ACTA CARDIOLOGICA

https://doi.org/10.1080/00015385.2021.1955480

ORIGINAL SCIENTIFIC PAPER

Prognostic value of statin therapy in patients with myocardial infarction

with nonobstructive coronary arteries (MINOCA): a meta-analysis
Walter Massona,b , Martın Loboa,c , Leandro Barbagelataa,b , Augusto Lavalle-Coboa,d and
Graciela Molineroa
a
Council of Epidemiology and Cardiovascular Prevention, Argentine Society of Cardiology, Buenos Aires, Argentina; bCardiology
Department, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina; cCardiology Department, Hospital Militar Campo de Mayo,
Buenos Aires, Argentina; dCardiology Department, Sanatorio Finochietto, Buenos Aires, Argentina

ABSTRACT ARTICLE HISTORY

Background: Given the complex aetiology and a limited amount of evidence, the medical treat- Received 8 March 2021
ment (including statin use) of myocardial infarction with non-obstructive coronary artery disease Revised 2 July 2021
(MINOCA) remains uncertain. The objective of the present study was to evaluate the effect of Accepted 8 July 2021
statin therapy on major cardiovascular events (MACE) and mortality in MINOCA patients.
KEYWORDS
Methods: A systematic review and meta-analysis of time-to-event outcomes were performed of Statin; MINOCA; meta-
studies of statin therapy on MINOCA patients, reporting data from MACE or mortality, after analysis; mortality; major
searching the PubMed/MEDLINE, Embase, Science Direct, Scopus, Google Scholar, and Cochrane cardiovascular events
databases. A fixed-effects meta-analysis model was then applied.
Results: Six observational studies of statin therapy on MINOCA, involving a total of 11,171
patients, were identified and considered eligible for analysis (9129 subjects received statin ther-
apy while 2042 patients were part of the respective control arms). Quantitative analysis (5 stud-
ies were included) showed that statin use was associated with lower mortality (HR: 0.65; 95% CI:
0.56–0.75, I2: 0%). Also, the meta-analysis showed that statin therapy was associated with a
lower incidence of MACE (HR: 0.78; 95% CI: 0.69–0.88, I2:27%).
Conclusion: Our data suggest that in a population with MINOCA, the use of statin therapy
results in significant reduction on MACE and mortality. These results must be confirmed in
future clinical trials.

Introduction remains uncertain [6]. It seems reasonable that cardio-

Myocardial infarction with non-obstructive coronary
artery disease (MINOCA) is a heterogeneous clinical
entity characterised by clinical evidence of myocardial
infarction with normal or near-normal coronary
arteries on angiography. This condition is present in
about 5% to 7% of patients presenting with acute cor-
onary syndromes [1,2].
Different factors such as plaque rupture or erosion,
epicardial coronary artery vasospasm, coronary micro-
vascular dysfunction, spontaneous coronary artery dis-
section, Takotsubo syndrome or myocarditis could
influence the diagnosis of MINOCA [3]. However,
according to the latest position paper and guidelines,
the current criteria for the MINOCA definition now
excludes myocarditis and Takotsubo syndrome from
the final diagnosis of MINOCA [4,5].
Given the complex aetiology and a limited amount
of evidence, the medical treatment of MINOCA
vascular risk factors (including dyslipidemia) are
aggressively addressed after a MINOCA. Statin use is
the cornerstone of cardiovascular disease risk manage-
ment, both in primary and secondary prevention. The
robust evidence showing a reduction of cardiovascular
events has made statins essential in a variety of clin-
ical conditions and are now one of the most com-
monly prescribed drugs in the world [7,8]. However,
the beneficial effect of statin therapy in MINOCA
patients is not clear.
Several observational studies have evaluated the
connection between statin use with major cardiovas-
cular events occurrence and mortality in MINOCA
patients, although the results were conflicting [9–14].
To date, there are no published randomised clinical
trials that have evaluated the use of statins in
this population.
Therefore, the main objective of the present sys-
tematic review and meta-analysis was to evaluate the

