Publications by authors named "Michel Zeitouni"

48 Publications

Economic Outcomes of Rehabilitation Therapy in Older Patients With Acute Heart Failure in the REHAB-HF Trial: A Secondary Analysis of a Randomized Clinical Trial.

JAMA Cardiol 2021 Nov 24. Epub 2021 Nov 24.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.

Importance: In the Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial, a novel 12-week rehabilitation intervention demonstrated significant improvements in validated measures of physical function, quality of life, and depression, but no significant reductions in rehospitalizations or mortality compared with a control condition during the 6-month follow up. The economic implications of these results are important given the increasing pressures for cost containment in health care.

Objective: To report the economic outcomes of the REHAB-HF trial and estimate the potential cost-effectiveness of the intervention.

Design, Setting, Participants: The multicenter REHAB-HF trial randomized 349 patients 60 years or older who were hospitalized for acute decompensated heart failure to rehabilitation intervention or a control group; patients were enrolled from September 17, 2014, through September 19, 2019. For this preplanned secondary analysis of the economic outcomes, data on medical resource use and quality of life (via the 5-level EuroQol 5-Dimension scores converted to health utilities) were collected. Medical resource use and medication costs were estimated using 2019 US Medicare payments and the Federal Supply Schedule, respectively. Cost-effectiveness was estimated using the validated Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model, which uses an individual-patient simulation model informed by the prospectively collected trial data. Data were analyzed from March 24, 2019, to December 1, 2020.

Interventions: Rehabilitation intervention or control.

Main Outcomes And Measures: Costs, quality-adjusted life-years (QALYs), and the lifetime estimated cost per QALY gained (incremental cost-effectiveness ratio).

Results: Among the 349 patients included in the analysis (183 women [52.4%]; mean [SD] age, 72.7 [8.1] years; 176 non-White [50.4%] and 173 White [49.6%]), mean (SD) cumulative costs per patient were $26 421 ($38 955) in the intervention group (excluding intervention costs) and $27 650 ($30 712) in the control group (difference, -$1229; 95% CI, -$8159 to $6394; P = .80). The mean (SD) cost of the intervention was $4204 ($2059). Quality of life gains were significantly greater in the intervention vs control group during 6 months (mean utility difference, 0.074; P = .001) and sustained beyond the 12-week intervention. Incremental cost-effectiveness ratios were estimated at $58 409 and $35 600 per QALY gained for the full cohort and in patients with preserved ejection fraction, respectively.

Conclusions And Relevance: These analyses suggest that longer-term benefits of this novel rehabilitation intervention, particularly in the subgroup of patients with preserved ejection fraction, may yield good value to the health care system. However, long-term cost-effectiveness is currently uncertain and dependent on the assumption that benefits are sustained beyond study follow-up, which needs to be corroborated in future trials in this patient population.
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http://dx.doi.org/10.1001/jamacardio.2021.4836DOI Listing
November 2021

Pretreatment in the Setting of Non-ST-Elevated Acute Coronary Syndrome-When It Is Time to Change.

JAMA Netw Open 2021 Nov 1;4(11):e2134472. Epub 2021 Nov 1.

Sorbonne Université, ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie (AP-HP), Paris, France.

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http://dx.doi.org/10.1001/jamanetworkopen.2021.34472DOI Listing
November 2021

Altered cardiac reserve is a determinant of exercise intolerance in sickle cell anaemia patients.

Eur J Clin Invest 2021 Aug 14:e13664. Epub 2021 Aug 14.

Sorbonne Université, ACTION Study Group, INSERM, UMR_S 1166, Institute of Cardiometabolism And Nutrition (ICAN), and Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.

Background: The underlying mechanisms of exercise intolerance in sickle cell anaemia (SCA) patients are complex and not yet completely understood. While latent heart failure at rest could be unmasked upon exercise, most previous studies assessed cardiac function at rest. We aimed to investigate exercise cardiovascular reserve as a potential contributor to exercise intolerance in adult SCA patients.

Methods: In this observational prospective study, we compared prospectively 60 SCA patients (median age 31 years, 60% women) to 20 matched controls. All subjects underwent symptom-limited combined exercise echocardiography and oxygen uptake (VO ) measurements. Differences between arterial and venous oxygen content (C(a-v)O ) were calculated. Cardiac reserve was defined as the absolute change in cardiac index (Ci) from baseline to peak exercise.

Results: Compared to controls, SCA patients demonstrated severe exercise intolerance (median peakVO , 34.3 vs. 19.7 ml/min/kg, respectively, p < .0001). SCA patients displayed heterogeneously increased Ci from rest to peak exercise (median +5.8, range 2.6 to 10.6 L/min/m²) which correlated with peakVO (r = 0.71, p < .0001). In contrast, the C(a-v)O exercise reserve was homogenously reduced and did not correlate with peakVO (r = 0.18, p = .16). While haemoglobin level and C(a-v)O were similar in SCA subgroups, SCA patients in the lower VO tertile had chronotropic incompetence and left ventricular diastolic dysfunction (left atrial peak longitudinal strain was reduced, and both E/e' ratio and left atrial volume index were increased) and were characterized by a reduced cardiac reserve, +5.0[4.2-5.5] compared to +6.7[5.5-7.8] L/min/m² for the rest of the patient cohort, p < .0001.

Conclusions: Altered cardiac reserve due to chronotropic incompetence and left ventricular diastolic dysfunction seems to be an important determinant of exercise intolerance in adult SCA patients.
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http://dx.doi.org/10.1111/eci.13664DOI Listing
August 2021

Beyond ischaemia: is there a place for physiologic and anatomic evaluations of coronary lesions?

EuroIntervention 2021 Jul 20;17(4):e267-e268. Epub 2021 Jul 20.

Sorbonne Université, ACTION Study Group, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.

