{"id":137808,"date":"2023-03-04T18:22:41","date_gmt":"2023-03-04T23:22:41","guid":{"rendered":"https:\/\/cardiologynownews.org\/?p=137808"},"modified":"2023-03-04T18:22:41","modified_gmt":"2023-03-04T23:22:41","slug":"viability-not-linked-to-survival-or-lv-improvement-the-revived-bcis2-randomized-trial","status":"publish","type":"post","link":"https:\/\/cardiologynownews.org\/?p=137808","title":{"rendered":"Viability Not Linked to Survival or LV improvement: The REVIVED-BCIS2 Randomized Trial"},"content":{"rendered":"<p>Key Points:<br \/>\n-It is unclear whether myocardial viability tests should be used to guide decisions about<br \/>\nrevascularization in patients with ischemic cardiomyopathy (ICMP).<br \/>\n-The randomized trial REVIVED-BCIS 2 found that for patients with severe ICMP,<br \/>\nmultivessel percutaneous coronary intervention (PCI) plus optimal medical therapy<br \/>\n(OMT) was not superior to OMT alone for event-free survival or recovery of left<br \/>\nventricular ejection fraction (LVEF).<br \/>\n-This analysis of REVIVED-BCIS 2 data asked whether myocardial viability was<br \/>\npredictive of event-free survival (a composite of death or heart failure hospitalization),<br \/>\nLVEF recovery, or positive response to PCI among ICMP patients<br \/>\n-No significant association was found between baseline viability characteristics for event-<br \/>\nfree survival, LVEF recovery, or positive response to PCI. However, scar burden was<br \/>\npredictive of both event-free survival and LVEF recovery, and LVEF recovery was<br \/>\nassociated with improved clinical outcomes.<\/p>\n<p><!--more--><\/p>\n<p>Despite the intuitive presumption that dysfunctional-yet-viable myocardium will predict a<br \/>\npositive response to revascularization in ICMP, there is little randomized evidence that using<br \/>\nviability testing to guide clinical decision making results in LVEF improvement or better clinical outcomes (1). There is also conflicting evidence on whether improvement in LVEF as assessed by imaging is necessarily associated with improvement in clinical outcomes among those with re-vascularized ICMP.<\/p>\n<p>The Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in<br \/>\nHeart Failure (REVIVED-BCIS2) was a parallel, open-label randomized trial comparing PCI<br \/>\nand OMT in patients with extensive coronary artery disease (CAD) and systolic dysfunction,<br \/>\ndefined as left ventricular ejection fraction (LVEF) &lt;\/= 35% (2).\u00a0 All patients had PCI-amenable<br \/>\nlesions subtending at least 4 dysfunctional but viable segments. There was no difference<br \/>\nbetween the groups in the combined primary outcome of all-cause mortality or heart failure<br \/>\nhospitalization (HFH) or in the individual secondary outcomes of mortality, acute myocardial<br \/>\ninfarction, or change in LVEF at 12 months.<\/p>\n<p>On March 4, 2023, Dr. Divaka Perera of Kings College London presented the results of the<br \/>\nEffect of Myocardial Viability, Percutaneous Coronary Intervention and Functional Recovery<br \/>\nOn Clinical Outcomes In The REVIVED-BCIS2 Randomized Trial as a part of the Featured<br \/>\nClinical Research Session of ACC.2023\/WCC.<\/p>\n<p>In this analysis, the baseline late gadolinium enhanced (LGE) CMR scans and serial<br \/>\nechocardiograms of REVIVED-BCIS 2 participants were reviewed by independent core<br \/>\nlaboratories blinding to treatment arm, clinical information, and temporal scan sequence. A<br \/>\nviable segment was defined as transmural LGE &lt;25% or contractile response during<br \/>\ndobutamine stress echocardiography.<\/p>\n<p>This analysis sought to answer four questions. Does viability predict event-free survival? Does<br \/>\nviability predict improvement in LVEF? Does viability predict a positive response to PCI versus<br \/>\nOMT? Finally, does LVEF improvement predict event-free survival?<\/p>\n<p>A total of 610 REVIVED-BCSI 2 patients were included in the analysis. Overall, 41% of the<br \/>\nhad diabetes. Median baseline LVEF was 32%. Roughly 80% of the patients had viability<br \/>\nassessed via CMR, with the remainder assessed by DSE. The median number of per-patient<br \/>\nnormal segments, dysfunctional but viable segments, and non-viable segments were 6, 5, and 5 respectively. An adjusted Cox proportional hazard was used to assess the relationship between viability and the primary outcome of death or HFH as well as in the influence of PCI on outcomes based on viability.