Prospective application of a risks-adjusted antithrombotic protocol in elderly patients treated with the last generation of everolimus-eluting stents. The SIERRA-75 (EPIC-05) registry

Abstract Background Elderly patients show a higher incidence of ischemic and bleeding events after PCI. Purpose We sought to investigate clinical outcomes in elderly patients revascularized with last generation everolimus-eluting stent (EES) treated with antithrombotic strategies guided by bleeding and ischemic risks. Methods Prospective multicenter registry including patients over 75 years revascularized with EES and subsequent antithrombotic therapy guided according to a protocol based on clinical presentation, PCI complexity and the PRECISE DAPT score. The primary safety endpoint was a composite of cardiac death, myocardial infarction and definitive/probable stent thrombosis and the primary efficacy endpoint was TLR. An historical matched group of patients treated with current drug eluting stents other than EES was used as control. Results Finally, 1,064 patients were included, 80.8±4.2 years, 36.6% women, 72% ACS and 53.6% complex PCI. Primary safety endpoint was met in 6.2% and primary efficacy endpoint in 1.5%. Bleeding BARC 2–5 was reported in 7.8% and definite or probable stent thrombosis in 1.3%. The multivariable adjusted model showed no significant association of the prescribed short/long therapies with any endpoint. No stent thrombosis were reported in the subgroup with shorter DAPT duration. As compared to control group, bleeding BARC 2–5 was significantly lower in SIERRA-75 group (7.4% vs 10.2%, p=0.04) as well as the composite of MACE and bleeding (14.3% vs 18.5%, p=0.02). Conclusions In elderly population the use of last generation EES along with a predefined risks-adjusted antithrombotic regimen seems to be associated with an improved prognosis in terms of ischemic and bleeding outcomes. FUNDunding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Abbott Laboratories

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Edoxaban versus warfarin in vitamin K antagonist experienced and naïve patients from the edoxaban versus warfarin in subjects undergoing cardioversion of atrial fibrillation (ENSURE-AF) randomised trial

Clinical Research in Cardiology ◽

10.1007/s00392-019-01594-9 ◽

2020 ◽

Vol 109 (8) ◽

pp. 1018-1024 ◽

Cited By ~ 2

Author(s):

Monika Kozieł ◽

Naab Al-Saady ◽

Søren P. Hjortshøj ◽

Assen Goudev ◽

Kurt Huber ◽

...

Keyword(s):

Atrial Fibrillation ◽

Vitamin K ◽

Randomised Trial ◽

Study Drug ◽

Comparable Efficacy ◽

Primary Efficacy ◽

Primary Efficacy Endpoint ◽

Efficacy And Safety ◽

Safety Endpoint ◽

Primary Safety Endpoint

Abstract Background In ENSURE-AF study, edoxaban had similar efficacy and safety profile versus enoxaparin–warfarin (enox–warf) in patients undergoing electrical cardioversion of non-valvular atrial fibrillation. Objectives To evaluate the efficacy and safety of edoxaban versus enox–warf in patients who were vitamin K antagonists (VKA) naïve or experienced at time of randomisation into ENSURE-AF trial. Methods The primary efficacy endpoint was a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death during the overall study period, 28 days on study drug after cardioversion and 30 days follow-up. The primary safety endpoint was the composite of major and clinically relevant nonmajor bleeding during the on-medication period from time of first dose to last dose of study drug taken + 3 days. Results Of 2199 patients enrolled in ENSURE-AF, 1095 were randomised to edoxaban and 1104 to enox–warf. There were numerically fewer primary efficacy endpoint events with edoxaban than enox–warf irrespective of whether VKA experienced or naïve (0.5% vs. 0.9%, 0.3% vs. 1.4%, respectively). There were no significant differences in the primary safety endpoint [odds ratio (OR) 2.09, 95% confidence interval (CI) 0.72–6.81 in anticoagulant experienced patients, OR 0.77, 95% CI 0.15–3.60 in anticoagulant naïve patients] and in major bleeding rates regardless of treatment or VKA experience (OR 0.69, 95%CI 0.06–6.04, OR 0.48, 95% CI 0.01–9.25, respectively). Conclusions Edoxaban had comparable efficacy and safety to optimized anticoagulation with enox–warf. The primary efficacy and safety endpoint outcomes were broadly similar between VKA experienced or naïve patients.

