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  • 1
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    Ambulatory blood pressure profile and stroke recurrence
    BMJ ; 2021
    In:  Stroke and Vascular Neurology Vol. 6, No. 3 ( 2021-09), p. 352-358
    Details
    In: Stroke and Vascular Neurology, BMJ, Vol. 6, No. 3 ( 2021-09), p. 352-358
    Abstract: To establish a new ambulatory blood pressure (ABP) parameter (24-hour ABP profile) and evaluated its performance on stroke outcome in ischaemic stroke (IS) or transient ischaemic attack (TIA) patients. Methods The prospective cohort consisted of 1996 IS/TIA patients enrolled for ABP monitoring and a 3-month follow-up for stroke recurrence as outcome. Profile groups of systolic blood pressure (SBP) were identified via an advanced functional clustering method, and the associations of the profile groups and conventional ABP parameters with stroke recurrence were examined in a Cox proportional hazards model. Results Three discrete profile groups (n=604, 781 and 611 in profiles 1, 2 and 3, respectively) in 24-hour ambulatory SBP were identified. Profile 1 resembled most to the normal diurnal blood pressure pattern; profile 2 also dropped at night, but climbed earlier and with higher morning surge; while profile 3 had sustained higher nocturnal SBP without significant nocturnal SBP decline. The incidence of stroke recurrence was 2.9%, 3.9% and 5.5% in profiles 1, 2 and 3, respectively. After adjustment for covariates, profile 3 was significantly associated with higher risk of stroke recurrence with profile 1 as reference (HR 1.76, 95% CI: 1.00 to 3.09), while no significant difference was observed between profiles 2 and 1 (HR 1.22, 95% CI: 0.66 to 2.25). None of conventional ABP parameters showed significant associations with the outcome. Conclusions Ambulatory 24-hour SBP profile is associated with short-term stroke recurrence. Profiles of ABP may help improve identification of stroke recurrence by capturing the additive effects of individual ABP parameters.
    Type of Medium: Online Resource
    ISSN: 2059-8688 , 2059-8696
    URL: Article
    DOI: 10.1136/svn-2020-000526
    Language: English
    Publisher: BMJ
    Publication Date: 2021
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  • 2
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    Association of thrombelastographic parameters with post-stenting ischemic events
    BMJ ; 2017
    In:  Journal of NeuroInterventional Surgery Vol. 9, No. 2 ( 2017-02), p. 192-195
    Details
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 9, No. 2 ( 2017-02), p. 192-195
    Abstract: Thrombelastography (TEG) is widely used for the measurement of platelet function. However, few studies have investigated the TEG parameters in patients receiving extracranial or intracranial artery stenting for ischemic cerebrovascular disease. This study sought to describe the association of TEG parameters before the procedure with post-procedural ischemic events after extracranial or intracranial artery stenting. Methods Patients in whom stenting was performed for extracranial or intracranial artery stenosis (70–99%) were recruited into the study. Blood samples were obtained for TEG to assess platelet function before stenting. The primary endpoint was ischemic stroke or transient ischemic attack in the territory of the stented artery. Results A total of 218 patients were included in the study. During a mean follow-up period of 132 days (range 98–226 days), 18 (8.3%) primary endpoint events were recorded. Compared with patients without ischemic events, the ADP-induced platelet-fibrin clot strength (MA ADP ) was significantly higher (41.57±15.10 vs 33.50±13.86, p=0.020) and the ADP inhibition rate (ADP%) was significantly lower in patients with ischemic events (39.54±23.15 vs 55.29±24.43, p=0.009). Multivariate analysis identified MA ADP and ADP% as significant independent predictors of subsequent ischemic events with HRs of 1.036 and 0.965, respectively. From receiver operating characteristic curve analysis, MA ADP 〉 49.95 mm had the best predictive value of ischemic events. Conclusions Our study suggests that TEG parameters MA ADP and ADP% are associated with subsequent ischemic events in patients with extracranial or intracranial stents. Clinical trial number NCT01925872.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    URL: Article
