American College of Cardiology Foundation

09/11/2019 | Press release | Distributed by Public on 09/11/2019 16:35

Surgical Replacement and Transcatheter Aortic Valve Implantation

Contribution To Literature:

The SURTAVI trial showed that TAVR with the self-expanding CoreValve was noninferior to SAVR for the primary endpoint at 2 years for the treatment of severe aortic stenosis in intermediate-risk patients (STS-PROM, 3-15%; median 4.5%).

Description:

The goal of the trial was to assess the safety and efficacy of transcatheter aortic valve replacement (TAVR) with the self-expanding CoreValve compared with surgical AVR (SAVR) in intermediate-risk patients.


Study Design

Patients were randomly assigned in a 1:1 ratio to undergo either TAVR (n = 864) or SAVR (n = 796). TAVR was performed with the self-expanding CoreValve Classic (84%) in the majority of cases. Stratification was further performed based on significant coronary artery disease (CAD) to either percutaneous coronary intervention (PCI) (in the TAVR arm) or concomitant coronary artery bypass grafting (CABG) (in the AVR arm).

  • Total number of enrollees: 1,746
  • Duration of follow-up: 24 months
  • Mean patient age: 80 years
  • Percentage female: 44%
  • Percentage with diabetes: 34.5%

Inclusion criteria:

  • Severe symptomatic aortic stenosis
  • Estimated risk of 30-day surgical death of 3-15%, according to Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM)

Exclusion criteria:

  • Contraindication for placement of a bioprosthetic valve
  • A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens
  • Any PCI or peripheral intervention within 30 days of randomization
  • Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 6 weeks of randomization
  • Recent cerebrovascular accident or transient ischemic attack
  • Acute myocardial infarction within 30 days
  • Multivessel CAD with SYNTAX score >22
  • Severe liver, lung, or renal disease
  • Unsuitable anatomy including native aortic annulus <18 mm or >29 mm
  • Severe mitral or tricuspid regurgitation
  • Congenital bicuspid or unicuspid valve verified by echocardiography

Other salient features/characteristics:

  • Median STS-PROM: 4.5%; logistic EuroSCORE: 11.8%
  • CAD: 64%, prior stroke: 7%, peripheral arterial disease: 30%
  • 5-meter (m) walk distance >6 seconds (measure of frailty): 52.3%
  • 6-minute walk test: 257 m

Principal Findings:

Primary endpoint: All-cause mortality or disabling stroke for TAVR vs. SAVR at 24 months: 12.6% vs. 14.0%, p < 0.05 for noninferiority

Also at 24 months for TAVR vs. SAVR:

  • All-cause mortality: 11.4% vs. 11.6%
  • Disabling stroke: 2.6% vs. 4.5%

Secondary outcomes for TAVR vs. SAVR:

  • All-cause mortality at 30 days: 2.2% vs. 1.7%, p > 0.05
  • All strokes at 30 days: 3.4% vs. 5.6%, p < 0.05
  • Major vascular complication at 30 days: 6.0% vs. 1.1%, p < 0.05
  • Life-threatening or major bleeding at 30 days: 12.2% vs. 9.3%, p > 0.05
  • New permanent pacemaker at 30 days: 25.9% vs. 6.6%, p < 0.05
  • Atrial fibrillation at 30 days: 12.9% vs. 43.4%, p < 0.05
  • Kansas City Cardiomyopathy Questionnaire (CCQ) change from baseline at 30 days: 18.4% vs. 5.9%, p < 0.05

Coronary revascularization:Patients were stratified according to need for revascularization prior to randomization. SYNTAX score >22 was an exclusion criterion. A total of 332 (20%) patients were assigned to revascularization. After randomization to treatment, there were 169 TAVR and PCI patients, 163 SAVR and CABG patients, 695 TAVR only patients, and 633 SAVR only patients. Complete revascularization was not significantly different between TAVR + PCI vs. SAVR + CABG: 44.4% vs. 51.5%, p = 0.19. No significant difference in the rate of the primary endpoint was found between TAVR and PCI and SAVR and CABG (16.0% vs. 14.0%; p = 0.62), or between TAVR and SAVR (11.9% vs. 12.3%; p = 0.76).

Interpretation:

The results of this landmark trial indicate that TAVR with the self-expanding CoreValve (84% first-generation CoreValve Classic) is noninferior to SAVR for the primary endpoint of mortality/disabling stroke at 24 months for the treatment of severe symptomatic aortic stenosis in intermediate-risk patients (median STS-PROM 4.5%). Vascular complications were higher in TAVR patients at 30 days, while new-onset atrial fibrillation, acute kidney injury, and transfusions were higher in the SAVR arm. More than 25% of patients required a new pacemaker post-TAVR, compared with approximately 7% post-surgery. Valve performance at 2 years was similar between the two strategies. From the patient's perspective, TAVR provided earlier symptomatic benefit; this was comparable to surgery at 2 years of follow-up.

Only 16% of patients (mostly US patients enrolled after April 2015) received the second-generation CoreValve Evolut R valve. This valve has a lower sheath size and pacemaker requirement than CoreValve classic, and may thus have better performance for these issues in the real world compared with what was noted in this trial.

This is a landmark trial in this field. Based on the results of the PARTNER 2A trial with the Edwards Sapien valves, the FDA approved TAVR for intermediate-risk patients with an STS score of 3 or higher. Lower-risk trials are now enrolling. Long-term follow-up is going to be essential to understand long-term performance and the risk of subclinical leaflet thrombosis and structural valve degeneration.

References:

Søndergaard L, Popma JJ, Reardon MJ, et al., on behalf of the SURTAVI Trial Investigators. Comparison of a Complete Percutaneous Versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk: Results From the Randomized SURTAVI Trial. Circulation 2019;Sep 3:[Epub ahead of print].

Reardon MJ, Van Mieghem NM, Popma JJ, et al., on behalf of the SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med 2017;376:1321-31.

Presented by Dr. Michael J. Reardon at the American College of Cardiology Annual Scientific Session (ACC 2017), Washington, DC, March 17, 2017.

Clinical Topics:Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords:ACC17, ACC Annual Scientific Session, Aortic Valve, Aortic Valve Stenosis, Atrial Fibrillation, Bayes Theorem, Bioprosthesis, Cardiac Surgical Procedures, Heart Valve Prosthesis, Heart Valve Diseases, Hemorrhage, Kidney Failure, Chronic, Myocardial Revascularization, Pacemaker, Artificial, Percutaneous Coronary Intervention, Standard of Care, Stroke, Transcatheter Aortic Valve Replacement


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