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
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
