| 1. |
- Frigoli, Enrico, et al.
(författare)
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Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study
- 2019
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Ingår i: American Heart Journal. - : MOSBY-ELSEVIER. - 0002-8703 .- 1097-6744. ; 209, s. 97-105
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Tidskriftsartikel (refereegranskat)abstract
- Background The optimal duration of antiplatelet therapy in high-bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents remains unclear. Design MASTER DAPT (clinicaltrial.gov NCT03023020) is an investigator-initiated, open-label, multicenter, randomized controlled trial comparing an abbreviated versus a standard duration of antiplatelet therapy after bioresorbable polymer-coated Ultimaster (TANSEI) sirolimus-eluting stent implantation in approximately 4,300 HBR patients recruited from >= 100 interventional cardiology centers globally. After a mandatory 30-day dual-antiplatelet therapy (DAPT) run-in phase, patients are randomized to (a) a single antiplatelet regimen until study completion or up to 5 months in patients with clinically indicated oral anticoagulation (experimental 1-month DAPT group) or (b) continue DAPT for at least 5 months in patients without or 2 in patients with concomitant indication to oral anticoagulation, followed by a single antiplatelet regimen (standard antipkitelet regimen). With a final sample size of 4,300 patients, this study is powered to assess the noninferiority of the abbreviated antiplatelet regimen with respect to the net adverse clinical and major adverse cardiac and cerebral events composite end points and if satisfied for the superiority of abbreviated as compared to standard antiplatelet therapy duration in terms of major or clinically relevant nonmajor bleeding. Study end points will be adjudicated by a blinded Clinical Events Committee. Conclusions The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation.
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| 2. |
- Kobo, Ofer, et al.
(författare)
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Impact of Multisite artery disease on Clinical Outcomes After Percutaneous Coronary Intervention : An Analysis from the e-Ultimaster Registry
- 2023
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Ingår i: European Heart Journal - Quality of Care and Clinical Outcomes. - : Oxford University Press. - 2058-5225 .- 2058-1742. ; 9:4, s. 417-426
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Multisite artery disease is considered a 'malignant' type of atherosclerotic disease associated with an increased cardiovascular risk, but the impact of multisite artery disease on clinical outcomes after percutaneous coronary intervention (PCI) is unknown.METHODS: Patients enrolled in the large, prospective e-Ultimaster study were grouped into 1) those without known prior vascular disease; 2) those with known single-territory vascular disease 3) those with known 2-3 territories (i.e, coronary, cerebrovascular, or peripheral) vascular disease (multisite artery disease). The primary outcome was coronary target lesion failure (TLF) defined as the composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target lesion revascularization at 1-year. Inverse propensity score weighted (IPSW) analysis was performed to address differences in baseline patient and lesion characteristics.RESULTS: Of the 37,198 patients included in the study, 62.3% had no prior known vascular disease, 32.6% had single-territory vascular disease, and 5.1% multisite artery disease. Patients with known vascular disease were older and were more likely to be men and to have more co-morbidities. After IPSW, the TLF rate incrementally increased with the number of diseased vascular beds (3.16%, 4.44% and 6.42% for no, single- and multisite artery disease, p<0.01 for all comparisons). This was also true for all cause death (2.22%, 3.28% and 5.29%, p<0.01 for all comparisons) and cardiac mortality (1.26%, 1.91% and 3.62%, p≤0.01 for all comparisons).CONCLUSIONS: Patients with previously known vascular disease experienced an increased risk for adverse cardiovascular events and mortality post percutaneous coronary intervention. This risk is highest among patients with multisite artery disease.
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| 3. |
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| 4. |
- Raposeiras-Roubin, Sergio, et al.
(författare)
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Development and external validation of a post-discharge bleeding risk score in patients with acute coronary syndrome : The BleeMACS score
- 2018
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Ingår i: International Journal of Cardiology. - : ELSEVIER IRELAND LTD. - 0167-5273 .- 1874-1754. ; 254, s. 10-15
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Tidskriftsartikel (refereegranskat)abstract
- Background: Accurate 1-year bleeding risk estimation after hospital discharge for acute coronary syndrome(ACS) may help clinicians guide the type and duration of antithrombotic therapy. Currently there are no predictive models for this purpose. The aim of this study was to derive and validate a simple clinical tool for bedside risk estimation of 1-year post-discharge serious bleeding in ACS patients.Methods: The risk score was derived and internally validated in the BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registry, an observational international registry involving 15,401 patients surviving admission for ACS and undergoing percutaneous coronary intervention (PCI) from 2003 to 2014, engaging 15 hospitals from 10 countries located in America, Europe and Asia. External validation was conducted in the SWEDEHEART population, with 96,239 ACS patients underwent PCI and 93,150 without PCI.Results: Seven independent predictors of bleeding were identified and included in the BleeMACS score: age, hypertension, vascular disease, history of bleeding, malignancy, creatinine and hemoglobin. The BleeMACS risk score exhibited a C-statistic value of 0.71 (95% CI 0.68-0.74) in the derivation cohort and 0.72 (95% CI 0.67-0.76) in the internal validation sample. In the SWEDEHEART external validation cohort, the C-statistic was 0.65 (95% CI 0.64-0.66) for PCI patients and 0.63 (95% CI 0.62-0.64) for non-PCI patients. The calibration was excellent in the derivation and validation cohorts.Conclusions: The BleeMACS bleeding risk score is a simple tool useful for identifying those ACS patients at higher risk of serious 1-year post-discharge bleeding.
