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Background: Percutaneous Coronary Intervention

Presentation: Adjunctive Devices for Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention

Keywords: background | percutaneous coronary intervention | PCI | myocardial infarction | MI | coronary bypass surgery | coronary stent

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Adjunctive Distal Balloon Embolic Protection Devices Versus PCI Alone in Patients With STEMI: Final and Intermediate Health Outcomes

Presentation: Adjunctive Devices for Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention

Keywords: adjunctive devices | distal balloon embolic protection | ST-segment resolution | myocardial blush grade | outcomes

Comparator and Applicability: Examples. A fixed-dose study that compared high-dose duloxetine to low-dose paroxetine. Many trials evaluating magnesium as a treatment for acute myocardial infarction that were conducted before thrombolytic drugs, antiplatelet drugs, beta-blockers, and primary percutaneous coronary intervention (PCI) were used. Only 1 of 23 trials that compared bypass surgery to PCI used drug-eluting stents.

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Comparator and Applicability: Examples

Presentation: Assessing Applicability

Keywords: comparator | applicability

Setting and Applicability: Examples. Studies evaluating the benefits of breast self-examinations conducted in China and Russia, countries that do not employ routine mammography screening as in the United States. Studies of open surgical abdominal aortic aneurysm repair showing an inverse relationship between hospital volume and short-term mortality.

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Setting and Applicability: Examples

Presentation: Assessing Applicability

Keywords: setting | applicability

Questions To Consider When Classifying Study Design. Did the study have more than one group or arm? If so, was a control group present? Did investigators have control over allocation and timing of the intervention? Did investigators randomly allocate subjects to interventions? Did investigators concurrently measure intervention and exposure status for intervention and comparison groups? Did investigators concurrently measure outcomes for intervention and comparison groups?

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Apply Predefined Criteria for All Study Types (I)

Presentation: Assessing the Quality of Individual Studies

Keywords: study design

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Clinical Management of Head and Neck Cancer

Presentation: Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer

Keywords: adverse events | clinical management | Head and neck cancer | outcomes | quality of life | treatment | Radiotherapy

On average, 91 patients with stable ischemic heart disease (IHD) and preserved left ventricular systolic function (LVSF) will need to be treated with an angiotensin-converting enzyme inhibitor (ACEI) over 4 years to prevent 1 additional death. In other words, on average, 8.5 in 100 patients with stable IHD will die in the next 4 years. If an ACEI were to be added to the treatment regimens of 100 patients, then 7.4 patients — or 1 less patient — will die. The absolute difference in event rates between the groups of patients who were treated or were not treated with an ACEI is 1.1, with a relative risk reduction in total mortality of 13%. The benefits with respect to nonfatal myocardial infarction (MI) are similar. On average, 91 patients with stable IHD and preserved LVSF will need to be treated with an ACEI over 4 years to prevent 1 additional nonfatal MI. So, on average, 6.1 in 100 patients with stable IHD will have a nonfatal MI in the next 4 years. If an ACEI were to be added to the treatment regimens of 100 patients, then 5 patients — or 1 less patient — will have a nonfatal MI. The absolute difference in event rates between the two treatment groups is also 1.1, with a relative risk reduction in nonfatal MIs of 17%.With regard to hospitalization for heart failure, on average, 167 patients with stable IHD and preserved LVSF will need to be treated with an ACEI over 4 years to prevent 1 additional hospitalization. On average, 2.6 in 100 patients with stable IHD will be hospitalized for heart failure-related reasons in the next 4 years. If an ACEI were to be added to the treatment regimens of 100 patients, then 2 patients — or nearly 1 less — would be hospitalized for heart failure-related reasons. The absolute difference in event rates between the two treatment groups is less than 1, with a relative risk reduction of 22% for heart failure-related hospitalizations. Finally, on average, 77 patients with stable IHD and preserved LVSF will need to be treated with an ACEI over 3.7 years to prevent 1 additional revascularization surgery. Stated another way, on average, 13.6 in 100 patients with stable IHD will need revascularization surgery in the next 4 years. If an ACEI were to be added to the treatment regimens of 100 patients, then 12.3 patients — or about 1 less patient — would need this surgery. The absolute difference in event rates between the two treatment groups is 1.3, with a relative risk reduction of 10% for revascularization surgery.Overall, the absolute difference in event rates between the patients treated with an ACEI and those who received standard treatment alone is 1.3 or less. Moreover, the addition of an ACEI did not significantly reduce atrial fibrillation or angina-related hospitalizations. All of these data were determined to be at a high level of evidence, meaning that future trials are unlikely to change the estimated differences between these treatment groups.

