Table 1 Main trials presented during the 2020 Virtual European Society of Cardiology Congress

EMPEROR-Reduced

Packer et al. [23]

Randomized, double-blind, parallel-group, placebo-controlled, event-driven trial

Chronic HF (NYHA class II-IV) with LVEF ≤ 40% (> 70% of patients with LVEF ≤ 30%) receiving appropriate treatment for HF

3730 patients

1863 assigned to empagliflozin 10 mg daily

1867 assigned to placebo

Empagliflozin reduced the primary endpoint (composite of CV death and HHF) by 25% compared with placebo (HR 0.75, 95% CI 0.65–0.86, p < 0.001), especially driven by a reduction in HHF (HR 0.75, 95% CI 0.65–0.86, p < 0.001)

Empagliflozin also reduced the total number of HHF patients (HR 0.70, 95% CI 0.58–0.85, p < 0.001) and decreased the decline in eGFR during treatment period (1.73 mL/min/1.73 m²/year [95% CI 1.10–2.37, p < 0.001]) compared with placebo

PARALLAX

Pieske et al. [14]

Randomized, active-controlled, parallel trial

Chronic HF (NYHA II-IV) with LVEF > 40% receiving appropriate treatment for HF and elevated NT-proBNP at screening

2572 patients

1286 assigned to sacubitril/valsartan (1281 for full analysis)

1286 assigned to IMT (1285 for full analysis)

Sacubitril/valsartan reduced one of the first primary co-outcome—NT-proBNP change from baseline to week 12—compared with IMT (AGMR 0.84, 95% CI 0.80–0.88) p < 0.0001). However, the other primary co-outcome—6MWT change from baseline to week 24—was not met when comparing sacubitril/valsartan to IMT (AMD − 2.5, 95% CI − 8.53 to 3.53, p = 0.24)

Among secondary outcomes, sacubitril/valsartan slowed eGFR decrease compared with IMT (− 1.47 ml/min/1.73 m² vs. − 2.57 ml/min/1.73 m², p = 0.016) and reduced death due to cardiac failure or HHF (HR 0.64, 95% CI 0.42–0.97, p = 0.034)

HOME-PE

Roy et al. [15]

Randomized, controlled, parallel, open-label trial

Patients with PE followed for 90 days

1970 patients

984 assigned to HESTIA group

986 assigned to sPESI group

The HESTIA rule was non-inferior to the sPESI score with respect to the primary composite outcome of all-cause death, recurrent VTE, or major bleeding at 30 days (3.8% vs. 3.6%, p for non-inferiority = 0.005)

The two strategies showed no differences in the proportion of patients treated at home or early discharged (38.4% for HESTIA group vs. 36.6% for PESI group, p for superiority = 0.41)

HESTIA rule identified less patients as eligible for outpatient management compared with sPESI score (39.4% vs. 48.4%), but it did better for those patients treated as outpatients among eligible patients (88.4% vs. 64.8%)

COLCOT

Bouabdallaoui et al. [17]

Randomized, double-blind trial

Patients with MI within the last 30 days

4745 patients

2366 assigned to colchicine 0.5 mg once daily

2379 assigned to placebo

Among patients who suffered a recent MI, low-dose colchicine was effective at reducing MACEs (CV death, MI, stroke, resuscitated cardiac arrest, or urgent hospitalization for UA leading to revascularization) which occurred in 5.5% of the colchicine group compared with 7.1% of the placebo group (HR 0.77, 95% CI 0.61–0.96, p = 0.02). Nevertheless, higher non-CV mortality with colchicine was noted

EVAPORATE

Budoff et al. [19]

Randomized, double-blind, placebo-controlled trial

Patients with angiographic CAD on statins

80 patients

40 assigned to icosapent ethyl 4 g/day

40 assigned to placebo

Icosapent ethyl reduced the primary endpoint—LAP volume at 18 months—compared with placebo (− 0.3 vs. 0.9 mm³, p = 0.006)

LoDoCo 2

Nidorf et al. [21]

Randomized, placebo-controlled trial

Patients with CHD

5522 patients

2761 assigned to colchicine 0.5 once daily

2761 assigned to placebo

Colchicine improved CV outcomes among patients with CCD compared with placebo during 1 month follow-up. Colchicine prevented CV death, MI, stroke, ischemia-driven revascularization when compared to placebo (6.8% vs. 9.6%; HR 0.69, 95% CI 0.57–0.83, p < 0.001).Nevertheless, higher non-CV mortality with colchicine was noted

COPS

Tong et al. [24]

Randomized, double-blind, placebo-controlled trial

Patients with ACS on statins

795 patients

396 assigned to colchicine 0.5 twice daily for 1 month, then 0.5 mg once daily for 11 months

