oru.sePublications
Change search
Link to record
Permanent link

Direct link
BETA
Fröbert, Ole
Alternative names
Publications (10 of 75) Show all publications
Holm, N. R., Mäkikallio, T., Lindsay, M. M., Spence, M. S., Erglis, A., Menown, I. B. A., . . . Christiansen, E. H. (2020). Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial. The Lancet, 395(10219), 191-199
Open this publication in new window or tab >>Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial
Show others...
2020 (English)In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 395, no 10219, p. 191-199Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Percutaneous coronary intervention (PCI) is increasingly used in revascularisation of patients with left main coronary artery disease in place of the standard treatment, coronary artery bypass grafting (CABG). The NOBLE trial aimed to evaluate whether PCI was non-inferior to CABG in the treatment of left main coronary artery disease and reported outcomes after a median follow-up of 3·1 years. We now report updated 5-year outcomes of the trial.

METHODS: The prospective, randomised, open-label, non-inferiority NOBLE trial was done at 36 hospitals in nine northern European countries. Patients with left main coronary artery disease requiring revascularisation were enrolled and randomly assigned (1:1) to receive PCI or CABG. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, repeat revascularisation, and stroke. Non-inferiority of PCI to CABG was defined as the upper limit of the 95% CI of the hazard ratio (HR) not exceeding 1·35 after 275 MACCE had occurred. Secondary endpoints included all-cause mortality, non-procedural myocardial infarction, and repeat revascularisation. Outcomes were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01496651.

FINDINGS: Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were enrolled and allocated to PCI (n=598) or CABG (n=603), with 17 subsequently lost to early follow-up. 592 patients in each group were included in this analysis. At a median of 4·9 years of follow-up, the predefined number of events was reached for adequate power to assess the primary endpoint. Kaplan-Meier 5-year estimates of MACCE were 28% (165 events) for PCI and 19% (110 events) for CABG (HR 1·58 [95% CI 1·24-2·01]); the HR exceeded the limit for non-inferiority of PCI compared to CABG. CABG was found to be superior to PCI for the primary composite endpoint (p=0·0002). All-cause mortality was estimated in 9% after PCI versus 9% after CABG (HR 1·08 [95% CI 0·74-1·59]; p=0·68); non-procedural myocardial infarction was estimated in 8% after PCI versus 3% after CABG (HR 2·99 [95% CI 1·66-5·39]; p=0·0002); and repeat revascularisation was estimated in 17% after PCI versus 10% after CABG (HR 1·73 [95% CI 1·25-2·40]; p=0·0009).

INTERPRETATION: In revascularisation of left main coronary artery disease, PCI was associated with an inferior clinical outcome at 5 years compared with CABG. Mortality was similar after the two procedures but patients treated with PCI had higher rates of non-procedural myocardial infarction and repeat revascularisation.

Place, publisher, year, edition, pages
Elsevier, 2020
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:oru:diva-78894 (URN)10.1016/S0140-6736(19)32972-1 (DOI)000507614200032 ()31879028 (PubMedID)2-s2.0-85077932447 (Scopus ID)
Note

Funding Agency:

Biosensors

Available from: 2020-01-07 Created: 2020-01-07 Last updated: 2020-01-31Bibliographically approved
Sharma, T., Rylance, R., Karlsson, S., Koul, S., Venetsanos, D., Omerovic, E., . . . Erlinge, D. (2020). Relationship between degree of heparin anticoagulation and clinical outcome in patients receiving potent P2Y12-inhibitors with no planned GPI during primary percutaneous coronary intervention in acute myocardial infarction: a VALIDATE-SWEDEHEART substudy. European Heart Journal - Cardiovascular Pharmacotherapy, 6(1), 6-13
Open this publication in new window or tab >>Relationship between degree of heparin anticoagulation and clinical outcome in patients receiving potent P2Y12-inhibitors with no planned GPI during primary percutaneous coronary intervention in acute myocardial infarction: a VALIDATE-SWEDEHEART substudy
Show others...
2020 (English)In: European Heart Journal - Cardiovascular Pharmacotherapy, ISSN 2055-6837, E-ISSN 2055-6845, Vol. 6, no 1, p. 6-13Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Heparin is the preferred choice of anticoagulant in percutaneous coronary intervention (PCI) for acute myocardial infarction (MI). An established dosage of heparin has not yet been determined, but treatment may be optimized through monitoring of activating clotting time (ACT). The aim of this study was to determine the relationship between heparin dose or ACT with a composite outcome of death, MI or bleeding using data from the registry-based, randomized, controlled and open-label VALIDATE-SWEDEHEART-trial, although patients were not randomized to heparin dose in this sub-study.