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Benefits With HIGH Levels of Evidence That Result From Adding an ACEI to Standard Medical Therapy for Stable Ischemic Heart Disease With Preserved Left Ventricular Systolic Function

Presentation: Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors and/or Angiotensin II Receptor Blockers Added to Standard Medical Therapy for Treating Patients With Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function

Keywords: evidence-based benefits | number needed to treat | relative risk | stable ischemic heart disease | angiotensin-converting enzyme inhibitor

Introduction to Recombinant Activated Factor VII (rFVIIa)
Recombinant activated factor VII (rFVIIa) is approved by the FDA for use in patients with hemophilia A or B with inhibitors, acquired hemophilia, and congenital factor VII deficiency. In the United States, prevalence of hemophilia A and hemophilia B are 1:10,000 and 1:25,000, respectively. Relatively few of these individuals will ever require rFVIIa for treatment as a result of developing antibody inhibitors to the exogenous replacement coagulation factors they are given to replace the deficient factor. In most cases, patients with inhibitors cannot be desensitized to their factor replacement regimen and require rFVIIa to bypass the inhibiting antibodies and to promote clotting during bleeding crises or for surgery and related procedures. The Stanford-UCSF Evidence-based Practice Center used the 2000–2008 data from the Perspective Comparative Database of Premier, Inc. (Charlotte, NC) to assess the in-hospital usage trends of rFVIIa. The Premier database includes information on 40 million annual hospitalizations occurring in 615 U.S. hospitals. Data from the Premier database indicated that in the past decade, off-label use of rFVIIa in the hospital has increased in many other nonhemophiliac bleeding situations that are unresponsive to conventional therapy to control excessive bleeding and reduce exposure to allogeneic blood.

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Introduction to Recombinant Activated Factor VII (rFVIIa)

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care

Keywords: comparative effectiveness | recombinant factor VIIa | off-label | FDA | hemophilia | spontaneous intracranial hemorrhage | trauma | adult cardiac surgery

FDA Approved Indications for rFVIIa
Since 1999, the FDA has approved four separate applications that have gradually expanded the scope of rFVIIa use in hemophilia:
Hemophilia A or B with inhibitors for bleeding episodes (March 25, 1999).
Bleeding and surgery in congenital factor VII deficiency (July 11, 2005).
Surgery and invasive procedures in hemophilia A or B with inhibitors (August 12, 2005).
Bleeding and surgery in acquired hemophilia (October 13, 2006).

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FDA Approved Indications for rFVIIa

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care

Keywords: acquired hemophilia | congenital factor VII deficiency | FDA-approved indications | hemophilia | inhibitors | recombinant factor VIIa

