BACKGROUND: Patients with severe aortic stenosis present frequently (∼50%) with concomitant obstructive coronary artery disease. Current guidelines recommend combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) as the preferred treatment. Transcatheter aortic valve implantation (TAVI) and fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) represent a valid treatment alternative. We aimed to test the non-inferiority of FFR-guided PCI plus TAVI versus SAVR plus CABG in patients with severe aortic stenosis and complex coronary artery disease. METHODS: This international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial was conducted at 18 tertiary medical centres across Europe. Patients (aged ≥70 years) with severe aortic stenosis and complex coronary artery disease, deemed feasible for percutaneous or surgical treatment according to the on-site Heart Team, were randomly assigned (1:1) to FFR-guided PCI plus TAVI or SAVR plus CABG according to a computer-generated sequence with random permuted blocks sizes stratified by site. The primary endpoint was a composite of all-cause mortality, myocardial infarction, disabling stroke, clinically driven target-vessel revascularisation, valve reintervention, and life-threatening or disabling bleeding at 1 year post-treatment. The trial was powered for non-inferiority (with a margin of 15%) and if met, for superiority. The primary and safety analyses were done per an intention-to-treat principle. This trial is registered with ClinicalTrials.gov (NCT03424941) and is closed. FINDINGS: Between May 31, 2018, and June 30, 2023, 172 patients were enrolled, of whom 91 were assigned to the FFR-guided PCI plus TAVI group and 81 to the SAVR plus CABG group. The mean age of patients was 76·5 years (SD 3·9). 118 (69%) of 172 patients were male and 54 (31%) patients were female. FFR-guided PCI plus TAVI resulted in favourable outcomes for the primary endpoint (four [4%] of 91 patients) versus SAVR plus CABG (17 [23%] of 77 patients; risk difference -18·5 [90% CI -27·8 to -9·7]), which was below the 15% prespecified non-inferiority margin (pnon-inferiority<0·001). FFR-guided PCI plus TAVI was superior to SAVR plus CABG (hazard ratio 0·17 [95% CI 0·06-0·51]; psuperiority<0·001), which was driven mainly by all-cause mortality (none [0%] of 91 patients vs seven (10%) of 77 patients; p=0·0025) and life-threatening bleeding (two [2%] vs nine [12%]; p=0·010). INTERPRETATION: The TCW trial is the first trial to compare percutaneous treatment versus surgical treatment in patients with severe aortic stenosis and complex coronary artery disease, showing favourable primary endpoint and mortality outcomes with percutaneous treatment. FUNDING: Isala Heart Centre and Medtronic.

• MeSH
• aortální stenóza * chirurgie   komplikace   MeSH
• chirurgická náhrada chlopně metody   MeSH
• frakční průtoková rezerva myokardu * MeSH
• koronární angioplastika * metody   MeSH
• koronární bypass * metody   MeSH
• lidé MeSH
• nemoci koronárních tepen * chirurgie   komplikace   terapie   MeSH
• prospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• transkatetrální implantace aortální chlopně * metody   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• hodnocení ekvivalence MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• srovnávací studie MeSH

BACKGROUND: Chronic thromboembolic pulmonary hypertension results from mechanical obstruction of major pulmonary artery lumina with fibrotic tissue. Main treatment has been pulmonary endarterectomy, a complex surgical procedure removing vascular obstruction. However, at least 40% of patients are not candidates for pulmonary endarterectomy because of technical inoperability, comorbidities, or limited access to surgery. Balloon pulmonary angioplasty (BPA) has emerged as an interventional treatment for these patients. OBJECTIVES: The International BPA Registry (NCT03245268) was designed to investigate BPA practice across 18 established centers in the United States, Europe, and Japan. METHODS: A total of 500 patients were prospectively and consecutively enrolled between March 2018 and March 2020, with follow-up until March 2022. Of these, 484 patients were included in the analysis set. RESULTS: Regional differences were seen in patient characteristics (fewer patients with prior pulmonary endarterectomy and more elderly women in Japan) and procedural details (less medical pretreatment, more jugular access, more segments and more occlusive lesions treated per session and patient, less conscious sedation, less contrast and less radiation, shorter intervals between BPA sessions in Japan). Female sex, procedure in Europe/United States, pulmonary hypertension medications at any time, and higher baseline pulmonary vascular resistance (PVR), calculated as transpulmonary pressure gradient divided by cardiac output, emerged as independent predictors of complications during BPA. After a median of 5 (Q1-Q3: 3-6) BPA sessions per patient within a median time of 4.9 months (Q1-Q3: 1.7-11.0 months), a 15-mm Hg (38%) decrease in mPAP, a 332 dynes/s/cm-5 (57%) decrease in PVR, and a 3.2% increase in arterial saturation (medians; P < 0.001) were observed, and there were significant improvements in functional class, 6-minute walk distance, serum levels of N-terminal probrain natriuretic peptide, and Borg dyspnea index. BPA complications occurred in 11.3% of sessions and 33.9% of patients and were mostly hemoptyses. No patient died within 30 days of BPA. CONCLUSIONS: Our data are in line with previous reports on changes of clinical and hemodynamic parameters and complication rates of BPA. Centers with more experience providing BPAs were more likely to achieve a higher percentage decrease in PVR.

