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Turkish Society of Cardiology
Young Cardiologists
President
Dr. Muzaffer Değertekin
Coordinator for the
Board of Directors
Dr. Ertuğrul Okuyan
Coordinator for the
Board of Directors
Dr. Can Yücel Karabay
Members
Dr. Adem Aktan
Dr. Gülşah Aktüre
Dr. Bayram Arslan
Dr. İnanç Artaç
Dr. Ahmet Oğuz Aslan
Dr. Görkem Ayhan
Dr. Ahmet Anıl Başkurt
Dr. Özkan Bekler
Dr. Oğuzhan Birdal
Dr. Yusuf Bozkurt Şahin
Dr. Serkan Bulgurluoğlu
Dr. Ümit Bulut
Dr. Veysi Can
Dr. Mustafa Candemir
Dr. Murat Çap
Dr. Göksel Çinier
Dr. Ali Çoner
Dr. Yusuf Demir
Dr. Ömer Furkan Demir
Dr. Murat Demirci
Dr. Ayşe İrem Demirtola Mammadli
Dr. Süleyman Çağan Efe
Dr. Mehmet Akif Erdöl
Dr. Kubilay Erselcan
Dr. Kerim Esenboğa
Dr. Duygu Genç
Dr. Kemal Göçer
Dr. Elif Güçlü
Dr. Arda Güler
Dr. Duygu İnan
Dr. Hasan Burak İşleyen
Dr. Muzaffer Kahyaoğlu
Dr. Sedat Kalkan
Dr. Yücel Kanal
Dr. Özkan Karaca
Dr. Ahmet Karaduman
Dr. Mustafa Karanfil
Dr. Ayhan Kol
Dr. Fatma Köksal
Dr. Mevlüt Serdar Kuyumcu
Dr. Yunus Emre Özbebek
Dr. Ahmet Özderya
Dr. Yasin Özen
Dr. Ayşenur Özkaya İbiş
Dr. Çağlar Özmen
Dr. Selvi Öztaş
Dr. Hasan Sarı
Dr. Serkan Sivri
Dr. Ali Uğur Soysal
Dr. Hüseyin Tezcan
Dr. Nazlı Turan
Dr. Berat Uğuz
Dr. Örsan Deniz Urgun
Dr. İdris Yakut
Dr. Mustafa Yenerçağ
Dr. Mehmet Fatih Yılmaz
Dr. Yakup Yiğit
Dr. Mehmet Murat Yiğitbaşı
Bulletin Editors
Dr. Muzaffer Değertekin
Dr. Can Yücel Karabay
Dr. Muzaffer Kahyaoğlu
Contributors
Dr. Ahmet Caner Canpolat
Dr. Aysu Oktay
Dr. Hadi Verdiyev
Dr. Kemal Göçer
Dr. Mehmet Altunova
Dr. Mehmet Murat Yiğitbaşı
Dr. Merve Kapçık
Dr. Muhammed Ali Söyler
Dr. Muhammet Ali Ekiz
Dr. Mustafa Yenerçağ
Dr. Mustafa Yılmaz
Dr. Özkan Karaca
Dr. Ramazan Furkan Demirkıran
Dr. Seda Kurat Güldoğmuş
Dr. Sefa Sarı
Dr. Selim Süleyman Sert
Dr. Serkan Bulguroğlu
Dr. Ülkü Nur Koç
Dr. Yücel Kanal
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Three-year results of a randomized study comparing two balloon-expandable TAVI valvesTürk Kardiyoloji Derneği Genç Kardiyologlar Bülteni - Three-year results of a randomized study comparing two balloon-expandable TAVI valves (Dr. Hadi Verdiyev)Prepared by: Dr. Hadi Verdiyev
Title of the Study: Three-year results of a randomized study comparing two balloon-expandable TAVI
valves
Presented at: EuroPCR 2025
Link: https://www.pcronline.com/Cases-resources-images/Resources/Course-videos-slides/2025/EuroPCR/Hotline-TAVI-1-extended-analysis-of-the-randomised-trials
Introduction
The long-term safety and efficacy of transcatheter aortic valve implantation (TAVI) technology are key factors influencing device selection. COMPARE-TAVI 1 is among the first long-term randomized studies directly comparing the new-generation Myval and Myval Octacor valves with the Sapien 3 and Sapien 3 Ultra valves. The 1-year results of this study demonstrated that Myval valves are an equivalent short-term alternative to the Sapien 3 series in terms of clinical safety and valve durability. However, long-term durability data are still needed.
Objective
The aim of this study was to compare Sapien 3/Ultra and Myval/Octacor valves in terms of clinical outcomes such as death, stroke, moderate-to-severe aortic regurgitation, and hemodynamic valve deterioration over a 3-year follow-up.
Methods
A total of 1,031 patients were randomized in a 1:1 ratio to receive either Sapien 3/Ultra or Myval/Octacor valves. Among them, 379 patients (Sapien 3 / Ultra [n=192] and Myval / Octacor [n=187]) who were randomized between June 2020 and August 2021 and completed a 3-year follow-up were included in the analysis. The composite endpoint was defined as death, stroke, moderate-to-severe aortic regurgitation, and moderate-to-severe hemodynamic valve deterioration.
Results
Both groups were balanced in terms of age, sex, NYHA classification, EURO Score 2, and STS PROM. The mean age was 81.8 years. In both groups, a high proportion of patients had STS PROM values of <2 and 2–4 (78% vs. 76%). Valve morphology was tricuspid in 89.7%, bicuspid in 6.6%, and valve-in-valve in 3.7% of patients. At 3-year follow-up, there were no statistically significant differences between groups in mortality (18.2% vs. 18.7%), stroke (7.3% vs. 7.0%), moderate-to-severe aortic regurgitation (2.6% vs. 6.4%; difference: –3.8%, CI: –8.0 to 0.4), or moderate-to-severe hemodynamic valve deterioration (3.1% vs. 2.7%). There was also no significant difference in the primary composite endpoint (27.6% vs. 28.3%; –0.7%, 95% CI: –9.8 to 8.3). Pacemaker implantation rates were similar between groups.
Conclusion
This 3-year sub-analysis of the COMPARE-TAVI 1 trial indicates that Myval/Octacor and Sapien 3/Ultra valves offer comparable clinical effectiveness. Key outcomes such as death, stroke, significant aortic regurgitation, and valve dysfunction occurred at similar rates. These findings support the safety and efficacy of Myval as a viable mid-term treatment option.
Commentary
There is a growing need for long-term data on next-generation transcatheter heart valves. This sub-analysis of COMPARE-TAVI 1 directly compares Myval/Octacor and Sapien 3/Ultra valves and shows similar results in terms of the primary composite outcome at 3 years. While this equivalence supports the mid-term performance of Myval, it is crucial that these findings be complemented by long-term data on durability, valve deterioration, and reintervention.
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