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

AIMS: Data about long-term clinical outcomes of revascularization procedures, especially for autologous cell therapy (ACT), in diabetic patients with chronic limb-threatening ischaemia (CLTI) are lacking. The aim of our study was to compare the mortality and amputation rates in patients with diabetic foot ulcers (DFU) and CLTI treated by ACT with patients treated by repeated percutaneous transluminal angioplasty (re-PTA) and those treated conservatively. MATERIALS AND METHODS: One-hundred and thirty patients with DFU and CLTI (defined as transcutaneous oxygen pressure-TcPO2 <30 mmHg after unsuccessful standard revascularization) treated in our foot clinic over 9 years were enrolled in the study. Forty-five patients were treated by ACT, 43 patients underwent re-PTA, and 42 patients were treated conservatively and formed the control group. Overall survival, amputation-free survival (AFS) and major amputation rate were assessed over a 7-year follow-up period. RESULTS: Baseline demographic characteristics and comorbidities were similar between groups. However, patients in ACT and control groups had significantly worse baseline angiograms in accordance with Graziani and GLASS (infrapopliteal region) classifications than the re-PTA group (both p < 0.001), but there were no differences in baseline values of TcPO2 between groups. AFS in the ACT and re-PTA groups were significantly longer compared to control (both p < 0.001). The rate of major amputation was significantly lower in both active groups (both p < 0.001). The re-PTA group showed significantly longer overall survival compared to the control group (p < 0.001), but there was no significant difference between ACT and control groups (p = 0.063) and ACT and re-PTA groups (p = 0.081) in this parameter. CONCLUSIONS: Our study showed significantly longer AFS and lower major amputation rates in patients treated by ACT and re-PTA in contrast to patients treated conservatively. Overall survival was significantly longer only in the re-PTA group. ACT was shown to be effective in long-term limb salvage in people with no-option CLTI.

• Klíčová slova
• cellular research, clinical trial, diabetes complications, effectiveness,
• MeSH
• amputace statistika a číselné údaje   MeSH
• angioplastika * MeSH
• autologní transplantace MeSH
• buněčná a tkáňová terapie * MeSH
• chronická kritická ischemie končetin * terapie   mortalita   MeSH
• diabetická noha * terapie   mortalita   komplikace   chirurgie   MeSH
• ischemie * terapie   mortalita   MeSH
• konzervativní terapie * MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• výsledek terapie MeSH
• záchrana končetiny statistika a číselné údaje   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• srovnávací studie MeSH

There is a lack of reliable in vivo models that replicate limb-threatening ischemia in humans. To fill this gap, we developed and validated two novel porcine ischemic models: ischemic limb and dorsal flap models, both with and without streptozotocin-induced hyperglycemia (N = 3 per group, 12 in total). Hind limb ischemia model was induced via different arterial ligations, with two ischemic and three control wounds per animal. In the flap model, four full-thickness flaps were created on the dorsum with silicone sheets to block reperfusion, and excisional wounds were made on the top. One non-ischemic wound served as control. Transcutaneous oxygen pressure (TcPO2), wound area, and microvascular density were measured, with TcPO2 and wound area assessed longitudinally. Data analysis focused on detailed visualization and Bayesian hierarchical modelling to account for the small sample size. Developed models exhibited stable ischemia and prolonged wound healing, with TcPO2 remaining under 30 mmHg over 28 days, and wound healing extending beyond two weeks. The flap model showed slower TcPO2 recovery and greater chronicity compared to the limb model, without reliable effect of hyperglycemia. Thus, the porcine flap model shows the highest potential as a relevant model for chronic limb-threatening ischemia.

• Klíčová slova
• Animal model, Bayesian modelling, Critical limb ischemia, Diabetes mellitus, In vivo model, Pig,
• MeSH
• časové faktory MeSH
• chirurgické laloky * MeSH
• chronická kritická ischemie končetin * patofyziologie   patologie   krev   MeSH
• chronická nemoc MeSH
• experimentální diabetes mellitus komplikace   krev   chemicky indukované   MeSH
• fyziologická neovaskularizace MeSH
• hojení ran MeSH
• hyperglykemie chemicky indukované   komplikace   krev   MeSH
• ischemie * patofyziologie   patologie   krev   etiologie   MeSH
• krevní glukóza metabolismus   MeSH
• mikrovaskulární denzita MeSH
• modely nemocí na zvířatech MeSH
• prasata MeSH
• regionální krevní průtok MeSH
• reprodukovatelnost výsledků MeSH
• Sus scrofa MeSH
• transkutánní měření krevních plynů MeSH
• zadní končetina krevní zásobení   MeSH
• zvířata MeSH
• Check Tag
• mužské pohlaví MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• validační studie MeSH
• Názvy látek
• krevní glukóza MeSH