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http://dx.doi.org/10.4244/EIJV17I4A46DOI Listing
July 2021

Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial.

Am J Cardiovasc Drugs 2021 Nov 30;21(6):681-691. Epub 2021 Jun 30.

ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Sorbonne University, 47-83 bld de l'Hôpital, 75013, Paris, France.

Background: Elderly patients are at high-risk of bleeding, but are under-represented in clinical trials.

Objectives: The aims were to determine the incidence and the predictive factors of bleeding and to assess the impact of bleeding on further ischemic outcomes in elderly patients after acute coronary syndrome (ACS) treated with percutaneous coronary intervention.

Methods: From the 877 patients aged ≥ 75 years included in the ANTARCTIC randomized trial, data on Bleeding Academic Research Consortium (BARC) bleeding complications and major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, myocardial infarction, and stroke, were collected over 1 year.

Results: Clinically relevant bleeding events (BARC types 2, 3, or 5) were observed in 20.6% of patients (n = 181) at 1 year, of which, one third occurred in the first month. Anemia (adjusted hazard ratio [adj.HR] 3.98, 95% confidence interval [CI] 1.41-11.22; p = 0.009), severe chronic renal failure (adj.HR 1.83, 95% CI 1.12-2.98; p = 0.015), and femoral access (adj.HR 2.54, 95% CI 1.71-3.77; p < 0.001) were independently associated with clinically relevant bleeding events, while age > 85 years (adj.HR 2.22, 95% CI 1.14-4.30; p = 0.018) was independently associated with major bleeding events (BARC types 3 or 5). Patients with a clinically relevant bleeding event had a higher rate of MACE at 1 year (adj.HR 2.04, 95% CI 1.24-3.38; p = 0.005), with a particularly strong effect on stroke (adj.HR 5.55, 95% CI 2.04-15.06; p < 0.001).

Conclusions: Clinically relevant bleeding events were observed in one out of five elderly patients undergoing stenting for an ACS and were strongly associated with further stroke occurrence. Rather than the antiplatelet therapy, comorbidities and an age > 85 years predicted bleeding outcomes in this elderly population.

Clinical Trial Registration: Clinicaltrials.gov identifier: NCT01538446. https://www.clinicaltrials.gov .
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http://dx.doi.org/10.1007/s40256-021-00468-8DOI Listing
November 2021

Prognostically relevant periprocedural myocardial injury and infarction associated with percutaneous coronary interventions: a Consensus Document of the ESC Working Group on Cellular Biology of the Heart and European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Eur Heart J 2021 07;42(27):2630-2642

Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.

A substantial number of chronic coronary syndrome (CCS) patients undergoing percutaneous coronary intervention (PCI) experience periprocedural myocardial injury or infarction. Accurate diagnosis of these PCI-related complications is required to guide further management given that their occurrence may be associated with increased risk of major adverse cardiac events (MACE). Due to lack of scientific data, the cut-off thresholds of post-PCI cardiac troponin (cTn) elevation used for defining periprocedural myocardial injury and infarction, have been selected based on expert consensus opinions, and their prognostic relevance remains unclear. In this Consensus Document from the ESC Working Group on Cellular Biology of the Heart and European Association of Percutaneous Cardiovascular Interventions (EAPCI), we recommend, whenever possible, the measurement of baseline (pre-PCI) cTn and post-PCI cTn values in all CCS patients undergoing PCI. We confirm the prognostic relevance of the post-PCI cTn elevation >5× 99th percentile URL threshold used to define type 4a myocardial infarction (MI). In the absence of periprocedural angiographic flow-limiting complications or electrocardiogram (ECG) and imaging evidence of new myocardial ischaemia, we propose the same post-PCI cTn cut-off threshold (>5× 99th percentile URL) be used to define prognostically relevant 'major' periprocedural myocardial injury. As both type 4a MI and major periprocedural myocardial injury are strong independent predictors of all-cause mortality at 1 year post-PCI, they may be used as quality metrics and surrogate endpoints for clinical trials. Further research is needed to evaluate treatment strategies for reducing the risk of major periprocedural myocardial injury, type 4a MI, and MACE in CCS patients undergoing PCI.
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http://dx.doi.org/10.1093/eurheartj/ehab271DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8282317PMC
July 2021

ST-segment elevation myocardial infarction: Management and association with prognosis during the COVID-19 pandemic in France.

Arch Cardiovasc Dis 2021 May 14;114(5):340-351. Epub 2021 Apr 14.

Cardiology Department, University Hospital of Montpellier, University of Montpellier, 34000 Montpellier, France.

Background: Systems of care have been challenged to control progression of the COVID-19 pandemic. Whether this has been associated with delayed reperfusion and worse outcomes in French patients with ST-segment elevation myocardial infarction (STEMI) is unknown.

Aim: To compare the rate of STEMI admissions, treatment delays, and outcomes between the first peak of the COVID-19 pandemic in France and the equivalent period in 2019.

Methods: In this nationwide French survey, data from consecutive STEMI patients from 65 centres referred for urgent revascularization between 1 March and 31 May 2020, and between 1 March and 31 May 2019, were analysed. The primary outcome was a composite of in-hospital death or non-fatal mechanical complications of acute myocardial infarction.

Results: A total of 6306 patients were included. During the pandemic peak, a 13.9±6.6% (P=0.003) decrease in STEMI admissions per week was observed. Delays between symptom onset and percutaneous coronary intervention were longer in 2020 versus 2019 (270 [interquartile range 150-705] vs 245 [140-646]min; P=0.013), driven by the increase in time from symptom onset to first medical contact (121 [60-360] vs 150 [62-420]min; P=0.002). During 2020, a greater number of mechanical complications was observed (0.9% vs 1.7%; P=0.029) leading to a significant difference in the primary outcome (112 patients [5.6%] in 2019 vs 129 [7.6%] in 2020; P=0.018). No significant difference was observed in rates of orotracheal intubation, in-hospital cardiac arrest, ventricular arrhythmias and cardiogenic shock.

