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Postprocedural Anticoagulation After Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial
Yan Yan1,2,3, Jincheng Guo4, Xiao Wang1,2,3
1Center for Coronary Artery Disease (Y.Y., X.W., W.G., S.N.), Division of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Insights
Postprocedural anticoagulation (PPA) after percutaneous coronary intervention for ST-segment-elevation myocardial infarction is safe but does not reduce ischemic events. This study found no significant difference in outcomes between PPA and placebo groups.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Postprocedural anticoagulation (PPA) is common after primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction (STEMI).
- Evidence supporting routine PPA in STEMI patients undergoing primary PCI is limited and inconclusive.
- The RIGHT trial aimed to clarify the role of PPA in this patient population.
Purpose of the Study:
- To determine if postprocedural anticoagulation (PPA) reduces ischemic events in STEMI patients after primary PCI.
- To evaluate the safety of PPA by assessing major bleeding events.
- To compare the efficacy of different anticoagulation regimens (enoxaparin, unfractionated heparin, bivalirudin) within the PPA group.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled superiority trial involving 2989 STEMI patients undergoing primary PCI.
- Patients were assigned to receive either low-dose PPA or a matching placebo for at least 48 hours.
- The primary endpoint was a composite of all-cause death, nonfatal MI, stroke, stent thrombosis, or urgent revascularization within 30 days. Safety endpoint was Bleeding Academic Research Consortium (BARC) 3-5 bleeding.
Main Results:
- The primary efficacy endpoint occurred in 2.5% of patients in both the PPA and placebo groups (HR, 1.00; 95% CI, 0.63-1.57).
- There was no significant difference in major bleeding events (BARC 3-5) between the PPA and placebo groups (0.5% vs 0.7%; HR, 0.74; 95% CI, 0.30-1.83).
- No specific PPA regimen demonstrated superiority in reducing ischemic events.
Conclusions:
- Routine postprocedural anticoagulation after primary PCI in STEMI patients is safe.
- PPA does not significantly reduce the risk of 30-day ischemic events compared to placebo.
- The practice of routine PPA in this setting is not supported by current evidence from the RIGHT trial.
Background:
Postprocedural anticoagulation (PPA) is frequently administered after primary percutaneous coronary intervention in ST-segment-elevation myocardial infarction, although no conclusive data support this practice.
Methods:
The RIGHT trial (Comparison of Anticoagulation Prolongation vs no Anticoagulation in STEMI Patients After Primary PCI) was an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled, superiority trial conducted at 53 centers in China. Patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention were randomly assigned by center to receive low-dose PPA or matching placebo for at least 48 hours. Before trial initiation, each center selected 1 of 3 PPA regimens (40 mg of enoxaparin once daily subcutaneously; 10 U·kg·h of unfractionated heparin intravenously, adjusted to maintain activated clotting time between 150 and 220 seconds; or 0.2 mg·kg·h of bivalirudin intravenously). The primary efficacy objective was to demonstrate superiority of PPA to reduce the primary efficacy end point of all-cause death, nonfatal myocardial infarction, nonfatal stroke, stent thrombosis (definite), or urgent revascularization (any vessel) within 30 days. The key secondary objective was to evaluate the effect of each specific anticoagulation regimen (enoxaparin, unfractionated heparin, or bivalirudin) on the primary efficacy end point. The primary safety end point was Bleeding Academic Research Consortium 3 to 5 bleeding at 30 days.
Results:
Between January 10, 2019, and September 18, 2021, a total of 2989 patients were randomized. The primary efficacy end point occurred in 37 patients (2.5%) in both the PPA and placebo groups (hazard ratio, 1.00 [95% CI, 0.63 to 1.57]). The incidence of Bleeding Academic Research Consortium 3 to 5 bleeding did not differ between the PPA and placebo groups (8 [0.5%] vs 11 [0.7%] patients; hazard ratio, 0.74 [95% CI, 0.30 to 1.83]).
Conclusions:
Routine PPA after primary percutaneous coronary intervention was safe but did not reduce 30-day ischemic events.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03664180.
