The effect of statins therapy in aortic stenosis: Meta-analysis comparison data of RCTs and observationals.
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ABSTRACT:
SUBMITTER: Zhao Y
PROVIDER: S-EPMC4781966 | biostudies-literature | 2016 Jun
REPOSITORIES: biostudies-literature
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The effect of statins therapy in aortic stenosis: Meta-analysis comparison data of RCTs and observationals.
Zhao Ying Y Nicoll Rachel R He Yi Hua YH Henein Michael Y MY
Data in brief 20160226
Aortic stenosis has been shown to share the same risk factors as atherosclerosis which suggested a potential benefit from statins therapy. Fourteen studies which provided the effect of statins treatment on aortic stenosis (AS) were meta-analyzed, including 5 randomized controlled trials (RCTs) and 9 observational studies. In the RCTs, statins did not have any influence on peak aortic valve velocity, peak valve gradient, mean valve gradient, aortic valve area and aortic calcification compared to ...[more]
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Project description:BackgroundAortic valve stenosis is the most common type of valvular heart disease in the USA and Europe. Aortic valve stenosis is considered similar to atherosclerotic disease. Some studies have evaluated statins for aortic valve stenosis.ObjectivesTo evaluate the effectiveness and safety of statins in aortic valve stenosis.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS - IBECS, Web of Science and CINAHL Plus. These databases were searched from their inception to 24 November 2015. We also searched trials in registers for ongoing trials. We used no language restrictions.Selection criteriaRandomised controlled clinical trials (RCTs) comparing statins alone or in association with other systemic drugs to reduce cholesterol levels versus placebo or usual care.Data collection and analysisPrimary outcomes were severity of aortic valve stenosis (evaluated by echocardiographic criteria: mean pressure gradient, valve area and aortic jet velocity), freedom from valve replacement and death from cardiovascular cause. Secondary outcomes were hospitalisation for any reason, overall mortality, adverse events and patient quality of life.Two review authors independently selected trials for inclusion, extracted data and assessed the risk of bias. The GRADE methodology was employed to assess the quality of result findings and the GRADE profiler (GRADEPRO) was used to import data from Review Manager 5.3 to create a 'Summary of findings' table.Main resultsWe included four RCTs with 2360 participants comparing statins (1185 participants) with placebo (1175 participants). We found low-quality evidence for our primary outcome of severity of aortic valve stenosis, evaluated by mean pressure gradient (mean difference (MD) -0.54, 95% confidence interval (CI) -1.88 to 0.80; participants = 1935; studies = 2), valve area (MD -0.07, 95% CI -0.28 to 0.14; participants = 127; studies = 2), and aortic jet velocity (MD -0.06, 95% CI -0.26 to 0.14; participants = 155; study = 1). Moderate-quality evidence showed no effect on freedom from valve replacement with statins (risk ratio (RR) 0.93, 95% CI 0.81 to 1.06; participants = 2360; studies = 4), and no effect on muscle pain as an adverse event (RR 0.91, 95% CI 0.75 to 1.09; participants = 2204; studies = 3; moderate-quality evidence). Low- and very low-quality evidence showed uncertainty around the effect of statins on death from cardiovascular cause (RR 0.80, 95% CI 0.56 to 1.15; participants = 2297; studies = 3; low-quality evidence) and hospitalisation for any reason (RR 0.84, 95% CI 0.39 to 1.84; participants = 155; study = 1; very low-quality evidence). None of the four included studies reported on overall mortality and patient quality of life.Authors' conclusionsResult findings showed uncertainty surrounding the effect of statins for aortic valve stenosis.The quality of evidence from the reported outcomes ranged from moderate to very low. These results give support to European and USA guidelines (2012 and 2014, respectively) that so far there is no clinical treatment option for aortic valve stenosis.