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| 5. |
- Sandin, Ylva, et al.
(författare)
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Design of Timber Buildings for Deconstruction and Reuse — Three methods and five case studies
- 2022
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Rapport (övrigt vetenskapligt/konstnärligt)abstract
- There is a need for a shift towards circular economy in the construction sector and design philosophies as Design for Deconstruction and Reuse (DfDR) and Design for Adaptability (DfA) are being developed as means to design out waste and enhance resource efficiency. However, applying these philosophies is not yet common practice. The amount of DfDR/A timber buildings described in literature is limited. This study aims at increasing and spreading knowledge on DfDR/A for timber buildings. It has four goals: 1) To suggest methods to apply DfDR/A. 2) To suggest new design solutions. 3) To collect experiences on connections in relation to DfDR. 4) To suggest how guidelines for deconstruction and reuse can be formulated. The study presents three methods that all proved valuable in applying DfDR/A: one discussion-based method to improve an already existing timber building design, one indicator system to assess the DfDR/A potential of building designs, and one matrix to guide design decisions. We used the first method to conduct five case studies in four European countries. The studied designs were judged to be well or relatively well adapted for deconstruction and reuse already today. The fact that the studied buildings are all offsite manufactured and of modular composition benefits the deconstruction process, partly because construction and deconstruction are similar processes so that the knowledge and infrastructure that companies have can be directly transferred to enable deconstruction and reuse. Where large modules can be recovered, the time and energy needed for deconstruction as well as the risk for damage will be reduced. Disadvantages to deconstruction and reuse identified were typically linked to the complexity of building modules and that individual components are not independent. This was reflected as irreversible or hidden connections, inaccessible services, interconnected layers of the structural modules and many different component sizes. One of the case study buildings, designed with mass timber panels, excelled in the simplicity and reduction of number of steps required for maximum material recovery. New designs suggested included making fasteners more accessible to deconstruction, avoiding letting sensitive materials as plastic foils and particle boards pass continuously over joints between elements, and (for cases where standard units are not already used) standardizing elements. One case suggested using solid wood components instead of engineered wood products to achieve durability. The study showed that simple changes in design can lead to an augmented reuse potential. Some of the new design solutions generated will be taken into production by the participating manufacturers. Insights on connections included recognizing the fact that the use of reversible screwed connections is not sufficient to ensure deconstructability and that although nailed or glued connections severely complicate reuse of components, they might be accepted within elements in case reuse on element level is the target. Guidelines for deconstruction and reuse were developed in all case studies. Taken as a group of studies, there are advantageous additions proposed to earlier guidance documents. Despite being based on the same source, the different plans suggested varied substantially. There was a noteworthy difference between manufacturers’ in-house plans to those proposed by architects, engineers, or researchers, which speaks to the uncertainty regarding the appropriate structure and format.
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| 6. |
- Weisz, Giora, et al.
