A support programme for secondary prevention in patients with transient ischaemic attack and minor stroke (INSPiRE-TMS): an open-label, randomised controlled trial

Ahmadi, Michael; Laumeier, Inga; Ihl, Thomas; Steinicke, Maureen; Ferse, Caroline; Endres, Matthias; Grau, Armin J.; Hastrup, Sidsel; Poppert, Holger; Palm, Frederick; Schoene, M; Seifert, Christian L.; Kandil, Farid I.; Weber, Joachim E.; Weitzel-Mudersbach, Paul von; Wimmer, Martin L J; Algra, Ale; Amarenco, Pierre; Greving, Jacoba P.; Busse, O.; Köhler, Friedrich; Marx, Peter; Audebert, Heinrich J.

doi:10.1016/s1474-4422(19)30369-2

Cited by 77 publications

(127 citation statements)

References 28 publications

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“…3 B) and overall better than in previous real-world surveys in Europe [28] , especially regarding the proportion of patients with atrial fibrillation taking anticoagulants (94.3%). Similar has been observed in the INSPiRE-TMS trial [22] and attributed to the facts that patients in both trial arms were managed by the same family doctors and trial inclusion per se enhances patient awareness. It is important to recognise that the inadvertent benefit in the control groups of INSPiRE-TMS and our trial may well have led to an underestimation of true effect sizes.…”

Section: Discussionsupporting

confidence: 73%

“…In the DMP Stroke trial, rates for incident vascular events were lower in the intensified care group but statistical significance was not reached (HR 0.52; 95% CI: 0.24-1.17; P = 0.11) [21] . The recent large-scale INSPiRE-TMS trial randomised patients with acute minor stroke or TIA to an intensified secondary prevention programme or to conventional care and reported improved achievements of secondary prevention targets but no significant reduction in major vascular events [22] . Three disease management trials have addressed quality of life.…”

Section: Discussionmentioning

confidence: 99%

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STROKE-CARD care to prevent cardiovascular events and improve quality of life after acute ischaemic stroke or TIA: A randomised clinical trial

et al. 2020

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Background Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of recurrent stroke and other cardiovascular diseases and commonly suffer from reduced quality of life. We aimed to determine whether the disease management programme STROKE-CARD can prevent cardiovascular diseases and improve quality of life in these patients. Methods In this pragmatic open-label two-centre randomised controlled trial with blinded outcome assessment, we randomly assigned patients with acute ischaemic stroke or TIA (ABCD 2 score ≥3) in a 2:1 ratio to receive STROKE-CARD care or standard care. STROKE-CARD care is a disease management programme by a multidisciplinary stroke team that comprises a standardised 3-month visit and access to a web-based patient portal targeting risk factor management, post-stroke complications, comorbidities and cardiovascular warning signs, rehabilitation demands, and patient education, counselling, and self-empowerment. Co-primary outcomes were analysed on an intention-to-treat basis and were: (i) major cardiovascular disease events defined as nonfatal ischaemic or haemorrhagic stroke, nonfatal myocardial infarction, or vascular death occurring between hospital discharge and 12 months; and (ii) health-related quality of life at 12 months quantified with the EuroQol-5-Dimensions-3-Levels (EQ-5D-3L) overall utility score. This trial is registered with ClinicalTrials.gov, number NCT02156778. Findings Of 2149 patients enrolled between January 2014 and December 2017 (mean age 69 years, 41% female, 83% with ischaemic stroke, 17% with TIA), 1438 were assigned to STROKE-CARD care and 711 to standard care. Major cardiovascular disease events occurred in 78 patients in the STROKE-CARD care group (5.4%) and in 59 patients in the standard care group (8.3%) (hazard ratio, 0.63; 95% confidence interval: 0.45-0.88; P=0.007). STROKE-CARD care also led to a better EQ-5D-3L overall utility score at 12 months (P<0.001). Among pre-specified secondary outcomes, STROKE-CARD care improved all individual EQ-5D-3L dimensions and functional outcome on the modified Rankin Scale at 12 months. Post hoc explanatory analyses identified considerable demands for additional rehabilitation and refinement of preventive therapy regimes at the 3-month visit and high proportions of post-stroke complications and warning signs of imminent cardiovascular diseases within the first three months. Interpretation The pragmatic and easily implementable STROKE-CARD care programme reduced cardiovascular risk and improved health-related quality of life and functional outcome in patients with acute ischaemic stroke or TIA. Funding Tirol Kliniken, Tyrolean Health Insurance Company, Tyrol Health Care Funds, Boehringer Ingelheim, Nstim Services, Sanofi, Bayer Healthcare.

