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
• srovnávací studie 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: 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
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• sirolimus MeSH
• zotarolimus MeSH Prohlížeč

BACKGROUND: There is a lack of evidence to guide treatment of patients with a concomitant indication for transcatheter aortic valve implantation (TAVI) and complex, high-risk percutaneous coronary intervention (PCI). AIMS: We aimed to assess different strategies of PCI timing in this high-risk TAVI cohort. METHODS: The ASCoP registry retrospectively included patients with a clinical indication for both TAVI and PCI with at least 1 criterion of complex or high-risk PCI. The primary endpoint was a composite of all-cause death and unplanned rehospitalisation for cardiovascular causes. The secondary endpoint was a composite of all-cause death, stroke, acute myocardial infarction, major bleeding, major vascular complication and unplanned revascularisation. Multivariable analysis was used to adjust for possible confounders. RESULTS: A total of 519 patients were included: 363 (69.9%) underwent staged procedures and 156 (30.1%) concomitant TAVI and PCI. After 441 (interquartile range 182-824) days, the primary endpoint occurred in 151 (36.5%) cases, without any significant difference between the 2 groups (p=0.98), while the secondary endpoint occurred more frequently in the concomitant group (n=36 [25.8%] vs n=57 [17.4%]; p=0.014). CONCLUSIONS: In patients undergoing TAVI and complex/high-risk PCI, a concomitant strategy is associated with a higher rate of adverse events and increased procedural risk. (ClinicalTrials.gov: NCT05750927).

• MeSH
• aortální stenóza * chirurgie   mortalita   MeSH
• koronární angioplastika * metody   škodlivé účinky   MeSH
• lidé MeSH
• registrace MeSH
• retrospektivní studie MeSH
• rizikové faktory MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• stupeň závažnosti nemoci MeSH
• transkatetrální implantace aortální chlopně * metody   škodlivé účinky   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
• klinické zkoušky MeSH

BACKGROUND AND AIMS: Myocardial infarction (MI) in multivessel disease (MVD) and chronic total occlusion (CTO) is associated with high mortality. However, all-cause mortality of matched cohort without a CTO is unclear. Our aim was to analyse clinical characteristics, presenting symptoms, and survival of patients with MI in MVD and the possible impact of CTO on 1-year mortality. METHODS: All MI patients with MVD (two or three vessel disease) hospitalized in our center from January 2020 to September 2022 (1309 patients) were selected. We conducted a propensity score matching (PSM) analysis based on age, gender, type of MI, and compared patients with CTO (CTO group, n = 90) and without CTO (Control group, n = 90). RESULTS: We observed no difference in presenting clinical symptoms and initial heart rhythm between the groups. 1-year follow-up shows all-cause mortality rate of 23.3 % (n = 21) in the CTO group (Mean survival [MS] = 292.1 days, 95 % CI = 263.8 to 320.4) and 18.9 % (n = 17) in the Control group (MS = 310.2 days, 95 % CI = 285.3 to 335.2), p = 0.44. PCI alone was performed in 64.4 % (n = 58) in both groups, CABG in 18.8 % (n = 17) and 24.4 % (n = 22) (CTO vs. Control group respectively). Combination of PCI and CABG occurred in 8.8 % (n = 8) in both groups. Conservative treatment was chosen for 7 CTO and 2 Control group patients. CONCLUSION: We observed no 1-year mortality difference in patients with MI, MVD and a CTO compared to a matched cohort of patients with MI, MVD without CTO. Excellent 1-year survival was observed in patients treated by CABG, irrespective of CTO presence.

• Klíčová slova
• Chronic total occlusion, Multivessel disease, Myocardial infarction, Percutaneous coronary intervention,
• MeSH
• chronická nemoc MeSH
• infarkt myokardu * mortalita   diagnóza   MeSH
• kohortové studie MeSH
• koronární angioplastika metody   MeSH
• koronární okluze * diagnóza   mortalita   chirurgie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• míra přežití trendy   MeSH
• následné studie MeSH
• nemoci koronárních tepen mortalita   diagnóza   chirurgie   MeSH
• retrospektivní studie MeSH
• senioři MeSH
• tendenční skóre MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

