AIMS: To describe outcomes of patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) randomized trial who were treated with the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily during long-term open-label extension (LTOLE). METHODS AND RESULTS: Of the 27 395 patients enrolled in COMPASS, 12 964 (mean age at baseline 67.2 years) from 455 sites in 32 countries were enrolled in LTOLE and treated with the combination of rivaroxaban and aspirin for a median of 374 additional days (range 1-1191 days). During LTOLE, the incident events per 100 patient years were as follows: for the primary outcome [cardiovascular death, stroke, or myocardial infarction (MI)] 2.35 [95% confidence interval (CI) 2.11-2.61], mortality 1.87 (1.65-2.10), stroke 0.62 (0.50-0.76), and MI 1.02 (0.86-1.19), with CIs that overlapped those seen during the randomized treatment phase with the combination of rivaroxaban and aspirin. The incidence rates for major and minor bleeding were 1.01 (0.86-1.19) and 2.49 (2.24-2.75), compared with 1.67 (1.48-1.87) and 5.11 (95% CI 4.77-5.47), respectively, during the randomized treatment phase with the combination. CONCLUSION: In patients with chronic CAD and/or PAD, extended combination treatment for a median of 1 year and a maximum of 3 years was associated with incidence rates for efficacy and bleeding that were similar to or lower than those seen during the randomized treatment phase, without any new safety signals.
- Klíčová slova
- Aspirin, Coronary artery disease, Peripheral artery disease, Rivaroxaban,
- MeSH
- Aspirin MeSH
- cévní mozková příhoda * epidemiologie MeSH
- infarkt myokardu * epidemiologie MeSH
- kojenec MeSH
- kombinovaná farmakoterapie MeSH
- lidé MeSH
- onemocnění periferních arterií * diagnóza farmakoterapie epidemiologie MeSH
- rivaroxaban MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- Aspirin MeSH
- rivaroxaban MeSH
BACKGROUND: All diagnostic procedures of peripheral arterial disease (PAD) in diabetic foot (DF) are complicated due to diabetes mellitus and its late complications.The aim of our study is to enhance diagnosis of PAD using a novel transcutaneous oximetry (TcPO2) stimulation test. METHODS: The study comprised patients with mild-to-moderate PAD(WIfI-I 1 or 2) and baseline TcPO2 values of 30-50 mmHg.TcPO2 was measured across 107 different angiosomes. Stimulation examination involved a modification of the Ratschow test. All patients underwent PAD assessment (systolic blood pressures (SBP), toe pressures (TP), the ankle-brachial indexes (ABI) and toe-brachial indexes (TBI), duplex ultrasound of circulation). Angiosomes were divided into two groups based on ultrasound findings: group M(n=60) with monophasic flow; group T(n=47) with triphasic flow. Large vessel parameters and TcPO2 at rest and after exercise (minimal TcPO2, changes in TcPO2 from baseline (Δ,%), TcPO2 recovery time) measured during the stimulation test were compared between study groups. RESULTS: During the TcPO2 stimulation exercise test, group M exhibited significantly lower minimal TcPO2 (26.2 ± 11.1 vs. 31.4 ± 9.4 mmHg; p<0.01), greater Δ and percentage decreases from resting TcPO2 (p=0.014 and p=0.007, respectively) and longer TcPO2 recovery times (446 ± 134 vs. 370 ± 81ms;p=0.0005) compared to group T. SBPs, TPs and indexes were significantly lower in group M compared to group T. Sensitivity and specificity of TcPO2 stimulation parameters during PAD detection increased significantly to the level of SBP, ABI, TP and TBI. CONCLUSION: Compared to resting TcPO2, TcPO2 measured during stimulation improves detection of latent forms of PAD and restenosis/obliterations of previously treated arteries in diabetic foot patients. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov [https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009V7W&selectaction=Edit&uid=U0005381&ts=2&cx=3j24u2], identifier NCT04404699.
