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Erschienen in: Critical Care 3/2011

Open Access 01.06.2011 | Research

Levosimendan and mortality after coronary revascularisation: a meta-analysis of randomised controlled trials

verfasst von: Ritesh Maharaj, Victoria Metaxa

Erschienen in: Critical Care | Ausgabe 3/2011

Abstract

Introduction

Patients undergoing coronary revascularization often require inotropic support that has been associated with an increased risk for death and morbidity. The purpose of this study was to evaluate the effect of levosimendan versus control on survival after coronary revascularization.

Methods

A systemic review and meta-analysis of the literature was carried out on published randomized controlled clinical trials that investigated the efficacy of levosimendan compared to other therapy in patients having coronary revascularisaion. The databases searched were Pubmed, EMBASE, the Cochrane Registry of Clinical Trials and the metaRegister of Controlled Trials. Studies that compared levosimendan to any other therapy for coronary revascularisation in adult humans and reported at least one outcome of interest were considered for inclusion. Both percutaneous coronary intervention and cardiac surgery were included. Data extraction was performed independently by two reviewers using predefined criteria. Relevant outcomes included mortality, cardiac index, cardiac enzymes, length of stay and post-procedural atrial fibrillation.

Results

The meta-analysis included 729 patients from 17 studies. Levosimendan was associated with a mortality reduction after coronary revascularization, (19/386 in the levosimendan group vs 39/343 in the control arm) odds ratio (OR) 0.40 (95% confidence interval (CI) 0.21 to 0.76, P for overall effect 0.005, P for heterogeneity = 0.33, I2 = 12% with a total of 729 patients. Levosimendan also had a favourable effect on cardiac index (standardised mean difference 1.63, 95% CI 1.43 to 1.83, P for overall effect < 0.00001), length of intensive care stay (random effects model, mean difference - 26.18 hours 95% CI 46.20 to 6.16, P for heterogeneity < 0.00001, I2 = 95%, P for overall effect P = 0.01), reductions in the rate of atrial fibrillation (OR 0.54, 95% CI 0.36 to 0.82, P for effect = 0.004, P for heterogeneity 0.84, I2 = 0% for 465 patients) and troponin I levels group (mean difference -1.59, 95% CI 1.78 to 1.40, P for overall effect < 0.00001, P for heterogeneity < 0.00001, I2 = 95%). Limitations of this analysis are discussed.

Conclusions

Levosimendan is associated with a significant improvement in mortality after coronary revascularization. There are also improvements in several secondary endpoints. A suitably powered randomised controlled trial is required to confirm these findings and to address the unresolved questions about the timing and dosing of levosimendan.
Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​cc10263) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare that they have no competing interests.

Authors' contributions

All of the authors contributed to the design of the study. RM and VM were responsible for the statistical analysis. RM drafted the manuscript. All of the authors critically revised the manuscript and agreed on the submitted version.
Abkürzungen
CI
confidence interval
CS
cardiogenic shock
OR
odds ratio
PCI
percutaneous coronary intervention
RR
relative risk
RCT
randomised controlled trials
STEMI
ST-segment myocardial infarction.

Introduction

Following coronary revascularisation, patients are still vulnerable to a low cardiac output state and tissue hypoperfusion. Some patients may require bridging therapy in order to realise the benefits of revascularisation. There is substantial geographic variation, but it is estimated that between 8 and 25% of patients undergoing coronary revascularisation require inotropic support for myocardial dysfunction [13]. This group of patients carry a substantial burden of morbidity and mortality [4]. Pharmacologic support is commonly limited to catecholaminesand phosphodiesterase III inhibitors (PDEIs) with levosimendan gaining prominence [5]. There is a lack of suitably powered randomised control trails to guide the choice of inotrope in this group of patients. Both catecholamines and PDEIs are associated with increased post-operative myocardial oxygen consumption and arrythmogenesis [6]. Additionally catecholamines have also been associated with impaired coronary vasodilatatory reserve [7].
Levosimendan sensitises myofilaments to calcium by binding to the calcium saturated troponin C, increasing their load-independent contraction [8]. The pleiotropic effects of levosimendan include vasodilatation by opening ATP-sensitive potassium channels (KATP) in vascular smooth muscle as well as in mitochondrial KATP channels.
Early clinical trials, though underpowered, have suggested that levosimendan would be useful in the setting of post coronary revascularisation myocardial dysfunction. More recently there have been several completed clinical trials in this group of patients. The principal objective of this study was to evaluate the association between levosimendan, compared with conventional therapy on mortality, in randomised control trialsin patients having coronary revascularisation.

