ACC 2023 Highlights

The American College of Cardiology (ACC) Annual Scientific Session, in conjunction with the World Congress of Cardiology (ACC.23/WCC), convened in New Orleans, LA, from March 4-6, 2023. Here is the curated list of the top highlights from the ACC.23/WCC.

BIOVASC¹: The BIOVASC study (NCT03621501) results indicated that immediate complete revascularization (CR) was non-inferior to staged CR in patients with acute coronary syndrome (ACS). The primary composite outcome included all-cause mortality, myocardial infarction (MI), unplanned ischemia-driven revascularization (IDR), or cerebrovascular events (CVEs) at 1 year; the composite occurred in 7.6% of patients in the immediate CR vs. 9.4% of patients in the staged CR (p_{non-inferiroity}=0.0011). Immediate CR was also associated with a reduction in MI and unplanned IDR.

UK Mini-Mitral Trial²: This trial (ISRCTN13930454) compared minimally invasive, thoracoscopically guided mini-thoracotomy (mini-mitral valve [MV] repair) vs. conventional sternotomy for MV repair. The primary composite outcome, change in physical function at 12 weeks from baseline, was not statistically different for mini-MV repair vs. sternotomy (p=0.61). Scores for mini-MV repair increased significantly from baseline to 6 weeks, but not for conventional sternotomy. Clinical outcomes were similar up to 1 year of follow-up.

REVIVED-BCIS2^3,4: The REVIVED-BCIS2 trial (NCT01920048) showed that percutaneous coronary intervention (PCI) offered no clinical advantage vs. optimal medical therapy (OMT) in patients with left-ventricular (LV) systolic dysfunction and extensive coronary artery disease (CAD).³ Primary outcomes (all-cause mortality or hospitalization for heart failure [HF]) occurred in 37.2% (PCI group) vs. 38.0% (OMT group; p=0.96).³ Secondary analysis of trial results⁴ showed viability testing for ‘hibernating’ myocardium was not a good predictor of clinical outcomes/risks; however, total myocardial scar burden was a potent one.

EVOLUT⁵: The EVOLUT trial (NCT02701283) investigated low-surgical–risk patients undergoing transcatheter aortic valve replacement (TAVR) randomized to TAVR+supra-annular valve or to standard-of-care (SoC) TAVR surgery. At 3 years, results showed the primary endpoint of all-cause mortality or disabling stroke occurred in 7.4% (TAVR) vs. 10.4% (surgery; p=0.051), with differences between treatment arms remaining broadly consistent over time (1.8% [year 1]; 2.0% [year 2]; 2.9% [year 3]). The TAVR+valve patients demonstrated significantly improved valve hemodynamics (p<0.001) and showed durable benefits compared to SoC TAVR surgery.

BETTER CARE-HF⁶: The BETTER CARE-HF (NCT05275920) trial explored how automated, patient-specific, electronic health record (EHR)-embedded alerts could increase mineralocorticoid receptor antagonists (MRA) prescriptions for patients with HF with reduced EF (HFrEF). Compared to general EHR-embedded messages or to usual SoC (no alerts), the specific-EHR–embedded alerts more than doubled MRA prescriptions. The number pf patients needed to alert (NNTA) to result in new MRA prescription was 5.6, whereas the NNTA for a message was 25.6.

PULSED AF⁷: The PULSED-AF trial (NCT041987010) showed that pulsed-field ablation (PFA), using a novel irreversible electroporation energy technology, offered a lower rate of primary safety adverse events (AEs; 0.7%) vs. SoC ablation technologies in patients with paroxysmal or persistent atrial fibrillation (AF). The primary efficacy composite (acute procedural failure, arrhythmia recurrence, etc.) exceeded performance goals: 66.2% (paroxysmal AF) and 55.1% (persistent AF). PFA may provide shorter, safer procedures, with similar efficacy to established ablation technologies.

BMAD⁸: The BMAD trial (NCT03476187) examined whether a wearable sensor detecting fluid build-up in the lungs could aid patients with HF avoid re-hospitalization (within 90 days). Patients wearing the device experienced a relative risk reduction (RR) of 38% compared to control arm (p=0.03). Absolute RR was 7% at 90 days, with NNT was 14.3. Furthermore, quality of life (QoL) improved significantly in the intervention arm vs. the control group (p=0.004).

