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Prasugrel Dose De-escalation Therapy After Complex Percutaneous Coronary Intervention in Patients With Acute Coronary
Doyeon Hwang1, Young-Hyo Lim2, Kyung Woo Park1
1Seoul National University Hospital, Seoul, Republic of Korea.
Insights
De-escalating prasugrel dosage after acute coronary syndrome (ACS) reduces bleeding events without increasing ischemic risks, even in complex percutaneous coronary intervention (PCI) patients. This strategy improves net clinical outcomes for ACS patients undergoing PCI.
Area of Science:
- Cardiology
- Pharmacology
- Interventional Cardiology
Background:
- Dual-antiplatelet therapy (DAPT) with prasugrel is standard after acute coronary syndrome (ACS) and percutaneous coronary intervention (PCI).
- Dose de-escalation of prasugrel has shown benefits in reducing net adverse clinical events, primarily by decreasing bleeding without compromising ischemic outcomes.
- The efficacy and safety of prasugrel dose de-escalation in patients undergoing complex PCI remain unclear.
Purpose of the Study:
- To evaluate the effectiveness of prasugrel dose de-escalation in patients who underwent complex percutaneous coronary intervention (PCI).
- To determine if the benefits of reduced prasugrel dosage are maintained in the complex PCI subgroup.
Main Methods:
- A post hoc analysis of the HOST-REDUCE-POLYTECH-ACS trial was conducted.
- Patients with ACS receiving PCI were randomized to either prasugrel dose de-escalation (5 mg daily) or conventional therapy (10 mg daily) at 1 month post-PCI.
- Complex PCI was defined by specific procedural characteristics, including multiple stents, lesions, bifurcation involvement, or left main intervention.
Main Results:
- Complex PCI was associated with higher ischemic event rates but not bleeding outcomes.
- Prasugrel dose de-escalation did not increase the risk of major adverse cardiac events (MACE) in either complex or non-complex PCI groups.
- A significant reduction in Bleeding Academic Research Consortium (BARC) class 2 or higher bleeding events was observed with prasugrel dose de-escalation in the complex PCI subgroup (HR, 0.25; 95% CI, 0.10-0.61).
Conclusions:
- Prasugrel dose de-escalation is a safe strategy for patients with ACS undergoing PCI, regardless of procedural complexity.
- This approach may reduce bleeding events without adversely affecting ischemic outcomes in complex PCI patients.
- The findings support individualized DAPT strategies based on PCI complexity to optimize patient outcomes.
Importance:
De-escalation of dual-antiplatelet therapy through dose reduction of prasugrel improved net adverse clinical events after acute coronary syndrome (ACS), mainly through the reduction of bleeding without an increase in ischemic outcomes. However, whether such benefits are similarly observed in those receiving complex procedures is unknown.
Objective:
To investigate whether the benefits of prasugrel dose de-escalation therapy are maintained in the complex percutaneous coronary intervention (PCI) subgroup.
Design, Setting, And Participants:
This was a post hoc analysis of the HOST-REDUCE-POLYTECH-ACS trial, a randomized, open-label, adjudicator-blinded, multicenter trial performed at 35 hospitals in South Korea. Study participants included patients with ACS who were receiving PCI. Data were collected from September 30, 2014, to December 18, 2015, and analyzed from September 17, 2020, to June 15, 2021.
Interventions And Exposures:
Patients were randomized to a prasugrel dose de-escalation (5 mg daily) at 1 month post-PCI group or a conventional (10 mg daily) group. Complex PCI was defined as having at least 1 of the following features: 3 or more stents implanted, 3 or more lesions treated, bifurcation PCI, total stent length 60 mm or larger, left main PCI, or heavy calcification.
Main Outcomes And Measures:
The main analysis end points were MACE (major adverse cardiac event, a composite of cardiovascular death, nonfatal myocardial infarction, stent thrombosis, and repeat revascularization) at 1 year for ischemic outcomes, and BARC (Bleeding Academic Research Consortium) class 2 or higher bleeding events at 1 year for bleeding outcomes.
Results:
Of 2271 patients (mean [SD] age, 58.9 [9.0] years; 2024 [89%] male patients) for whom full procedural data were available, 705 patients received complex PCI, and 1566 patients received noncomplex PCI. Complex PCI was associated with higher rates of ischemic outcomes but not with bleeding outcomes. Prasugrel dose de-escalation did not increase the risk of MACE (hazard ratio [HR], 0.88; 95% CI, 0.47-1.66; P = .70 in complex PCI; HR, 0.81; 95% CI, 0.45-1.46; P = .48 in noncomplex PCI; P for interaction = .84) but decreased BARC class 2 or higher bleeding events (HR, 0.25; 95% CI, 0.10-0.61; P = .002 in complex PCI; HR, 0.62; 95% CI, 0.38-1.00; P = .05 in noncomplex PCI; P for interaction = .08), albeit with wide 95% CIs.
Conclusions And Relevance:
In this post hoc analysis of patients with ACS, prasugrel dose de-escalation compared with conventional therapy was not associated with an increased risk of ischemic outcomes but may reduce the risk of minor bleeding events at 1 year, irrespective of PCI complexity.
Trial Registration:
ClinicalTrials.gov Identifier: NCT02193971.
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