• Klíčová slova
• balloon pulmonary angioplasty, balloon pulmonary angioplasty outcomes, balloon pulmonary angioplasty-related complication, chronic thromboembolic pulmonary hypertension,
• MeSH
• arteria pulmonalis chirurgie   MeSH
• balónková angioplastika * metody   MeSH
• chronická nemoc MeSH
• lidé středního věku MeSH
• lidé MeSH
• plicní embolie * komplikace   chirurgie   MeSH
• plicní hypertenze * etiologie   chirurgie   terapie   patofyziologie   MeSH
• prospektivní studie MeSH
• registrace * MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• Geografické názvy
• Evropa epidemiologie   MeSH
• Japonsko epidemiologie   MeSH
• Spojené státy americké epidemiologie   MeSH

INTRODUCTION: Acute ischemic stroke (AIS) is the second leading cause of death and one of the leading causes of long-term disability globally. Endovascular thrombectomy (EVT) has revolutionized treatment for large vessel occlusion (LVO), providing 20% increase in post-stroke functional independence compared to intravenous thrombolysis (IVT) alone. Despite its proven efficacy, EVT is underutilized. While it is suitable for at least 15-20% of AIS patients, its mean adoption ranges from less than 1% to 7% in different areas. AREAS COVERED: This review highlights key findings from pivotal randomized controlled trials and real-world data, focusing on patient selection criteria, advancements in thrombectomy devices, and procedural innovations. A comprehensive literature search was performed using PubMed, Scopus, EMBASE and the Cochrane Library for relevant randomized controlled trials and observational studies. EXPERT OPINION: Disparity in access to EVT requires strategic investments in healthcare systems and international multidisciplinary collaboration. Enhancing geographic coverage with thrombectomy-capable centers and optimizing prehospital triage systems are essential. Bridging the gap between treatment capability and real-world implementation is critical to improving global AIS outcomes.

• Klíčová slova
• ASPECTS, acute ischemic stroke, endovascular thrombectomy, expanded therapeutic window, large infarction, large vessel occlusion, posterior circulation stroke, thrombectomy techniques,
• MeSH
• endovaskulární výkony * metody   MeSH
• ischemická cévní mozková příhoda * chirurgie   MeSH
• lidé MeSH
• randomizované kontrolované studie jako téma MeSH
• trombektomie * metody   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

INTRODUCTION: It has been shown that general intensive care nurses are able to perform an examination of the deep venous system of the lower extremities for the diagnosis of proximal deep vein thrombosis (DVT) using a compression ultrasound test with a high degree of reliability. (Skulec et al. in Eur J Intern Med 76:130-131, 2020) Another challenge for the use of vascular point-of-care ultrasound in intensive care is the diagnosis of central venous catheter-related thrombosis. It is a common problem that is often underdiagnosed. Due to the simplicity of the examination and the possible link with nursing care of inserted central venous catheters, this may be another potential diagnostic competency for critical care nurses. METHODOLOGY: Before the start of the study, each nurse participating in the study completed a two-hour training in duplex ultrasonography and examined 5 patients under supervision. Then patients in the intensive care unit (ICU) included in the study, underwent a duplex ultrasound performed by a nurse. Within 24 h, the examination was repeated by the ICU doctor. In the case of catheter insertion into the internal jugular vein (VJI) or the subclavian vein (VSC), the jugular vein, subclavian vein, and axillary vein (VA) were examined bilaterally. When the catheter was inserted into the femoral vein (VF), the patients were subjected to a duplex ultrasound of the femoral vein and the popliteal vein (VP) of both lower limbs. The examination results of each patient were blinded until both tests were performed. Calculations were used to evaluate the reliability of the test. RESULT: A total of 160 patients aged 62.9 ± 12.3 years were included. In our sample, the prevalence of CRT was found to be 41%. The overall sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of examinations performed by general intensive care nurses were 90.8%, 97.1%, 91.8%, 96.8%, and 95.5%, respectively. CONCLUSION: The results of our study suggest that general ICU nurses are able to perform inpatient CRT duplex ultrasound with excellent specificity but only moderate sensitivity after a short, predefined training.