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Section: Discussionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 99%

STROKE-CARD care to prevent cardiovascular events and improve quality of life after acute ischaemic stroke or TIA: A randomised clinical trial

et al. 2020

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“…The STROKE-CARD results are different from the recently published international Intensified Secondary Prevention Intending a Reduction of Recurrent Events in TIA and Minor Stroke Patients (INSPiRE-TMS) [4] : The intervention tested in INSPiRE-TMS, consisted of feedback and motivational interviews during eight outpatient appointments over two years. While INSPiRE-TMS resulted in a higher rate of achieving treatment targets for secondary prevention, no difference in cardiovascular events was observed.…”

contrasting

confidence: 67%

Integrated care in stroke survivors: When and how much?

2020

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“…Hypertension, AF, and congestive heart failure are well-recognized stroke risk factors (27,29) and were identified in our cohort univariate analysis as independent readmission/death risk factors. Thus, in order to prevent subsequent readmissions/deaths, besides the constant monitoring of stroke secondary prevention treatments, patients must also be aware of stroke warning signs and educated about the importance of controlling stroke risk factors and adhering to the recommended medication and behavioral changes in the long term (29,(36)(37)(38)(39). This last goal may be achieved in the aftercare of stroke with well-designed and targeted multifactorial intervention programs of support, as described in the INSPiRE-TMS study (38).…”

Section: Discussionmentioning

confidence: 99%

“…Thus, in order to prevent subsequent readmissions/deaths, besides the constant monitoring of stroke secondary prevention treatments, patients must also be aware of stroke warning signs and educated about the importance of controlling stroke risk factors and adhering to the recommended medication and behavioral changes in the long term (29,(36)(37)(38)(39). This last goal may be achieved in the aftercare of stroke with well-designed and targeted multifactorial intervention programs of support, as described in the INSPiRE-TMS study (38). Although smoking habits are considered a deleterious stroke risk factor (40), the univariate analysis showed that being a current smoker may be a protective factor of readmission/death.…”

Section: Discussionmentioning

confidence: 99%

Readmissions and Mortality During the First Year After Stroke—Data From a Population-Based Incidence Study

et al. 2020

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Background: After a first-ever-in-a-lifetime stroke (FELS), hospital readmissions are common and associated with increased mortality and morbidity of stroke survivors, thus, raising the overall health burden of stroke. Population-based stroke studies on hospital readmissions are scarce despite it being an important healthcare service quality indicator. We evaluated unplanned readmissions or death during the first year after a FELS and their potential factors, based on a Portuguese community register. Methods: Data were retrieved from a population-based prospective register undertaken in Northern Portugal (ACIN2) in 2009-2011. Retrospective information about unplanned hospital readmissions and case fatality within 1 year after FELS index hospitalization (FELS-IH) was evaluated. Readmission/death-free survival 1 year after discharge was estimated using the Kaplan-Meyer method. Independent risk factors for readmission/death were identified using Cox proportional hazard models. Results: Unplanned readmission/death within 1 year occurred in 120 (31.6%) of the 389 hospitalized FELS survivors. In 31.2% and 33.5% of the cases, it occurred after ischemic stroke or intracerebral hemorrhage, respectively. Infections and cerebrovascular and cardiovascular diseases were the main causes of readmission. Of the readmissions, 65.3% and 52.5% were potentially avoidable or stroke related, respectively. The main cause of potentially avoidable readmissions was the continuation/recurrence of the event responsible for the initial admission or a closely related condition (71.2%). Male sex, age, previous and post-stroke functional status, and FELS-IH length of stay were independent factors of readmission/death within 1 year. Conclusions: Almost one-third of FELS survivors were readmitted/dead 1 year after their FELS-IH. This outcome persisted after the first months after stroke hospitalization in all stroke subtypes. More than half of readmissions were considered potentially avoidable or stroke related.

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A support programme for secondary prevention in patients with transient ischaemic attack and minor stroke (INSPiRE-TMS): an open-label, randomised controlled trial

Cited by 77 publications

References 28 publications

STROKE-CARD care to prevent cardiovascular events and improve quality of life after acute ischaemic stroke or TIA: A randomised clinical trial

STROKE-CARD care to prevent cardiovascular events and improve quality of life after acute ischaemic stroke or TIA: A randomised clinical trial

Integrated care in stroke survivors: When and how much?

Readmissions and Mortality During the First Year After Stroke—Data From a Population-Based Incidence Study

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