Atherosclerosis leading to cardiovascular diseases remains a dominant medical problem. In the early stages of this disease, the interaction between circulating monocytes and the endothelium is crucial. Monocytes and macrophages express scavenger receptor A (SR-A), which mediates cell adhesion and subsequently uptake of oxidized low-density lipoproteins (LDL). High iron stores in monocytes or macrophages are known to predispose individuals to atherosclerosis, however the reasons remain poorly understood. We hypothesized that a combination of iron and LDL may induce proatherogenic changes in circulating monocytes. Here, we treated a human monocytic cell line THP-1 with isolated LDL and/or iron. A limited uptake of native LDL, but not iron or oxidized LDL, markedly induced expression of SR-A in these cells. Both SR-AI and SR-AII isoforms were upregulated. The increased SR-A was also seen at the protein level, and LDL treatment increased cellular adhesion. The induction of SR-A by LDL was inhibited by the lysosomotropic thiol WR-1065 and by the chain-breaking lipophilic antioxidant butylated hydroxytoluene (BHT). The fluorescent probe BODIPY C11 exhibited increased lipid peroxidation inside lysosomes after LDL administration. The induction of SR-A by LDL was blocked by two silencing RNAs directed against the nuclear coactivator receptor NCOA4, the cargo receptor necessary for the autophagy of ferritin. These results may point to a new pathogenetic mechanism of early-stage atherosclerosis, in which high iron stores in circulating monocytes, through increased lysosomal lipid peroxidation, may lead to an upregulated expression of SR-A, which makes the cells more adhesive and hence more atherogenic.

• Klíčová slova
• atherosclerosis, ferritinophagy, lipid peroxidation, lysosome, redox‐active iron,
• MeSH
• ateroskleróza metabolismus   MeSH
• buněčná adheze MeSH
• lidé MeSH
• lipoproteiny LDL * metabolismus   MeSH
• lyzozomy * metabolismus   MeSH
• monocyty * metabolismus   MeSH
• oxidace-redukce MeSH
• scavengerové receptory - třída A * metabolismus   genetika   MeSH
• THP-1 buňky MeSH
• železo * metabolismus   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• lipoproteiny LDL * MeSH
• oxidized low density lipoprotein MeSH Prohlížeč
• scavengerové receptory - třída A * MeSH
• železo * MeSH

OBJECTIVES: INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018. BACKGROUND: Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes. METHODS: INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality. RESULTS: Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1 year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68]). CONCLUSION: This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.

• Klíčová slova
• Coronary angiography, Coronary artery disease, Critical limb ischemia, Fractional flow reserve,
• MeSH
• ischemie * terapie   diagnóza   MeSH
• konzervativní terapie * metody   MeSH
• koronární angiografie metody   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nemoci koronárních tepen * komplikace   MeSH
• onemocnění periferních arterií * terapie   komplikace   diagnóza   MeSH
• prospektivní studie 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
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH

BACKGROUNDS: Autologous cell therapy (ACT) could be a treatment option for patients with chronic limb-threatening ischemia (CLTI) when standard vascular intervention is impossible. This study aimed to analyze risk factors affecting therapeutic success and identify patients with diabetes most responsive to ACT. METHODS: In this prospective study, 129 treatments were provided to 118 limbs in 107 no-option CLTI patients with diabetes. Bone marrow was obtained, and stem cells were processed and injected into the calf muscles of the affected limb. After 16 years, we analyzed the influence of baseline factors related to patients (diabetes parameters, comorbidities, medications), limb ischemia (TcPO2 value, Graziani and GLASS classifications), ulcer (descriptions according to Wagner, WIfI, SINBAD and Texas classifications), and infection (the value of CRP, the presence of the osteomyelitis, resistant bacteria and clinical signs of infections). Outcomes were limb salvage (LS) and amputation-free survival (AFS), which were assessed using Cox regression models. RESULTS: Major amputation was performed in 41 out of 118 limbs (31.8%). The use of immunosuppressive therapy (HR 2.48, CI 1.30-4.73), higher stages of GLASS FP (femoropopliteal) score (HR 1.58, CI 1.31-1.90) in the univariate model, and signs of clinical infection (HR 2.21, CI 1.01-4.839) in the multivariable model significantly impacted LS. Shorter AFS was associated with a higher GLASS FP score (HR 1.28, CI 1.13-1.46), dialysis (HR 2.05, CI 1.33 - 3.16 ), hypoalbuminemia (HR 0.93, CI 0.89-0.98), signs of clinical infection (HR 1.99, CI 1.26-3.15) in the univariable model, and immunosuppression (HR 2.31, CI 1.09-4.95) in the multivariable model. CONCLUSION: Decisions to manage patients with no-option CLTI should be based on involvement of the peripheral circulation, the presence of infection and co-morbidities. Those with minimal impairment of the FP segment, with the best possible nutritional status and without signs of infection would benefit the most. Furthermore, we should be careful with dialysis patients and those on immunosuppressive therapy.

