Stephan D. Fihn

ACC/AHA 2002 Guideline Update for the Management of Patients With Chronic Stable Angina—Summary Article A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Chronic Stable Angina)

The Clinical Efficacy Assessment Subcommittee of the American College of Physicians–American Society of Internal Medicine acknowledges the scientific validity of this product as a background paper and as a review that captures the levels of evidence in the management of patients with chronic stable angina as of November 17, 2002. The American College of Cardiology (ACC)/American Heart Association (AHA) Task Force on Practice Guidelines regularly reviews existing guidelines to determine when an update or a full revision is needed. This process gives priority to areas in which major changes in text, and particularly recommendations, are merited on the basis of new understanding or evidence. Minor changes in verbiage and references are discouraged. The ACC/AHA/American College of Physicians–American Society of Internal Medicine (ACP-ASIM) Guidelines for the Management of Patients With Chronic Stable Angina, which were published in June 1999, have now been updated. The full-text guideline incorporating the updated material is available on the Internet (www.acc.org or www.americanheart.org) in both a track-changes version showing the changes in the 1999 guideline in strike-out (deleted text) and highlighting …

2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease: Executive Summary A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons

WRITING COMMITTEE MEMBERS* Stephan D. Fihn, MD, MPH, Chair†; Julius M. Gardin, MD, Vice Chair*‡; Jonathan Abrams, MD‡; Kathleen Berra, MSN, ANP*§; James C. Blankenship, MD*\; Apostolos P. Dallas, MD*†; Pamela S. Douglas, MD*‡; JoAnne M. Foody, MD*‡; Thomas C. Gerber, MD, PhD‡; Alan L. Hinderliter, MD‡; Spencer B. King III, MD*‡; Paul D. Kligfield, MD‡; Harlan M. Krumholz, MD‡; Raymond Y.K. Kwong, MD‡; Michael J. Lim, MD*\; Jane A. Linderbaum, MS, CNP-BC¶; Michael J. Mack, MD*#; Mark A. Munger, PharmD*‡; Richard L. Prager, MD#; Joseph F. Sabik, MD***; Leslee J. Shaw, PhD*‡; Joanna D. Sikkema, MSN, ANP-BC*§; Craig R. Smith, Jr, MD**; Sidney C. Smith, Jr, MD*††; John A. Spertus, MD, MPH*‡‡; Sankey V. Williams, MD*†

Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease.

OBJECTIVES This study sought to establish the validity, reproducibility and responsiveness of the Seattle Angina Questionnaire, a 19-item self-administered questionnaire measuring five dimensions of coronary artery disease: physical limitation, anginal stability, anginal frequency, treatment satisfaction and disease perception. BACKGROUND Assessing the functional status of patients is becoming increasingly important in both clinical research and quality assurance programs. No current functional status measure quantifies all of the important domains affected by coronary artery disease. METHODS Cross-sectional or serial administration of the Seattle Angina Questionnaire was carried out in four groups of patients: 70 undergoing exercise treadmill testing, 58 undergoing coronary angioplasty, 160 with initially stable coronary artery disease and an additional 84 with coronary artery disease. Evidence of validity was sought by comparing the questionnaires five scales with the duration of exercise treadmill tests, physician diagnoses, nitroglycerin refills and other validated instruments. Reproducibility and responsiveness were assessed by comparing serial responses over a 3-month interval. RESULTS All five scales correlated significantly with other measures of diagnosis and patient function (r = 0.31 to 0.70, p < or = 0.001). Questionnaire responses of patients with stable coronary artery disease did not change over 3 months. The questionnaire was sensitive to both dramatic clinical change, as seen after successful coronary angioplasty, and to more subtle clinical change, as seen among outpatients with initially stable coronary artery disease. CONCLUSIONS The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease. It is sensitive to clinical change and should be a valuable measure of outcome in cardiovascular research.

Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome.

