Leah Kosyakovsky, MD
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.
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.
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.
Dapagliflozin Reduces PCWP at Rest and Exercise, Plasma Volume, and Weight in HFpEF patients
Key Points:
- SGLT2i therapy reduces HF hospitalizations and CV mortality in HFpEF, but the mechanism is not yet clear.
- In this single-center, double-blinded RCT, patients with HFpEF were randomized to dapagliflozin or placebo and underwent exercise and resting hemodynamics at baseline and at 24 weeks.
- Dapagliflozin resulted in reduced resting and exercise PCWP, weight, and plasma volume relative to placebo.
Macitentan/Tadalafil Fixed Dose Combination reduces PVR compared with monotherapy
Key Points:
- Macitentan and Tadalfil are frequently used in combination for PAH, which opens up the possibility of a fixed-dose combination pill.
- In the DUE study, macitentan/tadalafil FDC therapy was compared against macitentan and tadalafil monotherapy. The primary outcome was PVR reduction at 16 weeks.
- M/T FDC resulted in a significant reduction in PVR at 16 weeks compared to either macitentan or tadalfil monotherapy. There was a non-significant trend towards reduction in 6MWD at 16 weeks.
Black women with TTR V122I variant have higher risk of CVD and all-cause mortality
Key Points:
The prognostic significance of the V122I variant (associated with wt-ATTR) in Black women has not yet been established.
A substudy of the WHI aimed to establish the association of the V122I variant with a composite of CVD and all-cause mortality in Black Women.
The V122I variant was associated with increased composite CVD and all-cause mortality in Black women; this association was particularly significant for women age 60+.
Elevated hs-cTnL levels precede and predict pre-eclampsia
Key Points:
- There have been limited data regarding the biomarkers that may predict the development and severity of preeclampsia.
- hs-cTnI was significantly elevated in pregnant women who would later develop preeclampsia starting at 14 weeks. A cutoff hs-cTnI value of >2.2pg/ml at 14 weeks and >2.6pg/ml at 26 weeks had a combined 100% negative predictive value for predicting severe preeclampsia in women at high a prior risk.
TRILUMINATE: Tri-Clip reduces tricuspid regurgitation and improves quality of life at one year
Key Points:
- There have been limited data examining the safety and efficacy of transcatheter tricuspid repair systems.
- In the TRILUMINATE study, Tri-Clip was compared against medical therapy in patients with severe symptomatic TR.
- Tri-Clip implantation reduced severity of TR and improved quality of life. Tri-Clip was safe and resulted in only a 1.7% rate of major adverse events.
FLAME: FlowTriever use for PE associated with decreased in-hospital adverse outcomes
Key Points:
- Mortality in high-risk PE remains unacceptably high (25%) despite advances in medical and interventional therapies.
- The FLAME study was a prospective, multi-center non-randomized observational study to describe the outcomes of patients undergoing mechanical thrombectomy and other modern therapies and generate evidence in high-risk PE. The primary outcome was a composite of all-cause mortality, bailout to alternate thrombus removal strategy, clinical deterioration, and major bleeding.
- Compared with a pre-established performance goal of 32%, patients treated with Flowtriever had a significant reduction in the primary endpoint. There was also significant reduction in in-hospital mortality (1.9% compared to 28.5%). There was no increase in adverse events in the FlowTriever group.
- Randomized evidence will be required to follow-up this observational study, but FlowTriever appears to be a safe, effective treatment which may reduce mortality in high-risk PE.
OPTION –Indobufen is Noninferior to Aspirin After Coronary Drug-Eluting Stent Implantation
Key Points:
- Indobufen, a platelet aggregation inhibitor, has been shown to be a shorter acting antiplatelet in comparison to aspirin. However, it has not been studied as a component of DAPT in patients requiring stent implantation.
- In the OPTION study, patients with CAD undergoing stent placement were randomized to either indobufen or aspirin. The primary outcome of interest was a 1-year composite of CV death, nonfatal MI, ischemic stroke, definite or probable stent thrombosis, or BARC type-2, 3, or 5 bleeding
- Indobufen was found to be non-inferior to aspirin in the primary endpoint.
