Author + information
- Received April 24, 2015
- Revision received June 8, 2015
- Accepted June 9, 2015
- Published online August 18, 2015.
- Corrado Tamburino, MD∗,†,
- Marco Barbanti, MD∗,†∗ (, )
- Paola D’Errigo, RS‡,
- Marco Ranucci, MD§,
- Francesco Onorati, MD‖,
- Remo Daniel Covello, MD¶,
- Francesco Santini, MD#,
- Stefano Rosato, RS§,
- Gennaro Santoro, MD∗∗,
- Danilo Fusco, RS††,
- Claudio Grossi, MD‡‡,
- Fulvia Seccareccia, RS‡,
- OBSERVANT Research Group
- ∗Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy
- †ETNA Foundation, Catania, Italy
- ‡National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy
- §Department of Cardiothoracic and Vascular Anesthesia and ICU, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy
- ‖Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy
- ¶Department of Cardiac Anesthesia, IRCCS San Raffaele, Milan, Italy
- #Division of Cardiac Surgery, San Martino Hospital, Genova, Italy
- ∗∗Division of Cardiology, Careggi Hospital, Florence, Italy
- ††Department of Epidemiology, Lazio Regional Health Service, Rome, Italy
- ‡‡Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy
- ↵∗Reprint requests and correspondence:
Dr. Marco Barbanti, Division of Cardiology, Ferrarotto Hospital, University of Catania, Via Citelli 1, Catania 95100, Italy.
Background There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting.
Objectives This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR.
Methods The OBSERVANT (Observational Study of Effectiveness of SAVR–TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year.
Results The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year.
Conclusions The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials.
The OBSERVANT Study was supported by a grant (Fasc. 1M30) from Italian Ministry of Health and Istituto Superiore di Sanità. The authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Barbanti and Tamburino contributed equally to this work.
- Received April 24, 2015.
- Revision received June 8, 2015.
- Accepted June 9, 2015.
- 2015 American College of Cardiology Foundation