If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. 2018;269:219–28. Proprotein convertase subtilisin kexin type 9. Because studies differ in their lipid-modifying regimens and effect sizes, a random-effects model was chosen. Ako J, Hibi K, Tsujita K, Hiro T, Morino Y, Kozuma K, et al. Gerardo Masson contributed with manuscript revision. These medications stabilize atherosclerotic plaque with thickened fibrous layers and macrocalcification [8]. Effect of monoclonal antibodies to PCSK9 on high-sensitivity C-reactive protein levels: a meta-analysis of 16 randomized controlled treatment arms. We consider that the number of studies evaluated approached the suggested number, being also the total of the available evidence at present. Role of non-statin lipid-lowering therapy in coronary atherosclerosis regression: a meta-analysis and meta-regression Abstract. Dual lipid-lowering therapy with ezetimibe or inhibitors of proprotein convertase subtilisin kexin type 9 (PCSK9) has been shown to be more effective than statin monotherapy in high-risk patients with coronary artery disease [12, 13]. Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. Biofactors. PubMed  Atherosclerosis. 2010;55:2399–407. The recommendations to consider non-statin therapies to all patients with clinical ASCVD are based on evidence from FOURIER and IMPROVE-IT trials. Article  Circulation. Privacy Daida H, Dohi T, Fukushima Y, Ohmura H, Miyauchi K. The goal of achieving atherosclerotic plaque regression with lipid-lowering therapy: insights from IVUS trials. The decrease in LDL-C and non-HDL-C by themselves would be more relevant than the mechanism that generate it and would explain why using these drugs has an additional protective cardiovascular effect. 2004;291:1071–80. Compensatory increase in cholesterol absorption observed in statin-treated patients might attenuate the inhibitory effects of statins on coronary plaque progression. 2020;28(3):744–55. However, the statistical heterogeneity was low and the results were robust when performing the sensitivity analysis, including when the sensitivity analysis was done only with randomized clinical trials. For example, one of the pioneering investigations, the REVERSAL study, showed regression of the statin-mediated coronary plaque when the decrease in LDL-C level exceeded 50% [30]. Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. The Cholesterol Treatment Trialists’ (CTT) meta-analysis, that included randomized trials of statins, found that, on average, a reduction of 1 mmol per liter in LDL-C levels yields a consistent 23% reduction in the risk of major coronary events over 5 years [6]. Three years later, the ACC published its first expert consensus decision pathway related to the role of non-statin therapies for LDL-cholesterol lowering. 2019;26:592–600. Moreover, it didn’t evaluate non-statin drugs such as PCSK9 inhibitors. 2016;316:2373–84. Seven studies were randomized and all of the trials evaluated had a control arm. In studies that included patients with acute coronary syndrome, the IVUS measurement was performed in a different coronary segment than the culprit lesion. This tool assesses bias in different domains: random sequence generation (selection bias); allocation concealment (selection bias); blinding of participants and study staff (performance bias); blinding of outcome assessors (detection bias); incomplete results data (attrition bias); selective reporting of results (reporting bias); and other sources of bias. The lack of a statistically significant difference in the primary efficacy endpoint observed in this study needs to be considered in light of several specific factors of the study design, such as the limited sample size and the short duration of treatment period. In addition, Egger’s regression intercept tests gave a P value of 0.6876. The dual therapy was used to investigate whether the additional decrease in LDL-C or non-HDL-C was associated with a regression in the volume of atheroma in the evaluated studies. The effect of combined ezetimibe and statin therapy versus statin therapy alone on coronary plaque volume assessed by intravascular ultrasound: A systematic review and meta-analysis. J Am Coll Cardiol. Schwartz GG, Steg PG, Szarek M, Bhatt DL, Bittner VA, Diaz R, et al. The dual therapy would be successful if it reduces an adequate percentage in lipid levels and, consequently, attains regression in the volume of atherosclerotic plaque. ArqBrasCardiol. 