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Publications (10 of 29) Show all publications
Lipcsey, M., Aronsson, A., Larsson, A., Renlund, H. & Gedeborg, R. (2019). Multivariable models using administrative data and biomarkers to adjust for case mix in the ICU. Acta Anaesthesiologica Scandinavica, 63(6), 751-760
Open this publication in new window or tab >>Multivariable models using administrative data and biomarkers to adjust for case mix in the ICU
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2019 (English)In: Acta Anaesthesiologica Scandinavica, ISSN 0001-5172, E-ISSN 1399-6576, Vol. 63, no 6, p. 751-760Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Routinely collected laboratory biomarkers could improve control of confounding from disease severity in non-interventional studies of general intensive care unit (ICU) patients. Their ability to predict both short- and long-term mortality was evaluated.

METHODS: The performance of age, sex, Charlson co-morbidity index, and baseline values of ten predefined blood biomarkers as predictors of 30-day and 1-year mortality was evaluated in 5505 general ICU stays.

RESULTS: Regression models based on age, sex, Charlson index, and biomarkers were somewhat less accurate in predicting 30-day mortality (c-index 0.83, Brier score 0.27) compared to the SAPS II score (c-index = 0.88, Brier score = 0.09) and in predicting 1-year mortality (c-index = 0.82, Brier score = 0.31) compared to the SAPS II score (c-index = 0.85, Brier score = 0.13). Cystatin C improved predictive ability slightly compared to creatinine, but age and Charlson comorbidity index were more important predictors. Using multiple imputation to replace missing biomarker values notably improved predictive ability of the models.

CONCLUSIONS: Automatically collected baseline variables are almost as predictive of both short- and long-term mortality in general ICU patients, as the SAPS II score. This can facilitate internal control of confounding in non-interventional studies of mortality using administrative data.

Keywords
creatinine, cystatin C, intensive care, logistic models, mortality
National Category
Anesthesiology and Intensive Care
Identifiers
urn:nbn:se:uu:diva-377642 (URN)10.1111/aas.13338 (DOI)000472664500008 ()30734281 (PubMedID)
Available from: 2019-02-23 Created: 2019-02-23 Last updated: 2019-09-12Bibliographically approved
Mahmoud, K. D., Jolly, S. S., James, S. K., Dzavik, V., Cairns, J. A., Olivecrona, G. K., . . . Zijlstra, F. (2018). Clinical impact of direct stenting and interaction with thrombus aspiration in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: Thrombectomy Trialists Collaboration. European Heart Journal, 39(26), 2472-2479
Open this publication in new window or tab >>Clinical impact of direct stenting and interaction with thrombus aspiration in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: Thrombectomy Trialists Collaboration
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2018 (English)In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 39, no 26, p. 2472-2479Article in journal (Refereed) Published
Abstract [en]

Aims Preliminary studies suggest that direct stenting (DS) during percutaneous coronary intervention (PCI) may reduce microvascular obstruction and improve clinical outcome. Thrombus aspiration may facilitate DS. We assessed the impact of DS on clinical outcome and myocardial reperfusion and its interaction with thrombus aspiration among ST-segment elevation myocardial infarction (STEMI) patients undergoing PCI. Methods and results Patient-level data from the three largest randomized trials on routine manual thrombus aspiration vs. PCI only were merged. A 1:1 propensity matched population was created to compare DS and conventional stenting. Synergy between DS and thrombus aspiration was assessed with interaction P-values in the final models. In the unmatched population (n= 17329), 32% underwent DS and 68% underwent conventional stenting. Direct stenting rates were higher in patients randomized to thrombus aspiration as compared with PCI only (41% vs. 22%; P < 0.001). Patients undergoing DS required less contrast (162 mL vs. 172 mL; P < 0.001) and had shorter fluoroscopy time (11.1 min vs. 13.3 min; P < 0.001). After propensity matching (n = 10944), no significant differences were seen between DS and conventional stenting with respect to 30-day cardiovascular death [1.7% vs. 1.9%; hazard ratio 0.88, 95% confidence interval (CI) 0.55-1.41; P=0.60; P-interaction = 0.96) and 30-day stroke or transient ischaemic attack (0.6% vs. 0.4%; odds ratio 1.02; 95% CI 0.14-7.54; P= 0.99; P-interaction = 0.81). One-year results were similar. No significant differences were seen in electrocardiographic and angiographic myocardial reperfusion measures. Conclusion Direct stenting rates were higher in patients randomized to thrombus aspiration. Clinical outcomes and myocardial reperfusion measures did not differ significantly between DS and conventional stenting and there was no interaction with thrombus aspiration.