Off-Label Uses of rFVIIa
The use of rFVIIa for off-label clinical indications originates in the ability of rFVIIa to “bypass” multiple defects in the coagulation pathway. These uses are listed by their relative proximity to the FDA approved uses. The following categories suggest increasing extension of rFVIIa use into clinical areas with diminishing similarity to the FDA approved uses.
Chronic prophylactic use in hemophilia A and B in the absence of bleeding episodes or procedures. While not approved by the FDA, this form of use has been approved in Australia.
Episodic use in other congenital and acquired clotting factor defects, including hemophilia C, von Willebrand’s disease, and factor VII deficiency, as well as in other rare coagulopathies.
Episodic use for isolated congenital or acquired clotting defects that arise from deficiency or dysfunction of other components of the coagulation process. This includes platelet dysfunction, such as Glanzmann’s thrombasthenia, which has been approved by the EMEA but not the FDA.
Episodic use in disease states where impaired coagulation is but one manifestation. Liver disease is a prominent example, but other conditions include leukemia, lymphoma, and other cancers.
Episodic use where anticoagulant therapy contributes to bleeding problems beyond what would exist otherwise. This includes patients on warfarin and those undergoing cardiac surgery with cardiopulmonary bypass that requires heparin anticoagulation.
Clinical circumstances where a consumptive coagulopathy has developed as the result of substantial and rapid blood loss. In practice, this often includes trauma patients and those with massive gastrointestinal bleeding.
Situations where significant blood loss is anticipated in the absence of pre-existing coagulopathy, as with prophylactic use of rFVIIa in prostatectomy or vascular surgery.
Clinical situations requiring prompt cessation of traumatic, surgical, or spontaneous bleeding in non-coagulopathic patients where hemorrhage extension is associated with significant adverse outcomes, as occurs with intracranial hemorrhage, brain surgery, and pulmonary hemorrhage.

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Off-Label Uses of rFVIIa

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care

Keywords: bleeding | clotting factor defects | consumptive coagulopathy | hemophilia | off-label uses | recombinant factor VIIa | comparative effectiveness

The CER Development Process (1)The comparative effectiveness review (CER) topic, Comparative Effectiveness of Recombinant Factor VIIa for Off-Label Uses vs. Usual Care in the Hospital Setting, was nominated in a public process. The nominated topic was reviewed and selected based on need, importance, and feasibility. Sufficient research into the current literature by experts in the field and stakeholders determined that a CER on the off-label usage trends and benefits and harms for select patient populations was needed and would not duplicate existing work. Based on this research, key clinical questions that the report would address were developed and made available for public comment. The Agency for Healthcare Research and Quality (AHRQ) then commissioned the Stanford-UCSF Evidence-Based Practice Center to prepare the CER with input from a Technical Expert Panel. This advisory panel was comprised of experts in different specialties, including anesthesiology, pediatric hematology/oncology, transplantation, pathology, hematology, pharmacology, trauma surgery, and drug risk management. The panel identified important issues, reviewed proposed methods, defined parameters for the review of evidence, and helped develop the draft report.

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The CER Development Process (1)

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care

Keywords: comparative effectiveness | recombinant factor VIIa | off-label | topic nomination | stakeholder | technical expert panel | research process

Framework for Analyzing Outcomes of Off-Label rFVIIa Use in the Hospital SettingThis slide delineates the analytic framework for evaluating the off-label use of rFVIIa for the CER titled Comparative Effectiveness of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care. The figure represents the trajectory of a patient who receives rFVIIa at some point during inpatient medical care. The first possible time of drug administration is in the case of prophylactic use (to limit blood loss) during a potentially bloody surgery, such as liver transplantation or cardiac surgery. The second possible time of drug administration is in the case of treatment use, which occurs as an attempt to arrest ongoing bleeding and is employed in numerous clinical scenarios, including intracranial hemorrhage and trauma. The final possible time of drug administration is in the case of end-stage use, as a last-ditch effort to salvage a patient who is dying from massive hemorrhage. Repeat doses of rFVIIa are possible during any of the above applications. Thick horizontal arrows near the top of the figure represent the overlap between the clinical questions addressed in the CER and the different types of rFVIIa use described above. For example, the bar representing the overall use of rFVIIa spans the entire range of potential uses—prophylaxis, treatment, and end-stage—whereas the bar representing the off-label indication of intracranial hemorrhage encompasses only treatment use.

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Framework for Analyzing Outcomes of Off-Label rFVIIa Use in the Hospital Setting

Presentation: Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care

Keywords: comparative effectiveness | recombinant factor VIIa | off-label | framework | outcomes | research process

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