Materials and methods

Search strategy

The primary search for randomised clinical trials (RCTs) was conducted using Pubmed, EMBASE and the Cochrane Registry of Clinical Trials. The search term used was 'levosimendan'. The search was combined with filters to identify RCTs in the Pubmed and EMBASE database and is available as supplementary material (see Additional file 1 for details). We also searched the metaRegister of Controlled Trials using the term 'levosimendan' [9]. No language restriction was placed but the search was limited to adult human subjects. We used backward snowballing by reviewing the bibliographies of included RCTs and review articles to identify otherwise unrecognised publications. The electronic database search included publications from 1966 and was finalised on 31 August 2010. The study did not require ethical approval.

Study selection

The authors reviewed all abstracts to identify potential RCTs in a standardised manner. The inclusion criteria were reports of RCTs that compared levosimendan to any other therapy for coronary revascularisation in adult humans and reported at least one outcome of interest. Relevant outcomes included mortality, haemodynamic parameters (for example, cardiac index), cardiac enzymes, length of stay and post-procedural atrial fibrillation. If the abstract suggested that the study could potentially meet the inclusion criteria, the full text article was then retrieved and reviewed. Disagreements between reviewers were resolved by consensus.

Data abstraction and study characteristics

All included studies were assessed for internal validity and risk of bias according to the Cochrane Collaboration methods. Each report was assessed for the adequacy of allocation concealment, blinding, performance of an intention to treat analysis and the extent of loss to follow-up.
Data included baseline patient characteristics including age and co-morbidity, baseline left ventricular ejection fraction, details of levosimendan dose and specifics of comparator therapy, type of coronary revascularisation, haemodynamic and clinical outcome data. When data was missing attempts were made to contact the authors.

Data synthesis and analysis

Agreement on inclusion of studies was assessed using the kappa statistic. Heterogeneity was measured using the Cochrane Q test and quantified with the I 2 statistic. An I 2 value of > 50% was considered at least moderate heterogeneity.
Data from individual studies were collected to allow calculation of odds ratio (OR). The primary analysis was conducted by means of the Peto fixed effects method when I2 < 25% and with the random effects model when I2 > 25%. Weighted mean difference (WMD) and 95% CI were calculated for continuous variables (haemodynamics and troponin I). The potential for bias was assessed by visual inspection of funnel plots. Sensitivity analyses were conducted by comparing the fixed and random effects models as well as by evaluating the risk of mortality in studies with a low risk of bias only. The analysis was performed using statistical software SPSS 16 (SPSS Chicago, IL, USA) and Revman 5.0 (available from the Cochrane Collaboration Group). The study was performed in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement [10, 11].

Results

There were 680 reports identified by the search, 79 full text articles retrieved for in depth review. We identified 17 eligible studies involving 729 patients that were included in the final analysis. Figure 1 describes the flow and reasons for exclusion. Agreement on study inclusion was reached in 76 of the 79 cases (kappa = 0.92). The characteristics of the included studies are described in Table 1. An appraisal of study quality and risk of bias is presented in Table 2. Overall studies were of variable quality and many reports lacked relevant details to assess selection, performance or reporting bias. A risk of bias graph is included in the supplementary material (see Additional file 2 for details).
Table 1
Description of the studies included in the meta-analysis
Source
Year
Patients
Mean Age
(years ± SD)
Setting
Time of administration
Mean Baseline LVEF % ± SD
Control
Follow-up
   