    DOI: 10.1136/neurintsurg-2015-011687
    Language: English
    Publisher: BMJ
    Publication Date: 2017
    detail.hit.zdb_id: 2506028-4
    detail.hit.zdb_id: 2514982-9
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  • 3
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    Ticagrelor plus aspirin versus clopidogrel plus aspirin for platelet reactivity in patients with minor stroke or transient ischaemic attack: open label, blinded endpoint, randomised controlled phase II trial
    BMJ ; 2019
    In:  BMJ
    Details
    In: BMJ, BMJ
    Abstract: To test the hypothesis that ticagrelor plus aspirin is safe and superior to clopidogrel plus aspirin for reducing high platelet reactivity at 90 days and stroke recurrence in patients with minor stroke or transient ischaemic attack, particularly in carriers of the CYP2C19 loss-of-function allele and patients with large artery atherosclerosis. Design Open label, blinded endpoint, randomised controlled phase II trial. Setting Prospective studies conducted at 26 centres in China, August 2015 to March 2017. Participants 675 patients with acute minor stroke or transient ischaemic attack. Intervention Ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (300 mg loading dose, 75 mg daily thereafter) on a background of aspirin (100 mg daily for the first 21 days) within 24 hours of symptom onset. Main outcome measures Primary outcome was the proportion of patients with high platelet reactivity at 90 days. High platelet reactivity was defined as P2Y12 reaction units of more than 208. Secondary outcomes included high platelet reactivity at 90 days (7 days either way) in patients carrying genetic variants that would affect clopidogrel metabolism, and any stroke (ischaemic or haemorrhagic) recurrence at 90 days (7 days either way), six months, and one year. Results At 90 days, high platelet reactivity occurred in 35 (12.5%) of 280 patients in the ticagrelor/aspirin group and 86 (29.7%) of 290 patients in the clopidogrel/aspirin group (risk ratio 0.40; 95% confidence interval 0.28 to 0.56; P 〈 0.001), and in 10.8% versus 35.4% (0.31; 0.18 to 0.49; P 〈 0.001) of patients carrying CYP2C19 loss-of-function alleles. Stroke occurred in 21 (6.3%) of 336 patients in the ticagrelor/aspirin group and 30 (8.8%) of 339 patients in the clopidogrel/aspirin group (hazard ratio 0.70; 95% confidence interval 0.40 to 1.22; P=0.20). Patients with large artery atherosclerosis in the ticagrelor/aspirin group had a lower stroke recurrence at 90 days than those in the clopidogrel/aspirin group (6.0% v 13.1%; hazard ratio 0.45, 95% confidence interval 0.20 to 0.98; P=0.04). No difference was seen in the rates of major or minor haemorrhagic events between the ticagrelor/aspirin and clopidogrel/aspirin groups (4.8% v 3.5%; P=0.42). Conclusion Patients with minor stroke or transient ischaemic attack who are treated with ticagrelor plus aspirin have a lower proportion of high platelet reactivity than those who are treated with clopidogrel plus aspirin, particularly for those who are carriers of the CYP2C19 loss-of-function allele. The results of this study should be evaluated further in large scale, phase III trials and in different populations. Trial registration Clinicaltrials.gov NCT02506140 .
