Clinical trial NCT02939976: Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)
Official title: Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE STEMI for Seniors)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myocardial Infarction
Keywords: ST-Elevation Myocardial Infarction
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Medtronic Vascular
name: Volcano Corporation
name: Terumo Medical Corporation
First posted: 2016-10-20
Enrollment: 427
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with partially blocked blood vessel(s) in their heart may need a medical procedure called "Percutaneous Coronary Intervention (PCI)" to open the narrowed blood vessel(s). The purpose of this study is to simultaneously address four potential advances in ST-Elevation Myocardial Infarction (STEMI) care for patients at least 65 years old. The investigators are looking to see if these advances can improve the outcome for these patients.

1. Opening the arteries with a Medtronic stent
2. Radial access (from wrist) success with a Medtronic stent
3. Checking the percent of blockage in the diseased artery/arteries using Volcano guide wires.
4. Reduced bleeding and vascular complications with radial arterial access for primary PCI in STEMI.

Detailed description: Multicenter, randomized, open-label, unblinded, active and historical-controlled trial in which approximately 875 seniors undergoing urgent PCI from approximately 70 centers will be enrolled. All consented subjects will undergo attempted radial arterial access.

For DES (Drug Eluting Stent) eligible patients without randomization exclusion criteria and with multi-vessel disease identified during initial angiogram will be randomized by site in a ratio of 1:1 to IRA-only revascularization or iFR-guided complete revascularization. After randomization, subjects with stable TIMI-3 flow established in the IRA using the protocol specified treatment will proceed with the randomized procedure. Subjects in whom IRA reperfusion with TIMI-3 flow is not achieved will be treated according to clinical best practice standard of care independent of randomized procedure assignment and will not be considered protocol violations. These patients will be followed identically to all study patients.

After stent implantation, subjects will be contacted for follow-up at 30 days by the enrolling site and at 1 year by the DCRI Call Center.

Primary endpoint results will be reported after all subjects have completed 1 year (12 months) of clinical follow-up.

STEMI patients eligible for radial access:

* DES Eligible with single vessel Coronary Artery Disease (CAD) will receive DES to IRA
* DES Eligible with Multi-vessel CAD will randomize 1:1 to IRA-only revascularization or Instantaneous Wave Free Radio (iFR)-guided complete revascularization

Eligibility criteria: Inclusion Criteria

1. Have the capacity to understand and sign an informed consent or have a Legally Authorized Representative that can understand and sign an informed consent prior to initial arteriotomy access.
2. Age ≥ 60 years of age at the time of signing the informed consent and/or randomization.
3. Significant ST-elevation myocardial infarction or left bundle branch block (LBBB) on ECG with chest pain \< 12 hours.
4. Accessible right or left radial artery conduit for PCI.
5. Physician intent to perform trans-radial PCI.
6. Willing to be contacted at 1 year by the DCRI Call Center

Study Randomization Inclusion Criteria

To be eligible for randomization in the 'IRA only vs. Complete Revascularization' phase of this trial, subjects must meet all of the above criteria and all of the following criteria subsequent to arterial access:

1. Subject eligible for DES implantation.
2. Angiographic multi-vessel CAD determined by local visual estimation.

Exclusion Criteria

1. Patient that have known medical conditions that would prevent or interrupt the recommended post procedure DES treatment regimen.
2. Patients that have known medical conditions that would prevent catheterization through the radial artery.
3. Patients that have known medical conditions that increase patient's risk above standard when using IFR.
4. Has had a cerebrovascular accident or transient ischemic neurological attack within the past 6 months.
5. Known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause noncompliance with the protocol.
6. Any condition associated with a life expectancy of less than 1 year.
7. Participation in another clinical study using an investigational agent or device within the past 3 months.

Study Randomization Exclusion Criteria If a subject who has been consented into the SAFE STEMI study develops or is found to have any of the following, they will not be eligible for randomization to an iFR guided complete revascularization vs. IRA-only primary PCI and will be excluded from the study.

1. Shock requiring pressors or mechanical circulatory assist support (IABP, Impella, ECMO, etc.) significant chronic renal disease (eGFR \< 30) and/or on dialysis.
2. Other angiographic exclusions:

   * Single vessel CAD
   * Unprotected left main coronary artery disease
   * One or more major coronary distributions with CTO or indeterminate IRA
3. Clinical circumstances, which, in the judgment of the operator, preclude randomization.

