News
A Low-Dose Triple Single-Pill Combination Effective at Lowering Blood Pressure
Key Points:
- A single pill containing low doses of three different medicines induced significant and rapid reductions in blood pressure (BP) vs. dual therapy or placebo, with around 70% of patients with hypertension achieving BP control.
- The triple single-pill combination had good tolerability with no increase in treatment withdrawals.
- A low-dose triple single-pill combination could help to reverse current therapeutic inertia and transform hypertension management.
OCCUPI: Optical Coherence Tomography (OCT) Outperforms Conventional Angiography in Guiding Revascularization for Complex Coronary Lesions
Key Points:
- In all-comer populations, coronary imaging guidance shows superior outcomes compared to conventional angiography in percutaneous coronary interventions (PCI).
- The OCCUPI trial demonstrated that OCT-guided PCI significantly improved clinical outcomes over conventional angiography-guided PCI in patients with complex coronary lesions.
EARTH STEMI: Complete Revascularization Reduces Ischemic Events up to 4 years Among Older Patients with STEMI with Multivessel Disease
Key Points:
- Approximately 50% of patients with STEMI have multivessel disease but data regarding the benefit of complete versus culprit only revascularization are limited among older adults.
- The EARTH STEMI meta-analysis, pooled individual patient level data from 7 randomized clinical trials, to examine the benefit of complete versus culprit only revascularization among 1,733 older patients (75 years or older) with STEMI and multivessel disease.
- Over 4 years of follow-up, complete revascularization resulted in a reduction in the primary composite endpoint of death, MI, or ischemia-driven revascularization as compared with culprit only revascularization. However, in the setting of a numeric increase in non-cardiovascular deaths and lower available follow-up data, the reduction in the primary endpoint was nullified beyond 4 years.
SENIOR-RITA: In Elderly Patients With NSTEMI, An Invasive Strategy Improved Clinical Outcomes Compared To Optimal Medical Therapy Alone
Key Points:
- Many older patients with NSTEMI do not receive coronary angiography during their index admission due to a high concern for complications and uncertainty regarding its benefits.
- SENIOR-RITA randomized type 1 NSTEMI patients aged 75 or older to a conservative strategy of optimal medical therapy alone or an invasive strategy of optimal medical therapy plus angiography, with revascularization if indicated.
- There was no difference in the primary composite endpoint of cardiovascular death or MI at a median of 4.1 years between the two strategies, but there was a significant reduction in non-fatal MI and subsequent revascularization procedures in the invasive arm, with a low procedural complication rate of <1%.
- The relative safety and potential benefit of an invasive strategy observed in SENIOR-RITA—the largest trial to date in this population—can help inform shared decision making for elderly patients with NSTEMI.
GUARD–AF: Wearable ECG Patch Increased the Yield of AF Diagnosis
Key Points:
- A 14-day heart rhythm monitoring with a wearable patch in primary care increased the diagnostic yield for atrial fibrillation by 52% compared to usual care.
- Despite treatment with oral anticoagulants, rates of stroke and hospitalizations were similar between screened patients and those receiving usual care.
OCEANIC AF – Asundexian is inferior to apixaban for stroke prevention in patients with atrial fibrillation
Key Points:
- Factor XIa inhibition may reduce stroke risk while causing bleeding.
- In this phase III trial, asundexian, a factor XIa inhibitor, was associated with a higher incidence of stroke or systemic embolism than apixaban but had fewer bleeding events.
Edoxaban Monotherapy Associated with Better Net Clinical Benefit than Edoxaban Plus Single Antiplatelet in Patients with AF and Stable CAD: EPIC-CAD
Key Points:
- In patients with stable coronary artery disease and atrial fibrillation, multiple society guidelines recommend the use of monotherapy with oral anticoagulants after an early period of dual antithrombotic therapy. However, randomized trial evidence supporting this practice is limited.
- In this open-label, randomized clinical trial, 1040 patients who had chronic coronary artery disease and atrial fibrillation were randomized to receiving either standard-dose edoxaban monotherapy or standard-dose edoxaban plus a single antiplatelet agent.
- Edoxaban monotherapy was found to be superior to dual antithrombotic therapy for net clinical events of death, stroke, myocardial infarction, systemic embolization, unplanned urgent revascularization, or major or clinically relevant nonmajor bleeding at 12 months.