IMPORTANCE: The Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure (ARIES-HM3) study demonstrated that aspirin may be safely eliminated from the antithrombotic regimen after HeartMate 3 (HM3 [Abbott Cardiovascular]) left ventricular assist device (LVAD) implantation. This prespecified analysis explored whether conditions requiring aspirin (prior percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG], stroke, or peripheral vascular disease [PVD]) would influence outcomes differentially with aspirin avoidance. OBJECTIVE: To analyze aspirin avoidance on hemocompatibility-related adverse events (HRAEs) at 1 year after implant in patients with a history of CABG, PCI, stroke, or PVD. DESIGN, SETTING, AND PARTICIPANTS: This was an international, multicenter, prospective, double-blind, placebo-controlled, randomized clinical trial including patients implanted with a de novo HM3 LVAD across 51 centers. Data analysis was conducted from April to July 2024. INTERVENTIONS: Patients were randomized in a 1:1 ratio to receive aspirin (100 mg per day) or placebo, in addition to a vitamin K antagonist (VKA) targeted to an international normalized ratio of 2 to 3 in both groups. MAIN OUTCOMES AND MEASURES: Primary end point (assessed for noninferiority) was a composite of survival free of any nonsurgical (>14 days after implant) HRAEs including stroke, pump thrombosis, bleeding, and arterial peripheral thromboembolism at 12 months. Secondary end points included nonsurgical bleeding, stroke, and pump thrombosis events. RESULTS: Among 589 of 628 patients (mean [SD] age, 57.1 [13.7] years; 456 male [77.4%]) who contributed to the primary end point analysis, a history of PCI, CABG, stroke, or PVD was present in 41% (240 of 589 patients). There was no interaction between the presence of an atherosclerotic vascular condition and effect of aspirin compared with placebo (P for interaction= .23). The preset 10% noninferiority margin was not crossed for the studied subgroup of patients. Thrombotic events were rare, with no differences between aspirin and placebo in patients with and without vascular disease (P for interaction = .77). Aspirin treatment was associated with a higher rate of nonsurgical major bleeding events in the group with prior vascular condition history compared with those without aspirin (rate ratio for placebo compared with aspirin, 0.52; 95% CI, 0.35-0.79). CONCLUSIONS AND RELEVANCE: Results of this prespecified analysis of the ARIES-HM3 randomized clinical trial demonstrate that in patients with advanced heart failure who have classical indications for antiplatelet therapy use at the time of LVAD implantation, aspirin avoidance was safe and not associated with increased thrombosis risk. Importantly, elimination of aspirin was associated with no increased thrombosis but a reduction in nonsurgical bleeding events in patients with a history of PCI, CABG, stroke, or PVD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04069156.

• MeSH
• Aspirin * terapeutické užití   MeSH
• ateroskleróza MeSH
• cévní mozková příhoda prevence a kontrola   MeSH
• dvojitá slepá metoda MeSH
• fibrinolytika terapeutické užití   MeSH
• inhibitory agregace trombocytů terapeutické užití   MeSH
• koronární angioplastika metody   MeSH
• krvácení chemicky indukované   MeSH
• lidé středního věku MeSH
• lidé MeSH
• podpůrné srdeční systémy * MeSH
• prospektivní studie MeSH
• senioři MeSH
• srdeční selhání MeSH
• trombóza prevence a kontrola   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• komentáře MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• Aspirin * MeSH
• fibrinolytika MeSH
• inhibitory agregace trombocytů MeSH

BACKGROUND: PICC is routinely inserted with assistance of ultrasonography and/or ECG navigation (RI- routine insertion). Only in a minority of patients the insertion of a PICC is difficult and fluoroscopic visualization with introduction of special guidewire is necessary for the success of the procedure (DI-difficult insertion). The aim of the study was to evaluate whether DI can be predicted and associated with a risk of complications during follow-up. METHODS: The study included patients who had a PICC insertion in 2022. The number of patients with RI and DI was recorded and the significance of selected parameters during insertion and the frequency of complications during 1 month follow-up was compared. RESULTS: About 1404 patients had successful PICC insertion in 2022, RI in 1360 (96.8%) and DI in 44 patients (3.2%). There was no significant effect of age, gender, selected vein, its size, insertion site, and tunneling on the course of PICC insertion. However the number of punctures for needle insertion was higher in DI. The complication rate during 1 month follow-up in DI was 9 (20.4%) versus 101 patients (7.4%) in RI (p = 0.002). CONCLUSION: PICC insertion was successful in both RI and DI patients. Of the analyzed parameters, the number of needle punctures was associated with DI, and complications during the 1-month follow-up were more frequently noted in the DI group.

• Klíčová slova
• ECG navigation, PICC, complications, fluoroscopy, ultrasonography,
• MeSH
• časové faktory MeSH
• centrální žilní katétry MeSH
• dialýza ledvin * MeSH
• dospělí MeSH
• hodnocení rizik MeSH
• intervenční ultrasonografie MeSH
• katetrizace centrálních vén * škodlivé účinky   přístrojové vybavení   MeSH
• lidé středního věku MeSH
• lidé MeSH
• periferní katetrizace * škodlivé účinky   přístrojové vybavení   MeSH
• punkce MeSH
• retrospektivní studie MeSH
• rizikové faktory MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• výsledek terapie MeSH
• zaváděcí katétry MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