- Klíčová slova
- PAD - peripheral arterial disease, TcPO2 and TcPCO2 measurement, diabetic foot, diagnosis, microcirculation,
- MeSH
- cvičení fyziologie MeSH
- diabetická noha komplikace diagnostické zobrazování MeSH
- dolní končetina krevní zásobení MeSH
- duplexní dopplerovská ultrasonografie MeSH
- krevní tlak MeSH
- lidé středního věku MeSH
- lidé MeSH
- onemocnění periferních arterií diagnóza diagnostické zobrazování etiologie MeSH
- prsty nohy krevní zásobení MeSH
- regionální krevní průtok MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- tlakový index kotník-paže MeSH
- transkutánní měření krevních plynů 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
- práce podpořená grantem MeSH
OBJECTIVE: In patients with chronic coronary or peripheral artery disease enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies trial, randomised antithrombotic treatments were stopped after a median follow-up of 23 months because of benefits of the combination of rivaroxaban 2.5 mg two times per day and aspirin 100 mg once daily compared with aspirin 100 mg once daily. We assessed the effect of switching to non-study aspirin at the time of early stopping. METHODS: Incident composite of myocardial infarction, stroke or cardiovascular death was estimated per 100 person-years (py) during randomised treatment (n=18 278) and after study treatment discontinuation to non-study aspirin (n=14 068). RESULTS: During randomised treatment, the combination compared with aspirin reduced the composite (2.2 vs 2.9/100 py, HR: 0.76, 95% CI 0.66 to 0.86), stroke (0.5 vs 0.8/100 py, HR: 0.58, 95% CI 0.44 to 0.76) and cardiovascular death (0.9 vs 1.2/100 py, HR: 0.78, 95% CI 0.64 to 0.96). During 1.02 years after early stopping, participants originally randomised to the combination compared with those randomised to aspirin had similar rates of the composite (2.1 vs 2.0/100 py, HR: 1.08, 95% CI 0.84 to 1.39) and cardiovascular death (1.0 vs 0.8/100 py, HR: 1.26, 95% CI 0.85 to 1.86) but higher stroke rate (0.7 vs 0.4/100 py, HR: 1.74, 95% CI 1.05 to 2.87) including a significant increase in ischaemic stroke during the first 6 months after switching to non-study aspirin. CONCLUSION: Discontinuing study rivaroxaban and aspirin to non-study aspirin was associated with the loss of cardiovascular benefits and a stroke excess. TRIAL REGISTRATION NUMBER: NCT01776424.
- Klíčová slova
- acute coronary syndrome, clinical, coronary artery disease, peripheral vascular diseases, pharmacology, stroke,
- MeSH
- Aspirin * aplikace a dávkování škodlivé účinky MeSH
- fibrinolytika aplikace a dávkování škodlivé účinky MeSH
- infarkt myokardu * etiologie mortalita prevence a kontrola MeSH
- ischemická cévní mozková příhoda * etiologie mortalita prevence a kontrola MeSH
- kombinovaná farmakoterapie metody MeSH
- koronární nemoc * diagnóza farmakoterapie MeSH
- lidé MeSH
- monitorování léčiv metody statistika a číselné údaje MeSH
- mortalita MeSH
- náhrada léků škodlivé účinky MeSH
- nenasazení léčby statistika a číselné údaje MeSH
- onemocnění periferních arterií * diagnóza farmakoterapie MeSH
- rivaroxaban * aplikace a dávkování škodlivé účinky MeSH
- senioři MeSH
- trvání terapie MeSH
- výsledky a postupy - zhodnocení (zdravotní péče) MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- Aspirin * MeSH
- fibrinolytika MeSH
- rivaroxaban * MeSH
BACKGROUND: Ankle brachial index (ABI) is the principal screening method for peripheral arterial disease (PAD). In this study, we compare various types of Doppler-derived and oscillometric ABIs with results obtained through duplex ultrasonography. METHODS: 62 patients were enrolled in the study. For each limb, blood pressures for both ankle arteries and the arm were measured using Doppler and an automated oscillometric device. Duplex ultrasound was performed for all limbs and occlusions >50% were considered PAD-positive. ABI was calculated using both higher (HABP) and lower (LABP) arterial blood pressure on the individual limbs and the ability to predict duplex-detected stenoses was evaluated. RESULTS: LABP calculation provided results superior to the guideline-recommended HABP. Considering patients with ABI >1.4 or measurement failure as PAD-positive further enhanced the test parameters. The higher ABI cut-off of 1.0 resulted in somewhat better sensitivities (max 92%) and negative predictive values (max 87%) at the expense of a substantial increase in the number of false positives. Oscillometric method yielded poor sensitivities but very good specificities (max 94%) and positive predictive values (max 90%). CONCLUSIONS: Doppler-based LABP provides better results than the guideline-recommended HABP in diabetic patients, nevertheless even this method is not perfect. Increasing the cut-off value to 1.0 in these patients does not bring a substantial improvement of the test performance. Patients with high ABI should be automatically considered PAD-positive and referred for further investigation using imaging techniques.