    Type of Medium: Online Resource
    ISSN: 0959-8138 , 1756-1833
    URL: Article
    DOI: 10.1136/bmj.l2211
    Language: English
    Publisher: BMJ
    Publication Date: 2019
    detail.hit.zdb_id: 1362901-3
    detail.hit.zdb_id: 1479799-9
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  • 4
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    Different contribution of SBP and DBP variability to vascular events in patients with stroke
    BMJ ; 2020
    In:  Stroke and Vascular Neurology Vol. 5, No. 2 ( 2020-06), p. 110-115
    Details
    In: Stroke and Vascular Neurology, BMJ, Vol. 5, No. 2 ( 2020-06), p. 110-115
    Abstract: High blood pressure variability (BPV) is a novel risk factor for cardiovascular disease. However, the heterogeneity of systolic blood pressure variability (SBPV) and diastolic blood pressure variability (DBPV) for different vascular events remains unclear. This study aims to investigate whether SBPV or DBPV has different contribution to vascular events in patients with acute ischaemic stroke (IS) or transient ischaemic attack (TIA). Methods Data from the BOSS (blood pressure and clinical outcome in TIA or IS) study were examined for vascular events at 3-month and 1-year follow-up. BPV was defined as the SD and coefficient of variation (CV) of day-to-day measurements within 3 months after IS/TIA. Vascular events include cardiovascular events (myocardial infarction, unstable angina, cardiac death and congestive heart failure) and cerebrovascular events (ischaemic or haemorrhagic stroke). Logistic regression model was used to test the associations between BPV and vascular events. Results Of 2325 patients with IS or TIA, 103 (4.43 %) experienced a recurrent stroke and 64 (2.75 %) had cardiovascular events within 3 months. Day-to-day SBPV was only associated with stroke recurrence (BPV SD : OR, 1.72, 95% CI 1.09 to 2.71; BPV CV : 1.86, 95% CI 1.19 to 2.92), but not cardiovascular events (BPV SD : 1.67, 95% CI 0.94 to 2.94; BPV CV : 1.51, 95% CI 0.86 to 2.64). However, DBPV seems to be related to both stroke (BPV SD : 1.60, 95% CI 1.02 to 2.49; BPV CV : 1.53, 95% CI 0.99 to 2.37) and cardiovascular events (BPV SD : 2.48, 95% CI 1.37 to 4.48; BPV CV : 1.92, 95% CI 1.09 to 3.36). Similar results were found at 1 year. Conclusions For patients with IS/TIA, stroke recurrence was associated with both SBPV and DBPV; however, cardiovascular events seem to be only related to DBPV.
    Type of Medium: Online Resource
    ISSN: 2059-8688 , 2059-8696
    URL: Article
    DOI: 10.1136/svn-2019-000278
    Language: English
    Publisher: BMJ
    Publication Date: 2020
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  • 5
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    Clopidogrel with aspirin in High-risk patients with Acute Non-disabling Cerebrovascular Events II (CHANCE-2): rationale and design of a multicentre randomised trial
    BMJ ; 2021
    In:  Stroke and Vascular Neurology Vol. 6, No. 2 ( 2021-06), p. 280-285
    Details
    In: Stroke and Vascular Neurology, BMJ, Vol. 6, No. 2 ( 2021-06), p. 280-285
    Abstract: In patients with a minor ischaemic stroke or transient ischaemic attack (TIA), separate trials have shown that dual antiplatelet therapy with clopidogrel plus aspirin (clopidogrel–aspirin) or ticagrelor plus aspirin (ticagrelor–aspirin) are more effective than aspirin alone in stroke secondary prevention. However, these two sets of combination have not been directly compared. Since clopidogrel was less effective in stroke patients who were CYP2C19 loss-of-function (LOF) allele carriers, whether ticagrelor–aspirin is clinically superior to clopidogrel–aspirin in this subgroup of patients with stroke is unclear. Aim To describe the rationale and design considerations of the Clopidogrel in High-risk patients with Acute Non-disabling Cerebrovascular Events (CHANCE-2) trial. Design CHANCE-2 is a randomised, double-blind, double-dummy, placebo-controlled, multicentre trial that compares two dual antiplatelet strategies for minor stroke or TIA patients who are CYP2C19 LOF allele carriers: ticagrelor (180 mg loading dose on day 1 followed by 90 mg twice daily on days 2–90) or clopidogrel (300 mg loading dose on day 1 followed by 75 mg daily on days 2–90), plus open-label aspirin with a dose of 75–300 mg on day 1 followed by 75 mg daily on day 2–21. All will be followed for 1 year. Study outcomes The primary efficacy outcome is any stroke (ischaemic or haemorrhagic) within 3 months and the primary safety outcome is any severe or moderate bleeding event within 3 months. Discussion The CHANCE-2 trial will evaluate whether ticagrelor–aspirin is superior to clopidogrel–aspirin for minor stroke or TIA patients who are CYP2C19 LOF allele carriers. Trial registration number NCT04078737 .