IVORY FINALE: Low-Dose IL-2 Reduces Arterial Inflammation after ACS
Key Points:
- While inflammation is critical to the pathogenesis of atherosclerosis, few available anti-inflammatory treatments have been tested in ACS.
- In IVORY FINALE, low-dose interleukin 2 (IL-2) was compared to placebo in ACS. The primary endpoint was change in arterial inflammation, as measured by PET scan. Safety and tolerability were also assessed.
- In the primary analysis, IL-2 resulted in a significant reduction in arterial inflammation in the index vessel on PET. Over a median of 2.6 years of follow-up, IL-2 also decreased MACE compared to placebo.
QUADRO – Quadruple Polypill More Effective In Lowering Blood Pressure Than Taking Three Separate Medications in Resistant Hypertension
Key Points:
- Treatment of resistant hypertension often involves at least three or more medications, but non-adherence increases as the number of pills increases.
- In the QUADRO trial, adding bisoprolol to a combination of perindopril, indapamide, and amlodipine in a single polypill significantly reduced blood pressure in patients with resistant hypertension over an 8-week period.
A Single Combined Measure Of hsCRP, LDL-C, And Lp(A) Predicts Incident CV Events Over 30 Years Among Women’s Health Study Participants
Key Points:
- While drug trials evaluate the short-term cardiovascular risk associated with elevated, blood biomarkers, little is known about the long term (20-30 year) risk conferred by these biomarkers, alone or in combination.
- This epidemiological study evaluated the association between baseline levels of hsCRP, LDL-C, and Lp(a) of ~28,000 initially healthy participants in the Women’s Health Study with incident cardiovascular events over 30 years of follow-up.
- Each of the measures were independently associated with an increased adjusted hazard of incident cardiovascular events, and each biomarker provided additive information. Women in the highest quintile of all three biomarkers had the highest risk.
- These data indicate that a single combined measure at one point in time can have predictive value beyond the traditional 10-year risk score. Since all three are potentially modifiable, these findings might have significant implications for how we prevent heart disease.
ASSURE DES: No Difference In Ischemic Events If Aspirin Is Interrupted Or Continued In Patients With DES Undergoing Non-Cardiac Surgery
Key Points:
- Anti-platelet therapy after coronary drug eluting stent (DES) placement reduces the risk of future ischemic events, but the risk of in-stent thrombosis with temporary interruption of anti-platelets decreases over time.
- Holding aspirin for non-cardiac surgery more than one year after DES placement could lower peri-operative bleeding risk, but whether this is outweighed by the ischemic risk remains uncertain.
- ASSURE DES randomized patients with prior DES undergoing non-cardiac surgery to continuation or interruption of aspirin, and found no difference in major ischemic or bleeding events, but the lower than expected event rates left the study underpowered.
Morning vs. evening dosing of blood pressure meds: No differences in outcomes or safety for either community-dwelling adults or frail nursing home residents
Key Points:
- Blood pressure follows a circadian rhythm, peaking after waking and dipping during sleep. While elevated nocturnal pressures are associated with adverse cardiovascular events, it is uncertain whether taking anti-hypertensive medication in the evening improves outcomes.
- BedMed and BedMed-Frail were pragmatic trials that randomized community-dwelling adults and nursing home residents, respectively, to their once-daily anti-hypertensives either before bed or in the morning.
- There were no differences in major cardiovascular or safety events between the two groups in either trial.
NOTION-3: Revascularization in Patients Undergoing TAVI Associated with Lower Risk of MACE vs Conservative Treatment
Key Points:
- The NOTION-3 trial found that FFR-guided revascularization with PCI in TAVI patients with coronary artery disease significantly reduced the composite endpoint of all-cause mortality, myocardial infarction, and urgent revascularization compared to conservative management.
- The reduction in the composite endpoint was mainly driven by significantly lower rates of myocardial infarction and urgent revascularization in the PCI group compared to the conservative group.
- The trial provides evidence that severe AS patients with CAD can benefit from PCI revascularization with TAVI.
TAVI Superior to Surgical Aortic Valve Replacement in Women: RHEIA Trial
Key Points:
- The RHEIA trial found that TAVI was superior to surgical aortic valve replacement (SAVR) in women with severe aortic stenosis, significantly reducing the composite endpoint of all-cause mortality, stroke, and rehospitalization for valve-related symptoms or worsening heart failure.
