Month: April 2024
IVUS-Guided DES Reduced MACE at 1 year Compared to Angiography-Guided PCI: IVUS-ACS Trial
Key Points:
- The IVUS-ACS trial assessed whether the use of intravascular ultrasound guidance, as compared with angiography guidance, improves the outcomes of percutaneous coronary intervention with contemporary drug-eluting stents in patients presenting with an acute coronary syndrome.
- The study showed that IVUS-guided implantation of contemporary DES resulted in a lower 1-year rate of the composite outcome of cardiac death, target vessel myocardial infarction, or clinically driven revascularization compared with angiography guidance alone.
IVUS -DBC: IVUS-guided drug-coated balloon angioplasty improves primary patency
Key Points:
- One-year success rates of angioplasty in peripheral artery disease (PAD) patients were significantly higher when guided by intravascular ultrasound (IVUS) alongside angiography.
- IVUS, offering precise vessel measurements and visualization, demonstrated its effectiveness in achieving longer-lasting benefits from the procedure.
- At 12 months, primary patency was achieved in 83.8% of patients who received IVUS and 70.1% of those receiving angiography alone, with IVUS group showing significant superiority.
A technology assisted Web App allowed >90% of consumers to correctly self-select for statin use and achieve clinically important LDL-C reduction
Key Points:
- Nonprescription statin access may help statin-eligible patients receive appropriate treatment.
- This prospective, actual-use study employed a Web App for participants to self-qualify for guideline-appropriate moderate intensity statin initiation use, and found that this technology had high accuracy in making clinician-concordant statin determinations and led to a significant reduction in participant LDL.
PROACT: Enalapril Does Not Mitigate Anthracycline Toxicity in Breast Cancer and NHL
Key Points:
- Anthracycline toxicity is an important cause of cardiomyopathy; it is unclear whether prophylactic treatment with ACE inhibitors could mitigate this risk.
- In PROACT, enalapril was compared to standard of care in individuals undergoing anthracycline treatment for breast cancer or NHL. The primary endpoint was myocardial injury (defined as cTnT≥14 ng/L).
- Enalapril did not result in a significant reduction in anthracycline toxicity as measured by myocardial injury, LVEF, or GLS a month after chemotherapy completion.
Topical TXA Does Not Reduce Peri-Operative Seizures but Increases Risk of Transfusion in Cardiac Surgery Compared to Intravenous TXA
Key Points:
- IV TXA is used to prevent peri-operative bleeding in cardiac surgery, but it carries a risk of seizure. It is hypothesized that topical TXA may reduce this risk of seizure.
- In DEPOSITION, topical and IV TXA were compared in individuals undergoing cardiac surgery. The primary endpoint was seizure. Authors also investigated differences in RBC transfusions between arms.
- Topical TXA did not result in a significant difference in peri-operative seizures, but it did increase RBC transfusion requirement relative to IV TXA.
IMPROVE-HCM: Cardiac Mitotrope -Ninerafaxstat- Improves Functional Capacity in Symptomatic Non-Obstructive HCM
Key Points:
- Despite the high symptomatic burden, very few effective treatments exits for symptomatic, non-obstructive HCM.
- In IMPROVE-HCM, a novel cardiac mitotrope (ninerafaxstat) was compared to placebo in non-obstructive HCM. The primary efficacy endpoint was change in KCCQ score from baseline. Safety and tolerability were also assessed.
- In the primary intention-to-treat analysis, ninerafaxstat did not improve symptoms; however, when restricting the population to patients with baseline limitation by KCCQ (or NYHA III), treatment resulted in a significant improvement in HF symptoms. Ninerafaxstat also improved exercise capacity on CPET in the total sample.
A Restrictive Benzodiazepine Strategy During Cardiac Surgery Does Not Reduce Post-Operative Delirium
Key Points:
- Benzodiazepine use contributes to delirium before and after cardiac surgery, but intra-operative benzodiazepine use has not been well-studied.
- In B-Free, a restrictive intraoperative benzodiazepine strategy was compared with a liberal benzodiazepine strategy in the reduction of post-operative delirium.