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Randomized, Double-Blind, Multi-Dose Efficacy, Safety and Biomarker Study of the Oral Factor Xa Inhibitor DU-176b Compared with Placebo for Prevention of Venous Thromboembolism in Patients after Total Knee Arthroplasty

Blood ◽

10.1182/blood.v112.11.34.34 ◽

2008 ◽

Vol 112 (11) ◽

pp. 34-34 ◽

Cited By ~ 6

Author(s):

Takashi Fuji ◽

Satoru Fujita ◽

Shintaro Tachibana ◽

Yohko Kawai

Keyword(s):

Total Knee Arthroplasty ◽

Venous Thromboembolism ◽

Primary Efficacy ◽

Primary Efficacy Endpoint ◽

Double Blind ◽

Safety Endpoint ◽

Total Knee ◽

Dose Dependent ◽

Primary Safety Endpoint ◽

D Dimer

Abstract Introduction: The objectives of this study were to assess the safety, efficacy and dose-response relationship of DU-176b for the prevention of venous thromboembolism (VTE) in Japanese patients after elective total knee arthroplasty (TKA). Changes in biomarkers in relation to VTE and bleeding were also evaluated. Methods: This was a randomized, parallel-group, placebo-controlled, double-blind, doubledummy, multicenter study. DU-176b (5–60 mg QD) or placebo was administered for 11–14 days after TKA. A placebo control was used because at the time no other anticoagulants had been approved for thromboprophylaxis after TKA in Japan. The primary efficacy endpoint included the adjudicated incidence of VTE, including asymptomatic and symptomatic deep vein thrombosis, as evaluated by venograms, and symptomatic pulmonary embolism. The primary safety endpoint included major and clinically relevant bleeding. Secondary efficacy endpoints included the pharmacodynamic (PD) indices prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (APTT), anti-FXa activity and key coagulation biomarkers including prothrombin fragment F1+2, plasmin-α2-plasmin inhibitor complex (PIC), D-dimer, thrombin-antithrombin III complex and soluble fibrin. Secondary safety endpoints included incidence of adverse events (AEs). Results: There were no clinically relevant differences in baseline demographics of the 523 patients randomized. Mean age was 71.1 ± 7.6 years, mean weight was 60.3 ± 9.9 kg and ~78% of patients were female. All DU-176b doses had significantly less VTE than placebo when each DU-176b dose group was compared with placebo (Table), and there was a dose-related response (P <0.001 across DU-176b dose). Paired comparisons showed no significant differences in VTE incidence between the 5 & 15 mg groups or between the 30 & 60 mg groups but significant differences between other paired groups (χ2 test; P<0.001 to P=0.021). PD indices were dose-related (Table, P <0.001 across DU-176b dose). After surgery, coagulation biomarkers increased with a trend for DU-176b to affect these markers more than placebo (Table, P <0.001 across DU-176b dose). The incidence of major and clinically relevant bleeding was comparable across all groups without any significant differences among groups or between DU-176b doses and placebo (Table). There were no trends in other AEs, including liver enzymes, across DU-176b dose. Conclusions: DU-176b demonstrated significant, dose-dependent reductions in VTE after TKA without increases in major or clinically relevant bleeding. There were also consistent dose-dependent changes in PD indices and coagulation biomarkers. The observed dose-dependent decreases in VTE without concomitant increases in bleeding should be further evaluated. Placebo DU-176b 5 mg DU-176b 15 mg DU-176b 30 mg DU-176b 60 mg *P<0.01, **P<0.001, †P=0.445, ‡P=1.00 vs placebo. Primary Efficacy Endpoint: VTE n/N (%) (95% CI) 43/89 (48.3) (37.9–58.7) 26/88 (29.5)* (20.0–39.1) 24/92 (26.1)** (17.1–35.1) 11/88 (12.5)** 5.6–19.4) 8/88 (9.1)** (3.1–15.1) Primary Safety Endpoint: % Major + Clinically Relevant bleeding n/N (%) 4/102 (3.9) 3/103 (2.9)† 5/106 (4.7)‡ 4/103 (3.9)‡ 5/106 (4.7)‡ PD and Coagulation Biomarkers, all data mean ± SD post-operation/pre-treatment initiation 1–3 h post-dose Day 7 N 87 86 91 87 87 86 86 89 87 87 PT (sec) 13.5±0.9 13.3±0.8 13.3±0.7 13.4±0.9 13.1±0.6 12.7±0.6 13.3±0.8** 14.9±1.5** 17.8±2.7** 22.1±5.9** anti-FXa activity (IU/mL) 0.10±0.0 0.10±0.0 0.10±0.0 0.13±0.23 0.10±0.0 0.10±0.0 0.44±0.80** 1.18±0.68** 2.40±1.17** 4.38±2.56** Prothrombin fragment F 1+2 , pM 479.6±229.7 431.4±257.5 468.7±249.0 428.9±269.0 417.9±223.6 588.9±228.9 484.6±184.9* 450.8±158.2** 414.0±172.8** 398.8±147.4** D-dimer μg/mL 12.4±10.5 13.6±10.5 14.3±11.2 12.2±10.3 11.4±10.1 9.4±5.7 7.5±3.7 6.7±2.7** 6.5±3.3** 5.8±2.4**