Place, publisher, year, edition, pages
OXFORD UNIV PRESS, 2018
Keywords
Myocardial infarction, Myocardial reperfusion, Percutaneous coronary intervention, Thrombectomy, Stents
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:uu:diva-361276 (URN)10.1093/eurheartj/ehy219 (DOI)000438554000008 ()29688419 (PubMedID)
Funder
AstraZeneca
Available from: 2018-09-27 Created: 2018-09-27 Last updated: 2018-09-27Bibliographically approved
Själander, S., Sjögren, V., Renlund, H., Norrving, B. & Sjalander, A. (2018). Dabigatran, rivaroxaban and apixaban vs. high TTR warfarin in atrial fibrillation. Thrombosis Research, 167, 113-118
Open this publication in new window or tab >>Dabigatran, rivaroxaban and apixaban vs. high TTR warfarin in atrial fibrillation
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2018 (English)In: Thrombosis Research, ISSN 0049-3848, E-ISSN 1879-2472, Vol. 167, p. 113-118Article in journal (Refereed) Published
Abstract [en]

Introduction: New oral anticoagulants are non-inferior compared with warfarin regarding stroke prevention in atrial fibrillation, with similar or decreased risk of bleeding. However, it is unclear whether high TTR warfarin is as effective and safe as NOACs. Our objective was to investigate efficacy and safety of apixaban, dabigatran or rivaroxaban compared with warfarin in clinical practice. Materials and methods: Nationwide retrospective cohort study based on Swedish quality registries. Atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban or warfarin between 2013-01-01 and 2015-1231 were included. Main outcome measures were all-cause stroke and systemic embolism, all-cause stroke, ischemic stroke, hemorrhagic stroke; major bleeding, intracranial bleeding, gastrointestinal bleeding, other bleeding (fatal or requiring hospital care); all-cause mortality; myocardial infarction. Results: The study included 64,382 patients corresponding to 81,176 treatment years. Of these, 37,174 patients were instituted on warfarin, 6574 on dabigatran, 8323 on rivaroxaban and 12,311 on apixaban. In warfarin treated patients, the time in therapeutic range was 71.4%. After propensity score matching, there was no significant difference in risk of stroke or systemic embolism between NOAC and warfarin treated patients. Hazard ratios for major bleeding events were 0.63(95% CI 0.52-0.75) for apixaban, 0.74(0.62-0.87) for dabigatran and 1.06(0.92-1.23) for rivaroxaban, compared with warfarin. Conclusions: This study showed no difference between apixaban, dabigatran, or rivaroxaban compared to high TTR warfarin treatment regarding stroke prevention. However, fewer bleeding events were seen for apixaban and dabigatran, but not for rivaroxaban. Further studies are needed on the comparability of individual NOACs with respect to bleeding risks.

Place, publisher, year, edition, pages
PERGAMON-ELSEVIER SCIENCE LTD, 2018
Keywords
Oral anticoagulation, Time in therapeutic range, Atrial fibrillation, Stroke
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:uu:diva-361101 (URN)10.1016/j.thromres.2018.05.022 (DOI)000437845800020 ()29803981 (PubMedID)
Funder
Swedish Heart Lung Foundation, 20150435
Available from: 2018-09-21 Created: 2018-09-21 Last updated: 2018-09-21Bibliographically approved
Edfors, R., Sahlen, A., Szummer, K., Renlund, H., Evans, M., Carrero, J.-J., . . . Jernberg, T. (2018). Outcomes in patients treated with ticagrelor versus clopidogrel after acute myocardial infarction stratified by renal function. Heart, 104(19), 1575-1582
Open this publication in new window or tab >>Outcomes in patients treated with ticagrelor versus clopidogrel after acute myocardial infarction stratified by renal function
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2018 (English)In: Heart, ISSN 1355-6037, E-ISSN 1468-201X, Vol. 104, no 19, p. 1575-1582Article in journal (Refereed) Published
Abstract [en]