Conclusions: During the first peak of the COVID-19 pandemic in France, there was a decrease in STEMI admissions, associated with longer ischaemic time, exclusively driven by an increase in patient-related delays and an increase in mechanical complications. These findings suggest the need to encourage the population to seek medical help in case of symptoms.
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http://dx.doi.org/10.1016/j.acvd.2021.01.005DOI Listing
May 2021

Aspirin-Free Strategies in ACS: Is It the Drug or the Stent?

JACC Cardiovasc Interv 2021 02;14(4):441-443

ACTION Group, INSERM UMRS 1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Sorbonne University, Paris, France.

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http://dx.doi.org/10.1016/j.jcin.2020.12.040DOI Listing
February 2021

Clinical manifestations and outcomes of coronavirus disease-19 in heart transplant recipients: a multicentre case series with a systematic review and meta-analysis.

Transpl Int 2021 04 5;34(4):721-731. Epub 2021 Mar 5.

Département de Chirurgie Cardiaque, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris, France.

Available data on clinical presentation and mortality of coronavirus disease-2019 (COVID-19) in heart transplant (HT) recipients remain limited. We report a case series of laboratory-confirmed COVID-19 in 39 HT recipients from 3 French heart transplant centres (mean age 54.4 ± 14.8 years; 66.7% males). Hospital admission was required for 35 (89.7%) cases including 14/39 (35.9%) cases being admitted in intensive care unit. Immunosuppressive medications were reduced or discontinued in 74.4% of the patients. After a median follow-up of 54 (19-80) days, death and death or need for mechanical ventilation occurred in 25.6% and 33.3% of patients, respectively. Elevated C-reactive protein and lung involvement ≥50% on chest computed tomography (CT) at admission were associated with an increased risk of death or need for mechanical ventilation. Mortality rate from March to June in the entire 3-centre HT recipient cohort was 56% higher in 2020 compared to the time-matched 2019 cohort (2% vs. 1.28%, P = 0.15). In a meta-analysis including 4 studies, pre-existing diabetes mellitus (OR 3.60, 95% CI 1.43-9.06, I  = 0%, P = 0.006) and chronic kidney disease stage III or higher (OR 3.79, 95% CI 1.39-10.31, I  = 0%, P = 0.009) were associated with increased mortality. These findings highlight the aggressive clinical course of COVID-19 in HT recipients.
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http://dx.doi.org/10.1111/tri.13837DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8014589PMC
April 2021

Predictive Value of the Residual SYNTAX Score in Patients With Cardiogenic Shock.

J Am Coll Cardiol 2021 01;77(2):144-155

ACTION Study Group, INSERM UMRS_1166 Cardiology Institute, University of the Sorbonne, Paris, France. Electronic address:

Background: In hemodynamically stable patients, complete revascularization (CR) following percutaneous coronary intervention (PCI) is associated with a better prognosis in chronic and acute coronary syndromes.

Objectives: This study sought to assess the extent, severity, and prognostic value of remaining coronary stenoses following PCI, by using the residual SYNTAX score (rSS), in patients with cardiogenic shock (CS) related to myocardial infarction (MI).

Methods: The CULPRIT-SHOCK (Culprit Lesion Only Percutaneous Coronary Intervention [PCI] Versus Multivessel PCI in Cardiogenic Shock) trial compared a multivessel PCI (MV-PCI) strategy with a culprit lesion-only PCI (CLO-PCI) strategy in patients with multivessel coronary artery disease who presented with MI-related CS. The rSS was assessed by a central core laboratory. The study group was divided in 4 subgroups according to tertiles of rSS of the participants, thereby isolating patients with an rSS of 0 (CR). The predictive value of rSS for the 30-day primary endpoint (mortality or severe renal failure) and for 30-day and 1-year mortality was assessed using multivariate logistic regression.

Results: Among the 587 patients with an rSS available, the median rSS was 9.0 (interquartile range: 3.0 to 17.0); 102 (17.4%), 100 (17.0%), 196 (33.4%), and 189 (32.2%) patients had rSS = 0, 0 < rSS ≤5, 5 < rSS ≤14, and rSS >14, respectively. CR was achieved in 75 (25.2%; 95% confidence interval [CI]: 20.3% to 30.5%) and 27 (9.3%; 95% CI: 6.2% to 13.3%) of patients treated using the MV-PCI and CLO-PCI strategies, respectively. After multiple adjustments, rSS was independently associated with 30-day mortality (adjusted odds ratio per 10 units: 1.49; 95% CI: 1.11 to 2.01) and 1-year mortality (adjusted odds ratio per 10 units: 1.52; 95% CI: 1.11 to 2.07).

Conclusions: Among patients with multivessel disease and MI-related CS, CR is achieved only in one-fourth of the patients treated using an MV-PCI strategy. and the residual SYNTAX score is independently associated with early and late mortality.
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http://dx.doi.org/10.1016/j.jacc.2020.11.025DOI Listing
January 2021

Risk Factor Burden and Long-Term Prognosis of Patients With Premature Coronary Artery Disease.

J Am Heart Assoc 2020 12 8;9(24):e017712. Epub 2020 Dec 8.

Duke Clinical Research Institute Duke University School of Medicine Durham NC.