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Neuroform Atlas Stent System for the treatment of intracranial aneurysm: primary results of the Atlas Humanitarian Device Exemption cohort

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2018-014455 ◽

2019 ◽

Vol 11 (8) ◽

pp. 801-806 ◽

Cited By ~ 30

Author(s):

Brian T Jankowitz ◽

Ricardo Hanel ◽

Ashutosh P Jadhav ◽

David N Loy ◽

Donald Frei ◽

...

Keyword(s):

High Rate ◽

Parent Artery ◽

Primary Efficacy ◽

Primary Efficacy Endpoint ◽

Stent System ◽

Safety Endpoint ◽

The Mean ◽

Primary Safety Endpoint ◽

Humanitarian Device Exemption

Background and objectiveStent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial.MethodThe Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints.Results30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths.ConclusionThe Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort.Clinical trial.gov registration numberNCT0234058;Results

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Randomised controlled trial to investigate optimal antithrombotic therapy in patients with non-valvular atrial fibrillation undergoing percutaneous coronary intervention: a study protocol of the OPTIMA-AF trial

BMJ Open ◽

10.1136/bmjopen-2020-048354 ◽

2021 ◽

Vol 11 (12) ◽

pp. e048354

Author(s):

Yohei Sotomi ◽

Ken Kozuma ◽

Kosuke Kashiwabara ◽

Yoshiharu Higuchi ◽

Kenji Ando ◽

...

Keyword(s):

