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  • BMJ  (6)
  • Xu, Haiyan  (6)
  • 1
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    Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 11 ( 2023-11), p. e076781-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 11 ( 2023-11), p. e076781-
    Abstract: The strategy for initiating antithrombotic therapy to prevent bioprosthetic valve thrombosis (BPVT) after transcatheter aortic valve replacement (TAVR) remains uncertain. There is still lacking evidence on the efficacy and safety of early 6 months usage of single-antiplatelet therapy (SAPT) or oral anticoagulant (OAC) after TAVR in patients without anticoagulant indications. Methods and analysis This is a multicentre, randomised controlled, open-label trial, and 650 patients undergoing TAVR from 13 top TAVR centres in China will be recruited. Each eligible participant will be randomly assigned to two groups (1:1 ratio) as (1) SAPT (aspirin 75–100 mg for 6 months) group or (2) OAC group (warfarin, therapeutic international normalised ratio at 1.8–2.5 for 6 months), both followed by sequential aspirin 75–100 mg for 6 months. Participants in both groups will be invited for three follow-up visits of 1, 6 and 12 months after discharge. We will use both the net clinical benefit endpoint (composite of all-cause mortality, myocardial infarction, stroke/transient ischaemic attacks, peripheral artery thrombosis, intracardiac thrombosis and major bleeding and disabling or life-threatening bleeding) and the BPVT endpoint evaluated by four-dimensional CT as our primary endpoints. P value of 〈 0.05 of two-sided test will be considered statistically significant. Ethics and dissemination The present study was approved by the Institutional Review Boards at Fuwai Hospital, National Center for Cardiovascular Diseases of China (Approval No. 2023-1947). All patients will be informed of the details of the study and will sign an informed consent prior to inclusion in the study. Results of this study will be published in a peer-reviewed journal. Trial registration number NCT05375474 .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2023-076781
    DOI: 10.1136/bmjopen-2023-076781.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2023
    detail.hit.zdb_id: 2599832-8
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  • 2
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    Simple risk score based on the China Acute Myocardial Infarction registry for predicting in-hospital mortality among patients with non-ST-segment elevation myocardial infarction: results of a prospective observational cohort study
    BMJ ; 2019
    In:  BMJ Open Vol. 9, No. 9 ( 2019-09), p. e030772-
    Details
    In: BMJ Open, BMJ, Vol. 9, No. 9 ( 2019-09), p. e030772-
    Abstract: To simplify our previous risk score for predicting the in-hospital mortality risk in patients with non-ST-segment elevation myocardial infarction (NSTEMI) by dropping laboratory data. Design Prospective cohort. Setting Multicentre, 108 hospitals across three levels in China. Participants A total of 5775 patients with NSTEMI enrolled in the China Acute Myocardial Infarction (CAMI) registry. Primary outcome measures In-hospital mortality. Results The simplified CAMI-NSTEMI (SCAMI-NSTEMI) score includes the following nine variables: age, body mass index, systolic blood pressure, Killip classification, cardiac arrest, ST-segment depression on ECG, smoking status, previous angina and previous percutaneous coronary intervention. Within both the derivation and validation cohorts, the SCAMI-NSTEMI score showed a good discrimination ability (C-statistics: 0.76 and 0.83, respectively); further, the SCAMI-NSTEMI score had a diagnostic performance superior to that of the Global Registry of Acute Coronary Events risk score (C-statistics: 0.78 and 0.73, respectively; p 〈 0.0001 for comparison). The in-hospital mortality increased significantly across the different risk groups. Conclusions The SCAMI-NSTEMI score can serve as a useful tool facilitating rapid risk assessment among a broader spectrum of patients admitted owing to NSTEMI. Trial registration number NCT01874691 .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2019-030772
    DOI: 10.1136/bmjopen-2019-030772.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2019
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  • 3
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    Development and validation of dynamic models to predict postdischarge mortality risk in patients with acute myocardial infarction: results from China Acute Myocardial Infarction Registry
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 3 ( 2023-03), p. e069505-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 3 ( 2023-03), p. e069505-
