Meta-analysis Comparing Complete or Culprit Only Revascularization in
Patients with Multivessel Disease Presenting with Cardiogenic Shock
Maurizio Bertaina MDa; Ilenia Ferraro MDa; Pierlugi Omedè MDa; Federico Conrotto MDa; Gaelle Saint-Hilaryb; Matthew A. Cavender MD, MPHc; Bimmer E. Claessen MDd; José P.S. Henriques, MD, PhDd; Simone Frea MDa; Tullio Usmiani MDa; Mauro Pennone MDa; Claudio Moretti MDa; Maurizio D’Amico MDa; Fabrizio D’Ascenzo MDa
Affiliations:
a Department of Cardiology; Città della Salute e della Scienza, Ospedale Molinette Hospital, Turin, Italy
b Department of Mathematical Sciences "G. L. Lagrange", Politecnico di Torino, Turin, Italy
c Department of Medicine, Division of Cardiology, University of North Carolina, Chapel Hill, NC, USA
d Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands
Running Title: Complete or culprit only revascularization in post-MI cardiogenic shock. Corresponding Author:
Maurizio Bertaina, MD
maurizio.bertaina@gmail.com
Tel. +390116336023
Division of Cardiology; Department of Medical sciences, Città della Salute e della Scienza, Molinette Hospital, Corso Bramante 88-90,
10125,Turin, Italy
ABSTRACT.
Best strategy for patients presenting with Cardiogenic Shock (CS) following Myocardial Infarction (MI) with multivessel (MV) disease remain to be elucidated. We conducted a meta -analysis of all randomized controlled trial (RCT) and observational studies with multivariate adjustment evaluating the impact of MV-PCI (Percutaneous Coronary Intervention) vs. Culprit only (C)-PCI in patients admitted for (CS ) and multivessel MV disease at coronary angiography. Primary endpoint was short term mortality at multivariate analysis; long term mortality, myocardial infarction (MI) and Acute Renal Injury (AKI) were the secondary ones. 6886 patients in twelve 12 studies (one 1 randomized and 11 observational ones) were included, 2042 treated with MV-PCI and 5841 with C-PCI. MV-PCI was not associated with an increased risk of short term death in comparison to C-PCI both at univariate as multivariate analysis (respectively: OR 1.14, 95%CI 0.87-1.48, p=0.35 and OR 1.0, 95% CI 0.7-1.43, p=1.00). Meta-regression analysis suggested worse in hospitalshort term survival with MV-PCI vs C-PCI for CS patients needing dialysis (beta 0.123, 95% CI from 0.049 to 0.198; p 0.001) while in anterior MI patients a survival benefit could be seen (beta -0.022, 95% CI from -0.033 to -0.012; p <0.001). MV-PCI strategy was associated with a more frequent need for dialysis or CIN after revascularization (OR 1.36, 95% CI 1.06-1.75, p=0.02). In conclusion, PCI MV-PCI seems not to increase risk of death both at short and long-term follow-up when compared to C-PCI in patients admitted for CS following MI. Furthermore, it appearsappears a more favorable strategy in patients with MV disease admitted for CS after anterior MI. The increased risk for AKI and its negative prognostic impact should be considered in decision making process.
Key Words: cardiogenic shock; multivessel disease; myocardial infarction; Culprit or Complete.
Patients with ST-Segment Elevation Myocardial Infarction (STEMI) presenting with cardiogenic shock (CS) are at increased risk of in hospital mortality, which, despite primary Percutaneous Coronary Intervention (PCI), pharmacological and mechanical support, still account for up to 50% of cases (1,2). CS secondary to an Acute Myocardial Infarction (AMI) is most commonly due to a coronary occlusion, decline of cardiac output, hypotension and decreased systemic perfusion. These effects result in aA consequent compensatory increase in heart rate and myocardial oxygen demand with inevitable leads to further worsening of myocardial ischemia. (1,2). In this setting, presence of multivessel (MV) disease is found in up to frequent (up to 60% of cases) and its treatment remain to be elucidated (1). On one hand, multiple significant stenosis stenoses may trigger and sustain the mechanism of decreased systemic and cardiac perfusion, increasing the negative loop of CS. On the other hand, a complete revascularization in such a critical acute setting is not devoid by complications, particularly for patients with complex lesions and renal frailty (3,42,3). In patients without CS, complete revascularization has shown to reduce long term adverse events mainly due to reduced risk of future revascularization in RCT and an association with lower risk of recurrent infarctions in observational studies (5-7).
