- 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 MACE 6.9% vs 7.1% (HR 0.98, noninferiority p=0.0008). 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 (24% vs 26% composite endpoint, HR 0.89) with significantly less major bleeding (6% vs 15%). 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 (4.0% vs 10.3%; RR 0.39, 95% CI 0.20-0.77, P=0.005) 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 (5.7% vs 4.8% composite CV death/stroke/embolism at 3 years) and statistically superior for safety, with 43% less non-procedural major bleeding (10.9% vs 19.0%). Net clinical benefit favored the device (15.1% vs 21.8%).
— 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 (30.8% vs 31.9%, NS) in anterior STEMI without shock. Device-related bleeding/vascular complications were significantly higher (34% vs 6%).
— Acute MI - VESALIUS-CV: Evolocumab vs Placebo in Patients With Atherosclerosis or Diabetes Without Prior MI or Stroke
Evolocumab reduced 3-point MACE 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 45 mg/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 <55 mg/dL vs <70 mg/dL reduced major CV events by 33% at 3 years (6.6% vs 9.7%) in ASCVD patients. CV death/MI/stroke was also significantly lower (2.3% vs 3.6%). 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 (5.7 vs 2.3 mm Hg reduction) and LDL-C by 6.2 mg/dL more (8.0 vs 1.8 mg/dL) 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 (p<0.0001) but did NOT reduce office systolic BP more than single dose at Week 20 (both ~6.7 mmHg, p=0.97). 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 MACE 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 (win ratio 0.85, p=0.30) and was associated with HIGHER all-cause mortality (32.6% vs 23.4%, HR 1.54) and CV death (26.7% vs 14.5%).
— Interventional - SCOUT-HCM: Mavacamten in Symptomatic Adolescents With Obstructive Hypertrophic Cardiomyopathy
Mavacamten reduced LVOT gradient by 48.0 mmHg more than placebo (p<0.0001) 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 significantly reduced pulmonary vascular resistance in HFpEF with CpcPH (0.3 mg/kg: -0.67 Wood units, p=0.004; 0.7 mg/kg: -0.33, p=0.024 vs +0.26 placebo). 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 significantly reduce HF hospitalizations or CV death in HFpEF/HFmrEF (12.7 vs 10.8 events per 100 patient-years). 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 (14% vs 23%). 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 (4.9% vs 5.0%) with the lowest stroke rates in a trial of this size (2% vs 2.1%). 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 (5.3% vs 20.8%, HR 0.23, p=0.005). 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 (60-64%), olezarsen did NOT reduce noncalcified coronary plaque volume vs placebo at 12 months (p=0.36). 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 (1%) 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