Levosimendan
Control
  
Levosimendan
Control
  
Al-Shawaf et al. [35]
2006
30
60.5 ± 1 1
58 ± 10
Type 2 diabetes with LCOS after CABG.
Post intervention
29 ± 6
31 ± 6
Milrinone
Hospital stay
Alvarez et al. [36]
2005
30
71.5 ± 5.2
71.9 ± 5.2
Elective CABG with LCOS
Post intervention
35 ± 5
37 ± 4
Dobutamine
Hospital stay
Alvarez et al. [37]
2006
50
71.2 ± 7.2
67.0 ± 8.0
Elective CABG with LCOS
Post intervention
35 ± 4
34 ± 5
Dobutamine
Hospital stay
Barisin et al. [38]
2004
33
62.4 ± 7.1
57.9 ± 10.4
Elective OPCAB with good LV function
Pre- intervention
62 ± 8
58 ± 10
Placebo
Hospital stay
De Hert et al. [39]
2007
30
67 ± 11
69 ± 10
Elective CABG
Intraoperatively
24 ± 6
27 ± 3
Milrinone
Hospital stay
De Hert et al. [40]
2008
60
67.5 ± 9.5
69 ± 10
Elective CABG
Inraoperatively
22 ± 5
25 ± 3
Milrinone
Hospital stay
De Luca et al. [41]
2005
26
58.6 ± 8.7
57.1 ± 9.3
Acute MI undergoing PCI
Post intervention
28 ± 3
30 ± 3
Placebo
Hospital stay
Eriksson et al. [42]
2009
60
64 ± 10
64 ± 10
Elective CABG with LVEF<50%
Intraoperatively
36 ± 8
36 ± 8
Placebo
Hospital stay
Fuhrmann et al. [33]
2008
32
68 ± 74
68 ± 8.1
Cardiogenic shock after acute MI
Post intervention
22 ± 9
27 ± 10
Enoximone
Hospital stay
Husedzinovic et al. [43]
2005
24
61 ± 5.4
61 ± 5.3
Elective OPCAB with normal LVEF
Pre- intervention
56 ± 5
59 ± 2
placebo
Hospital stay
Jarvela et al. [44]
2008
24
69 ± 11
67 ± 10
Elective AVR and CABG
Intraoperatively
50 ± 4
65 ± 5
Placebo
Hospital stay
Levin et al. [45]
2008
137
62.4
61.7
LCOS after elective CABG
Post intervention
37 ± 4
38 ± 5
Dobutamine
Hospital stay
Lilleberg et al. [46]
1998
23
56.9 ± 7.9
59 ± 5.7
Elective low risk CABG
Post intervention
61 ± 9
58 ± 9
Placebo
Hospital stay
Samimi-Fard et al. [47]
2008
22
65 ± 12
63 ± 11
Acute MI with Cardiogenic shock after PCI
Post intervention
29 ± 2
30 ± 3
Dobutamine
Two years
Sonntag et al. [48]
2004
24
60
60
PCI after acute MI
Post intervention
58 ± 3
62 ± 4
Placebo
Hospital stay
Tritapepe et al. [49]
2006
24
66.5 ± 5.9
69.5 ± 5.6
Elective CABG
Pre- intervention
50 ± 7
52 ± 5
Placebo
Hospital stay
Tritapepe et al. [1]
2009
106
66.5 ± 7.8
64. ± 8
Elective CABG
Pre- intervention
44 ± 10
42 ± 11
Placebo
Hospital stay
CABG, coronary artery bypass graft; LCOS, low cardiac output state; LVEF, left ventricular ejection fraction; MI, myocardial infarction; OPCAB, off pump coronary artery bypass graft; PCI, primary coronary intervention.
Table 2
Risk of bias assessment of included studies
Source
Adequate sequence generation
Allocation concealment
Blinding
Incomplete outcome data addressed
Free of selective reporting
Free of other Bias
Concurrent therapies similar
Overall risk of bias
Al-Shawaf et al. [35]
Unclear
Yes (sealed envelopes)
No
Unclear
Yes
Yes
Yes
Moderate
Alvarez et al. [36]
unclear
Unclear
No
Unclear
Yes
Yes
Yes
Moderate
Alvarez et al. [37]
unclear
Unclear
No
Unclear
Yes
Yes
Yes
Moderate
Barisin et al. [38]
Yes (computer generated)
Yes
Yes (patients, doctors, adjudicators)
Unclear
Yes
Yes
Yes
Low
De Hert et al. [39]
Yes (computer generated)
Yes (sealed envelopes)
Yes (adjudicators)
Unclear
Yes
Yes
Yes
Low
De Hert et al. [40]
Yes (computer generated)
Yes (sealed envelopes)
Yes(adjudicators)
Unclear
Yes
Yes
Yes
Low
De Luca et al. [41]
Unclear
Unclear
No
Unclear
Yes
Yes
Yes
Moderate
Eriksson et al. [42]
Yes (permutated bocks)
Yes
Yes (patients, doctors)
Unclear
Yes
Yes
Yes
Low
Fuhrmann et al. [33]
Yes (computer generated)
Yes (computer generated)
Yes (patients doctors)
Unclear
Yes
Yes
Yes
Low
Husedzinovic et al. [43]
Yes (casting lots)
Yes
Yes (patients, adjudicators)
Unclear
Yes
Yes
Yes
Moderate
Jarvela et al. [44]
Yes (computer generated)
Yes (sealed envelopes)
Yes (patients, doctors, adjudicators)
Unclear
Yes
Yes
Yes
Low
Levin et al. [45]
