Statin Use and Survival Outcomes in Elderly Patients With Heart Failure

Ray, Joel G.; Gong, Yanjun; Sykora, Kathy; Tu, Jack V.

doi:10.1001/archinte.165.1.62

Cited by 104 publications

(2 citation statements)

References 42 publications

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“…ELITE-II) 94 Post hoc analysis of RCT 1997–1998 Multiregional 18 a 3132 2734 398 0.61 (0.45–0.83; P < 0.0007) 0.61 (0.44–0.84; P < 0.003) Anker, UK, 2006 (2. European Centres Study) 94 Retrospective cohort study 1992–2000 Europe 24 a 2068 705 1363 0.59 (0.49–0.72; P < 0.0001) 0.58 (0.44–0.77; P < 0.0001) Goldberger, USA, 2006 (DEFINITE) 95 Post hoc analysis of RCT (non-ischaemic DCM) 1998–2002 USA 29 458 110 348 0.22 (0.09–0.55; P < 0.001) 0.23 (0.09–0.58; P < 0.04) Ray, Canada, 2005 96 Retrospective cohort study (66–85 years) 1995–2001 Canada 24 28 828 1146 27 682 0.50 (0.43–0.59) 0.67 (0.57–0.78) Mozaffarian, USA, 2004 (PRAISE) 97 Post hoc analysis of RCT 1992–1994 USA 15 1153 134 1019 0.38 (0.23–0.64) 0.44 (0.26–0.75) Observational studies—neutral treatment effect ...…”

Section: Resultsmentioning

confidence: 99%

Association is not causation: treatment effects cannot be estimated from observational data in heart failure

Rush

Campbell

Jhund

et al. 2018

European Heart Journal

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AimsTreatment ‘effects’ are often inferred from non-randomized and observational studies. These studies have inherent biases and limitations, which may make therapeutic inferences based on their results unreliable. We compared the conflicting findings of these studies to those of prospective randomized controlled trials (RCTs) in relation to pharmacological treatments for heart failure (HF).Methods and resultsWe searched Medline and Embase to identify studies of the association between non-randomized drug therapy and all-cause mortality in patients with HF until 31 December 2017. The treatments of interest were: angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, mineralocorticoid receptor antagonists (MRAs), statins, and digoxin. We compared the findings of these observational studies with those of relevant RCTs. We identified 92 publications, reporting 94 non-randomized studies, describing 158 estimates of the ‘effect’ of the six treatments of interest on all-cause mortality, i.e. some studies examined more than one treatment and/or HF phenotype. These six treatments had been tested in 25 RCTs. For example, two pivotal RCTs showed that MRAs reduced mortality in patients with HF with reduced ejection fraction. However, only one of 12 non-randomized studies found that MRAs were of benefit, with 10 finding a neutral effect, and one a harmful effect.ConclusionThis comprehensive comparison of studies of non-randomized data with the findings of RCTs in HF shows that it is not possible to make reliable therapeutic inferences from observational associations. While trials undoubtedly leave gaps in evidence and enrol selected participants, they clearly remain the best guide to the treatment of patients.

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Section: Resultsmentioning

confidence: 99%

Association is not causation: treatment effects cannot be estimated from observational data in heart failure

Rush

Campbell

Jhund

et al. 2018

European Heart Journal

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“…The criteria for determining bleeding events in this study are mainly based on thrombolytic therapy for myocardial infarction thrombolysis in myocardial infarction (TIMI) bleeding grade. 19 Statistical Analysis SPSS26.0 was used to process the data. The measurement data was expressed as mean ± by t-test, while the counting data was expressed as percentage by sher , s exact test.…”

Section: Endpoints and De Nitionsmentioning

confidence: 99%

Study of the safety and efficacy of postoperative antiplatelet therapy after percutaneous coronary intervention: a single-center retrospective cohort study

Dai

2023

Preprint

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Aim: In view of the ethnic characteristics, the safety and efficacy of ticagrelor and clopidogrel in East Asian patients who need recieve dual antiplatelet therapy (DAPT) is a topic which still worth discussing. For the safety and efficacy of aspirin and P2Y12 receptor inhibitors in long-term single antiplatelet therapy (SAPT) after DAPT, there is no conclusion yet. Our study aimed to analyse the safety and efficacy of ticagrelor and clopidogrel in patients who received DAPT after percutaneous coronary intervention (PCI) as well as to analyse the safety and efficacy of aspirin and P2Y12 receptor inhibitors in patients who received DAPT for 1 year after PCI retrospectively. Methods: A total of 1006 patients undergoing PCI who received DAPT were retrospectively analysed in this study, which were divided into clopidogrel group (n=321) and ticagrelor group (n=685) according to different antiplatelet regiments. The incidence of major cardiovascular and cerebrovascular events (MACCEs) and bleeding events in two groups were compared and analysed during 12 months follow-up. For above-mentioned patients who completed 12 months DAPT then converted to long-term SAPT which add up to 814, these patients were divided into aspirin group (n=706) and non-aspirin group (n=108) according to different SAPT regimen. The incidence of MACCEs and bleeding events in two groups were compared and analysed during 36 months follow-up. Results: In patients who received DAPT after PCI, there was no significant difference in the incidence of MACCEs between ticagrelor group and clopidogrel group (4.2% vs. 6.2%, HR=1.47, 95% CI: 0.85-2.57; p＞0.05). The incidence of bleeding events in the ticagrelor group was significantly higher than the clopidogrel group (10.8% vs. 6.2%, HR=0.58, 95% CI: 0.36-0.93, p=0.020). Kaplan-Meier survival curve analysis showed that there was no significant difference in the incidence of MACCEs between ticagrelor group and clopidogrel group (4.2% vs. 6.2%, Plog-rank>0.05). The incidence of bleeding events in the ticagrelor group was higher than clopidogrel group (10.8% vs. 6.2%, Plog-rank=0.021). In patients who after PCI and received DAPT for 1 year then converted to SAPT, the incidence of MACCEs in the aspirin group was significantly higher than the non-aspirin group (7.2% vs. 1.9%, HR=0.26, 95% CI: 0.06-1.04; p=0.035). There was no significant difference in the incidence of bleeding events between aspirin group and non-aspirin group (2.7% vs. 3.7%, HR=1.38, 95% CI: 0.48-3.97; p＞0.05). Kaplan-Meier survival curve analysis showed that the incidence of MACCEs in aspirin group was higher than non-aspirin group (7.2% vs. 1.9%, Plog-rank=0.037). There was no significant difference in the incidence of bleeding events between aspirin group and non-aspirin group (2.7% vs. 3.7%, Plog-rank>0.05). Conclusions: In patients after PCI and accepted DAPT, ticagrelor had a similar MACCEs event incidence than clopidogrel, but had a higher risk of bleeding. P2Y12 receptor inhibitors do not increase bleeding risk versus aspirin and significantly reduce the occurence of MACCEs in patients who received long-term SAPT after DAPT.

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