- Klíčová slova
- ankle brachial index, diabetes, dopplerometric measurement, duplex ultrasonography, oscillometric measurement,
- MeSH
- arteriální okluzní nemoci diagnóza patofyziologie MeSH
- diabetické angiopatie diagnóza patofyziologie MeSH
- krevní tlak fyziologie MeSH
- lidé MeSH
- onemocnění periferních arterií diagnóza patofyziologie MeSH
- senioři MeSH
- senzitivita a specificita MeSH
- tlakový index kotník-paže metody MeSH
- ultrasonografie dopplerovská metody MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
BACKGROUND & AIMS: Proton pump inhibitors (PPIs) are effective at treating acid-related disorders. These drugs are well tolerated in the short term, but long-term treatment was associated with adverse events in observational studies. We aimed to confirm these findings in an adequately powered randomized trial. METHODS: We performed a 3 × 2 partial factorial double-blind trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease randomly assigned to groups given pantoprazole (40 mg daily, n = 8791) or placebo (n = 8807). Participants were also randomly assigned to groups that received rivaroxaban (2.5 mg twice daily) with aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg) alone. We collected data on development of pneumonia, Clostridium difficile infection, other enteric infections, fractures, gastric atrophy, chronic kidney disease, diabetes, chronic obstructive lung disease, dementia, cardiovascular disease, cancer, hospitalizations, and all-cause mortality every 6 months. Patients were followed up for a median of 3.01 years, with 53,152 patient-years of follow-up. RESULTS: There was no statistically significant difference between the pantoprazole and placebo groups in safety events except for enteric infections (1.4% vs 1.0% in the placebo group; odds ratio, 1.33; 95% confidence interval, 1.01-1.75). For all other safety outcomes, proportions were similar between groups except for C difficile infection, which was approximately twice as common in the pantoprazole vs the placebo group, although there were only 13 events, so this difference was not statistically significant. CONCLUSIONS: In a large placebo-controlled randomized trial, we found that pantoprazole is not associated with any adverse event when used for 3 years, with the possible exception of an increased risk of enteric infections. ClinicalTrials.gov Number: NCT01776424.
- Klíčová slova
- Bacteria, CVD, Reflux, Thrombosis,
- MeSH
- Aspirin aplikace a dávkování škodlivé účinky MeSH
- časové faktory MeSH
- dvojitá slepá metoda MeSH
- gastrointestinální krvácení chemicky indukované prevence a kontrola MeSH
- hodnocení rizik MeSH
- inhibitory agregace trombocytů aplikace a dávkování škodlivé účinky MeSH
- inhibitory faktoru Xa aplikace a dávkování škodlivé účinky MeSH
- inhibitory protonové pumpy aplikace a dávkování škodlivé účinky MeSH
- kardiovaskulární nemoci diagnóza farmakoterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- onemocnění periferních arterií diagnóza farmakoterapie MeSH
- pantoprazol aplikace a dávkování škodlivé účinky MeSH
- prospektivní studie MeSH
- pseudomembranózní enterokolitida chemicky indukované mikrobiologie MeSH
- rivaroxaban aplikace a dávkování škodlivé účinky MeSH
- rizikové faktory MeSH
- rozvrh dávkování léků 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
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- Aspirin MeSH
- inhibitory agregace trombocytů MeSH
- inhibitory faktoru Xa MeSH
- inhibitory protonové pumpy MeSH
- pantoprazol MeSH
- rivaroxaban MeSH
Aim of this study was to evaluate the possible use of infrared thermography as a supplementary method to the ankle-brachial index used in assessing the treatment effect of percutaneous transluminal angioplasty. The study included 21 patients, mean age was 60.22 years. Healthy control group included 20 persons, mean age was 55.60 years. Patients with symptomatic peripheral arterial disease (Fontaine stages I-III) were admitted for endovascular treatment by percutaneous transluminal angioplasty. Thermal images and ankle-brachial index values were obtained before and after treatment by percutaneous transluminal angioplasty. Median temperature change in the treated limb was 0.4℃, for non-treated limb was -0.5℃. The median value of ankle-brachial index in the treated limb increased by 0.17 from 0.81 after the procedure. The median value of ankle-brachial index in the non-treated limb decreased by 0.03 from the value of 1.01. Significant difference between treated limb and non-treated limb in change of ankle-brachial index was found with p value = .0035. The surface temperature obtained by the infrared thermography correlates with ankle-brachial index. We present data showing that the increase of ankle-brachial index is associated with increase of skin temperature in the case of limbs treated by percutaneous transluminal angioplasty. Our results also suggest potential of the use of infrared thermography for monitoring foot temperature as a means of early detection of onset of foot ischemic disorders.
