POPular ACE TAVI
Firstly, Doctor Christiaan Overduin (St Antonius Hospital - Nieuwegein, Netherlands) described the POPular ACE TAVI trial assessing the safety and efficacy of routine vs. selective protamine administration before large-bore arterial sheath removal after transfemoral TAVI. Routine protamine reduced all-cause death or clinically relevant bleeding at 30 days vs. selective protamine (risk difference −10.9%; p<0.001). A small but significant increase in anaphylaxis was observed (risk difference +1.3%; p=0.01). It was concluded that the data support routine protamine after TAVI to reduce minor bleeding, but this should be balanced against a small risk of anaphylaxis.
TAVI PCI
The TAVI PCI trial, presented by Assistant Professor Barbara Elisabeth Stähli (University Hospital Zurich - Zurich, Switzerland), was designed to answer a daily dilemma: “if a patient needs both TAVI and PCI, which should we do first?” At 1 year, a TAVI-first strategy was noninferior to a PCI-first strategy for the primary composite endpoint, which included cardiovascular and bleeding outcomes. Assistant Prof. Stähli concluded, “The TAVI PCI trial shows that we as clinicians now have a choice. It gives us randomised evidence to individualise the sequence of TAVI and PCI according to what is best for each patient.”
TRIC-I-HF
As described by Professor Jörg Hausleiter (Ludwig Maximilians University - Munich, Germany), the TRIC-I-HF trial was designed to investigate whether transcatheter tricuspid valve repair (TTVR) plus medical therapy improves hard clinical outcomes vs. medical therapy alone in patients with severe tricuspid regurgitation at high risk of heart failure events. The first primary endpoint of all-cause mortality, heart failure hospitalisation and failure to achieve quality-of-life improvement at 1 year significantly favoured TTVR over medical therapy alone (win ratio 2.42; p<0.001). TTVR also resulted in significantly greater freedom from the co-primary endpoint of all-cause mortality or heart failure hospitalisation at 3 years than medical therapy alone (52.4% vs. 21.0%; p<0.001).
ACASA-TAVI
Next, Doctor Øyvind H Lie (Oslo University Hospital Rikshospitalet - Oslo, Norway) presented results from the ACASA-TAVI trial in patients after TAVI without an indication for anticoagulation. The researchers observed significant reductions in hypo-attenuated leaflet thickening (HALT) with an anti-factor Xa non-vitamin K antagonist oral anticoagulant vs. aspirin monotherapy after 1 year. There was no difference in VARC-3 bleeding events, thromboembolic events and all-cause death between the groups.
NOTION-4
As described by Doctor Troels Hojsgaard Jorgensen (Rigshospitalet - Copenhagen University Hospital - Copenhagen, Denmark), 3 months of direct oral anticoagulant therapy (DOAC) followed by single antiplatelet therapy (SAPT) was compared with SAPT only in TAVI patients with no indication for oral anticoagulants in the NOTION-4 trial. The DOAC-SAPT regimen reduced HALT at 3 months but not at 12 months vs. SAPT. At 12 months, all-cause mortality, stroke or major/life-threatening bleeding was 8.8% in the DOAC-SAPT group and 2.3% in the SAPT group (p=0.008). The results of ACASA-TAVI and NOTION-4 highlight the ongoing uncertainty regarding the clinical relevance of HALT and of anticoagulation after TAVI.