Background Coronary artery disease (CAD) is increasing among young adults. We aimed to describe the cardiovascular risk factors and long-term prognosis of premature CAD. Methods and Results Using the Duke Databank for Cardiovascular Disease, we evaluated 3655 patients admitted between 1995 and 2013 with a first diagnosis of obstructive CAD before the age of 50 years. Major adverse cardiovascular events (MACEs), defined as the composite of death, myocardial infarction, stroke, or revascularization, were ascertained for up to 10 years. Cox proportional hazard regression models were used to assess associations with the rate of first recurrent event, and negative binomial log-linear regression was used for rate of multiple event recurrences. Past or current smoking was the most frequent cardiovascular factor (60.8%), followed by hypertension (52.8%) and family history of CAD (39.8%). Within a 10-year follow-up, 52.9% of patients had at least 1 MACE, 18.6% had at least 2 recurrent MACEs, and 7.9% had at least 3 recurrent MACEs, with death occurring in 20.9% of patients. Across follow-up, 31.7% to 37.2% of patients continued smoking, 81.7% to 89.3% had low-density lipoprotein cholesterol levels beyond the goal of 70 mg/dL, and 16% had new-onset diabetes mellitus. Female sex, diabetes mellitus, chronic kidney disease, multivessel disease, and chronic inflammatory disease were factors associated with recurrent MACEs. Conclusions Premature CAD is an aggressive disease with frequent ischemic recurrences and premature death. Individuals with premature CAD have a high proportion of modifiable cardiovascular risk factors, but failure to control them is frequently observed.
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http://dx.doi.org/10.1161/JAHA.120.017712DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7955368PMC
December 2020

Procedural myocardial injury, infarction and mortality in patients undergoing elective PCI: a pooled analysis of patient-level data.

Eur Heart J 2021 01;42(4):323-334

The Hatter Cardiovascular Institute, University College London, London, UK.

Aims: The prognostic importance of cardiac procedural myocardial injury and myocardial infarction (MI) in chronic coronary syndrome (CCS) patients undergoing elective percutaneous coronary intervention (PCI) is still debated.

Methods And Results: We analysed individual data of 9081 patients undergoing elective PCI with normal pre-PCI baseline cardiac troponin (cTn) levels. Multivariate models evaluated the association between post-PCI elevations in cTn and 1-year mortality, while an interval analysis evaluated the impact of the size of the myocardial injury on mortality. Our analysis was performed in the overall population and also according to the type of cTn used [52.0% had high-sensitivity cTn (hs-cTn)]. Procedural myocardial injury, as defined by the Fourth Universal Definition of MI (UDMI) [post-PCI cTn elevation ≥1 × 99th percentile upper reference limit (URL)], occurred in 52.8% of patients and was not associated with 1-year mortality [adj odds ratio (OR), 1.35, 95% confidence interval (CI) (0.84-1.77), P = 0.21]. The association between post-PCI cTn elevation and 1-year mortality was significant starting ≥3 × 99th percentile URL. Major myocardial injury defined by post-PCI ≥5 × 99th percentile URL occurred in 18.2% of patients and was associated with a two-fold increase in the adjusted odds of 1-year mortality [2.29, 95% CI (1.32-3.97), P = 0.004]. In the subset of patients for whom periprocedural evidence of ischaemia was collected (n = 2316), Type 4a MI defined by the Fourth UDMI occurred in 12.7% of patients and was strongly associated with 1-year mortality [adj OR 3.21, 95% CI (1.42-7.27), P = 0.005]. We also present our results according to the type of troponin used (hs-cTn or conventional troponin).

Conclusion: Our analysis has demonstrated that in CCS patients with normal baseline cTn levels, the post-PCI cTn elevation of ≥5 × 99th percentile URL used to define Type 4a MI is associated with 1-year mortality and could be used to detect 'major' procedural myocardial injury in the absence of procedural complications or evidence of new myocardial ischaemia.
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http://dx.doi.org/10.1093/eurheartj/ehaa885DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7850039PMC
January 2021

Impact of chronic total occlusion and revascularization strategy in patients with infarct-related cardiogenic shock: A subanalysis of the culprit-shock trial.

Am Heart J 2021 02 27;232:185-193. Epub 2020 Nov 27.

First Department of Medicine-Cardiology, University Medical Centre Mannheim (UMM), University of Heidelberg, Mannheim, Germany.

Background: The impact of coronary artery chronic total occlusion (CTO) and its management with percutaneous coronary intervention (PCI) in the setting of myocardial infarction (MI) related cardiogenic shock (CS) remains unclear.

Methods: This is a pre-specified analysis from the culprit-lesion-only PCI vs multivessel PCI in CS (CULPRIT-SHOCK) trial which randomized patients presenting with MI and multivessel disease complicated by CS to a culprit-lesion-only or immediate multivessel PCI strategy. CTO was defined by central core-laboratory evaluation. The independent associations between the presence of CTO and adverse outcomes at 30 days and 1 year were assessed using multivariate logistics models.

Results: A noninfarct related CTO was present in 157 of 667 (23.5%) analyzed patients. Patients presenting with CTO had more frequent diabetes mellitus or prior PCI but less frequently presented with ST segment elevation MI as index event. The presence of CTO was associated with higher rate of death at 30 days (adjusted Odds ratio 1.63; 95% confidence interval [CI] 1.01-2.60). Rate of death at 1 year was also increased but did not reach statistical significance (adjusted Odds ratio 1.62; 95%CI 0.99-2.66). Compare to immediate multivessel PCI, a strategy of culprit-lesion-only PCI was associated with lower rates of death or renal replacement therapy at 30 days in patients with and without CTO (Odds ratio 0.79 95%CI 0.42-1.49 and Odds ratio 0.67 95%CI 0.48-0.96, respectively), without significant interaction (P = .68).

Conclusions: In patients with MI-related CS and multivessel disease, the presence of CTO is associated with adverse outcomes while a strategy of culprit-lesion-only PCI seems beneficial regardless of the presence of CTO.
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http://dx.doi.org/10.1016/j.ahj.2020.11.009DOI Listing
February 2021

Clinical Outcomes According to ECG Presentations in Infarct-Related Cardiogenic Shock in the Culprit Lesion Only PCI vs Multivessel PCI in Cardiogenic Shock Trial.