- Klíčová slova
- Infrared thermography, ankle-brachial index, percutaneous transluminal angioplasty, peripheral arterial disease,
- MeSH
- balónková angioplastika * MeSH
- dolní končetina krevní zásobení MeSH
- dospělí MeSH
- infračervené záření * MeSH
- lidé středního věku MeSH
- lidé MeSH
- onemocnění periferních arterií diagnóza patofyziologie terapie MeSH
- prediktivní hodnota testů MeSH
- prospektivní studie MeSH
- průchodnost cév MeSH
- regionální krevní průtok MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- studie případů a kontrol MeSH
- teplota kůže * MeSH
- termografie metody MeSH
- termoregulace MeSH
- tlakový index kotník-paže MeSH
- výsledek terapie 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
- srovnávací studie MeSH
OBJECTIVES: Thrombolysis has been reported to be suboptimal in occluded vein grafts and cryopreserved allografts, and there are no data on the efficacy of thrombolysis in occluded cold stored venous allografts. The aim was to evaluate early outcomes, secondary patency and limb salvage rates of thrombolysed cold stored venous allograft bypasses and to compare the outcomes with thrombolysis of autologous bypasses. METHODS: This was a single center study of consecutive patients with acute and non-acute limb ischemia between September 1, 2000, and January 1, 2014, with occlusion of cold stored venous allografts, and between January 1, 2012, and January 1, 2014, with occlusion of autologous bypass who received intra-arterial thrombolytic therapy. RESULTS: Sixty-one patients with occlusion of an infrainguinal bypass using a cold stored venous allograft (n = 35) or an autologous bypass (n = 26) underwent percutaneous intra-arterial thrombolytic therapy. The median duration of thrombolysis was 20 h (IQR 18-24) with no difference between the groups (p = .14). The median follow up was 18.5 months (IQR 11.0-52.0). Secondary patency rates of thrombolysed bypass at 6 and 12 months were 44 ± 9% and 32 ± 9% in patients with a venous allograft bypass and 46 ± 10% and 22 ± 8% with an autologous bypass, with no difference between groups (p = .40). Limb salvage rates at 1, 6, and 12 months after thrombolysis in the venous allograft group were 83 ± 7%, 72 ± 8% and 63 ± 9%, and in the autologous group 91 ± 6%, 76 ± 9%, and 65 ± 13%, with no difference between groups (p = .69). CONCLUSIONS: Long-term results of thrombolysis of venous allograft bypasses are similar to those of autologous bypasses. Occluded cold stored venous allograft can be successfully re-opened in most cases with a favorable effect on limb salvage.
- Klíčová slova
- Infrainguinal bypass, Limb salvage, Thrombolysis, Venous allograft,
- MeSH
- alografty MeSH
- autologní štěp MeSH
- časové faktory MeSH
- cévy - implantace protéz škodlivé účinky MeSH
- fibrinolytika škodlivé účinky terapeutické užití MeSH
- ischemie diagnóza farmakoterapie etiologie patofyziologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nízká teplota * MeSH
- odběr tkání a orgánů MeSH
- okluze cévního štěpu diagnóza farmakoterapie etiologie patofyziologie MeSH
- onemocnění periferních arterií diagnóza patofyziologie chirurgie MeSH
- průchodnost cév účinky léků MeSH
- retrospektivní studie MeSH
- senioři MeSH
- trombolytická terapie * škodlivé účinky MeSH
- uchovávání tkání metody MeSH
- vena saphena účinky léků patofyziologie transplantace MeSH
- výsledek terapie MeSH
- záchrana končetiny 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
- Názvy látek
- fibrinolytika MeSH
BACKGROUND: Peripheral arterial disease (PAD) has the risk equivalent of coronary heart disease. The biochemical parameters associated with functionally significant coronary artery stenosis were investigated in asymptomatic patients with PAD who were scheduled for major vascular intervention. METHODS: A total of 50 PAD patients asymptomatic for coronary heart disease were examined using coronary computed tomography angiography (CTA). A stress myocardial CT perfusion (CTP) test was performed in patients who exhibited coronary stenosis >40%. In patients with stress-induced perfusion defects, the severity of stenosis was assessed using invasive coronary angiography including fractional flow reserve assessment. The CT findings were correlated with both classical and more recently developed parameters of atherosclerosis. RESULTS: According to the combined CT examination (CTA and stress CT perfusion), 36% of patients exhibited significant coronary stenosis. Stress-induced hypoperfusion was observed in 95.7% of severe stenotic lesions. After adjustment for confounders, the level of high-sensitivity troponin I was associated with severe coronary stenosis (OR 1.260 [95% CI 1.054 to 1.505]). Other biochemical parameters did not correlate with coronary stenosis. The annual mortality rate was 4%. CONCLUSIONS: The results of the present study confirm a significant diagnostic contribution of a complex cardiac CT examination in patients scheduled for major vascular surgery. A high prevalence of asymptomatic coronary heart disease was observed in this particular patient group. High-sensitivity measurements of troponin I correlated with the extent of the coronary stenosis.