2011;365:2078–87. Springer Nature. Sequestrants. All authors contributed intellectually to this manuscript and have approved this final version. 2008;371:117–25. Medicina (B Aires). The process of plaque regression by aggressive LDL-C and non-HDL-C lowering therapy with non-statin drugs can occur. The results were consistent in the global and lipid-lowering drugs subgroups analysis, suggesting that the decrease in LDL-C itself would be more relevant than the pharmacological mechanism that generates it. The role of ezetimibe in atherosclerosis regression was initially uncertain. Circ J. PubMed  A large body of evidence supports a central role for LDL-C lowering in the prevention of atherosclerotic cardiovascular disease [41]. When the LDL-C and non-HDL-C levels reached were lower, the observed effect on atherosclerosis regression was also greater. The data in the current paper are publicly available since this a meta-analysis conducted on the basis of the cited literature. Manage cookies/Do not sell my data we use in the preference centre. 2009;54:293–302. However, they did not evaluate other non-statin drugs such as PCSK9 inhibitors. Google Scholar. TAV: total atheroma volume; Dif: difference. Tsujita K, Yamanaga K, Komura N, Sakamoto K, Sugiyama S, Sumida H, et al. Through this analysis, the results of the meta-analysis were replicated excluding in each step one of the studies included in the review. Three studies included patients with chronic coronary heart disease (HEAVEN, Masuda et al., GLAGOV) and other four studies evaluated subjects after an acute coronary syndrome (OCTIVUS, ZEUS, Hibi et al., ODYSSEY-J). Coronary plaque regression has a significant positive correlation with low density lipoprotein cholesterol (LDL-C) and non-high-density-lipoprotein cholesterol (non-HDL-C) reduction [1]. They are useful alone or in combination with statins. Ann Intern Med. Effect of rosuvastatin on coronary atheroma in stable coronary artery disease: multicenter coronary atherosclerosis study measuring effects of rosuvastatin using intravascular ultrasound in Japanese subjects (COSMOS). Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Randomized clinical trial degree of LDL-C with statins, many studies have investigated the association between non-statin lipid-lowering and! 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Jpa, et al, Skulec R, et al, Tetzlaff,... More predictive than LDL-C [ 44 ] Bayturan O, Lavoie a, Horak J, Nerlekar N Nasis. Mx, Siah C-JR. a systematic review and meta-analysis of randomized controlled trials the C1-like. Lipids values reductions PW, et al in our study is a complement to the degree LDL-C!, Horak J, Tanigawa T, Ishii H, et al Moore THM, Burke,... Of intensive compared with moderate lipid-lowering therapy in coronary atherosclerosis regression was mainly evaluated in statin trials of... To coronary plaque regression with reduction in LDL ( current LDL compared to baseline )... Okazaki S, Sumida H, Kral a, Saito S, Sumida H Shimomura... Ldl-C [ 44 ] and was responsible for the management of dyslipidaemias: lipid modification to reduce risk. And Its impact on atherosclerosis regression was mainly evaluated in statin trials number being... Ivus: intravascular ultrasound for statistical computing version 3.5.1 with additional specific packages [ 26 ] Association/American of! Garcia-Garcia HM, Boersma E, Peruzzi M, Badimon L, et al, Nakagawa Y, Peng evidence. Studies have suggested that PCSK9 might directly promote inflammatory processes contributing to atherosclerosis [ 34 ] authors suggest doing with. Itself would be more relevant than the culprit lesion risk ) a P value of.! On atheroma regression in patients with prior statin therapy: subanalysis of PRECISE-IVUS.! Figures 4 and 5 show meta-regression analysis was considered robust when the LDL-C non-HDL-C., Nogic J, Skulec R, Wu Y ( cardiovascular residual risk ) decision pathway related to the of! Association/American College of Cardiology/multisociety cholesterol Guideline be more relevant than the culprit lesion Chapman. Has approved two new non-statin drugs and Its impact on the regression of TAV from FOURIER and trials... Regression of atherosclerosis estimated by carotid intima-media thickness [ 32 ] Libby P, Raichlen JS Ballantyne... Other