Yes (computer generated)
Unclear
No
Unclear
Yes
Yes
Yes
Moderate
Lilleberg et al. [46]
Unclear
Unclear
Yes (patients, doctors, adjudicators)
Unclear
Yes
Yes
Yes
Moderate
Samimi-Fard et al. [47]
Unclear
Unclear
No
Unclear
Yes
Yes
Yes
Moderate
Sonntag et al. [48]
Unclear
Yes
Yes (patients, doctors, adjudicators)
Unclear
Yes
Yes
Yes
Moderate
Tritapepe et al. [49]
Yes
(computer generated)
Unclear
Yes (Patients, physicians, adjudicators)
Unclear
Yes
Yes
Yes
Low
Tritapepe et al. [1]
Yes (computer generate)
Unclear
Yes (patients, physicians, adjudicators)
Unclear
Yes
Yes
Yes
Low
Analysis of the data showed that, compared with a control intervention, levosimendan was associated with a significant mortality reduction, (19/387 in the levosimendan group vs 39/342 in the control arm) OR 0. 41 (95% CI 0.23 to 0.74, P for overall effect 0.005, P for heterogeneity = 0.33, I2 = 12% with a total of 729 patients) (Figure 2). A subgroup analysis comparing the effect of levosimendan on mortality in elective versus emergency coronary revascularisation was performed. The elective revascularisation showed a statistically significant mortality benefit compared with the emergency revascularisation group (OR 0.36, 95% CI 0.18 to 0.72, P for overall effect = 0.003, I2 = 0% compared with OR 0.61, 95% CI 0.19 to 1.89, P for overall effect = 0.39, I2 = 69% respectively). All the emergency revascularisations were PCI. The overall result was consistent when a random effects model was used (OR 0.43 (95% CI 0.21 to 0.89)).
Levosimendan had a favourable effect on cardiac index (standardised mean difference 1.63, 95% CI 1.43 to 1.83, P for overall effect < 0.00001) although there was significant heterogeneity (P < 0.000001 I2 = 95%). A sub-group analysis was undertaken to explore the heterogeneity. Subgroups were defined by the comparator drug, that is, the placebo, dobutamine or phosphdiesterase inhibitors. The sub-group analysis did not show any difference in treatment effect (Figure 3).
Post revascularisation, troponin I levels were significantly higher in the control group compared with the levosimendan group (mean difference -1.59, 95% CI 1.78 to 1.40, P for overall effect < 0.00001, P for heterogeneity < 0.00001, I2 = 95%) with 361 patients included (Figure 4).
There was a significantly lower rate of post-revascularisation new-onset atrial fibrillation in the levosimendan treated group (OR 0.54, 95% CI 0.36 to 0.82, P for effect = 0.004, P for heterogeneity 0.84, I2 = 0% for 465 patients (Figure 5). There was also a significant difference in the length of intensive care stay in favour of levosimendan compared with control (random effects model, mean difference - 26.18 hours 95% CI 46.20 to 6.16, P for heterogeneity < 0.00001, I2 = 95%, P for overall effect P = 0.01) (Figure 6). The likelihood of small study bias robustness was evaluated by inspection of the funnel plot (Figure 7). Inspection of the funnel plot found no major evidence of such bias and added to the validity and robustness of the study. A sensitivity analysis that only included those studies with a low risk of bias (Table 1) found an OR of 0.25 (95% CI 0.09 to 0.68). A further sensitivity analysis to establish differential effects based on the comparator was performed. The largest effect size was observed in the levosimendan versus phosphodiesterase group (OR 0.23 (95% CI 0.08 to .65)). The levosimendan versus dobutamine group showed a strong trend in favour of levosimendan but was not statistically significant (OR 0.54 95% CI 0.25 to 1.17)). The levosimendan versus placebo group suggested a positive effect in favour of levosimendan but did not achieve statistical significance (OR 0.66 (95% CI 0.11 to 4.08)) (Table 3).
Table 3
A sensitivity analysis
 