- The reduction in the primary endpoint was primarily driven by a significant decrease in rehospitalizations for valve- or procedure-related symptoms in the TAVI group compared to the SAVR group.
- TAVI demonstrated clear advantages over SAVR, suggesting that TAVI could be the preferred therapy for women with severe symptomatic aortic stenosis.
SWEDEGRAFT Trial: No Advantage of No-Touch vs Conventional Vein Harvesting in Coronary Artery Bypass Surgery
Key Points:
- The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated non-emergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 patients.
- The SWEDEGRAFT trial found no significant difference in vein graft failure or clinical outcomes between no-touch and conventional vein harvesting techniques in coronary artery bypass grafting (CABG).
- Patients undergoing no-touch harvesting experienced higher rates of leg wound complications compared to those who underwent conventional harvesting.
Transcatheter Mitral-valve Repair Lowers Hospitalization or CV Death vs Medical Therapy Alone in HF with Moderate to Severe MR: RESHAPE-HF2 Trial
Key Points:
- The Mitral Transcatheter Edge-to-Edge Repair (M-TEER) procedure with the MitraClip device has shown in the previous COAPT trial to reduce heart failure hospitalizations and mortality in patients with heart failure and severe functional mitral regurgitation (FMR).
- The RESHAPE-HF2 trial demonstrated that M-TEER, when added to standard care, significantly reduces heart failure hospitalizations compared to optimal standard of care alone in patients with FMR but did not significantly reduce mortality. M-TEER also substantially improved quality of life scores in heart failure patients as compared to optimal standard of care alone.
- RESHAPE-HF2 provides further evidence of the benefits of M-TEER in patients with reduced ejection fraction and FMR.
Continuation of Anticoagulation Non-Inferior to Interruption during TAVI: POPular PAUSE TAVI Trial.
Key Points:
- Many patients who undergo transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation. However, there is uncertainty over the safety and efficacy of continuing anticoagulation versus holding periprocedural anticoagulation during TAVI.
- In this international, international, open-label, randomized, noninferiority trial clinical trial, 869 patients undergoing TAVI who were also receiving long-term anticoagulants were randomized to either continuation strategy or interruption strategy of their anticoagulation.
- Continuation of anticoagulation was found to be non-inferior to interruption of anticoagulation for composite outcomes of death, stroke, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI.
Pooled Analysis Showed Semaglutide Reduced Combined CV death or Worsening HF and Worsening HF alone but No Significant Effect on CV Death
Key Points:
- Heart failure with mildly reduced or preserved ejection fraction (hereafter referred to as HFpEF) is the most common type of heart failure and is associated with a high risk of adverse clinical events, especially in patients with overweight, obesity, or type 2 diabetes.
- Whether semaglutide reduces heart failure (HF) events in patients with HFpEF remains an unresolved and important clinical question.
- This study aimed to investigate whether semaglutide reduces the risk of adverse HF events by conducting a pooled, patient-level analysis of participants with HFpEF from the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM trials.
Transcatheter Edge-To-Edge Repair Is Non-Inferior To Surgery In Patients With Secondary Mitral Regurgitation: MATTERHORN Trial
Key Points:
- The MATTERHORN trial found that the transcatheter edge-to-edge repair (TEER) procedure was non-inferior to surgical mitral valve repair in reducing functional mitral regurgitation in heart failure patients with depressed left ventricular ejection fraction.
- Both TEER and surgical groups showed similar outcomes in terms of the primary composite efficacy endpoint, and both had low rates of severe MR recurrence at 1 year.
- The TEER group had significantly fewer safety events compared to the surgical group, highlighting its potential as a safer alternative for patients at high risk for surgery.
T-TEER Significantly Reduced the Severity of Secondary Tricuspid Regurgitation and Improved Quality of Life. TRI-FR Trial
Key Points:
- The TRI.FR trial found that tricuspid transcatheter edge-to-edge repair (T-TEER) together with optimal medical therapy significantly improved the clinical outcomes and reduced tricuspid regurgitation severity compared to optimal medical therapy alone.
- Patient-reported outcomes, including quality of life, were significantly better in the T-TEER group than in the control group.
- The trial underscores the importance of a multidisciplinary approach to treating tricuspid regurgitation, integrating T-TEER with guideline-directed medical management.