    Abstract: The risk of adverse events and prognostic factors are changing in different time phases after acute myocardial infarction (AMI). The incidence of adverse events is considerable in the early period after AMI hospitalisation. Therefore, dynamic risk prediction is needed to guide postdischarge management of AMI. This study aimed to develop a dynamic risk prediction instrument for patients following AMI. Design A retrospective analysis of a prospective cohort. Setting 108 hospitals in China. Participants A total of 23 887 patients after AMI in the China Acute Myocardial Infarction Registry were included in this analysis. Primary outcome measures All-cause mortality. Results In multivariable analyses, age, prior stroke, heart rate, Killip class, left ventricular ejection fraction (LVEF), in-hospital percutaneous coronary intervention (PCI), recurrent myocardial ischaemia, recurrent myocardial infarction, heart failure (HF) during hospitalisation, antiplatelet therapy and statins at discharge were independently associated with 30-day mortality. Variables related to mortality between 30 days and 2 years included age, prior renal dysfunction, history of HF, AMI classification, heart rate, Killip class, haemoglobin, LVEF, in-hospital PCI, HF during hospitalisation, HF worsening within 30 days after discharge, antiplatelet therapy, β blocker and statin use within 30 days after discharge. The inclusion of adverse events and medications significantly improved the predictive performance of models without these indexes (likelihood ratio test p 〈 0.0001). These two sets of predictors were used to establish dynamic prognostic nomograms for predicting mortality in patients with AMI. The C indexes of 30-day and 2-year prognostic nomograms were 0.85 (95% CI 0.83–0.88) and 0.83 (95% CI 0.81–0.84) in derivation cohort, and 0.79 (95% CI 0.71–0.86) and 0.81 (95% CI 0.79–0.84) in validation cohort, with satisfactory calibration. Conclusions We established dynamic risk prediction models incorporating adverse event and medications. The nomograms may be useful instruments to help prospective risk assessment and management of AMI. Trial registration number NCT01874691 .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2022-069505
    DOI: 10.1136/bmjopen-2022-069505.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2023
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  • 4
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    Association between smoking and in-hospital mortality in patients with acute myocardial infarction: results from a prospective, multicentre, observational study in China
    BMJ ; 2019
    In:  BMJ Open Vol. 9, No. 8 ( 2019-08), p. e030252-
    Details
    In: BMJ Open, BMJ, Vol. 9, No. 8 ( 2019-08), p. e030252-
    Abstract: Smoking is a well-established risk factor for cardiovascular disease. However, the effect of smoking on in-hospital mortality in patients with acute myocardial infarction (AMI) who are managed by contemporary treatment is still unclear. Methods A cohort study was conducted using data from the China AMI registry between 2013 and 2016. Eligible patients were diagnosed with AMI in accordance with the third universal definition of MI. Propensity score (PS) matching and multivariable logistic regression were used to control for confounders. Subgroup analysis was performed to examine whether the association between smoking and in-hospital mortality varies according to baseline characteristics. Results A total of 37 614 patients were included. Smokers were younger and more frequently men with fewer comorbidities than non-smokers. After PS matching and multivariable log regression analysis were performed, the difference in in-hospital mortality between current smokers versus non-smokers was reduced, but it was still significant (5.1% vs 6.1%, p=0.0045; adjusted OR 0.78, 95% CI 0.69 to 0.88, p 〈 0.001). Among all subgroups, there was a trend towards lower in-hospital mortality in current or ex-smokers compared with non-smokers. Conclusions Smoking is associated with lower in-hospital mortality in patients with AMI, even after multiple analyses to control for potential confounders. This ‘smoker’s paradox’ cannot be fully explained by confounding alone. Trial registration number NCT01874691 .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2019-030252
    Language: English
    Publisher: BMJ
    Publication Date: 2019
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  • 5
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    Organ-specific immune checkpoint inhibitor treatment in lung cancer: a systematic review and meta-analysis
    BMJ ; 2023
    In:  BMJ Open Vol. 13, No. 3 ( 2023-03), p. e059457-
    Details
    In: BMJ Open, BMJ, Vol. 13, No. 3 ( 2023-03), p. e059457-
