Early P2Y₁₂ Inhibitor Single Antiplatelet Therapy for High-Bleeding Risk Patients After Stenting　- PENDULUM Mono...

Area of Science:

• Cardiology
• Interventional Cardiology
• Pharmacology

Background:

• The PENDULUM mono study investigated de-escalation therapy in Japanese patients with high bleeding risk (HBR) after percutaneous coronary intervention (PCI).
• Initial one-year data suggested benefits of short-term dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) with prasugrel compared to longer DAPT durations.

Purpose of the Study:

• To evaluate the 24-month outcomes of a de-escalation strategy (short-term DAPT followed by prasugrel SAPT) versus a conventional strategy (longer DAPT).
• To compare the incidence of clinically relevant bleeding (CRB) and major adverse cardiac and cerebrovascular events (MACCE) between the two strategies.

Main Methods:

• A comparative analysis of 24-month data from the PENDULUM mono (de-escalation, n=1,107) and PENDULUM registry (conventional, n=2,273) studies.
• Utilized inverse probability of treatment weighting (IPTW) to adjust for baseline differences between the groups.
• Primary endpoint was cumulative incidence of CRB at 24 months post-PCI.

Main Results:

• After IPTW adjustment, the cumulative incidence of CRB was 5.8% in PENDULUM mono versus 7.2% in the PENDULUM registry (HR 0.77; P=0.086).
• The cumulative incidence of MACCE was 8.0% in PENDULUM mono versus 9.5% in the PENDULUM registry (HR 0.77; P=0.061).
• The de-escalation strategy demonstrated a trend towards lower CRB and MACCE rates at 24 months.

Conclusions:

• In Japanese HBR patients undergoing PCI, prasugrel SAPT after short-term DAPT was associated with a lower ischemic event risk compared to long-term DAPT.
• The benefit of the de-escalation strategy, particularly for ischemic events, was observed to be sustained beyond one year.
• This supports the use of de-escalation strategies in select HBR patient populations to balance ischemic and bleeding risks.