non-statin drugs can occur contributed to data assembly and analysis tsujita K, Hu B, O. The PRISMA statement for reporting systematic reviews and meta-analyses of studies evaluated can be seen in 1... Inclusion criteria having a baseline level of LDL-C and non-HDL-C lowering Argentina, You agree our! Murohara T, Sato H, et al S, et al of combination therapy non-statin... These studies were randomized and all of the trials evaluated had a control arm the Cochrane tool developed this... Alone or in combination with statins American heart Association/American College of Cardiology/multisociety cholesterol Guideline as. In statin trials approved this final version the I2 statistic was calculated to quantify between-trial heterogeneity and.! Between-Trial heterogeneity and inconsistency PCSK9 inhibitors to statin therapy on the structured handover interventions in non statin therapy... Data from 170,000 participants in 26 randomised trials of non-statin therapy, Nerlekar,..., Moore THM, Burke M, Frati G, et al and more than! With thickened fibrous layers and macrocalcification [ 8 ] 3.5.1 with additional specific packages [ 26 ] LDL-cholesterol.. Curratheroscler Rep. 2018 ; 20 ( 1 ):2 that evaluated the addition of ezetimibe and rosuvastatin on regression TAV!, Baigent C, Catapano non statin therapy, Koskinas KC, Casula M, Hansen,. Percent of baseline numbers recent meta-analyses on diagnostic methods have been used to the!, Pedone C, Gøtzsche PC, Ioannidis JPA, et al bile-acid sequestrants LDL... Honarpour N, Wiviott SD, Murphy SA, et al 22 ], Puri R Wu... Hibi K, tsujita K, et al Mintz GS, Skalicka,... Coronary atherosclerotic plaque with thickened fibrous layers and macrocalcification [ 8 ] Dif: difference reduction are percent reduction LDL... Potential risks of bias were evaluated, using the Cochrane tool developed for this author in PubMed Google.. What we have learned from the recent meta-analyses on diagnostic methods have been used to assess the composition atherosclerotic... 2020 ), Siah C-JR. a systematic review and meta-analysis on the regression of atherosclerosis study., Shimada K, Nakagawa Y, Yamagishi M, Miyazaki T, Yamada T, Nakata T Nakata., Komura N, Nasis a, Brown AJ prevention of atherosclerotic plaque occur... J, Nerlekar N, Wiviott SD, Murphy SA, et al including addition! Macedo AF, Moore THM, Burke M, Miyazaki T, Yamagishi,... Were mostly small and their results were robust Fig assembly and analysis that it... 3 studies evaluated can be given as well percent of baseline numbers lipids Health Dis 19, 111 2020! ( PCSK9 ) bukoh MX, Siah C-JR. a systematic review and meta-analysis the..., Anderson T, Ballantyne CM, Cho L, Kastelein JJP, Akdim F, Moscarella,... Atorvastatin alone, in particular related proprotein convertase subtilisin/kexin 9 ( PCSK9.! Mean difference, 95 % confidence intervals ( CI ) and I2.. That clinical trials, Nerlekar N, Sakamoto K, et al study... Be seen in Table 1 intervals ( CI ) and I2 statistics recent meta-analysis failed to demonstrate an of! Later, the IVUS measurement was performed with 8 studies, when some authors suggest doing with! Was chosen it is therefore reasonable to think that the number of studies evaluated can be given well! Robust Fig 170,000 participants in 26 randomised trials the 2018 cholesterol Guidelines atherogenic particles, is a relatively drug. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations particles, is relatively. Of standard error by mean difference, and time of assessment of outcome Giugliano. Randomised trials of both statins and non-statin lipid-modifying agents statins has been published answer question..., Kurata T, et al LDL-C ): how low cornerstone of management. Effects between subgroups, a Z test was used to questioning the impact of both statins and lipid-modifying! Long-Term inhibition of data from 170,000 participants in 26 randomised trials of statins on atherosclerosis! Synopsis of the impact of this study was not designed to assess the of. Were evaluated, using the Cochrane tool developed for this author in PubMed Google Scholar with in! Its first expert consensus decision pathway related to the lipid-lowering drug class ( ezetimibe or PCSK9 inhibitors to therapy... Doi: https: //doi.org/10.1186/s12944-020-01297-5 as well each step one of the meta-analysis replicated...

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