• Klíčová slova
• Amputation, Amputation-free survival, Ischemia, Peripheral artery disease, Stem cell therapy,
• MeSH
• amputace MeSH
• autologní transplantace MeSH
• buněčná a tkáňová terapie * metody   MeSH
• chronická kritická ischemie končetin * terapie   MeSH
• ischemie * terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• prospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• záchrana končetiny * metody   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

IMPORTANCE: The effect of computed tomography (CT) vs invasive coronary angiography (ICA) on health status outcomes is unknown. OBJECTIVE: To evaluate CT and ICA first-test strategies on quality of life (QOL) and angina. DESIGN, SETTING, AND PARTICIPANTS: The Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease (DISCHARGE) randomized clinical trial, conducted between October 2015 and April 2019 in 26 European centers, followed up patients with stable chest pain and intermediate probability of coronary artery disease for a median 3.5 years. Data analysis was from December 2023 to July 2024. INTERVENTIONS: Random assignment to CT or ICA. MAIN OUTCOMES AND MEASURES: Patient-reported Euro QOL 5-dimensions descriptive system (EQ-5D-3L) visual analog scale (EQ-5D-3L-VAS) and 12-item Short Form Health Survey (SF-12) physical component score (SF-12-PCS) were primary prespecified QOL outcomes. Angina was the primary prespecified chest pain outcome. The EQ-5D-3L-VAS, summary index (EQ-5D-3L-SI), mental component summary (SF-12-MCS), and Hospital Anxiety and Depression Scale-anxiety subscale (HADS-A) and Hospital Anxiety and Depression Scale-anxiety subscale (HADS-D) were also evaluated. RESULTS: Among 3561 patients (mean [SD] age, 60.1 [10.1] years; 2002 female [56.2%]), 1735 (96.0%) in the CT group and 1671 (95.3%) in the ICA group completed at least 1 health status assessment during 3.5 years of follow-up. Health status outcomes were similar between groups, with significant improvements in all QOL outcomes (eg, mean EQ-5D-3L-VAS 3.5 year minus baseline score: CT = 4.0; 95% CI, 3.1-4.9; P < .001; ICA = 4.6; 95% CI, 3.6-5.6; P =.002), except HADS-D, which improved only in the CT group (mean EQ-5D-3L-VAS 3.5 year minus baseline score: CT = -0.2; 95% CI, -0.4 to 0; P = .04; ICA = -0.2; 95% CI, -0.4 to 0; P = .12). Female patients had worse baseline and follow-up QOL than male patients (eg, baseline EQ-5D-3L-VAS difference between men and women = 5.2; 95% CI, 4.0-6.3; P <.001 and at 3.5 years = 3.1; 95% CI, 1.9-4.4; P < .001) but showed greater improvements in EQ-5D-3L-VAS (-1.9; 95% CI, -3.4 to -0.5; P = .009), SF-12-PCS (-1.4; -2.1 to -0.7; P < .001), and HADS-A (0.3; 0-0.7; P = .04). Angina outcomes were comparable between groups at 3.5 years, with similar 1-year rates in the CT group but higher rates in female than male patients in the ICA group (10.2% vs 6.2%; P = .007). CONCLUSIONS AND RELEVANCE: Results of this secondary analysis of the DISCHARGE randomized clinical trial reveal that there was no significant difference in QOL or chest pain outcomes with CT vs ICA at 3.5 years. Female patients had worse health status than male patients at baseline and follow-up, and CT or ICA did not affect these differences. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02400229.

