"Cangrelor During PCI".The New England Journal of Medicine. 2013. 368:1303-1313.PubMed•Full text•PDF

Contents

1 Clinical Question
2 Bottom Line
3 Major Points
4 Guidelines
5 Design
6 Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Baseline Characteristics
7 Interventions
8 Outcomes
8.1 Primary Outcome
8.2 Secondary Outcomes
9 Criticisms
10 Funding
11 Further Reading

Clinical Question

In patients undergoing PCI and receiving guideline-recommended therapy, does cangrelor compared to clopidogrel reduce periprocedural ischemic complications without increasing the risk of severe bleeding?

Bottom Line

In patients undergoing PCI, cangrelor reduced ischemic events, including stent thrombosis during PCI, with no significant increase in severe bleeding compared to clopidogrel.

Major Points

Guidelines

The role of cangrelor during PCI has not been fully reflected in current guidelines.

Design

- Multicenter, double-blind, placebo-controlled trial.
- N=11,145 patients undergoing urgent or elective PCI.
- Cangrelor + clopidogrel placebo (n=5,571).
- Clopidogrel + cangrelor placebo (n=5,574).
- Setting: 153 sites globally.
- Enrollment: September 30, 2010, to October 3, 2012.
- Primary efficacy outcome: Composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 hours.
- Primary safety outcome: Severe bleeding at 48 hours.

Population

Inclusion Criteria
- Coronary atherosclerosis requiring PCI for stable angina, non–ST-segment elevation acute coronary syndrome, or STEMI
- Not received pretreatment with platelet inhibitors

Exclusion Criteria
- Receipt of P2Y12 inhibitor or abciximab within 7 days before randomization
- Receipt of eptifibatide or tirofiban or fibrinolytic therapy within 12 hours before randomization.

Baseline Characteristics
- Mean age 64 years.
- 28% were female.
- 56.1% stable angina, 25.7% non–ST-segment elevation acute coronary syndrome, 18.2% STEMI.

Interventions

- Cangrelor was administered as a bolus followed by an infusion for at least 2 hours or the duration of the procedure, whichever was longer.
- Clopidogrel loading dose determined by site investigator (600 mg or 300 mg).

Outcomes

Primary Outcome
- Rate of primary composite efficacy end point at 48 hours was 4.7% in the cangrelor group vs. 5.9% in the clopidogrel group (adjusted odds ratio 0.78; P=0.005).

Secondary Outcomes
- Stent thrombosis developed in 0.8% in the cangrelor group and 1.4% in the clopidogrel group (odds ratio, 0.62; P=0.01).

Criticisms

- The role of cangrelor in patients pretreated with oral P2Y12 inhibitors or those who require transition to prasugrel or ticagrelor was not assessed in this trial.
- A further study is needed to determine the most effective way to transition from cangrelor to other P2Y12 inhibitors.

Funding

Supported and designed by the Medicines Company.

Further Reading

Original publication at NEJM.org.