For patients with CS, tTwo recent meta-analysis have shown conflicting results in the comparison between MV-PCI and C-PCI: Kolte et al. (54,5) reported neutral results both at short as well as at long term follow up, while de Waha et al. suggested worse in hospital outcome with single stage MV-PCI (10). However, These two studies, however,their conclusions were biased influenced by pooling only results derived from observational studies without multivariate adjustment, maybe increasing risk of selection bias.
Interventional cardiologist approaching CS patients with multi-vessels disease (MVD), decide on MV or C-PCI according to single patient risk profile, taking care of improvement of clinical scenario after treatment of culprit lesion and anatomical and technical considerations such as
presence of Chronic Total Occlusions (CTOs) or not-revascularizable vessels. Thus, we sought to perform a meta-analysis pooling together results both from adjusted observational studies and from the only recently published RCT (116) on this topic to further better characterize the association between extent of revascularization and outcome.
METHODS.
This analysis was conducted according to the recommendations of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) amendment to the Quality of Reporting of Meta-analyses (QUOROM) statement, and respecting recommendations from The Cochrane Collaboration and Meta-analysis Of Observational Studies in Epidemiology (MOOSE) (12-177-9) were exploited. Possible articles for inclusion were found using established search methods(16)rigorous methodology looking for the terms “shock” or “complete revascularization” or ”culprit only revascularization” or “revascularization” or “stemi”. The corresponding authors of possible studies were then directly contacted via email asking for further specific data when needed. (17). Moreover, abstract presentations at congresses of last 10 years were reviewed to identify other relevant studies. Three independent reviewers (FDA, MB, IF) first screened at the abstracts level of all studies identified using the search criteria abovefor inclusion. If thought potentially eligible, the complete article was then reviewed. Studies included in the meta-analysis were those which included (i) patients with CS and multivessel MV disease undergoing PCI; (ii) reporting independent predictive value of complete PCI evaluated at multivariate analysis or through RCTs (iii) with at least 6 30 daysmonths follow up. Exclusion criteria were any of: (i) non-human study, (ii) duplicate reporting (in which case the manuscript reporting the largest sample of patients was selected), (iii) not English. Three unblinded independent reviewers (FDA,MB,IF) abstracted the the following data on outcome and CS definitions of included articles as well as baseline characteristics of enrolled populations, in hospital and follow-up events rates on pre-specified data collection forms: authors, journal, year of publication,
location of the study group, baseline features, definitioand n of CAD, admission and death rates, inclusion and exclusion criteria, multivariate predictors of adverse outcomes (point summary estimate of risk, with 95% confidence interval). Short term mortality at multivariate analysis was the primary end point, while in hospital mortality at univariate analysis, long term mortality both at univariate and multivariate analysis, AKI (defined as need for dialysis or combined endpoint of need for dialysis or Contrast Induced Nephropathy [CIN]), myocardial infarction (MI), stroke and major bleeding were the secondary ones. At meta regression analysis, impact of clinical presentation (NSTEMI or STEMI diagnosis), MI site and need for dialysis after PCI on primary endpoint was evaluated. Unblinded independent reviewers (MB, a FDA) iependently evaluated the quality of the selected studies on pre-specified data collection forms using modified MOOSE criteria to take into account the specific features of included studies (149 12). The 3 independent reviewersA and IF separately appraised study design, setting, data source, and statistical methods for multivariable analysis, as well as risk of analytical, selection, adjudication, detection, and attrition bias. (expressed as low, moderate, or high risk of bias). Continuous variables are reported as mean (standard deviation) or median (range). Categorical variables are expressed as n/N (%). Statistical pooling was performed according to a random-effect model with generic inverse-variance weighting, computing risk estimates with 95% confidence intervals, using RevMan 5 (The Cochrane Collaboration, The Nordic Cochrane Centre, and Copenhagen, Denmark). Graphical inspection of funnel plots was used to assess for study bias. Standard hypothesis testing was set at the two-tailed 0.05 level.
