vs vitamin K antagonists (VKA) in patients with nonvalvular AF undergoing catheter ablation (http://www.ClinicalTrials.gov: NCT02942576). A total of 560 patients are planned for randomization to edoxaban or VKA (2:1 ratio) to obtain 450 patients fully compliant with the protocol. Patients will complete 21 to 28 days of anticoagulation prior to the ablation and a 90-day post-ablation period. The primary efficacy endpoint is the composite of all-cause death, stroke, and major bleeding. The primary safety endpoint is major bleeding. A magnetic resonance imaging substudy will assess the incidence of silent cerebral lesions post-ablation. ELIMINATE-AF will define the efficacy and safety of edoxaban for uninterrupted oral anticoagulation during catheter ablation of AF.

• Klíčová slova
• Atrial Fibrillation, Catheter Ablation, Direct Oral Anticoagulant, Direct Oral Anticoagulant Edoxaban, Non-Vitamin K Oral Anticoagulants, Periprocedural,
• MeSH
• antikoagulancia aplikace a dávkování   škodlivé účinky   MeSH
• časové faktory MeSH
• cévní mozková příhoda diagnostické zobrazování   etiologie   prevence a kontrola   MeSH
• fibrilace síní komplikace   mortalita   patofyziologie   chirurgie   MeSH
• inhibitory faktoru Xa aplikace a dávkování   škodlivé účinky   MeSH
• ischemie mozku diagnostické zobrazování   etiologie   prevence a kontrola   MeSH
• katetrizační ablace * škodlivé účinky   mortalita   MeSH
• klinické protokoly MeSH
• krvácení chemicky indukované   MeSH
• lidé MeSH
• magnetická rezonanční tomografie MeSH
• prospektivní studie MeSH
• pyridiny aplikace a dávkování   škodlivé účinky   MeSH
• rizikové faktory MeSH
• rozvrh dávkování léků MeSH
• thiazoly aplikace a dávkování   škodlivé účinky   MeSH
• vitamin K antagonisté a inhibitory   MeSH
• výsledek terapie MeSH
• výzkumný projekt MeSH
• warfarin aplikace a dávkování   škodlivé účinky   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• antikoagulancia MeSH
• edoxaban MeSH Prohlížeč
• inhibitory faktoru Xa MeSH
• pyridiny MeSH
• thiazoly MeSH
• vitamin K MeSH
• warfarin MeSH

Survivors after cardiac arrest (CA) due to AMI undergo PCI and then receive dual antiplatelet therapy. Mild therapeutic hypothermia (MTH) is recommended for unconscious patients after CA to improve neurological outcomes. MTH can attenuate the effectiveness of P2Y12 inhibitors by reducing gastrointestinal absorption and metabolic activation. The combined effect of these conditions on the efficacy of P2Y12 inhibitors is unknown. We compared the antiplatelet efficacies of new P2Y12 inhibitors in AMI patients after CA treated with MTH. Forty patients after CA for AMI treated with MTH and received one P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) were enrolled in a prospective observational single-center study. Platelet inhibition was measured by VASP (PRI) on days 1, 2, and 3 after drug administration. In-hospital clinical data and 1-year survival data were obtained. The proportion of patients with ineffective platelet inhibition (PRI > 50 %, high on-treatment platelet reactivity) for clopidogrel, prasugrel, and ticagrelor was 77 vs. 19 vs. 1 % on day 1; 77 vs. 17 vs. 0 % on day 2; and 85 vs. 6 vs. 0 % on day 3 (P < 0.001). The platelet inhibition was significantly worse in clopidogrel group than in prasugrel or ticagrelor group. Prasugrel and ticagrelor are very effective for platelet inhibition in patients treated with MTH after CA due to AMI, but clopidogrel is not. Using prasugrel or ticagrelor seems to be a more suitable option in this high-risk group of acute patients.

• Klíčová slova
• Cardiac arrest, Clopidogrel, Hypothermia, Myocardial infarction, Prasugrel, Ticagrelor,
• MeSH
• adenosin aplikace a dávkování   analogy a deriváty   MeSH
• infarkt myokardu komplikace   terapie   MeSH
• klopidogrel MeSH
• lidé středního věku MeSH
• lidé MeSH
• prasugrel hydrochlorid aplikace a dávkování   MeSH
• prospektivní studie MeSH
• purinergní receptory P2Y - agonisté aplikace a dávkování   MeSH
• senioři MeSH
• srdeční zástava etiologie   terapie   MeSH
• terapeutická hypotermie metody   MeSH
• ticagrelor MeSH
• tiklopidin aplikace a dávkování   analogy a deriváty   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH
• pozorovací studie MeSH
• práce podpořená grantem MeSH
• srovnávací studie MeSH
• Názvy látek
• adenosin MeSH
• klopidogrel MeSH
• prasugrel hydrochlorid MeSH
• purinergní receptory P2Y - agonisté MeSH
• ticagrelor MeSH
• tiklopidin MeSH