Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement - PROTECTED TAVR

Oct 29, 2024
Font Size
A
A
A
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC; Kim A. Eagle, MD, MACC
Trial Sponsor:
Boston Scientific
Date Presented:
10/29/2024
Date Published:
10/29/2024
Date Updated:
10/29/2024
Original Posted Date:
09/17/2022
References

Contribution To Literature:

Highlighted text has been updated as of October 29, 2024.

The PROTECTED TAVR trial showed that routine use of a CEP device does not result in a lower risk of stroke within 72 hours among patients undergoing transfemoral TAVR for aortic stenosis.

Description:

The goal of the trial was to evaluate the efficacy of intraprocedural cerebral embolic protection (CEP) in reducing strokes among patients undergoing transfemoral TAVR for aortic stenosis.

Study Design

Patients were randomized in 1:1 fashion to either CEP (n = 1,501) or control (n = 1,499). A Sentinel device (Boston Scientific) was used for CEP. All investigators had performed at least 20 procedures involving its use.

  • Total randomized: 3,000
  • Duration of follow-up: 72 hours
  • Mean patient age: 79 years
  • Percentage female: 40%

Inclusion criteria:

  • Documented aortic valve stenosis
  • Plan for treatment with an approved TAVR device via transfemoral access
  • Patient with recommended artery diameter at the site of filter placement (9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery)

Exclusion criteria:

  • Arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery
  • Brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium
  • Compromised blood flow to the right upper extremity
  • Access vessels with excessive tortuosity
  • Uncorrected bleeding disorders
  • Contraindication to anticoagulant and antiplatelet therapy

Other salient features/characteristics:

  • Society of Thoracic Surgeons–Predicted Risk of Mortality (STS PROM): 3.4%
  • History of cerebral vascular accident/transient ischemic attack (TIA): 8%
  • TAVR details: bicuspid aortic stenosis: 8%, valve-in-valve (ViV): 3%, pre-procedure bicuspid aortic valve: 40%, use of balloon-expandable valve: 64%

Principal Findings:

The primary outcome, stroke within 72 hours of TAVR or before discharge for CEP vs. control, was: 2.3% vs. 2.9% (p = 0.30). 

Secondary outcomes for CEP vs. control:

  • Disabling stroke: 0.5% vs. 1.3% (p < 0.05)
  • All-cause mortality: 0.5% vs. 0.3%
  • Stroke/TIA/delirium: 3.1% vs. 3.7%
  • Acute kidney injury: 0.5% vs. 0.5%
  • Modified Rankin scale (mRS) score: 0.6 vs. 0.6

Results by geographic region: There were 1,833 patients in the US cohort (TAVR alone: 919, TAVR with CEP: 914) and 1,167 patients in the outside the US (OUS) cohort (TAVR alone: 580, TAVR with CEP: 587).

US cohort:

  • Stroke at discharge for CEP vs. control: 1.3% vs. 2.6% (p = 0.045)
  • Disabling stroke: 0.4% vs. 1.5% (p = 0.02)

OUS cohort:

  • Stroke at discharge for CEP vs. control: 3.7% vs. 3.3% (p = 0.66)
  • Disabling stroke: 0.7% vs. 1.0% (p = 0.55)
  • P for interaction by geographic region > 0.05

Interpretation:

The results of this trial show that routine use of a CEP device does not result in a lower risk of stroke within 72 hours among patients undergoing transfemoral TAVR for aortic stenosis. This is the largest trial on this topic to date. Earlier smaller studies had suggested a benefit with CEP based on brain magnetic resonance imaging findings but were underpowered for clinical outcomes. These are important findings for the field and will likely impact guidelines on this topic, as these devices can add extra time and expense to the procedure. A reduction in disabling strokes is hypothesis generating but needs to be viewed in the context of an overall negative trial. Although mortality and patient risk profiles for TAVR have decreased in recent years, the periprocedural stroke rate has remained consistent, around 2–2.5%, as was noted in this trial as well. An important strength of this trial is that every patient was independently assessed by a neurologist post-procedure.

In a subgroup analysis, the effectiveness of CEP in reducing strokes was greater among US patients/hospitals compared with OUS, although the interaction term was not statistically significant. This can therefore be considered hypothesis generating. Results of the BHF PROTECT-TAVI ongoing trial are awaited.

References:

Makkar RR, Gupta A, Waggoner TE, et al. Cerebral Embolic Protection by Geographic Region: A Post Hoc Analysis of the PROTECTED TAVR Randomized Clinical Trial. JAMA Cardiol 2024;Oct 29:[Epublished].

Presented by Dr. Raj Makkar at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2024), Washington, DC, October 29, 2024.

Kapadia SR, Makkar R, Leon M, et al., on behalf of the PROTECTED TAVR Investigators. Cerebral Embolic Protection During Transcatheter Aortic-Valve Replacement. N Engl J Med 2022;387:1253-63.

Editorial: Carroll JD, Saver JL. Does Capturing Debris During TAVR Prevent Strokes? N Engl J Med 2022;387:1318-9.

Presented by Dr. Samir R. Kapadia at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2022), Boston, MA, September 17, 2022.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: Aortic Valve Stenosis, Cardiac Surgical Procedures, Heart Valve Diseases, Heart Valve Prosthesis, Stroke, TCT22, TCT24, Transcatheter Aortic Valve Replacement, Transcatheter Cardiovascular Therapeutics, Vascular Diseases


< Back to Listings