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The EFFect of hIgh-dose ClopIdogrel treatmENT in patients with clopidogrel resistance (the EFFICIENT trial)
Hasan Ari1, Hakan Ozkan, Ali Karacinar
1Bursa Postgraduate Hospital, Department of Cardiology, Bursa, Turkey. hasanari03@yahoo.com
Insights
High-dose clopidogrel effectively prevents major adverse cardiovascular and cerebrovascular events (MACCE) in patients with clopidogrel resistance after PCI. This intensified treatment did not increase bleeding risk compared to standard doses.
Area of Science:
- Cardiology
- Pharmacology
- Interventional Cardiology
Background:
- Clopidogrel resistance is a concern in patients undergoing percutaneous coronary intervention (PCI).
- Standard clopidogrel dosing may be insufficient for patients with resistance.
- Optimizing antiplatelet therapy is crucial for preventing adverse events post-PCI.
Purpose of the Study:
- To assess the efficacy of high-dose clopidogrel continuation therapy in mitigating MACCE.
- To compare high-dose versus standard-dose clopidogrel in patients with demonstrated clopidogrel resistance.
- To evaluate the safety profile, specifically bleeding risk, associated with high-dose clopidogrel.
Main Methods:
- A study involving 192 patients undergoing elective PCI.
- Patients were categorized into a control group (no resistance) and two resistance groups: standard-dose (75 mg/day) and high-dose (150 mg/day) clopidogrel.
- Clopidogrel resistance was determined using the VerifyNow P2Y12 test; resistance was defined as <40% platelet inhibition.
Main Results:
- The high-dose group showed a significantly lower event rate for MACCE compared to the standard-dose group (p=0.045).
- No significant difference in MACCE was observed between the high-dose group and the control group (p=0.82).
- Bleeding rates and the rate of non-cardiovascular adverse events (NACE) were similar across all treatment groups.
Conclusions:
- High-dose clopidogrel continuation therapy is more effective than standard-dose therapy in preventing MACCE in patients with clopidogrel resistance post-PCI.
- Increased clopidogrel dosage did not elevate the risk of bleeding complications.
- The EFFICIENT Trial (NCT01032668) supports the use of high-dose clopidogrel for resistant patients.
Objectives:
The aim of this study was to evaluate the effect of high-dose clopidogrel continuation treatment on the development of MACCE after elective PCI in patients with clopidogrel resistance.
Methods:
The study group consisted of 192 patients. Of these, 98 participants without resistance served as the control group (Group 1) and received 75 mg/day clopidogrel for 1 month. Ninety-four patients with resistance were randomly divided into two groups: 47 patients in the standard-dose group (Group 2) received 75 mg/day continuation therapy, whereas 47 patients in the high-dose group (Group 3) received 150 mg/day continuation therapy for 1 month. Clopidogrel resistance was evaluated with the VerifyNow P2Y12 test. Patients with a platelet inhibition value lower than 40% were classified as resistant.
Results:
During the 6-month follow-up for MACCE, the event-rate in Group 2 was significantly higher than both Groups 1 and 3 (Group 1 vs Group 2; p=0.019, Group 1 vs Group 3; p=0.82, Group 2 vs Group 3; p=0.045). Total bleeding rate in all groups were similar (Group 1 vs Group 2; p=0.54, Group 1 vs Group 3; p=0.27, Group 2 vs Group 3; p=0.16). The rate of NACE was similar in all groups (Group 1 vs Group 2; p=0.08, Group 1 vs Group 3; p=0.50, Group 2 vs Group 3; p=0.39).
Conclusion:
In patients who underwent elective PCI and had clopidogrel resistance, high-dose clopidogrel continuation therapy was more efficient in preventing MACCE than the standard dose. High-dose continuation therapy did not increase the risk of bleeding complication (The EFFICIENT Trial; ClinicalTrials.gov number: NCT01032668).
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