- In the primary intention-to-treat analysis, the restrictive benzodiazepine strategy did not result in a significant reduction in post-operative delirium. However, this endpoint was significantly reduced in the restrictive arm using either an on-policy analysis approach or after excluding patients receiving pre-operative benzodiazepines.
TRAVERSE: Transseptal approach to LV ablation results in fewer cerebral emboli compared to retrograde aortic approach
Key Points:
- Among patients who undergo endocardial ablation for left ventricular arrythmias, it is uncertain whether the number of imaging-detected cerebral emboli differs based on the anatomical approach.
- In this randomized trial, participants who were assigned to a transseptal approach had significantly lower rates of imaging-detected cerebral emboli compared to those assigned to a retrograde aortic approach.
FFR-Guided Complete Revascularization in STEMI did not reduce MACE vs Culprit-lesion only PCI: The FULL REVASC Trial
Key Points
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- Researchers compared outcomes in patients with STEMI or very-high-risk non-STEMI (NSTEMI) and multivessel disease who were undergoing primary percutaneous coronary intervention (PCI) of the culprit lesion to receive either FFR-guided complete revascularization of nonculprit lesions or no further revascularization.
- There was no significant difference in the composite primary outcome of death, myocardial infarction or unplanned revascularization, between patients randomized to culprit lesion only PCI versus FFR-guided complete revascularization
PREVENT: PCI of non-flow-limiting vulnerable plaques reduced MACE compared to medical therapy alone
Key Points:
- Vulnerable plaques can lead to acute coronary syndromes, but it is unknown whether performing PCI on these lesions improves outcomes.
- In this RCT, patients with at least one non-flow limiting vulnerable plaque who received PCI plus OMT had significantly lower rates of target-vessel failure compared to OMT alone at a median follow up of 4.4 years.
PERFORM-TAVR: Home based exercise and protein supplementation improves physical performance in frail adults post-TAVR
Key Points:
- Many frail patients experience poor physical performance after TAVR, even when the procedure is a technical success.
- In frail, older patients undergoing TAVR, a combined program of home based exercise and protein supplementation 4 weeks before and 12 weeks after the procedure significantly improved standardized physical performance scores compared to a control of lifestyle education.
EMBO-ABL: Cryoballoon non-inferior to radiofrequency catheter ablation for AF for silent cerebral events
Key Points:
- Among AF patients undergoing catheter ablation, cryoballoon was non-inferior compared to radiofrequency for the primary endpoint of silent cerebral embolic events detected on MRI.
RELIEVE HF: Inter-Atrial Shunting Does Not Reduce Symptoms or Improve Prognosis in HF
Key Points:
- Inter-atrial shunting (IAS) may provide a useful opportunity to dynamically regulate left atrial pressure in heart failure.
- In the RELIEVE-HF study, IAS was compared with placebo in patients with at least a 6-month history of HF, across all LVEF categories and HF etiologies. The primary endpoint was a hierarchical composite of all-cause death, transplant or LVAD placement, all HF hospitalizations, and change in KCCQ score from baseline to 12 months; the primary safety endpoint was a composite of major adverse cardiac or neurologic events over 30 days.
- IAS was well-tolerated with zero adverse safety events, but it did not result in a significant reduction in the primary endpoint. However, in exploratory pre-specified stratified analyses by LVEF, IAS appeared to cause harm in patients with HFpEF and confer benefit in HFrEF.
SHASTA 2: Novel RNAi Therapeutic Plozasiran Results in Sustained Reduction In Triglycerides in Severe Hypertriglyceridemia
Key Points:
- Severe hypertriglyceridemia portends high risk of both CVD and acute pancreatitis, but there are limited effective treatment options.
- A novel RNA interference (RNAi) therapeutic plozasiran can reduce APOC3, a mediator of triglyceride elevation.
- In the Phase 2B trial SHASTA-2, two doses of plozasiran were compared with placebo in long-term (24 and 48 week) reduction of triglycerides and other cholesterol pathway mediators.
- All doses of plozasiran was well-tolerated and resulted in sustained reduction in triglycerides, APOC3, and remnant cholesterol with increased HDL-C by 24 weeks, with a still-significant but attenuated effect at 48 weeks.