| S-EPMC6457620 | biostudies-literature
Project description:Background: In recent years, trans-catheter aortic valve implantation (TAVI) has emerged as an excellent alternative to surgical aortic valve replacement (SAVR). Currently, there are several approved devices on the market, yet comparisons among them are scarce. We aimed to compare the various devices via a network meta-analysis. Methods: We performed a network meta-analysis including randomized controlled trials (RCTs) and propensity-matched studies that provide comparisons of either a single TAVI with SAVR or two different TAVI devices and report clinical outcomes. Results: We included 12 RCT and 13 propensity-matched studies comprising 42,105 patients, among whom 27,134 underwent TAVI using various valve systems (Sapien & Sapien XT, Sapien 3, Corvalve, Evolut & Evolut Pro, Acurate Neo, Portico). The mean follow-up time was 23.4 months. Sapien 3 was superior over SAVR in the reduction of all-cause mortality (OR = 0.53; 95%CrI 0.31-0.91), while no significant difference existed between other devices and SAVR. Aortic regurgitation was more frequent among TAVI devices compared to SAVR. There was no significant difference between the various THVs and SAVR in cardiovascular mortality, myocardial infarction, NYHA class III-IV, and endocarditis. Conclusions: Newer generation TAVI devices, especially Sapien 3 and Evolut R/Pro are associated with improved outcomes compared to SAVR and other devices of the older generation.
| S-EPMC9506011 | biostudies-literature
Project description:BACKGROUND:Transcatheter aortic valve replacement (TAVI) is an alternative treatment for patients with symptomatic severe aortic stenosis ineligible for surgical aortic valve replacement (SAVR) or at increased perioperative risk. Due to continually emerging evidence, we performed a systematic review and meta-analysis comparing benefits and harms of TAVI, SAVR, medical therapy, and balloon aortic valvuloplasty. METHODS:We searched MEDLINE, Embase, and Cochrane CENTRAL from 2002 to June 6, 2017. We dually screened abstracts and full-text articles for randomized controlled trials (RCTs) and propensity score-matched observational studies. Two investigators independently rated the risk of bias of included studies and determined the certainty of evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation). If data permitted, we performed meta-analyses using random- and fixed-effects models. RESULTS:Out of 7755 citations, we included six RCTs (5862 patients) and 13 observational studies (6376 patients). In meta-analyses, patients treated with SAVR or TAVI had similar risks for mortality at 30 days (relative risk [RR] 1.05; 95% confidence interval [CI] 0.82 to 1.33) and 1 year (RR 1.02; 95% CI 0.93 to 1.13). TAVI had significantly lower risks for major bleeding but increased risks for major vascular complications, moderate or severe paravalvular aortic regurgitation, and new pacemaker implantation compared to SAVR. Comparing TAVI to medical therapy, mortality did not differ at 30 days but was significantly reduced at 1 year (RR 0.51; 95% CI 0.34 to 0.77). CONCLUSIONS:Given similar mortality risks but different patterns of adverse events, the choice between TAVI and SAVR remains an individual one.
| S-EPMC6362570 | biostudies-literature
Project description:BackgroundThis study aims to compare valve durability between transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR).MethodsWe conducted a systematic review and meta-analysis using data from randomized controlled trials (RCTs). The primary outcome was structural valve deterioration (SVD). Secondary outcomes were bioprosthetic valve failure, reintervention, effective orifice area (EOA), mean pressure gradient, and moderate-severe aortic regurgitation (AR, transvalvular and/or paravalvular).ResultsTwenty-five publications from seven RCTs consisting of 7,970 patients were included in the analysis with follow-up ranges of 2-8 years. No significant difference was found between the two groups with regard to SVD [odds ratio (OR) 0.72; 95% CI: 0.25-2.12]. The TAVI group was reported to exhibit a statistically significant higher risk of reintervention (OR 2.03; 95% CI: 1.34-3.05) and a moderate-severe AR (OR 6.54; 95% CI: 3.92-10.91) compared with the SAVR group. A trend toward lower mean pressure gradient in the TAVI group [(mean difference (MD) -1.61; 95% CI: -3.5 to 0.28)] and significant higher EOA (MD 0.20; 95% CI: 0.08-0.31) was noted.ConclusionThe present data indicate that TAVI provides a comparable risk of SVD with favorable hemodynamic profile compared with SAVR. However, the higher risk of significant AR and reintervention was demonstrated.Systematic review registrationPROSPERO (CRD42022363060).
