Systematic review and meta-analysis of placebo-controlled invasive interventions for the management of chronic stable angina

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Rivera ◽  
D.L Brown

Abstract Background The benefits of invasive therapies for chronic stable angina are in large part supported by open label studies comparing invasive procedures to medical therapy alone. Placebo effects are frequently unaccounted for as control arms rarely receive placebo (sham) interventions. This review pools studies comparing invasive therapies for chronic stable angina to placebo interventions and aims to measure the true effects of different invasive interventions. Methods We performed a systematic review and meta-analysis of double blinded randomized placebo-controlled trials of invasive therapies for the management of chronic stable angina. The outcomes of interest were change in exercise tolerance time, change in Canadian cardiovascular society angina grade and rate of post-procedural complications including myocardial infarction and all-cause mortality. Results Six randomized placebo-controlled trials were included, with a total of 742 participants. Median follow-up ranged from 6 weeks to 16 months. Contrary to data reported in individual studies, pooled analysis favored invasive therapies over placebo procedures: exercise tolerance time was higher (standard mean difference (SMD) 35.2 seconds [4.4- 66.0]), angina scores were more likely to improve by ≥1 class (Odds Ratio (OR) 2.16 [1.05- 4.46]) and by ≥2 classes (OR 1.76 [1.13- 2.74]). There was no difference in post-procedural myocardial infarction (incidence rate ratio (IRR) 2.91 [0.61–13.93]) and all-cause mortality (IRR 0.39 [0.35–4.27]). Conclusions This meta-analysis of placebo-controlled trials for chronic stable angina found a beneficial effect from invasive therapies. This favorable effect has not been seen in individual studies. Our findings suggest that sample sizes should be adjusted upwards in placebo-controlled studies to detect true treatment effects independent of the placebo effect. Funding Acknowledgement Type of funding source: None

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
N Zamiri ◽  
H Alradaddi ◽  
T Adli ◽  
S Jolly ◽  
C Ainsworth ◽  
...  

Abstract Background Since the inception of clinical guidelines on the management of patients with acute coronary syndrome (ACS), betablocker therapy has been included as a class I recommendation. However, most studies evaluating betablockers in ACS were conducted in the pre-reperfusion era. Currently, the great majority of patients undergo reperfusion and secondary prevention therapy has evolved; the impact of treatment with a betablocker in these patients may be different. Purpose We conducted a systematic review and meta-analysis to evaluate the impact of betablockers on mortality in patients after an ACS in the reperfusion era. Methods We searched MEDLINE, EMBASE, and Cochrane Central Registry of Controlled Trials for RCTs from inception to September 2019. We included randomized controlled trials comparing betablockers to no betablockers in adult patients presenting with an ACS. Independently and in duplicate, we screened titles and abstracts, reviewed the full-text report of potentially eligible studies and extracted data. Two reviewers also evaluated the risk of bias in duplicate. Disagreements were addressed by consensus. We considered trials to be conducted in the reperfusion era if reperfusion was attempted in more than 50% of patients, either with thrombolytics or primary angioplasty. Our primary outcome of interest was all-cause mortality. Secondary outcomes included hospitalization for heart failure, nonfatal myocardial infarction, stroke and cardiogenic shock. We pooled trial outcomes using a fixed effects model. The study protocol is registered with PROSPERO (CRD42019143158). Results After the initial screening of 10,969 references and full-text review of 176 articles, nine RCTs comprising a total of 49,639 patients with ACS were eligible for the final analysis. Predominantly, these patients presented with ST elevation myocardial infarction. Treatment with a betablocker did not improve all-cause mortality at 30 days (risk ratio (RR) 0.98 [95% CI 0.92–1.04], I2=44%), or at longest follow up (up to three years) with RR 0.97 ([95% CI 0.91–1.03], I2=0%). Betablocker therapy was associated with an increased risk of HF hospitalization (RR 1.10 [95% CI 1.05–1.15], I2=52%) and cardiogenic shock during index hospitalization (RR 1.29, [95% CI 1.18–1.40], I2=0%). However, betablocker therapy reduced the risk of nonfatal myocardial infarction (RR 0.72 [95% CI 0.63–0.83], I2=0%); it did not impact the risk of stroke (RR 1.13 [95% CI 0.95–1.35], I2=0%). Conclusion In the reperfusion era, betablocker therapy after an ACS does not appear to improve short or long-term survival. Although betablocker therapy was associated with a reduction in nonfatal myocardial infarction, it increased the risk of heart failure hospitalization and cardiogenic shock. In light of these findings, clinical guidelines should reconsider the strength of their recommendation for betablocker use in the ACS population until further contemporary evidence is available. Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J.Y Levett ◽  
S.B Windle ◽  
K.B Filion ◽  
J Cabaussel ◽  
M.J Eisenberg

