International prospective cohort study of microvascular angina - Rationale and design

Area of Science:

• Cardiology
• Vascular Medicine
• Clinical Research

Background:

• Patients with myocardial ischemia symptoms and non-obstructive coronary artery disease (CAD) often exhibit coronary functional abnormalities, particularly coronary microvascular dysfunction.
• Microvascular angina (MVA) is diagnosed based on specific criteria, yet its clinical profile and long-term prognosis require further investigation.
• The COVADIS (COronary VAsomotor Disorders International Study) group has proposed diagnostic criteria for MVA, increasing its recognition in clinical practice.

Purpose of the Study:

• To prospectively evaluate the clinical characteristics of patients diagnosed with MVA.
• To assess the long-term prognosis and major adverse cardiovascular events (MACE) in MVA patients.
• To gather international, multicenter data on MVA within the current clinical era.

Main Methods:

• An international, multicenter, observational, prospective registry study.
• Inclusion criteria: signs/symptoms of myocardial ischemia, absence of obstructive CAD, and evidence of myocardial ischemia/coronary microvascular dysfunction (COVADIS criteria).
• Primary endpoint: composite of MACE (cardiovascular death, MI, stroke, HF or unstable angina hospitalization). 706 MVA subjects enrolled across 15 centers in 7 countries (July 2015-Dec 2018), with at least 1-year follow-up.

Main Results:

• Data collection is ongoing, with 706 MVA subjects registered between July 2015 and December 2018.
• The study cohort comprised 256 males and 450 females, with a mean age of 61.1 ± 11.8 years.
• Long-term follow-up data on MACE is pending.

Conclusions:

• This study is expected to yield significant insights into the clinical characteristics and management strategies for MVA.
• The findings will elucidate the long-term prognosis of MVA patients in the current healthcare landscape.
• Results will contribute valuable information for refining diagnostic and therapeutic approaches for microvascular angina.