Intravascular Imaging-Guiding PCI in Complex Coronary Lesions Linked to Better Outcomes: The RENOVATE-COMPLEX-PCI Study

Key Points:

  1. Intravascular imaging-guided PCI shows promise in improving outcomes for patients with complex coronary artery lesions, with a 36% reduction on the primary outcome (composite of cardiac death, target vessel myocardial infarction,  and clinically-driven target vessel revascularization; HR: 0.64; p = 0.008) compared with the angiography guided PCI group.
  2. RENOVATE-COMPLEX PCI trial highlights the potential benefits of utilizing intravascular imaging devices during PCI procedures, especially on complex coronary artery lesions.
  3. Ongoing medical research is crucial in advancing medical treatments and improving patient care, as demonstrated by the RENOVATE-COMPLEX PCI trial.

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TARGET Trial: On-site CT-FFR Feasible and Effective in stable CAD

Key points:

  1. The TARGET trial is the first randomized trial designed to assess the impact of an on-site CT-FFR strategy using machine learning compared to standard care in patients with new onset stable chest pain with an intermediate-to-high pretest of coronary artery disease probability found to have intermediate stenosis on CCTA.

 

  1. Utilization of on-site CT-FFR compared to standard care with stress testing reduced the proportion of patients referred for invasive coronary angiography who did not have obstructive coronary artery disease or require intervention within 90 days. In addition, the on-site CT-FFR strategy increased revascularization overall but did not improve quality of life, symptoms of angina, or clinical outcomes.

 

  1. On-site CT-FFR measurement was based on a deep learning algorithm, which has been shown to perform equally well as computational fluid dynamics CT-FFR in identifying hemodynamically significant stenosis.

 

  1. The TARGET trial provides support for the use of on-site CT-FFR in the management of intermediate-to-high risk patients with stable chest pain and is expected to further consolidate the role of CCTA as a “gatekeeper” of the Cath lab.

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BIOVASC Trial: Immediate complete revascularization non-inferior to staged complete in MVD ACS patients

Key Points:

  • Complete revascularization is recommended in patients with multivessel CAD who present with ACS without cardiogenic shock, but the optimal timing of non-culprit lesion revascularization is unknown.
  • The BIOVASC study was a randomized, open-label, non-inferiority clinical trial which sought to determine whether an immediate complete revascularization strategy was inferior to a staged complete revascularization strategy in patients with ACS and multivessel disease (MVD). The primary outcome was a composite of all-cause death, MI, unscheduled ischemia-driven revascularization, or cerebrovascular events at 1 year.
  • At one year of follow-up, immediate complete revascularization was non-inferior to staged complete revascularization for the primary composite outcome. Patients who underwent immediate complete revascularization had fewer MIs and required fewer unplanned revascularizations.

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HALO – Baxdrostat Fails to Beat Placebo for Blood Pressure Reduction in Uncontrolled Hypertension

Key Points

  • Baxdrostat, a highly selective aldosterone synthase inhibitor, reduced systolic blood pressure as compared with placebo among patients with resistant hypertension in the BrigHTN trial. Efficacy and safety data are needed for individuals with uncontrolled hypertension.
  • In this randomized, double-blind, placebo-controlled, phase 2 clinical trial, treatment with baxdrostat did not meet primary endpoint of statistically significant change from baseline in mean seated SBP versus placebo in patients with uncontrolled hypertension

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Evolocumab Effect on Plaque Characteristics in Stable CAD Patients

Key Points

  • The YELLOW III study aimed to assess the effect of 26 weeks of evolocumab on plaque morphology using intravascular imaging (OCT and NIRS/IVUS) and peripheral blood mononuclear cell (PBMC) gene expression analysis in patients with stable CAD on maximally tolerated statin therapy.
  • In patients with stable CAD on maximally tolerated statins, more intensive lipid lowering with addition of evolocumab for 26 weeks resulted in significant and substantial increase in the minimum FCT by OCT, reduction in NIRS maxLCBI4mm and reduction in atheroma volume by IVUS in angiographically non-obstructive lesions.
  • The prevalence of high-risk vulnerable TCFA lesions was reduced from 48% to 13%.
  • This is the first multimodality imaging report in stable patients with non-obstructive lesions and lower levels of LDL-C at baseline.