(författare)
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Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI) : a multicentre, randomised, double-blind, placebo-controlled trial
- 2016
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Ingår i: The Lancet. - 0140-6736 .- 1474-547X. ; 387:10014, s. 136-145
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Incomplete revascularisation is common after percutaneous coronary intervention and is associated with increased mortality and adverse cardiovascular events. We aimed to assess whether adjunctive anti-ischaemic pharmacotherapy with ranolazine would improve the prognosis of patients with incomplete revascularisation after percutaneous coronary intervention.METHODS: We performed this multicentre, randomised, parallel-group, double-blind, placebo-controlled, event-driven trial at 245 centres in 15 countries in Europe, Israel, Russia, and the USA. Patients (aged ≥18 years) with a history of chronic angina with incomplete revascularisation after percutaneous coronary intervention (defined as one or more lesions with ≥50% diameter stenosis in a coronary artery ≥2 mm diameter) were randomly assigned (1:1), via an interactive web-based block randomisation system (block sizes of ten), to receive either twice-daily oral ranolazine 1000 mg or matching placebo. Randomisation was stratified by diabetes history (presence vs absence) and acute coronary syndrome presentation (acute coronary syndrome vs non-acute coronary syndrome). Study investigators, including all research teams, and patients were masked to treatment allocation. The primary endpoint was time to first occurrence of ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT01442038.FINDINGS: Between Nov 3, 2011, and May 27, 2013, we randomly assigned 2651 patients to receive ranolazine (n=1332) or placebo (n=1319); 2604 (98%) patients comprised the full analysis set. After a median follow-up of 643 days (IQR 575-758), the composite primary endpoint occurred in 345 (26%) patients assigned to ranolazine and 364 (28%) patients assigned to placebo (hazard ratio 0·95, 95% CI 0·82-1·10; p=0·48). Incidence of ischaemia-driven revascularisation and ischaemia-driven hospitalisation did not differ significantly between groups. 189 (14%) patients in the ranolazine group and 137 (11%) patients in the placebo group discontinued study drug because of an adverse event (p=0·04).INTERPRETATION: Ranolazine did not reduce the composite rate of ischaemia-driven revascularisation or hospitalisation without revascularisation in patients with a history of chronic angina who had incomplete revascularisation after percutaneous coronary intervention. Further studies are warranted to establish whether other treatment could be effective in improving the prognosis of high-risk patients in this population.FUNDING: Gilead Sciences, Menarini.
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| 7. |
- Wilkinson, John L., et al.
(författare)
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Pharmaceutical pollution of the world's rivers
- 2022
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Ingår i: Proceedings of the National Academy of Sciences of the United States of America. - : Proceedings of the National Academy of Sciences. - 0027-8424 .- 1091-6490. ; 119:8
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Tidskriftsartikel (refereegranskat)abstract
- Environmental exposure to active pharmaceutical ingredients (APIs) can have negative effects on the health of ecosystems and humans. While numerous studies have monitored APIs in rivers, these employ different analytical methods, measure different APIs, and have ignored many of the countries of the world. This makes it difficult to quantify the scale of the problem from a global perspective. Furthermore, comparison of the existing data, generated for different studies/regions/continents, is challenging due to the vast differences between the analytical methodologies employed. Here, we present a global-scale study of API pollution in 258 of the world's rivers, representing the environmental influence of 471.4 million people across 137 geographic regions. Samples were obtained from 1,052 locations in 104 countries (representing all continents and 36 countries not previously studied for API contamination) and analyzed for 61 APIs. Highest cumulative API concentrations were observed in sub-Saharan Africa, south Asia, and South America. The most contaminated sites were in low- to middle-income countries and were associated with areas with poor wastewater and waste management infrastructure and pharmaceutical manufacturing. The most frequently detected APIs were carbamazepine, metformin, and caffeine (a compound also arising from lifestyle use), which were detected at over half of the sites monitored. Concentrations of at least one API at 25.7% of the sampling sites were greater than concentrations considered safe for aquatic organisms, or which are of concern in terms of selection for antimicrobial resistance. Therefore, pharmaceutical pollution poses a global threat to environmental and human health, as well as to delivery of the United Nations Sustainable Development Goals.
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| 8. |
- Zeymer, Uwe, et al.
(författare)
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Differences in the use of guideline-recommended therapies among 14 European countries in patients with acute coronary syndromes undergoing PCI
- 2013
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Ingår i: European Journal of Preventive Cardiology. - : Oxford University Press (OUP). - 2047-4873 .- 2047-4881. ; 20:2, s. 218-228
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Tidskriftsartikel (refereegranskat)abstract
- Aims:Despite common European Society of Cardiology recommendations, adherence to guideline therapy varies, both temporally and geographically. We sought to examine current differences in the use of guideline-recommended therapies among 14 European countries in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).Methods and Results: Data were obtained from the Antiplatelet Therapy Observational Registry (APTOR), a non-interventional, prospective observational cohort study enrolling patients with ACS undergoing PCI. Medication data were captured through 1 year. The large majority of patients in the APTOR registry received statins at hospital discharge (89%) and remained on statins at 1 year (87%), a finding that was consistent across countries. Likewise, beta-blocker use was similar at discharge and 1 year (83 and 81%, respectively). There was large disparity in aspirin loading dose between countries, but the discharge maintenance dose was more consistent, with most receiving ≤100 mg (87%). While 95% of patients were discharged on dual antiplatelet therapy, 71% remained on both treatments by 1 year, with wide variation by country in 1-year use.Conclusions:These data from the APTOR study provide key information on current European ACS patient care management from hospitalization through 1 year. Even with European Society of Cardiology (ESC) guidelines, variations in practice patterns exist among ACS patients treated with PCI between the 14 European countries studied, including the use of proven therapies, as well as appropriate duration and dosing of antiplatelet regimens. Efforts are needed to further explain why such variation exists and to continue to improve adherence to ESC guidelines to improve patient care.
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