Chest 2021 04 26;159(4):1415-1425. Epub 2020 Nov 26.

ACTION Study Group, Institut de Cardiologie (AP-HP), INSERM UMRS_1166, Sorbonne Université, Paris. Electronic address:

Background: The impact of ECG presentations of acute myocardial infarction (AMI) in cardiogenic shock is unknown.

Research Question: In myocardial infarction with cardiogenic shock, is there a difference in the outcomes and effect of revascularization strategies between non-ST-segment elevation myocardial infarction (NSTEMI) and left bundle branch block myocardial infarction (LBBBMI) vs ST-segment elevation myocardial infarction (STEMI)?

Study Design And Methods: Cardiogenic shock patients from the CULPRIT-SHOCK trial with NSTEMI or LBBBMI were compared with STEMI patients for 30-day and 1-year all-cause mortality. The interaction between ECG presentation and the effect of revascularization strategies on outcomes was evaluated.

Results: Of 665 cardiogenic shock patients analyzed, 55.9% demonstrated STEMI, 29.3% demonstrated NSTEMI, and 14.7% demonstrated LBBBMI. Patients differed in mean age (68.0 years in STEMI patients, 71.0 years in NSTEMI patients, and 73.5 years in LBBBMI patients; P = .015), cardiovascular risk factors, and angiographic severity. No difference was found in the 30-day risk of death between NSTEMI and STEMI patients (48.7% vs 43.0%; adjusted OR [aOR], 1.05; 95% CI, 0.66-1.67; P = .85), nor between LBBBMI and STEMI patients (59.2% vs 43.0%; aOR, 1.31; 95% CI, 0.73-2.34; P = .36). Although the univariate risk of death by 1 year was higher in NSTEMI and LBBBMI patients compared with STEMI patients, ECG presentation was not an independent risk factor of mortality after adjustment (NSTEMI vs STEMI: 56.4% vs 46.8%; aOR, 1.21; 95% CI, 0.76-1.92; P = .42; LBBBMI vs STEMI: 69.4% vs 46.8%; aOR, 1.59; 95% CI, 0.89-2.84; P = .12). ECG presentation did not modify the effect of the revascularization strategy on 30-day and 1-year mortality (P = .91 and P = .97 for interaction).

Interpretation: In patients with cardiogenic shock, NSTEMI and LBBBMI presentations reflect higher-risk profiles than STEMI presentations, but are not independent risk factors of mortality. ECG presentations did not modify the treatment effect, supporting culprit-lesion-only percutaneous coronary intervention as the preferred strategy across the AMI spectrum.
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http://dx.doi.org/10.1016/j.chest.2020.10.089DOI Listing
April 2021

Resting Coronary Physiology in Stable Coronary Artery Disease: Still Building Evidence.

JACC Cardiovasc Interv 2020 11 28;13(22):2699-2701. Epub 2020 Oct 28.

Sorbonne Université, ACTION Study Group, INSERM UMRS_1166, Institut de Cardiologie (AP-HP), Paris, France.

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http://dx.doi.org/10.1016/j.jcin.2020.07.033DOI Listing
November 2020

Culprit lesion location and outcomes in patients with multivessel disease and infarct-related cardiogenic shock: a core laboratory analysis of the CULPRIT-SHOCK trial.

EuroIntervention 2021 Aug 6;17(5):e418-e424. Epub 2021 Aug 6.

Sorbonne Université, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie (AP-HP), Paris, France.

Background: Critical culprit lesion locations (CCLL) such as left main (LM) and proximal left anterior descending (LAD) are associated with worse clinical outcome in myocardial infarction without cardiogenic shock (CS).

Aims: We aimed to assess whether CCLL identify a subgroup of patients with poorer prognosis when presenting with CS.

Methods: In the CULPRIT-SHOCK trial, a core laboratory reviewed all coronary angiograms to identify CCLL. A CCLL was defined as a culprit lesion with a >70% diameter stenosis of the LM, LM equivalent (>70% diameter stenosis of both proximal LAD and proximal circumflex), proximal LAD or last remaining vessel. We evaluated the primary study endpoint of the CULPRIT-SHOCK trial according to CCLL.

Results: A total of 269 (43%) out of 626 patients eligible for this analysis had a CCLL. Death or renal replacement therapy within 30 days, death within 30 days and death within one year were significantly higher in the CCLL than in the non-CCLL group (58.4% vs 43.4%, p<0.001, 55.8% vs 39.5%, p<0.001, 61.0% vs 44.5%, p<0.001, respectively). This was consistent after adjustment for baseline and angiographic characteristics. No interaction with the randomisation group (culprit lesion-only or immediate multivessel PCI) was found.

Conclusions: CCLL is frequent in CS and independently associated with worse clinical outcomes irrespective of the revascularisation strategy.

Trial Registration: www.clinicaltrials.gov NCT01927549.
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http://dx.doi.org/10.4244/EIJ-D-20-00561DOI Listing
August 2021

Interleukin-1β and Risk of Premature Death in Patients With Myocardial Infarction.

J Am Coll Cardiol 2020 10 27;76(15):1763-1773. Epub 2020 Aug 27.

INSERM UMRS1166 Hôpital de la Pitié, Paris, France, Sorbonne Université, Paris, France, ICAN - Institute of CardioMetabolism and Nutrition, Hôpital de la Pitié, Paris, France.

Background: Inhibition of the interleukin (IL)-1β innate immunity pathway is associated with anti-inflammatory effects and a reduced risk of recurrent cardiovascular events in stable patients with previous myocardial infarction (MI) and elevated high-sensitivity C-reactive protein (hs-CRP).

