On 2014 Mar 17, Gaetano Santulli commented:

Mega et al. report that in patients across the spectrum of acute coronary syndrome (ACS) low doses of the oral anticoagulant rivaroxaban reduced the risk of death from cardiovascular causes, myocardial infarction or stroke (1). Unfortunately, a large percentage of the enrolled patients was not at high cardiovascular risk. Thus, these results may be not applicable to subjects with an ACS who are commonly treated in routine practice (2). Moreover, patients with atrial fibrillation (AF), which represent up to 22% of subjects with ACS(3), were excluded from the study. Of interest, the Authors report that more than 1% of patients experienced AF, as ‘adverse event’, after rivaroxaban or placebo treatment. Although this is a small number of subjects, it would be of interest to see the data for this group presented separately. Indeed, this population represent the best category that may benefit from combined antiplatelet and anticoagulant therapy and these data could be noteworthy especially after the recent caveats stated by the Food and Drug Administration concerning this issue (4).

Disclosures: None.

References 1. Mega JL, Braunwald E, Wiviott SD, et al. Rivaroxaban in Patients with a Recent Acute Coronary Syndrome. N Engl J Med 2011. 2. Roe MT, Messenger JC, Weintraub WS, et al. Treatments, trends, and outcomes of acute myocardial infarction and percutaneous coronary intervention. J Am Coll Cardiol 2010;56:254-63. 3. Jabre P, Roger VL, Murad MH, et al. Mortality associated with atrial fibrillation in patients with myocardial infarction: a systematic review and meta-analysis. Circulation 2011;123:1587-93. 4. Mitka M. FDA advisory decision highlights some problems inherent in pragmatic trials. JAMA 2011;306:1851-2.

Gaetano Santulli, MD, PhD Columbia University gs2620@columbia.edu

On 2014 Mar 17, Gaetano Santulli commented:

Mega et al. report that in patients across the spectrum of acute coronary syndrome (ACS) low doses of the oral anticoagulant rivaroxaban reduced the risk of death from cardiovascular causes, myocardial infarction or stroke (1). Unfortunately, a large percentage of the enrolled patients was not at high cardiovascular risk. Thus, these results may be not applicable to subjects with an ACS who are commonly treated in routine practice (2). Moreover, patients with atrial fibrillation (AF), which represent up to 22% of subjects with ACS(3), were excluded from the study. Of interest, the Authors report that more than 1% of patients experienced AF, as ‘adverse event’, after rivaroxaban or placebo treatment. Although this is a small number of subjects, it would be of interest to see the data for this group presented separately. Indeed, this population represent the best category that may benefit from combined antiplatelet and anticoagulant therapy and these data could be noteworthy especially after the recent caveats stated by the Food and Drug Administration concerning this issue (4).

Disclosures: None.

References 1. Mega JL, Braunwald E, Wiviott SD, et al. Rivaroxaban in Patients with a Recent Acute Coronary Syndrome. N Engl J Med 2011. 2. Roe MT, Messenger JC, Weintraub WS, et al. Treatments, trends, and outcomes of acute myocardial infarction and percutaneous coronary intervention. J Am Coll Cardiol 2010;56:254-63. 3. Jabre P, Roger VL, Murad MH, et al. Mortality associated with atrial fibrillation in patients with myocardial infarction: a systematic review and meta-analysis. Circulation 2011;123:1587-93. 4. Mitka M. FDA advisory decision highlights some problems inherent in pragmatic trials. JAMA 2011;306:1851-2.

Gaetano Santulli, MD, PhD Columbia University gs2620@columbia.edu