| S-EPMC10525352 | biostudies-literature
Project description:ObjectivesBicuspid aortic valve (BAV) is an important aetiology of aortic stenosis and the use of transcatheter aortic valve implantation (TAVI) has not been fully explored in this cohort. This systematic review and meta-analysis compared the outcomes of TAVI in stenotic BAV against tricuspid aortic valve (TAV).MethodsAn electronic literature search was performed in PubMed, MEDLINE, EMBASE, and Scopus to identify all studies comparing TAVI in stenotic BAV versus TAV. Only studies comparing TAVI in BAV versus TAV were included, without any limit on the study date. Primary endpoints were 30-day and 1-year mortality, while secondary endpoints were postoperative rates of stroke, acute kidney injury (AKI), and permanent pacemaker (PPM) requirement. A trial sequential analysis (TSA) was performed for all endpoints to understand their significance.ResultsThirteen studies met the inclusion criteria (917 BAV and 3079 TAV patients). The BAV cohort was younger (76.8±7.43 years vs. 78.5±7.12 years, P=0.02), had a higher trans-aortic valve gradient (P=0.02), and larger ascending aortic diameters (P<0.0001). No significant difference was shown for primary (30-day mortality [P=0.45] and 1-year mortality [P=0.41]) and secondary endpoints (postoperative stroke [P=0.49], AKI [P=0.14], and PPM requirement [P=0.86]). The BAV group had a higher rate of significant postoperative aortic regurgitation (P=0.002). TSA showed that there was sufficient evidence to conclude the lack of difference in PPM requirements, and 30-day and 1-year mortality between the two cohorts.ConclusionTAVI gives satisfactory outcomes for treating stenotic BAV and should be considered clinically.
| S-EPMC8973142 | biostudies-literature
Project description:Calcific aortic stenosis (CAS) is the most common cause of acquired valvular heart disease in adults with no available pharmacological treatment to inhibit the disease progression to date. This review provides an up-to-date overview of current knowledge of molecular mechanisms underlying CAS pathobiology and the related treatment pathways. Particular attention is paid to current randomized trials investigating medical treatment of CAS, including strategies based on lipid-lowering and antihypertensive therapies, phosphate and calcium metabolism, and novel therapeutic targets such as valvular oxidative stress, coagulation proteins, matrix metalloproteinases, and accumulation of advanced glycation end products.
| S-EPMC8708539 | biostudies-literature
Project description:BackgroundAortic stenosis (AS) remains a prevalent and serious global health concern, exacerbated by an aging population worldwide. This valvular disease, when symptomatic and without appropriate intervention, severe AS can drastically reduce life expectancy. In our systematic review and meta-analysis, we aim to synthesize available evidence to guide clinical decision-making by comparing the performance of TAVR and SAVR, specifically in patients with severe AS and a small aortic annulus.MethodsWe searched PubMed, EMBASE, Cochrane, Web of Science, and Scopus from inception till May 2024. The risk ratio (RR) and mean difference (MD) with a 95 % confidence interval (CI) are provided as effect size estimates, with all analyses being conducted using RevMan 5.4.ResultsEleven studies with 3,670 patients were included. TAVR significantly increased the risk of 2-year new permanent pacemaker implantation (PPI) (RR = 2.42; 95 % CI: [1.70-3.44], P < 0.0001) and major vascular complications (RR = 3.73; 95 % CI: [1.98-6.99], P < 0.0001) than SAVR. However, TAVR significantly decreased the risk of patient-prosthesis mismatch (PPM) (RR = 0.56; 95 % CI: [0.48-0.65], P < 0.00001) and new-onset atrial fibrillation (AF) (RR = 0.31; 95 % CI: [0.23-0.41], P < 0.00001). Also, SAVR reduced the risk of paravalvular leak (PVL) (RR = 3.35; 95 % CI: [1.79-6.27], P = 0.0002).ConclusionTAVR had a significantly reduced risk of PPM and new-onset AF but with increased PPI and vascular complications. Also, TAVR significantly improved EOA and iEOA. Furthermore, SAVR had less risk of PVL, and better LVEF improvement at predischarge. Therefore, TAVR and SAVR remain valid alternatives, and decisions should be based on anatomy of the annulus and aortic root,operative risk, and comorbidities.
