- ALL-RISE: CathWorks FFRangio vs Invasive Pressure Wire-Based Physiology Assessment for Coronary Revascularization Guidance
FFRangio (AI-based angiography-derived FFR) was noninferior to invasive pressure wire for guiding PCI: 1-year major cardiovascular events. First FDA-approved angiography-derived physiology trial in the US.
- PRO-TAVI: Deferral of Routine PCI in Patients Undergoing Transcatheter Aortic Valve Implantation
Deferring PCI until after TAVI was noninferior to PCI-first with less major bleeding. Only 11% of deferred patients needed subsequent PCI.
- SMART-DECISION: Discontinuation of Beta-Blocker Therapy in Stabilized Patients After Acute Myocardial Infarction
Discontinuing beta-blockers in stable post-MI patients without HF or LV dysfunction was noninferior to continuing treatment — first RCT evidence supporting beta-blocker de-escalation in this population.
- DKCRUSH-VIII: IVUS-Guided vs Angiography-Guided Double Kissing Crush Stenting for Complex Coronary Bifurcation Lesions
IVUS guidance for DK crush stenting in complex bifurcation lesions — results from 556-patient multicenter Chinese trial presented at ACC.26 and published in JACC.
- HI-PEITHO: Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for Acute Pulmonary Embolism
Ultrasound-facilitated catheter-directed fibrinolysis plus anticoagulation reduced the composite of PE-related death, cardiopulmonary decompensation, or symptomatic recurrence by 61% vs anticoagulation alone with no increase in major bleeding.
— Pulmonary Embolism - CHAMPION-AF: Left Atrial Appendage Closure vs NOACs as First-Line Therapy for Stroke Risk Reduction in Atrial Fibrillation
WATCHMAN FLX LAAC was non-inferior to NOACs for stroke prevention and superior for safety, with 43% less non-procedural major bleeding. Net clinical benefit favored the device.
— Atrial Fibrillation - STEMI-DTU: Left Ventricular Unloading Before Reperfusion in Anterior STEMI Without Cardiogenic Shock
LV unloading with Impella CP for 30 min before PCI did NOT reduce infarct size vs immediate PCI in anterior STEMI without shock. Device-related bleeding/vascular complications were higher.
— Acute MI - VESALIUS-CV: Evolocumab vs Placebo in Patients With Atherosclerosis or Diabetes Without Prior MI or Stroke
Evolocumab reduced 3-point major cardiovascular events by 25% vs placebo in patients with ASCVD or diabetes but no prior MI/stroke (first demonstration of PCSK9 inhibitor benefit in primary prevention). Heart attack risk reduced 36%. LDL-C reduced 55% to median /dL.
— Lipid / Prevention - Intensive LDL-C Targeting in ASCVD: Intensive vs Conventional LDL-C Targeting in Patients With Atherosclerotic Cardiovascular Disease (Ez-PAVE)
Targeting LDL-C </dL vs </dL reduced major CV events by 33% at 3 years in ASCVD patients. CV death/MI/stroke was also lower. First randomized head-to-head comparison of LDL-C targets.
— Lipid / Prevention - GoFreshRx: Home-Delivered DASH Groceries and Effects on Blood Pressure and LDL-C in Black Adults With Hypertension
Home-delivered DASH groceries reduced systolic BP by 3.4 mm Hg more than grocery stipends and LDL-C by /dL more in Black adults in food deserts. Benefits did not persist after intervention ended.
— Hypertension - Kardinal: Phase 2 Study of Tonlamarsen, an Antisense Oligonucleotide Targeting Angiotensinogen, in Uncontrolled Hypertension
Tonlamarsen achieved 67% reduction in plasma angiotensinogen but did NOT reduce office systolic BP more than single dose at Week 20. Intriguingly, BP effects persisted after dosing stopped. Phase 2b trial in acute severe hypertension planned.
— Hypertension - FAST III: Angiography-Based vFFR vs Invasive Pressure Wire-Based FFR for Guiding Coronary Revascularization
Angiography-based vFFR was noninferior to pressure wire-based FFR for guiding coronary revascularization: identical 1-year major cardiovascular events rates with shorter procedures, less radiation, and less contrast.
— Interventional - ORBITA-CTO: Percutaneous Coronary Intervention for Chronic Total Occlusion: A Randomized Placebo-Controlled Trial
CTO PCI significantly reduced angina symptoms vs sham procedure in the first placebo-controlled CTO trial: 31 more angina-free days over 168 days, with improved quality of life scores. No deaths, MIs, or withdrawals.