Abstract Background Approximately half of patients with ST-segment elevation myocardial infarction (STEMI) present with multivessel coronary artery disease (CAD) during primary percutaneous coronary intervention (PCI). Purpose To compare the risks of major cardiovascular outcomes and procedural complications in patients with STEMI and multivessel CAD randomized to complete revascularization versus culprit-only PCI. Methods We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing complete to culprit-only PCI, identified via a systematic search of MEDLINE, Embase, and the Cochrane Libraries. Count data were pooled using DerSimonian and Laird random-effects models with inverse variance weighting to obtain relative risks (RRs) and corresponding 95% confidence intervals (CIs). Results A total of 8 RCTs (n=6,632) were included, with mean/median follow-up times ranging from 6 to 36 months. Compared to culprit-only PCI, complete PCI was associated with a substantial reduction in MACE (12.6% vs. 22.0%), repeat myocardial infarction (4.5% vs. 6.9%), and repeat revascularization (3.3% vs. 12.1%) (Table 1). Complete PCI may also improve all-cause and cardiovascular mortality, but estimates were accompanied by wide 95% CIs. Findings for stroke, major bleeding, and contrast-induced AKI were inconclusive. Conclusion Complete revascularization appears to confer benefit over culprit-only PCI in patients with STEMI and multivessel CAD, and should be considered a first-line strategy in these patients. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Mr. Levett is supported by a Dr. Clarke K. McLeod Memorial Scholarship, funded through the McGill University Faculty of Medicine Research Bursary Program. Dr. Filion is supported by a Junior 2 Research Scholar award from the Fonds de recherche du Québec – Santé and a William Dawson Scholar award from McGill University.


2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Shahab Hajibandeh ◽  
Shahin Hajibandeh

Abstract Aims to evaluate prognostic significance of metabolic syndrome (MetS) in patients undergoing carotid artery revascularisation. Methods A systematic review and meta-analysis was performed in compliance with PRISMA standards to evaluate prognostic significance of MetS in patients undergoing carotid endarterectomy or carotid stenting. Short-term (<30 days) postoperative outcomes (all-cause mortality, stroke or transient ischaemic attack (TIA), myocardial infarction, major adverse events) and long-term outcomes (restenosis, all-cause mortality, stroke or TIA, myocardial infarction, major adverse events) were considered as outcomes of interest. Random effects modelling was applied for the analyses. Results Analysis of 3721 patients from five cohort studies showed no difference between the MetS and no MetS groups in terms of the following short-term outcomes: all-cause mortality (OR: 1.67,P=0.32), stroke or TIA (OR: 2.44,P=0.06), myocardial infarction (OR: 1.01,P=0.96), major adverse events (OR: 1.23, P = 0.66). In terms of long-term outcomes, MetS was associated with higher risk of restenosis (OR: 1.75,P=0.02), myocardial infarction (OR: 2.12,P=0.04), and major adverse events (OR: 1.30, P = 0.009) but there was no difference between the two groups in terms of all-cause mortality (OR: 1.11, P = 0.25), and stroke or TIA (OR: 1.24, P = 0.33). The quality and certainty of the available evidence were judged to be moderate. Conclusions The best available evidence suggest that although MetS may not affect the short-term postoperative morbidity and mortality outcomes in patients undergoing carotid revascularisation, it may result in higher risks of restenosis, myocardial infarction and major adverse events in the long-term. Evidence from large prospective cohort studies are required for more robust conclusions.