• Klíčová slova
• Catheter thrombosis (CRT), Duplex ultrasonography (DUS), General nurse,
• MeSH
• dospělí MeSH
• duplexní dopplerovská ultrasonografie * metody   MeSH
• jednotky intenzivní péče MeSH
• katetrizace centrálních vén * škodlivé účinky   MeSH
• klinické kompetence MeSH
• lidé středního věku MeSH
• lidé MeSH
• ošetřovatelská péče o pacienty v kritickém stavu * MeSH
• reprodukovatelnost výsledků MeSH
• senioři MeSH
• vena subclavia diagnostické zobrazování   MeSH
• venae jugulares diagnostické zobrazování   MeSH
• žilní trombóza * diagnostické zobrazování   etiologie   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

Monotherapy with a potent P2Y12 receptor antagonist after 1 month of dual antiplatelet therapy (DAPT) may reduce bleeding in the absence of increased ischaemic events compared to 12-month DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). PCI guidance with optical coherence tomography (OCT) may enhance stent expansion. COMPARE STEMI ONE is an international, multicentre, open-label, randomised controlled trial. In 1,656 ST-segment elevation myocardial infarction (STEMI) patients, prasugrel monotherapy after 1 month of DAPT, as compared to standard 12-month prasugrel-based DAPT, will be tested for non-inferiority for the primary composite endpoint of net adverse clinical events - defined as all-cause death, myocardial infarction, stroke, or Bleeding Academic Research Consortium Type 3 or 5 bleeding events - at 11 months after randomisation. Furthermore, an ancillary substudy will test the superiority of OCT-guided versus angiography-guided staged complete revascularisation in achieving a larger minimal stent area (MSA) in non-culprit lesions during staged procedures. COMPARE STEMI ONE is the first randomised controlled trial assessing an abbreviated 1-month DAPT regimen followed by prasugrel monotherapy in the context of STEMI. The trial will also study the value of OCT-guided PCI in terms of the MSA of non-culprit lesions and may elucidate potential synergies between intravascular imaging-guided PCI and abbreviated DAPT regimens. (ClinicalTrials.gov: NCT05491200).

• MeSH
• antagonisté purinergních receptorů P2Y * terapeutické užití   MeSH
• infarkt myokardu s elevacemi ST úseků * terapie   farmakoterapie   diagnostické zobrazování   chirurgie   MeSH
• inhibitory agregace trombocytů * terapeutické užití   MeSH
• koronární angiografie metody   MeSH
• koronární angioplastika * metody   MeSH
• lidé MeSH
• optická koherentní tomografie * metody   MeSH
• prasugrel hydrochlorid * terapeutické užití   MeSH
• randomizované kontrolované studie jako téma MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• protokol klinické studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• antagonisté purinergních receptorů P2Y * MeSH
• inhibitory agregace trombocytů * MeSH
• prasugrel hydrochlorid * MeSH