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No difference in Heart Failure Outcomes with Advanced Imaging modalities vs SPECT: The AIMI-HF Trial

Key Points:

  • Imaging may be underused in patients with ischemic heart failure (HF) to evaluate ischemia/viability and guide management.
  • The Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) Project directly compared advanced imaging modalities (CMR or PET vs. SPECT) to determine its impact on a composite endpoint of cardiac death, myocardial infarction, resucitated cardiac arrest and cardiac re-hospitalization.
  • For the total study population, the primary endpoint was similar between the CMR/PET vs. SPECT groups, with a trend towards improved outcomes in the CMR/PET groups (HR 0.95, 95% CI 0.71-1.25, p=0.696).
  • Investigators concluded that choice of imaging study was not associated with a difference in outcomes, though an advanced imaging strategy with PET/CMR may be associated with a reduction in CV death.

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Viability Not Linked to Survival or LV improvement: The REVIVED-BCIS2 Randomized Trial

Key Points:
-It is unclear whether myocardial viability tests should be used to guide decisions about
revascularization in patients with ischemic cardiomyopathy (ICMP).
-The randomized trial REVIVED-BCIS 2 found that for patients with severe ICMP,
multivessel percutaneous coronary intervention (PCI) plus optimal medical therapy
(OMT) was not superior to OMT alone for event-free survival or recovery of left
ventricular ejection fraction (LVEF).
-This analysis of REVIVED-BCIS 2 data asked whether myocardial viability was
predictive of event-free survival (a composite of death or heart failure hospitalization),
LVEF recovery, or positive response to PCI among ICMP patients
-No significant association was found between baseline viability characteristics for event-
free survival, LVEF recovery, or positive response to PCI. However, scar burden was
predictive of both event-free survival and LVEF recovery, and LVEF recovery was
associated with improved clinical outcomes.

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Atorvastatin Reduced Left Ventricular Dysfunction From Anthracyclines: The STOP-CA Trial

 

Key Points

-Anthracycline therapy is associated with the development of heart failure, yet anthracyclines are among the most widely used and most effective antineoplastics.

-Limiting the cumulative dose of anthracycline, when possible, and screening for cardiotoxicity with echocardiograms should be standard practice.

-In the STOP-CA study, in patients with lymphoma treated with anthracyclines, the prophylactic use of atorvastatin over 12 months was associated with a lower rate of left ventricular dysfunction compared to placebo.

 

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RIVARAD: Post-Procedural Rivaroxaban Use After Radial Access for Coronary Procedures Reduces Radial Artery Occlusion at 30 Days

Key Points:

  • Radial artery occlusion (RAO) is the most common complication after radial access for coronary procedures; while routine intra-procedural heparin administration is a protective factor, the role of post-procedural anticoagulation has not been established.
  • In the RIVARAD study, patients undergoing trans-radial access for coronary procedures were randomized to a week of post-procedural rivaroxaban vs no additional treatment. The primary outcome of interest was 30-day incidence of RAO by ultrasound.
  • Patients receiving rivaroxaban experienced a 50% reduction in RAO by ultrasound and a 52% reduction in RAO by palpation compared to the control group. Rivaroxaban use was safe with no increase in overall hemorrhagic complications relative to the control arm.

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EPIC-STEMI: Early Routine PCSK-9 Use Added to High Intensity Statin Reduces LDL after Primary PCI for STEMI

Key Points:

  • Early high-intensity statin therapy is standard of practice in acute STEMI patients, but this is often insufficient to achieve LDL targets. PCSK-9 therapy has never been tested as routine therapy in STEMI.
  • In the EPIC STEMI trial, routine PCSK-9 initiation in addition to high-intensity statin prior to primary PCI resulted in a 22% LDL reduction at 6 weeks relative to sham, with a higher proportion of patients achieving therapeutic LDL targets.

