Deferred or Immediate Stent Implantation Based on Microvascular Function in STEMI (SALVAGE)

Deferred Versus Immediate Stent Implantation for Preventing Microvascular Dysfunction and Improving Clinical Outcomes in Patients With ST-Segment Elevation Myocardial Infarction (SALVAGE)

Timely percutaneous coronary intervention (PCI) with stenting implantation is the current standard treatment for patients with ST-segment elevation myocardial infarction (STEMI). However, stenting in thrombus-laden artery is associated with higher risk of embolization and no-or slow-reflow, leading to larger infarct size and poor prognosis. The SALVAGE study is a prospective, multicenter, randomized, controlled study aimed to optimize the therapeutic strategies (deferred vs. immediate stenting) to protect microvascular function and eventually improve clinical outcomes at 12-months in STEMI.

Study Overview

• Status: Terminated
• Conditions: ST Elevation Myocardial Infarction; Microcirculatory Perfusion
• Intervention / Treatment: Procedure: Deferred or Immediate Stent Implantation

Detailed Description

Methodology:

A multicenter, prospective, randomized, controlled clinical study enroll patients with ST-segment elevation myocardial infarction (STEMI) intended for PCI with stenting implantation. Eligible patients are randomly assigned to the immediate stenting group or delayed stenting group in a 1:1 ratio when residual stenosis >70% and TIMI grade 3 with angiography guidance.

The index of microcirculation resistance (IMR) is quantitative analysis by an invasive approach for evaluating post-infarct myocardial microcirculatory perfusion. IMR correlates with the infarct size of patients with acute myocardial infarction and predicts the improvement in left ventricular ejection fraction. Studies have shown that acute myocardial infarction patients with IMR >40 after primary PCI predict adverse long-term clinical outcomes with higher mortality and heart failure rehospitalization rates.

According to therapeutic strategies and microvascular function detected by IMR, participants are classified into four groups: immediate stenting with IMR ≥ 40, immediate stenting with IMR < 40, deferred stenting with IMR ≥ 40 and deferred stenting with IMR < 40. All randomized patients will be followed by phone call or clinical visit at 12 months.

Patient enrollment and procedure overview:

Patients aged from 18 to 80 with STEMI<12h in whom PCI is planned will be screened. Thrombectomy and balloon dilatation will be performed at the operator's discretion to restore an effective antegrade blood flow with TIMI flow grade 3. Patients with residual diameter stenosis >70% visually and TIMI blood flow grade 3 are eligible for including in the study. All patients must provide written informed consent and patients will be randomized to immediate stenting group or deferred stenting group in a 1:1 ratio. All participants in immediate stenting group will be treated with stent implantation immediately. Those assigned to the deferred arm will undergo stenting after an interval of 7±2 days. This interval will be bridged with anti-coagulant and anti-platelet therapy to reduce thrombus burden. All patients in both groups are required to take dual antiplatelet treatment while the application of low molecular weight heparin and glycoprotein IIb/IIIa inhibitor are determined by the operators. All participants are required to perform IMR pre-stenting and post-stenting to evaluate microcirculation function. All randomized patients will be followed up to 12 months to evaluate the prevalence of heart failure, all-cause mortality, recurrent infarction or targeted vessel revascularization.

Study follow-up:

Clinical follow-up:

Participants will be followed by phone calls or clinical visits by study coordinators at 1 month (+/-7 days), 3 months (+/-15 days), 6 months (+/-15 days), 9 months (+/-15 days) and 12 months (+/-30 days) after randomization. Major adverse cardiovascular events (MACEs) will be recorded throughout the study period until last patient has been followed for 12 months.

• Study Type: Interventional
• Enrollment (Actual): 629
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Beijing An Zhen Hospital, Capital Medical University
  • Hebei
    • Shijiazhuang, Hebei, China
      • Second Hospital of Hebei Medical University
  • Heilongjiang
    • Daqing, Heilongjiang, China
      • Daqing Longnan Hospital
    • Harbin, Heilongjiang, China
      • The 2nd Affiliated Hospital of Harbin Medical University
    • Jiamusi, Heilongjiang, China
      • Jiamusi City Central Hospital
    • Jiamusi, Heilongjiang, China
      • The First Affiliated Hospital of Jiamusi University
    • Mudanjiang, Heilongjiang, China
      • Mudanjiang Cardiovascular Hospital
    • Shuangyashan, Heilongjiang, China
      • Shuangyashan Mining Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years old ≤ age ≤ 80 years old;
• STEMI and the onset time <12h;
• The culprit lesions are de novo lesion;
• Sign written informed consent.