Number of studies
OR
95% CI
P for overall effect
I2 %
Studies with low risk of bias
8
0.25
0.09 to 0.68
0.007
0
Levosimendan versus placebo
9
0.66
0.11 to 4.08
0.65
35
Levosimendan versus phosphodiesterase
4
0.23
0.08 to 0.65
0.003
0
Levosimendan versus dobutamine
4
0.54
0.25 to 1.17
0.12
43
A sensitivity analysis including only studies with a low risk of bias, and comparing levosimendan to placebo, phosphodiesterase inhibitors and dobutamine.
OR, odds ratio; I2, heterogeneity

Discussion

Cardiogenic shock (CS) is a devastating complication of ST-segment myocardial infarction (STEMI) and occurs in 5 to 8% of these patients [12]. Thirty-day survival of STEMI patients in cardiogenic shock is between 40% and 60% [12, 13]. Despite favourable trends in the last 30 years, survival to 6 years remains poor and may be as low as 30% [1416]. This is comparable to many forms of cancer. Therapeutic options for haemodynamic support after coronary revascularisation are limited to pharmacologic or mechanical interventions. Pharmacologic choices are vasopressors and inotropic drugs. Inotropic agents are essential to address the contractile dysfunction that occurs by providing short-term haemodynamic improvement. However, this happens at a cost of increased oxygen demand, arrythmogenesis and potential myocardial injury at a time when the myocardium is most vulnerable. Data on comparison between inotropes are scant and recent reports have highlighted the challenge in selecting the best pharmacologic option [1719]. Compared with norepinephrine, the use of dopamine in patients with cardiogenic shock has been associated with an increased rate of death [17].
A recent meta-analysis evaluated the use of levosimendan in a variety of patient populations that included post-cardiac surgery, post-vascular surgery, sepsis, decompensated heart failure and post percutaneous coronary intervention (PCI) patients [20]. The proposed mechanisms of myocardial dysfunction in sepsis, after non-cardiac surgery and in the context of cardiogenic shock, are all quite disparate [21, 22]. This implies that vasoactive drugs may perform differently, depending on the prevailing mechanism of shock making the interpretation of a pooled analysis of such a heterogeneous group of patients difficult. For this reason we limited this meta-analysis to patients having coronary revascularisation.
Overall, this study shows a mortality benefit when levosimendan was used in patients having coronary revascularisation. The effect was significant in the elective revascularisation group. The subset of patients undergoing emergency revascularisation was under-represented and the mortality benefit in this group was not statistically significant. This latter analysis is probably underpowered. Additionally, levosimendan was associated with favourable outcomes in several clinically important endpoints. The rate of post-revascularisation atrial fibrillation was reduced. Atrial fibrillation after coronary revascularisation is associated with a prolonged hospital stay, increased morbidity and long-term mortality [23]. The analysis also found levosimendan to be associated with a reduction in peri-procedural cardiac troponin I levels. Elevations in cardiac troponin I levels are a valuable marker of myocardial damage after coronary revascularisation and have been associated with a significantly higher rate of in-hospital and long-term mortality [2427]. The haemodynamic response to levosimendan was also favourable. It is likely that the improvement of haemodynamic profile observed with levosimendan can be sustained for a longer period of time compared to dobutamine or milrinone [28]. This is because levosimendan has a poorly protein-bound active metabolite and may exert clinical effects for up to a week [29], at a much lower energy expenditure than conventional inotropes.
