PNR in 2011: Recalling Ten Years of Transatlantic Cooperation in PNR Information

In Fall 2011, U.S. and EU negotiators agreed on new parameters for the collection, processing, use, storage and crossborder transfer of Passenger Name Record (PNR) data. 2011 also marks the tenth anniversary of the September 11, 2001 terrorist attacks on the World Trade Center in New York City and the Pentagon in Washington D.C., which provides the historic reason for the cooperation in this area. These two events thus provide a timely basis and background against which to review the ten year history of the cooperation between the U.S. and the EU in PNR information management. This article maps the evolution of collaboration between the U.S. and the EU with respect to the PNR program by presenting the major dimensions involved. Moreover, it provides a comprehensive framework with a particular focus on the constant struggle for a consistent EU policy as well as the creation of the U.S.-EU Agreements in 2004 and 2007. It furthermore sketches major legal and political developments that have most likely had a significant impact on the negotiations and are, as a consequence, reflected in the concrete design of the new PNR Agreement. All this leads the author to the conclusion that—as thoroughly as it may have been designed and as complete as it may seem—the new PNR Agreement will not be the end of the transatlantic PNR saga, but rather the beginning of another intriguing chapter

PNR in 2011: Recalling Ten Years of Transatlantic Cooperation in PNR Information

In Fall 2011, U.S. and EU negotiators agreed on new parameters for the collection, processing, use, storage and crossborder transfer of Passenger Name Record (PNR) data. 2011 also marks the tenth anniversary of the September 11, 2001 terrorist attacks on the World Trade Center in New York City and the Pentagon in Washington D.C., which provides the historic reason for the cooperation in this area. These two events thus provide a timely basis and background against which to review the ten year history of the cooperation between the U.S. and the EU in PNR information management. This article maps the evolution of collaboration between the U.S. and the EU with respect to the PNR program by presenting the major dimensions involved. Moreover, it provides a comprehensive framework with a particular focus on the constant struggle for a consistent EU policy as well as the creation of the U.S.-EU Agreements in 2004 and 2007. It furthermore sketches major legal and political developments that have most likely had a significant impact on the negotiations and are, as a consequence, reflected in the concrete design of the new PNR Agreement. All this leads the author to the conclusion that—as thoroughly as it may have been designed and as complete as it may seem—the new PNR Agreement will not be the end of the transatlantic PNR saga, but rather the beginning of another intriguing chapter

Rationale and design of ACTIVE: the atrial fibrillation clopidogrel trial with irbesartan for prevention of vascular events

BACKGROUND: Atrial fibrillation (AF) is the most frequently occurring cardiac arrhythmia with often serious clinical consequences. Many patients have contraindications to anticoagulation, and it is often underused in clinical practice. The addition of clopidogrel to aspirin (ASA) has been shown to reduce vascular events in a number of high-risk populations. Irbesartan is an angiotensin receptor-blocking agent that reduces blood pressure and has other vascular protective effects. METHODS AND RESULTS: ACTIVE W is a noninferiority trial of clopidogrel plus ASA versus oral anticoagulation in patients with AF and at least 1 risk factor for stroke. ACTIVE A is a double-blind, placebo-controlled trial of clopidogrel in patients with AF and with at least 1 risk factor for stroke who receive ASA because they have a contraindication for oral anticoagulation or because they are unwilling to take an oral anticoagulant. ACTIVE I is a partial factorial, double-blind, placebo-controlled trial of irbesartan in patients participating in ACTIVE A or ACTIVE W. The primary outcomes of these studies are composites of vascular events. A total of 14000 patients will be enrolled in these trials. CONCLUSIONS: ACTIVE is the largest trial yet conducted in AF. Its results will lead to a new understanding of the role of combined antiplatelet therapy and the role of blood pressure lowering with an angiotensin II receptor blocker in patients with A

Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: The ASSENT-3 randomised trial in acute myocardial infarction

Background: Current fibrinolytic therapies fail to achieve optimum reperfusion in many patients. Low-molecular-weight heparins and platelet glycoprotein IIb/IIIa inhibitors have shown the potential to improve pharmacological reperfusion therapy. We did a randomised, open-label trial to compare the efficacy and safety of tenecteplase plus enoxaparin or abciximab, with that of tenecteplase plus weight-adjusted unfractionated heparin in patients with acute myocardial infarction. Methods: 6095 patients with acute myocardial infarction of less than 6 h were randomly assigned one of three regimens: full-dose tenecteplase and enoxaparin for a maximum of 7 days (enoxaparin group; n=2040), half-dose tenecteplase with weight-adjusted low-dose unfractionated heparin and a 12-h infusion of abciximab (abciximab group; n=2017), or full-dose tenecteplase with weight-adjusted unfractionated heparin for 48 h (unfractionated heparin group; n=2038). The primary endpoints were the composites of 30-day mortality, in-hospital reinfarction, or in-hospital refractory ischaemia (efficacy endpoint), and the above endpoint plus in-hospital intracranial haemorrhage or in-hospital major bleeding complications (efficacy plus safety endpoint). Analysis was by intention to treat. Findings: There were significantly fewer efficacy endpoints in the enoxaparin and abciximab groups than in the unfractionated heparin group: 233/2037 (11.4%) versus 315/2038 (15.4%; relative risk 0.74 [95% CI 0.63-0.87], p=0.0002) for enoxaparin, and 223/2017 (11.1%) versus 315/2038 (15.4%; 0.72 [0.61-0.84], p<0.0001) for abciximab. The same was true for the efficacy plus safety endpoint: 280/2037 (13.7%) versus 347/2036 (17.0%; 0.81 [0.70-0.93], p=0.0037) for enoxaparin, and 287/2016 (14.2%) versus 347/2036 (17.0%; 0.84 [0.72-0.96], p=0.01416) for abciximab. Interpretation: The tenecteplase plus enoxaparin or abciximab regimens studied here reduce the frequency of ischaemic complications of an acute myocardial infarction. In light of its ease of administration, tenecteplase plus enoxaparin seems to be an attractive alternative reperfusion regimen that warrants further study