Primary Results of the EVOLVE Short DAPT Study
Key result
Three-month DAPT proves noninferior to 12 months for death or MI in high bleeding risk patients.
- difference -0.12%
- 95% CI 97.5% upper bound 1.63%
- P=0.0016
- n=2,009
Why the study?
Prolonged DAPT after PCI increases bleeding despite reducing ischemic events, and the SYNERGY stent's design elements may facilitate rapid endothelialization and enable shorter DAPT.
Does 3-month DAPT maintain non-inferior rates of death/myocardial infarction and stent thrombosis compared to 12-month DAPT in high bleeding risk patients treated with the SYNERGY everolimus-eluting stent?
Population
2009 high bleeding risk patients treated with the SYNERGY everolimus-eluting stent at 110 global sites
Comparison
3-month DAPT vs historical control and performance goal
Design
Prospective multicenter study with historical control and performance goal
Follow-up
At least 1 year
Authors
Discussion
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Member takes
Implication
Supports 3-month DAPT feasibility in high-bleeding-risk SYNERGY PCI; hypothesis-generating without randomized controls.
Key Points
- To prospectively evaluate the safety and ischemic outcomes of a 3-month dual antiplatelet therapy regimen in high-bleeding-risk patients treated with a thin-strut bioabsorbable polymer everolimus-eluting stent.
- Prospectively enrolled 2,009 high-bleeding-risk patients across 110 global sites undergoing percutaneous coronary intervention with the SYNERGY stent (NCT02605447), excluding acute myocardial infarction or complex lesions.
- Patients event-free on dual antiplatelet therapy (aspirin plus P2Y12 inhibitor) at 3 months discontinued the P2Y12 inhibitor and continued aspirin monotherapy, yielding a primary analysis cohort of 1,487 patients followed through 15 months.
- Coprimary endpoints evaluated death/myocardial infarction between 3 and 15 months against a 12-month historical control and stent thrombosis against a 1.0% performance goal.
- The adjusted rate of death or myocardial infarction between 3 and 15 months was 5.6% in the 3-month group versus 5.7% in the 12-month historical control (propensity-adjusted difference = -0.12%, 97.5% upper bound = 1.63%, prespecified margin = 2.52, P non-inferiority = 0.0016).
- Study stent-related definite or probable stent thrombosis between 3 and 15 months occurred in 0.2% of patients (97.5% upper bound = 0.63%, P = 0.0005 compared to the 1.0% performance goal).
Study Design
Type
Cohort (n=2,009)
Multicenter
Yes
Structured PICO
Does 3-month DAPT maintain non-inferior rates of death/myocardial infarction and stent thrombosis compared to 12-month DAPT in high bleeding risk patients treated with the SYNERGY everolimus-eluting stent?
P
Population
2009 high bleeding risk patients (1487 in primary analysis) treated with the SYNERGY everolimus-eluting stent at 110 global sites. Excluded: acute myocardial infarction or complex lesions.
I
Intervention
3-month dual antiplatelet therapy (aspirin + P2Y12 inhibitor) followed by P2Y12 inhibitor discontinuation and aspirin continuation.
C
Comparator
Historical control receiving 12-month DAPT (for death/MI) and a 1% performance goal (for stent thrombosis).
O
Outcome
Coprimary end points: (1) death/myocardial infarction between 3 and 15 months compared with a historical control, and (2) study stent-related definite/probable stent thrombosis between 3 and 15 months compared to a performance goal.composite
Main Result
Effect estimate: difference -0.12% (95% CI 97.5% upper bound 1.63%)
Absolute Event Rate: 5.6% vs 5.7%
p-value: p=0.0016
In selected high bleeding risk patients undergoing PCI with the SYNERGY everolimus-eluting stent, 3 months of DAPT was non-inferior to 12 months of DAPT for ischemic outcomes.
Cite This Study
Kirtane et al. (2021) conducted a cohort in High bleeding risk after percutaneous coronary intervention (n=2,009). 3-month dual antiplatelet therapy (DAPT) vs. 12-month DAPT historical control was evaluated on Death or myocardial infarction between 3 and 15 months (difference -0.12%, 95% CI 97.5% upper bound 1.63%, p=0.0016). Three-month DAPT in high bleeding risk patients receiving the SYNERGY stent was noninferior to a 12-month historical control for death or MI (5.6% vs 5.7%; P=0.0016 for noninferiority).