— Interventional - CHIP-BCIS3: Percutaneous Left Ventricular Unloading During High-Risk Coronary Intervention in Patients With Severe LV Dysfunction
LV unloading with Impella CP during complex PCI did NOT reduce adverse events in severe LV dysfunction and was associated with HIGHER all-cause mortality and CV death.
— Interventional - SCOUT-HCM: Mavacamten in Symptomatic Adolescents With Obstructive Hypertrophic Cardiomyopathy
Mavacamten reduced LVOT gradient by 48.0 mmHg more than placebo in adolescent oHCM — first positive Phase 3 trial extending mavacamten to patients ages 12-17. Consistent efficacy across all secondary endpoints with favorable safety.
— Heart Failure - Lung Impedance-Guided HFpEF Therapy: Non-Invasive Lung Impedance-Guided Preemptive Treatment in Heart Failure With Preserved Ejection Fraction
Lung impedance-guided therapy reduced HF hospitalizations by 74% and HF mortality by 74% in HFpEF over 3+ years. Clinicians adjusted medications 2x more frequently with earlier intervention at the preclinical stage.
— Heart Failure - CADENCE: Sotatercept in Combined Post- and Precapillary Pulmonary Hypertension With Heart Failure and Preserved Ejection Fraction
Sotatercept reduced pulmonary vascular resistance in HFpEF with CpcPH. Time to clinical worsening reduced 82%.
— Heart Failure - Spironolactone in Heart Failure: Spironolactone in Heart Failure With Preserved or Mildly Reduced Ejection Fraction (SPIRIT-HF)
Spironolactone did NOT reduce HF hospitalizations or CV death in HFpEF/HFmrEF. Unexpected increase in total hospitalizations, hypotension, and renal dysfunction in the spironolactone group.
— Heart Failure - TRI-FR (2-Year): Transcatheter Tricuspid Edge-to-Edge Repair vs Medical Therapy for Severe Tricuspid Regurgitation: 2-Year Outcomes
T-TEER for severe TR reduced the primary endpoint from 35% to 20% at 2 years, with 40% fewer HF hospitalizations. No crossover in the control group — first unconfounded long-term T-TEER outcomes.
— Valvular - PROTECT: Emboliner vs Sentinel Cerebral Embolic Protection Devices During TAVR (PROTECT H2H)
Emboliner was noninferior to Sentinel for 30-day MACCE during TAVR with the lowest stroke rates in a trial of this size. Emboliner captured 3x more large debris particles.
— Valvular - SURVIV: Transcatheter Mitral Valve-in-Valve vs Redo Mitral Valve Replacement for Failed Bioprosthetic Valves
Transcatheter mVIV reduced death/disabling stroke by 77% vs redo surgery at 1 year. Zero CV deaths at 30 days with mVIV vs 12.5% with surgery. First randomized comparison of mVIV vs rMVR.
— Valvular - ESSENCE-TIMI 73b: Effect of Olezarsen on Noncalcified Coronary Plaque Volume: The ESSENCE-TIMI 73b Coronary CTA Substudy
Despite dramatic triglyceride reduction, olezarsen did NOT reduce noncalcified coronary plaque volume vs placebo at 12 months. Neutral imaging results despite robust lipid changes.
— Lipid / Prevention - Digoxin in Rheumatic Heart Disease: Digoxin and Clinical Outcomes in Rheumatic Heart Disease (Dig-RHD)
Digoxin reduced the composite of death or new/worsening HF by 18% in rheumatic heart disease — first randomized trial of digoxin in RHD. Toxicity was rare with no related deaths.
— Heart Failure - OPTIMAL: OPTIMAL Trial — ACC.26 Late-Breaking Clinical Trial
Late-breaking results from the OPTIMAL trial presented at ACC.26 — published in NEJM.
— Interventional - IVUS CHIP: Intravascular Ultrasound-Guided vs Angiography-Guided PCI in Complex Coronary Lesions
IVUS-guided PCI in complex coronary lesions — results from a landmark European multicenter trial presented at ACC.26 and published in NEJM.
— Interventional - SirPAD: Sirolimus-Coated Balloon vs Uncoated Balloon Angioplasty for Peripheral Arterial Disease
Results from the world's largest sirolimus-coated balloon trial in peripheral artery disease (N>1,250) were presented at ACC.26 and published in NEJM.
— Interventional - THRIVE Pilot: THRIVE Pilot Trial — ACC.26 Late-Breaking Clinical Trial
Late-breaking results from the THRIVE Pilot trial presented at ACC.26.
— Hypertension
