How can TAVI benefit your low-risk patients with severe aortic stenosis (sAS) now and in the future?

Supported by proven results from PARTNER 3,¹ low-risk patients with sAS now have the opportunity for TAVI. As these patients are usually younger and healthier than those in higher risk categories,^1-6 further considerations for this group include valve durability and valve-in-valve (ViV) procedures that support their longer-term management.

Now you can give your low-risk AS patients a chance at the lowest-risk option

Low risk patients are younger and healthier and, for them, sAS is their primary concern

Low-risk patients are healthier¹

Low-risk patients are younger¹

Low-risk patients have fewer comorbidities

Baseline patient characteristics of AS treated populations

Low-risk
PARTNER 3 Trial(n=950)

Intermediate-risk
PARTNER IIA Trial (n=938)

High-risk
PARTNER IA Trial (n=657)

NYHA Class III / IV

27.7%¹

76.7%²

94.5%³

KCCQ Score

70.2⁴

54.1⁵

41.8⁶

CAD

27.8%¹

67.8%²

75.9%³

Previous CABG

2.4%⁷

24.6%²

43.3%³

COPD

5.6%¹

30.8%²

43.7%³

Permanent PPM

2.6%¹

11.8%²

21.2%³

CABG, coronary artery bypass grafting; CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; KCCQ, Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart Association; PPM, permanent pacemaker; STS, Society of Thoracic Surgeons.

Only SAPIEN 3 TAVI was proven superior to surgery on the primary endpoints (all-cause death, all-stroke, or rehospitalisation)^{1, 7}

PARTNER 3 Low-Risk Trial

Primary Endpoint: Baseline Death, Stroke or Rehospitalisation

Change from baseline in KCCQ-OS score at 1 month, 6 months and 1 year with SAPIEN 3 TAVI ⁴

KCCQ-OS, Kansas City Cardiomyopathy Questionnaire–Overall Summary.

With half-a-million transcatheter heart valve implants and 18 years of experience, TAVI has evolved to deliver faster procedures, shorter hospital stays, less rehospitalisation, and low pacemaker rates¹
Additionally, SAPIEN 3 TAVI has demonstrated substantially improved early and sustained QoL benefits in low-risk patients with sAS at 1 month, 6 months and 1 year compared with sAVR^†4

Proven to be superior to surgery on primary end points in PARTNER 3, refer your low-risk patients with sAS for TAVI evaluation

Valve durability and future treatment options are a key consideration in low-risk patients with sAS and longer life expectancies^8-10

Especially in younger and healthier AS patients, valve durability and future treatment options should be considered.

5 year-data from PARTNER 2S3i shows long-term durability with SAPIEN 3 TAVI is equivalent to surgery, with¹¹
Sustained improvements in haemodynamic performance^‡
Similar rates of reintervention for TAVI vs sAVR^§
Similar rates of haemodynamic valve deterioration (HVD) and bioprosthetic valve failure (BVF) for TAVI vs sAVR

Keep your low-risk patients active with a TAVI that is supported by real-world durability data

No matter what their future brings, know they have the option of ViV TAVI

The PARTNER 3 Trial proved SAPIEN 3 TAVI is superior to surgery for the primary endpoint and multiple pre-specified secondary endpoints.¹

1 month = 16.0 points; 95% CI 14.2 to 17.8; p<0.001. 6 months = 2.6 points; 95% CI 1.0 to 4.3; p=0.002. 1 year = 1.8 points; 95% CI 0.1 to 3.5; p=0.033.⁴

45.9mmHg at baseline, 11.6mmHg at 1 Year, 11.6mmHg at 3 Years and 11.2mmHg at 5 Years. ¹¹

1.3% vs 0.8% for TAVI and sAVR, respectively. Odds ratio 0.60 (95% CI, 0.22-1.65; p = 0.31)¹¹

0.63% vs 0.60% for rate of Stage 2 & 3 for TAVI and sAVR, respectively; p = 0.86. Stage 2 & 3 HVD defined as: + Δ mean gradient ≥ 10 mmHg and -Δ AVA ≥ 0.3 cm² or ≥ 25%, -Δ DVI ≥ 0.1 or ≥ 20%, AND/OR ≥ 1 grade Δ transvalvular AR with final grade ≥ moderate.¹¹

0.63% vs 0.37% for TAVI and sAVR, respectively; p = 0.22. Bioprosthetic valve failure defined as: Re-intervention or death related to valve dysfunction, or severe (Stage 3) structural valve deterioration-related HVD.¹¹

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References

1Mack MJ, et al. N Engl J Med. 2019;380(18):1695—1705 and supplementary material.
2Leon MB, et al. N Engl J Med 2016;374:1609—1620 and supplementary material.
3Smith CR et al. N Engl J Med 2011;364:2187—2198 and supplementary material.
4Baron SJ, et al. J Am Coll Cardiol. 2019;74(23):2833—2842.
5Baron SJ, et al. JACC Cardiovascr Interv. 2018;11(12):1188—1198.
6Reynolds MR, et al. J Am Coll Cardiol 2012;60(6):548—558.
7Leon MB & Mack MJ. PARTNER 3: Transcatheter or Surgical Aortic Valve Replacement in Low Risk Patients with Aortic Stenosis. Presented at: American College of Cardiology Annual Scientific Session (ACC 2019), New Orleans, LA, March 17, 2019.
8Rodriquez-Gabella T, et al. J Am Coll Cardiol. 2017;70(8):1013—1028.
9Kuck K, et al. Cardiologist 2020;14: 182—204.
10Sathananthan J, et al. Catheter Cardiovasc Interv. 2021;97(3):E431—E437.
11Kodali SK, et al. Presentation at the Transcatheter Valve Therapies (TVT) Summit virtual event: TVT Connect 2020. Available at:
https://www.tctmd.com/slide/sapien-3-transcatheter-aortic-valve-replacement-compared-surgery-intermediate-risk-patients-0 (accessed March 2021).
12Silaschi M et al. Interactive Cardiovasc Thorac Surg. 2017;24(1):63—70.
13Tam DY, et al. JACC Cardiovasc Interv. 2020;13(6):765—774.

How can TAVI benefit your low-risk patients with severe aortic stenosis (sAS) now and in the future?

Now you can give your low-risk AS patients a chance at the lowest-risk option

Valve durability and future treatment options are a key consideration in low-risk patients with sAS and longer life expectancies8-10

Check our latest articles

Stay informed with our newsletter

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References

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Valve durability and future treatment options are a key consideration in low-risk patients with sAS and longer life expectancies^8-10