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Published on: May 14, 2013
One-Month Dual Antiplatelet Therapy in Patients With Chronic and Acute Coronary Syndromes Treated With Bioresorbable
Carmine Musto1, Luca Paolucci1, Carlo Andrea Pivato2
1Department of Cardiosciences, A.O. San Camillo-Forlanini Hospital, Rome, Italy.
Insights
A 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is safe for high bleeding risk (HBR) patients with acute coronary syndromes (ACS). Outcomes were similar to those with chronic coronary syndrome (CCS), showing comparable ischemic and bleeding risks.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Limited data exists on 1-month dual antiplatelet therapy (DAPT) safety post-percutaneous coronary intervention (PCI) for high bleeding risk (HBR) patients with acute coronary syndromes (ACS).
- Bioresorbable polymer everolimus-eluting stents (BP-EES) are increasingly used in PCI procedures.
Purpose of the Study:
- To compare clinical outcomes of HBR patients undergoing PCI with BP-EES, comparing those with ACS versus chronic coronary syndrome (CCS) using a 1-month DAPT strategy.
- To evaluate the safety and efficacy of a shortened DAPT duration in a complex patient population.
Main Methods:
- Prospective enrollment of 443 HBR patients (180 ACS, 263 CCS) across 10 Italian centers undergoing PCI with BP-EES.
- All patients received 1-month DAPT, with specific protocols for concomitant oral anticoagulation.
- Primary endpoint: composite of cardiac death, myocardial infarction, or stent thrombosis at 12 months. Secondary endpoint: Bleeding Academic Research Consortium (BARC) bleeding events.
Main Results:
- No significant difference in the primary endpoint between ACS and CCS groups (4.3% vs 5.6%, p=0.497).
- Individual ischemic event rates were also similar between the groups.
- Bleeding risk (BARC types 1-5 and 3-5) was comparable between ACS and CCS patients (4.3% vs 5.2%, p=0.677 and 1.6% vs 2.9%, p=0.351, respectively).
Conclusions:
- A 1-month DAPT strategy following PCI with BP-EES in HBR patients demonstrates similar ischemic and bleeding event rates for both ACS and CCS presentations.
- This supports the feasibility and safety of abbreviated DAPT in HBR patients, irrespective of ACS or CCS status.
Abstract:
There is a paucity of data regarding the safety of a 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients at high bleeding risk (HBR) presenting with acute coronary syndromes (ACS). We aimed to compare the clinical outcomes of patients at HBR with chronic coronary syndrome (CCS) or ACS treated with PCI using bioresorbable polymer everolimus-eluting stent (BP-EES) followed by 1-month DAPT. Patients at HBR who underwent PCI with BP-EES were prospectively enrolled in 10 Italian centers. All patients were treated with 1-month DAPT. In case of need for anticoagulation, patients received an oral anticoagulant in addition to a P2Y12 inhibitor for 1 month, followed by oral anticoagulation only after that. The primary end point was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12 months. Overall, 263 patients (59.4%) with CCS and 180 patients (40.6%) with ACS were enrolled. No significant difference was evident between patients with CCS and ACS for the primary end point (4.3% vs 5.6%, respectively, p = 0.497) and for each isolated component. The risk for Bleeding Academic Research Consortium (BARC) type 1 to 5 or type 3 to 5 bleedings was also similar between patients with CCS and ACS (4.3% vs 5.2%, p = 0.677, and 1.6% vs 2.9%, p = 0.351, respectively). In conclusion, among HBR patients with ACS who underwent PCI with BP-EES, a 1-month DAPT strategy is associated with a similar risk of ischemic and bleeding events compared with those with CCS.
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