Objectives: This study assessed the association between IL-1β level with all-cause mortality in patients with acute ST-segment elevation MI who underwent primary percutaneous coronary intervention and the interplay between IL-1β and hs-CRP concentrations on the risk of premature death.

Methods: IL-1β concentration was measured in 1,398 patients with ST-segment elevation MI who enrolled in a prospective cohort. Crude and hazard ratios for all-cause and cardiovascular mortality were analyzed at 90 days and 1 year using multivariate Cox proportional regression analysis. Major adverse cardiovascular events (MACEs) were analyzed.

Results: IL-1β concentration measured at admission was associated with all-cause mortality at 90 days (adjusted hazard ratio [adjHR]: 1.47 per 1 SD increase; 95% confidence interval [CI]: 1.16 to 1.87; p < 0.002). The relation was nonlinear, and the highest tertile of IL-1β was associated with higher mortality rates at 90 days (adjHR: 2.78; 95% CI: 1.61 to 4.79; p = 0.0002) and at 1 year (adjHR: 1.93; 95% CI: 1.21 to 3.06; p = 0.005), regardless of the hs-CRP concentration. Significant relationships were equally observed when considering cardiovascular mortality and MACEs at 90 days (adjHR: 2.42; 95% CI: 1.36 to 4.28; p = 0.002, and adjHR: 2.29; 95% CI: 1.31 to 4.01; p = 0.004, respectively) and at 1 year (adjHR: 2.32; 95% CI: 1.36 to 3.97; p = 0.002, and adjHR: 2.35; 95% CI: 1.39 to 3.96; p = 0.001, respectively).

Conclusions: IL-1β measured at admission in patients with acute MI was independently associated with the risk of mortality and recurrent MACEs.
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http://dx.doi.org/10.1016/j.jacc.2020.08.026DOI Listing
October 2020

Acute Multivessel Coronary Occlusion Revealing COVID-19 in a Young Adult.

JACC Case Rep 2020 Jul 9;2(9):1297-1301. Epub 2020 Jun 9.

ACTION (Allies in Cardiovascular Trials Initiatives and Organized Networks) Study Group, Sorbonne Université, INSERM UMRS 1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière, Paris, France.

A 42-year-old man was admitted for an ST-segment elevation myocardial infarction revealing an acute thrombosis of the left anterior descending and right coronary arteries. Following this acute multivessel coronary occlusion in a young individual at low cardiovascular risk, he tested positive for severe acute respiratory syndrome-coronavirus-2 infection. ().
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http://dx.doi.org/10.1016/j.jaccas.2020.06.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7280128PMC
July 2020

Performance of Guideline Recommendations for Prevention of Myocardial Infarction in Young Adults.

J Am Coll Cardiol 2020 08;76(6):653-664

Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. Electronic address:

Background: The 2018 cholesterol guidelines of the American Heart Association and the American College of Cardiology (AHA/ACC) changed 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitor (statin) eligibility criteria for primary prevention to include multiple risk enhancers and novel intensive lipid-lowering therapies for secondary prevention.

Objectives: This study sought to determine how guideline changes affected identification for preventive therapy in young adults with premature myocardial infarction (MI).

Methods: The study identified adults presenting with first MI at Duke University Medical Center in Durham, North Carolina. Statin therapy eligibility was determined using the 2013 ACC/AHA and 2018 AHA/ACC guidelines criteria. The study also determined potential eligibility for intensive lipid-lowering therapies (very high risk) under the 2018 AHA/ACC guidelines, by assessing the composite of all-cause death, recurrent MI, or stroke rates in adults considered "very high risk" versus not.

Results: Among 6,639 patients with MI, 41% were <55 years of age ("younger"), 35% were 55 to 65 years of age ("middle-aged"), and 24% were 66 to 75 years of age ("older"). Younger adults were more frequently smokers (52% vs. 38% vs. 22%, respectively) and obese (42% vs. 34% vs. 31%, respectively), with metabolic syndrome (21% vs. 19% vs. 17%, respectively) and higher low-density lipoprotein cholesterol (117 vs. 107 vs. 103 mg/dl, respectively) (p trend <0.01 for all). Pre-MI, fewer younger adults met guideline indications for 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase inhibitor (statin) therapy than middle-aged and older adults. The 2018 guideline identified fewer younger adults eligible for statin therapy at the time of their MI than the 2013 guideline (46.4% vs. 56.7%; p < 0.01). Younger patients less frequently met very high-risk criteria for intensive secondary prevention lipid-lowering therapy (28.3% vs. 40.0% vs. 81.4%, respectively; p < 0.01). Over a median 8 years of follow-up, very high-risk criteria were associated with increased risk of major adverse cardiovascular events in individuals <55 years of age (hazard ratio: 2.09; 95% confidence interval: 1.82 to 2.41; p < 0.001), as was the case in older age groups (p interaction = 0.54).

Conclusions: Most younger patients with premature MI are not identified as statin candidates before their event on the basis of the 2018 guidelines, and most patients with premature MI are not recommended for intensive post-MI lipid management.
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http://dx.doi.org/10.1016/j.jacc.2020.06.030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444655PMC
August 2020

2019 ESC/EAS Guidelines for management of dyslipidaemia: strengths and limitations.

Eur Heart J Cardiovasc Pharmacother 2021 Jul;7(4):324-333

Department of Cardiology, Institut de cardiologie (AP-HP), Sorbonne Université, ACTION Study Group, INSERM UMRS_1166, 47-83 bld de l'Hôpital, 75013 Paris, France.

