Aspirin for primary prevention of cardiovascular disease: a review of recent literature and updated guideline recommendations

Mogul, Amanda; Leppien, Emily; Laughlin, Elizabeth; Spinler, Sarah A.

doi:10.1080/14656566.2020.1817389

Cited by 11 publications

(6 citation statements)

References 28 publications

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“…Approximately half of the patients in our study were already on aspirin at study entry, which is significant considering that the use of antiplatelet therapy in primary prevention is a matter of debate because it has been associated with an increased risk of total bleeding without a clear reduction in the risk of major CV events (MACE) [ 32 – 34 ]. Thus, in general, clinical guidelines recommend its use in selected patients, such as those younger than 70 years, with DM and at very high CV risk, at low risk of bleeding, or with difficulties in controlling modifiable CV risk factors [ 35 – 37 ]. In our study, patients were at very high CV risk and those at elevated risk or with a medical history of bleeding episodes were excluded from the trial because this was considered a contraindication for the polypill.…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial

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Súarez-Fernández

Cosı́n-Sales

et al. 2022

BMC Cardiovasc Disord

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Background Cardiovascular (CV) polypills are a useful baseline treatment to prevent CV diseases by combining different drug classes in a single pill to simultaneously target more than one risk factor. The aim of the present trial was to determine whether the treatment with the CNIC-polypill was at least non-inferior to usual care in terms of low-density lipoprotein cholesterol (LDL-c) and systolic BP (SBP) values in subjects at high or very high risk without a previous CV event. Methods The VULCANO was an international, multicentre open-label trial involving 492 participants recruited from hospital clinics or primary care centres. Patients were randomised to the CNIC-polypill -containing aspirin, atorvastatin, and ramipril- or usual care. The primary outcome was the comparison of the mean change in LDL-c and SBP values after 16 weeks of treatment between treatment groups. Results The upper confidence limit of the mean change in LDL-c between treatments was below the prespecified margin (10 mg/dL) and above zero, and non-inferiority and superiority of the CNIC-polypill (p = 0.0001) was reached. There were no significant differences in SBP between groups. However, the upper confidence limit crossed the prespecified non-inferiority margin of 3 mm Hg. Significant differences favoured the CNIC-polypill in reducing total cholesterol (p = 0.0004) and non-high-density lipoprotein cholesterol levels (p = 0.0017). There were no reports of major bleeding episodes. The frequency of non-serious gastrointestinal disorders was more frequent in the CNIC-polypill arm. Conclusion The switch from conventional treatment to the CNIC-polypill approach was safe and appears a reasonable strategy to control risk factors and prevent CVD. Trial registration This trial was registered in the EU Clinical Trials Register (EudraCT) the 20th February 2017 (register number 2016-004015-13; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-004015-13).

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Section: Discussionmentioning

confidence: 99%

Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial

Mostaza

Súarez-Fernández

Cosı́n-Sales

et al. 2022

BMC Cardiovasc Disord

View full text Add to dashboard Cite

show abstract

“…Approximately half of the patients in our study were already on aspirin at study entry, which is signi cant considering that the use of antiplatelet therapy in primary prevention is a matter of debate because it has been associated with an increased risk of total bleeding without a clear reduction in the risk of major CV events (MACE) [32][33][34]. Thus, in general, clinical guidelines recommend its use in selected patients, such as those younger than 70 years, with DM and at very high CV risk, at low risk of bleeding, or with di culties in controlling modi able CV risk factors [35][36][37]. In our study, patients were at very high CV risk and those at elevated risk or with a medical history of bleeding episodes were excluded from the trial because this was considered a contraindication for the polypill.…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of a Cardiovascular Polypill in People at High and Very High Risk without a Previous Cardiovascular Event The International VULCANO Randomised Clinical Trial

Mostaza

Súarez-Fernández

Cosı́n-Sales

et al. 2022

Preprint

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BackgroundCardiovascular (CV) polypills are a useful baseline treatment to prevent CV diseases by combining different drug classes in a single pill to simultaneously target more than one risk factor. The aim of the present was to determine whether the treatment with the CNIC-polypill was at least non-inferior to usual care in terms of low-density lipoprotein cholesterol (LDL-c) and systolic BP (SBP) values in subjects at high or very high risk without a previous CV event. MethodsThe VULCANO was an open-label trial involving 492 participants randomised to the CNIC-polypill or usual care. The primary outcome was the mean change in LDL-c and SBP values after 16 weeks of treatment. ResultsThe upper confidence limit of the mean change in LDL-c between treatments was below the prespecified margin of 10 mg/dL and above zero, and non-inferiority and superiority of the CNIC-polypill (p =0.0001) was reached. There were no significant differences in SBP between groups. However, the upper confidence limit crossed the prespecified non-inferiority margin of 3 mm Hg. Significant differences favoured the CNIC-polypill in reducing total cholesterol (p =0.0004) and non-high-density lipoprotein cholesterol levels (p =0.0017). There were no reports of major bleeding episodes. The frequency of non-serious gastrointestinal disorders was more frequent in the CNIC-polypill arm.ConclusionThe switch from conventional treatment to the CNIC-polypill approach in patients at high CV risk without a previous event was safe and appears a reasonable strategy to control risk factors and prevent CVD.

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“…The applicability of aspirin for patients with silent cerebrovascular disease must also be considered in light of recent trials (without neuroimaging) that either failed to find a beneficial effect of aspirin or found a small effect similar in size to the increased harm from major bleeding (150). Contemporary guidelines either do not recommend aspirin use for primary prevention (151) or only recommend that it be considered in higher risk patients (based on cardiovascular risk factor profile or predicted risk from validated models) but not in the elderly older than 70 (152).…”

Section: Current Evidencementioning

confidence: 99%

Antithrombotic dilemmas in stroke medicine: new data, unsolved challenges

Best

Cardus

Klijn³

et al. 2022

J Neurol Neurosurg Psychiatry

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Antithrombotic therapy is a key element of secondary prevention in patients who have had an ischaemic stroke or transient ischaemic attack. However, its use in clinical practice is not always straightforward. This review provides an update on certain difficult scenarios in antithrombotic management, with a focus on recent clinical trials and large observational studies. We discuss the approach to patients with an indication for antithrombotic treatment who also have clinical or radiological evidence of previous intracranial bleeding, patients with indications for both anticoagulant and antiplatelet treatment, and patients in whom antithrombotic treatment fails to prevent stroke. We also review the timing of anticoagulation initiation after cardioembolic stroke, and the use of antithrombotics in patients with asymptomatic cerebrovascular disease. Despite a wealth of new evidence, numerous uncertainties remain and we highlight ongoing trials addressing these.

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Aspirin for primary prevention of cardiovascular disease: a review of recent literature and updated guideline recommendations

Cited by 11 publications

References 28 publications

Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial

Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial

Safety and Efficacy of a Cardiovascular Polypill in People at High and Very High Risk without a Previous Cardiovascular Event The International VULCANO Randomised Clinical Trial

Antithrombotic dilemmas in stroke medicine: new data, unsolved challenges

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