- MeSH
- biologické markery krev MeSH
- CT angiografie MeSH
- frakční průtoková rezerva myokardu MeSH
- incidence MeSH
- komorbidita MeSH
- koronární angiografie metody MeSH
- koronární stenóza krev diagnostické zobrazování epidemiologie patofyziologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- onemocnění periferních arterií diagnóza epidemiologie chirurgie MeSH
- prediktivní hodnota testů MeSH
- prevalence MeSH
- schůzky a rozvrhy * MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- troponin I krev MeSH
- výkony cévní chirurgie * MeSH
- zobrazování myokardiální perfuze 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
- Geografické názvy
- Česká republika epidemiologie MeSH
- Názvy látek
- biologické markery MeSH
- troponin I MeSH
Matrix Gla protein (MGP), a natural inhibitor of calcification, strongly correlates with the extent of coronary calcification. Vitamin K is the essential cofactor for the activation of MGP. The nonphosphorylated-uncarboxylated isoform of MGP (dp-ucMGP) reflects the status of this vitamin. We investigated whether there is an association between dp-ucMGP and stiffness of elastic and muscular-type large arteries in a random sample from the general population. In a cross-sectional design, we analyzed 1087 subjects from the Czech post-MONICA study. Aortic and femoro-popliteal pulse wave velocities (PWVs) were measured using a Sphygmocor device. Dp-ucMGP concentrations were assessed in freshly frozen samples by enzyme-linked immunosorbent assay methods using the InaKtif MGP iSYS pre-commercial kit developed by IDS and VitaK. Aortic PWV significantly (P<0.0001) increased across the dp-ucMGP quartiles. After adjustment for all potential confounders, aortic PWV independently correlated with dp-ucMGP (with beta coefficient (s.d.) 11.61 (5.38) and P-value=0.031). In a categorized manner, subjects in the top quartile of dp-ucMGP (⩾ 671 pmol l(-1)) had a higher risk of elevated aortic PWV, with corresponding adjusted odds ratio (95% confidence interval) 1.73 (1.17-2.5). In contrast, no relation between dp-ucMGP and femoro-popliteal PWV was found. In conclusion, increased dp-ucMGP, which is a circulating biomarker of vitamin K status and vascular calcification, is independently associated with aortic stiffness, but not with stiffness of distal muscular-type arteries.
- MeSH
- analýza pulzové vlny MeSH
- biologické markery krev MeSH
- dospělí MeSH
- ELISA MeSH
- extracelulární matrix - proteiny krev MeSH
- fosforylace MeSH
- lidé středního věku MeSH
- lidé MeSH
- lineární modely MeSH
- logistické modely MeSH
- matrixový protein Gla MeSH
- multivariační analýza MeSH
- nemoci aorty krev diagnóza patofyziologie MeSH
- odds ratio MeSH
- onemocnění periferních arterií krev diagnóza patofyziologie MeSH
- proteiny vázající vápník krev MeSH
- průřezové studie MeSH
- rizikové faktory MeSH
- senioři MeSH
- tuhost cévní stěny * MeSH
- upregulace MeSH
- Check Tag
- dospělí MeSH
- 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
- Česká republika MeSH
- Názvy látek
- biologické markery MeSH
- extracelulární matrix - proteiny MeSH
- proteiny vázající vápník MeSH
