Title: Impact of Femoral Vascular Closure Devices and Antithrombotic Therapy on Access Site Bleeding in Acute Coronary Syndromes: The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) Trial
Topic: Interventional Cardiology
Date Posted: 2/9/2010
Author(s): Sanborn TA, Ebrahimi R, Manoukian SV, et al.
Citation: Circ Cardiovasc Interv 2010;3:57-62.
Clinical Trial: No
Study Question: What is the impact of vascular closure devices (VCDs) on access site bleeding in patients undergoing an early invasive approach for acute coronary syndromes (ACS) and coronary angiography using femoral arterial access?
Methods: The authors assessed the impact of VCD use on access site bleeding (ASB) among 11,621 patients undergoing femoral angiography in the ACUITY trial. The ACUITY trial randomized patients with ACS to receive heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibitor (GPI), bivalirudin plus GPI, or bivalirudin monotherapy in an open-label fashion. Major ASB was defined as ASB requiring interventional or surgical correction, hematoma ≥5 cm at the access site, retroperitoneal bleeding, or hemoglobin drop ≥3 g/dl with ecchymosis or hematoma <5 cm, oozing blood, or prolonged bleeding (>30 minutes) at the access site.
Results: A VCD was used in 4,307 (37.1%) patients, and 7,314 (62.9%) had manual compression. The rate of ASB was lower in patients treated with VCD (2.5% vs. 3.3%, relative risk, 0.76; 95% confidence interval [CI], 0.61-0.94; p = 0.01). Rates of bleeding were lowest in patients treated with bivalirudin monotherapy and a VCD (0.7%). After adjusting for differences in baseline variables, both VCD use (odds ratio, 0.78; 95% CI, 0.61-0.99; p = 0.04) and bivalirudin monotherapy (odds ratio, 0.35; 95% CI, 0.25-0.49; p < 0.0001) were both independently associated with freedom from ASB.
Conclusions: Use of VCD was associated with a reduced rate of ASB in patients with ACS undergoing an early invasive approach.
Perspective: There are no large well-designed randomized trials supporting a reduction in bleeding events with VCDs. Prior meta-analyses suggest worse outcome with VCDs, whereas observational studies suggest better outcomes in patients treated with VCDs. It is not clear whether the findings of the current study reflect inability to adjust for confounding or are truly reflective of better outcomes with VCDs. The most effective strategy for reducing access site bleeding complications is radial access, and this strategy should be considered in all patients at risk for ASB. Hitinder S. Gurm, M.B.B.S., F.A.C.C.
Title: Comparison of Ticagrelor With Clopidogrel in Patients With a Planned Invasive Strategy for Acute Coronary Syndromes (PLATO): A Randomised Double-Blind Study
Topic: Interventional Cardiology
Date Posted: 2/10/2010
Author(s): Cannon CP, Harrington RA, James S, et al., on behalf of the PLATelet inhibition and patient Outcomes (PLATO) Investigators.
Citation: Lancet 2010;375:283-293.
Clinical Trial: yes
Study Question: What is the relative efficacy and safety of ticagrelor compared with clopidogrel in patients undergoing an early invasive approach for acute coronary syndromes (ACS)?
Methods: The authors reported the outcome of 13,408 patients who were treated with a planned invasive strategy for an ACS and were enrolled in the PLATO trial. In this trial, patients were randomly assigned in a double dummy fashion to ticagrelor and placebo (180 mg loading dose followed by 90 mg twice a day), or to clopidogrel and placebo (300-600 mg loading dose or continuation with maintenance dose followed by 75 mg per day) for 6-12 months. All patients were also treated with aspirin. The primary composite endpoint was cardiovascular death, myocardial infarction (MI), or stroke.
Results: PCI was performed in 76.8% of the cohort and coronary artery bypass grafting in 5.8%. The primary composite endpoint at 1 year was less frequent in the ticagrelor group compared with the clopidogrel group (9.0% vs. 10.7%; hazard ratio, 0.84; 95% confidence interval, 0.75-0.94; p = 0.0025). There was no difference between clopidogrel and ticagrelor groups in the rates of total major bleeding (11.6% vs. 11.5%, p = 0.8803) or GUSTO severe bleeding (3.2% vs. 2.9%, p = 0.3785). All-cause mortality was lower with ticagrelor (3.9% vs. 5.0%, p = 0.0103).
Conclusions: Ticagrelor seems to be preferable to clopidogrel for patients with ACS, for whom an early invasive strategy is planned.
Perspective: Ticagrelor is a reversible and direct-acting oral P2Y12- receptor antagonist with rapid onset and offset of action. It is a more potent platelet inhibitor compared with clopidogrel, and has demonstrated a reduction in ischemic events with no increase in bleeding over contemporary therapy. While the reduction in mortality may be a chance finding (there was no adjustment for multiple testing), the trends in both MI and death favor ticagrelor. This drug may displace the use of thienopyridines in patients with ACS. Hitinder S. Gurm, M.B.B.S., F.A.C.C.