This clinical trial aims to compare conventional radial access versus distal radial access in patients with STEMI undergoing PCI. The main question it aims to answer is: • Mayor adverse cardiac events (MACE) at 30 days in STEMI patients treated by PCI are not inferior when comparing the distal radial approach versus the conventional radial approach ? Participants will: * sign the informed consent to enroll in the clinical trial. * will agree to be treated by PCI * will be randomized 1:1 to perform PCI by conventional radial or distal radial approach. If there is a comparison group: Researchers will compare conventional radial access vs distal radial access to see if the distal approach is not inferior compared to the conventional radial access in order to offer less or equal MACE and a similar rate of a successful procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,922
* Randomized patients with a right patent radial artery. * The outcomes of the distal radial approach will be compared with those of the conventional radial approach. * Technique and devices (introducer and compression devices) are the same in both approaches.
Instituto Nacional de Cardiología Ignacio Chávez
Mexico City, Mexico
RECRUITINGComposite of adverse events of all-cause mortality, myocardial infarction, cerebral vascular event, BARC 3-5 (Bleeding Academic Research Consortium), myocardial infarction and cerebrovascular event, bleeding measure will be with BARC classification.
At 24 hours and 30 days after the procedure, patients will be evaluated by radial doppler ultrasonography, lab test, and interrogation of clinical adverse events during hospital stay or 30 days after PCI.
Time frame: 24 hours and 30 days after PCI.
Incidence of myocardial infarction after the procedure
A new STEMI event is an event that meets the fourth definition of a myocardial infarction according to the current guidelines.
Time frame: 24 hours to 30 days after PCI
Incidence of cerebral vascular event (hemorrhagic or ischemic stroke) after the procedure
Diagnosed by a doctor based on clinical symptoms and imaging tests (CT scan).
Time frame: 24 hours to 30 days after PCI.
Urgent TVR (Revascularization of the treated vessel)
Diagnosed by coronary angiography or intracoronary imaging (IVUS/OCT) showing a complication related to the culprit vessel of the initial event.
Time frame: If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.
Definite stent thrombosis
Diagnosed by coronary angiography or intracoronary imaging (IVUS/OCT) showing a complication related to the culprit vessel of the initial event.
Time frame: If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.
Bleeding assessed by BARC 3-5 to 30 days of evolution in patients with STEMI who received interventional treatment via RD access versus RC access.
Evaluated by BARC scale will be used to classify the severity of bleeding into types 0-5 (3-5 are the most important criteria for the clinical trial will define the worse outcome ) Type 0 = no evidence of bleeding Type 1 = minimal bleeding Type 2 = clinically evident bleeding other than 3, 4 or 5 Type 3 = with haematocrit fall ≥ 3g% and/or hemodynamic compromise and/or requiring transfusion and/or intracranial or intraocular bleeding Type 4 = associated with Myocardial Revascularization Surgery Type 5 = fatal bleeding.
Time frame: 24 hours to 30 days after PCI.
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