CONTEXT Prior mechanistic studies reported that omeprazole decreases the platelet inhibitory effects of clopidogrel, yet the clinical significance of these findings is not clear. OBJECTIVE To assess outcomes of patients taking clopidogrel with or without a proton pump inhibitor (PPI) after hospitalization for acute coronary syndrome (ACS). DESIGN, SETTING, AND PATIENTS Retrospective cohort study of 8205 patients with ACS taking clopidogrel after discharge from 127 Veterans Affairs hospitals between October 1, 2003, and January 31, 2006. Vital status information was available for all patients through September 30, 2006. MAIN OUTCOME MEASURES All-cause mortality or rehospitalization for ACS. RESULTS Of 8205 patients taking clopidogrel after discharge, 63.9% (n = 5244) were prescribed PPI at discharge, during follow-up, or both and 36.1% (n = 2961) were not prescribed PPI. Death or rehospitalization for ACS occurred in 20.8% (n = 615) of patients taking clopidogrel without PPI and 29.8% (n = 1561) of patients taking clopidogrel plus PPI. In multivariable analyses, use of clopidogrel plus PPI was associated with an increased risk of death or rehospitalization for ACS compared with use of clopidogrel without PPI (adjusted odds ratio [AOR], 1.25; 95% confidence interval [CI], 1.11-1.41). Among patients taking clopidogrel after hospital discharge and prescribed PPI at any point during follow-up (n = 5244), periods of use of clopidogrel plus PPI (compared with periods of use of clopidogrel without PPI) were associated with a higher risk of death or rehospitalization for ACS (adjusted hazard ratio, 1.27; 95% CI, 1.10-1.46). In analyses of secondary outcomes, patients taking clopidogrel plus PPI had a higher risk of hospitalizations for recurrent ACS compared with patients taking clopidogrel without PPI (14.6% vs 6.9%; AOR, 1.86 [95% CI, 1.57-2.20]) and revascularization procedures (15.5% vs 11.9%; AOR, 1.49 [95% CI, 1.30-1.71]), but not for all-cause mortality (19.9% vs 16.6%; AOR, 0.91 [95% CI, 0.80-1.05]). The association between use of clopidogrel plus PPI and increased risk of adverse outcomes also was consistent using a nested case-control study design (AOR, 1.32; 95% CI, 1.14-1.54). In addition, use of PPI without clopidogrel was not associated with death or rehospitalization for ACS among patients not taking clopidogrel after hospital discharge (n = 6450) (AOR, 0.98; 95% CI, 0.85-1.13). CONCLUSION Concomitant use of clopidogrel and PPI after hospital discharge for ACS was associated with an increased risk of adverse outcomes than use of clopidogrel without PPI, suggesting that use of PPI may be associated with attenuation of benefits of clopidogrel after ACS.

ACC/AHA/ACP-ASIM Guidelines for the Management of Patients With Chronic Stable Angina A Report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients With Chronic Stable Angina)

### Table of contents It is important that the medical profession play a significant role in critically evaluating the use of diagnostic procedures and therapies in the management or prevention of disease states. Rigorous and expert analysis of the available data documenting relative benefits and

The Risk for and Severity of Bleeding Complications in Elderly Patients Treated with Warfarin