METHODS: Patients with MI undergoing PCI and receiving treatment with a potent P2Y12-inhibitor and anticoagulation with heparin, without the planned use of glycoprotein IIb/IIIa inhibitor (GPI), were enrolled in this substudy. The primary endpoint was a composite end point of death, MI and bleeding at 30 days. The individual components and stent thrombosis were analyzed separately. We divided patients into groups according to the initial dose of unfractionated heparin during PCI (<70U/kg, 70-100U/kg and >100U/kg) or ACT (ACT <250 sec, 250-350 sec and >350 sec) as well as investigating them as continuous variables in Cox proportional hazards models using univariable and multivariable analyses.

RESULTS: No major differences were noted between heparin stratified in groups (p = 0.22) or heparin as a continuous variable in relation to the primary composite endpoint HR 1.0 CI (0.99-1.01) for heparin dose/kg. No differences were found between ACT stratified in groups (p = 0.453) or ACT in seconds HR 1.0 CI (0.99-1.00) regarding the primary endpoint. The individual components of death, MI, major bleeding and stent thrombosis were not significantly different across heparin doses or ACT levels either.

CONCLUSIONS: We found no association between heparin dose or ACT levels and death, MI bleeding complications or stent thrombosis. Therefore, there is no strong support for a specific heparin dose or mandatory ACT monitoring in patients treated with potent P2Y12-inhibitors with no planned GPI.

Place, publisher, year, edition, pages
Oxford University Press, 2020
Keywords
Heparin, NSTEMI, PCI, STEMI, activated clotting time
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:oru:diva-74319 (URN)10.1093/ehjcvp/pvz015 (DOI)31093662 (PubMedID)
Available from: 2019-05-20 Created: 2019-05-20 Last updated: 2020-01-10Bibliographically approved
Buccheri, S., Sarno, G., Fröbert, O., Gudnason, T., Lagerqvist, B., Lindholm, D., . . . James, S. (2019). Assessing the Nationwide Impact of a Registry-Based Randomized Clinical Trial on Cardiovascular Practice The TASTE Trial in Perspective. Circulation. Cardiovascular Interventions, 12(3), Article ID e007381.
Open this publication in new window or tab >>Assessing the Nationwide Impact of a Registry-Based Randomized Clinical Trial on Cardiovascular Practice The TASTE Trial in Perspective
Show others...
2019 (English)In: Circulation. Cardiovascular Interventions, ISSN 1941-7640, E-ISSN 1941-7632, Vol. 12, no 3, article id e007381Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Registry-based randomized clinical trials have emerged as useful tools to provide evidence on the comparative efficacy and safety of different therapeutic strategies. However, it remains unknown whether the results of registry-based randomized clinical trials have a sizable impact on daily clinical practice. We sought, therefore, to describe the temporal trends in thrombus aspiration (TA) use in Sweden before, during, and after dissemination of the TASTE trial (Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia) results.