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Extended outcomes of BEST: No difference in MACE between PCI and CABG in MVD at 12 years, but higher repeat revascularization and spontaneous MI in PCI arm

Key Points:

  • Previous studies have demonstrated the superiority of CABG over PCI in the treatment of multivessel disease; however, most studies were performed without the use of newer second-generation stents.
  • The two-year outcomes of the BEST trial demonstrated superiority of CABG compared to PCI with second-generation everolimus-eluting DES; however, the authors then pursued an extended outcome analysis up to a median follow-up of 11.8 years.
  • There was no difference between PCI and CABG at extended follow-up in the primary outcome composite of all-cause death, MI, and total revascularization. However, the rate of spontaneous MI and repeat revascularization was higher in the PCI arm.
  • IVUS use reduced the incidence of the primary composite amongst patients undergoing PCI.

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FLASH: The FlowTriever system has an excellent safety profile in the treatment of pulmonary embolism

Key Points:

  • Mortality for acute PE remains high. While percutaneous mechanical thrombectomy has been used in patients with hemodynamic instability, safety and effectiveness data from large clinical trials are needed.
  • In the single-arm FLASH study, patients with acute lobar or main PA pulmonary embolism received the FlowTriever System (percutaneous mechanical thrombectomy), and both short-term and 6 month safety and effectiveness outcomes were assessed. This was perfomed as part of the FLASH multicenter, prospective registry enrolling up to 1,000 US and European PE patients.
  • The FlowTriever had an excellent safety profile with only 1.8% risk of MAE and all-cause mortality of 0.8% at 30 days. Additionally, FlowTriever use was associated with substantial immediate improvements in hemodynamics, sustained improvement in echocardiographic measures of RV function, and improvement in quality of life and dyspnea at 6 months relative to presentation.

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UNIVERSAL: Routine ultrasound guidance of femoral vascular access did not reduce bleeding or vascular complications but did facilitate access

Key Points:

  • Femoral access is used for 30% of all coronary procedures, and femoral access site complication can be catastrophic. Since the development of ultrasound-guided vascular access, many institutions have adopted ultrasound-guidance as the standard of care for femoral access. However, there is a paucity of randomized data to understand the role of ultrasound in improving the safety of coronary procedures via femoral access.
  • In the UNIVERSAL study, patients randomized to ultrasound-guided femoral access did not experience a reduction in major bleeding or vascular complications at 30 days; however, ultrasound guidance did improve first attempt success and reduce the number of attempts and accidental venipuncture.

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PADN-CFDA: Pulmonary artery denervation in addition to PDE-5i therapy improves exercise capacity in patients with pulmonary arterial hypertension

Key Points:

  • Pulmonary artery denervation (PADN) has never been studied with a randomized trial in the treatment of pulmonary arterial hypertension (PAH). The PADN-CFDA study was a sham-control randomized trial conducted in China evaluating PADN in addition to phosphodiesterase inhibitor (PDE-5i) therapy in patients with PAH compared to PDEi therapy with a sham procedure.
  • In the primary analysis, PADN with PDE-5i therapy resulted in substantial increase in 6-minute walk distance (a measure of exercise capacity) at 6 months. PADN also reduced PVR, NT-pro BNP, and mPAP, as well as improved echocardiographic measures of RV function compared to sham treatment.

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RADIANCE II: Endovascular ultrasound denervation met primary/secondary efficacy BP lowering endpoints at 2 months

Key Points:

  • Endovascular ultrasound denervation (uRDN) is a potentially useful technique in the management of hypertension; however, its effect in patients with mild to moderate HTN has not been well studied. The RADIANCE II study was a sham-controlled RCT aimed at determining the efficacy and safety of uRDN on patients with mild-moderate HTN.
  • uRDN resulted in substantial reductions in daytime ambulatory sBP compared to sham and led to a higher percentage of time spent in therapeutic BP range.
  • uRDN was a safe procedure, with no major adverse events at 30 days.