ACCESS^9,10: The randomized, 2×2 factorial, ACCESS trial (NCT02579655) studied two distinct interventions, a value-based formulary eliminating copayments⁹ and a comprehensive patient education (and support) program.¹⁰ The incidence rate ratio (IRR) for the copayment-elimination primary outcome was not significantly reduced (521 vs. 533 events; IRR 0.84, p=0.162); however, the tailored SMES program did reduce modestly the rate of clinical outcomes vs. usual care (IRR 0.78, p=0.047). Overall health costs were not reduced in either intervention.

COAPT¹¹: Five-year data from the COAPT trial (NCT01626079) showed benefits of transcatheter edge-to-edge repair (TEER) over OMT in patients with severe mitral regurgitation (MR) and HF. Primary endpoint (all hospitalizations for HF) revealed the annualized rate of hospitalizations was 33.1% vs. 57.2% (hazard ratio [HR], 0.53). All-cause mortality (5 years) was 57.3% vs. 67.2% (HR, 0.72). Results show TEER continues to be safe with fewer hospitalizations vs. OMT; however, to date, 73.6% and 91.5% (respectively) of patients with HF have been hospitalized or have died.

RENOVATE-COMPLEX-PCI^12,13: The RENOVATE-COMPLEX-PCI trial (NCT03381872) ­­investigated the use of intravascular imaging (IVI; optical coherence imaging [OCT]; intravascular ultrasound [IVUS]) to guide complex PCI vs. conventional angiography. After a median follow-up of 2.1 years, in patients with complex CAD undergoing PCI, the use of either imaging modality lowered risk of cardiac death, target-vessel MI, or clinically driven revascularization by 36% vs. angiography-guided PCI. No apparent between-group differences were found in procedure-related safety events.

CLEAR Outcomes¹⁴: The CLEAR Outcomes trial (NCT02993406) sought to study treating high-risk patients unable to tolerate statins with bempedoic acid. In the latest update, incidence of the primary composite endpoint (major adverse cardiovascular events [MACE]) was significantly lower with bempedoic acid vs. placebo: 13.3% vs. 11.7%, respectively (HR, 0.87%, p=0.004). Bempedoic acid reduced mean low-density lipoprotein cholesterol (LDL-C) by 21.1% vs. placebo. Incidences of gout and cholelithiasis were higher than with placebo, with slight increases in serum creatinine, uric acid and hepatic-enzyme levels noted.

TRILUMINATE¹⁵: The TRILUMINATE pivotal trial (NCT03904147) investigated the safety and effectiveness of TEER using the TriClip® (Abbott) vs. medical therapy for patients with symptomatic severe tricuspid regurgitation (TR). At 1 year, the primary composite outcome (all-cause death or tricuspid valve [TV] surgery, hospitalization for HF, improvement in QoL) favoured TEER vs. control arm (win ratio, 1.48, p=0.02). QoL in the TEER arm increased significantly vs. control arm (12.3 points vs. 0.6, p<0.001). At 30 days, TR graded moderate or less improved considerably in the TEER group vs control arm (87.0% vs. 4.8%, p<0.001), with only 1.7% of patients who underwent the procedure experiencing any major AEs.

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References:

1. Diletti R et al. The Lancet 5 March 2023.
2. Presented by Dr. Enoch Akowuah at the American College of Cardiology Annual Scientific Session (ACC.23/WCC), New Orleans, LA, 5 March 2023.
3. Presented by Dr. Divaka Perera at the ACC.23/WCC, New Orleans, LA, 4 March 2023.
4. Perera D, Clayton T, O’Kane PD, Greenwood JP, Weerackody R, Ryan M, et al. N Eng J Med. 2022;387:1351-1360.
5. Forrest JK et al. Journal of the American College of Cardiology 5 March 2023.
6. Mukhopadhyay A et al. Journal of the American College of Cardiology 5 March 2023.
7. Verma A et al. Circulation 6 March 2023.
8. Presented by Dr. John P Boehmer at the ACC.23/WCC, New Orleans, LA 6 March 2023.
9. Campbell DJT et at. Circulation 5 March 2023.
10. Campbell DJT et al. Circulation 5 March 2023.
11. Stone GW et al. The New England Journal of Medicine 5 March 2023.
12. Presented by Dr. Joo-Yong Hahn at the ACC.23/WCC, New Orleans, LA, 5 March 2023.
13. Lee JM et al. The New England Journal of Medicine 5 March 2023.
14. Nissen SE et al. The New England Journal of Medicine 4 March 2023.
15. Sorajja P et al. The New England Journal of Medicine 4 March 2023.