Best of #AHA21 Scientific Sessions: coronary and valvular heart disease trials
Reviews from the AHA 2021 Scientific Sessions
Vijay Kunadian provides summaries of study designs and findings in Interventional Cardiology released at the 2021 virtual edition of the American Heart Association Congress. View an infographic of the AVATAR late-breaking trial by Ali Nazmi Calik.
AHA Scientific Sessions 2021
Late-breaking science in coronary and valvular heart disease
AVATAR:
Asymptomatic severe aortic stenosis patients
Among patients with symptomatic severe aortic stenosis, surgical aortic valve replacement (SAVR) has a class IB indication (ESC 2021 Guidelines on the management of valvular heart disease).
However, there are only a few studies evaluating patients with asymptomatic severe aortic stenosis. ESC guidelines currently have a Class IIA/B recommendation for intervention in asymptomatic severe AS patients with EF > 55 % and normal exercise test.
The RECOVERY trial that was published last year (N Engl J Med 2020;382:111-9) consisting of 145 patients, showed that among asymptomatic patients with very severe aortic stenosis, the incidence of the composite of operative mortality or death from cardiovascular causes during the follow-up period was significantly lower among those who underwent early aortic valve replacement surgery than among those who received conservative care (Hazard Ratio, 0.09; 95 % confidence interval [CI], 0.01 to 0.67; P = 0.003).
AVATAR Study Design:
At the AHA Scientific Sessions 2021, the AVATAR (The Aortic Valve replAcemenT versus conservative treatment in Asymptomatic seveRe aortic stenosis) trial was presented with simultaneous publication Circulation adding to the growing evidence on the best care of asymptomatic patients with severe AS.
AVATAR is an investigator-initiated international prospective RCT that evaluated the safety and efficacy of early SAVR in the treatment of asymptomatic patients with severe AS.
The study recruited 157 patients from 9 centres in 7 European countries with a mean age of 67 years (43 % women). Patients were randomly allocated to early surgery (n = 78) or conservative treatment (n = 79).
- Severe AS was defined as valve area ≤ 1 cm2 with aortic jet velocity > 4 m/s or a mean trans-aortic gradient ≥ 40 mm Hg, and with normal LV function.
- Patients with positive exercise test were excluded. Positive exercise test included onset of AS-related symptoms, fall in systolic blood pressure (≥ 20 mmHg from the baseline values) or ECG or stress echocardiography signs of myocardial ischemia.
AVATAR Study Findings:
Courtesy of Ali Nazmi Calik
- In the early surgery group, 92.3 % underwent SAVR with operative mortality of 1.4 %.
- Patients randomized to early surgery had a 54 % relative reduction in the incidence of primary composite endpoint (all-cause death, acute myocardial infarction, stroke or unplanned hospitalization for heart failure) than those in the conservative arm (HR 0.46, 95 % CI 0.23-0.90, p = 0.02).
AVATAR supports early SAVR in asymptomatic severe AS patients adding to the growing evidence among these patients.
There are a few more ongoing studies evaluating the same clinical question and we await the results.
RAPID CABG:
RAPID CABG is a physician-initiated multi-centre randomized study evaluating the safety of early surgery at 2 to 3 days after ticagrelor cessation compared to a delay of 5 to 7 days, among patients presenting with ACS (unstable angina, NSTEMI, STEMI) requiring non-emergent CABG.
RAPID CABG Study Design:
143 patients were enrolled. Patients were randomized 1:1 to early CABG versus delayed CABG following coronary angiography.
RAPID CABG Study Findings:
- An early surgical strategy was non-inferior with respect to the occurrence of severe or massive bleeding compared to delaying surgery (4.6 % early vs. 5.2 % delayed, p = 0.025 for non-inferiority).
- Early surgery 2-3 days was non-inferior with respect to the occurrence of severe or massive perioperative bleeding compared to delayed surgery.
- There were no differences in TIMI CABG, BARC Types 4 or 5 bleeding.
- Patients in the delayed group had ischemic events requiring earlier surgery.
- The early surgery group had a reduced length of hospital stay by 3 days.
The findings of RAPID CABG are of clinical relevance given majority of our ACS patients are on a P2Y12 inhibitor and alleviate the concerns regarding bleeding among patients referred for early CABG albeit in the context of a sample size in RAPID CABG.
Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation
Tricuspid regurgitation is common in patients with severe degenerative mitral regurgitation. It is not clear if tricuspid-valve repair during mitral-valve surgery should be performed in patients who have moderate tricuspid regurgitation or less-than-moderate regurgitation with annular dilatation.
Gammie and colleagues evaluated this in the late-breaking trial presented at AHA and simultaneously published in NEJM (DOI: 10.1056/NEJMoa2115961).
Study Design:
401 patients who were undergoing mitral-valve surgery for degenerative mitral regurgitation were randomised to receive a procedure with or without tricuspid annuloplasty (TA).
Study findings:
- Patients who underwent mitral-valve surgery plus TA had fewer primary-end-point events (composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death) than those who underwent mitral-valve surgery alone (3.9 % vs. 10.2 %; relative risk, 0.37; 95 % CI, 0.16 to 0.86; P = 0.02).
- Two-year mortality was 3.2 % vs. 4.5 % (relative risk, 0.69; 95 % CI, 0.25 to 1.88) in the surgery-plus-TA group and in the surgery-alone group.
- The 2-year prevalence of progression of tricuspid regurgitation was lower in the surgery-plus-TA group than in the surgery-alone group (0.6 % vs. 6.1 %; relative risk, 0.09; 95 % CI, 0.01 to 0.69).
- The incidence of permanent pacemaker implantation was higher in the surgery-plus-TA group than in the surgery-alone group (14.1 % vs. 2.5 %; rate ratio, 5.75; 95 % CI, 2.27 to 14.60).
This trial showed that the combination of mitral-valve and tricuspid valve surgery resulted in a less frequent progression to severe tricuspid regurgitation at the expense of more frequent permanent pacemaker implantation.
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