BACKGROUND: Mineralocorticoid receptor antagonists have been shown to reduce mortality in patients after myocardial infarction with congestive heart failure. Whether routine use of spironolactone is beneficial after myocardial infarction is uncertain. METHODS: In this multicenter trial with a 2-by-2 factorial design, we randomly assigned patients with myocardial infarction who had undergone percutaneous coronary intervention to receive either spironolactone or placebo and either colchicine or placebo. The results of the spironolactone trial are reported here. The two primary outcomes were a composite of death from cardiovascular causes or new or worsening heart failure, evaluated as the total number of events; and a composite of the first occurrence of myocardial infarction, stroke, new or worsening heart failure, or death from cardiovascular causes. Safety was also assessed. RESULTS: We enrolled 7062 patients at 104 centers in 14 countries; 3537 patients were assigned to receive spironolactone and 3525 to receive placebo. At the time of our analyses, the vital status was unknown for 45 patients (0.6%). For the first primary outcome, there were 183 events (1.7 per 100 patient-years) in the spironolactone group as compared with 220 events (2.1 per 100 patient-years) in the placebo group over a median follow-up period of 3 years (hazard ratio adjusted for competing risk of death from noncardiovascular causes, 0.91; 95% confidence interval [CI], 0.69 to 1.21; P = 0.51). With respect to the second primary outcome, an event occurred in 280 of 3537 patients (7.9%) in the spironolactone group and 294 of 3525 patients (8.3%) in the placebo group (hazard ratio adjusted for competing risk, 0.96; 95% CI, 0.81 to 1.13; P = 0.60). Serious adverse events were reported in 255 patients (7.2%) in the spironolactone group and 241 (6.8%) in the placebo group. CONCLUSIONS: Among patients with myocardial infarction, spironolactone did not reduce the incidence of death from cardiovascular causes or new or worsening heart failure or the incidence of a composite of death from cardiovascular causes, myocardial infarction, stroke, or new or worsening heart failure. (Funded by the Canadian Institutes of Health Research and others; CLEAR ClinicalTrials.gov number, NCT03048825.).

• MeSH
• antagonisté mineralokortikoidních receptorů * terapeutické užití   škodlivé účinky   MeSH
• cévní mozková příhoda epidemiologie   prevence a kontrola   MeSH
• dvojitá slepá metoda MeSH
• infarkt myokardu * farmakoterapie   mortalita   terapie   komplikace   MeSH
• Kaplanův-Meierův odhad MeSH
• kardiovaskulární nemoci mortalita   prevence a kontrola   MeSH
• kolchicin terapeutické užití   škodlivé účinky   MeSH
• koronární angioplastika MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• spironolakton * terapeutické užití   škodlivé účinky   MeSH
• srdeční selhání prevence a kontrola   etiologie   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
• randomizované kontrolované studie MeSH
• Názvy látek
• antagonisté mineralokortikoidních receptorů * MeSH
• kolchicin MeSH
• spironolakton * MeSH

Background Randomized clinical trials have demonstrated that endovascular thrombectomy reduces functional disability in patients with large ischemic stroke; arterial collateral status might be used to select these patients for endovascular thrombectomy. Purpose To investigate whether arterial collateral status modifies the treatment effect of endovascular thrombectomy in patients with large ischemic stroke. Materials and Methods The Efficacy and Safety of Thrombectomy in Stroke with Extended Lesion and Extended Time Window (TENSION) trial was a prospective, multicenter, randomized study investigating participants with acute large ischemic stroke due to anterior circulation large-vessel occlusion. Participants with an Alberta Stroke Program Early CT Score of 3-5 were enrolled at 41 participating centers between July 2018 and February 2023. Participants were randomly assigned to undergo either endovascular thrombectomy with best medical treatment or best medical treatment alone within 12 hours from stroke onset. Collateral status was graded on pretreatment single-phase CT angiography (CTA) images using the Tan score and dichotomized into poor (grade, 0-1) or good (grade, 2-3) based on the extent of collateral supply filling the affected middle cerebral artery territory. The primary outcome was the shift on the 90-day modified Rankin Scale (mRS). Results Of 253 randomized patients, 201 with pretreatment CTA were included (median age, 74 years; IQR, 66-80 years; 103 [51.2%] female patients; 103 [51.2%] patients underwent endovascular thrombectomy). Endovascular thrombectomy compared with best medical treatment (adjusted common odds ratio [OR], 3.69; 95% CI: 2.12, 6.54; P < .001) and good collaterals compared with poor collaterals (adjusted common OR, 2.88; 95% CI: 1.63, 5.11; P < .001) were independently associated with a shift in the 90-day mRS scores toward better functional outcomes. The treatment effect of endovascular thrombectomy over best medical treatment was not modified by collateral status (interaction, P = .88). The treatment effect of endovascular thrombectomy versus best medical treatment was found in patients with good collaterals (adjusted common OR, 3.93; 95% CI: 1.65, 9.69; P = .002) and poor collaterals (adjusted common OR, 3.92; 95% CI: 1.86, 8.52; P < .001). Conclusion In this secondary analysis of data from the TENSION trial, endovascular thrombectomy reduced 90-day functional disability compared with best medical treatment in patients with good and poor collaterals. These findings suggest that patients with large ischemic stroke manifesting within 12 hours after onset should undergo endovascular thrombectomy irrespective of single-phase CTA collateral status. ClinicalTrials.gov Identifier: NCT03094715 © RSNA, 2025 Supplemental material is available for this article. See also the editorial by Benomar and Raymond in this issue.

• MeSH
• CT angiografie metody   MeSH
• endovaskulární výkony * metody   MeSH
• ischemická cévní mozková příhoda * diagnostické zobrazování   chirurgie   terapie   MeSH
• kolaterální oběh * MeSH
• lidé středního věku MeSH
• lidé MeSH
• prospektivní studie 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