BACKGROUND: A multicentre European randomized control trial - European Uncomplicated Type B Aortic Repair (EU-TBAR) is being developed to compare pre-emptive thoracic endovascular aortic repair (TEVAR) with custom-made devices versus conventional optimal medical therapy. The pretrial set-up is confluent on different pillars, including evaluation of 1) European activity, trends, and governance; 2) outcome reporting; and 3) cost evaluation. This article aimed to demonstrate the observational cross-sectional survey results from participating centers and highlight the risk assessment, activity, practices, and governance of uncomplicated type B aortic dissection (uTBAD). METHODS: This observational cross-sectional European survey used a questionnaire that examined the understanding, risk assessment, local governance oversight, and clinical activity of uTBAD. The data were collected and managed using Research Electronic Data Capture (REDCap). RESULTS: Out of 43 surveyed surgeons, 37 (86%) responded within a month from 14 European countries. Most reported low annual uTBAD encounters, with autumn being the most common season for cases. Pre-emptive TEVAR was recommended by 43.2% of participants, who favored subacute intervention timing. The Gore TAG was the most used TEVAR device, and custom devices were available for 73% of respondents. Risk factors for uTBAD were ranked, with 'Rapid Aortic Enlargement' deemed most critical. A majority of centers had protocols and multidisciplinary teams, with most having readily available radiology services. Only 45.9% had transfer services to specialized centers. CONCLUSIONS: uTBAD remains a misnomer of a dynamic, ongoing disease process requiring early diagnosis and intervention. Pre-emptive TEVAR in high-risk uTBAD is becoming more common, with encouraging results prompting an expansion of indication criteria to a broader uTBAD population managed conservatively. Nevertheless, further evidence is needed through large randomized controlled trials, mainly European collaboratives, to reach a definitive conclusion on the optimum surgical management of uTBAD.

• MeSH
• aneurysma hrudní aorty * chirurgie   diagnostické zobrazování   ekonomika   MeSH
• časové faktory MeSH
• cévní protézy trendy   MeSH
• cévy - implantace protéz * škodlivé účinky   přístrojové vybavení   trendy   ekonomika   MeSH
• chirurgové * trendy   MeSH
• disekce aorty * chirurgie   diagnostické zobrazování   ekonomika   MeSH
• endovaskulární výkony * škodlivé účinky   přístrojové vybavení   trendy   ekonomika   MeSH
• hodnocení rizik MeSH
• lékařská praxe - způsoby provádění * trendy   MeSH
• lidé MeSH
• protézy - design MeSH
• průřezové studie MeSH
• průzkumy zdravotní péče MeSH
• rizikové faktory MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH
• Geografické názvy
• Evropa MeSH

BACKGROUND AND AIM: Diabetes has been shown in last decades to be associated with a significantly higher mortality among patients with ST-segment elevation myocardial infarction (STEMI) treated with primary PCI (PPCI). Therefore, the aim of current study was to evaluate the impact of diabetes on times delays, reperfusion and mortality in a contemporary STEMI population undergoing PPCI, including treatment during the COVID pandemic. METHODS AND RESULTS: The ISACS-STEMI COVID-19 is a large-scale retrospective multicenter registry involving PPCI centers from Europe, Latin America, South-East Asia and North-Africa, including patients treated from 1st of March until June 30, 2019 and 2020. Primary study endpoint of this analysis was in-hospital mortality. Secondary endpoints were postprocedural TIMI 0-2 flow and 30-day mortality. Our population is represented by 16083 STEMI patients. A total of 3812 (23,7 %) patients suffered from diabetes. They were older, more often males as compared to non-diabetes. Diabetic patients were less often active smokers and had less often a positive family history of CAD, but they were more often affected by hypertension and hypercholesterolemia, with higher prevalence of previous STEMI and previous CABG. Diabetic patients had longer ischemia time, had more often anterior MI, cardiogenic shock, rescue PCI and multivessel disease. They had less often out-of-hospital cardiac arrest and in-stent thrombosis, received more often a mechanical support, received less often a coronary stent and DES. Diabetes was associated with a significantly impaired postprocedural TIMI flow (TIMI 0-2: 9.8 % vs 7.2 %, adjusted OR [95 % CI] = 1.17 [1.02-1.38], p = 0.024) and higher mortality (in-hospital: 9.1 % vs 4.8 %, Adjusted OR [95 % CI] = 1.70 [1.43-2.02], p < 0.001; 30-day mortality: 10.8 % vs 6 %, Adjusted HR [95 % CI] = 1.46 [1.26-1.68], p < 0.001) as compared to non-diabetes, particularly during the pandemic. CONCLUSIONS: Our study showed that in a contemporary STEMI population undergoing PPCI, diabetes is significantly associated with impaired epicardial reperfusion that translates into higher in-hospital and 30-day mortality, particularly during the pandemic.