| S-EPMC11745981 | biostudies-literature
Project description:AimsThoracic aortic aneurysm (TAA) that progress to acute aortic dissection is often fatal and there is no pharmacological treatment that can reduce TAA progression. We aim to evaluate statins' effects on TAA growth rate and outcomes using a meta-analysis approach.Methods and resultsA detailed search related to the effects of statins on TAA was conducted according to PRISMA guidelines. The analyses of statins' effects on TAA growth rate were performed on 4 studies (n = 1850), while the impact on outcomes was evaluated on 3 studies (n = 2,867). Patients under statin treatment showed a reduced TAA growth rate (difference in means = -0.36 cm/year; 95%CI: -0.64, -0.08; p = 0.013) when compared to controls, patients not taking statins. Regarding the outcomes (death, dissection, or rupture of the aorta, and the need for operative repair), statins exhibited a protective effect reducing the number of events (log odds ratio = -0.56; 95%CI: -1.06, -0.05; p = 0.030). In vitro, the anti-fibrotic effect of atorvastatin was tested on vascular smooth muscle cells (VMSC) isolated from patients with TAA. Our results highlighted that, in transforming growth factor beta 1 (TGF-β1) pro-fibrotic condition, VSMC expressed a significant lower amount of collagen type I alpha 1 chain (COL1A1) when treated with atorvastatin (untreated = +2.66 ± 0.23 fold-change vs. treated = +1.63 ± 0.09 fold-change; p = 0.014).ConclusionStatins show a protective effect on TAA growth rate and adverse outcomes in patients with TAA, possibly via their anti-fibrotic properties on VSMC. Given the current lack of effective drug treatments for TAA, we believe our findings highlight the need for more in-depth research to explore the potential benefits of statins in this context.
| S-EPMC11324425 | biostudies-literature
Project description:IntroductionTranscatheter aortic valve replacement (TAVR) has become a suitable alternative to surgical aortic valve replacement (SAVR) for the treatment of symptomatic severe aortic stenosis (AS). A high proportion of patients with AS have mixed aortic valve disease (MAVD) with mild or more concurrent aortic regurgitation (AR). Differential outcomes of TAVR among patients with AS and MAVD have not been well characterized. We compared 1-year mortalities following TAVR among patients with MAVD and AS.MethodsWe conducted a meta-analysis of studies published in PubMed/Medline. The primary outcome was 1-year all-cause mortality following TAVR among patients with MAVD vs. AS. Secondary endpoints were: (1) incidence of AR within 30 days following TAVR (post TAVR AR); and (2) 1-year all-cause mortality within each group stratified according to severity of post TAVR AR.ResultsNine studies involving 9505 participants were included in the analysis. At 1 year following TAVR, mortality was lower in MAVD than in AS; HR 0.89, 95% CI 0.81-0.98. The mortality advantage increased when pre-TAVR AR was moderate or more; HR 0.84, 95% CI 0.72-0.99. The mortality advantage was attenuated after correction for publication bias. There was a higher risk of post TAVR AR in the MAVD group; OR 1.51, 95% CI 1.20-1.90 but the impact on mortality of moderate vs. mild post TAVR AR was greater among patients with AS than in patients with MAVD HR 1.67 95% CI 0.89-3.14 vs. 0.93 95% CI 0.47-1.85.ConclusionsPatients with MAVD have similar or improved survival 1 year after TAVR compared to those with AS.
| S-EPMC9986165 | biostudies-literature
Project description:ObjectivesThe management of severe aortic stenosis mandates consideration of aortic valve intervention for symptomatic patients. However, for asymptomatic patients with severe aortic stenosis, recent randomised trials supported earlier intervention. We conducted a systematic review and meta-analysis to evaluate all the available data comparing the two management strategies.MethodsPubMed, Cochrane and Web of Science databases were systematically searched from inception until 10 January 2022. The search key terms were 'asymptomatic', 'severe aortic stenosis' and 'intervention'.ResultsMeta-analysis of two published randomised trials, AVATAR and RECOVERY, included 302 patients and showed that early intervention resulted in 55% reduction in all-cause mortality (HR=0.45, 95% CI 0.24 to 0.86; I2 0%) and 79% reduction in risk of hospitalisation for heart failure (HR=0.21, 95% CI 0.05 to 0.96; I2 15%). There was no difference in risk of cardiovascular death between the two groups (HR=0.36, 95% CI 0.03 to 3.78; I2 78%). Additionally, meta-analysis of eight observational studies showed improved mortality in patients treated with early intervention (HR=0.38, 95% CI 0.26 to 0.56; I2 77%).ConclusionThis meta-analysis provides evidence that, in patients with severe asymptomatic aortic stenosis, early intervention reduces all-cause mortality and improves outcomes compared with conservative management. While this is very encouraging, further randomised controlled studies are needed to draw firm conclusions and identify the optimal timing of intervention.Prospero registration numberCRD42022301037.
| S-EPMC9109115 | biostudies-literature