Primary outcomes:
measure: Adjudicated 1-year Infarct-related Artery Major Adverse Cardiac and Cerebrovascular Event (MACE)
timeFrame: 1 year
measure: Adjudicated 1-year Modified CvLPRIT (Complete Versus Lesion-only Primary PCI Trial) MACE
timeFrame: 1 year
measure: Estimate of the Incidence Rate of Radial Artery Occlusion (RAO)
timeFrame: During procedure
measure: Estimate of the Incidence Rate of Radial Artery Occlusion (RAO)
timeFrame: 30 day
Secondary outcomes:
measure: Adjudicated Death (All Causes)
timeFrame: Baseline to 30 days
measure: Adjudicated Death (All Causes)
timeFrame: Day 31 to 1 year
measure: Adjudicated Cardiac Death
timeFrame: Baseline to 30 days
measure: Adjudicated Cardiac Death
timeFrame: Day 31 to 1 year
measure: Adjudicated Nonfatal (re-) MI Myocardial (Infarction)
timeFrame: Baseline to 30 days
measure: Adjudicated Nonfatal (re-) MI
timeFrame: Day 31 to 1 year
measure: Adjudicated Index Infarct Related Vessel (re-) MI
timeFrame: Baseline to 30 days
measure: Adjudicated Index Infarct Related Vessel (re-) MI
timeFrame: Day 31 to 1 year
measure: Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)
timeFrame: Baseline to 30 days
measure: Adjudicated Index Infarct Related Lesion Revascularization (IILR) (Ischemia Driven)
timeFrame: Day 31 to 1 year
measure: Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)
timeFrame: Baseline to 30 days
measure: Adjudicated Index Infarct Vessel Revascularization (IIVR) (Ischemia Driven)
timeFrame: Day 31 to 1 year
measure: Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
timeFrame: Post-Procedure (0-24 hours post stent)
measure: Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
timeFrame: 30 days (>24 hours through 30 days post stent)
measure: Adjudicated Academic Research Consortium (ARC) Definite/Probable Stent Thrombosis
timeFrame: 1 year (>30 days post stent)
measure: Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
timeFrame: Post-procedure (0-24hr post stent)
measure: Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
timeFrame: 30 days (>24hr to 30 days post stent)
measure: Adjudicated Academic Research Consortium (ARC) Definite Stent Thrombosis
timeFrame: 1 year (>30 days post stent)
measure: Adjudicated Stroke
timeFrame: Post-procedure
measure: Adjudicated Stroke
timeFrame: Baseline to 30 days
measure: Adjudicated Stroke
timeFrame: Day 31 to 1 year
measure: Adjudicated Death (All Causes)
timeFrame: Baseline to 30 days
measure: Adjudicated Death (All Causes)
timeFrame: Day 31 to 1 year
measure: Adjudicated Cardiac Death (All Causes)
timeFrame: Baseline to 30 days
measure: Adjudicated Cardiac Death (All Causes)
timeFrame: Day 31 to 1 year
measure: Heart Failure (Requiring Hospitalization or 12 Hour ER Visit)
timeFrame: Baseline to 30 days
measure: Heart Failure (Requiring Hospitalization or 12 Hour ER Visit)
timeFrame: Day 31 to 1 year
measure: Ischemia-driven Revascularization for Index Infarct Vessel Revascularization (IIVR) or Any Treated Index Non-infarct Related Vessels (INIVR)
timeFrame: 30 days
measure: Incidence of RAO, Stratified by Whether or Not the Terumo TR Band Was Employed in Combination With GlideSheath Slender
timeFrame: 30 days
measure: Site Reported Time to Achieve Hemostasis
timeFrame: Post-procedure
measure: Incidence Rate of Cross Over From the Initial Access Point to Another Stratified by Whether or Not Terumo Slender GlideSheath Was Employed
timeFrame: During procedure
measure: Incidence Rate of Access Success
timeFrame: During procedure
Other outcomes:
measure: Medtronic Resolute® Family of Stents - Site Determination of Procedure Success
timeFrame: During index procedure in-hospitalization
measure: Medtronic Resolute® Family of Stents - Site Determination of Lesion Success
timeFrame: During index procedure
measure: Medtronic Resolute® Family of Stents - Site Determination of Device Success
timeFrame: During index procedure
measure: iFR Guided Revascularization - Site Reported Index Hospitalization Bleeding and Vascular Complication Defined as Bleeding or Vascular Complication Requiring Intervention
timeFrame: During procedure
measure: iFR Guided Revascularization With Volcano Based Pressure Wires Verrata®, Verrata Plus® and Any Subsequent Marketed Volcano Pressure Wire Technology - Total Procedure Time
timeFrame: During procedure
measure: iFR Guided Revascularization With Volcano Based Pressure Wires Verrata®, Verrata Plus® and Any Subsequent Marketed Volcano Pressure Wire Technology - Total Contrast Used
timeFrame: During procedure
measure: Occurrence of Renal Insufficiency
timeFrame: 48-72 hours post-procedure
measure: Occurrence of Renal Insufficiency
timeFrame: 30 days
Locations:
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: David F Kong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Mitchell W Krucoff, MD
role: STUDY_CHAIR
References: