Quadritherapy vs standard tritherapy immunosuppressant regimen after heart transplantation: A propensity score–matched cohort analysis

Nguyen, Lee S.; Suc, Gaspard; Kheav, Vissal David; Coutance, Guillaume; Carmagnat, Maryvonnick; Rouvier, Philippe; Zahr, Noël; Salem, Joe‐Elie; Leprince, Pascal; Ouldammar, Salima; Varnous, Shaïda

doi:10.1111/ajt.15849

Cited by 5 publications

(5 citation statements)

References 26 publications

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“…The effect of HCQ/AZI on clinical outcomes was assessed in the weighted inflated population. This method aims to mitigate non-randomized allocation of treatment and was used previously in other retrospective studies including one in COVID-19 setting [14][15][16]. Kaplan-Meier curves were used to compare HCQ/AZI group and control group on time to the first outcome with a censorship at 28 days.…”

Section: Statistical Analysesmentioning

confidence: 99%

Lack of efficacy of hydroxychloroquine and azithromycin in patients hospitalized for COVID-19 pneumonia: A retrospective study

et al. 2021

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Background Hydroxychloroquine combined with azithromycin (HCQ/AZI) has initially been used against coronavirus disease-2019 (COVID-19). In this retrospective study, we assessed the clinical effects of HCQ/AZI, with a 28-days follow-up. Methods In a registry-study which included patients hospitalized for COVID-19 between March 15 and April 2, 2020, we compared patients who received HCQ/AZI to those who did not, regarding a composite outcome of mortality and mechanical ventilation with a 28-days follow-up. QT was monitored for patients treated with HCQ/AZI. Were excluded patients in intensive care units, palliative care and ventilated within 24 hours of admission. Three analyses were performed to adjust for selection bias: propensity score matching, multivariable survival, and inverse probability score weighting (IPSW) analyses. Results Overall, 203 patients were included: 60 patients treated by HCQ/AZI and 143 control patients. During the 28-days follow-up, 32 (16.3%) patients presented the primary outcome and 23 (12.3%) patients died. Propensity-score matching identified 52 unique pairs of patients with similar characteristics. In the matched cohort (n = 104), HCQ/AZI was not associated with the primary composite outcome (log-rank p-value = 0.16). In the overall cohort (n = 203), survival and IPSW analyses also found no benefit from HCQ/AZI. In the HCQ/AZI group, 11 (18.3%) patients prolonged QT interval duration, requiring treatment cessation. Conclusions HCQ/AZI combination therapy was not associated with lower in-hospital mortality and mechanical ventilation rate, with a 28-days follow-up. In the HCQ/AZI group, 18.3% of patients presented a prolonged QT interval requiring treatment cessation, however, control group was not monitored for this adverse event, making comparison impossible.

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Section: Statistical Analysesmentioning

confidence: 99%

Lack of efficacy of hydroxychloroquine and azithromycin in patients hospitalized for COVID-19 pneumonia: A retrospective study

et al. 2021

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“…We could not assess the efficacy of desensitization on DSA after HTx, specifically de novo DSA, due to the lack of sera in the historical control cohort. Maintenance immunosuppression regimen has been subject to change in the past 15 years with tacrolimus suggested instead of ciclosporin ( 19 ) and mammalian target of rapamycin (mTOR) inhibitors in addition to, or in place of, calcineurin inhibitors ( 12 , 20 ). These may impact the treatment effect observed due to desensitization.…”

Section: Discussionmentioning

confidence: 99%

“…Except for postoperative desensitization, the standard immunosuppressive regimen did not change during the study period (2004)(2005)(2006)(2007)(2008)(2009)(2010). As previously described (12), in the postoperative period it included thymoglobulin induction therapy from day 0 to day 4 (rabbit ATG, Thymoglobuline, Genzyme, Lyon, France), methylprednisolone bolus infusion on day 1, ciclosporine after day 1, and mycophenolate mofetil (MMF) after day 4. Corticosteroids were converted to oral form starting on day 4, with a dosage of 1 mg/kg initially.…”