<\/p>\n<p>This analysis found that there was no association between the degree of dysfunctional-viable<br \/>\nmyocardium and the primary outcome of event free survival (HR 0.98 CI 0.93-1.014, p=0.056).<br \/>\nThere was also no difference in the treatment effect of PCI versus OMT by viability<br \/>\ncharacterization. However, there was an association between scar burden (per 10% increase in<br \/>\nscar volume) and the primary outcome, with lower scar volume associated with improved event-free survival (HR 1.18 CI 1.04-1.33, p=0.009). They also found that LVEF recovery (defined as an improvement greater than median change of 4.7%) correlated with improved clinical outcomes; those who recovered their EF at 6 months had a 38% reduction in mortality or HFH. However, if you correct the LVEF recovery for scar burden, this effect disappears.<\/p>\n<p>In conclusion, this secondary analysis of REVIVED-BCIS 2 found that among patients with<br \/>\nsevere ICMP, PCI does not improve clinical outcomes or LVEF recovery compared to OMT<br \/>\nregardless of baseline viability characteristics. According to Dr. Perera, there is no \u201csweet<br \/>\nspot\u201d found for viability whereby PCI is preferred over OMT for the outcomes measured. \u201cThe<br \/>\nabundance of dysfunctional-yet-viable-segments was not associated with prognosis or likelihood of LV recovery; however, the scar burden was highly predictable of prognosis and likelihood of LV recovery,\u201d Dr. Perera said. \u201cWe need to challenge the paradigm of hibernation as we have known it. There is absolutely no evidence that we should use viability to guide our decision on revascularization. Instead using scar and non-viable myocardium [to guide decision making will need to be tested in future trials.\u201d<\/p>\n<p>References<br \/>\n1. Ryan M, Morgan H, Chiribiri A, Nagel E, Cleland J, Perera D. Myocardial viability<br \/>\ntesting: All STICHed up, or about to be REVIVED? Eur Heart J 2022;43(2):118-126a.<br \/>\n2. Perera D, Clayton T, O\u2019Kane PD, et al. Percutaneous Revascularization for Ischemic Left<br \/>\nVentricular Dysfunction. N Engl J Med 2022;387(15):1351\u201360.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Key Points: -It is unclear whether myocardial viability tests should be used to guide decisions about revascularization in patients with ischemic cardiomyopathy (ICMP). -The randomized trial REVIVED-BCIS 2 found that for patients with severe ICMP, multivessel percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) was not superior to OMT alone for event-free survival or [&hellip;]<\/p>\n","protected":false},"author":40603,"featured_media":137809,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[878],"tags":[877,47,185],"ppma_author":[1029],"class_list":{"0":"post-137808","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-acc-2023","8":"tag-acc-2023","9":"tag-featured","10":"tag-news","11":"author-leah-kosyakovsky"},"authors":[{"term_id":1029,"user_id":40603,"is_guest":0,"slug":"leah-kosyakovsky","display_name":"Leah Kosyakovsky","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/864bde69f6f1f80e91e4a97f0a0ba8daa64c2bb702be09ed787444c7dfa045bb?s=96&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/137808","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/users\/40603"}],"replies":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=137808"}],"version-history":[{"count":1,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/137808\/revisions"}],"predecessor-version":[{"id":137810,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/137808\/revisions\/137810"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/media\/137809"}],"wp:attachment":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=137808"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=137808"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=137808"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fppma_author&post=137808"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}