• Klíčová slova
• COVID, Diabetes mellitus, PCI, ST-Segment myocardial infarction,
• MeSH
• čas zasáhnout při rozvinutí nemoci MeSH
• časové faktory MeSH
• COVID-19 * mortalita   epidemiologie   MeSH
• diabetes mellitus * mortalita   diagnóza   epidemiologie   MeSH
• hodnocení rizik MeSH
• infarkt myokardu s elevacemi ST úseků * mortalita   terapie   diagnóza   MeSH
• koronární angioplastika * mortalita   škodlivé účinky   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mortalita v nemocnicích MeSH
• registrace MeSH
• retrospektivní studie MeSH
• rizikové faktory MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH

BACKGROUND: Current therapy for in-stent restenosis (ISR) is based on drug-eluting stents (DES) or drug-eluting balloon catheters. This prospective randomized study compared the efficacy of a novel sirolimus-eluting balloon (SEB) catheter to that of a paclitaxel-eluting balloon (PEB) catheter for the treatment of bare-metal stent (BMS-ISR) or DES-ISR. METHODS: A total of 145 patients with 158 BMS or DES-ISR lesions were randomly assigned to the treatment with either SEB or PEB. The in-segment late lumen loss at 12 months, the 12-month incidence of binary ISR, and major adverse cardiac events (cardiac death, nonfatal acute myocardial infarction, or target lesion revascularization) were compared between groups. RESULTS: The noninferiority of SEB compared with PEB in the treatment of BMS/DES-ISR with respect to late lumen loss was not demonstrated (Δlate lumen loss, -0.024 mm [95% CI, -0.277 to 0.229]; for a noninferiority margin of 0.20 mm), except in the post hoc subanalysis for the BMS-ISR group (-0.203 mm [95% CI, -0.584 to 0.178]). No significant differences in the incidence of repeated binary ISR (31.6% versus 30.4%, P=0.906) or 12-month major adverse cardiac events (31% for both; P>0.999) between the SEB and PEB groups were observed. CONCLUSIONS: The noninferiority of SEB relative to PEB in the treatment of BMS/DES-ISR with respect to late lumen loss was not confirmed. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03667313.

• Klíčová slova
• angioplasty, balloon, coronary, coronary restenosis, paclitaxel, sirolimus,
• MeSH
• balónková koronární angioplastika * škodlivé účinky   přístrojové vybavení   mortalita   MeSH
• biokompatibilní potahované materiály * MeSH
• časové faktory MeSH
• kardiovaskulární látky * aplikace a dávkování   škodlivé účinky   MeSH
• koronární angioplastika * škodlivé účinky   přístrojové vybavení   mortalita   MeSH
• koronární restenóza * diagnostické zobrazování   terapie   mortalita   etiologie   MeSH
• kovy MeSH
• lidé středního věku MeSH
• lidé MeSH
• nemoci koronárních tepen * diagnostické zobrazování   terapie   mortalita   MeSH
• paclitaxel * aplikace a dávkování   škodlivé účinky   MeSH
• prospektivní studie MeSH
• protézy - design MeSH
• rizikové faktory MeSH
• senioři MeSH
• sirolimus * aplikace a dávkování   škodlivé účinky   MeSH
• srdeční katétry * MeSH
• stenty uvolňující léky MeSH
• stenty * MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• hodnocení ekvivalence MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• biokompatibilní potahované materiály * MeSH
• kardiovaskulární látky * MeSH
• kovy MeSH
• paclitaxel * MeSH
• sirolimus * MeSH

BACKGROUND: Recent randomized trials demonstrated the beneficial effect of endovascular therapy in patients with low Alberta Stroke Program Early CT Score. Despite large follow-up infarct volumes, a significantly increased rate of good functional outcomes was observed, challenging the role of infarct volume as a predictive imaging marker. This analysis evaluates the extent to which the effects of endovascular thrombectomy on functional outcomes are explained by (1) follow-up infarct volume and (2) early neurological status in patients with stroke with low Alberta Stroke Program Early CT Score. METHODS: TENSION (Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window) was a randomized trial conducted from February 2018 to January 2023 across 41 stroke centers. Two hundred fifty-three patients with ischemic stroke due to anterior circulation large vessel occlusion and Alberta Stroke Program Early CT Score of 3 to 5 were randomized to endovascular thrombectomy plus medical treatment or medical treatment alone. All patients with the availability of relevant data points were included in this secondary as-treated analysis. The primary outcome was the 90-day modified Rankin Scale score. Confounder-adjusted mediation analysis was performed to quantify the proportion of the treatment effect on a 90-day modified Rankin Scale score explained by (1) 24-hour follow-up infarct volume and (2) 24-hour National Institutes of Health Stroke Scale scores. RESULTS: One hundred eighty-eight patients were included; thereof, 87 (46%) were female patients. Median age was 72 (interquartile range, 63-79) years. The endovascular thrombectomy cohort had a 20.5 (95% CI, 8.3-33.7) percentage points higher probability of achieving independent ambulation (modified Rankin Scale, 0-3) and a 24.2 (95% CI, 13.4-35.8) percentage points lower mortality at 90 days compared with medical treatment alone. The reduction in 24-hour follow-up infarct volume explained 30% of the treatment effect on functional outcomes, while the 24-hour National Institutes of Health Stroke Scale score explained 61%. CONCLUSIONS: In patients with low Alberta Stroke Program Early CT Score, infarct volume demonstrated limited explanatory power for functional outcomes compared with the early neurological status, which may more effectively reflect factors such as the involvement of specific brain regions, disruption of structural networks, and selective neuronal loss.

