Representation of Patients With Kidney Disease in Trials of Cardiovascular Interventions

Konstantinidis, Ioannis; Nadkarni, Girish N.; Yacoub, Rabi; Saha, Aparna; Simoes, Priya; Parikh, Chirag R.; Coca, Steven G.

doi:10.1001/jamainternmed.2015.6102

Cited by 125 publications

(96 citation statements)

References 8 publications

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“…Patients with CKD were excluded from 57% of clinical trials of cardiovascular interventions during 2000-2014 [12] . Patients with CKD were less likely to receive acute evidence-based therapies post MI including aspirin, beta-blockers or clopidogrel, undergo any reperfusion or revascularisation or be referred for Cardiac Rehabilitation [18,21] .…”

Section: Discussionmentioning

confidence: 99%

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Impact of Mild-to-Moderate Chronic Kidney Disease on One Year Outcomes after Percutaneous Coronary Intervention

Grandjean-Thomsen

Marley²,

Shadbolt³

et al. 2017

Nephron

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Background/Aim: Patients with severe chronic kidney disease (CKD) have a higher risk of adverse events after percutaneous coronary intervention (PCI). There is conflicting evidence regarding the benefit of drug-eluting stents (DES) in patients with CKD. This study is aimed at assessing the effect of mild-to-moderate CKD on PCI outcomes, and determining if DES reduce adverse events amongst these patients. Method: We used our PCI database to determine demographic, procedural and outcome variables for 1960 consecutive patients (October 2009-October 2012). Kidney function was measured by the estimated glomerular filtration rate (eGFR - CKD-Epidemiology Collaboration creatinine based). Multivariate analysis was performed to determine independent variables associated with mortality and major adverse cardiovascular events (MACE). Results: The independent variables, predictive of 12-month mortality in PCI patients, were: age >64 years (hazard ratio [HR] 3.10 [95% CI 1.73-5.55], p < 0.001), 3-vessel disease (HR 1.72 [95% CI 1.10-2.68], p = 0.016) and CKD stage. Compared to stage 1 CKD (eGFR >89), HR of death increased in a progressive pattern below eGFR <75: eGFR 60-74, HR 2.40 (95% CI 1.2-4.78), p = 0.013, eGFR 45-59, HR 3.27 (95% CI 1.55-6.9), p = 0.002, eGFR 30-44, HR 4.10 (95% CI 1.82-9.24), p = 0.001, eGFR <30, HR 7.97 (95% CI 3.65-17.40), p < 0.001. In patients with eGFR <75, multivariate analysis demonstrated that DES use was an independent predictor of lower MACE (HR BMS vs. DES 1.8, p = 0.0044). Conclusion: Age, severity of CKD and 3-vessel disease were independent predictors of mortality following PCI. The mortality risk in CKD patients increased progressively with eGFR <75. The use of DES was associated with a lower rate of MACE in CKD patients with eGFR <75.

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Section: Discussionmentioning

confidence: 99%

“…However, there is conflicting evidence regarding the benefit of DES in patients with varying severities of CKD [4,6,[9][10][11] , as patients with CKD are commonly excluded from clinical trials evaluating DES [12] . The aim of this study was to investigate the effect of different stages of CKD on 1-year outcomes post PCI.…”

Section: Introductionmentioning

confidence: 99%

Impact of Mild-to-Moderate Chronic Kidney Disease on One Year Outcomes after Percutaneous Coronary Intervention

Grandjean-Thomsen

Marley²,

Shadbolt³

et al. 2017

Nephron

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“…Nevertheless, patients with advanced CKD and ESRD are underrepresented in clinical trials of CVD [3]. The Kidney Disease Outcome and Quality Initiative 2005 Cardiovascular Disease in Dialysis Patients guidelines recommend the assessment and treatment of risk factors and end organs for CVD in dialysis patients, but they lack detailed specifics on screening modalities and risk stratification beyond transthoracic echocardiography for valvular disease in dialysis patients [4].…”

Section: Introductionmentioning

confidence: 99%

Detection of Atherosclerotic Cardiovascular Disease in Patients with Advanced Chronic Kidney Disease in the Cardiology and Nephrology Communities

et al. 2018

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Background: Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of morbidity and mortality among patients with chronic kidney disease (CKD) with a glomerular filtration rate of < 60 mL/min/1.73 m² body surface area. The availability of high-quality randomized controlled trial data to guide management for the population with CKD and ASCVD is limited. Understanding current practice patterns among providers caring for individuals with CKD and CVD is important in guiding future trial questions. Methods: A qualitative survey study was performed. An electronic survey regarding the diagnosis and management of CVD in patients with CKD was conducted using a convenience sample of 450 practicing nephrology and cardiology providers. The survey was administered using Qualtrics® (https://www.qualtrics.com). Results: There were a total of 113 responses, 81 of which were complete responses. More than 90% of the respondents acknowledged the importance of CVD as a cause of morbidity and mortality in patients with CKD. Outside the kidney transplant evaluation setting, 5% of the respondents would screen an asymptomatic patient with advanced CKD for ASCVD. Outside the kidney transplant evaluation scenario, the respondents did not opt for invasive management strategies in advanced CKD. Conclusions: The survey results reveal a lack of consensus among providers caring for patients with advanced CKD about the management of ASCVD in this setting. Future randomized controlled trials will be needed to better inform the clinical management of ASCVD in these patients. The limitations of the study include its small sample size and the relatively low response rate among the respondents.

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“…Impaired kidney function leads to changes in pharmacokinetics and pharmacodynamics; thus, commonly used drugs frequently exhibit altered risk-benefit profiles in patients with CKD (3). Unfortunately, clinical trials are notorious for excluding patients with kidney disease (4,5), often leading to a lack of data to inform drug selection and dosing and forcing clinicians to extrapolate clinical data derived from the general population to patients with CKD. It is no surprise then that patients with CKD experience increased rates of adverse drug events and toxicity compared with those with normal kidney function (6).…”

mentioning

confidence: 99%

Introduction to Nephropharmacology for the Clinician

Nolin

Perazella

2018

CJASN

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Representation of Patients With Kidney Disease in Trials of Cardiovascular Interventions

Cited by 125 publications

References 8 publications

Impact of Mild-to-Moderate Chronic Kidney Disease on One Year Outcomes after Percutaneous Coronary Intervention

Impact of Mild-to-Moderate Chronic Kidney Disease on One Year Outcomes after Percutaneous Coronary Intervention

Detection of Atherosclerotic Cardiovascular Disease in Patients with Advanced Chronic Kidney Disease in the Cardiology and Nephrology Communities

Introduction to Nephropharmacology for the Clinician

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