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

From: Cardiology on the cutting edge: updates from the European Society of Cardiology (ESC) Congress 2020

Trial References Study design General patient characteristics Number of patients Main results
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