Same-Day Discharge After Elective Transradial Percutaneous Coronary Intervention: A Pilot Randomized Trial

PAULO CASTRO CHERPAK58 enrolled

Overview

This single-center pilot randomized trial evaluated the safety and feasibility of same-day discharge (within 6 hours) compared with conventional overnight hospitalization (≥24 hours) in patients with chronic coronary artery disease undergoing successful elective transradial PCI in a Brazilian public tertiary center. Participants were followed by structured telemedicine consultation at 7 days.

Adults (≥18 years) with chronic CAD scheduled for elective transradial PCI were screened. After successful PCI and confirmation of eligibility, participants were randomized 1:1 (computer-generated sequence; allocation concealment via sequentially numbered opaque sealed envelopes) to same-day discharge (≤6 h, minimum 3 h monitoring with clinical assessment, ECG and radial access evaluation) or conventional hospitalization (≥24 h). Follow-up was performed by an outcome assessor blinded to allocation via structured 7-day telemedicine consultation. Pilot/feasibility design; the full confirmatory trial targets 232 participants (116/group).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Coronary Artery Disease Chronic Coronary Syndrome Elective Percutaneous Coronary Intervention

Interventions

same day dischargeBEHAVIORAL

discharge within 6 h after successful elective transradial PCI, with 7-day telemedicine follow-up.

Conventional HospitalizationBEHAVIORAL

overnight stay ≥24 h per institutional protocol.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults ≥18 with chronic CAD undergoing successful elective transradial PCI; written informed consent. Exclusion Criteria: * LVEF ≤40%; MI within 14 days; creatinine clearance ≤45 mL/min; hemoglobin ≤10 g/dL; platelets ≤100,000/µL; INR \>1.5; allergy to aspirin, clopidogrel, or iodinated contrast; procedural (angiographic or clinical) complications; access-site complications requiring prolonged monitoring.

Locations (1)

PROCAPE

Recife, Pernambuco, Brazil

Outcomes

Primary Outcomes

Composite of major adverse clinical events

All-cause death, myocardial infarction, unplanned revascularization, stroke, hospital readmission, or major bleeding (BARC ≥3)

Time frame: 7 days after PCI

Secondary Outcomes

Emergency department visits

Any unplanned visit to an emergency department or urgent-care unit during follow-up, ascertained by the blinded assessor using the standardized structured telemedicine clinical follow-up form.

Time frame: 7 days after PCI

Recurrent chest pain

Self-reported recurrent chest pain, assessed by the blinded assessor during the standardized structured telemedicine (video) consultation using a predefined symptom checklist within the clinical follow-up form (presence vs. absence).

Time frame: 7 days after PCI

Radial access-site complications

Radial access-site complications (ARC-aligned; hematoma grades)

Time frame: 7 days after PCI

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.