RESULTS.
Five hundred and five studies were initially screened. After exclusions, 12 studies, one 1 randomized controlled trial (RCT) (116) and 11 observational studies (18-2810-20) were included in our analysis (Figure S1 in supplementary appendix). Number of included patients, specific definitions of CS and MVD are described in Table S1 (supplementary appendix);
baseline and procedural characteristics are shown in Table S2 (supplementary appendix). Totally 6886 patients were included, admitted predominantly for STEMI. 2042 and 5841 were treated with multi-vessels (MV-PCI) and culprit only (C-PCI) revascularization respectively.
Short term death (variably defined from in-hospital to 3 months events, see table S3 in supplementary appendix for each study definition) was assessed for 7330 patients (1786 MV-PCI and 5544 C-MV-PCI) in 10 observational studies (10-15,17,19,2018-23,25,27,28) and in the only one RCT (116). Multivariate adjustment was available for 6 observational ( 10-12,14,18,2018-20,22,26,28) and the RCT (116) study. Both analysis did not show significant association in terms of short term mortality in the comparison between MV-PCI vs C-PCI (univariate OR 1.14, 95%CI 0.87-1.48, p=0.35; and multivariate OR 1.00, 95%CI 0.7-1.43, p=1.00; figure 1 and 2).
Long term death (events which occurred between 6 months to 1 year;see table S3 in supplementary appendix for each study definition) was available only in the observational studies (12-18,2020-26,28) for a total of 2553 patients (766 MV-PCI and 1787 C-PCI). No significant association emerged between MV-PCI compared to C-PCI at univariate analysis (OR 0.90, 95% CI 0.61-1.33, p=0.61; figure 3) with just a not significant trend favoring MV-PCI in the multivariate pooled analysis (OR 0.75, 95% CI 0.52-1.07, p=0.11; figure 4).
In terms of safety outcome, there was no association between MV-PCI, when compared to C-PCI, and re-infarction as well as for stroke at univariate analysis (respectively: OR 0.71, 95% CI 0.41-1.22, p=0.22 and OR 1.33, 95% CI 0.82-2.16, p=0.25;see figure S2 in supplementary appendix) in univariate analysis. Moreover, there was a not significant association for higher bleeding incidence with MV-PCI vs C-PCI (OR 1.18, 95% CI 0.95-1.48, p=0.13; figure S3 in supplementary appendix). MV-PCI was associated withand a significant higher incidence of CIN or need for dialysis (OR 1.35, 95% CI 1.11-1.65,p=0.003). Finally, and oonly a trend emerged for single at univariate analysis on higher need for dialysis during
index admission with MV-PCI strategy (OR 1.31,95% CI 0.9-1.9, p=0.16 figure S4 in supplementary appendix).
Meta-regression analysis showed no evidence of effect modification between index diagnosis (STEMI versus NSTEMI: beta for NSTEMI diagnosis 0.03, 95% CI -0.15 to 0.1; p=0.89,see table S4 in supplementary appendix). In hospital/short term mortality tended to increase with MV-PCI vs C-PCI for CS patients needing dialysis (beta 0.123, 95% CI from 0.049 to 0.198; p 0.001), while appear to be reduced for anterior MI patients (beta -0.022, 95% CI from -0.033 to -0.012; p <0.001, figure S5 and table S4 in supplementary appendix). DISCUSSION.
