Angina Pectoris, Coronary Artery Disease
Conditions
Keywords
Coronary artery disease, Angina pectoris, Angioplasty, Appropriateness, Prognosis, Treatment
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.
Interventions
PROCEDUREPercutaneous Coronary Intervention (PCI)
A percutaneous coronary intervention (PCI) is a minimally invasive procedure to open blocked coronary (heart) arteries. An older name for PCI is coronary angioplasty with stenting or angioplasty for short.
Sponsors
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
University of Sao Paulo General Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical and sociodemographic predictors of rarely appropriate elective PCI | Immediately following the procedure | Clinical and sociodemographic predictors of rarely appropriate elective PCI |
Countries
Brazil
Contacts
Primary ContactLuis Henrique W Gowdak, MD, PhD
Backup ContactSara DV Ziotti, MD
Outcome results
None listed