Appropriateness of Angioplasty in Patients With Chronic Coronary Syndromes

Recruiting

• Conditions: Coronary Artery Disease; Angina Pectoris
• Interventions: Procedure: Percutaneous Coronary Intervention (PCI)

• Registration Number: NCT06545448
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

Percutaneous coronary intervention (PCI) has dramatically changed the treatment of obstructive coronary artery disease patients. PCI is indicated in patients with chronic coronary syndrome (CCS) symptoms unresponsive to optimized medical therapy. The American College of Cardiology Foundation and partners developed in 2009 - and updated them in May 2017 - the appropriateness criteria for PCI to support the rational use of PCI in chronic patients and to provide patients with high-quality cardiovascular care. Since then, these criteria have been applied to guide physicians and serve as metrics of the quality of care based on the best available scientific evidence. Countries like the United States and Japan already have robust studies on the topic with important repercussions on clinical practice. In Brazil, to date, there are no studies on the adequacy of PCIs in patients with CCS.

Detailed Description

Percutaneous coronary intervention (PCI) has dramatically changed the treatment of obstructive coronary artery disease patients. PCI is indicated in patients with chronic coronary syndrome (CCS) symptoms unresponsive to optimized medical therapy. The American College of Cardiology Foundation and partners developed in 2009 - and updated them in May 2017 - the appropriateness criteria for PCI to support the rational use of PCI in chronic patients and to provide patients with high-quality cardiovascular care. Since then, these criteria have been applied to guide physicians and serve as metrics of the quality of care based on the best available scientific evidence. Countries like the United States and Japan already have robust studies on the topic with important repercussions on clinical practice. In Brazil, to date, there are no studies on the adequacy of PCIs in patients with CCS.

The primary goal of the RIGHT-PCI study is to determine the rate of PCI indications categorized as appropriate, possibly appropriate, or rarely appropriate in patients with CCS undergoing elective PCI based on criteria established in medical literature at a Cardiology reference university hospital. To achieve this objective, we plan to analyze approximately 2,500 consecutive angioplasties performed between 2017 and 2020.

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2020-12-12
• Status Verified: 2024-08
• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-05
• Last Update Submitted: 2024-08-05
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1875

Inclusion Criteria

• All patients within the age range who underwent elective PCI defined as a procedure indicated in an outpatient scenario or an inpatient in a non-acute setting when the Heart Team was called to evaluate the patient and agreed with the indication for PCI

Exclusion Criteria

• History of acute coronary syndrome < 30 days of the referral for PCI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing elective PCI	Percutaneous Coronary Intervention (PCI)	Patients undergoing elective PCI for chronic coronary syndrome in a tertiary hospital in a single center in Brazil between 2017-2020.

Primary Outcome Measures

Name	Time	Method
Determine the rates of elective PCI classified as appropriate, possibly appropriate, or rarely appropriate.	Immediately following the procedure	Determine the rates of elective PCI classified as appropriate, possibly appropriate, or rarely appropriate based on the Appropriateness Criteria proposed by the ACC / AHA in 2017.

Secondary Outcome Measures

Name	Time	Method
Incidence of persistent or recurrent post-PCI angina or new onset/worsening heart failure	12 months after the procedure index	Incidence of persistent or recurrent post-PCI angina or new onset/worsening heart failure both clinically manifest
Incidence of the composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, periprocedural stroke, or the need for new revascularization)	12 months after the procedure index	Incidence of the composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction based on the 4th Universal Definition of MI, periprocedural stroke occurring during the hospitalization index, or the need for new revascularization either by CABG or PCI)

Trial Locations

Locations (1)

Heart Institute (InCor-HCFMUSP); 🇧🇷 São Paulo, SP, Brazil