    Abstract: Based on the acknowledged organ-specific immune microenvironment, little is known regarding the efficacy of immunotherapy in patients with lung cancer according to metastatic sites. This meta-analysis aimed to explore the efficacy of immune checkpoint inhibitors (ICIs) vs chemotherapy in patients with lung cancer with liver metastases (LM) or brain metastases (BM). Design Meta-analysis and systematic review. Data sources We systematically searched in electronic databases (PubMed, EMBASE, Cochrane Library and Web of Science), up to 31 January 2022. We also reviewed the abstracts from major international conferences. Eligibility criteria were randomised controlled phase II or III trials reporting the overall survival (OS) or progression-free survival (PFS) of LM or BM subsets. Data extraction and synthesis Hazard ratios (HRs) with 95% CIs for OS and PFS were extracted and aggregated using a random-effects model. Results Twenty-four randomised controlled trials with available outcomes for patients with BMs or LMs were identified. A total of 1124 patients with BM and 2077 patients with LM were included in the analysis. The pooled OS HR of patients with LMs was 0.83 (95% CI 0.72 to 0.95), and that of patients without LM 0.73 (95% CI 0.69 to 0.79). LM was associated with less benefits from ICIs. In patients with BM treated with ICIs, the pooled OS HR compared with the control arms was 0.71 (95% CI 0.53 to 0.94). Subgroup analyses by histology suggested that only patients with non-small cell lung cancer (NSCLC) with BM could gain benefit from ICIs (HR 0.53, 95% CI 0.41 to 0.68). BM negatively influenced efficacy of immunotherapy in patients with small cell lung cancer. Conclusions Our results showed immunotherapy demonstrated efficacy in patients with lung cancer with LM and BM, survival benefits dominantly favoured patients with NSCLC. Patients with lung cancer with LM obtained less benefits from ICIs than those without. Therefore, organ-specific immunotherapeutic approaches should be considered. PROSPERO registration number CRD42020212797.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2021-059457
    DOI: 10.1136/bmjopen-2021-059457.supp2
    DOI: 10.1136/bmjopen-2021-059457.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2023
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  • 6
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    Recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) versus alteplase (rt-PA) as fibrinolytic therapy for acute ST-segment elevation myocardial infarction (China TNK STEMI): protocol for a randomised, controlled, non-inferiority trial
    BMJ ; 2017
    In:  BMJ Open Vol. 7, No. 9 ( 2017-09), p. e016838-
    Details
    In: BMJ Open, BMJ, Vol. 7, No. 9 ( 2017-09), p. e016838-
    Abstract: To evaluate the efficacy and safety of recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) in lowering major adverse cardiovascular and cerebrovascular events (MACCEs) in Chinese acute ST-segment elevation myocardial infarction (STEMI) patients. Methods and analysis The study is designed as a multicentre, randomised, controlled non-inferiority phase IV trial with balanced randomisation (1:1) in patients with STEMI. The planned sample size is 6200 participants (or 3100 per arm). Participants with STEMI will be randomised to receive either rhTNK-tPA or alteplase (rt-PA), with stratification by research centre, age and the time from symptom onset to randomisation. All patients will receive concomitant antiplatelet and anticoagulant therapy before fibrinolytic therapy. The participants assigned to the intervention group will receive an intravenous bolus of 16 mg rhTNK-tPA, while those assigned to the control group will receive an intravenous bolus of 8 mg rt-PA followed by 42 mg infusion over 90 mins. Other medications can also be administered at the discretion of the cardiologists in charge. All participants will be followed up for the primary study endpoint, the occurrence of MACCEs within 30 days after fibrinolytic therapy, which is defined as all-cause mortality, non-fatal re-infarction, non-fatal stroke, percutaneous coronary intervention (PCI) due to thrombolysis failure, and PCI due to reocclusion. Both intention-to-treat and per-protocol analyses will be done for the primary analyses. Ethics and dissemination The study procedures and informed consent form were approved by all participating hospitals. The results will be disseminated in peer review journals and academic conferences. This multicentre randomised controlled trial will provide high-quality data about the efficacy and safety of rhTNK-tPA and, once approved, its easier use should help improve the application of reperfusion therapy and hence the treatment outcomes of STEMI patients. Trial registration number NCT02835534 .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2017-016838
    Language: English
    Publisher: BMJ
    Publication Date: 2017
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