SURPASS-CVOT Trial Completion Timeline
The SURPASS-CVOT trial is currently ongoing and fully recruited as of 2024, with completion expected when at least 1,615 adjudication-confirmed major adverse cardiovascular events (MACE) have occurred, though no specific completion date has been publicly announced. 1
Trial Design and Event-Driven Timeline
The SURPASS-CVOT trial is an event-driven cardiovascular outcomes trial, meaning completion depends on accumulating a predetermined number of events rather than a fixed calendar date. 1
The trial requires ≥1,615 participants to experience an adjudication-confirmed component of MACE (cardiovascular death, myocardial infarction, or stroke) before the primary analysis can be conducted. 1
Recruitment was completed over a 2-year period, with 13,299 participants randomized at 640 sites across 30 countries between 2022-2024. 1
Based on typical cardiovascular outcomes trial timelines for event-driven studies, completion is anticipated to take >5 years total duration from trial initiation, consistent with similar large-scale cardiovascular outcomes trials. 2
Baseline Population Characteristics Affecting Timeline
The enrolled population has characteristics that influence event accrual rates:
Mean age of 64.1 years with established atherosclerotic cardiovascular disease in all participants. 1
65.0% had coronary artery disease, with 47.3% reporting prior myocardial infarction and 57.4% having prior coronary revascularization. 1
19.1% had prior stroke and 25.3% had peripheral artery disease, indicating a high-risk population likely to accrue events at a reasonable rate. 1
Mean diabetes duration of 14.7 years and baseline HbA1c of 8.4%, suggesting advanced disease that may accelerate event rates. 1
Interim Analysis Considerations
While specific interim analysis plans for SURPASS-CVOT have not been publicly detailed, typical event-driven cardiovascular outcomes trials include:
Interim analyses at 50% and 75% of target events (approximately 800 and 1,200 events for a 1,600-event trial), with stringent stopping boundaries for superiority (p <0.0002) to preserve trial integrity. 2
Data Monitoring Committee reviews occurring every few months for safety surveillance, though formal stopping boundaries for safety are typically not pre-specified. 2
Practical Implications for Clinical Practice
Until SURPASS-CVOT results are available:
Real-world evidence from 2025 suggests comparable cardiovascular benefit between tirzepatide and semaglutide in clinical practice (HR 1.06; 95% CI 0.95-1.18 for head-to-head comparison). 3
Current treatment decisions should rely on established cardiovascular benefits of GLP-1 receptor agonists like dulaglutide (the active comparator in SURPASS-CVOT), which has demonstrated cardiovascular benefit in prior trials. 1