• Klíčová slova
• brain, infarction, ischemia, stroke, thrombectomy,
• MeSH
• endovaskulární výkony metody   MeSH
• ischemická cévní mozková příhoda * chirurgie   diagnostické zobrazování   MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• trombektomie * metody   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
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH

BACKGROUND: Long-term outcomes following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) might be changing because of improved techniques and better medical therapy. This final prespecified analysis of the Fractional Flow Reserve (FFR) versus Angiography for Multivessel Evaluation (FAME) 3 trial aimed to reassess their comparative effectiveness at 5 years. METHODS: FAME 3 was a multicentre, randomised trial comparing FFR-guided PCI using current-generation zotarolimus-eluting stents versus CABG in patients with three-vessel coronary artery disease not involving the left main coronary artery. 48 hospitals in Europe, USA and Canada, Australia, and Asia participated in the trial. Patients (aged ≥21 years with no cardiogenic shock, no recent ST segment elevation myocardial infarction, no severe left ventricular dysfunction, and no previous CABG) were randomly assigned to either PCI or CABG using a web-based system. At 1 year, FFR-guided PCI did not meet the prespecified threshold for non-inferiority for the outcome of death, stroke, myocardial infarction, or repeat revascularisation versus CABG. The primary endpoint for this intention-to-treat analysis was the 5-year incidence of the prespecified composite outcome of death, stroke, or myocardial infarction. The trial was registered at ClinicalTrials.gov, NCT02100722, and is completed; this is the final report. FINDINGS: Between Aug 25, 2014 and Nov 28, 2019, 757 of 1500 participants were assigned to PCI and 743 to CABG. 5-year follow-up was achieved in 724 (96%) patients assigned to PCI and 696 (94%) assigned to CABG. At 5 years, there was no significant difference in the composite of death, stroke, or myocardial infarction between the two groups, with 119 (16%) events in the PCI group and 101 (14%) in the CABG group (hazard ratio 1·16 [95% CI 0·89-1·52]; p=0·27). There were no differences in the rates of death (53 [7%] vs 51 [7%]; 0·99 [0·67-1·46]) or stroke (14 [2%] vs 21 [3%], 0·65 [0·33-1·28]), but myocardial infarction was higher in the PCI group than in the CABG group (60 [8%] vs 38 [5%], 1·57 [1·04-2·36]), as was repeat revascularisation (112 [16%] vs 55 [8%], 2·02 [1·46-2·79]). INTERPRETATION: At the 5-year follow-up, there was no significant difference in a composite outcome of death, stroke, or myocardial infarction after FFR-guided PCI versus CABG, although myocardial infarction and repeat revascularisation were higher with PCI. These results provide contemporary evidence to allow improved shared decision making between physicians and patients. FUNDING: Medtronic and Abbott Vascular.

• MeSH
• frakční průtoková rezerva myokardu * MeSH
• infarkt myokardu epidemiologie   MeSH
• koronární angiografie MeSH
• koronární angioplastika * metody   MeSH
• koronární bypass * metody   MeSH
• lidé středního věku MeSH
• lidé MeSH
• následné studie MeSH
• nemoci koronárních tepen * chirurgie   mortalita   MeSH
• senioři MeSH
• sirolimus analogy a deriváty   aplikace a dávkování   MeSH
• stenty uvolňující léky MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• sirolimus MeSH
• zotarolimus MeSH Prohlížeč