    Type of Medium: Online Resource
    ISSN: 2059-8688 , 2059-8696
    URL: Article
    DOI: 10.1136/svn-2020-000791
    Language: English
    Publisher: BMJ
    Publication Date: 2021
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  • 6
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    Safety and efficacy of Edaravone Dexborneol versus edaravone for patients with acute ischaemic stroke: a phase II, multicentre, randomised, double-blind, multiple-dose, active-controlled clinical trial
    BMJ ; 2019
    In:  Stroke and Vascular Neurology Vol. 4, No. 3 ( 2019-09), p. 109-114
    Details
    In: Stroke and Vascular Neurology, BMJ, Vol. 4, No. 3 ( 2019-09), p. 109-114
    Abstract: Edaravone Dexborneol is a novel neuroprotective agent that comprised edaravone and (+)-borneol, a food additive with an anti-inflammatory effect in animal ischaemic stroke models. This study aims to assess the safety and efficacy of Edaravone Dexborneol compared with edaravone in treating patients with acute ischaemic stroke (AIS). Methods In this multicentre, randomised, double-blind, multiple-dose, active-controlled, phase II clinical trial, patients with AIS within 48 hours after stroke onset were randomly assigned (1:1:1:1) to low-dose (12.5 mg), medium-dose (37.5 mg) or high-dose (62.5 mg) Edaravone Dexborneol groups, and an active control group with edaravone (30 mg) by 30 min intravenous infusion every 12 hours, for 14 consecutive days. The primary efficacy outcome was the proportion of modified Rankin Scale (mRS)score ≤1 at 90 days and National Institutes of Health Stroke Scale (NIHSS) score change from baseline to 14 days after randomisation. The safety outcome included any adverse event during 90 days after treatment. Results Of 385 patients included in the efficacy analysis, 94 were randomised to low-dose group, 97 to medium-dose group, 98 to high-dose group and 96 to the control group. No significant difference was observed among the four groups on mRS score (mRS ≤1, p=0.4054) at 90 days or NIHSS score change at 14 days (p=0.6799). However, a numerically higher percentage of patients with mRSscore ≤1 at 90 days in the medium-dose (69.39%) and high-dose (65.63%) groups was observed than in the control group (60.64%). No significant difference in severe adverse events was found among the four groups (p=0.3815). Conclusions Compared with edaravone alone, Edaravone Dexborneol was safe and well tolerated at all doses, although no significant improvement in functional outcomes was observed at 90days. Trial registration number NCT01929096 .
    Type of Medium: Online Resource
    ISSN: 2059-8688 , 2059-8696
    URL: Article
    DOI: 10.1136/svn-2018-000221
    Language: English
    Publisher: BMJ
    Publication Date: 2019
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  • 7
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    Endovascular therapy for Acute ischemic Stroke Trial (EAST): study protocol for a prospective, multicentre control trial in China
    BMJ ; 2016
    In:  Stroke and Vascular Neurology Vol. 1, No. 2 ( 2016-06), p. 44-51
    Details
    In: Stroke and Vascular Neurology, BMJ, Vol. 1, No. 2 ( 2016-06), p. 44-51
    Abstract: 5 recent trials have shown the benefit of endovascular treatment for acute ischaemic stroke (AIS) due to large vessel occlusion of the anterior circulation. This study aims to evaluate the safety and efficacy of Solitaire thrombectomy in patients with moderate-to-severe stroke in the Chinese population, which has a high prevalence of intracranial atherosclerosis. Methods and analysis This multicentre prospective control study will involve 17 stroke centres in China, and plans to recruit 150 patients in the intervention group, and 150 patients in the medical group, in which patients meet enrolment criteria but refuse intervention. Patients with AIS due to large vessel occlusion indicated for treatment with Solitaire stent retriever within 12 hours of symptom onset, and who meet the inclusion and exclusion criteria, will be enrolled in this study. The primary efficacy endpoint is functional independence as defined by a modified Rankin Scale (mRS) score ≤2 at 90 days or by functional improvement as defined by mRS, using shift analysis. The procedural efficacy endpoint is arterial recanalisation of the occluded target vessel measured by a modified Thrombolysis in Cerebral Infarction (mTICI) score equal or superior to 2b right following the use of the study device. The primary safety endpoint is symptomatic intracranial haemorrhage (sICH) within 24±3 hours postprocedure. Ethics and dissemination The protocol was approved by the Ethics Committee at the coordinating centre and by the local Institutional Review Board of each participating centre. Trial registration number NCT02350283.
