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Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
Duration of antiplatelet therapy after complex percutaneous coronary intervention in patients at high bleeding risk:
Marco Valgimigli1, Pieter C Smits2, Enrico Frigoli3
1Cardiocentro Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana (USI), CH-6900 Lugano, Switzerland.
Insights
Short dual antiplatelet therapy (DAPT) after biodegradable-polymer sirolimus-eluting stents in high bleeding risk patients reduced bleeding events without increasing ischemic events or death.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- High bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) often require dual antiplatelet therapy (DAPT).
- Determining optimal DAPT duration in HBR patients with complex PCI and/or acute coronary syndrome (ACS) is crucial for balancing ischemic and bleeding risks.
Purpose of the Study:
- To assess the clinical outcomes of abbreviated (1-month) versus standard (≥3-month) DAPT in HBR patients treated with biodegradable-polymer sirolimus-eluting stents for complex PCI and/or ACS.
Main Methods:
- The MASTER DAPT trial randomized 3383 patients to abbreviated or standard DAPT after PCI.
- Co-primary outcomes included net adverse clinical events (NACE), major adverse cardiac or cerebral events (MACCE), and Bleeding Academic Research Consortium (BARC) bleeding events at 335 days.
Main Results:
- Abbreviated DAPT did not differ in NACE or MACCE compared to standard DAPT in complex or non-complex PCI patients.
- BARC 2, 3, or 5 bleeding events were significantly reduced with abbreviated DAPT in both complex and non-complex PCI groups.
Conclusions:
- In HBR patients, a 1-month DAPT strategy following biodegradable-polymer sirolimus-eluting stent implantation is associated with similar ischemic event rates and lower bleeding rates compared to standard DAPT.
- This approach is safe and effective regardless of PCI complexity or ACS presence.
Aim:
To assess the effects of 1- or ≥3-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients who received biodegradable-polymer sirolimus-eluting stents for complex percutaneous coronary intervention (PCI) and/or acute coronary syndrome (ACS).
Methods And Results:
In the MASTER DAPT trial, 3383 patients underwent non-complex (abbreviated DAPT, n = 1707; standard DAPT, n = 1676) and 1196 complex (abbreviated DAPT, n = 588; standard DAPT, n = 608) PCI. Co-primary outcomes at 335 days were net adverse clinical events [NACE; composite of all-cause death, myocardial infarction, stroke, and bleeding academic research consortium (BARC) 3 or 5 bleeding events]; major adverse cardiac or cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and Types 2, 3, or 5 BARC bleeding. Net adverse clinical events and MACCE did not differ with abbreviated vs. standard DAPT among patients with complex [hazard ratio (HR): 1.03, 95% confidence interval (CI): 0.69-1.52, and HR: 1.24, 95% CI: 0.79-1.92, respectively] and non-complex PCI (HR: 0.90, 95% CI: 0.71-1.15, and HR: 0.91, 95% CI: 0.69-1.21; Pinteraction = 0.60 and 0.26, respectively). BARC 2, 3, or 5 was reduced with abbreviated DAPT in patients with and without complex PCI (HR: 0.64; 95% CI: 0.42-0.98, and HR: 0.70; 95% CI: 0.55-0.89; Pinteraction = 0.72). Among the 2816 patients with complex PCI and/or ACS, NACE and MACCE did not differ and BARC 2, 3, or 5 was lower with abbreviated DAPT.
Conclusion:
In HBR patients free from recurrent ischaemic events at 1 month, DAPT discontinuation was associated with similar NACE and MACCE and lower bleeding rates compared with standard DAPT, regardless of PCI or patient complexity.
Clinical Trial Registration:
This trial is registered with ClinicalTrials.gov, number NCT03023020, and is closed to new participants, with follow-up completed.
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