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Background: In the randomized SOLVE-TAVI (compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anesthesia in Transcatheter Aortic Valve Implantation) trial comparing newer-generation self-expanding valves (SEV) and balloon-expandable valves (BEV), as well as conscious sedation (CS) and general anesthesia (GA), clinical outcomes were similar both for valve and anesthesia comparison at 30 days and 1 year. Prosthesis durability may affect clinical outcomes during long-term follow-up. Moreover, the impact of the anesthesia strategy on long-term clinical outcomes is unknown so far., Objectives: The authors sought to compare clinical outcomes during 5-year follow-up in the randomized SOLVE-TAVI trial., Methods: In the randomized, multicenter, 2 × 2 factorial, open-label SOLVE-TAVI trial, 447 intermediate- to high-risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral transcatheter aortic valve replacement (TAVR) using either SEV (Evolut R, Medtronic) or BEV (SAPIEN 3, Edwards Lifesciences) and also to CS vs GA. Patients were followed-up for 5 years., Results: During 5 years of follow-up, the combined predefined endpoint of all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation was similar in the SEV and BEV groups (67.7% vs 63.4%; HR: 0.89; 95% CI: 0.70-1.13; P = 0.34). Stroke rates at 5 years were lower in the SEV group (2.2% vs 9.6%; HR: 4.84; 95% CI: 1.65-14.18; P = 0.002). Regarding the anesthesia comparison, the primary endpoint of all-cause mortality, stroke, myocardial infarction, and acute kidney injury occurred in 51.4% in the CS group and 61.3% in the GA group (HR: 0.80; 95% CI: 0.62-1.04; P = 0.09). All-cause mortality at 5 years was lower for CS (41.5% vs 54.3%; HR: 0.70; 95% CI: 0.53-0.94; P = 0.02)., Conclusions: Transfemoral TAVR using either SEV and BEV as well as CS and GA showed similar clinical outcomes at 5 years using a combined clinical endpoint., Competing Interests: Funding Support and Author Disclosures Funding was provided by the German Heart Research Foundation and the Helios Health Institute (formerly the Leipzig Heart Institute). The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures Dr Marinacci has received research support from grant T32-HL160522 from the National Institutes of Health. Dr Wadhera has received research support from the National Heart, Lung, and Blood Institute at the National Institutes of Health (R01HL164561, R01HL174549), the National Institute for Nursing Research at the National Institutes of Health (R01NR021686), the American Heart Association Established Investigator Award, and the Donaghue Foundation (West Hartford, CT); and has served as a consultant for Abbott, CVS Health, and Chambercardio, outside of the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Competing Interests: Funding Support and Author Disclosures The author has reported that she has no relationships relevant to the contents of this paper to disclose.

Background: Side branch stenting is often required during provisional stenting, leading to suboptimal results. Drug-coated balloons (DCB) for the compromised side branch have emerged as an attractive strategy. However, the benefit of DCB for coronary bifurcations remains unclear., Objectives: This study aimed to investigate whether DCB, compared with a noncompliant balloon (NCB), for the pinched side branch improves the outcomes of provisional stenting in patients with simple, true coronary bifurcations., Methods: In this multicenter, randomized controlled trial, patients with true coronary bifurcations who had side branch diameter stenosis of ≥70% after main vessel stenting at 22 centers in China, Indonesia, Italy, and Korea were randomly assigned to either DCB or NCB intervention. The primary endpoint was major adverse cardiac events, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target-lesion revascularization at the 1-year follow-up., Results: Between September 8, 2020, and June 2, 2023, 784 patients with true coronary bifurcation lesions undergoing main vessel stenting and having a severely compromised side branch were randomly assigned to the DCB (n = 391) or NCB (n = 393) group. One-year follow-up was completed in all patients. The primary endpoint occurred in 28 patients in the DCB group and 49 patients in the NCB group (Kaplan-Meier rate: 7.2% vs 12.5%; HR: 0.56; 95% CI: 0.35-0.88; P = 0.013), driven by a reduction in myocardial infarction. There were no significant differences between groups in procedural success, crossover to a 2-stent approach, all-cause death, revascularization, or stent thrombosis., Conclusions: In patients with simple and true coronary bifurcation lesions undergoing provisional stenting, main vessel stenting with a DCB for the compromised side branch resulted in a lower 1-year rate of the composite outcome compared with an NCB intervention for the side branch. The high rates of periprocedural myocardial infarction, which occurred early and did not lead to revascularization, are of unclear clinical significance., Competing Interests: Funding Support and Author Disclosures This trial was funded by the National Key Research and Development Plan (2022YFC2503503), the Chinese Society of Cardiology (grant number CSCF 2019-A0003), the National Natural Scientific Foundation of China (grant numbers NSFC 91639303, 81770441, and 82121001), and the Jiangsu Provincial and Nanjing Municipal Clinical Trial Project (grant number BE 2019615) and jointly supplied by B Braun Medical (Melsungen, German), Shenqi Medical (Shanghai, China), Yinyi Medical (Dalian, China), Yingsheng Medical (Shanghai, China), and Kaidenuo Medical (Wuhan, China). The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)