BHF PROTECT-TAVI (Kharbanda RK, Kennedy J, Dodd M, et al.)
The largest randomized trial carried out across 33 UK centers between 2020 and 2024, assessing 7,635 patients (mean age 81.2; 38.7 % women) with aortic stenosis undergoing TAVR with or without SENTINEL cerebral embolic protection device (CEP). There were no differences in stroke incidence at 72 hours between the groups (2.1 % vs. 2.2 %), or in mortality, disabling stroke or adverse events. Seeing these results, recruitment was stopped earlier than originally planned. The study concluded that routine use of CEP during TAVR does not bring any benefits, though future research may identify subgroups that could benefit from new generation devices.
ALIGN-AR (Yasser Jamil, et al.): Multicenter clinical trial carried out in US between 2018 and 2024, including 500 patients with symptomatic aortic insufficiency (≥3+) undergoing TAVR with JenaValve Trilogy. There was high device success rate with acceptable complications rate: 0% periprocedural mortality and 1.4 % at 30 days; 1.6 % valve embolization and 0.8 % disabling stroke. At 2 years, mortality resulted 8.1 %, with improved functional class (59 % in NYHA I) and quality of life (+19,4 KCCQ-OS). Also, there was significant left ventricular remodeling, with LV mass index reduction (152.3 g/m² to 114.3 g/m², p < 0.0001). Paravalvular regurgitation resulted minimal in 95.7 % of cases. Pacemaker implantation rate was higher in 27 mm valves (28.9 %).
Evolut Low Risk 5-Years (Forrest J, Yakubov S, Deeb G, et al.): This study compared TAVR vs SAVR in 1,414 patients with severe aortic stenosis and low surgical risk. At 5 years, there were no significant differences in mortality or disabling stroke (15.5 % vs. 16.4 %; p = 0.47). TAVR showed improved hemodynamic parameters with lower valve gradient (10.7 mmHg vs. 12.8 mmHg) and larger effective orifice area (2,1 cm² vs. 1,9 cm²), but more need for pacemaker implantation and mild paravalvular leak. Both groups presented similar reintervention rates (3.3 % para TAVR vs. 2.5 % para SAVR; p = 0.44), quality of life (KCSS: 88.3 vs. 88.5) and complications. The study supports TAVR durability, though long term 10-year outcomes remain pending.
FLAVOUR II (Hu X, Zhang J, Yang S, et al.): Carried out in 22 centers across China between May 2020 and September 2023, this study compared AngioFFR guided PCI (AI based calculation of FFR from a single-view coronary angiography) vs IVUS in 1,839 patients with significant coronary stenosis. At 12 months, there were no differences in death, MI or revascularization (6.3 % vs. 6.0 %; p = 0.022), but AngioFFR reduced stent use by 11.5 % and antiplatelet therapy by 5.4 %. Both groups presented similar rates of mortality and recurrent angina. Followup will continue up to 5 years to assess differences at long term.
Read also: ACC 2025 | FAME 3: FFR Guided PCI vs CABG 5 Year Outcomes.
TRILUMINATE Pivotal 2-Year (Saibal Kar, et al.): With a total 572 patients (mean age: 78; 60 % women) from 5 countries (US., Canada, Germany, Italy and Spain), the study showed transcatheter edge-to-edge repair (TEER) with TriClip in patients with severe tricuspid regurgitation reduced the risk of recurrent hospitalization for cardiac failure by 28 % at 2 years, vs medical treatment alone. 77.6 % of patients treated with TEER remained alive and free of surgery vs 29.3 % in the control group. Also, 84 % of TEER patients had moderate or mild tricuspid regurgitation, vs 21 % in the control group. Followup will continue up to 5 years to assess long term efficacy and safety.
FAME 3 5-Year (Prof William F Fearon, MD): This study included 1,500 patients in North America, Europe, Asia and Australia (mean age 65; 82 % men) with three-vessel disease (at least 50 % obstruction, with no left main compromise). It compared CABG against PCI, finding similar results as to death, stroke and AMI at 5 years. Though patients treated with PCI presented higher incidence of AMI (8.2 % vs. 5.3 %) and reintervention (15.6 % vs. 7.8 %), there were no significant differences in mortality rate (7.2 % in both groups). These findings suggest PCI can be viable in select patients, which allows better informed decision making for both doctors and patients.
SMART-CHOICE 3 (Choi H, Park H, Lee JY, et al.): Carried out in South Korea, this study compared clopidogrel monotherapy against aspirin after dual antiplatelet therapy in 5,506 patients undergoing PCI. At 2.3 year followup, the clopidogrel group showed lower incidence of the composite end point of death, MI or stroke (4.4 % vs. 6.6 %), with absolute risk reduction 2.2% and no increase in bleeding risk. The benefit resulted higher in patients with no prior MI. despite few limitations, the study suggests clopidogrel might be a better option than aspirin in the maintenance phase.
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