News
ONCO-DVT– 1 Year of Anticoagulation With Edoxaban Is Superior To 3-Months In Cancer Patients With Distal DVT
Key Points:
- The optimal duration of therapy for distal deep vein thrombosis (DVT) among patients with an active malignancy is unknown.
- ONCO-DVT was the first randomized controlled trial comparing 12-months to 3-months of Edoxaban in patients with an active malignancy and recently diagnosed distal DVT
- Treatment with Edoxaban for 12 months compared to 3 months reduced symptomatic recurrent venous thromboembolism (VTE) or VTE-related death events without significantly increasing major bleeding risk.
ILUMIEN IV: OCT-guided complex PCI led to increased minimal stent area, improved safety, and lower in-stent thrombosis rates but no difference in target vessel failure at 2 years
Key Points
- This trial randomizing patients with diabetes and/or complex lesions to optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) or angiography-guided PCI found that post-PCI minimum stent area (MSA) was larger in the OCT arm, but there was no significant difference in the two-year rate of target vessel failure (TVF).
- Patients in the OCT arm experienced significantly fewer angiographic complications and stent thrombosis at two years with a trend towards lower mortality.
- These results indicate that among a high-risk cohort, OCT significantly increases the MSA while reducing peri-procedural complications and stent thrombosis at two years, but did not lead to reductions in TVF. COVID-19 might have contributed to lower observed TVF rates due to apprehension to seek care.
MULTISTARS AMI Trial: Immediate Complete Multivessel PCI non-inferior to staged approach in patients with STEMI and MVD
Key Points:
- It is well known that patients with STEMI often have multivessel disease (MVD) and those with MVD have worse outcomes compared to patients without it.
- Current US and European guidelines support complete revascularization in a staged fashion but trials examining immediate versus staged percutaneous coronary intervention (PCI) are lacking.
- The MULTISTARS AMI trial demonstrated that immediate revascularization with PCI was associated with a reduction in non-fatal myocardial infarction and unplanned revascularization compared to staged revascularization at 1 year.
FRAIL-AF: Switching to NOACs in Frail Elderly with AF Linked to Increased Bleeding
Key Points:
- The FRAIL-AF trial is an open-label, randomized controlled trial that randomized frail adults (75 years or older) who were on VKA for atrial fibrillation to either continuing VKA or switching to a NOAC.
- The study found a relative 69% increased risk in bleeding events among patients who were switched from VKA to NOACs (p=0.001). This was driven primarily by a 77% increase in clinically relevant non-major bleeding, as there was no significant difference in major bleeding events.
ARREST: Transfer to a cardiac arrest center instead of the nearest ED does not improve mortality in OHCA patients
Key Points:
- Sudden cardiac death causes a fifth of all deaths in industrialized countries, but survival to hospital discharge remains low.
- Transfer to a specialized, cath-lab capable cardiac arrest center may expedite care of patients with an ischemic cause of arrest.
- This multicenter randomized trial compared transfer to a specialized cardiac arrest center with the nearest ED in patients with a resuscitated out-of-hospital cardiac arrest (OHCA). The primary endpoint was 30-day all-cause mortality.
- There were no differences in the primary endpoint of all-cause mortality between the two transportation strategies, nor any difference in the secondary endpoints of 3-month mortality and neurological outcome.
ATTRibute-CM: Acoramidis Linked to Improved clinical outcomes in transthyretin amyloid cardiomyopathy
Key Points:
- Transthyretin amyloid cardiomyopathy develops because of mis-folded proteins infiltrating the myocardium, leading to clinical heart failure. Currently, tafamidis is the only commercially approved medication and is the most expensive cardiovascular drug on the market.
- Acoramidis is a once-daily medication that stabilizes the transthyretin tetrameric protein, preventing its degradation and subsequent deposition into the myocardium.
- Acoramidis in ATTR-CM resulted in a statistically significant reduction in hospitalization for heart failure and mortality based on a hierarchical analysis of a composite outcome with an overall win ratio of 1.8 (p<0.0001) compared to placebo.
The ADVENT of Pulsed Field Ablation for Atrial Fibrillation: just as effective and safe as traditional thermal ablation, but faster
Key Points:
- ADVENT was the first randomized controlled trial comparing pulsed field ablation (PFA) to conventional strategies for ablation (including either radiofrequency or cryothermal ablation).
- The success rate was 73.3% and 71.3% in the PFA and thermal groups, respectively. PFA met the prespecified criteria for noninferiority.
- PFA is as effective and safe as conventional thermal ablation for the treatment of paroxysmal atrial fibrillation.
STOPDAPT-3: Prasugrel monotherapy after PCI with DES not superior to DAPT for major bleeding but non-inferior for CV events
Key Points:
- This trial randomized 6,000 patients with high bleeding risk or acute coronary syndrome undergoing planned PCI to a strategy of 3.75mg of prasugrel or DAPT with aspirin 81-100 mg and prasugrel 3.75mg, following a prasugrel load in both arms.