Section: Standard Immunosuppressive Protocolmentioning

confidence: 99%

Impact of Sex in the Efficacy of Perioperative Desensitization Procedures in Heart Transplantation: A Retrospective Cohort Study

et al. 2021

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BackgroundSensitized patients, i.e. recipients with preformed donor-specific HLA antibodies (pfDSA), are at high-risk of developing antibody-mediated rejections (AMR) and dying after heart transplantation (HTx). Perioperative desensitization procedures are associated with better outcomes but can cause sensitization, which may influence their efficacy.MethodsIn sensitized patients (pfDSA>1000 mean immunofluorescence (MFI) units), we assessed the effect of perioperative desensitization by comparing treated patients to a historical control cohort. Multivariable survival analyses were performed on the time to main outcome, a composite of death and biopsy-proven AMR with 5-year follow-up.ResultsThe study included 68 patients: 31 control and 37 treated patients. There was no difference in preoperative variables between the two groups, including cumulative pfDSA [4026 (1788;8725) vs 4560 (3162;13392) MFI units, p=0.28]. The cause of sensitization was pregnancy in 24/68, 35.3%, transfusion in 61/68, 89.7%, and previous HTx in 4/68, 5.9% patients. Multivariable analysis yielded significant protective association between desensitization and events (adjusted (adj.) hazard ratio (HR)=0.44 (95% confidence interval (95CI)=0.25-0.79), p=0.006) and deleterious association between cumulative pfDSA and events [per 1000-MFI increase, adj.HR=1.028 (1.002-1.053), p=0.031]. There was a sex-difference in the efficacy of desensitization: in men (n=35), the benefit was significant [unadj.HR=0.33 (95CI=0.14-0.78); p=0.01], but not in women (n=33) [unadj.HR=0.52 (0.23-1.17), p=0.11]. In terms of the number of patients treated, in men, 2.1 of patients that were treated prevented 1 event, while in women, 3.1 required treatment to prevent 1 event.ConclusionPerioperative desensitization was associated with fewer AMR and deaths after HTx, and efficacy was more pronounced in men than women.

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“…• Association between immunosuppression regime (triple or quadruple therapy) in heart transplant recipients and death and rejection episodes ( 76 ).…”

Section: Does Screening For Coronary Artery Disease Reduce Post-trans...mentioning

confidence: 99%

Propensity Score and Instrumental Variable Techniques in Observational Transplantation Studies: An Overview and Worked Example Relating to Pre-Transplant Cardiac Screening

et al. 2022

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Inferring causality from observational studies is difficult due to inherent differences in patient characteristics between treated and untreated groups. The randomised controlled trial is the gold standard study design as the random allocation of individuals to treatment and control arms should result in an equal distribution of known and unknown prognostic factors at baseline. However, it is not always ethically or practically possible to perform such a study in the field of transplantation. Propensity score and instrumental variable techniques have theoretical advantages over conventional multivariable regression methods and are increasingly being used within observational studies to reduce the risk of confounding bias. An understanding of these techniques is required to critically appraise the literature. We provide an overview of propensity score and instrumental variable techniques for transplant clinicians, describing their principles, assumptions, strengths, and weaknesses. We discuss the different patient populations included in analyses and how to interpret results. We illustrate these points using data from the Access to Transplant and Transplant Outcome Measures study examining the association between pre-transplant cardiac screening in kidney transplant recipients and post-transplant cardiac events.

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Quadritherapy vs standard tritherapy immunosuppressant regimen after heart transplantation: A propensity score–matched cohort analysis

Cited by 5 publications

References 26 publications

Lack of efficacy of hydroxychloroquine and azithromycin in patients hospitalized for COVID-19 pneumonia: A retrospective study

Lack of efficacy of hydroxychloroquine and azithromycin in patients hospitalized for COVID-19 pneumonia: A retrospective study

Impact of Sex in the Efficacy of Perioperative Desensitization Procedures in Heart Transplantation: A Retrospective Cohort Study

Propensity Score and Instrumental Variable Techniques in Observational Transplantation Studies: An Overview and Worked Example Relating to Pre-Transplant Cardiac Screening

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