Surgical v/s conservative management in patients with Asymptomatic severe Aortic Stenosis

1. Recovery trial
Presenter: Dr. Himanshu
Chair: Dr. Mathew Iype

2. Funded by the Korean Institute of Medicine; RECOVERY ClinicalTrials.gov number,
NCT01161732.

3. Background
• Aortic stenosis - most common valvular disease in
developed countries & common in developing
countries for which surgery is indicated
• Prevalence is increasing because of aging population
• Only effective T/t for severe symptomatic AS - AVR
• 30-50% severe AS patients are asymptomatic

7. Trial design
• Randomized Comparison of Early Surgery versus
Conventional Treatment in Very Severe Aortic
Stenosis (RECOVERY) trial was designed to compare
long-term clinical outcomes of early surgical AVR
with those of a conservative care strategy based on
current guidelines in asymptomatic patients
• Multicenter, randomized, parallel-group, open-label
trial

8. Trial design
• The Korean Institute of Medicine, which
supported the trial coordinators during the first 2
years of the trial, had no role in the collection,
analysis, or interpretation of the data, writing of
the manuscript, or any other aspect of the trial.
• The trial received no other external sources of
funding.

9. Hypothesis
• The major hypothesis was that the incidence of
CV death would be lower among patients with
early surgery than who received conservative
care

10. Inclusion Criteria:
1. Male or female
2. Age: 20-80 years
3. AV area ≤ 0.75 cm2 with one of the following
– Either a peak aortic velocity ≥ 4.5 m/s or a
– mean transaortic pressure gradient ≥ 50 mm Hg
4. The patient agrees to the study

11. Exclusion Criteria
1. Patients with exertional dyspnea, syncope, presyncope or angina
2. Patients with left ventricular ejection fraction < 50%
3. Patients not candidates for surgery:
– age > 80 years and/or
– poor medical status, such as coexisting malignancies
4. Significant aortic regurgitation or significant mitral valve disease
5. Previous open heart surgery.
6. Patients who did not consent
7. Pregnancy
8. Positive exercise test

12. Trial Procedures
• Patients were randomly assigned in 1:1 ratio to early
surgery or conservative care with the use of a Web-based
interactive response system.
• Surgery group should undergo aortic valve replacement
within 2 months after randomization.
• Patients assigned to the conservative-care group received
treatment according to the ACC– AHA guidelines and they
were referred for surgery if
– they became symptomatic during follow- up,
– if the left ventricular ejection fraction decreased to less than
50%, or
– if the peak aortic jet velocity increased each year by more than
0.5 m/s

13. End points
• The primary end point
– composite of operative mortality or death from
cardiovascular causes during the follow-up period
(continuing till 4 yrs after the last patient was
enrolled)
• Secondary end points
– Death from any cause,
– Repeat aortic-valve surgery,
– Clinical thromboembolic events, and
– Hospitalization for heart failure during follow-up.

16. Aortic-Valve Replacement Procedures
• In the early-surgery group, surgical AVR was
successfully performed in all 72 patients in
whom the procedure was attempted;
– 36 patients (50%) received mechanical valve &
– 36 (50%) received a biologic prosthesis

17. Follow-up and End Points

18. Follow-up and End Points
• The cumulative incidence of the primary end
point was
– 1% at both 4 and 8 years in the early-surgery
group, v/s
– 6% at 4 years and 26% at 8 years in the conservative-
care group (P = 0.003)
• The NNT to prevent one death from
cardiovascular causes within 4 years was 20
patients

22. Conclusion
• Trial provides evidence to support early AVR in
asymptomatic patients with very severe AS

23. Limitations
• Trial involved patients with very severe AS
• Trial was not blinded, the nonfatal outcomes could
have been influenced
• Exercise testing was performed only selectively in
this trial
• The small numbers of trial patients
• Trial included relatively young patients

24. Thank you…