13
The PIIS3i study used an independent Data Safety Monitoring Board (DSMB) that was instructed to notify
Edwards Lifesciences of any safety or compliance issues and a Clinical Events Committee (CEC) that
was responsible for adjudicating endpoint related events reported during the trial in accordance with the
pre-specified, primarily Valve Academic Research Consortium-2 VARC-2 definitions
[1]
, with the following
exceptions:
• Prosthetic valve dysfunction was adjudicated per VARC-1
• Aortic valve reintervention was adjudicated per protocol definition
• Rehospitalization for symptoms of aortic stenosis and/or complications of the valve procedure
were adjudicated using the protocol and VARC-2 definitions as guidelines
The events in the PIIA-SAVR cohort were adjudicated by the CEC in accordance with the pre-specified,
primarily VARC-1 definitions, with the following exceptions:
• Acute Kidney Injury (AKI) was adjudicated with a modified VARC-1 definition in which the CEC
applied the 72-hour staging window to any AKI event that occurred within 30-days
• Aortic valve reintervention were adjudicated per the protocol definition
• Rehospitalization for symptoms of AS and/or complications of the valve procedure were
adjudicated using the protocol and VARC-1 as guidelines
• Bleeding events were adjudicated irrespective of whether there was an identifiable, overt source
of bleeding
An electrocardiogram (ECG) core laboratory was used for independent analysis of rhythm, an
echocardiographic core laboratory for echocardiograms, and a computerized tomography (CT) core
laboratory for baseline CTs for annulus dimensions.
PARTNER II SAPIEN 3 HIGH-RISK/INOPERABLE COHORT
Accountability
All 583 eligible patients were successfully implanted with a SAPIEN 3 valve, which constitutes the Valve
Implant (VI) population. Among the VI population, 491 patients were implanted via the transfemoral (TF)
access route, and 92 patients via the transapical (TA) or transaortic (TAo) access route.
Table 5:
Patient Accountability
SAPIEN 3
Valve
Overall
SAPIEN 3
Valve
Transfemoral
Access
Valve
Non-
Transfemoral
Eligible Patient
Population (EPP)
583 491 92
Valve Implant
(VI) Population
583 491 92
Eligible Patient Population (EPP) consists of all enrolled patients who received
treatment assignment from the database and entered into the catheterization
laboratory/hybrid suite and who remained eligible to receive the implant.
Valve Implant (VI) Population consists of all enrolled patients who received a
SAPIEN 3 valve, and retained the valve upon leaving the catheterization
Study Population Demographics and Baseline Parameters
The demographics of the study population are summarized in Table 6, which are typical of a TAVR study
performed in the U.S.
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