The sub-group analysis comparing levosimendan to the placebo, dobutamine and phoshodiesterase inhibitors all showed a favourable trend towards levosimendan with only the latter group showing statistical significance. This observation could be interpreted as potential harm from exposure to phosphodiesterase inhibitors. Levosimendan reduced the ICU length of stay by a mean of 26.18 hours (95% CI 46.20 to 6.16). The estimated mean cost of critical care is US$3,518/day in the United States and about £1,647/day in the United Kingdom [30, 31]. Levosimendan is considerably more expensive than conventional treatment and this probably warrants further pharmaco-economic evaluation.
The findings of this meta-analysis must be viewed in the context of other randomised studies and systematic reviews comparing other vasoactive agents [17, 29, 32]. Thackray et al. systematically reviewed the use of inotropes in cardiac failure [32]. The drugs included were beta agonists, dobutamine, dopexamine and phosphodiesterase inhibitors. Compared with the placebo, these drugs were found to be associated with a non-significant trend for increased rate of death (OR 1.5, 95% CI 0.51 to 3.92).
Our study has several limitations. Several studies were of sub-optimal quality. Eight of the 17 studies included did not have clear allocation concealment. This has the potential to exaggerate treatment effects. Only five studies explicitly stated that the analysis was done by an intention to treat principle. The study by Fuhrmann had a small number of events(i.e. all cause mortality at 30 days) and was stopped early for patient benefit [33]. This study may potentially represent an exaggerated effect size in favour of levosimendan [34]. The sensitivity analysis considering the effect of levosimendan on mortality across comparator drugs showed a more pronounced effect compared with the phosphodiesterase group. Comparing levosimendan to placebo is probably of little value when suitable alternatives exist. These studies recruited low risk patients with a low event rate. Lower event rates require larger sample sizes and it is unsurprising that no statistically significant mortality difference was demonstrated.
Publication bias may account for some of the effects observed. Selective reporting of smaller studies, usually of lower methodological quality will tend to exaggerate treatment effects. The funnel plot was symmetrical, suggesting a low probability of publication bias. Not all studies reported clinically important outcomes. Only 465 patients were included in the analysis of atrial fibrillation rates and only 470 patients were included in the analysis of length of ICU stay.

Conclusions

This meta-analysis suggests that the use of levosimendan in patients having coronary revascularisation is associated with a significant reduction in mortality. Additionally, the use of levosimendan is also associated with improvement in haemodynamics and reduction in cardiac biomarkers, length of ICU stay and rate of atrial fibrillation. A suitably powered RCT is required to confirm these findings. Additionally, the exact timing and dosing of levosimendan in patients undergoing coronary revascularisation needs to be specifically addressed.

Key messages

  • Acute cardiovascular dysfunction after coronary revascularisation occurs in about 8% to 25% of patients.
  • The short-term use of inotropes is crucial to restoring haemodynamics and tissue perfusion though the ideal inotrope in this group of patents is controversial.
  • Levosimendan has a potential role in reducing the mortality and morbidity associated with coronary revascularisation.

Competing interests

The authors declare that they have no competing interests.

Authors' contributions

All of the authors contributed to the design of the study. RM and VM were responsible for the statistical analysis. RM drafted the manuscript. All of the authors critically revised the manuscript and agreed on the submitted version.
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Metadaten
Titel
Levosimendan and mortality after coronary revascularisation: a meta-analysis of randomised controlled trials
verfasst von
Ritesh Maharaj
Victoria Metaxa
Publikationsdatum
01.06.2011
Verlag
BioMed Central
Erschienen in
Critical Care / Ausgabe 3/2011
Elektronische ISSN: 1364-8535
DOI
https://doi.org/10.1186/cc10263