10-Year Outcomes of Deferred or Conventional Stent Implantation in Patients With STEMI (DANAMI-3-DEFER)
Marquard JM, Engström T, Kelbæk H, Beske RP, Islam U, Høfsten DE, Holmvang L, Pedersen F, Terkelsen CJ, Christiansen EH, Tilsted HH, Glinge C, Jabbari R, Eftekhari A, Raungaard B, Clemmensen P, Bøtker HE, Jensen LO, Køber L, Lønborg JT (2025) · Circulation: Cardiovascular Interventions · n=1215
Характеристика исследования
- Дизайн
- 10-year follow-up of the DANAMI-3-DEFER open-label multicenter randomized controlled trial in 4 Danish PCI centers; n=1,215 STEMI patients randomized to deferred stenting (>24h after index PCI; bivalirudin or GPIIb/IIIa inhibitor administered intravenously during the deferral period) vs conventional immediate-stent PCI (NCT01435408)
- Размер выборки (n)
- 1215
- Вмешательство
- Deferred stenting >24h after index PCI with bivalirudin or glycoprotein IIb/IIIa antagonist IV bridging (n=603)
- Компаратор
- Conventional immediate-stent primary PCI (n=612)
- Первичная конечная точка
- Composite of hospitalization for heart failure or all-cause mortality at 10 years
- Основной результат
- Primary composite not significantly reduced (HR 0.82, 95% CI 0.67-1.02, p=0.08); 10-year all-cause mortality 24% (deferred) vs 25% (conventional), HR 0.95 (95% CI 0.75-1.19); hospitalization for heart failure significantly lower with deferred stenting (OR 0.58, 95% CI 0.39-0.88); target vessel revascularization similar
- Длительность наблюдения
- 10 years
- PMID
- 40391569
Ключевые выводы
- Largest 10-year follow-up of a STEMI deferred-stenting RCT incorporating bivalirudin
- Deferred stenting reduces heart-failure hospitalization (OR 0.58)
- No 10-year mortality difference between strategies
- Demonstrates feasibility of bivalirudin-bridged deferred PCI
- Anchors long-term safety profile of bivalirudin as STEMI anticoagulant
Ограничения
- Bivalirudin was one of two bridging-arm options (GPIIb/IIIa antagonist also allowed)
- Long-term follow-up incomplete in some subgroups
- Danish single-country cohort — generalizability to other systems uncertain
- Open-label trial
- Not applicable to whole-leech hirudotherapy
Клиническое значение
Marquard 2025 anchors the long-term safety profile of bivalirudin-bridged deferred PCI in STEMI patients. For ASH, the trial serves as a landmark long-term reference for the synthetic hirudin-derivative drug pathway — distinct from the K040187 device-leech US clinical practice. The trial reinforces how the drug pathway operates under rigorous multi-year RCT follow-up that is structurally different from device-clearance pathways. Not directly applicable to US hirudotherapy clinical practice.
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