METHODS AND RESULTS: From January 1, 2006, to December 31, 2017, we included all consecutive patients with ST-segment-elevation myocardial infarction undergoing percutaneous revascularization in Sweden. All patients were registered in the Swedish Coronary Angiography and Angioplasty Registry. A total of 55 809 ST-segment-elevation myocardial infarction patients were included. TA use in Sweden substantially decreased after dissemination of TASTE results (from 39.8% to 11.8% during and after TASTE, respectively). Substantial variability in TA use across treating centers was observed before TASTE (TA use ranging from 0% to 70%), but after TASTE both the interhospital variability and the frequency of TA use were markedly reduced. A constant shift in medical practice was seen about 4 months after dissemination of the TASTE trial results. Time trends for all-cause mortality and definite stent thrombosis at 30 days were not associated with variations in TA use (P values >0.05 using the Granger test).

CONCLUSIONS: In Sweden, the results of the TASTE trial were impactful in daily clinical practice and led to a relevant decrease in TA use in ST-segment-elevation myocardial infarction patients undergoing percutaneous revascularization.

Place, publisher, year, edition, pages
Lippincott Williams & Wilkins, 2019
Keywords
clinical trial, mortality, myocardial infarction, registry, thrombosis
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:oru:diva-74645 (URN)10.1161/CIRCINTERVENTIONS.118.007381 (DOI)000469353600004 ()30841711 (PubMedID)2-s2.0-85062595619 (Scopus ID)
Note

Funding Agencies:

Swedish government  

Swedish Association of Local Authorities and Regions 

Available from: 2019-06-10 Created: 2019-06-10 Last updated: 2019-06-10Bibliographically approved
Erlinge, D., Koul, S., Omerovic, E., Fröbert, O., Linder, R., Danielewicz, M., . . . James, S. (2019). Bivalirudin versus heparin monotherapy in non-ST-segment elevation myocardial infarction. European heart journal. Acute cardiovascular care., 8(6), 492-501
Open this publication in new window or tab >>Bivalirudin versus heparin monotherapy in non-ST-segment elevation myocardial infarction
Show others...
2019 (English)In: European heart journal. Acute cardiovascular care., ISSN 2048-8726, Vol. 8, no 6, p. 492-501Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: The optimal anti-coagulation strategy for patients with non-ST-elevation myocardial infarction treated with percutaneous coronary intervention is unclear in contemporary clinical practice of radial access and potent P2Y12-inhibitors. The aim of this study was to investigate whether bivalirudin was superior to heparin monotherapy in patients with non-ST-elevation myocardial infarction without routine glycoprotein IIb/IIIa inhibitor use.

METHODS: In a large pre-specified subgroup of the multicentre, prospective, randomised, registry-based, open-label clinical VALIDATE-SWEDEHEART trial we randomised patients with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention, treated with ticagrelor or prasugrel, to bivalirudin or heparin monotherapy with no planned use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention. The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days.

RESULTS: A total of 3001 patients with non-ST-elevation myocardial infarction, were enrolled. The primary endpoint occurred in 12.1% (182 of 1503) and 12.5% (187 of 1498) of patients in the bivalirudin and heparin groups, respectively (hazard ratio of bivalirudin compared to heparin treatment 0.96, 95% confidence interval 0.78-1.18, p=0.69). The results were consistent in all major subgroups. All-cause death occurred in 2.0% versus 1.7% (hazard ratio 1.15, 0.68-1.94, p=0.61), myocardial infarction in 2.3% versus 2.5% (hazard ratio 0.91, 0.58-1.45, p=0.70), major bleeding in 8.9% versus 9.1% (hazard ratio 0.97, 0.77-1.24, p=0.82) and definite stent thrombosis in 0.3% versus 0.2% (hazard ratio 1.33, 0.30-5.93, p=0.82).

CONCLUSION: Bivalirudin as compared to heparin during percutaneous coronary intervention for non-ST-elevation myocardial infarction did not reduce the composite of all-cause death, myocardial infarction or major bleeding in non-ST-elevation myocardial infarction patients receiving current recommended treatments with modern P2Y12-inhibitors and predominantly radial access.