Objectives We aimed to analyse outcomes of ticagrelor and clopidogrel stratified by estimated glomerular filtration rate (eGFR) in a large unselected cohort of patients with acute myocardial infarction (MI). Methods We used follow-up data in MI survivors discharged on ticagrelor or clopidogrel enrolled in the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies registry. The association between ticagrelor versus clopidogrel and the primary composite outcome of death, MI or stroke and the secondary outcome rehospitalisation with bleeding diagnosis at 1year, was studied using adjusted Cox proportional hazards models, stratifying after eGFR levels. Results In total, 45 206 patients with MI discharged on clopidogrel (n=33472) or ticagrelor (n=11734) were included. The unadjusted 1-year event rate for the composite endpoint of death, MI or stroke was 7.0%, 18.0% and 48.0% for ticagrelor treatment and 11.0%, 33.0% and 64.0% for clopidogrel treatment in patients with eGFR(>60) (n=33668), eGFR(30-60) (n=9803) and eGFR(<30) (n=1735), respectively. After adjustment, ticagrelor as compared with clopidogrel was associated with a lower 1-year risk of the composite outcome (eGFR(>60): HR 0.87, 95%CI 0.76 to 99, eGFR(30-60): 0.82 (0.70 to 0.97), eGFR(<30): 0.95 (0.69 to 1.29), P for interaction=0.55) and a higher risk of bleeding (eGFR(>60): HR 1.10, 95%CI 0.90 to 1.35, eGFR(30-60): 1.13 (0.84 to 1.51), eGFR(<30): 1.79 (1.00 to 3.21), P for interaction=0.30) across the eGFR strata. Conclusions Treatment with ticagrelor as compared with clopidogrel in patients with MI was associated with lower risk for the composite of death, MI or stroke and a higher bleeding risk across all strata of eGFR. Of caution, bleeding events were more abundant in patients with eGFR(<30).

Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2018
Keywords
acute myocardial infarction, coronary artery disease, acute coronary syndromes, epidemiology
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:uu:diva-367414 (URN)10.1136/heartjnl-2017-312436 (DOI)000446083900007 ()29574413 (PubMedID)
Funder
Swedish Foundation for Strategic Research Swedish Heart Lung FoundationStockholm County Council
Available from: 2018-12-03 Created: 2018-12-03 Last updated: 2019-01-21Bibliographically approved
Sanden, P., Renlund, H., Svensson, P. J. & Sjalander, A. (2017). Bleeding complications and mortality in warfarin-treated VTE patients, dependence of INR variability and iTTR. Thrombosis and Haemostasis, 117(1), 27-32
Open this publication in new window or tab >>Bleeding complications and mortality in warfarin-treated VTE patients, dependence of INR variability and iTTR
2017 (English)In: Thrombosis and Haemostasis, ISSN 0340-6245, Vol. 117, no 1, p. 27-32Article in journal (Refereed) Published
Abstract [en]

High quality of warfarin treatment is important to prevent recurrence of venous thromboembolism (VTE) without bleeding complications. The aim of this study was to examine the effect of individual time in therapeutic range (iTTR) and International Normalised Ratio (INR) variability on bleeding risk and mortality in a large cohort of well managed patients with warfarin due to VTE. A cohort of 16612 patients corresponding to 19502 treatment periods with warfarin due to VTE between January 1, 2006 and December 31, 2011 was retrieved from the Swedish national quality register AuriculA and matched with the Swedish National Patient Register for bleeding complications and background characteristics and the Cause of death register for occurrence and date of death. The rate of bleeding was 1.79 (confidence interval (CI) 95 % 1.66-1.93) per 100 treatment years among all patients. Those with poor warfarin treatment quality had a higher rate of clinically relevant bleeding, both when measured as iTTR below 70%, 2.91 (CI 95% 2.61-3.21) or as INR variability over the mean value 0.85, 2.61 (CI 95% 2.36-2.86). Among those with both high INR variability and low iTTR the risk of clinically relevant bleeding was clearly increased hazard ratio (HR) 3.47 (CI 95 % 2.89-4.17). A similar result was found for all-cause mortality with a HR of 3.67 (CI 95 % 3.02-4.47). Both a low iTTR and a high INR variability increase the risk of bleeding complications or mortality. When combining the two treatment quality indicators patients at particular high risk of bleeding or death can be identified.