In 2019, the European Society of Cardiology and European Atherosclerosis Society released a new guideline document with substantial changes regarding the assessment of cardiovascular risk and treatments. The update of high-risk criteria and categories led to a better detection and primary prevention of patients at risk of a first cardiovascular event. Nonetheless, additional efforts are needed for a better inclusion of risk modifiers, especially specific to women, to improve risk stratification and direct primary prevention. Eventually, we discuss how these new guidelines implement PCSK9 inhibitors for very high-risk individuals and the evidence supporting new low-density lipoprotein cholesterol goals below, such as 55 and 40 mg/dL.
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http://dx.doi.org/10.1093/ehjcvp/pvaa077DOI Listing
July 2021

Angiographic predictors of outcome in myocardial infarction patients presenting with cardiogenic shock: a CULPRIT-SHOCK angiographic substudy.

EuroIntervention 2021 02 5;16(15):e1237-e1244. Epub 2021 Feb 5.

Alviss.ai - Read Better, Paris, France.

Aims: The aim of this study was to determine the prognostic impact of pre- and post-PCI TIMI flow grade and TIMI myocardial perfusion grade (TMPG) in a well-defined group of patients with cardiogenic shock due to acute myocardial infarction.

Methods And Results: Patients with infarct-related cardiogenic shock randomised into the CULPRIT-SHOCK trial were included in the angiographic predictor analysis whenever their TIMI flow grade or TMPG was available in the core lab database (96.9% of cases). A multivariable logistic regression analysis, adjusted on non-angiographic covariates, was performed to investigate whether TIMI flow grade or TMPG was independently associated with all-cause mortality or renal replacement therapy up to one year. Pre-PCI TIMI flow grade and TMPG did not impact on mortality. When analysed in separate multivariable models, post-PCI TIMI 3 flow and TMPG grade 3 were both significantly associated with reduced risk of 30-day mortality: aOR 0.61 (95% CI: 0.38-0.97, p=0.037) and 0.46 (95% CI: 0.29-0.72, p<0.001), respectively. When considered in the same multivariable model, only TMPG was significantly associated with 30-day mortality (aOR 0.38 [0.20-0.71], p=0.002), the 30-day composite of all-cause mortality and renal replacement therapy (aOR 0.34 [0.18-0.66], p=0.001) and mortality at one-year follow-up (aOR 0.46 [0.24-0.88], p=0.02).

Conclusions: Post-PCI TIMI flow grade and TMPG are associated with mortality after PCI. TMPG is a better discriminator, supporting microcirculation rather than epicardial reperfusion for prognosis estimation.
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http://dx.doi.org/10.4244/EIJ-D-20-00139DOI Listing
February 2021

Precision Medicine in TAVR: How to Select the Right Device for the Right Patient.

Can J Cardiol 2021 01 6;37(1):4-6. Epub 2020 Apr 6.

Sorbonne University, ACTION Group, INSERM UMRS 1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière, Paris, France.

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http://dx.doi.org/10.1016/j.cjca.2020.03.043DOI Listing
January 2021

Catheterization Laboratory Activation Time in Patients Transferred With ST-Segment-Elevation Myocardial Infarction: Insights From the Mission: Lifeline STEMI Accelerator-2 Project.

Circ Cardiovasc Qual Outcomes 2020 07 26;13(7):e006204. Epub 2020 Jun 26.

Duke University School of Medicine, Durham, NC (J.G.J.).

Background: Catheterization laboratory (cath lab) activation time is a newly available process measure for patients with ST-segment-elevation myocardial infarction requiring inter-hospital transfers for primary percutaneous coronary intervention that reflects inter-facility communication and urgent mobilization of interventional laboratory resources. Our aim was to determine whether faster activation is associated with improved reperfusion time and outcomes in the American Heart Association Mission: Lifeline Accelerator-2 Project.

Methods And Results: From April 2015 to March 2017, treatment times of 2063 patients with ST-segment-elevation myocardial infarction requiring inter-hospital transfer for primary percutaneous coronary intervention from 12 regions around the United States were stratified by cath lab activation time (first hospital arrival to cath lab activation within [timely] or beyond 20 minutes [delayed]). Median cath lab activation time was 26 minutes, with a delayed activation observed in 1241 (60.2%) patients. Prior cardiovascular or cerebrovascular disease, arterial hypotension at admission, and black or Latino ethnicity were independent factors of delayed cath lab activation. Timely cath lab activation patients had shorter door-in door-out times (40 versus 68 minutes) and reperfusion times (98 versus 135 minutes) with 80.1% treated within the national goal of ≤120 minutes versus 39.0% in the delayed group.

Conclusions: Cath lab activation within 20 minutes across a geographically diverse group of hospitals was associated with performing primary percutaneous coronary intervention within the national goal of ≤120 minutes in >75% of patients. While several confounding factors were associated with delayed activation, this work suggests that this process measure has the potential to direct resources and practices to more timely treatment of patients requiring inter-hospital transfer for primary percutaneous coronary intervention.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.119.006204DOI Listing
July 2020

Radial versus femoral artery access for percutaneous coronary artery intervention in patients with acute myocardial infarction and multivessel disease complicated by cardiogenic shock: Subanalysis from the CULPRIT-SHOCK trial.

Am Heart J 2020 07 30;225:60-68. Epub 2020 Apr 30.

First Department of Medicine-Cardiology, University Medical Centre Mannheim (UMM), University of Heidelberg, Mannheim, Germany.

Background: The use and impact of transradial artery access (TRA) compared to transfemoral artery access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) complicated by cardiogenic shock (CS) remain unclear.

Methods: This is a post hoc analysis of the CULPRIT-SHOCK trial where patients presenting with MI and multivessel disease complicated by CS were randomized to a strategy of culprit-lesion-only or immediate multivessel PCI. Arterial access was left at operator's discretion. Adjudicated outcomes of interest were the composite of death or renal replacement therapy (RRT) at 30 days and 1 year. Multivariate logistic models were used to assess the association between the arterial access and outcomes.