Place, publisher, year, edition, pages
Sage Publications, 2019
Keywords
Bivalirudin, heparin, non-ST-elevation myocardial infarction
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:oru:diva-69263 (URN)10.1177/2048872618805663 (DOI)000484942800002 ()30281320 (PubMedID)
Funder
Swedish Heart Lung FoundationSwedish Research CouncilAstraZenecaSwedish Foundation for Strategic Research
Note

Funding Agency:

the Medicines Company

Available from: 2018-10-04 Created: 2018-10-04 Last updated: 2019-11-08Bibliographically approved
Buccheri, S., James, S., Lindholm, D., Fröbert, O., Olivecrona, G. K., Persson, J., . . . Sarno, G. (2019). Clinical and angiographic outcomes of bioabsorbable vs. permanent polymer drug-eluting stents in Sweden: a report from the Swedish Coronary and Angioplasty Registry (SCAAR). European Heart Journal, 40(31), 2607-2615
Open this publication in new window or tab >>Clinical and angiographic outcomes of bioabsorbable vs. permanent polymer drug-eluting stents in Sweden: a report from the Swedish Coronary and Angioplasty Registry (SCAAR)
Show others...
2019 (English)In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 40, no 31, p. 2607-2615Article in journal (Refereed) Published
Abstract [en]

AIMS: Randomized clinical trials have consistently demonstrated the non-inferiority of bioabsorbable polymer drug-eluting stents (BP-DES) with respect to DES having permanent polymers (PP-DES). To date, the comparative performance of BP- and PP-DES in the real world has not been extensively investigated.

METHODS AND RESULTS: From October 2011 to June 2016, we analysed the outcomes associated with newer generation DES use in Sweden. After stratification according to the type of DES received at the index procedure, a total of 16 504 and 79 106 stents were included in the BP- and PP-DES groups, respectively. The Kaplan-Meier estimates for restenosis at 2 years were 1.2% and 1.4% in BP- and PP-DES groups, respectively. Definite stent thrombosis (ST) was low in both groups (0.5% and 0.7% in BP- and PP-DES groups, respectively). The adjusted hazard ratio (HR) for either restenosis or definite ST did not differ between BP- and PP-DES [adjusted HR 0.95, 95% confidence interval (CI) 0.74-1.21; P = 0.670 and adjusted HR 0.79, 95% CI 0.57-1.09; P = 0.151, respectively]. Similarly, there were no differences in the adjusted risk of all-cause death and myocardial infarction (MI) between the two groups (adjusted HR for all-cause death 1.01, 95% CI 0.82-1.25; P = 0.918 and adjusted HR for MI 1.05, 95% CI 0.93-1.19; P = 0.404).

CONCLUSION: In a large, nationwide, and unselected cohort of patients, percutaneous coronary intervention with BP-DES implantation was not associated with an incremental clinical benefit over PP-DES use at 2 years follow-up.

Place, publisher, year, edition, pages
Oxford University Press, 2019
Keywords
Bioabsorbable polymer, Clinical outcomes, Drug-eluting stents, Permanent polymer, Stent failure
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:oru:diva-75831 (URN)10.1093/eurheartj/ehz244 (DOI)000490151500012 ()31079155 (PubMedID)2-s2.0-85071349781 (Scopus ID)
Note

Funding Agencies:

Swedish government  

Swedish Association of Local Authorities and Regions 

Available from: 2019-08-23 Created: 2019-08-23 Last updated: 2019-11-15Bibliographically approved
Ritsinger, V., Jensen, J., Ohm, D., Omerovic, E., Koul, S., Fröbert, O., . . . Norhammar, A. (2019). Elevated admission glucose is common and associated with high short-term complication burden after acute myocardial infarction: Insights from the VALIDATE-SWEDEHEART study. Diabetes & Vascular Disease Research, 16(6), 582-584
Open this publication in new window or tab >>Elevated admission glucose is common and associated with high short-term complication burden after acute myocardial infarction: Insights from the VALIDATE-SWEDEHEART study
Show others...
2019 (English)In: Diabetes & Vascular Disease Research, ISSN 1479-1641, E-ISSN 1752-8984, Vol. 16, no 6, p. 582-584Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: To investigate the association between admission plasma glucose and cardiovascular events in patients with acute myocardial infarction treated with modern therapies including early percutaneous coronary intervention and modern stents.