    Type of Medium: Online Resource
    ISSN: 2059-8688 , 2059-8696
    URL: Article
    DOI: 10.1136/svn-2016-000022
    Language: English
    Publisher: BMJ
    Publication Date: 2016
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  • 8
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    Cerebral small vessel disease or intracranial large vessel atherosclerosis may carry different risk for future strokes
    BMJ ; 2020
    In:  Stroke and Vascular Neurology Vol. 5, No. 2 ( 2020-06), p. 128-137
    Details
    In: Stroke and Vascular Neurology, BMJ, Vol. 5, No. 2 ( 2020-06), p. 128-137
    Abstract: The effect of cerebral small vessel disease (CSVD) and intracranial arterial stenosis (ICAS) on stroke outcomes remains unclear. Methods Data of 1045 patients with minor stroke or transient ischaemic attack (TIA) were obtained from 45 sites of the Clopidogrel in High-Risk Patients with Acute Non-disabling Cerebrovascular Events (CHANCE) trial. We assessed the associations of burdens of CSVD and ICAS with new strokes and bleeding events using multivariate Cox regression models and those with modified Rankin Scale (mRS) scores using ordinal logistic regression models. Results Among the 1045 patients, CSVD was present in 830 cases (79.4%) and ICAS in 460 (44.0%). Patients with 〉 1 ICAS segment showed the highest risk of new strokes (HR 2.03, 95% CI 1.15 to 3.56, p=0.01). No association between CSVD and the occurrence of new strokes was found. The presence of severe CSVD (common OR (cOR) 2.01, 95% CI 1.40 to 2.89, p 〈 0.001) and 〉 1 ICAS segment (cOR 2.15, 95% CI 1.57 to 2.93, p 〈 0.001) was associated with higher mRS scores. Severe CSVD (HR 10.70, 95% CI 1.16 to 99.04, p=0.04), but not ICAS, was associated with a higher risk of bleeding events. Six-point modified CSVD score improved the predictive power for bleeding events and disability. Interpretation CSVD is associated with more disability and bleeding events, and ICAS is associated with an increased risk of stroke and disability in patients with minor stroke and TIA at 3 months. CSVD and ICAS may represent different vascular pathologies and play distinct roles in stroke outcomes. Trial registration number NCT00979589
    Type of Medium: Online Resource
    ISSN: 2059-8688 , 2059-8696
    URL: Article
    DOI: 10.1136/svn-2019-000305
    Language: English
    Publisher: BMJ
    Publication Date: 2020
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  • 9
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    Randomised study of bailout intracranial angioplasty following thrombectomy for acute large vessel occlusion (ANGEL-REBOOT): protocol of a multicentre randomised controlled trial
    BMJ ; 2024
    In:  Stroke and Vascular Neurology Vol. 9, No. 2 ( 2024-04), p. 181-188
    Details
    In: Stroke and Vascular Neurology, BMJ, Vol. 9, No. 2 ( 2024-04), p. 181-188
    Abstract: Unsuccessful thrombectomy of acute large vessel occlusions (LVOs) has been associated with unfavourable outcomes. Multiple randomised controlled trials (RCTs) have reported a failure rate of 12%–41% for thrombectomy procedures. Various factors contribute to failed thrombectomy, including technical difficulties in accessing the occlusion, unsuccessful thrombus retrieval, thrombotic reocclusion and pre-existing intracranial atherosclerotic stenosis. Although some studies have explored balloon dilation or permanent stenting as rescue intracranial angioplasty for failed thrombectomy in individual cases, there is currently no evidence from RCTs on this specific topic. Aim To evaluate the potential superiority of bailout angioplasty over standard treatment in cases of unsuccessful recanalisation (eTICI 0 to 2a) or residual severe stenosis ( 〉 70%) after thrombectomy in acute LVO patients within 24 hours of stroke onset. Design This study is a