One-Year Results From PORTICO I Presented for Abbott's Portico TAVR Device
September 28, 2018—Abbott Structural Heart announced 1-year results from the PORTICO I trial, a real-world, international, multicenter, 941-patient study of the company's Portico transcatheter aortic valve replacement (TAVR) system in patients with symptomatic, severe aortic stenosis. The data were presented at TCT 2018, the 30th Transcatheter Cardiovascular Therapeutics annual scientific symposium held September 21–25 in San Diego, California. The findings were simultaneously published online by Lars Søndergaard, MD, et al in the Journal of the American College of Cardiology.
At 1 year after implantation, the Portico valve was safe and associated with low rates of stroke, death, and leaks between patients' natural heart tissue and the Portico valve. These 1-year results were consistent with 30-day results reported earlier this year with data used to support European approval and with results from other commercially available TAVR valves.
According to Abbott Structural Heart, the PORTICO I trial is an ongoing, prospective, long-term study of patients with symptomatic, severe aortic stenosis treated with the self-expanding, repositionable Portico transcatheter aortic valve via a transfemoral access.
The study's primary endpoint is all-cause mortality at 1 year. Secondary endpoints include device performance, improvement in functional capacity, and adverse event rates at 30 days, 1 year, and annually for 5 years. The study is evaluating 941 patients treated between April 2013 and September 2017 at 61 sites across 14 countries in Europe, Australia, and Canada.
In the company's press release, Dr. Søndergaard, who is the study's principal investigator, commented, "Portico offers physicians the ability to safely and successfully treat patients suffering from symptomatic, severe aortic stenosis with a high level of confidence. These 1-year results in a real-world setting give us assurance that Portico is an excellent and important treatment option for patients with severe aortic stenosis who are at increased risk for open-heart surgery." Dr. Søndergaard is from Rigshospitalet in Copenhagen, Denmark.
At 1 year, the investigators found that patients who received a Portico valve had low rates of mortality, stroke, paravalvular leak, and sustained significantly improved hemodynamic performance. All-cause and cardiovascular mortality were 12.1% and 6.6%, respectively; disabling stroke was observed in 2.2% of patients and myocardial infarction in 2.5%. Mean aortic valve area increased from baseline (0.72 ± 0.37 cm2) to 30 days (1.79 ± 0.48 cm2) and was durable at 1 year (1.74 ± 0.49 cm2). The moderate paravalvular leak was low, decreasing from 3.9% of patients at 30 days to 2.6% of patients at 1 year. The proportion of patients classified with severe heart failure (New York Heart Association Class III/IV) decreased from 63.8% at baseline to 7.7% at 1 year.
The Portico TAVR device is intended for patients diagnosed with severe aortic stenosis who are high-risk candidates for open heart surgery. In Europe, Abbott received CE Mark approval for Portico in 2012 and has completed enrollment in the randomized treatment arm of a United States pivotal study. In the United States, Portico is approved for investigational use only in the United States, advised Abbott Structural Heart.
The company recently received regulatory approval in Europe for a sheathless introduction of the Portico valve, which makes it easier for doctors to use the valve in patients with severe disease and complex anatomies.