METHODS: = 5309) with established diabetes and patients without previously known diabetes with a reported admission plasma glucose, included in the VALIDATE trial 2014-2016, were followed for cardiovascular events (first of mortality, myocardial infarction, stroke, heart failure) within 180 days. Event rates were analysed by four glucose categories according to the World Health Organization criteria for hyperglycaemia and definition of diabetes. Odds ratios were calculated in a multivariate logistic regression model.

RESULTS: < 0.001), while bleeding complications did not differ significantly (9.1%, 8.5%, 8.4%, 12.2% and 8.5%, respectively). After adjustment, odds ratio (95% confidence interval) was 1.00 (0.65-1.53) for group II, 1.62 (1.14-2.29) for group III and 3.59 (1.99-6.50) for group IV compared to the lowest admission plasma glucose group (group I). The corresponding number for known diabetes was 2.42 (1.71-3.42).

CONCLUSION: In a well-treated contemporary population of acute myocardial infarction patients, 42% of those without diabetes had elevated admission plasma glucose levels with a greater risk for clinical events already within 180 days. Event rate increased with increasing admission plasma glucose levels. These findings highlight the importance of searching for undetected diabetes in the setting of acute myocardial infarction and that new treatment options are needed to improve outcome.

Place, publisher, year, edition, pages
Sage Publications, 2019
Keywords
Myocardial infarction, diabetes, hyperglycaemia, prognosis
National Category
Endocrinology and Diabetes
Identifiers
urn:nbn:se:oru:diva-76167 (URN)10.1177/1479164119871540 (DOI)000485080700001 ()31476896 (PubMedID)2-s2.0-85072090902 (Scopus ID)
Funder
Swedish Heart Lung FoundationSwedish Research CouncilAstraZenecaSwedish Foundation for Strategic Research
Note

Funding Agencies:

Department of Research and Development Region Kronoberg  

Kamprad Family Foundation 

Medicines Company

Available from: 2019-09-10 Created: 2019-09-10 Last updated: 2019-11-15Bibliographically approved
Athlin, S., Larsson, E., Nordenskjöld, A. M. & Fröbert, O. (2019). Evaluation of the novel IMMUVIEW RSV antigen test for detection of respiratory syncytial virus in adults and children. In: : . Paper presented at 29th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), Amsterdam, Netherlands, 13-16 April, 2019.
Open this publication in new window or tab >>Evaluation of the novel IMMUVIEW RSV antigen test for detection of respiratory syncytial virus in adults and children
2019 (English)Conference paper, Poster (with or without abstract) (Other academic)
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-73799 (URN)
Conference
29th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), Amsterdam, Netherlands, 13-16 April, 2019
Available from: 2019-04-16 Created: 2019-04-16 Last updated: 2019-04-24Bibliographically approved
Arevström, L., Bergh, C., Landberg, R., Wu, H., Rodriguez-Mateos, A., Waldenborg, M., . . . Fröbert, O. (2019). Freeze-dried bilberry (Vaccinium myrtillus) dietary supplement improves walking distance and lipids after myocardial infarction: an open-label randomized clinical trial. Nutrition Research, 62, 13-22
Open this publication in new window or tab >>Freeze-dried bilberry (Vaccinium myrtillus) dietary supplement improves walking distance and lipids after myocardial infarction: an open-label randomized clinical trial
Show others...
2019 (English)In: Nutrition Research, ISSN 0271-5317, E-ISSN 1879-0739, Vol. 62, p. 13-22Article in journal (Refereed) Published
Abstract [en]