multicentre, prospective, randomised, controlled clinical trial designed by investigators. It compares bailout angioplasty with standard therapy and follows an open-label treatment approach while maintaining a blinded outcome assessment (PROBE design). Our objective is to allocate 348 patients in a 1:1 ratio to either receive bailout angioplasty as an intervention or standard therapy as a control, following unsuccessful thrombectomy. Outcome The main measure of interest is the modified Rankin Scale (mRS) Score, which will be assessed in a blinded manner at 90 (±14) days following randomisation. The primary effect size will be determined using ordered logistic regression to calculate the common OR, representing the shift on the six-category mRS Scale at the 90-day mark. Additionally, the safety outcomes will be evaluated, including symptomatic intracranial haemorrhage within 18–36 hours, severe procedure-related complications and mortality within 90 (±14) days, among others. Discussion The ANGEL-REBOOT study aims to generate substantial evidence regarding the efficacy and safety of bailout intracranial angioplasty as a treatment option for patients with LVO who have experienced unsuccessful thrombectomy. Trial registration number NCT05122286 .
    Type of Medium: Online Resource
    ISSN: 2059-8688 , 2059-8696
    URL: Article
    DOI: 10.1136/svn-2023-002433
    Language: English
    Publisher: BMJ
    Publication Date: 2024
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  • 10
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    Efficacy and safety of dual antiplatelet therapy in the elderly for stroke prevention: a subgroup analysis of the CHANCE-2 trial
    BMJ ; 2024
    In:  Stroke and Vascular Neurology
    Details
    In: Stroke and Vascular Neurology, BMJ
    Abstract: Evidence of the optimal antiplatelet therapy for elderly patients who had a stroke is limited, especially those elder than 80 years. This study aimed to explore the efficacy and safety of dual antiplatelet therapy (DAPT) in old-old patients compared with younger patients in the ticagrelor or Clopidogrel with aspirin in High-risk patients with Acute Non-disabling Cerebrovascular Events-II (CHANCE-2) trial. Methods CHANCE-2 was a randomised, double-blind, placebo-controlled trial in China involving patients with high-risk transient ischaemic attack or minor stroke with CYP2C19 loss-of-function alleles. In our substudy, all enrolled patients were stratified by age: old-old (≥80 years), young-old (65–80 years) and younger ( 〈 65 years). The primary outcomes were stroke recurrence and moderate to severe bleeding within 90 days, respectively. Results Of all the 6412 patients, 406 (6.3%) were old-old, 2755 (43.0%) were young-old and 3251 (50.7%) were younger. Old-old patients were associated with higher composite vascular events (HR 1.41, 95% CI 1.00 to 1.98, p=0.048), disabling stroke (OR 2.43, 95% CI 1.52 to 3.88, p=0.0002), severe or moderate bleeding (HR 8.40, 95% CI 1.95 to 36.21, p=0.004) and mortality (HR 7.56, 95% CI 2.23 to 25.70, p=0.001) within 90 days. Ticagrelor-aspirin group was associated with lower risks of stroke recurrence within 90 days in younger patients (HR 0.68, 95% CI 0.51 to 0.91, p=0.008), which was no differences in old-old patients. Conclusion Elderly patients aged over 80 in CHANCE-2 trial had higher risks of composite vascular events, disabling stroke, severe or moderate bleeding and mortality within 90 days. Genotype-guided DAPT might not be as effective in old-old patients as in younger ones. Trial registration number NCT04078737 .
    Type of Medium: Online Resource
    ISSN: 2059-8688 , 2059-8696
    URL: Article
    DOI: 10.1136/svn-2023-002450
    Language: English
    Publisher: BMJ
    Publication Date: 2024
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