Exclusion Criteria:

• Patients are hemodynamically unstable;
• Infract-related artery diameter stenosis ≤ 70%;
• Left main disease;
• AMI caused by surgery, trauma, gastrointestinal bleeding or PCI and complications;
• AMI occurs in patients who have been hospitalized for other reasons;
• The investigator judges that the patient has poor compliance and cannot complete the study as required;
• Life expectancy ≤ 12 months;
• Heart transplant patients;
• Definite diagnosis of patients with tumors;
• Participate in other clinical studies (excluding other trials of this project) and haven't reach the primary endpoints.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IMR<40 and defer PCI; Patients whose IMR<40 undergo stent implantation after an interval of 7±2 days.	Procedure: Deferred or Immediate Stent Implantation; IMR can be used to measure the microcirculatory resistance of coronary artery. It is not clear whether the IMR value could determine the time of PCI for STEMI patients.
ACTIVE_COMPARATOR: IMR<40 and immediately PCI; Patients whose IMR<40 undergo immediately stent implantation.	Procedure: Deferred or Immediate Stent Implantation; IMR can be used to measure the microcirculatory resistance of coronary artery. It is not clear whether the IMR value could determine the time of PCI for STEMI patients.
EXPERIMENTAL: IMR≥40 and defer PCI; Patients whose IMR≥40 undergo stent implantation after an interval of 7±2 days.	Procedure: Deferred or Immediate Stent Implantation; IMR can be used to measure the microcirculatory resistance of coronary artery. It is not clear whether the IMR value could determine the time of PCI for STEMI patients.
ACTIVE_COMPARATOR: IMR≥40 and immediately PCI; Patients whose IMR≥40 undergo immediately stent implantation.	Procedure: Deferred or Immediate Stent Implantation; IMR can be used to measure the microcirculatory resistance of coronary artery. It is not clear whether the IMR value could determine the time of PCI for STEMI patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of heart failure, all-cause death, reinfarction and targeted vessel revascularization within 1 year of STEMI	MACE including the prevalence of heart failure, all-cause death, reinfarction and targeted vessel revascularization will be collected as the primary outcome.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-procedural myocardial reperfusion reinjury	Prevalence of in-hospital heart failure, all-cause death, re-myocardial infarction or targeted vessel revascularization.	through hospitalization, an average of 7 days
Procedural success and clinical success	Culprit lesion stenosis<30% in the presence of TIMI 3 grade flow after PCI are regarded as procedural success. Clinical success is determined as procedural success in the absence of in-hospital cardiac death, target vessel myocardial infarction and clinically-driven target lesion revascularization.	postprocedure and through hospitalization, an average of 7 days
ECG ST-segment resolution at 90 minutes after primary PCI	We will compare the differences of the ST-segment resolution at 90 minutes among groups after primary PCI.	90 minutes postprocedure
Peaks of CK, CK-MB, cTnI and area under CK curve	We will compare the peaks of CK, CK-MB, cTnI and area under CK curve while in hospital.	through hospitalization, an average of 7 days
LVEF detected by echocardiographic indices at 7 days after stenting, 1 month and 12 months after discharge	LVEF will be detected by echocardiographic indices at 7 days after stenting, 1 month and 12 months after discharge	7 days, 1 month and 12months
Contrast score index and myocardial blood flow detected by myocardial contrast echocardiography 7 days after stenting and 1 month after discharge	Contrast score index and myocardial blood flow detected by myocardial contrast echocardiography 7 days after stenting and 1 month after discharge	7 days and 1 month
Hospitalization due to heart failure	Prevalence of hospitalization for heart failure will be compared among groups.	1 year

Collaborators and Investigators

• Sponsor: Harbin Medical University
• Collaborators: The Second Hospital of Hebei Medical University; Beijing Anzhen Hospital; Daqing Longnan Hospital; Jiamusi City Central Hospital; Mudanjiang cardiovascular hospital; Shuangyashan Mining Hospital; First Affiliated Hospital of Jiamusi University
• Investigators: Principal Investigator: Xinshun Gu, The Second Hospital of Hebei Medical University; Principal Investigator: Lixin Lu, Daqing Longnan Hospital; Principal Investigator: Zhiyuan Weng, Jiamusi City Central Hospital; Principal Investigator: Hui Li, Shuangyashan Mining Hospital; Principal Investigator: Shan Gao, The First Affiliated Hospital of Jiamusi University; Principal Investigator: ChunMei Wang, Beijing An Zhen Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 20, 2017
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (ACTUAL): July 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: ST Elevation Myocardial Infarction; deferred stent implantation; immediate stent implantation; microcirculation function
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 2016YFC1301104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No