- At 1 month, prasugrel alone failed to demonstrate superiority for the co-primary endpoint of major bleeding. However, the aspirin-free strategy was non-inferior to DAPT for the co-primary endpoint of cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke).
- DAPT remains the standard strategy post-PCI even in the current era with the newest generation of drug-eluting stents.
FIRE: Complete revascularization better than culprit-only strategy for elderly with MI and MVD
Key Points
- The FIRE trial aimed to address the lack of evidence regarding complete revascularization in older MI patients and examined the superiority of complete revascularization based on coronary physiology.
- The trial enrolled 1,445 patients with a median age of 80, and the primary outcome (death, MI, stroke, or ischemia-driven coronary revascularization) occurred in fewer patients in the physiology-guided complete revascularization group compared to the culprit-only group.
- Physiology-guided complete revascularization reduces ischemic events compared with culprit-only revascularization in myocardial infarction patients aged 75 years or older with multivessel disease.
Meta-analysis demonstrates that IV Iron is associated with reduced HF hospitalizations in HF patients with iron deficiency
Key Points:
- Iron-deficiency is common in heart failure (HF) and associated with increased mortality and hospitalization.
- Previous trials of intravenous (IV) iron in the form of ferric carboxymaltose (FCM) in iron-deficient HF patients have shown improvements in symptoms and quality of life, but effects on clinical events have been unclear.
- This meta-analysis pooled data from three randomized controlled trials (RCTs) – CONFIRM-HF, AFFIRM-HF, and HEART-FID – to assess both a composite endpoint of total CV hospitalizations and death, as well as a composite endpoint of total HF hospitalizations and CV death through 52 weeks.
- In iron-deficient patients with HF with reduced ejection fraction (HFrEF) or HF with mildly reduced ejection fraction (HFmrEF), IV FCM is associated with reduced risk of composite outcome of total cardiovascular (CV) hospitalization and death through 52 weeks compared with placebo.
ECLS-SHOCK: ECMO does not reduce mortality in acute MI-related cardiogenic shock compared to control
Key Points:
- The use of ECLS has increased substantially over the past decade despite stagnant, high mortality in cardiogenic shock.
- This multicenter randomized trial compared ECLS with control in patients with acute MI-related cardiogenic shock. The primary endpoint was 30-day all-cause mortality.
- There were no differences in the primary endpoint of all-cause mortality between ECLS and placebo; however, ECLS resulted in higher rates of moderate-to-severe bleeding and peripheral ischemia requiring intervention.
QUEST: Chinese Herbal Medicine (Qiliqiangxin) reduces heart failure hospitalizations and cardiovascular mortality in HFrEF
Key Points:
- Qiliqiangxin is a traditional Chinese herbal medicine extract which has been approved since 2004 for the treatment of HF in China.
- This multicenter, double-blind, placebo-controlled trial compared qiliqiangxin with placebo amongst patients with HFrEF (EF<40%). The primary endpoint was a composite of CV death and HF hospitalizations.
- Over a median follow-up of 18 months, qiliqiangxin use resulted in a reduction in the composite primary endpoint.
STEP-HFpEF: Semaglutide reduces heart failure symptoms and body weight in HFpEF patients at one year
Key Points:
- More than 80% of patients with HFpEF are overweight or obese, but there has not yet been a study examining the use of weight-loss agents in body weight reduction or HF symptomatology in HFpEF.
- In the Step-HFpEF study, subcutaneous once-weekly semaglutide was compared with placebo in patients with HFpEF and obesity. The two primary endpoints were change of KCCQ-CCS and body weight from baseline after 52 weeks of treatment.
- Semaglutide use resulted in a significant reduction in both heart failure symptomatology and body weight at 52 weeks.
COP-AF: Colchicine did not reduce AF or myocardial injury after non-cardiac surgery, but post-hoc analysis suggest benefit in composite outcomes
Key Points
- This trial randomizing patients aged 55 or older to colchicine or placebo following non-cardiac thoracic surgery found no difference in the co-primary endpoints of atrial fibrillation or myocardial injury, but post-hoc analyses indicated benefit in composite outcomes without a signal for increased harm.
- Colchicine increased risk of diarrhea, but patients reported that these symptoms were mostly temporary and benign.
- Further research is needed to explore the encouraging and consistent trend of fewer cardiovascular events with colchicine after non-cardiac surgery.
NOAH-AFNET 6: No benefit of oral anticoagulation among patients with atrial high-rate episodes in the absence of confirmed AF
Key Points
- This trial randomized elderly patients without a known diagnosis of atrial fibrillation with device-detected atrial high-rate episodes (AHREs) and a median CHA2DS2VASC of 4 to edoxaban or placebo.