CONTACT Walter Masson walter.masson@hospitalitaliano.org.ar Per

on 4190. Ciudad Aut
onoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina
ß 2021 Belgian Society of Cardiology
2 W. MASSON ET AL.
effect of statin therapy on cardiovascular morbidity
and mortality in MINOCA patients.
Materials and methods
Data extraction and quality assessment
The Meta-analysis Of Observational Studies (MOOSE)
and the Strengthening the Reporting of Observational
Studies in Epidemiology (STROBE) guidelines were
used to check the reporting of observational stud-
ies [15,16].
The protocol was presented, discussed and
approved by the Council of Cardiovascular
Epidemiology and Prevention of the Argentine Society
of Cardiology.
A literature search was performed that identified
observational studies of statin therapy and cardiovas-
cular morbidity and mortality in MINOCA patients.
Two independent reviewers searched the electronic
PubMed/MEDLINE, Embase, Science Direct, Scopus,
Google Scholar, and Cochrane Controlled Trials data-
bases using ‘MINOCA’ and ‘non-obstructive coronary
artery disease’ terms, alone or combined with the fol-
lowing terms: ‘major cardiovascular events (MACE)’,
‘mortality’, ‘statin’, ‘pravastatin’, ‘simvastatin’,
‘pitavastatin’, ‘atorvastatin’, ‘fluvastatin’
‘rosuvastatin’.
The following inclusion criteria were used to select
eligible studies: (1) Observational studies with a cohort
design (prospective or retrospective). No case-series,
cross-sectional or case-control studies were included,
(2) Studies that included patients with MINOCA. The
definition of MINOCA implied clinical evidence of myo-
cardial infarction and angiographic demonstration of
nonobstructive coronary artery disease (coronary sten-
osis less than 50% of luminal diameter). (3) Studies
that examined the statin users versus non-statin users
groups, (4) Studies that evaluated the relationship
between statin use and the risk of MACE or mortality.
The primary endpoint of the study was all-cause
mortality. The incidence of MACE was evaluated as a
secondary endpoint.
The quality of the included studies was assessed by
two independent review authors using the Newcastle-
Ottawa Scale (NOS) [17]. The NOS risk of bias assess-
ment tool consists of nine items, which are divided
into three domains (selection, comparability, and
results). We consider that the studies showed a low,
moderate or high quality, when the obtained score
was 1–4, 5–6 or equal to or more than 7 points,
respectively. Any discrepancy between the two
reviewers was resolved through discussion and by
involving a third reviewer.
Statistical analysis
Since the number of events in the subgroups with or
without statins were not reported in most studies, a
meta-analysis of time-to-event outcomes was per-
formed [18]. Hazard ratios (HRs) and 95% confidences
intervals (CIs) were abstracted from each individual
study and standard error were calculated. All study-
specific estimates were combined using inverse vari-
ance method for pooling. The logarithm of the HRs
and their standard errors were used.
The summary effect of statin therapy on the end-
points were calculated. Measures of effect size were
expressed as HRs, and the I2 statistic was calculated to
quantify between-studies heterogeneity and inconsist-
ency. Because the I2 was low, a fixed-effects model
was chosen.
Statistical analyses were performed using the R
software for statistical computing version 3.5.1 with
additional specific packages [19]. The level of statistical
significance was set at a 2-tailed alpha of 0.05.
and Sensitivity analyses
The sensitivity analysis consists of replicating the
results of the meta-analysis, excluding in each step 1
of the studies included in the review. If the results
obtained are similar, both in direction and magnitude
of the effect and statistical significance, it indicates
that the analysis is robust. A sensitivity analysis for the
primary endpoint was performed.
Analysis of publication bias
A funnel plot using the standard error (SE) for log HR
was created. In addition, Egger’s regression intercept
tests were done. A p-value less than 0.1 was consid-
ered significant for the linear regression test.
Results
Six eligible studies, including 11,171 patients, were
identified and considered eligible for the qualitative
analyses. A total of 9129 subjects received statins, while
2042 subjects received the respective control arms.
Five eligible studies, including 10,930 patients, were
identified and considered eligible for the quantitative
analyses. A total of 8945 subjects received statins,
while 1985 subjects received the respective control

arms. From the total of studies included in the system-
atic review, those that reported HRs and their 95% CIs
related to the use of statins were selected for meta-
analysis. One study was not included because the
measure of association reported was the Odds Ratio. A
flow diagram of the study’s screening process has
been shown in Figure 1.
All included studies were prospective or retrospect-
ive observational cohort studies. According to the NOS
scale, two studies showed moderate risk of bias and
four studies showed low risk of bias. Likewise, none of
the evaluated studies were classified as low quality
when applying the NOS tool.
The average age and the proportion of women
ranged between 42 and 52 years and between 60 and
70%, respectively. Two studies reported lower mortality
Figure 1. Flow diagram of the study screening process.
ACTA CARDIOLOGICA 3
with statin use but two other studies did not. Also, two
studies reported a significant association between statin
use and a lower incidence of MACE, but two other
studies did not. Median follow-up duration ranged from
1.3 to 7.5 years. The characteristics of the studies
selected for our analysis are summarised in Table 1.
Quantitative analysis showed that statin use was
associated with a lower mortality (HR: 0.65; 95% CI:
0.56–0.75). Statistical heterogeneity was low (I2¼0%).
On the other hand, the meta-analysis showed that sta-
tin therapy was associated with lower incidence of
MACE (HR: 0.78; 95% CI: 0.69–0.88), showing low het-
erogeneity as well (I2¼27%) (Figure 2).
The graphical (Figure 3) and analytical evaluation
do not suggest publication bias (Egger’s asymmetry
test, p ¼ 0.41).
 4
W. MASSON ET AL.