399 assigned to placebo

Colchicine did not improve CV outcomes (death from any cause, ACS, ischemia-driven urgent revascularization and non-cardioembolic ischemic stroke) compared with placebo in patients with ACS after 1 year (6.1% vs. 9.5%, p = 0.09). Nevertheless, higher non-CV mortality with colchicine was noted

BRACE-CORONA

Renato et al. [13]

Randomized, parallel trial

Patients with COVID-19 and ACE-is/ARBs

659 patients

334 stopping ACE-is/ARBS

325 continuing ACE-is/ARBs

Suspending ACE-Is/ARBs compared with continuing them did not improve the days alive and out of the hospital (22.9 days in the continuing ACEI/ARB group vs. 21.9 days in the suspending ACEI/ARB group, p = 0.09)

EXPLORER-HCM

Olivotto et al. [22]

Randomized, double-blind, placebo controlled, parallel trial

Patients with HCM with LVOT gradient ≥ 50 mmHg and NYHA class II-III symptoms

251 patients

123 assigned to mavacamten (starting dose 5 mg) for 30 weeks

128 assigned to placebo for 30 weeks

The primary endpoint (≥ 1.5 mL/kg/min increase in pVO₂ and at least 1 NYHA class reduction or a ≥ 3.0 mL/kg/min pVO₂ increase without NYHA class worsening) was met by 37% of patients on mavacamten versus 17% of those on placebo (difference + 19.4%, 95% CI 8.7–30.1, p = 0.0005)

Secondary endpoints were also met, with patients on mavacamten experiencing reduction in post-exercise LVOT gradient, increase in pVO₂, and improvement in in symptom scores compared with placebo (p < 0.001 for all)

Safety and tolerability were comparable between groups

POPular TAVI

Brouwer et al. [18]

Randomized, open-label, controlled trial

Patients undergoing TAVI without indication for long-term AC

665 patients

331 assigned to aspirin alone for 3 months

334 assigned to aspirin and clopidogrel for 3 months

One co-primary outcome—all bleedings—occurred in 15.1% of patients on aspirin versus 26.6% of those on aspirin and clopidogrel (RR 0.57, 95% CI 0.42–0.77, p = 0.001). The second co-primary outcome—non-procedure-related bleeding across 12 months—was observed in 15.1% of patients on aspirin versus 24.9% of those on aspirin and clopidogrel (RR 0.61, 95% CI 0.44–0.83, p = 0.005)

Composite secondary endpoints (death from CV causes, non-procedure-related bleeding, stroke, or MI; death from CV causes, ischemic stroke, or MI) occurred less frequently in patients assigned to aspirin alone compared with those assigned to aspirin and clopidogrel (p < 0.05 for both)

REALITY

Steg et al. [16]

Randomized, parallel trial

Patients with acute MI and Hgb ≤ 8 to ≤ 10 g/dL at admission

666 patients

342 assigned to liberal (Hgb ≤ 10 g/dL, goal Hgb > 11 g/dL) RBC transfusion

324 assigned to restrictive (Hgb ≤ 8 g/dL, goal Hgb 8–10 g/dL) RBC transfusion

Primary outcome—all-cause death, reinfarction, stroke, and emergency revascularization prompted by ischemia, was 11.0% versus 14.0% for restrictive versus liberal transfusion strategy (HR 0.77, 95% CI 0.50–1.18, p < 0.05 for non-inferiority, p = 0.22 for superiority)

Among secondary outcomes, infections and ALI were higher in those assigned to a more liberal strategy

EAST-AFNET 4

Kirchhof et al. [20]

Randomized, parallel trial

Patients with new-onset or untreated, early AF (diagnosis within 1 year) and concomitant CV conditions

2789 patients

1395 assigned to rhythm therapy

1394 assigned to usual care

Rhythm control reduced the primary outcome—CV death, stroke, HHF, or ACS, for rhythm control versus usual care—compared with usual care (HR 0.79, 95% CI 0.66–0.94, p = 0.005). The trial was stopped early due to efficacy

RATE-AF

Kotecha et al. [12]

Randomized, open label, parallel trial

Patients with permanent AF

160 patients

80 assigned to digoxin

80 assigned to β-blocker (bisoprolol)

No difference was observed between digoxin and β-blocker for the primary outcome -patient-reported quality of life at 6 months

Digoxin improved some quality of life measures at 12 months and was associated with greater reductions in NYHA class and NT-proBNP levels

Fewer adverse events were observed for those treated with digoxin compared with β-blocker (29 vs. 142 events, p < 0.001)

CASA-AF

Haldar et al. [29]

Randomized, parallel, controlled trial

Patients with long-standing persistent AF

120 patients

80 assigned to surgical ablation

60 assigned to catheter ablation

No group differences on primary outcomes observed at 12 months—freedom from AF, AF burden or serious adverse effects. One death in surgical group. Improved symptomatic relief, cost-effectiveness, and quality of life in catheter group