Bilberries, Vaccinium myrtillus, have a high content of phenolic compounds including anthocyanins, which could provide cardiometabolic health benefits following acute myocardial infarction (AMI). We hypothesized that standard medical therapy supplemented with freeze-dried bilberry after AMI would have a more beneficial effect on cardiovascular risk markers and exercise capacity than medical therapy alone. Patients were allocated in a 1:1 ratio within 24 hours of percutaneous coronary intervention in an 8-week trial either to V myrtillus powder (40 g/d, equivalent to 480 g fresh bilberries) and standard medical therapy or to a control group receiving standard medical therapy alone. High-sensitivity C-reactive protein and exercise capacity measured with the 6-minute walk test were the primary biochemical and clinical end points, respectively. Fifty subjects completed the study. No statistically significant difference in high-sensitivity C-reactive protein was detected between groups. The mean 6-minute walk test distance increased significantly more in the bilberry group compared to the control group: mean difference 38 m at follow-up (95% confidence interval 14-62, P = .003). Ex vivo oxidized low-density lipoprotein was significantly lowered in the bilberry group compared to control, geometric mean ratio 0.80 (95% confidence interval 0.66-0.96, P = .017), whereas total cholesterol and low-density lipoprotein cholesterol did not differ significantly between groups. Anthocyanin-derived metabolites in blood increased significantly in the bilberry group during the intervention and were different after 8 weeks between the bilberry group and control. Findings in the present study suggest that bilberries may have clinically relevant beneficial effects following AMI; a larger, double-blind clinical trial is warranted to confirm this.

Place, publisher, year, edition, pages
Elsevier, 2019
Keywords
Anthocyanins, Bilberries, Cholesterol, Exercise test, Inflammation, Myocardial Infarction
National Category
Nutrition and Dietetics
Identifiers
urn:nbn:se:oru:diva-73342 (URN)10.1016/j.nutres.2018.11.008 (DOI)000460848800002 ()30803503 (PubMedID)2-s2.0-85058196483 (Scopus ID)
Note

Funding Agency:

Örebro University Hospital Research Foundation

Available from: 2019-03-26 Created: 2019-03-26 Last updated: 2019-03-26Bibliographically approved
Relton, C., Zwarenstein, M., Hemkens, L. G., Verkooijen, H. M. & Fröbert, O. (2019). Health System Trials. Paper presented at 5th International Clinical Trials Methodology Conference (ICTMC 2019), Brighton, UK, October 6-9, 2019. Trials, 20, 115-115
Open this publication in new window or tab >>Health System Trials
Show others...
2019 (English)In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 20, p. 115-115Article in journal, Meeting abstract (Other academic) Published
Abstract [en]

Pragmatic randomised trials aim to provide evidence to support decisions by stakeholders in healthcare systems (patients, clinicians, funders, policy makers). The typical pragmatic trial recruits participantwho provide data for the trial using purpose built data collection systems. At the end of the trial–all is disbanded. This approach is costland frequently fails to recruit sufficiently large or representativsamples.

Since the advent of electronic data, pragmatic trials are increasingly using routine health data collected from administrative, clinical and patient sources. A new group of trial designs have emerged which we describe as ‘Health System Trials’. These include Registry-based Randomised Controlled Trials (RRCTs), Electronic Health Record (EHR) Trials, Administrative Data (AD) Trials and Trials within Cohorts (TwiCs). These four designs purposefully utilise existing and/or newly created health system data structures for one or more trial activities: identifying potential trial participants, recruitment, randomisation, process and outcome data collection, etc. The process of informed consent is often spread out (staged) as occurs in routine healthcare especially with TwiCs designs.

By utilising populations within health systems and the data that derives from their healthcare encounters, these trials efficiently recruit large representative populations and obtain both short and longerterm outcomes. These designs reduce the effort and cost of trials whilst improving the applicability of the trial results for decision makers in health systems.

We discuss the opportunities for these types of trial designs to be integrated within health systems, enabling the continuous generation of knowledge that is an essential feature of learning health systems. CONSORT Reporting guidelines for Trials Using Cohorts and Routine Health Data are currently being developed. Drawing on development work for these guidelines we describe real world examples of ‘HealthSystem Trials’, including examples of both nascent vertical (disease focused) and horizontal (e.g. practice based) learning health systems.