Keywords
TTR, INR variability, venous thromboembolism, bleeding, warfarin, all-cause mortality
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:uu:diva-315071 (URN)10.1160/TH16-06-0489 (DOI)000391350600006 ()
Available from: 2017-02-28 Created: 2017-02-28 Last updated: 2017-11-29Bibliographically approved
Sjögren, V., Byström, B., Renlund, H., Svensson, P. J., Oldgren, J., Norrving, B. & Själander, A. (2017). Non-vitamin K oral anticoagulants are non-inferior for stroke prevention but cause fewer major bleedings than well-managed warfarin: A retrospective register study. PLoS ONE, 12(7), Article ID e0181000.
Open this publication in new window or tab >>Non-vitamin K oral anticoagulants are non-inferior for stroke prevention but cause fewer major bleedings than well-managed warfarin: A retrospective register study
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2017 (English)In: PLoS ONE, ISSN 1932-6203, E-ISSN 1932-6203, Vol. 12, no 7, article id e0181000Article in journal (Refereed) Published
Abstract [en]

Background For patients with atrial fibrillation, non-vitamin K oral anticoagulants, or NOACs (dabigatran, rivaroxaban, edoxaban, and apixaban) have been proven non-inferior or superior to warfarin in preventing stroke and systemic embolism, and in risk of haemorrhage. In the pivotal NOAC studies, quality of warfarin treatment was poor with mean time in therapeutic range (TTR) 55-65%, compared with >= 70% in Swedish clinical practice. Methods We compared NOACs (as a group) to warfarin in non-valvular atrial fibrillation, studying all 12,694 patients starting NOAC treatment within the Swedish clinical register and dosing system Auricula, from July 1, 2011 to December 31, 2014, and matching them to 36,317 patients starting warfarin using propensity scoring. Endpoints were thromboembolic events and major bleedings that were fatal or required hospital care. Outcome data were collected from validated Swedish hospital administrative and clinical registers. Results Mean age was 72.2 vs 72.3 years, proportion of males 58.2% vs 57.0%, and mean follow-up time 299 vs 283 days for NOACs and warfarin. Distribution of NOACs was: dabigatran 40.3%, rivaroxaban 31.2%, and apixaban 28.5%. Mean TTR was 70%. There were no significant differences in rates of thromboembolic/thrombotic events or gastrointestinal bleeding. NOAC treated patients had lower rates of major bleeding overall, hazard ratio 0.78 (95% confidence interval 0.67-0.92), intracranial bleeding 0.59 (0.40-0.87), haemorrhagic stroke 0.49 (0.28-0.86), and other major bleeding 0.71 (0.57-0.89). Conclusion For patients with atrial fibrillation, NOACs are as effective for stroke prevention as well-managed warfarin but cause fewer major bleedings.

National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:uu:diva-332432 (URN)10.1371/journal.pone.0181000 (DOI)000405544800113 ()28700711 (PubMedID)
Funder
Swedish Heart Lung Foundation, 20150435
Available from: 2017-11-01 Created: 2017-11-01 Last updated: 2017-11-29Bibliographically approved
Hellström, V., Enström, Y., Enblad, G., Tufveson, G., Renlund, H., Lorant, T. & Nyberg, F. (2017). Risk Factors for De Novo Squamous Cell Carcinoma Development in Renal Transplant Recipients with a Previous Squamous Cell Carcinoma.. Acta Dermato-Venereologica, 97(6), 751-753
Open this publication in new window or tab >>Risk Factors for De Novo Squamous Cell Carcinoma Development in Renal Transplant Recipients with a Previous Squamous Cell Carcinoma.
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2017 (English)In: Acta Dermato-Venereologica, ISSN 0001-5555, E-ISSN 1651-2057, Vol. 97, no 6, p. 751-753Article in journal, Editorial material (Refereed) Published
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-333244 (URN)10.2340/00015555-2606 (DOI)000405575100018 ()28093599 (PubMedID)
Available from: 2017-11-09 Created: 2017-11-09 Last updated: 2018-02-16Bibliographically approved
Sjögren, V., Grzymala-Lubanski, B., Renlund, H., Svensson, P. J. & Själander, A. (2017). Safety and Efficacy of Bridging With Low-Molecular-Weight Heparin During Temporary Interruptions of Warfarin: A Register-Based Cohort Study. Clinical and applied thrombosis/hemostasis, 23(8), 961-966
Open this publication in new window or tab >>Safety and Efficacy of Bridging With Low-Molecular-Weight Heparin During Temporary Interruptions of Warfarin: A Register-Based Cohort Study
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2017 (English)In: Clinical and applied thrombosis/hemostasis, ISSN 1076-0296, E-ISSN 1938-2723, Vol. 23, no 8, p. 961-966Article in journal (Refereed) Published
Abstract [en]