Percutaneous Coronary Intervention ◽

Controlled Trial ◽

Dual Therapy ◽

Coronary Intervention ◽

Primary Efficacy ◽

Primary Efficacy Endpoint ◽

Percutaneous Coronary ◽

Safety Endpoint ◽

Randomised Controlled ◽

Primary Safety Endpoint

IntroductionThe optimal antithrombotic strategy for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) is uncertain. For patients with non-AF, many trials are now evaluating short 1-month dual antiplatelet therapy. In patients with AF undergoing PCI, in contrast, short dual therapy (P2Y12 inhibitor +direct oral anticoagulant (DOAC)) has not yet been evaluated.Methods and analysisThe OPTIMA-AF trial (OPTIMAl antiplatelet therapy in combination with direct oral anticoagulants in patients with non-valvular Atrial Fibrillation undergoing percutaneous coronary intervention with everolimus-eluting stent) is an investigator-initiated, open-label, nationwide, multicentre, prospective, randomised controlled trial. The primary objective is to compare the efficacy and safety of short dual therapy (1-month DOAC +P2Y12 inhibitor followed by DOAC monotherapy) against long dual therapy (12-month DOAC +P2Y12 inhibitor followed by DOAC monotherapy) in the treatment of AF subjects undergoing PCI. The primary efficacy endpoint is a composite of death or thromboembolic events (myocardial infarction, definite stent thrombosis, stroke or systemic embolism) at 365 days; and the primary safety endpoint is bleeding (International Society on Thrombosis and Haemostasis major or clinically relevant non-major bleeding) at 365 days. This trial is intended to show the non-inferiority of short dual therapy versus long dual therapy in terms of the primary efficacy endpoint and show superiority in terms of the primary safety endpoint. A total of 1090 subjects will be randomised in a 1:1 ratio at approximately 60 sites.Ethics and disseminationThis study received approval from the Certified Review Board of Osaka University (a certified research ethics committee by the Japanese Clinical Research Act). The findings will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberJapan Registry of Clinical Trials: jRCTs051190053; Pre-results.

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Optimizing diagnosis of obstructive coronary artery disease by CT angiography: RCT's final results and 12-months follow-up

European Heart Journal ◽

10.1093/ehjci/ehaa946.1379 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

J.P Dias Ferreira Reis ◽

R Ramos ◽

P Modas Daniel ◽

S Aguiar Rosa ◽

L Almeida Morais ◽

...

Keyword(s):

Coronary Artery Disease ◽

Coronary Artery ◽

Functional Test ◽

Control Group ◽

Diagnostic Strategy ◽

Coronary Syndrome ◽

Tertiary Center ◽

Safety Endpoint ◽

Artery Disease ◽

Primary Safety Endpoint

Abstract Aim In patients (pts) with suspected coronary artery disease (CAD), computed tomographic angiography (CTA) may improve pt selection for invasive coronary angiography (ICA) as alternative to functional testing. However. the role of CTA in symptomatic pts after abnormal functional test (FT) is incompletely defined. Methods and results This randomized clinical trial conducted in single academic tertiary center selected 218 symptomatic pts with mild to moderately abnormal FT referred to ICA to receive either the originally intended ICA (n=103) or CTA (n=115). CTA interpretation and subsequent care decisions were made by the clinical team. Pts with high risk features on FT, previous acute coronary syndrome, previously documented CAD, chronic kidney disease (GFR<60ml/min/1.73m2) or persistent atrial fibrillation were excluded. The primary endpoint was the percentage of ICA with no significant obstructive CAD (no stenosis ≥50%) in each group. Diagnostic (DY) and revascularization (RY) yields of ICA in either group were also assessed. Pts were followed up for at least 1 year for the primary safety endpoint of all cause death/ nonfatal myocardial infarction/ stroke. Unplanned revascularization (UP) and symptomatic status (SS) were also evaluated. Pts averaged 68±9 years of age, 60% were male, 29% were diabetic. Nuclear perfusion stress test was used in 33.9% in CTA group and 31.1% in control group (p=0.655). Mean post (functional) test probability of obstructive CAD was 34%. Overall prevalence of obstructive CAD was 32.1%. In the CTA group, ICA was cancelled by referring physicians in 83 of the pts (72.2%) after receiving CTA results. For those undergoing ICA, non-obstructive CAD was found in 5 pts (15.6%) in the CTA-guided arm and 60 (58.3%) in the usual care arm (p<0.001 Mean cumulative radiation exposure related to diagnostic work up was similar in both groups (6±14 vs 5±14mSv, p=0.152). Both DY (84.4% vs 41.7, p<0.001) and RY (71.9% vs 38.8%, p=0.001) yields were significantly higher for CTA-guided ICA as compared to standard FT-guided ICA. The rate of the primary safety endpoint was similar between both groups (1.9% vs 0%, p=0.244), as well as the rates of UP (0.9% vs 0.9%, p=1.000) and SS (persistent angina: 29.6% vs 24.8%, p=0.425). Conclusions In pts with suspected CAD and mild to moderately abnormal ischemia test, a diagnostic strategy including CTA as gatekeeper is safe, effective and significantly improves diagnostic and revascularization yields of ICA. Funding Acknowledgement Type of funding source: None

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Comparative Safety and Efficacy of Left Atrial Appendage Occlusion with the Watchman Device and Amplatzer Cardiac Plug: Results of the Russian National Registry

BioMed Research International ◽

10.1155/2020/2352648 ◽

2020 ◽

Vol 2020 ◽

pp. 1-7

Author(s):

Karapet Davtyan ◽

Georgiy Simonyan ◽

Arpi Topchyan ◽

Andrey Kalemberg ◽

Alexander Romanov ◽

...