Place, publisher, year, edition, pages
BMC, 2019
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
urn:nbn:se:oru:diva-77764 (URN)10.1186/s13063-019-3688-6 (DOI)000491426300351 ()
Conference
5th International Clinical Trials Methodology Conference (ICTMC 2019), Brighton, UK, October 6-9, 2019
Available from: 2019-11-05 Created: 2019-11-05 Last updated: 2019-11-05Bibliographically approved
Karlsson, S., Andell, P., Mohammad, M. A., Koul, S., Olivecrona, G. K., James, S. K., . . . Erlinge, D. (2019). Heparin pre-treatment in patients with ST-segment elevation myocardial infarction and the risk of intracoronary thrombus and total vessel occlusion: Insights from the TASTE trial. European heart journal. Acute cardiovascular care., 8(1), 15-23
Open this publication in new window or tab >>Heparin pre-treatment in patients with ST-segment elevation myocardial infarction and the risk of intracoronary thrombus and total vessel occlusion: Insights from the TASTE trial
Show others...
2019 (English)In: European heart journal. Acute cardiovascular care., ISSN 2048-8726, Vol. 8, no 1, p. 15-23Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Pre-treatment with unfractionated heparin is common in ST-segment elevation myocardial infarction (STEMI) protocols, but the effect on intracoronary thrombus burden is unknown. We studied the effect of heparin pre-treatment on intracoronary thrombus burden and Thrombolysis in Myocardial Infarction (TIMI) flow prior to percutaneous coronary intervention in patients with STEMI.

METHODS: The Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia (TASTE) trial angiographically assessed intracoronary thrombus burden and TIMI flow, prior to percutaneous coronary intervention, in patients with STEMI. In this observational sub-study, patients pre-treated with heparin were compared with patients not pre-treated with heparin. Primary end points were a visible intracoronary thrombus and total vessel occlusion prior to percutaneous coronary intervention. Secondary end points were in-hospital bleeding, in-hospital stroke and 30-day all-cause mortality.

RESULTS: Heparin pre-treatment was administered in 2898 out of 7144 patients (41.0%). Patients pre-treated with heparin less often presented with an intracoronary thrombus (61.3% vs. 66.0%, p<0.001) and total vessel occlusion (62.9% vs. 71.6%, p<0.001). After adjustments, heparin pre-treatment was independently associated with a reduced risk of intracoronary thrombus (odds ratio (OR) 0.73, 95% confidence interval (CI)=0.65-0.83) and total vessel occlusion (OR 0.64, 95% CI=0.56-0.73), prior to percutaneous coronary intervention. There were no significant differences in secondary end points of in-hospital bleeding (OR 0.84, 95% CI=0.55-1.27), in-hospital stroke (OR 1.17, 95% CI=0.48-2.82) or 30-day all-cause mortality (hazard ratio 0.88, 95% CI=0.60-1.30).

CONCLUSIONS: Heparin pre-treatment was independently associated with a lower risk of intracoronary thrombus and total vessel occlusion before percutaneous coronary intervention in patients with STEMI, without evident safety concerns, in this large multi-centre observational study.

Place, publisher, year, edition, pages
Sage Publications, 2019
Keywords
Heparin, STEMI, pre-treatment
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:oru:diva-61684 (URN)10.1177/2048872617727723 (DOI)000458875700004 ()28862032 (PubMedID)2-s2.0-85061236039 (Scopus ID)
Funder
Swedish Heart Lung Foundation, 20160495Swedish Research Council, K2013-65X-13130-15-5Knut and Alice Wallenberg Foundation, Dnr KAW 2014.0292
Note

Funding Agencies:

SSF (TOTAL-AMI)  KF10-0024

ALF  

Skåne University Hospital funds 

Available from: 2017-11-14 Created: 2017-11-14 Last updated: 2019-03-07Bibliographically approved
Organisations

Search in DiVA

Show all publications