PRECISE–A precision diagnostic strategy in patients with suspected CAD improves outcomes
Key Points:
- There is substantial heterogeneity in the use of different non-invasive and invasive modalities for CAD risk stratification; however, there limited is RCT evidence dictating the optimal strategy.
- In the PRECISE study, patients with typical or atypical symptoms suggestive of potential CAD were randomized to either a risk-score based, “precision” strategy or usual care. The primary outcome of interest was a 1-year composite of death, nonfatal MI, or a coronary catheterization yielding no obstructive CAD.
- The precision strategy resulted in a significant 70% reduction in the primary outcome at 1 year compared to usual care.
RAPCO: Radial artery grafting is superior to both RITA and SVG in patients undergoing CABG
Key Points:
- Recent guidelines have supported the use of arterial grafts over venous grafts in coronary artery bypass grafting (CABG), but there has yet to be a single randomized trial examining long-term cardiovascular outcomes with these different grafting methods.
- In the RAPCO study, patients undergoing CABG were randomized to either a) radial artery (RA) grafting versus right internal thoracic artery (RITA) grafting or b) radial artery (RA) grafting versus saphenous vein grafting (SVG). The primary outcome of interest was MACE, a composite of cardiovascular mortality, acute MI, and revascularization.
- RA grafting was superior to both RITA and SVG grafting over 15 years of follow-up.
ECMO-CS: Early ECMO Does not Improve Outcomes in Severe Cardiogenic Shock
Key Points:
- ECMO has been used as a salvage strategy in severe cardiogenic shock. However, it is unclear whether immediate ECMO initiation is superior to an initial trial of medical therapy with subsequent MCS utilization as needed if no improvement occurs.
- In the ECMO-CS study, patients presenting with severe cardiogenic shock (SCAI stage D-E) were randomized to either immediate ECMO or medical therapy (with downstream MCS as needed) The primary outcome of interest was a 30-day composite of death from any cause, resuscitated circulatory arrest, and implementation of any other MCS device.
- Immediate ECMO initiation was not associated with a significant reduction in the primary outcome relative to medical therapy with downstream as-needed MCS. There was a 40% crossover in the conservative arm to eventual downstream ECMO.
CTS-AMI: Tongxinluo (TXL) improves CV outcomes in acute STEMI
Key Points:
- Tongxinluo (TXL) is a traditional Chinese medicine with endothelial-protective effects which has been used for angina and stroke prevention in China. It has yet to be tested as a means of improving clinical outcomes in acute STEMI.
- In the CTS-MI study, patients presenting with STEMI were randomized to either TXL (at randomization, and then continued for a year) or placebo. The primary outcome of interest was 30-day MACCE, a composite of cardiovascular mortality, recurrent MI, stroke, and emergent coronary revascularization. Secondary outcomes included 1-year MACCE as well as the individual components of MACCE, severe MI complications, and adverse events.
- TXL use resulted in a 36% reduction of MACCE at 30-days and 1-year, as well as reduced severe STEMI complications. TXL use was safe, with no increase in adverse events.
IRONMAN: Intravenous Ferric Derisomaltose did not not meet primary endpoint in HFrEF
Key Points:
- Iron deficiency is common and a poor prognostic feature in patients with heart failure. However, while iron infusion has improved symptoms in patients with HFrEF, there has been no association with improved “hard” outcomes such as hospitalization or CV death.
- In the IRONMAN study, patients with HFrEF and iron deficiency were randomized to Intravenous Ferric Derisomaltose (IV FDI) or placebo. The primary outcome of interest was a composite of recurrent HF hospitalizations and CV death.
- The observed reduction in primary endpoint with Intravenous Ferric Derisomaltose did not reach statistical significance compared to usual care.
COACH – A Patient-Risk Based Health System Intervention for Acute Heart Failure Care: The Comparison of Outcomes and Access to Care for Heart Failure (COACH) Trial
Key Points:
- HF patients frequently present to the ED for acute exacerbations, and the decision whether to discharge, observe, or admit these patients can be complex.
- The COACH trial randomized acute HF patients presenting to the ED to either a standardized clinical risk stratification algorithm (based on the EHMRG30-ST score) with associated rapid outpatient HF clinic or to standard of care.
- Patients receiving the intervention had reduced 30-day and 20-month composite death and non-elective cardiovascular hospitalizations.