Keyword(s):

Left Atrial ◽

Left Atrial Appendage ◽

Primary Efficacy ◽

Left Atrial Appendage Occlusion ◽

Safety Endpoint ◽

Watchman Device ◽

Comparative Safety ◽

Major Adverse Events ◽

Primary Safety Endpoint

Purpose. This multicenter, prospective registry evaluated the comparative safety and efficacy of left atrial appendage occlusion (LAAO) using the Watchman device (WD) and the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (NVAF) in real-world clinical practice in Russia. Methods. The study included data from 200 consecutive NVAF patients ( 66.8 ± 7.8 years, 44.5% female, median CHA2DS2VASc 4, median HAS-BLED 3) who had undergone LAAO implantation using WD ( n = 108 ) or ACP ( n = 92 ) from September 2015 to December 2017 in 5 medical centers in Russia. The primary safety endpoint was the procedure-related major adverse events, and the primary efficacy endpoint was the composite of thromboembolic events, device thrombosis, hemorrhagic events, and unexplained death during the 12-month follow-up. Results. Successful LAAO was performed in all 92 (100%) patients with ACP and 105 (97.2%) with WD ( p = 0.053 ). At 12 months, primary safety endpoint occurred in 6.5% of patients in the ACP group with no events in the WD group (6.5% vs. 0%, p = 0.008 ). During the 12-month follow-up, the primary efficacy endpoint has occurred in 8.3% of patients in the WD group ( n = 9 ) and 1.1% of patients in the ACP group ( n = 1 ) ( p = 0.016 ). Conclusions. In this multicenter prospective registry, LAA closure with the WD was associated with significantly higher thromboembolic events rate in NVAF patients. Patients, receiving the ACP, had more procedure-related major adverse events. However, further multicenter studies are necessary to evaluate these findings.

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Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty

Thrombosis and Haemostasis ◽

10.1160/th10-09-0601 ◽

2011 ◽

Vol 105 (03) ◽

pp. 444-453 ◽

Cited By ~ 172

Author(s):

Michael Rud Lassen ◽

Bengt Eriksson ◽

Michael Gent ◽

Scott Berkowitz ◽

Frank Misselwitz ◽

...

Keyword(s):

Venous Thromboembolism ◽

Treatment Period ◽

Knee Arthroplasty ◽

Phase Iii ◽

Primary Efficacy ◽

Primary Efficacy Endpoint ◽

Bleeding Events ◽

Once Daily ◽

All Cause Mortality ◽

Total Treatment

SummaryFour phase III studies compared oral rivaroxaban with subcutaneous enoxaparin for the prevention of venous thromboembolism (VTE) after total hip or knee arthroplasty (THA or TKA). A pooled analysis of these studies compared the effect of rivaroxaban with enoxaparin on symptomatic VTE plus all-cause mortality and bleeding events, and determined whether these effects were consistent in patient subgroups. Patients (N=12,729) aged ≥18 years and scheduled for elective THA or TKA received rivaroxaban 10 mg once daily or enoxaparin 40 mg once daily or 30 mg every 12 hours. The composite of symptomatic VTE and all-cause mortality, the prespecified primary efficacy endpoint and adjudicated bleeding events were analysed in the day 12 ± 2 active treatment pool. Subgroup analyses of these outcomes were performed over the total treatment period. In the day 12 ± 2 pool, the primary efficacy endpoint occurred in 29/6,183 patients receiving rivaroxaban (0.5%) versus 60/6,200 patients receiving enoxaparin (1.0%; p=0.001). Major bleeding occurred in 21 (0.3%) versus 13 (0.2%) patients, p=0.23; major plus non-major clinically relevant bleeding in 176 (2.8%) versus 152 (2.5%) patients, p=0.19; and any bleeding in 409 (6.6%) versus 384 (6.2%) patients, p=0.38, respectively. The reduction of symptomatic VTE plus all-cause mortality was consistent across prespecified subgroups (age, gender, body weight, creatinine clearance) in the total treatment period. Compared with enoxaparin regimens, rivaroxaban reduces the composite of symptomatic VTE and all-cause mortality after elective THA or TKA, with a small increase in bleeding, no signs of compromised liver safety and fewer serious adverse events.