Results: Among the 673 analyzed patients, TRA and TFA were successfully performed in 118 (17.5%) and 555 (82.5%) patients, respectively. Compared to TFA, TRA was associated with a lower 30-day rate of death or RRT (37.3% vs 53.2%, adjusted odds ratio [aOR]: 0.57; 95% confidence interval [CI] 0.34-0.96), a lower 30-day rate of death (34.7% vs 49.7%; aOR: 0.56; 95% CI 0.33-0.96), and a lower 30-day rate of RRT (5.9% vs 15.9%; aOR: 0.40; 95% CI 0.16-0.97). No significant differences were observed regarding the 30-day risks of type 3 or 5 Bleeding Academic Research Consortium bleeding and stroke. The observed reduction of death or RRT and death with TRA was no longer significant at 1 year (44.9% vs 57.8%; aOR: 0.85; 95% CI 0.50-1.45 and 42.4% vs 55.5%, aOR: 0.78; 95% CI 0.46-1.32, respectively).

Conclusions: In patients undergoing PCI for acute MI complicated by CS, TRA may be associated with improved early outcomes, although the reason for this finding needs further research.
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http://dx.doi.org/10.1016/j.ahj.2020.04.014DOI Listing
July 2020

Selatogrel for Acute Myocardial Infarction: The Promise and Challenges of Self-Medication.

J Am Coll Cardiol 2020 05;75(20):2598-2601

Sorbonne Université, ACTION Study Group, Institut National de la Santé et de la Recherche Médicale UMRS1166, ICAN-Institut de Cardiologie, Hôpital Pitié-Salpêtrière (Assistance Publique-Hôpitaux de Paris), Paris, France.

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http://dx.doi.org/10.1016/j.jacc.2020.03.054DOI Listing
May 2020

Prognostic Value of SYNTAX Score in Patients With Infarct-Related Cardiogenic Shock: Insights From the CULPRIT-SHOCK Trial.

JACC Cardiovasc Interv 2020 05;13(10):1198-1206

ACTION Study Group, INSERM UMRS_1166, Institut de cardiologie, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France. Electronic address:

Objectives: This study sought to evaluate the prognostic value of the SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) scores in patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary disease with infarct-related cardiogenic shock (CS).

Background: The prognostic value of the SYNTAX score in this high-risk setting remains unclear.

Methods: The CULPRIT-SHOCK (Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock) trial was an international, open-label trial, where patients presenting with infarct-related CS and multivessel disease were randomized to a culprit-lesion-only or an immediate multivessel PCI strategy. Baseline SYNTAX score was assessed by a central core laboratory and categorized as low SYNTAX score (SS ≤22), intermediate SYNTAX score (2232). Adjudicated endpoints of interest were the 30-day risk of death or renal replacement therapy (RRT) and 1-year death. Associations between baseline SYNTAX score and outcomes were assessed using multivariate logistic regression.

Results: Pre-PCI SYNTAX score was available in 624 patients, of whom 263 (42.1%), 207 (33.2%) and 154 (24.7%) presented with low, intermediate and high SYNTAX score, respectively. A stepwise increase in the incidence of adverse events was observed from low to intermediate and high SYNTAX score for the 30-day risk of death or RRT and the 1-year risk of death (p < 0.001, for all). After multiple adjustments, intermediate and high SYNTAX score remained strongly associated with 30-day risk of death or renal replacement therapy and 1-year risk of all-cause death. There was no significant interaction between SYNTAX score and the coronary revascularization strategy for any outcomes.

Conclusions: In patients presenting with multivessel disease and infarct-related CS, the SYNTAX score was strongly associated with 30-day death or RRT and 1-year mortality.
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http://dx.doi.org/10.1016/j.jcin.2020.04.003DOI Listing
May 2020

Indirect comparison of the efficacy and safety of alirocumab and evolocumab: a systematic review and network meta-analysis.

Eur Heart J Cardiovasc Pharmacother 2021 May;7(3):225-235

Department of Cardiology, Sorbonne Université, ACTION study group, UMR_S 1166, Institut de Cardiologie, Pitié Salpêtrière Hospital (AP-HP), Paris, France.

Aims: Although alirocumab and evolocumab have both been associated with improved outcomes in patients with dyslipidaemia or established atherosclerotic cardiovascular disease, data on their respective performances are scarce. This study aimed at providing an indirect comparison of the efficacy and safety of alirocumab vs. evolocumab.

Methods And Results: We conducted a systematic review and network meta-analysis of randomized trials comparing alirocumab or evolocumab to placebo with consistent background lipid-lowering therapy up to November 2018. We estimated the relative risk (RR) and the 95% confidence intervals (CIs) using fixed-effect model in a frequentist pairwise and network meta-analytic approach. A total of 30 trials, enrolling 59 026 patients were included. Eligibility criteria varied significantly across trials evaluating alirocumab and evolocumab. Compared with evolocumab, alirocumab was associated with a significant reduction in all-cause death (RR 0.80, 95% CI 0.66-0.97) but not in cardiovascular death (RR 0.83, 95% CI 0.65-1.05). This study did not find any significant differences in myocardial infarction (RR 1.15, 95% CI 0.99-1.34), stroke (RR 0.96, 95% CI 0.71-1.28), or coronary revascularization (RR 1.13, 95% CI 0.99-1.29) between the two agents. Alirocumab was associated with a 27% increased risk of injection site reaction compared to evolocumab; however, no significant differences were found in terms of treatment discontinuations, systemic allergic reaction, neurocognitive events, ophthalmologic events, or new-onset of or worsening of pre-existing diabetes.

Conclusion: Alirocumab and evolocumab share a similar safety profile except for injection site reaction. No significant differences were observed across the efficacy endpoints, except for all-cause death, which may be related to the heterogeneity of the studied populations treated with the two drugs.
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http://dx.doi.org/10.1093/ehjcvp/pvaa024DOI Listing
May 2021
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