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Impact Of Diabetes Mellitus On The Safety And Effectiveness Of Bivalirudin In Patients With Acute Myocardial Infarction Undergoing Primary Angioplasty: The HORIZONS AMI Trial.

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  1. Impact Of Diabetes Mellitus On The Safety And Effectiveness Of Bivalirudin In Patients With Acute Myocardial Infarction Undergoing Primary Angioplasty: The HORIZONS AMI Trial Bernhard Witzenbichler, Giulio Guagliumi, Martin Desaga, Janusz Kochman, Dennis W. Nilsen, Ariel Finkelstein, Morris Mosseri, Helen Parise, Roxana Mehran, Gregg W. Stone

  2. Background • Outcomes in the HORIZONS AMI trial were analyzed according to the presence of medically treated diabetes mellitus (DM) at the time of admission. • This subgroup analysis was pre-specified in the protocol / statistical analysis plan. • Since subgroups are generally underpowered, these analyses will be considered exploratory and hypothesis generating. Witzenbichler et al ACC 2008

  3. Baseline characteristics • 593 of 3.599 study patients (16.5%) in HORIZONS had medically treated diabetes. Baseline characteristics demonstrate that diabetics represent a significantly higher risk group compared to non-diabetics. Witzenbichler et al ACC 2008

  4. Baseline characteristics (ii) Witzenbichler et al ACC 2008

  5. Endpoints in non-diabetics, by study drug • Non-Diabetics (n=3006) RR=0.60 [0.61, 0.94] P=0.006 RR=0.55 [0.41, 0.74] P=0.001 RR=1.14 [0.83, 1.56] P= n.s. • *MACE = All cause death, reinfarction, ischemic TVR or stroke Witzenbichler et al ACC 2008

  6. Endpoints in diabetics, by study drug • Diabetics (n=593) RR=0.60 [0.61, 0.94] P=0.006 RR=0.55 [0.41, 0.74] P=0.001 RR=1.14 [0.83, 1.56] P= n.s. • *MACE = All cause death, reinfarction, ischemic TVR or stroke Witzenbichler et al ACC 2008

  7. 30-day MACE components among diabetics Witzenbichler et al ACC 2008

  8. 30 day bleeding endpoints among diabetics Witzenbichler et al ACC 2008

  9. Conclusions • Compared to patients without diabetes mellitus, those with diabetes had greater rates of major bleeding (8.8% vs. 6.2%, P=0.02), MACE (8.1% vs. 5.0%, P=0.002) and NACE (14.2% vs. 10.0%, P=0.003). • Among the diabetic subgroup: • Bivalirudin significantly reduced cardiac death at 30 days (p=0.037). • Total and hemorrhagic stroke rate occurred more often in the UFH + GPI group, whereas non-cardiac death rate was slightly increased in the Bivalirudin group, although based on small patient numbers. • All other 30 day endpoints including stent thrombosis rate were not significantly different among diabetics between the two treatment arms • In patients with AMI undergoing primary PCI, Bivalirudin monotherapy significantly reduces major bleeding and net adverse clinical events, effects which are independent of diabetic status (interaction P value for major bleeding = 0.22, for MACE = 0.10, and NACE = 0.90). Witzenbichler et al ACC 2008

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