Antiplatelet Resumption after Antiplatelet-Related Intracerebral Hemorrhage: A Retrospective Hospital-Based Study

Teo, Kay‐Cheong; Lau, Kui Kai; Mak, Ryan H.Y.; Leung, Ho-Yan; Chang, Richard S K; Tse, Man-Yu; Lee, Raymand; Leung, Gilberto Ka-Kit; Ho, Shu-Leong; Cheung, Raymond Tak Fai; Siu, David C.W.; Chan, Koon‐Ho

doi:10.1016/j.wneu.2017.06.015

Cited by 23 publications

(35 citation statements)

References 41 publications

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“…In the longer term (months to years), findings from a systematic review and meta-analysis 9 of observational studies of patients with any type of intracranial haemorrhage (ie, intracerebral, subarachnoid, or subdural haemorrhage) showed lower risks of occlusive vascular events and no difference in haemorrhagic events associated with resumption compared with avoidance of antiplatelet therapy. Small, non-randomised observational studies of patients with intracerebral haemorrhage have reported similar associations with starting antiplatelet therapy compared with its avoidance 10, 11, 12, 13, 14. Because of the paucity of evidence, no guidelines with strong recommendations about long-term antiplatelet therapy after intracerebral haemorrhage are available,15, 16 so variations in clinical practice occur 3 .…”

Section: Introductionmentioning

confidence: 99%

Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

Salman¹,

Dennis²,

Sandercock³

et al. 2019

The Lancet

142

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Summary Background Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. Methods The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). Findings Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29–146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0– 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25–1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39–1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65–1·60]; p=0·92). Interpretation These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention. Funding British Heart Foundation.

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Section: Introductionmentioning

confidence: 99%

Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

Salman¹,

Dennis²,

Sandercock³

et al. 2019

The Lancet

142

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“…A recent systematic review and meta-analysis of observational studies of all sub-types of intracranial haemorrhage found lower risks of ischaemic events and no difference in haemorrhagic events associated with antiplatelet drug resumption [9]. Small, non-randomised observational studies restricted to patients with stroke due to ICH have reported similar associations [10][11][12][13][14], but these associations were not 'dramatic' so randomised controlled trials (RCTs) are needed to resolve this therapeutic dilemma [15]. However, such RCTs have not been published [16].…”

Section: Introductionmentioning

confidence: 93%

The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial

Salman

Murray

Dennis

et al. 2019

Preprint

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Background: For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet drugs modifies the risks of recurrent ICH, haemorrhagic events, vaso-occlusive events, or a composite of all serious vascular events compared to avoiding antiplatelet drugs. Methods/design: The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, parallel group, open, assessor-blind, randomised trial comparing starting versus avoiding antiplatelet drugs for adults surviving antithrombotic-associated ICH. Recruitment began on 22 May 2013 and ended on 31 May 2018. Follow-up ended on 30 November 2018. This update to the protocol describes the statistical analysis plan (version 1.7, finalised on 25 January 2019). Database lock and un-blinding occured on 29 January 2019, after which the un-blinded trial statistician conducted the final analyses according to this statistical analysis plan. Discussion: Final results of RESTART will be analysed and disseminated in May 2019. Trial registration: ISRCTN registry 71907627. Prospectively registered on 25 April 2013. The trial is funded by a British Heart Foundation special project grant (SP/12/2/29422) and a travel fellowship (FS/13/72/30531). The trial sponsor is the Academic and Clinical Central Office for Research and Development (ACCORD), which is a partnership between the University of Edinburgh and NHS Lothian Health Board.

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“… If it is decided to restart antithrombotic treatment, start after one month (class IIb, LoE B) [ 12 , 21 , 36 ]. Restart single antiplatelet therapy in patients with deep intracranial haemorrhage and a high thrombotic risk after one month [ 42 , 46 ]. In patients with lobar intracranial haemorrhage restarting antiplatelet therapy is not advised [ 45 ].…”

Section: Intracranial Haemorrhage While Using Antiplatelet Therapymentioning

confidence: 99%

“…Restart single antiplatelet therapy in patients with deep intracranial haemorrhage and a high thrombotic risk after one month [ 42 , 46 ].…”

Section: Intracranial Haemorrhage While Using Antiplatelet Therapymentioning

confidence: 99%

A practical guide on how to handle patients with bleeding events while on oral antithrombotic treatment

2018

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Bleeding is a feared complication in patients who are treated with antithrombotic therapy (oral anticoagulation or antiplatelet therapy). Management of antithrombotic therapy after bleeding poses a dilemma where restarting the crucial medication could lead to recurrent bleeding, while interrupting or even discontinuing treatment could increase the thrombotic risk. In this review, we provide recommendations regarding the treatment of patients with a bleeding event while on oral antithrombotic therapy, based on the literature and expert opinion.

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Antiplatelet Resumption after Antiplatelet-Related Intracerebral Hemorrhage: A Retrospective Hospital-Based Study

Cited by 23 publications

References 41 publications

Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial

A practical guide on how to handle patients with bleeding events while on oral antithrombotic treatment

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