The European Society of Cardiology (ESC) 2021 occurred virtually this year from 27-30 August. Here is our curated list of the top 10 highlights of ESC 2021.
EMPEROR-Preserved trial1 (NCT03057951): This phase 3 trial randomized 5988 adults with chronic heart failure (HF) with preserved ejection fraction (HFpEF) to take either sodium-glucose cotransporter 2 inhibitor empagliflozin (n=2997) or a placebo (n=2997) over a median of 26.2 months. The primary outcome was a composite of time to cardiovascular (CV) death or hospitalization for HF. In the empagliflozin group, a primary outcome occurred in 415 (13.8%) participants, as compared with 511 (17.1%) in the placebo group (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.69-0.90; p<0.001). The reduced risk of hospitalization or death seen in the empagliflozin group was maintained in patients both with and without diabetes.
The prespecified EMPEROR-Pooled2 analysis pooled results of the 9718 participants who had been followed in EMPEROR-Preserved and the EMPEROR-Reduced (NCT03057977) trials. Both trials used nearly identical protocols to assess the efficacy of empagliflozin versus placebo in patients with heart failure. The only major difference between the trials was the ejection fraction associated with the HF: ≤ 40% in EMPERIOR-Reduced, and >40% in EMPEROR-Preserved. Both trials used the same primary outcome measure (time to CV death, or hospitalization for HF). The risk of hospitalization for HF was reduced by about 30% in patients taking empagliflozin in both groups. Major renal outcomes were also reduced with the use of empagliflozin in EMPEROR-Reduced.
The STOPDAPT-2 ACS3 trial (NCT03462498) investigated if the duration of dual antiplatelet therapy (DAPT) could be safely reduced in patients with acute coronary syndrome (ACS) who had undergone percutaneous coronary intervention (PCI). Patients were randomized to receive either 1 month of DAPT followed by 11 months of clopidogrel monotherapy (n=2078) or the standard 12 months of DAPT with aspirin and clopidogrel (n=2078). The primary endpoint, a composite of major ischemic or bleeding events, for 1-month vs. 12-month DAPT, was 3.2% vs. 2.8% (hazard ratio [HR] 1.14, 95% CI 0.80-1.62, p for noninferiority = 0.06). Although there was a reduction in major bleeds, there a significant increase in cardiovascular events. Investigators concluded that one-month DAPT followed by clopidogrel monotherapy did not demonstrate noninferiority as compared with standard 12-month DAPT in post-PCI ACS patients.
TWILIGHT-HBR4 (NCT02270242) was a phase 4 study which compared the use of ticagrelor alone with ticagrelor used in combination with aspirin in >7119 patients deemed to be at high risk for an ischemic or bleeding event following PCI. Patients were randomized to receive either 15 months of continuous DAPT or 3 months of DAPT followed by 12 months of ticagrelor monotherapy. At 12 months, there were fewer bleeds in the group who had undergone the shorter DAPT period than in the group on continuous DAPT. The rate of ischemic events met noninferiority criteria.
The Phase 4 TOMAHAWK5trial (NCT02750462) compared 30-day rates of all-cause mortality in 558 patients who had experienced an out-of-hospital cardiac arrest (OHCA) without ST-segment elevation. Patients were randomized to undergo either immediate angiography or further diagnostic testing, followed by angiography if indicated (“delayed” or “selective” angiography). There was no benefit of immediate angiography over delayed angiography. The composite of death or severe neurological deficit occurred more frequently in those who had received immediate angiography.
ENVISAGE-TAVI AF6 (NCT02943785) was a phase 3 trial which compared outcomes in patients receiving (direct oral anticoagulant [DOAC]) edoxaban with patients receiving a vitamin K antagonist (VKA) following transcatheter atrial valve replacement (TAVR). The trial followed 1426 patients (713 in each group) over a 36 month time frame, the majority of whom had atrial fibrillation (AF) prior to TAVR. Edoxaban was deemed non-inferior to VKA therapy with respect to the adverse event primary outcome (a composite of all-cause death, myocardial infarction, ischemic stroke, systemic embolic events, and valve thrombosis). However, edoxaban did not meet the criteria for non-inferiority with respect to the co-primary outcome of major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH). More bleeds occurred in patients taking edoxaban, a finding driven primarily by gastrointestinal bleeds.
