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| | Notion | Evolut Low-Risk Trial | PARTNER III |
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| Valve type | Self-expanding | Self-expanding | Balloon-expandable |
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| Number of patients | 280 | 1200 | 1328 |
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| Average age | 79.1 years | 74 years | 73 years |
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| Inclusion STS PROM score | N/A (81.8% of patients were at low-risk, with a STS<4) | <3 | <4 |
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| Mean STS PROM score | 3.0% | 1.9% | 1.9% |
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| Inclusion Criteria | (i) Patients ≥70 years of age with severe
degenerative AS referred for SAVR and also
candidates for TAVR were eligible for inclusion
regardless of their predicted risk of death after
surgery.
(ii) Severe AS was defined as an effective orifice
area <1 cm2 or indexed for body surface area
<0.6 cm2/m2 and a mean AV gradient >40 mm Hg
or peak systolic velocity >4 m/s.
(iii) Symptomatic patients had to have dyspnea,
NYHA class II or higher, angina pectoris, or
cardiac syncope to qualify for the trial.
(iv) Asymptomatic patients could be included if
they had left ventricular posterior wall thickness
≥17 mm, decreasing LVEF, or new-onset AF.
(v) Eligible patients were expected to survive for
more than 1 year.
| (A) Severe aortic stenosis:
(a) for symptomatic patients, AVA ≤1.0 cm2
(or AVA index of ≤0.6 cm2/m2) or mean gradient
≥40 mmHg or maximal AV velocity ≥4.0 m/sec
by TTE at rest.
(b) For asymptomatic patients,
(i) very severe AS with an AVA of ≤1.0 cm2
(or AVA index of ≤0.6 cm2/m2) and maximal
aortic velocity ≥5.0 m/sec, or mean gradient
≥60 mmHg by TTE at rest or
(ii) AVA of ≤1.0 cm2 (or AVA index of
≤0.6 cm2/m2) and a mean gradient ≥40 mmHg
or maximal AV velocity ≥4.0 m/sec by TTE at
rest and an exercise tolerance test that
demonstrates a limited exercise capacity,
abnormal BP response or arrhythmia or
(iii) AVA of ≤1.0 cm2 (or AVA index of
≤0.6 cm2/m2) and mean gradient ≥40 mmHg
or maximal AV velocity ≥4.0 m/sec by TTE at
rest and LVEF <50%.
(B) The patient is considered low risk for surgery,
with a predicted risk of mortality for surgery <3%
at 30 days per multidisciplinary local heart team
assessment.
C) Agreement that the patient will return for all
required postprocedure follow-up visits. | (A) Severe calcific AS with AVA ≤1.0 cm2 or AVA
index ≤0.6 cm2/m2 and Jet velocity ≥4.0 m/s or
mean gradient ≥40 mmHg.
(B) NYHA functional class ≥2 or exercise
tolerance test that demonstrates a limited exercise
capacity, abnormal BP response or arrhythmia or
asymptomatic with LVEF <50% (echo must be
within the 90 days prior to randomization).
(C) Heart team agrees the patient has a low risk of
operative mortality and an STS < 4.
D) The patient has provided written informed
consent.
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| Selected exclusion criteria | (i) Other severe valvular disease or CAD requiring
intervention.
(ii) Previous cardiac surgery.
(iii) Stroke or MI within 30 days.
(iv) Renal failure requiring dialysis.
(v) Pulmonary failure with forced expiratory
volume within 1 second (FEV1) <40% of expected.
| (i) Bicuspid AV.
(ii) Preexisting prosthetic heart valve
(iii) Candidates for mechanical valves.
(iv) Valvular disease (severe MR, severe TR,
≥moderate MS) that is amenable to surgery
or repair.
(v) Unprotected left main coronary artery
and/or multivessel coronary disease with
SYNTAX score >22.
(vi) Stroke or TIA within 2 months,
MI within 30 days.
(vii) Estimated life expectancy under
2 years.
| (i) AV that is bicuspid, unicuspid, or noncalcified.
(ii) Severe MR, severe AR, or ≥ moderate MS.
(iii) Preexisting mechanical or bioprosthetic valve
(not including mitral ring).
(iv) LVEF < 30%.
(v) unprotected left main coronary artery,
SYNTAX score >32 (in absence of prior
revascularization), no ability for optimal
coronary revascularization.
(vi) Stroke or TIA within 90 days.
(vii) MI within 30 days.
(viii) Renal insufficiency (eGFR< 30 mL/min) or
requiring renal replacement therapy.
(ix) Severe lung disease with FEV1 < 50% of
predicted or currently on home oxygen.
(x) Significant frailty.
(xi) History of cirrhosis or active liver disease.
(xii) Estimated life expectancy under 2 years. |
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| Endpoint | All-cause mortality, stroke and MI at one year. | All-cause mortality or disabling stroke at 2 years. | All-cause mortality, stroke, and rehospitalization at 1 year |
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| Result | No significant difference between TAVR and SAVR. | TAVR noninferior to SAVR. | TAVR superior to SAVR, with significantly lower rate of death, stroke, or rehospitalizations. |
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