Table 1. Characteristics of the included studies.

Statin Control Follow-up
Study (year) MINOCA definition Population characteristics (n) (n) MACE Mortality (years)
Lindahl et al. (2017) [9] Acute MI (International classification of Age 65.3 ± 11.4 years 7512 1624 HR: 0.77 (0.68–0.87) HR: 0.66 (0.57–0.77) 4.1
diseases,10th revision code: Female; 61.0%
I21–I22) and a coronary Hypertension: 57.6% Diabetes
angiography performed during the :16.5% STEMI:17.1%
index hospitalisation did not show
a stenosis of  50%
Cespon et al. (2019) [10] Diagnosis acute Age 69 ± 13 years 556 87 Not reported HR: 0.8 (0.4–1.6) 1.3
MI þ coronary lesions < 50% Female: 42.8%
Hypertension: 70.9% Diabetes:
33.0%, STEMI:49.9%
Ciliberti et al. (2020) [11] 2018 ESC guidelines of the fourth Age 65.1 ± 13.9 years 503 118 HR: 1.05 (0.65–1.69) Not reported 7.5
universal Female: 55.4%
definition of MI Hypertension: 61.4%
Diabetes:16.1%, STEMI:17.7%
Paolisso et al. (2020) [12] 2016 ESC working group position Age 65.7 ± 14.0 years 85 49 HR: 0.44 (0.16–1.21) HR: 0.31 (0.09–1.01) 1.6
paper on MINOCA Female; 59.0%
Hypertension: 61.7%
Diabetes:13.5%, STEMI:18.9%
Abdu et al. (2020) [13] 2016 ESC working group position Age 62.8 ± 13.5 years 184 57 OR: 0.47 (0.24–0.91) Not reported 2
paper on MINOCA Female; 49.0%
Hypertension: 49.0%
Diabetes:13.5%, STEMI:40.2%
Choo et al. (2020) [14] 2016 ESC working group position Age 62.3 ± 12.6 years 289 107 Not reported HR: 2.17# (1.04–4.54) 2
paper on MINOCA Female; 42.7%
Hypertension: 50.8%
Diabetes:22.0%, STEMI:14.9%
ESC: European Society of Cardiology; HR: hazard ratio; MACE: major cardiovascular events; MI: myocardial infarction; MINOCA: myocardial infarction with non-obstructive coronary arteries; OR: odds ratio; STEMI: ST-
segment elevation myocardial infarction.
The association was estimated based on pooled propensity score stratified analysis (1107 patients with statin vs. 1107 patients without statin).
#
The association was estimated for patients without statins.
 ACTA CARDIOLOGICA 5

Figure 2. Effect of statin therapy on mortality and major cardiovascular events (MACE). Fixed effects, hazard ratios (HR), 95% con-
fidence intervals (CI) and I2 statistics.

Figure 3. Funnel plot to assess publication bias.

The sensitivity analysis for the primary endpoint

showed that the results were robust (Figure 4).

