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

OBJECTIVE: The objective of this study was to assess the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug-eluting stent (PF-SES) in an unselected patient population with a focus on acute coronary syndrome (ACS). Furthermore, stable coronary artery disease (CAD) with short (≤6 months) versus long (>6 months) dual antiplatelet therapy (DAPT) were also studied. METHODS: Patients who received PF-SES were investigated in an unselected large-scale international, single-armed, multicenter, 'all comers' observational study. The primary endpoint was the 9-month target lesion revascularisation (TLR) rate, whereas secondary endpoints included the 9-month major adverse cardiac events (MACE) and procedural success rates. A priori defined subgroups such as patients with ACS, diabetes, lesion subsets and procedural characteristics relative to DAPT were investigated. RESULTS: A total of 2877 patients of whom 1084 had ACS were treated with PF-SES (1.31±0.75 stents per patient). At 9 months, the accumulated overall TLR rate was 2.3% (58/2513). There was no significant difference between ACS and stable CAD (2.6% vs 2.1%, p=0.389). However, the overall MACE rate was 4.3% (108/2513) with a higher rate in patients with ACS when compared with the stable CAD subgroup (6.1%, 58/947 vs 3.2%, 50/1566, p<0.001). CONCLUSIONS: PF-SES angioplasty is safe and effective in the daily clinical routine with low rates of TLR and MACE in an unselected patient population. Our data are in agreement with prior clinical findings that extended DAPT duration beyond 6 months do not improve clinical outcomes in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575). TRIAL REGISTRATION NUMBER: NCT02629575.

• Klíčová slova
• ACUTE CORONARY SYNDROME, CORONARY ARTERY DISEASE, CORONARY INTERVENTION (PCI),
• Publikační typ
• časopisecké články MeSH