To the best of our knowledge this is the largest meta-analysis on patients admitted for CS with MVD comparing MV vs C-PCI using pooled multivariable analysis. The The main results are: 1) MV-PCI is not associated with an increased risk of death compared to C-PCI, but with a significant higher risk of AKIPCI both at short and long term follow up; 2) Meta-regression analysis suggest a better outcome profile for CS patients with anterior MI treated with MV-PCI, while in those needing dialysis benefit for C-PCI strategy raises.;3) Patients treated with MV-PCI were at increased risk of AKI compared to C-MV-PCI.
Both short term death as well as re-infarction incidence did not show any significant association with MV-PCI
Our meta-analysis shows no association between short term death and MV-PCI when compared to C-PCI in patients admitted for post-MI CS. The same conclusions can be tract in terms of re-infarction incidence. Even if It is widely reported that MVD disease is frequent in this setting, with an obvious adverse impact among patients admitted for CS after myocardial infarction with an inevitably negative impact on prognosis (11,18-296,10-21), both European as well as US societies of cardiology do not give solid recommendations on best
revascularisation strategy ar . According to latest European of cardiology Society of Cardiology (ESC) guidelines (22,23302), revascularization of non-Infarct Related Artery (IRA) lesions during index procedure should be considered in patients with STEMI complicated by CS (IIa class of recommendation, level of evidence C). In the US, AUC guidelines suggest MV PCI is appropriate in patients with CS (31), while practice guidelines have not addressed this formally (32).). In fact, Literature literature on this topic is mainly based on observational studies with conflicting results influenced by large baseline population heterogeneity (4,5,10-205,10,18-28). Indeed, the inevitable selection bias of non-randomized studies tends to distort the comparison between MV vs C-PCI, because of the “sicker” profile of CS patients allocated to the first interventional strategy. Our meta-analysis, using multivariate adjustment techniques, tries to overcome these limitations, showing a “neutral” result on short term follow-up with a not significant trend favouring MV-PCI on long term. From a pathophysiological point of view, a complete revascularization in a such critical setting, would limit systemic and cardiac hypoperfusion, reducing ischemic area potentially reversing the negative loop of cardiac function deterioration (3324), but many technical and clinical consideratis can influence the success of MV revascularization and consequent prognostic benefit (33,34). For example, On the other hand, many technical and clinical considerations can influence the success of multivessel revascularization and its potential prognostic benefit. Wwhile treating non-IRA lesions could reduce early and late re-infarction or need for subsequent urgent revascularization as demonstrated in more stable patients (25-27)6,7,35), the typical hyperinflammatory response of CS, could favour peri-procedural thrombotic events such as acute stent thrombosis particularly if a suboptimal stent deployment occurs in a context prone to undersizing a stent due to coronary vasoconstriction (3628). Furthermore, the large use of many of the studies published on this topic largely used BMS or first generation DES in the studies published on this topic, partially limitsing nowadays applicability of their results and, potentially reducing MV-PCI safety and efficacy (11,12,15,1616,17,19,20,23,24). Aiming to
overcome this uncertainty a randomized controlled trial has recently been published, suggesting a lower 30-day incidence of the composite endpoint (death or severe renal failure leading to renal-replacement therapy) using a C-PCI approach (116). Of note, up to 24% of enrolled patients presented a CTO lesion at angiography. TThis challenging coronary lesion in a non-IRA is not so infrequent in CS following STEMI and is obviously associated with a rapid haemodynamic deterioration and worse prognosis (37,3829). The coronary collaterals supporting CTO myocardium territory may be compromised by donor artery occlusion during AMI with a consequent larger infarct area and a severe global cardiac function impairment (39). However, the only RCT conducted in patients admitted for STEMI who underwent CTO PCI subsequently in a staged procedure failed to demonstrate a primary outcome benefit (based on LV systolic function and size) , only showing some positive results reopening Left Anterior Descending (LAD) coronary artery CTO in subgroup analysis (4030). In the CVLPRIT SHOCK trial, revascularization success of CTO lesions was achieved only in one third of cases, while an inevitable increase in procedural length and CM doses were registered (116). It may not be optimal to approach such a challenging interventional lesion in the acute phase, but perhaps delayed to a more "elective" situation which could increase the success rate and potential positive prognostic benefit. Another point of interest important issue to be considered analysing such a conflicting literature with conflicting results, should be culprit vessel and infarct site. the culprit vessel type and infarct site. While Park at al. (2214) reported no effect modification on mortality incidence, Sonrn et al. for example (2921), found that right coronary artery (RCA) culprit was associated with better survival rates than a non-RCA one. Moreover, in the CVLPRIT SHOCK trial (116) subgroup analysis, C-PCI survival benefit was only evident in patients with non-anterior STEMI. Our meta-regression confirms these reports, suggesting a greater benefit of MV-PCI vs C-PCI for anterior MI, perhaps based on worse cardiac status after an infarct due to a LAD culprit lesion.
