Limits...
Ticagrelor versus clopidogrel in patients with acute coronary syndromes intended for non-invasive management: substudy from prospective randomised PLATelet inhibition and patient Outcomes (PLATO) trial.

James SK, Roe MT, Cannon CP, Cornel JH, Horrow J, Husted S, Katus H, Morais J, Steg PG, Storey RF, Stevens S, Wallentin L, Harrington RA, PLATO Study Gro - BMJ (2011)

Bottom Line: Overall mortality was also lower (6.1% (147) v 8.2% (195); 0.75, 0.61 to 0.93; P=0.01).The incidence of total major bleeding (11.9% (272) v 10.3% (238); 1.17, 0.98 to 1.39; P=0.08) and non-coronary artery bypass grafting related major bleeding (4.0% (90) v 3.1% (71); 1.30, 0.95 to 1.77; P=0.10) was numerically higher with ticagrelor than with clopidogrel.In patients with acute coronary syndrome initially intended for non-invasive management, the benefits of ticagrelor over clopidogrel were consistent with those from the overall PLATO results, indicating the broad benefits of P2Y12 inhibition with ticagrelor regardless of intended management strategy.

View Article: PubMed Central - PubMed

Affiliation: Uppsala Clinical Research Center, Uppsala University, Sweden. Stefan.James@ucr.uu.se

ABSTRACT

Objective: To evaluate efficacy and safety outcomes in patients in the PLATelet inhibition and patient Outcomes (PLATO) trial who at randomisation were planned for a non-invasive treatment strategy.

Design: Pre-specified analysis of pre-randomisation defined subgroup of prospective randomised clinical trial.

Setting: 862 centres in 43 countries.

Participants: 5216 (28%) of 18,624 patients admitted to hospital for acute coronary syndrome who were specified as planned for non-invasive management.

Interventions: Randomised treatment with ticagrelor (n=2601) versus clopidogrel (2615).

Main outcome measurements: Primary composite end point of cardiovascular death, myocardial infarction, and stroke; their individual components; and PLATO defined major bleeding during one year.

Results: 2183 (41.9%) patients had coronary angiography during their initial hospital admission, 1065 (20.4%) had percutaneous coronary intervention, and 208 (4.0%) had coronary artery bypass surgery. Cumulatively, 3143 (60.3%) patients had been managed non-invasively by the end of follow-up. The incidence of the primary end point was lower with ticagrelor than with clopidogrel (12.0% (n=295) v 14.3% (346); hazard ratio 0.85, 95% confidence interval 0.73 to 1.00; P=0.04). Overall mortality was also lower (6.1% (147) v 8.2% (195); 0.75, 0.61 to 0.93; P=0.01). The incidence of total major bleeding (11.9% (272) v 10.3% (238); 1.17, 0.98 to 1.39; P=0.08) and non-coronary artery bypass grafting related major bleeding (4.0% (90) v 3.1% (71); 1.30, 0.95 to 1.77; P=0.10) was numerically higher with ticagrelor than with clopidogrel.

Conclusions: In patients with acute coronary syndrome initially intended for non-invasive management, the benefits of ticagrelor over clopidogrel were consistent with those from the overall PLATO results, indicating the broad benefits of P2Y12 inhibition with ticagrelor regardless of intended management strategy.

Trial registration: Clinical trials NCT00391872.

Show MeSH

Related in: MedlinePlus

Fig 4 Cumulative incidence of total mortality in ticagrelor and clopidogrel groups in patients intended for invasive and non-invasive management at time of randomisation
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
getmorefigures.php?uid=PMC3117310&req=5

fig4: Fig 4 Cumulative incidence of total mortality in ticagrelor and clopidogrel groups in patients intended for invasive and non-invasive management at time of randomisation

Mentions: Compared with patients with intended invasive treatment, patients with intended non-invasive management had an initially lower primary event rate, but the event curves crossed at approximately 30 days and increased more over time (fig 3). The benefit for ticagrelor compared with clopidogrel was consistent between the two cohorts; the hazard ratio was 0.85 (0.85 to 1.00) in the non-invasive cohort and 0.84 (0.75 to 0.94) in the invasive cohort (P for interaction=0.89). The total mortality was higher in the intended non-invasive cohort than in the intended invasive cohort during the entire course of the study (fig 4), but the relative benefit with ticagrelor was consistent (hazard ratio 0.75 (0.61 to 0.93) v 0.80 (0.61 to 0.93): P for interaction=0.64).