Low-molecular-weight heparin (LMWH) is often recommended as a bridging therapy during temporary interruptions in warfarin treatment, despite lack of evidence. The aim of this study was to see whether we could find benefit from LMWH bridging. We studied all planned interruptions of warfarin within the Swedish anticoagulation register Auricula during 2006 to 2011. Low-molecular-weight heparin bridging was compared to nonbridging (control) after propensity score matching. Complications were identified in national clinical registers for 30 days following warfarin cessation, and defined as all-cause mortality, bleeding (intracranial, gastrointestinal, or other), or thrombosis (ischemic stroke or systemic embolism, venous thromboembolism, or myocardial infarction) that was fatal or required hospital care. Of the 14 556 identified warfarin interruptions, 12 659 with a known medical background had a mean age of 69 years, 61% were males, mean CHADS(2) (1 point for each of congestive heart failure, hypertension, age 75 years, diabetes, and 2 points for stroke or transient ischemic attack) score was 1.7, and CHA(2)DS(2)-VASc score was 3.4. The total number of LMWH bridgings was 7021. Major indications for anticoagulation were mechanical heart valve prostheses 4331, atrial fibrillation 1097, and venous thromboembolism 1331. Bridging patients had a higher rate of thrombotic events overall. Total risk of any complication did not differ significantly between bridging (1.5%) and nonbridging (1.2%). Regardless of indication for warfarin treatment, we found no benefit from bridging. The type of procedure prompting bridging was not known, and the likely reason for the observed higher risk of thrombosis with LMWH bridging is that low-risk procedures more often meant no bridging. Results from randomized trials are needed, especially for patients with mechanical heart valves.

Place, publisher, year, edition, pages
SAGE PUBLICATIONS INC, 2017
Keywords
bridging, low-molecular-weight heparin, dalteparin, enoxaparin, tinzaparin, warfarin
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-337311 (URN)10.1177/1076029617706756 (DOI)000412901900009 ()28468510 (PubMedID)
Available from: 2018-01-10 Created: 2018-01-10 Last updated: 2018-01-10Bibliographically approved
Jolly, S. S., James, S., Dzavik, V., Cairns, J. A., Mahmoud, K. D., Zijlstra, F., . . . Frobert, O. (2017). Thrombus Aspiration in ST-Segment-Elevation Myocardial Infarction An Individual Patient Meta-Analysis: Thrombectomy Trialists Collaboration. Circulation, 135(2), 143-+
Open this publication in new window or tab >>Thrombus Aspiration in ST-Segment-Elevation Myocardial Infarction An Individual Patient Meta-Analysis: Thrombectomy Trialists Collaboration
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2017 (English)In: Circulation, ISSN 0009-7322, E-ISSN 1524-4539, Vol. 135, no 2, p. 143-+Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Thrombus aspiration during percutaneous coronary intervention (PCI) for the treatment of ST-segment-elevation myocardial infarction (STEMI) has been widely used; however, recent trials have questioned its value and safety. In this meta-analysis, we, the trial investigators, aimed to pool the individual patient data from these trials to determine the benefits and risks of thrombus aspiration during PCI in patients with ST-segment-elevation myocardial infarction. METHODS: Included were large (n >= 1000), randomized, controlled trials comparing manual thrombectomy and PCI alone in patients with ST-segment-elevation myocardial infarction. Individual patient data were provided by the leadership of each trial. The prespecified primary efficacy outcome was cardiovascular mortality within 30 days, and the primary safety outcome was stroke or transient ischemic attack within 30 days. RESULTS: The 3 eligible randomized trials (TAPAS [Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Myocardial Infarction], TASTE [Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia], and TOTAL [Trial of Routine Aspiration Thrombectomy With PCI Versus PCI Alone in Patients With STEMI]) enrolled 19 047 patients, of whom 18 306 underwent PCI and were included in the primary analysis. Cardiovascular death at 30 days occurred in 221 of 9155 patients (2.4%) randomized to thrombus aspiration and 262 of 9151 (2.9%) randomized to PCI alone (hazard ratio, 0.84; 95% confidence interval, 0.70-1.01; P=0.06). Stroke or transient ischemic attack occurred in 66 (0.8%) randomized to thrombus aspiration and 46 (0.5%) randomized to PCI alone (odds ratio, 1.43; 95% confidence interval, 0.98-2.10; P=0.06). There were no significant differences in recurrent myocardial infarction, stent thrombosis, heart failure, or target vessel revascularization. In the subgroup with high thrombus burden (TIMI [Thrombolysis in Myocardial Infarction] thrombus grade >= 3), thrombus aspiration was associated with fewer cardiovascular deaths (170 [2.5%] versus 205 [3.1%]; hazard ratio, 0.80; 95% confidence interval, 0.65-0.98; P=0.03) and with more strokes or transient ischemic attacks (55 [0.9%] versus 34 [0.5%]; odds ratio, 1.56; 95% confidence interval, 1.02-2.42, P=0.04). However, the interaction P values were 0.32 and 0.34, respectively. CONCLUSIONS: Routine thrombus aspiration during PCI for ST-segment-elevation myocardial infarction did not improve clinical outcomes. In the high thrombus burden group, the trends toward reduced cardiovascular death and increased stroke or transient ischemic attack provide a rationale for future trials of improved thrombus aspiration technologies in this high-risk subgroup.

