A Less Invasive Option

A Less Invasive Option

Collaborate With a Heart Team

and give your patients the benefits of TAVR

Guide your symptomatic severe AS patients – including low-risk patients – to excellent outcomes*1-3,6.

PARTNER 3 Trial demonstrated unprecedented clinical outcomes2,4-6.

* The PARTNER 3 Trial, SAPIEN 3 Transcatheter Aortic Valve Replacement proven superior to surgery on the primary endpoint of all-cause death, all stroke, and rehospitalization (valve-related or procedure-related and including heart failure) at one year, and multiple pre-specified secondary endpoints in low risk patients.

PARTNER 3 Trial 5-Year Results in Low-Risk Patients - Low rates of cardiovascular mortality through five years (5.5% SAPIEN 3 Transcatheter Aortic Valve Replacement to 5.1% SAVR). Low rates of all-cause mortality through five years (10.0% SAPIEN 3 Transcatheter Aortic Valve Replacement vs. 8.2% with SAVR). Low rates of disabling stroke through five years (2.9% SAPIEN 3 Transcatheter Aortic Valve Replacement to 2.7% SAVR). Low rates of stroke through five years (5.85% SAPIEN 3 Transcatheter Aortic Valve Replacement vs. 6.4% SAVR). Lower rates of rehospitalization with SAPIEN 3 Transcatheter Aortic Valve Replacement through five years (13.7% vs. 17.4%).

PARTNER 3 Trial: Primary endpoint

30 Days 1 Year 5 Years
SAPIEN 3 Transcatheter Aortic Valve Replacement
(n = 496)		 Surgery
(n = 454)		 SAPIEN 3 Transcatheter Aortic Valve Replacement
(n = 496)		 Surgery
(n = 454)		 P-Value SAPIEN 3 Transcatheter Aortic Valve Replacement
(n = 496)		 Surgery
(n = 454)		 P-Value
All-Cause Death 0.4% 1.1% 1.0% 2.5% P = 0.09 10.0% 8.2% P = 0.35
All Stroke 0.6% 2.4% 1.2% 3.1% P = 0.04 5.8% 6.4% P = 0.60
Rehospitalization** 3.4% 6.5% 7.3% 11.0% P = 0.046 13.7% 17.4% P = 0.09
30 Days
SAPIEN 3 Transcatheter Aortic Valve Replacement
(n = 496)		 Surgery
(n = 454)
All-Cause Death 0.4% 1.1%
All Stroke 0.6% 2.4%
Rehospitalization** 3.4% 6.5%
1 Year
SAPIEN 3 Transcatheter Aortic Valve Replacement
(n = 496)		 Surgery
(n = 454)		 P-Value
All-Cause Death 1.0% 2.5% P = 0.09
All Stroke 1.2% 3.1% P = 0.04
Rehospitalization** 7.3% 11.0% P = 0.046
5 Years
SAPIEN 3 Transcatheter Aortic Valve Replacement
(n = 496)		 Surgery
(n = 454)		 P-Value
All-Cause Death 10.0% 8.2% P = 0.35
All Stroke 5.8% 6.4% P = 0.60
Rehospitalization** 13.7% 17.4% P = 0.09

Low rate of permanent pacemaker

7.3%

at 1 year3

vs. 5.4% for surgery

13.5%

at 5 years5

vs. 10.4% for surgery

*The PARTNER 3 Trial, SAPIEN 3 Transcatheter Aortic Valve Replacement proven superior to surgery on the primary endpoint of all-cause death, all stroke, and rehospitalization (valve-related or procedure-related and including heart failure) at one year, and multiple pre-specified secondary endpoints in low risk patients.

PARTNER 3 Trial 5-Year Results in Low-Risk Patients - Low rates of cardiovascular mortality through five years (5.5% SAPIEN 3 Transcatheter Aortic Valve Replacement to 5.1% SAVR). Low rates of all-cause mortality through five years (10.0% SAPIEN 3 Transcatheter Aortic Valve Replacement vs. 8.2% with SAVR). Low rates of disabling stroke through five years (2.9% SAPIEN 3 Transcatheter Aortic Valve Replacement to 2.7% SAVR). Low rates of stroke through five years (5.85% SAPIEN 3 Transcatheter Aortic Valve Replacement vs. 6.4% SAVR). Lower rates of rehospitalization with SAPIEN 3 Transcatheter Aortic Valve Replacement through five years (13.7% vs. 17.4%).

** Rehospitalization (valve-related or procedure-related and inclduing heart failure).

Give your patients the best chance at these outcomes and experiences.

Guide them to a Heart Team  for a TAVR evaluation

References:   1. FDA Letter: SAPIEN approval letter 2011. 2. Mack MJ, Leon MB, Thourani VH. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019;380(18):1695-1705. 3. Fifteen Years of TAVR; Where Are They Now? American College of Cardiology, July 20, 2017. https://www.acc.org/latest-in-cardiology/articles/2017/07/19/15/42/fifteen-years-of-tavr-where-are-we-now. 4. Leon MB, Mack MJ. PARTNER 3: transcatheter or surgical aortic valve replacement in low risk patients with aortic stenosis. Presented at ACC 2019; March 2019; New Orleans, LA. 5. The Partner 3 Trial Clinical Study Report; April 2019. 6. Mack MJ, Leon MB, Thourani P, Transcatheter aortic valve replacement in low-risk patients at five years. N Engl J Med. 2023;10.1056/NEJMoa2307447.