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Abstract 1439: Cytochrome P450 Genetic Variants Predict Cardiovascular Outcomes following Treatment with Clopidogrel but not with Prasugrel

Circulation ◽

10.1161/circ.118.suppl_18.s_325-c ◽

2008 ◽

Vol 118 (suppl_18) ◽

Author(s):

Jessica L Mega ◽

Lei Shen ◽

Stephen D Wiviott ◽

Joseph R Walker ◽

Richard D Hockett ◽

...

Keyword(s):

Cytochrome P450 ◽

Stent Thrombosis ◽

Genetic Variants ◽

Platelet Inhibition ◽

Primary Efficacy ◽

Primary Efficacy Endpoint ◽

Active Metabolites ◽

Functional Polymorphisms ◽

Increased Risk ◽

The Impact

Background : Prasugrel and clopidogrel require transformation into active metabolites by cytochrome P450 (CYP) enzymes. Variants in CYP genes, particularly CYP2C19 , are associated w/ reduced levels of metabolite and platelet inhibition w/ clopidogrel but not prasugrel. We investigated the impact of variants in CYP genes on clinical outcomes. Methods : TRITON-TIMI 38 randomized ACS patients w/ planned PCI to prasugrel (60 mg load, 10 mg qd) or clopidogrel (300 mg, 75 mg qd) for 6–15 mos. DNA was available in 2943 subjects who were genotyped for functional polymorphisms in CYP2C19 , 2C9 , 3A4/5 , 2B6 , and 1A2 and classified for each gene as carriers or non-carriers of ≥1 reduced function allele. Results : Among subjects treated with clopidogrel, CYP2C19 reduced function allele carriers (27% of population) had a 53% increased risk of the primary efficacy endpoint of CV death, MI, or stroke (HR 1.53, P=0.007, Fig ) and a 3-fold increased risk of ARC-defined definite or probable stent thrombosis (HR 3.09, P=0.038) compared w/ non-carriers. In contrast, with prasugrel CYP2C19 reduced function allele carriers were not at increased risk of CV death, MI, or stroke (HR 0.89, P=0.86) or stent thrombosis (HR 0.60, P=0.57). No association between genotype and bleeding was observed w/ either treatment. There were no statistically significant associations between any other tested CYP genotypes and outcomes. Conclusions : CYP2C19 genetic variants identify patients at significantly higher risk for CV death, MI, or stroke and for stent thrombosis among those treated with clopidogrel but not among those treated with prasugrel. CYP2C19 genotyping offers the potential to help tailor antiplatelet therapy.

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Comparison of Triflusal with Aspirin in the Secondary Prevention of Atherothrombotic Events; Α Randomised Clinical Trial

Current Vascular Pharmacology ◽

10.2174/1570161116666180605090520 ◽

2019 ◽

Vol 17 (6) ◽

pp. 635-643

Author(s):

Kallirroi I. Kalantzi ◽

Ioannis V. Ntalas ◽

Vasileios G. Chantzichristos ◽

Maria E. Tsoumani ◽

Dimitrios Adamopoulos ◽

...

