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Reduction in recurrent ischemic events with vorapaxar: results from TRACER

Session Poster Session 6

Speaker Harvey White

Congress : ESC Congress 2013

  • Topic : coronary artery disease, acute coronary syndromes, acute cardiac care
  • Sub-topic : Acute Coronary Syndromes: Antiplatelet Agents
  • Session type : Poster Session
  • FP Number : P4842

Authors : H D White (Auckland,NZ), Z Huang (Durham, NC,US), P Tricoci (Durham, NC,US), F Van De Werf (Leuven,BE), L Wallentin (Uppsala,SE), Y Lokhnygina (Durham, NC,US), D Moliterno (Lexington,US), PE Aylward (Adelaide,AU), K Mahaffey (Durham, NC,US), PW Armstrong (Edmonton, Alberta,CA)

Authors:
H.D. White1 , Z. Huang2 , P. Tricoci2 , F. Van De Werf3 , L. Wallentin4 , Y. Lokhnygina2 , D. Moliterno5 , P.E. Aylward6 , K. Mahaffey2 , P.W. Armstrong7 , 1Auckland City Hospital - Auckland - New Zealand , 2Duke Clinical Research Institute - Durham, NC - United States of America , 3University Hospitals (UZ) Leuven, Division of Clinical Cardiology - Leuven - Belgium , 4Uppsala Clinical Research Center, Uppsala University, Department of Medical Sciences - Uppsala - Sweden , 5Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky Lexington, KY, - Lexington - United States of America , 6SAHMRI, Flinders University and Medical Centre - Adelaide - Australia , 7Canadian VIGOUR Centre, University of Alberta - Edmonton, Alberta - Canada ,

Citation:
European Heart Journal ( 2013 ) 34 ( Abstract Supplement ), 880

Purpose: Clinical trials use "time-to-first-event" analysis embedded often within the composite endpoint of cardiovascular death (CVD), MI, and stroke. However, many patients experienced nonfatal events before a fatal event and this method may not fully reflect patient benefit. We analyzed recurrent events in TRACER.

Methods: TRACER randomized 12,944 patients with ACS without ST-segment elevation. Vorapaxar did not reduce the primary endpoint but reduced the secondary endpoint of CVD, MI, and stroke; 14.7% vorapaxar vs 16.4% placebo, HR 0.89, 95% CI 0.81-0.98; nominal p=0.02. Analysis of vorapaxar's effect on recurrent CVD, MI, and stroke was prespecified using the Wei, Lin, and Weishield (WLW) approach.

Results: Only 1 event occurred in 10.1% vorapaxar vs 11.3% placebo. Recurrent events; n=348 occurred in 2.6% vorapaxar vs 2.8% placebo; p=0.6331. Vorapaxar significantly reduced the risk of recurrent CVD, MI and stroke after adjustment; HR 0.885; 95% CI 0.793–0.987; p=0.0284. Factors associated with risk of recurrent events are in the Table.

Conclusions: Vorapaxar reduced risk of "time-to-first" event and recurrent events broadening understanding of vorapaxar's potential to reduce recurrent events.

HR (95% CI)P
Age ≥75 y1.368; 1.173–1.594<0.0001
Multi-race1.388; 1.049–1.8360.0216
Region, North America1.309; 1.115–1.5350.0010
Weight, kg1.007; 1.003–1.0110.0014
Diabetes1.419; 1.262–1.597<0.0001
Stroke1.274; 1.023–1.5860.0305
MI1.375; 1.198–1.577<0.0001
PAD1.558; 1.320–1.838<0.0001
PCI1.161; 1.010–1.3340.0353
CABG1.611; 1.384–1.876<0.0001
Troponin/CK-MB, >ULN1.771; 1.330–2.358<0.0001
ST-segment depression1.417; 1.258–1.597<0.0001
Creatinine clearance <30 mL/min1.883; 1.340–2.6480.0003
Killip class I0.572; 0.476–0.687<0.0001
TIMI risk score ≥31352.25; 428.36–4268.8<0.0001


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