Study Identifies Predictors of Stent Thrombosis, Mortality After Primary PCI

Bivalirudin appears to carry an excess risk of stent thrombosis in the first 4 hours after primary PCI for STEMI compared with heparin with or without the use of glycoprotein IIb/IIIa inhibitors (GPIs). However, among patients who develop stent thrombosis, bivalirudin use is associated with less mortality, according to data presented in a Featured Clinical Research session Saturday at TCT 2014.

George D. Dangas, MD, PhD, of Mount Sinai Medical Center, New York, and colleagues pooled data on 5,800 patients from the EUROMAX and HORIZONS-AMI trials, both of which randomized patients to bivalirudin (Angiomax, The Medicines Company) or heparin with or without GPI use.

In all, 100 patients (1.7%) developed early stent thrombosis (n=60 bivalirudin and 40 heparin ± GPI), of whom 20 died within 30 days.

Landmark analysis at 1 day showed 1.3% of patients in the bivalirudin group and 0.2% of those in the heparin ± GPI group developed acute stent thrombosis (P<.0001). Between 1 and 30 days, subacute stent thrombosis rates were 1.2% and 0.9%, respectively.

sat.dangas.figureMoreover, in the first 4 hours after PCI, 0.94% of those assigned to bivalirudin and 0.03% of those assigned to heparin ± GPI developed stent thrombosis (P<.0001). Between 4 and 24 hours after PCI, the rates were equivalent between the two groups at 0.32% and 0.17%, respectively (P=.27).

Thirty-day mortality among patients who developed subacute stent thrombosis (1-30 days) was higher for the heparin ± GPI group than for the bivalirudin group (44.1% vs. 12%; log-rank P=.01). However, 30-day mortality after acute stent thrombosis (<1 day) only showed a trend toward difference between heparin ± GPI and bivalirudin (16.7% vs. 2.8%, respectively; log-rank P=.12). Overall, among the patients who had early stent thrombosis, 40% of patients in the heparin ± GPI group and 6.7% of those in the bivalirudin group died within 30 days (RR 0.19; 95% CI 0.07-0.52; P=.0002).

“The mortality in this study was much higher in subacute rather than acute stent thrombosis,” Dangas said. “In both categories, if you received bivalirudin up front, you survived that thrombosis event better in respect to mortality than [if you did] not. That’s consistent with prior data.”

Dangas also outlined several predictors of stent thrombosis and mortality after stent thrombosis (see Figure).

“The Killip class — at least 2 during acute MI presentation — and pre-procedure TIMI flow 0 or 1 independently predicted early stent thrombosis after primary PCI for STEMI,” Dangas said. “The excess of stent thrombosis associated with bivalirudin in comparison to heparin ± GPI is confined to the acute stent thrombosis phase — meaning day 1 and more specifically, to the first 4 hours after primary PCI.”

  

 Disclosures: 

  • The HORIZONS-AMI and EUROMAX trials were funded by The Medicines Company.
  •  Dangas reports receiving speaker honoraria from The Medicines Company.

 

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