Ticagrelor versus clopidogrel in patients with acute coronary syndromes intended for non-invasive management: substudy from prospective randomised PLATelet inhibition and patient Outcomes (PLATO) trial.

James SK, Roe MT, Cannon CP, Cornel JH, Horrow J, Husted S, Katus H, Morais J, Steg PG, Storey RF, Stevens S, Wallentin L, Harrington RA, PLATO Study Gro - BMJ (2011)

Fig 4 Cumulative incidence of total mortality in ticagrelor and clopidogrel groups in patients intended for invasive and non-invasive management at time of randomisation
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC3117310&req=5

fig4: Fig 4 Cumulative incidence of total mortality in ticagrelor and clopidogrel groups in patients intended for invasive and non-invasive management at time of randomisation
Mentions: Compared with patients with intended invasive treatment, patients with intended non-invasive management had an initially lower primary event rate, but the event curves crossed at approximately 30 days and increased more over time (fig 3). The benefit for ticagrelor compared with clopidogrel was consistent between the two cohorts; the hazard ratio was 0.85 (0.85 to 1.00) in the non-invasive cohort and 0.84 (0.75 to 0.94) in the invasive cohort (P for interaction=0.89). The total mortality was higher in the intended non-invasive cohort than in the intended invasive cohort during the entire course of the study (fig 4), but the relative benefit with ticagrelor was consistent (hazard ratio 0.75 (0.61 to 0.93) v 0.80 (0.61 to 0.93): P for interaction=0.64).

Bottom Line: Overall mortality was also lower (6.1% (147) v 8.2% (195); 0.75, 0.61 to 0.93; P=0.01).The incidence of total major bleeding (11.9% (272) v 10.3% (238); 1.17, 0.98 to 1.39; P=0.08) and non-coronary artery bypass grafting related major bleeding (4.0% (90) v 3.1% (71); 1.30, 0.95 to 1.77; P=0.10) was numerically higher with ticagrelor than with clopidogrel.In patients with acute coronary syndrome initially intended for non-invasive management, the benefits of ticagrelor over clopidogrel were consistent with those from the overall PLATO results, indicating the broad benefits of P2Y12 inhibition with ticagrelor regardless of intended management strategy.

View Article: PubMed Central - PubMed

Affiliation: Uppsala Clinical Research Center, Uppsala University, Sweden. Stefan.James@ucr.uu.se

ABSTRACT

Objective: To evaluate efficacy and safety outcomes in patients in the PLATelet inhibition and patient Outcomes (PLATO) trial who at randomisation were planned for a non-invasive treatment strategy.

Design: Pre-specified analysis of pre-randomisation defined subgroup of prospective randomised clinical trial.

Setting: 862 centres in 43 countries.

Participants: 5216 (28%) of 18,624 patients admitted to hospital for acute coronary syndrome who were specified as planned for non-invasive management.

Interventions: Randomised treatment with ticagrelor (n=2601) versus clopidogrel (2615).

Main outcome measurements: Primary composite end point of cardiovascular death, myocardial infarction, and stroke; their individual components; and PLATO defined major bleeding during one year.

Results: 2183 (41.9%) patients had coronary angiography during their initial hospital admission, 1065 (20.4%) had percutaneous coronary intervention, and 208 (4.0%) had coronary artery bypass surgery. Cumulatively, 3143 (60.3%) patients had been managed non-invasively by the end of follow-up. The incidence of the primary end point was lower with ticagrelor than with clopidogrel (12.0% (n=295) v 14.3% (346); hazard ratio 0.85, 95% confidence interval 0.73 to 1.00; P=0.04). Overall mortality was also lower (6.1% (147) v 8.2% (195); 0.75, 0.61 to 0.93; P=0.01). The incidence of total major bleeding (11.9% (272) v 10.3% (238); 1.17, 0.98 to 1.39; P=0.08) and non-coronary artery bypass grafting related major bleeding (4.0% (90) v 3.1% (71); 1.30, 0.95 to 1.77; P=0.10) was numerically higher with ticagrelor than with clopidogrel.

Conclusions: In patients with acute coronary syndrome initially intended for non-invasive management, the benefits of ticagrelor over clopidogrel were consistent with those from the overall PLATO results, indicating the broad benefits of P2Y12 inhibition with ticagrelor regardless of intended management strategy.

Trial registration: Clinical trials NCT00391872.

Show MeSH
Related in: MedlinePlus