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Cardiology

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Cardiology for September 1, 2010

SUMMARY AND COMMENT

Clopidogrel and Aspirin for Acute Coronary Syndromes: Have We Found an OASIS?

September 1, 2010 | Harlan M. Krumholz, MD, SM

Trial data provide scant sustenance on the quest for an optimal dosing strategy.

Reviewing: The CURRENT–OASIS 7 Investigators. N Engl J Med 2010 Sep 2; 363:930

Fuster V. N Engl J Med 2010 Sep 2; 363:976

Mehta SR et al. Lancet 2010 Sep 1;

Stone GW. Lancet 2010 Sep 1;

SUMMARY AND COMMENT

Safety and Dosing of Unfractionated Heparin in Fondaparinux-Treated Patients Undergoing Percutaneous Coronary Intervention

September 1, 2010 | Beat J. Meyer, MD

In this large, randomized trial, fondaparinux-treated patients had similar rates of adverse events with standard-dose versus low-dose heparin.

Reviewing: The FUTURA/OASIS-8 Trial Group. JAMA 2010 Aug 31;

SUMMARY AND COMMENT

Is Better Risk Assessment Within REACH?

September 1, 2010 | Harlan M. Krumholz, MD, SM

An analysis of registry data could be a first step toward an improved strategy for predicting cardiovascular events.

Reviewing: Bhatt DL et al. JAMA 2010 Aug 30;

SUMMARY AND COMMENT

CYP2C19 and Clopidogrel: Don't Order That Test Just Yet

August 30, 2010 | Harlan M. Krumholz, MD, SM

New evidence casts doubt on the role of genetic variation in determining treatment effects.

Reviewing: Pare G et al. N Engl J Med 2010 Aug 29;

Wallentin L et al. Lancet 2010 Aug 29;

Mega JL et al. Lancet 2010 Aug 29;

SUMMARY AND COMMENT

Shifting Attention to Heart Rate

August 30, 2010 | Harlan M. Krumholz, MD, SM

Slowing heart rates with ivabradine improves outcomes — and provokes questions about the optimal use of beta-blockers — in patients with heart failure.

Reviewing: Swedberg K et al. Lancet 2010 Aug 29;

Böhm M et al. Lancet 2010 Aug 29;

SUMMARY AND COMMENT

Does Omega-3 Fatty Acid Supplementation Prevent Cardiovascular Events?

August 30, 2010 | Harlan M. Krumholz, MD, SM

In a new study, adding omega-3 fatty acids — from fish, plants, or both — to patients' diets had no significant effect.

Reviewing: Kromhout D et al for the Alpha Omega Trial Group. N Engl J Med 2010 Aug 29;

SUMMARY AND COMMENT

More Good News About Dabigatran

August 30, 2010 | Mark S. Link, MD

Dabigatran's advantages over warfarin are increased at centers with poor control of international normalized ratio in warfarin therapy.

Reviewing: Wallentin L et al. Lancet 2010 Aug 29;

Free Full-Text Article

Summary and Comment

Clopidogrel and Aspirin for Acute Coronary Syndromes: Have We Found an OASIS?

Trial data provide scant sustenance on the quest for an optimal dosing strategy.

Although the efficacy of clopidogrel plus aspirin for treating acute coronary syndromes (ACS) is well established, considerable uncertainty remains about dosing. Investigators for the manufacturer-sponsored CURRENT–OASIS 7 trial employed a 2x2 factorial design to examine the effects of doubling the standard loading dose and first-week maintenance dose of clopidogrel (from 300 to 600 mg and from 75 to 150 mg, respectively), and compared the effects of high-dose (300–325 mg/day) versus low–dose (75–100 mg/day) aspirin. All 25,086 patients (mean age, 61; 27% women) had ACS and were scheduled for coronary angiography with percutaneous coronary intervention (PCI) as indicated within 72 hours after randomization, and all received a loading aspirin dose of >300 mg. The primary 30-day outcome was a composite of cardiovascular death, myocardial infarction (MI), and stroke. The study had 80% power to detect a 16% reduction in risk.

In the clopidogrel comparison, the rate of the primary outcome was similar in the double-dose and standard-dose groups (4.2% and 4.4%, respectively; hazard ratio, 0.94; 95% confidence interval, 0.83–1.06). Major bleeding, as determined by increased red-cell transfusion, was more common in the double-dose group (2.5% vs. 2.0%; HR, 1.24; 95% CI, 1.05–1.46; P=0.01). In the aspirin comparison, the rates of the primary outcome in both groups were the same as in the clopidogrel comparison, but the between-group bleeding rates were also similar.

In a prespecified analysis involving the 17,263 participants who underwent PCI (95% received a stent), a primary endpoint occurred in 3.9% of the double-dose clopidogrel group compared with 4.5% of the standard-dose clopidogrel group (HR, 0.86; 95% CI, 0.74–0.99; P=0.04); the difference was mostly attributable to the difference in MI rate. The stent thrombosis rate was significantly lower in the double-dose group than in the standard-dose group (1.6% vs. 2.3%; HR, 0.68; 95% CI, 0.55–0.85). The rate of major bleeding was higher in the double-dose group (1.6% vs. 1.1%; HR, 1.41; 95% CI, 1.09–1.83).

Comment: This study failed to show a benefit of high-dose clopidogrel or high-dose aspirin in patients with ACS who were expected to undergo cardiac catheterization. However, benefits were found in those who did undergo PCI, albeit at the cost of an increase in major bleeding. These findings were significant, although they were not adjusted for multiple comparisons. The comparison in the PCI recipients, as an expanded subgroup analysis, cannot bear the same weight as the full trial in the body of evidence. Interpretation of the aspirin results is problematic because the effect of the loading dose lasts for a week or more, and many patients on the higher dose also received a proton-pump inhibitor. The best antiplatelet regimen for PCI, therefore, remains uncertain.

Harlan M. Krumholz, MD, SM

Published in Journal Watch Cardiology September 1, 2010

Citation(s):

The CURRENT–OASIS 7 Investigators. Dose comparisons of clopidogrel and aspirin in acute coronary syndromes. N Engl J Med 2010 Sep 2; 363:930.

Fuster V. Fine-tuning therapy for acute coronary syndromes. N Engl J Med 2010 Sep 2; 363:976.

Mehta SR et al. Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): A randomized factorial trial. Lancet 2010 Sep 1; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S0140-6736(10)61088-4)

Stone GW. Acute coronary syndromes: Finding meaning in OASIS 7. Lancet 2010 Sep 1; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S0140-6736(10)61262-7)

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