Stent Thrombosis

This page includes clinical data from the TRITON-TIMI 38 trial about reductions in stent thrombosis in the following categories:

Reductions in Stent Thrombosis Through 15 Months

In TRITON-TIMI 38, Effient® (prasugrel) plus ASA provided greater protection against stent thrombosis that manifested early and was maintained through one year of follow-up compared with Plavix® (clopidogrel bisulfate) plus ASA.

Stent thrombosis reductions through 15 months chart

Related content:

Clinical Guidelines for Effient Dosing Patient Identification

*Stent thrombosis was a prespecified secondary endpoint using the Academic Research Consortium (ARC) definition of definite or probable stent thrombosis. This analysis represents stent thrombosis in any stent postrandomization.

  • Observed rates of stent thrombosis in TRITON-TIMI 38 for Effient plus ASA and Plavix plus ASA were 1.1% vs 2.2%, respectively (1.1% ARR; P<0.0001)1
  • In TRITON-TIMI 38, 94% of the 13,608 patients received stents1,2
    • Of the 12,844 patients who received stents during the index procedure, 45% received only drug-eluting stents (DES) (n=5743), 50% received only bare-metal stents (BMS) (n=6461), and 5% received a combination of DES and BMS (n=640)
  • In TRITON-TIMI 38, the LD of Plavix was delayed relative to the placebo-controlled trials that supported its approval for ACS3

SELECTED SAFETY: BLEEDING RATES IN TRITON-TIMI 38

Effient can cause significant, sometimes fatal, bleeding. Overall rates of non-CABG TIMI major or minor bleeding were significantly higher with Effient plus ASA (4.5%) compared with Plavix plus ASA (3.4%). The rates of fatal bleeding were 0.3% with Effient plus ASA and 0.1% with Plavix plus ASA. In patients who underwent CABG (N=437), the rates of CABG-related TIMI major or minor bleeding were 14.1% with Effient plus ASA and 4.5% with Plavix plus ASA. Click here for Safety Information and Boxed Warning.

References:
  1. Data on file: #EFF20091204b: DSI/Lilly.
  2. Wiviott SD, Braunwald E, McCabe CH, et al; for the TRITON-TIMI 38 Investigators. Lancet. 2008;371:1353-1363.
  3. Effient® (prasugrel) prescribing information. Daiichi Sankyo, Inc. and Eli Lilly and Company.

Reductions in Stent Thrombosis by Stent Type

In TRITON-TIMI 38, Effient® (prasugrel) plus ASA provided greater protection against stent thrombosis compared with Plavix® (clopidogrel bisulfate) plus ASA in patients with ACS managed with PCI.

Stent thrombosis by all ACS and by stent type through 15 months chart

Related content:

Clinical Guidelines for Effient Dosing Patient Identification

*Patients who received a combination of DES and BMS were excluded from the analysis (n=640). †Stent thrombosis was a prespecified secondary endpoint using the Academic Research Consortium (ARC) definition of definite or probable stent thrombosis. This analysis represents stent thrombosis in any stent postrandomization.

  • TRITON-TIMI 38 was a head-to-head study comparing Effient (60-mg loading dose, followed by a 10-mg once-daily maintenance dose) plus ASA with Plavix (300-mg loading dose, followed by a 75-mg once-daily maintenance dose) plus ASA in 13,608 patients with ACS managed with PCI (median duration 14.5 months)3,4
  • In TRITON-TIMI 38, 94% of the 13,608 patients received stents1,2
    • Of the 12,844 patients who received stents during the index procedure, 45% received only drug-eluting stents (DES) (n=5743), 50% received only bare-metal stents (BMS) (n=6461), and 5% received a combination of DES and BMS (n=640)
  • In TRITON-TIMI 38, the LD of Plavix was delayed relative to the placebo-controlled trials that supported its approval for ACS3

Patient Subgroups

  • 57% RRR in the UA/NSTEMI population (0.9% with Effient plus ASA [N=4798] vs 2.0% with Plavix plus ASA [N=4789]; 1.1% ARR; P<0.0001)5
  • 42% RRR in the STEMI population (1.6% with Effient plus ASA [N=1624] vs 2.8% with Plavix plus ASA [N=1633]; 1.2% ARR; P<0.02)5
  • 47% RRR in the overall ACS population with diabetes (1.8% with Effient plus ASA [N=1460] vs 3.4% with Plavix plus ASA [N=1472]; 1.6% ARR; P<0.007)6

SELECTED SAFETY: BLEEDING RATES IN TRITON-TIMI 38

Effient can cause significant, sometimes fatal, bleeding. Overall rates of non-CABG TIMI major or minor bleeding were significantly higher with Effient plus ASA (4.5%) compared with Plavix plus ASA (3.4%). The rates of fatal bleeding were 0.3% with Effient plus ASA and 0.1% with Plavix plus ASA. In patients who underwent CABG (N=437), the rates of CABG-related TIMI major or minor bleeding were 14.1% with Effient plus ASA and 4.5% with Plavix plus ASA. Click here for Safety Information and Boxed Warning.

References:
  1. Data on file: #EFF20091204b: DSI/Lilly.
  2. Wiviott SD, Braunwald E, McCabe CH, et al; for the TRITON-TIMI 38 Investigators. Lancet. 2008;371:1353-1363.
  3. Effient® (prasugrel) prescribing information. Daiichi Sankyo, Inc. and Eli Lilly and Company.
  4. Wiviott SD, Braunwald E, McCabe CH, et al; for the TRITON-TIMI 38 Investigators. N Engl J Med. 2007;357:2001-2015.
  5. Data on file: #EFF20100129c: DSI/Lilly.
  6. Data on file: #EFF20100129d: DSI/Lilly.

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