Electronic Real-Time Heart Team Decision-making vs. Usual Care in Patients With Triple-Vessel Coronary Artery Disease and Diabetes Mellitus

Clinical adverse events

Incidence and time to first clinical event, including: all-cause mortality, cardiac mortality, non-fatal myocardial infarction, stroke, target-vessel or graft revascularization, repeat revascularization, unplanned revascularization, rehospitalization for recurrent angina, cardiac rehospitalization, and all-cause rehospitalization.

Time frame: From randomization through 1-year follow-up (events recorded during index hospitalization and at follow-up visits up to 12 months).

Guideline-concordant revascularization decision rate

Proportion of coronary revascularization decisions that are concordant with the Guidelines class I or IIa recommendations.

Time frame: During index hospitalization (typically within 30 days of admission)

Percutaneous coronary intervention (PCI) utilization rate

Proportion of patients who undergo PCI as part of their coronary revascularization strategy.

Time frame: During index hospitalization (typically within 30 days of admission)

Coronary artery bypass grafting (CABG) utilization rate

Proportion of patients who undergo CABG as part of their coronary revascularization strategy.

Time frame: During index hospitalization (typically within 30 days of admission)

Medical therapy rate

Proportion of patients managed with medical therapy.

Time frame: During index hospitalization (typically within 30 days of admission)

Waiting time from diagnostic angiography to treatment initiation

Time from completion of diagnostic coronary angiography to initiation of the definitive treatment strategy (PCI, CABG, or medical therapy).

Time frame: During index hospitalization (typically within 30 days of admission)

Medical costs

Medical costs during the index hospitalization.

Time frame: Index hospitalization until discharge (typically within 30 days of admission).

Hospital length of stay

Number of days from hospital admission to hospital discharge for the index hospitalization.

Time frame: From hospital admission to discharge for the index hospitalization (up to 30 days).

Prolonged PCI hospitalization

Proportion of patients with prolonged length of stay after PCI, defined according to the Centers for Medicare and Medicaid Services (CMS) criteria.

Time frame: From index PCI procedure to discharge for the index hospitalization (up to 30 days).

Time spent per heart team case

Duration of each heart team discussion.

Time frame: At the time of the heart team discussion during the index hospitalization (up to 30 days from admission).

Specialist satisfaction with discussion adequacy

Satisfaction of participating specialists (interventional cardiologists and cardiac surgeons) with the adequacy of the discussion, assessed using a numeric rating scale (0-10, higher scores indicating greater satisfaction); reported as mean (±SD) score per group.

Time frame: Immediately after each heart team discussion during the index hospitalization (up to 30 days from admission).

Seniority of participating specialist in heart team discussions

Proportion of specialists with different seniority, such as associated chief, chief etc..

Time frame: From index PCI procedure to discharge for the index hospitalization (up to 30 days)

Multidisciplinary synchronous shared decision-making

Proportion of cases in which interventional cardiology and cardiac surgery participate in a synchronous discussion with patient or relatives.

Time frame: From index PCI procedure to discharge for the index hospitalization (up to 30 days)

Patient satisfaction with the decision-making process

Patient-reported satisfaction with the coronary revascularization decision-making process, assessed using a structured questionnaire with a 5-point Likert scale.

Time frame: Within 24 hours before discharge from the index hospitalization (up to 30 days from admission).

Recatheterization rate

Repeat invasive coronary angiography after the index procedure.

Time frame: During index hospitalization (typically within 30 days of admission)

Specialist workload

Workload of participating specialists based on NASA-TLX scale

Time frame: During index hospitalization (typically within 30 days of admission)

Real-time consultation response rate

A real-time response from cardiac surgeon during the coronary angiography.

Time frame: During index hospitalization (typically within 30 days of admission)