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Amulet IDE: Continued safety and effectiveness of the Amulet LAA occluder device at three years in patients with nonvalvular atrial fibrillation

Key Points:

  • In 2021, the Amulet IDE study demonstrated that the novel Amulet left atrial appendage occluder device was noninferior to the standard Watchman device for stroke prevention in patients with nonvalvular atrial fibrillation. The study investigators have now pursued an analysis of the three year outcomes.
  • The Amulet device continued to demonstrate safety and effectiveness through 3 years of follow up.

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CLASP IID: The PASCAL system is a safe and beneficial therapy for severe degenerative mitral regurgitation

Key Points:

  • The MitraClip system has been established as a robust platform for transcatheter repair of both degenerative and functional mitral regurgitation. However, it has not been compared against more novel therapies (such as the PASCAL system). The CLASP IID trial is the first RCT to directly compare two transcatheter valve repair therapies for degenerative MR.
  • The PASCAL system met the primary safety and effectiveness endpoints of this pivotal noninferiority trial. There was a low composite MAE rate (3.4%) at 30 days, and 97.7% of patients achieved sustained reduction of MR (≤ 2+) at 6 months.
  • This trial establishes the PASCAL system as a safe, beneficial therapy for patients with significant symptomatic DMR and prohibitive surgical risk.

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PROTECTED TAVR: No Overall Stroke Reduction With Embolic Protection Devices in TAVR, But Fewer Disabling Strokes

Key Points:

  • Stroke is a feared complication of TAVR. However, the potential impact of cerebral embolic protection (CEP) devices is unclear. The PROTECTED TAVR study was a post-market RCT to examine the utility of CEP devices in TAVR patients across all risk categories.
  • CEP device use did not result in a significant difference in all strokes at 72 hours or discharge, but it did reduce the rate of disabling strokes in secondary analysis.
  • CEP device use was safe, with no difference in the safety composite of all-cause mortality and stroke and only a 0.1% risk of vascular complication related to CEP.

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Stem Cells Did Not Decrease Heart Failure Readmissions in DREAM-HF

Key Points:

  • In the DREAM-HF study, patients with persistent NYHA II-III HFrEF were treated with transendocardial mesenchymal precursor cells (MPCs) or a sham procedure. The primary outcome was a mean cumulative rate of recurrent non-fatal decompensated HF events. Pre-specified secondary analyses included evaluation of non-fatal MI or non-fatal stroke and cardiac death; post—hoc analyses included time to first event for cardiac death or non-fatal MI/stroke, as well as cardiac death alone, stratified by baseline CRP.
  • Treatment with MPCs did not reduce the primary endpoint, but MPC administration did significantly reduce non-fatal MI or non-fatal stroke, cardiac death in NYHA II but not III patients, and a composite of cardiac death, non-fatal-MI, and non-fatal stroke (which appeared to be largely driven by patients with elevated baseline CRP).

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EMPULSE: Empagliflozin improves outcomes in all Heart Failure admissions

Key Points:

  • In the EMPULSE study, patients admitted with acute HF of any ejection fraction with or without diabetes were treated with either empagliflozin or placebo. The primary outcome was 90-day clinical benefit determined by a stratified “win ratio,” which included a comparison of death, HF events, time to first HF event, and change in baseline Kansas City Cardiomyopathy Questionnaire Total Summary Score (KCCQ). Secondary analyses included change in KCCQ from baseline, subgroup analyses of the primary endpoint by clinical characteristics including diabetes, and individual outcome components of the primary endpoint.
  • Treatment with empagliflozin resulted in a reduction in the primary outcome, as well as a significant reduction in time to all-cause death or HF events. There was also a significant improvement in KCCQ score. The primary outcome was similar in patients with or without diabetes.

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