The RIPCORD 2 trial7 (NCT02892903) explored if routine pressure wire assessment (fractional-flow reserve [FFR]) measurement at the time of coronary angiography would affect hospital costs at one year or patient reported quality of life outcomes. Investigators found that neither hospital costs were reduced, nor were quality of life outcomes improved.
MASTER DAPT8 (NCT03023020) aimed to clarify optimal duration of DAPT in high bleeding risk (HBR) patients following stent implantation. Following 1 month of post PCI DAPT, patients either discontinued DAPT, or continued for at least another 2 months. At 1 year post PCI, the shortened DAPT regimen was deemed noninferior to continuation of DAPT for at least 3 months, in terms of net adverse clinical advents and major adverse cardiac or cerebral events. Furthermore, fewer bleeding events occurred in the abbreviated DAPT group. Investigators noted that their trial specifically used the Ultimaster (Terumo) bioresorbable polymer stent, and cautioned that these results may not be generalizable to other stents.
ACST-29 (NCT00883402), was the largest trial to date that compared carotid artery stenting (CAS) with carotid endarterectomy (CEA). The study randomized 3625 asymptomatic patients with severe unilateral or bilateral carotid stenosis to undergo either CAS (n=1811) or CEA (n=1814). The primary outcome measures were procedural risks including death, MI, or stroke at 30 days, and non-procedural strokes at 5 years. While there was a slightly increased risk of periprocedural stroke in the stenting arm, long term outcomes between the groups were similar.
The STEP trial10 (NCT03015311) randomized 8511 elderly patients with hypertension to undergo intensive blood pressure management (n=4243) or standard blood pressure management (n=4268). Targeting a blood pressure of 110 to <130 mmHg was defined as intensive while targeting a blood pressure of 130 to <150 mm Hg was defined as standard. After a median follow-up of 3.3 years, fewer cardiovascular events had occurred in the group undergoing intensive management than in the group undergoing standard management.
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Author: Kelly Schoonderwoerd
- Presented by Dr. Stefan Anker at ESC Congress 2021, 27-30 August 2021. Publication of EMPEROR-Preserved trial results: Anker SD, et al. N Engl J Med. 2021.
- Presented by Dr. Milton Packer at ESC Congress 2021, 27-30 August 2021. Publication of EMPEROR-Pooled analysis results: Packer M, et al. N Engl J Med. 2021.
- Presented by Dr. Hirotoshi Watanabe at ESC Congress 2021, 27-30 August 2021.
- Presented by Dr. Davide Cao at ESC Congress 2021, 27-30 August 2021.
- Presented by Dr. Steffen Desch at ESC Congress 2021, 27-30 August 2021. Publication of TOMAHAWK trial results: Desch S, et al. N Engl J Med. 2021.
- Presented by Dr. George Dangas at ESC Congress 2021, 27-30 August 2021. Publication of ENVISAGE-TAVI AF results: Van Mieghem NM, et al. N Engl J Med. 2021.
- Presented by Dr. Nicholas Curzen at ESC Congress 2021, 27-30 August 2021.
- Presented by Dr. Marco Valgimigli at ESC Congress 2021, 27-30 August 2021. Publication of MASTER DAPT trials results: Valgimigli M, et al. N Engl J Med. 2021.
- Presented by Alison Halliday at ESC Congress 2021, 27-30 August 2021. Publication of ACST-2 trial results: Halliday A, et al. Lancet. 2021.
- Presented by Jun Cai at ESC Congress 2021, 27-30 August 2021. Publication of STEP trial results: Zhang et al. N Engl J Med. 2021.