Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition– PCI - CHAMPION PCI

Sep 03, 2013
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
The Medicines Company
Date Updated:
09/03/2013
Original Posted Date:
09/03/2013
References

Description:

The goal of this trial was to compare treatment with intravenous cangrelor compared with clopidogrel 600 mg among patients undergoing percutaneous coronary intervention (PCI).

Hypothesis:

Cangrelor would be superior at reducing adverse events early after PCI.

Study Design

  • Randomized
  • Blinded
  • Parallel

Patients Enrolled: 8,877
Mean Follow Up: 1 year
Mean Patient Age: Median 62 years
Female: 26

Patient Populations:

  • Patients with stable angina, unstable angina, NSTEMI, or STEMI scheduled for PCI

Exclusions:

  • Fibrinolytic or glycoprotein IIb/IIIa inhibitor in the previous 12 hours
  • Clopidogrel in the previous 5 days

Primary Endpoints:

  • All-cause mortality, MI, and urgent revascularization at 48 hours

Secondary Endpoints:

  • All-cause mortality
  • MI
  • Urgent revascularization

Drug/Procedures Used:

Stable angina or acute coronary syndrome patients who were scheduled for PCI were randomized to intravenous cangrelor administered prior to PCI (n = 4,367) versus clopidogrel 600 mg prior to PCI (n = 4,355).

Cangrelor was administered 30 minutes before PCI (30 µg/kg bolus) with infusion continued 2 hours or until the end of the procedure (4 µg/kg/min). Clopidogrel 600 mg was administered at the end of cangrelor infusion.

Concomitant Medications:

Procedurally, 55% of patients received unfractionated heparin, 30% bivalirudin, 8% low molecular weight heparin, and 26% a glycoprotein IIb/IIIa inhibitor.

Principal Findings:

Overall, 8,877 patients were randomized. In the cangrelor group, the median age was 62 years, 26% were women, 15% had stable angina, 25% had unstable angina, 49% had non-ST-elevation myocardial infarction (NSTEMI), 11% had STEMI, and 31% had diabetes. Drug-eluting stents were used in 59% and bare-metal stents in 38%. The median time from admission to PCI was 6.3 hours.

The primary outcome of death, MI, or urgent revascularization at 48 hours occurred in 7.5% of the cangrelor group versus 7.1% of the clopidogrel group (p = 0.59). Death was 0.2% versus 0.1%, MI was 7.1% versus 6.6%, urgent revascularization was 0.3% versus 0.6%, stroke was 0.2% versus 0.2%, and stent thrombosis was 0.2% versus 0.2%, respectively.

Need for blood transfusion was 1.1% versus 1.0% (p = 0.68), groin hematoma >5 cm was 1.9% versus 1.7% (p = 0.48), ACUITY major bleeding was 3.6% versus 2.9% (p = 0.06), GUSTO severe/life-threatening bleeding was 0.2% versus 0.3% (p = 0.82), and TIMI major bleeding was 0.4% versus 0.3% (p = 0.39), respectively.

In a pooled analysis of the three CHAMPION trials (n = 24,910), the composite efficacy endpoint of death, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours occurred in 3.8% of the cangrelor group versus 4.7% in the control group (p = 0.0007). Stent thrombosis: 0.5% vs. 0.8% (p = 0.0008), respectively. The composite safety endpoint of GUSTO severe or life-threatening bleeding at 48 hours occurred in 0.2% of the cangrelor group versus 0.2% in the control group (p = 0.49). ACUITY major bleeding: 4.2% vs. 2.8% (p < 0.001), GUSTO minor bleeding: 16.8% vs. 13.0% (p < 0.001), respectively.

Interpretation:

Among patients undergoing PCI, the use of cangrelor was not superior to clopidogrel; however, efficacy and safety outcomes appeared to be similar. Cangrelor did not reduce the outcome of death, MI, or urgent revascularization at 48 hours, although there was evidence for efficacy in a pooled analysis. Significant bleeding was similar between the two treatment arms except for a marginal increase in ACUITY major bleeding.

This trial complements the CHAMPION PLATFORM trial, which compared cangrelor to placebo, with clopidogrel given to all patients after PCI. Future studies may identify subgroups of patients who may benefit from this agent.

References:

Steg PG, Bhatt DL, Hamm CW, et al., on behalf of the CHAMPION Investigators. Effect of cangrelor on periprocedural outcomes in percutaneous coronary interventions: a pooled analysis of patient-level data. Lancet 2013;382:1981-92.

Presented by Dr. Christian Hamm at the European Society of Cardiology Congress, Amsterdam, Holland, September 3, 2013.

Harrington RA, Stone GW, McNulty S, et al. Platelet inhibition with cangrelor in patients undergoing PCI. N Engl J Med 2009;Nov 15:[Epub ahead of print].

Presented by Dr. Robert Harrington at the American Heart Association Scientific Sessions, Orlando, FL, November 15, 2009.

Keywords: Myocardial Infarction, Stroke, Acute Coronary Syndrome, Platelet Aggregation Inhibitors, Angina, Stable, Drug-Eluting Stents, Ticlopidine, Hematoma, Groin, Purinergic P2Y Receptor Antagonists, Percutaneous Coronary Intervention, Blood Transfusion, Thrombosis, Diabetes Mellitus


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