Coronary artery disease and heart failure: Late-breaking trials presented at American Heart Association scientific session 2023

Table 1 Summary of coronary artery disease and heart failure trials from the late-breaking trials presented at the American Heart Association 3 scientific sessions

Trial name	Ref.	Type of study	Sample size	Follow-up duration	Inclusion criteria	Exclusion criteria	Study findings	Study highlights
DAPA-MI	James et al[1]	Randomized control Trial	4017	24 months	NSTEMI or STEMI < 10 days, impaired LV systolic function or q-wave MI, hemodynamically stable	Type 1 or type 2 DM, chronic symptomatic HF with a prior HF hospitalization within the last year and known LVEF ≤ 40%, eGFR) < 20 mL/min/1.73 m2	The primary endpoint for dapagliflozin vs placebo was a win ratio of 1.34, 95%CI 1.20–1.50; P < 0.001b	The DAPA-MI trial indicated that for acute MI patients, without diabetes or chronic heart failure, the use of dapagliflozin results in improved cardiometabolic outcomes while it does not lead to any changes in cardiovascular outcomes
MINT trial	Carson et al[2]	Randomized control trial	3504	30 days	Age ≥ 18 years, STEMI or NSTEMI, Hgb < 10 g/dL	Uncontrolled bleeding requiring blood transfusion, declined transfusion, anticipated cardiac surgery, palliative treatment intent	The primary outcome, composite of all-cause death or recurrent nonfatal MI, for restrictive vs liberal transfusion strategies at 30 days, was: 16.9% vs 14.5%; RR: 1.15, 95%CI: 0.99-1.34; P = 0.07	The MINT trial showed that in patients with acute MI and Hgb < 10 g/dL, a liberal transfusion goal (Hgb ≥ 10 g/dL) was not superior to a restrictive strategy (Hgb 7-8 g/dL) with respect to 30-day all-cause death and recurrent MI
ORBITA-2	Rajkumar et al[5]	Randomized control trial	301	12 weeks	PCI eligible, had angina or angina equivalents, had anatomical evidence of at least one severe coronary stenosis that was identified on invasive diagnostic coronary angiography or CCTA, had evidence of ischemia on the basis of noninvasive imaging or invasive coronary physiological test	Age < 18 years and age > 85 years, recent ACS, Previous CABG, significant left main stem CAD, chronic total occlusion in the target vessel, contraindication to PCI or drug-eluting stent implantation, contraindication to antiplatelet therapy, severe valvular disease, severe LV dysfunction, severe respiratory disease, life expectancy < 2 years, pregnancy	The primary outcome, mean angina symptom score for PCI vs placebo, was: 2.9 vs 5.6, OR: 2.21, 95%CI: 1.41-3.47; P < 0.001b. Mean daily angina frequency: 0.3 vs 0.7 (OR: 3.44, 95%CI: 2.00-5.91)	The ORBITA-2 trial showed that among patients with stable angina on little or no antianginal therapy, PCI results in greater improvements in anginal frequency and exercise times compared with a sham procedure
ARIES-HM3	Mehra et al[10]	Randomized control trial	628	24 months	Age ≥ 18 years, first durable LVAD implantation with HM3 for an approved indication per local guidelines	Additional MCS in addition to HM3, alternative indication or contraindication for antiplatelet therapy, inability to take oral medications through day 7 postoperatively, aspirin allergy	The primary outcome, survival free from nonsurgical hemocompatibility-related adverse event (i.e., stroke, pump thrombosis, major bleeding, or arterial thromboembolism > 14 days post-implant), for placebo vs aspirin at 1 year, was: 74.2 vs 68.1 events per 100 patient-years (P for noninferiority < 0.0001b)	The ARIES-HM3 trial demonstrated that for patients with advanced heart failure treated with a HeartMate 3 LVAD and anticoagulated with a vitamin K antagonist, aspirin did not surpass placebo in terms of the combined incidence of bleeding and clotting events after one year
TEAMMATE	Almond et al[11]	Randomized control trial	211	30 months	Cardiac transplantation at age ≤ 21 years, ≥ 6 months after heart transplantation, stable immunosuppression	Recurrent rejection/graft dysfunction, steroid dose > 0.1 mg/kg/day eGFR < 30 mL/min/1.73 m2, active infection or wound healing problem, severe hyperlipidemia or proteinuria	The co-primary outcomes, median MATE-6 score at 30 months, was 1.96 in everolimus group vs 2.18 in tacrolimus group, median MATE-3 score at 30 months, was 0.93 in everolimus group vs 1.25 in tacrolimus group (P = NS)	The TEAMMATE trial showed that everolimus + low-dose tacrolimus is safe in children and young adults when given ≥ 6 months after cardiac transplantation
POCKET-COST-HF	Montembeau et al[12]	Randomized control trial	247	-	LVEF ≤ 40%		The primary outcome, which was cost-informed decision-making, defined as the clinician or patient mentioning costs of HFrEF medication, occurred in 49% of encounters with the checklist only control group compared with 68% of encounters in the OOP cost group (P = 0.021a)	Providing detailed cost information had notable effect on discussions about costs during medical appointments for patients with HFrEF

^aP < 0.05.

^bP < 0.001.

NSTEMI: Non-ST segment elevation myocardial infarction; STEMI: Segment elevation myocardial infarction; PCI: Percutaneous coronary intervention; CCTA: Coronary computed tomography angiography; ACS: Acute coronary syndrome; CABG: Coronary artery bypass graft; HF: Heart failure; LVEF: Left ventricular ejection fraction; eGFR: Estimated glomerular filtration rate; DM: Diabetes mellitus; MI: Myocardial infarction; LVAD: Left ventricular assist device; VKA: Vitamin K antagonist; MATE: Major adverse transplant event; HFrEF: Heart failure with reduced ejection fraction; OOP: Out-of-pocket; MCS: Mechanical circulatory support.