Discussion
In this systematic review, the main observational stud-
ies that evaluated the prognostic value of statins in
patients with MINOCA have been described. In add- Figure 4. Sensitivity analysis for the primary endpoint. After repli-
ition, in this meta-analysis, the use of statins compared cating the results of the meta-analysis, excluding in each step one
of the studies included in the review, the results obtained
with the control arm was associated with a marked
are similar.
reduction in the risk of MACE and mortality.
MINOCA is defined by clinical evidence of myocar- consensus recommend identification of underlying
dial infarction with normal or near-normal coronary causes of MINOCA in order to optimise treatment,
arteries on angiography. Current guidelines and improve prognosis, and promote prevention of
6 W. MASSON ET AL.
recurrent myocardial infarction [4,5]. Patients with
MINOCA are most commonly young, non-white
women with fewer traditional risk factors than those
with myocardial infarction involving coronary artery
disease [3]. Given the absence of significant athero-
sclerosis, it is intuitive that the prognosis of patients
with MINOCA is better than that for myocardial infarc-
tion and coronary artery disease. However, not all
published studies reported similar results. Several
studies have suggested a more favourable prognosis
for patients with MINOCA compared with patients
with coronary artery disease [1,20–22] but other stud-
ies have shown similar or worse outcomes for
MINOCA patients [23,24].
Although the MINOCA syndrome is caused by vari-
ous pathophysiological mechanisms and the informa-
tion on the prognosis reported by the different
studies does not always coincide, it seems that the
risk of recurrence of events in this population is not
low. In this context, it is appropriate to hypothesise
that statin treatment could have a beneficial impact in
this group of patients.
Coronary plaque disruption is one of the most com-
mon causes of MINOCA, and generally involves plaque
rupture, ulcer, corrosion, erosion, and plaque bleeding
[25]. A recent study using coronary optical coherence
tomography and cardiac magnetic resonance imaging
to assess mechanisms of MINOCA in women, identified
a definite or possible culprit lesion in 46.2% of partici-
pants, the majority due to plaque rupture, intra-plaque
cavity or layered plaque [26]. The cholesterol content
of atherosclerotic plaques contributes to their instabil-
ity, and most acute cardiac events including myocar-
dial infarction are produced by coronary plaque
disruption [27]. Several studies have shown that lipid
lowering with statins leads to plaque stabilisation,
probably because it affects the plaque lipid pool com-
position and reduces inflammation [28].
Coronary macro and microvascular spasm are fre-
quently found in patients with MINOCA and repre-
sents a likely cause of myocardial injury [3,29].
Coronary artery spasm is associated with vascular
smooth muscle hyper-reactivity. Statins suppress cor-
onary spasm by inhibiting the vascular smooth muscle
contraction [30]. Likewise, some studies have docu-
mented a positive role of statins in suppressing the
coronary spasm episode and decreasing the risk of
recurrence via improving endothelial function [31,32].
Yasue et al. showed that, compared to conventional
treatment with calcium channels blocker, after
6 months of follow up, the addition of fluvastatin
reduced the number of patients with acetylcholine
induced coronary spasm [33].
Spontaneous coronary-artery dissection has
emerged as an important cause of MINOCA in young
subjects, especially in women [34]. Since usually this
entity is not mediated by atherosclerotic plaque rup-
ture, routine use of statins in these patients does not
seem reasonable [35]. However, the coexistence of
spontaneous coronary artery dissection and plaque
rupture in the context of a myocardial infarction is
possible [36].
The studies analysed in this review have included
many patients with all of these conditions.
Consequently, the reduction in the incidence of car-
diovascular events observed is consistent with many
of the pathophysiological reports previously cited.
A previously systematic review described the preva-
lence, risk factors, potential pathophysiological mecha-
nisms and 12-month prognosis in patients with
MINOCA, but did not assess the prognostic value of
statins therapy [1]. Another meta-analysis was
designed to determine the long-term mortality of
patients with MINOCA [37]. The authors reported a
supplementary meta-regression analysis and demon-
strated that normal ejection fraction and normal cor-
onary arteries at angiography were inversely related to
long-term mortality, whereas use of b-blockers and ST
depression on the admission electrocardiogram were
directly related with worse outcome. However, this
study did not report an association between statin use
and survival. Then, to our knowledge, this is the first
meta-analysis that has specifically examined the effect
of statins on MACE and mortality in patients
with MINOCA.
Finally, previous studies have shown that the use of
secondary-prevention medications was low in MINOCA
patients compared to ‘classical’ myocardial infarction
[38,39]. Therefore, verifying our findings through rand-
omised clinical trials could reverse this situation and
improve the prognosis of patients with MINOCA.
This meta-analysis presented several limitations.
First, they were related with clinical heterogeneity
(popular characteristics, different MINOCA definitions
and follows-up) and it is possible that the one larger
publication influences the results. However, the statis-
tical heterogeneity was low and the results were
robust when performing the sensitivity analysis.
Second, the analysis included only aggregate data
without having the individual data. Third, our analysis
included observational studies. Consequently, the
presence of biases and confounders was highly
expected. Finally, few studies were included in our

analysis. However, until randomised clinical trials with
MINOCA patients are performed, this study analysed
the best evidence available to date.
Conclusion
Our data suggest that in a population with MINOCA,
the use of statin results in significant reduction on
MACE and mortality. However, since the present study
included a limited number of observational studies,
these results should be investigated and confirmed in
future clinical trials.
Acknowledgement
This research did not receive any specific grant from funding
agencies in the public, commercial, or not-for-profit sectors.
Author contributions
WM and ML participated in the conception and design of
the research. WM and ALC participated in the data collec-
tion. The interpretation of the data and the statistical ana-
lysis was done by WM and ML. WM, ALC and LB drafted the
manuscript. All authors performed a critical review of the
final document. All authors have read and agreed to the
published version of the manuscript.
Disclosure statement
No potential conflict of interest was reported by
the author(s).
ORCID
Walter Masson http://orcid.org/0000-0002-5620-6468
Martın Lobo http://orcid.org/0000-0003-1377-7313
Leandro Barbagelata http://orcid.org/0000-0003-
3694-1083
Augusto Lavalle-Cobo http://orcid.org/0000-0002-
1257-9211
Graciela Molinero http://orcid.org/0000-0001-7199-5306
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