Keyword(s):

Clinical Trial ◽

Secondary Prevention ◽

Ischaemic Stroke ◽

Primary Efficacy ◽

Primary Efficacy Endpoint ◽

Bleeding Events ◽

Vascular Events ◽

Once Daily ◽

To Receive

Background: Triflusal has demonstrated an efficacy similar to aspirin in the prevention of vascular events in patients with acute myocardial infarction (ΜΙ) and ischaemic stroke but with less bleeding events. Objective: We performed a randomised, multicentre, phase 4 clinical trial to compare the clinical efficacy and safety of triflusal versus aspirin, administered for 12 months in patients eligible to receive a cyclooxygenase-1 (COX-1) inhibitor. Methods: Patients with stable coronary artery disease or with a history of non-cardioembolic ischaemic stroke were randomly assigned to receive either triflusal 300 mg twice or 600 mg once daily or aspirin 100 mg once daily for 12 months. The primary efficacy endpoint was the composite of: (a) ΜΙ, (b) stroke (ischaemic or haemorrhagic), or, (c) death from vascular causes for the entire follow-up period. The primary safety endpoints were the rate of bleeding events as defined by Bleeding Academic Research Consortium (BARC) criteria. Results: At 12-month follow-up, an equivalent result was revealed between the triflusal (n=559) and aspirin (n=560) in primary efficacy endpoint. Specifically, the combined efficacy outcome rate (i.e. MI, stroke or death from vascular causes) difference was equal to -1.3% (95% confidence interval -1.1 to 3.5) and lied within the a-priori defined equivalence interval (p<0.001). Regarding the primary safety endpoints, patients on triflusal treatment were 50% less likely to develop bleeding events according to the BARC criteria, and especially any clinically overt sign of haemorrhage that requires diagnostic studies, hospitalisation or special treatment (BARC type 2). Conclusion: The efficacy of triflusal in the secondary prevention of vascular events is similar to aspirin when administered for 12 months. Importantly, triflusal significantly reduced the incidence of ΜΙ and showed a better safety profile compared with aspirin. : (ASpirin versus Triflusal for Event Reduction In Atherothrombosis Secondary prevention, ASTERIAS trial; Clinical Trials.gov Identifier: NCT02616497).

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The Effect of Cognitive Remediation Therapy on Social Skills in Institutionalized Elderly Patients with Schizophrenia

Reviews on Recent Clinical Trials ◽

10.2174/1574887112666170522142315 ◽

2017 ◽

Vol 12 (3) ◽

pp. 182-186 ◽

Cited By ~ 1

Author(s):

Fatemeh Mohammadi ◽

Yadollah Abolfathi Momtaz ◽

Seyedeh Ameneh Motalebi ◽

Shahnaz Boosepasi

Keyword(s):

Social Skills ◽

Elderly Patients ◽

Behavioral Problems ◽

Psychiatric Patients ◽

Intervention Group ◽

Cognitive Remediation ◽

Control Group ◽

Cognitive Remediation Therapy ◽

Chi Square ◽

Institutionalized Elderly

Background: There are limited scientific investigations on cognitive remediation in elderly patients with schizophrenia. The present study was aimed to examine the efficacy of cognitive remediation therapy on social skills in institutionalized elderly patients with schizophrenia. Methods: The study employed a randomized clinical trial. A total of 60 institutionalized elderly patients with schizophrenia from Razi Psychiatric Hospital, Tehran were selected and randomly allocated into two equal groups (control and intervention). The intervention group attended to cognitive remediation therapy for 8 weeks. The Evaluation of Living Skills Scale for psychiatric patients was used for data collection. The Chi Square, independent and paired t-tests using SPSS, version 22, were employed to analyze the data. Results: The mean age of 60 elderly patients participated in the study was 65.25 ± 4.19 years. No significant differences were found between two groups at baseline. However, independent t-tests showed significant differences between the intervention and the control group in social skills after implementation of intervention. Additionally, the results of paired t-tests revealed significant improvements in intervention group on communication skills (t=5.50, p<0.001), behavioral problems with others (t=5.44, p<0.001), and self-care (t=4.70, p<0.001). No significant differences were observed from pretest to post test in control group. Conclusion: The results of the present study may support the efficacy of cognitive remediation therapy on social skills of elderly patients with schizophrenia.

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