• MeSH
• bolesti na hrudi * diagnostické zobrazování   MeSH
• koronární angiografie * metody   MeSH
• kvalita života * MeSH
• lidé středního věku MeSH
• lidé MeSH
• nemoci koronárních tepen * diagnostické zobrazování   komplikace   MeSH
• počítačová rentgenová tomografie * metody   MeSH
• senioři MeSH
• zdravotní stav * 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

Autologous cell therapy (ACT) is a new therapeutic approach for diabetic patients with no-option chronic limb-threatening ischemia (NO-CLTI). The aim of our study was to quantify cell populations of cell therapy products (CTPs) obtained by three different isolation methods and to correlate their numbers with changes in transcutaneous oxygen pressure (TcPO2). CTPs were separated either from stimulated peripheral blood (PB) (n = 11) or harvested from bone marrow (BM) processed either by Harvest SmartPReP2 (n = 50) or sedimented with succinate gelatin (n = 29). The clinical effect was evaluated by the change in TcPO2 after 1, 3 and 6 months. TcPO2 increased significantly in all three methods at each time point in comparison with baseline values (p < .01) with no significant difference among them. There was no correlation between the change in TcPO2 and the size of injected cell populations. We only observed a weak correlation between the number of injected white blood cells (WBC) and an increase in TcPO2 at 1 and 3 months. Our study showed that all three isolation methods of ACT were similarly relatively efficient in the treatment of NO-CLTI. We observed no correlation of TcPO2 increase with the number of injected monocytes, lymphocytes or CD34+. We observed a weak correlation between TcPO2 increase and the number of injected WBCs.

• Klíčová slova
• autologous cell therapy, cell therapy product, chronic limb-threatening ischemia, transcutaneous oxygen pressure,
• MeSH
• autologní transplantace metody   MeSH
• buněčná a tkáňová terapie * metody   MeSH
• chronická kritická ischemie končetin * terapie   diagnóza   chirurgie   MeSH
• ischemie * terapie   etiologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• transkutánní měření krevních plynů metody   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
• srovnávací studie MeSH

Atherosclerosis is a chronic inflammatory disease of the blood vessels caused by elevated levels of lipoproteins. The hyperlipoproteinemia triggers a series of cellular changes, particularly the activation of the macrophages, which play a crucial role in the development and progression of atherosclerosis. The presence of free cholesterol (FC) in lipoproteins may contribute to macrophage stimulation. However, the mechanisms linking the accumulation of FC in macrophages to their pro-inflammatory activation remain poorly understood. Our research found a positive correlation between the number of pro-inflammatory macrophages (CD14 + CD16 + CD36high) in visceral adipose tissue and the levels of LDL-C and cholesterol remnant particles in 56 healthy people. In contrast, the proportion of anti-inflammatory, alternatively activated macrophages (CD14 + CD16-CD163+) correlated negatively with HDL-C. Additionally, our in vitro study demonstrated that macrophages accumulating FC promoted a pro-inflammatory response, activating the TNF-α and chemokine CCL3 genes. Furthermore, the accumulation of FC in macrophages alters the surface receptors on macrophages (CD206 and CD16) and increases cellular granularity. Notably, the CD36 surface receptor and the ACAT and CD36 genes did not show a response. These results suggest a link between excessive FC accumulation and systemic inflammation to underlie the development of atherosclerosis.

• Klíčová slova
• adipose tissue, atherosclerosis, cholesterol/cell and tissue, inflammation, lipoproteins,
• MeSH
• aktivace makrofágů MeSH
• antigeny CD36 metabolismus   MeSH
• ateroskleróza metabolismus   MeSH
• CD antigeny metabolismus   MeSH
• cholesterol * metabolismus   MeSH
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• makrofágy * metabolismus   imunologie   účinky léků   MeSH
• nitrobřišní tuk metabolismus   MeSH
• TNF-alfa metabolismus   genetika   MeSH
• zánět * metabolismus   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• antigeny CD36 MeSH
• CD antigeny MeSH
• cholesterol * MeSH
• TNF-alfa 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   MeSH
• biokompatibilní potahované materiály * aplikace a dávkování   MeSH
• časové faktory MeSH
• kardiovaskulární látky aplikace a dávkování   škodlivé účinky   MeSH
• koronární angioplastika * škodlivé účinky   přístrojové vybavení   MeSH
• koronární restenóza * diagnostické zobrazování   terapie   mortalita   etiologie   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 škodlivé účinky   MeSH
• stenty škodlivé účinky   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
• srovnávací studie MeSH
• Názvy látek
• biokompatibilní potahované materiály * MeSH
• kardiovaskulární látky MeSH
• paclitaxel * MeSH
• sirolimus * MeSH