2021 ◽  
Vol 8 ◽  
Author(s):  
Hongxuan Xu ◽  
Yunqing Liu ◽  
Lingbing Meng ◽  
Li Wang ◽  
Deping Liu

Background: Elevated serum uric acid (SUA) level is considered an independent predictor of all-cause mortality and the combined endpoint of death or readmission in cardiovascular disease patients. However, the causal relationship between uric acid-lowering therapies (ULTs) and heart failure is still controversial.Design: Meta-analyses were performed to systematically compile available evidence to determine the overall effect of ULTs on heart failure patients.Method: We conducted this systematic review following the PRISMA statement guidelines. Databases were searched to identify randomised controlled trials related to the influence of a ULT intervention in people with heart failure. Data extracted from the included studies were subjected to a meta-analysis to compare the effects of ULTs to a control.Results: Pooled analysis of left ventricular ejection fraction (LEVF) showed an insignificant result towards the ULT group (MD, 1.63%; 95%CI, −1.61 to 4.88; p = 0.32; three studies). Pooled analysis of the 6-Minute Walk Test (6MWT) showed an insignificant result towards the ULT group (MD, 4.59; 95%CI, −12.683 to 22.00; p = 0.61; four studies). Pooled analysis of BNP/NT-pro-BNP led to a nearly statistically significant result towards the ULT group (SMD, −0.30; 95%CI, −0.64 to 0.04; p = 0.08; five studies). Pooled analysis of all-cause mortality and cardiovascular death between ULTs (all XOIs) and placebo did not show a significant difference (RR, 1.26; 95% CI, 0.74 to 2.15, p = 0.39).Conclusion: ULTs did not improve LVEF, BNP/NT-pro-BNP, 6MWT, all-cause mortality, and CV death in heart failure patients. UA may just be a risk marker of heart failure.


2020 ◽  
Vol 50 (9) ◽  
pp. 773 ◽  
Author(s):  
Christina Kalvelage ◽  
Christian Stoppe ◽  
Nikolaus Marx ◽  
Gernot Marx ◽  
Carina Benstoem

2021 ◽  
Vol 8 ◽  
Author(s):  
Alberto Domínguez-Rodríguez ◽  
Pedro Abreu-González ◽  
Néstor Báez-Ferrer ◽  
Russel J. Reiter ◽  
Pablo Avanzas ◽  
...  

Myocardial ischemia/reperfusion (IR) injury represents a critical problem associated with interventional approaches for coronary reperfusion. Pharmacological cardioprotective interventions are advocated to ameliorate IR injury. Melatonin is an anti-inflammatory and antioxidant agent with a wide range of therapeutic properties that may contribute to its cardioprotective effects. No systematic review or meta-analysis has compared melatonin vs. placebo as a cardioprotective agent in humans. The present study, based on a systematic review and meta-analysis, was carried out to assess melatonin's efficacy as a cardioprotective treatment. We performed a systematic review of the available literature. Randomized controlled trials (RCTs) were identified and information was extracted using predefined data extraction forms. The primary outcomes were (a) left ventricular ejection fraction (LVEF) and (b) blood troponin levels in patients who underwent myocardial revascularization and were randomized to melatonin or placebo. The inverse-variance random-effects method was used to pool the estimates. Heterogeneity and publication bias were assessed. Weighted mean differences or standardized mean differences were calculated. A total of 283 records were screened and seven RCTs met all the inclusion criteria. After the pooled analysis, the results on LVEF were consistent across all studies, and a significant heterogeneity was found in the results on troponin levels. The melatonin-treated patients had on average higher LVEF than the placebo-treated individuals with a weighted mean difference = 3.1% (95% CI 0.6–5.5, p = 0.01). Five works compared the levels of troponin after melatonin or placebo treatment. The melatonin-treated patients had lower levels of troponin with a standardized mean difference = −1.76 (95% CI −2.85 to −0.67, p = 0.002). The findings of this meta-analysis revealed that melatonin administration in humans as a cardioprotective agent attenuated heart dysfunction with a favorable effect on the LVEF.


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