DanGer Shock: Impella Reduces All-Cause Mortality in STEMI Cardiogenic Shock
Key Points:
- Cardiogenic shock (CS) mortality remains high despite increased utilization of mechanical circulatory support. Specifically, no randomized data has supported the use of Impella CP in CS.
- In DanGer Shock, routine use of Impella CP was compared with standard of care in selected individuals with cardiogenic shock after STEMI.
- Impella CP use was associated with a 13% reduction in 6-month all-cause-mortality but increased rates of both ischemic and hemorrhagic adverse events.
AT-001, a potent aldose reductase inhibitor, did not improve exercise capacity in diabetic cardiomyopathy with impaired exercise capacity
Key Points:
- The ARISE-HF trial evaluates the use of AT-001, a potent aldose reductase inhibitor, to reduce the risk of diabetic cardiomyopathy among patients with Type II diabetes.
- The trial did not find a significant difference in its primary outcome, change in a patient’s peak VO2 consumption, or secondary outcomes, including risk of progression to overt heart failure, between patients who received the higher dose of AT-001 (1500 mg) compared to placebo.
- In a pre-specified secondary analysis of patients who were not receiving either a GLP1 agonist or an SGLT2 inhibitor, there was a statistically significant difference in VO2 consumption after 15 months between patients receiving AT-001 1500 mg and those receiving placebo.
TAVR non-inferior to SAVR in Low to Intermediate Risk Patients With Severe Aortic Stenosis: DEDICATE-DZHK6 Trial
Key Points
- In the DEDICATE-DZHK6 trial, patients with a history of severe aortic stenosis who were ≥ 65 years old and low to intermediate risk for surgery were randomized to receive TAVR versus SAVR.
- TAVR was noninferior to SAVR with respect to death from any cause or stroke at 1 year.
- Patients who received a TAVR had improved secondary outcomes including lower rates of disabling stroke, cardiovascular death, bleeding and new-onset atrial fibrillation compared to those who received a SAVR
ORBITA COSMIC: Coronary sinus reducer did not improve transmural myocardial perfusion but angina symptoms
Key Points
– Coronary sinus reduction (CSR) is a potential therapeutic device for patients with refractory angina
– In this first-of-its-kind randomized, placebo-controlled, double-blind trial, participants underwent CSR implantation or a placebo procedure, with pre- and post-trial CMR and daily angina reporting
-Participants who received a CSR reported fewer episodes of angina, but CMR did not demonstrate improved blood flow
TARGET BP I: Alcohol-mediated renal artery denervation reduced SBP in treatment-resistant hypertension at 3 months compared to sham control
Key Points:
- Achieving hypertension control has remained an elusive goal in the US and globally, and procedural treatments like renal denervation have gained traction as a means to successfully overcome non-adherence to traditional lifestyle and medical treatment for hypertension.
- The TARGET BP I investigated a novel percutaneous device, capable of injecting a small amount of alcohol into the renal artery perivascular space, to achieve a circumferential and confluent (yet self-limited) arc of ablation of the sympathetic nervous system.
- Between 2019 and 2023, 301 patients with hypertension despite treatment with 2-5 medications were randomized 1:1 to renal denervation or sham control. At 3 months of follow-up, there was a modest but statistically significant reduction in 24-hour ambulatory systolic blood pressure (-10.0 ± 14.2 mm Hg versus -6.8 ± 12.1 mm Hg, i.e. a delta of -3.2 mm Hg with 95%CI -6.3 to 0.0, P=0.049), but no reduction in office systolic blood pressure, nor office or ambulatory diastolic blood pressure. This was in the context of an alarmingly high rate of medication non-adherence in both arms (50-60%).
- While encouraging, these results require confirmation via longer follow-up beyond 3 months, in order to understand whether alcohol-mediated renal denervation will demonstrate persistent reduction in blood pressure and perhaps show a larger advantage of the sham control arm, which may be expected to further worsen in hypertension control over time.
Hózhó: Phone-based GDMT Initiation and Uptitration Feasible and Effective among HFrEF patients in Navajo Nation
Key Points:
- GDMT utilization is suboptimal among American Indian patients with HFrEF in Navajo Nation.
- In this pragmatic, stepped-wedge, randomized clinical trial, a telehealth intervention using telephone calls and remote BP monitoring was significantly more effective than usual care in rapid GDMT optimization.