Keywords
meta-analysis [publication type], myocardial infarction, thrombectomy
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:uu:diva-316036 (URN)10.1161/CIRCULATIONAHA.116.025371 (DOI)000392289500011 ()27941066 (PubMedID)
Available from: 2017-02-24 Created: 2017-02-24 Last updated: 2017-11-29Bibliographically approved
Bellavia, A., Wallentin, L., Orsini, N., James, S. K., Cannon, C. P., Himmelmann, A., . . . Lytsy, P. (2017). Time-based measures of treatment effect: reassessment of ticagrelor and clopidogrel from the PLATO trial. Open heart, 4(2), Article ID e000557.
Open this publication in new window or tab >>Time-based measures of treatment effect: reassessment of ticagrelor and clopidogrel from the PLATO trial
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2017 (English)In: Open heart, E-ISSN 2053-3624, Vol. 4, no 2, article id e000557Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: Treatment effects to binary endpoints using time-to-event data in randomised controlled trials are typically summarised by reporting HRs derived with Cox proportional hazard models. Alternative and complementary methods include summarising the between-treatment differences on the metric time scale, quantifying the effect as delay of the event (DoE). The aim of this study was to reassess data from the PLATO study expressing the effects as the time by which the main outcomes are delayed or hastened due to treatment.

METHODS: PLATO was a randomised controlled double-blind multicentre study (n=18,624), conducted between 2006 and 2008, which demonstrated superiority of the antiplatelet treatment ticagrelor over clopidogrel in reducing risk of several cardiovascular events. In the present study, four of the main PLATO outcomes were reassessed by calculating the time by which an event may be delayed due to the treatment.

RESULTS: The effects of ticagrelor, as compared with clopidogrel, consisted of a substantial delay of the evaluated outcomes, ranging from 83 to 98 days over 400-day follow-up. The Delay of Events Curves showed that the effects progressively increased over time, and the significant findings were concordant with those presented in the original PLATO study.

CONCLUSIONS: This study confirmed evidence of a beneficial effect of ticagrelor over clopidogrel, and provided the magnitude of such effects in terms of delayed event time. Investigating time-to-event data with a percentile approach allows presenting treatment effects from randomised controlled studies as absolute measures of the time by which an event may be delayed due to the treatment.

TRIAL REGISTRATION NUMBER: PLATO (www.clinicaltrials.gov; NCT00391872); Results.

Keywords
acute coronary syndrome, anticoagulation, clinical trials
National Category
Cardiac and Cardiovascular Systems
Identifiers
urn:nbn:se:uu:diva-342526 (URN)10.1136/openhrt-2016-000557 (DOI)000443629200005 ()28761675 (PubMedID)
Funder
AstraZeneca
Available from: 2018-02-21 Created: 2018-02-21 Last updated: 2018-10-29Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0002-2141-6086

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