Comparison of Anticoagulation Prolongation vs no Anticoagulation in STEMI Patients After Primary PCI - RIGHT

Mar 05, 2024
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Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
Beijing Anzhen Hospital, Beijing, China
Date Presented:
08/28/2023
Date Published:
02/26/2024
Date Updated:
03/05/2024
Original Posted Date:
08/28/2023
References

Contribution To Literature:

The RIGHT trial showed that in patients with STEMI undergoing primary PCI while anticoagulated with bivalirudin, routine post-PCI anticoagulation with bivalirudin, enoxaparin, or unfractionated heparin was not associated with decreased incidence of 30-day mortality, nonfatal stroke or MI, stent thrombosis, or urgent revascularization.

Description:

The goal of the trial was to determine the efficacy and safety of continuing anticoagulation after primary percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) compared with placebo.

Study Design

  • Randomized
  • Double-blind
  • Multicenter

Patients with STEMI who underwent primary PCI of the culprit lesion with bivalirudin were randomized to continued low-dose post-procedural anticoagulation (PPA, n = 1,494) or placebo (n = 1,495) post-PCI. Anticoagulation was continued for 48 hours or on discharge from the coronary care unit, whichever occurs later. Each participating center was limited to one of three anticoagulation regimens: intravenous unfractionated heparin (UFH) starting at 10 units/kg/hour and titrated to an activated clotting time (ACT) of 150-220 seconds, subcutaneous enoxaparin 40 mg/day, or bivalirudin 0.2 mg/kg/hour.

  • Total number of enrollees: 2,989
  • Duration of follow-up: 30 days
  • Mean patient age: 61 years
  • Percentage female: 21%

Inclusion criteria:

  • Age ≥18 years
  • STEMI with primary PCI of culprit lesion
  • Anticoagulation with bivalirudin during primary PCI

Exclusion criteria:

  • Other indication for anticoagulation after primary PCI (e.g., atrial fibrillation, intra-aortic balloon pump)
  • Previous treatment with thrombolytics
  • Cardiogenic shock, ventricular arrhythmias, or mechanical complications of MI
  • Transient ischemic attack, stroke, or intracranial hemorrhage <6 months prior
  • Gastrointestinal or genitourinary bleeding <2 weeks prior

Other salient features/characteristics:

  • Prior MI: 7%
  • Anterior STEMI: 43%
  • Median door-to-balloon time: 74 minutes
  • P2Y12 inhibitor loading before angiography: 95%

Principal Findings:

The primary efficacy outcome, composite of all-cause mortality, nonfatal MI or stroke, in-stent thrombosis, or urgent revascularization of any vessel at 30 days, for PPA vs. placebo, was: 2.5% vs. 2.5% (p = 0.988).

  • Enoxaparin vs. placebo: 2.1% vs. 4.5%, hazard ratio [HR] 0.46 (0.22-0.98)
  • UFH vs. placebo: 2.2% vs. 0.6%, HR 3.71 (1.03-13.28)
  • Bivalirudin vs. placebo: 3.1% vs. 2.5%, HR 1.24 (0.60-2.59)

The primary safety outcome, major bleeding at 30 days, for PPA vs. placebo, was: 1.6% vs. 2.3% (p = 0.511).

  • Enoxaparin vs. placebo: 0.6% vs. 1.1%, HR 0.60 (0.14-2.52)
  • UFH vs. placebo: 0.4% vs. 0.8%, HR 0.50 (0.09-2.75)
  • Bivalirudin vs. placebo: 0.6% vs. 0.4%, HR 1.54 (0.26-9.24)

Interpretation:

The RIGHT trial did not observe a reduction in ischemic events or death with low-dose PPA compared with placebo following primary PCI in STEMI. Interestingly, prespecified subgroup analysis demonstrated variable treatment effects, with net reduction in the primary endpoint with enoxaparin and a higher event rate with UFH compared with placebo. These findings remain hypothesis-generating, particularly given the variable event rate across the placebo arms in each treatment group.

In the BRIGHT-4 trial, full-dose bivalirudin infusion was continued for 2-4 hours (mean 3 hours) post-primary PCI. In this setting, bivalirudin was superior to UFH in reducing bleeding and ischemic endpoints at 30 days among STEMI patients. Similarly, a post hoc analysis of the MATRIX trial previously suggested a possible benefit of full-dose bivalirudin PPA compared with placebo or low-dose infusion without increase in bleeding risk. Although the findings of the RIGHT trial do not support routine PPA in STEMI, future investigation may therefore be warranted into the effect of full-dose PPA in STEMI among those treated with low molecular weight heparin as well as patients with non–ST-elevation acute coronary syndrome. Cardiology society guidelines do not provide recommendations on PPA outside of an alternate indication for anticoagulation, and current practices can vary widely by center and region.

References:

Highlighted text has been updated as of March 5, 2024.

Yan Y, Guo J, Wang X, et al., on behalf of the RIGHT Investigators. Postprocedural Anticoagulation After Primary Percutaneous Coronary Intervention for ST-Segment–Elevation Myocardial Infarction: A Multicenter, Randomized, Double-Blind Trial. Circulation 2024;Feb 26:[Epub ahead of print].

Presented by Dr. Shaoping Nie at the European Society of Cardiology Congress, Amsterdam, Netherlands, August 28, 2023.

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Interventions and ACS, Interventions and Vascular Medicine, Chronic Angina

Keywords: Acute Coronary Syndrome, ESC23, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction


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