Culprit-first in Primary Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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The aim of this study is to assess the impact of culprit-first versus culprit-last percutaneous coronary intervention on the door to balloon time and clinical outcomes in patients with ST-elevation myocardial infarction.

Detailed Description
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Ischemic heart disease (IHD) is the single most common cause of death and its frequency is increasing globally. It is estimated that IHD is the cause of 1.8 million deaths or 20% of all deaths in Europe. Despite advancements in the fields of rapid diagnosis and in treatment strategies, the morbidity, and mortality in patients with ST-segment myocardial infarction remains substantial, with an estimated mortality rate of 4-12% according to registries of the ESC countries. According to the 2017 European Society of Cardiology (ESC) guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation (STEMI), there is a level 1 recommendation with a level of evidence A for primary percutaneous coronary intervention (PPCI) strategy in patients with STEMI, and this strategy is preferred over fibrinolytic therapy. In addition, the ESC guidelines recommend a first medical contact to reperfusion time within 60 minutes in STEMI patients for primary PCI-capable centers. This recommendation is supported by a recently published study that showed shortening door to balloon (D2B) time was significantly associated with survival benefit. Based on the recommendation for maximal D2B time in STEMI patients to be 60 minutes, many countries and institutions worldwide have established programs, among them the national program for quality indicators by the Israeli ministry of health, to shorten D2B times. According to data published by the Israeli ministry of health in the year 2018, 88% of STEMI patients had a D2B time of <90 minutes. The common practice during PPCI is to complete diagnostic angiography of the whole coronary tree before performing culprit-vessel revascularization. This practice is not evidence-based and current guidelines do not prioritize full diagnostic angiography over culprit-vessel revascularization first. As was found in previous studies, this practice might result in delaying revascularization by 4-8 minutes in D2B time. This delay might potentially lead to worse outcomes in STEMI patients, although not proven in the above-cited studies.

Official Title
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Culprit-first Versus Culprit-last Approach During Primary Percutaneous Coronary Intervention in Patients With ST-elevation Myocardial Infarction: A Randomized Controlled Study

Conditions
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STEMI, Coronary Artery Disease, Ischemic Heart Disease, Myocardial Infarction, Stent

Intervention / Treatment
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* Procedure: Culprit-first PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting with STEMI who are eligible for PPCI Exclusion Criteria: Cardiac arrest Cardiopulmonary resuscitation or extracorporeal membrane oxygenation on arrival to the catheterization laboratory Prior coronary artery bypass grafting surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culprit-first PCI<br>In this arm, primary PCI with stent implantation will be performed prior to the demonstration of the whole coronary tree. The suspected culprit artery will be demonstrated first and the PCI will be performed. | Procedure: Culprit-first PCI<br>* PCI to the culprit artery prior to the demonstration of the whole coronary tree.<br>|
| No Intervention: Culprit-last PCI<br>In this arm, primary PCI with stent implantation will be performed after the demonstration of the whole coronary tree. The suspected culprit artery will be demonstrated after the contralateral side and then PCI will be performed. This is the common approach. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle-to-balloon time of 10 minutes or less | Change in needle-to-balloon time in minutes | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for hemodynamic (mechanical/medical) support during PCI | Number of patients that needed mechanical support during PCI | through study completion, an average of 1 year | 
| Need for respiratory support during PCI | Number of patients that needed respiratory support during PCI | through study completion, an average of 1 year | 
| Rate of failed PCI | As determined by the operator | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, STEMI, primary PCI, door-to-balloon time