- The study was stopped early due to safety concerns and trend towards futility for efficacy after enrollment of all planned patients.
- Among patients with AHREs detected by implantable devices, anticoagulation with edoxaban did not result in lower incidence of a composite of cardiovascular death, stroke, or systemic embolism as compared with placebo. Rather, it was associated with a higher incidence of a composite of death or major bleeding.
- The results indicate that patients with AHREs on their implanted device should not be prescribed anticoagulation unless atrial fibrillation is diagnosed on surface ECG. However, the stroke rates in the control arm were lower than expected.
HOST-IDEA: 3-Month DAPT Noninferior to 12-Month DAPT in Patients Undergoing PCI using third-generation stents
Key Points:
- Among patients undergoing PCI using third-generation DES with ultrathin struts and advanced polymer technology, 3- to 6-month DAPT was noninferior to 12-month DAPT for net adverse clinical events (NACE; defined as the composite of cardiac death, TVMI, CD-TLR, stent thrombosis, or major bleeding) at one year (3.7% vs. 4.1%; HR, 0.93; 95% CI, 0.60 to 1.45; p=0.75).
- The rates of target lesion failure (TLR; defined as the composite of cardiac death, TVMI, or CD-TLR) were comparable (2.4% vs. 2.5%; HR, 0.98; 95% CI, 0.56 to 1.71; p=0.94).
- No significant difference in major bleeding (BARC type 3 or 5) was observed (1.5% vs. 1.9%; HR, 0.82; 95% CI, 0.41 to 1.61; p=0.56).
- NACE, TLR, or major bleeding was not affected by the mode of presentation (stable ischemic heart disease or acute coronary syndrome).
UK Biobank Analysis: Self-reported LCHF Diet May be Linked to Cardiac Events
Key Points:
- In spite of the increase popularity of low-carbohydrate high-fat diet due to purported benefit in a variety of conditions, there is limited data on the effect of LCHF diet on overall lipid profile and risk of ASCVD
- Compared to the standard diet, regular consumption of a self-reported low-carbohydrate, high-fat diet was associated with elevated levels of total cholesterol (6.08 vs. 5.85 mmol/L; p=0.002), LDL cholesterol (3.80 vs. 3.64 mmol/L; p=0.004), and apolipoprotein B (1.09 vs. 1.04 g/L; p<0.001).
- At 11 years, LCHF diet was associated with a two-fold risk of incident major adverse cardiac event (MACE; defined as the composite of angina, myocardial infarction, coronary artery disease, ischemic stroke, peripheral arterial disease, or coronary/carotid revascularization) compared to standard diet (9.8% vs. 4.3%; p<0.001).
- Other covariates linked to a greater MACE risk included diabetes (HR=3.37), current smoking (HR=2.44), and hypertension (HR=1.89).
hsCRP is a Stronger Predictor of CV Events and Death than LDL-C in High-Risk Patients on Statins
Key Points:
- Both inflammatory risk and hyperlipidemia and crucial risk factors for MACE in patients at high risk of CVD.
- In a large collaborative study of patients combining data from the PROMINENT (N = 9,988), REDUCE-IT (N = 8,179) and STRENGTH (N = 13,078) trials, the effect of residual inflammatory risk (as measured by hsCRP) and LDL-C levels on MACE were assessed.
- Residual inflammatory risk as assessed by hsCRP was a stronger determinant of risk for future cardiovascular events and death than residual cholesterol risk as assessed by LDL-C.
FREEDOM COVID: Therapeutic dose anticoagulation does not reduce MACE in non-critically ill COVID-19 patients
Key Points:
- There have been conflicting data on the role and recommended dosage of anticoagulation in non-critically-ill patients with COVID-19.
- In the open-label FREEDOM COVID study, therapeutic anticoagulation was compared with prophylactic doses of enoxaparin in patients hospitalized for COVID-19. The primary endpoint was a 30-day composite of all-cause mortality, requirement For ICU level-of-care, systemic thromboembolism, or ischemic stroke.
- Therapeutic anticoagulation did not result in any significant differences in the composite endpoint, but it did result in lower 30-day mortality and endotracheal intubation compared with prophylaxis.
STELLAR: Sotatercept improves 6MWD in PAH patients and WHO FC II-III
Key Points:
- Sotatercept is a novel activin signaling inhibitor which was designed to target pulmonary vascular remodeling in PAH.
- In the STELLAR study, sotatercept was tested against placebo on a background of baseline PAH therapy in adults with WHO II/III PAH. The primary endpoint was change in 6MWD at 16 weeks.
- Sotatercept resulted in an improvement in 6MWD, PVR, NT-proBNP, and a composite of time to clinical worsening and all-cause mortality at 16 weeks compared to placebo.