In our meta-analysisFurthermore, MV-PCI group was associated with a higher incidence of AKI (defined as CIN or need for renal replacement therapy) and meta-regression shows suggest an increased survival benefit for C-PCI when a dialysis treatment was required. Obviously, a longer procedure aimed to MV revascularization inevitably increase contrast media (CM) doses leading to higherincreased risk of CIN (116). Alternatively, as reported in a recent paper of Caspi et al. (41), clinical risk profile, independently by CM volume, could play an important role in development of AKI after PCI in STEMI patients. Older age, baseline eGFR, heart failure, and hemodynamic instability are the main predictors (31). InSome observational studies included in our meta-analysis had a higher prevalence of patients with previous chronic kidney disease (CKD) allocated to MV-PCI cohort with an inevitable higher post-PCI need for dialysis (26). Other studies (18,20,22) showed more homogeneity at baseline and no significant differences emerged in AKI incidence at follow up. In t the only RCT included in our meta-analysis (116), onjust a not significant no association between MV-PCI strategy itself and need for renal replacement therapy emerged emerged even if eGFR were significantly lower following emergency procedure. It isAs largely described, that AKI and need for dialysis are associated with a worse outcome, also in terms of hard endpoints (short-term and long-(short-term mortality), besides bleeding events (4,4232). Therefore, the detrimental prognostic effect of need for dialysis during hospitalization for CS could overcome the potential benefit of a MV-PCI strategy in terms of final survival outcome, as strengthen by our meta-regression analysis. In this setting, an adequate intravenous volume expansion, started in the emergency room whenever feasible, may help to prevent CIN in patients undergoingfollowing PCI for CS, even if often limited by risk of acute pulmonary edema in a severely reduced pump function (4333). Alternative Other nephroprotective approaches such as remote ischemic preconditioning or postconditioning, which showed good resultsvalidated in more stable hemodynamic conditions, has not yet been tested in this emergency setting (4434).
Our study presents many limitations. As with any meta-analysis all included study limitations are shared by our work. Particularly Some results show borderline statistical significance so that a larger sample size could increase statistical reliability to the present conclusions.only one RCT and a limited number of observational studies was available on this topic. Both outcome definitions as well as final results showed significant inter-study heterogeneity, even if with meta-regression analysis we tried to reveal confounding factors. Even Furthermore, even if, in case of doubt on data interpretation, corresponding author of included papers were contacted, the lack of patient level data as well as incomplete records on revascularization success and presence of CTO did not permit solid conclusions and complete confounding factors evaluation.n;
Both outcome definitions as well as final results showed significant inter-study heterogeneity, even if with meta-regression analysis we tried to reveal confounding factors. Moreover, the absence of complete data in included papers, did not permit us to evaluate the impact of revascularization success and presence of CTO on outcome according to PCI strategy. Finally, some results show borderline statistical significance so that a larger sample size could increase statistical reliability to the present results. In conclusion, in patients admitted for post-MI CS we found no association between MV-PCI and increased risk of death over short and long-term follow-up when compared to C-PCI. Patients treated with MV-PCI were at increased risk of AKI. Meta-regression suggests a possible survival benefit for MV-PCI in CS patients interested bycase of anterior MI. Both objective as well as subjective elements must guide interventional cardiologist decision in this challenging context.
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