Warfarin is prescribed for more than 1 million persons in the United States, many of whom are elderly and take the drug indefinitely. The pooled results of five randomized trials document that warfarin reduced the incidence of stroke by 68% in persons with atrial fibrillation, a benefit that substantially outweighs the risk for bleeding that accompanies warfarin therapy [1-6]. Atrial fibrillation is present in 4% of persons older than 60 years of age and 10% of persons older than 80 years of age [7]. Paradoxically, many studies have found that elderly persons are at higher risk for hemorrhagic complications than are younger patients [8-17]. It has been suggested that older patients are more prone to bleeding because they metabolize warfarin more slowly [18-20]; they have an elevated risk for drug interactions because of polypharmacy [21]; and they often have chronic illnesses, such as renal insufficiency [22], heart failure [9], cancer [10, 22], and cerebrovascular disease [23], that increase the risk for bleeding during warfarin therapy. On the other hand, numerous studies have not found elderly persons to be at greater risk for bleeding [24-31]. These discrepant findings have not been adequately explained. Because of the clinical importance of this problem, we analyzed data from six sites to determine whether elderly patients who were receiving warfarin had a higher incidence of complications than similar younger patients who were also receiving warfarin. Methods We collected our data in two phases. The first phase involved a retrospective review of medical records from 1980 to 1990; other results from this review have been reported previously [30]. In the second phase, we analyzed data collected prospectively between 1990 and 1993, including the results from a multicenter, randomized trial of a computerized scheduling system for patients receiving warfarin [32]. Study Setting and Patients Our study was done in the six anticoagulation clinics that make up the National Consortium of Anticoagulation Clinics. These clinics represent a mix of geographic locations, practice settings, and patient populations. Clinic personnel were responsible for managing anticoagulation therapy for all patients throughout the study, although in two clinics, personnel also provided primary medical care [33]. The sites were the University of California at Davis, Sacramento, California; Jefferson Medical College, Philadelphia, Pennsylvania; the University of Virginia, Charlottesville, Virginia; the Veterans Affairs Medical Center, Buffalo, New York; the Veterans Affairs Medical Center, Palo Alto, California; and the Veterans Affairs Medical Center, Seattle, Washington. Because Jefferson Medical College did not join the Consortium until 1992, data from that site were used only in the prospective phase of the study, which followed completion of the randomized trial of computerized scheduling. Retrospective Data Collection During the retrospective phase of our study, we abstracted the medical records of all patients who were currently receiving anticoagulation therapy and all patients whose anticoagulation therapy had been discontinued within the previous 18 to 24 months. If patients had received multiple courses of warfarin (that is, if there were extended periods during which a patient did not receive warfarin), we abstracted data from all courses. All patients were eligible for inclusion unless they had received warfarin for 6 weeks or less. We have described our data collection methods in detail elsewhere [30]. Trained abstractors reviewed inpatient and outpatient records using standard forms that have been extensively tested for reliability. All records from inpatient admissions and visits to the anticoagulation clinic; other medical, surgical, and urgent care clinics (excluding visits made for psychiatric reasons); and emergency departments were abstracted. We also reviewed any records that were maintained separately from the formal medical record by a practitioner responsible for anticoagulation therapy. At each of the three Veterans Affairs medical centers, data were also retrieved from the hospitals information system. We excluded seven patients whose charts were missing. Indications for anticoagulation therapy were organized into seven main categories and 29 subcategories. For patients who had more than one indication, the most serious problem (the one that required the greatest intensity or longest duration of therapy) was deemed the primary indication. During the retrospective phase of our study, only one of the five medical centers reported results using the international normalized ratio. Because the international sensitivity index values of the thromboplastins used at some of the participating centers were unavailable before 1988, we analyzed all results using the prothrombin time ratio. However, we contacted each laboratory to determine whether the international sensitivity index values of the reagents used were known; this information was available from several of the study sites after 1985 and from all sites after 1990. All laboratories used standard North American thromboplastins that had international sensitivity index values ranging from 2.0 to 2.4. Practitioners typically adhered to therapeutic recommendations published by the American College of Chest Physicians (ACCP) in 1986 [34, 35], which set the target range as a prothrombin time ratio of 1.5 to 1.8 (high intensity) for patients with mechanical valves and 1.3 to 1.5 (low intensity) for most other patients. Records from outpatient visits were reviewed to ascertain the reason for the appointment, the occurrence of any intercurrent illnesses, all medications prescribed in addition to warfarin, and the dates on which therapy with each medication was started and stopped [36]. Prospective Study The prospective data collection was done over a 3-year period (1990 to 1993). During the first year of this period, we did a randomized trial of a computerized scheduling intervention [32]. Because the scheduling system produced no statistically significant differences in control of anticoagulation or frequency of complications, we have included data collected during that 1-year period in our present analysis. During the 2 years after completion of the trial, we continued to collect identical information on patients who had participated in the trial and on all eligible patients subsequently enrolled into participating clinics for the management of warfarin therapy. Jefferson Medical College did not participate in the trial of computerized scheduling. Patients who were actively enrolled in one of the six participating clinics or who were newly referred to one of the clinics were eligible for this portion of the study if the total planned duration of their anticoagulation therapy was 6 weeks or longer. Before the start of prospective data collection, we abstracted the medical records of all active eligible patients in each clinic. These data were collected according to the same protocol used in the retrospective study. At the three clinics located in university medical centers, our trial was exempted from requirements for verbal or written informed consent by the local institutional review boards, and all eligible patients were enrolled. At the three Veterans Affairs clinics, the local review boards required informed consent, and we invited the participation of all eligible patients in person or by mail; 5.2% of patients in these clinics declined to participate. At each visit to each anticoagulation clinic during the prospective phase of the study, all data, including those on the prothrombin time ratio (or international normalized ratio) results, warfarin dosage, complications, and follow-up plans, were entered directly into a notebook computer. Classification of Outcomes In both the retrospective and prospective phases of data collection, we used the same detailed scheme to classify bleeding complications as minor (no associated costs or medical consequences), serious (requiring treatment or medical evaluation), life-threatening, or fatal. Minor complications required no additional testing, referrals, or outpatient visits but were remarkable enough to report to the provider. Examples of minor bleeding included mild nosebleeds, bruising, mild hemorrhoidal bleeding, and microscopic hematuria. Examples of serious bleeding included overt gastrointestinal bleeding, occult gastrointestinal bleeding if endoscopic or radiographic studies were done, gross hematuria that prompted cystoscopy or intravenous urography or lasted more than 2 days, and hemoptysis. If blood was transfused, 2 units or fewer were given. Life-threatening bleeding was defined as that leading to cardiopulmonary arrest, surgical or angiographic intervention, or irreversible sequelae, such as myocardial infarction, neurologic deficit consequent to intracerebral hemorrhage, or massive hemothorax. Bleeding was also considered to be life-threatening if it led to at least two of the following consequences: loss of 3 or more units of blood; systolic hypotension (systolic blood pressure less than 90 mm Hg); or critical anemia (hematocrit less than equals 0.20). Fatal bleeding was defined as that leading directly to the death of the patient. All serious, life-threatening, and fatal complications were independently reviewed by a physician investigator at the local site and by three investigators at the coordinating center. Using standardized criteria, we determined whether deaths were related to bleeding caused by warfarin therapy or to thromboembolic complication. Disagreements were resolved by discussion. Deviation in the Prothrombin Time Ratio We previously described [37] a method that can be used to characterize the degree to which a patients prothrombin time ratios deviate from his or her target prothrombin time ratio over time, and we have shown that the level of variability in the prothrombin time ratio is stati

ACC/AHA 2002 Guideline Update for the Management of Patients With Chronic Stable Angina—Summary Article

The Clinical Efficacy Assessment Subcommittee of the American College of Physicians–American Society of Internal Medicine acknowledges the scientific validity of this product as a background paper and as a review that captures the levels of evidence in the management of patients with chronic stable angina as of November 17, 2002. The American College of Cardiology (ACC)/American Heart Association (AHA) Task Force on Practice Guidelines regularly reviews existing guidelines to determine when an update or a full revision is needed. This process gives priority to areas in which major changes in text, and particularly recommendations, are merited on the basis of new understanding or evidence. Minor changes in verbiage and references are discouraged. The ACC/AHA/American College of Physicians–American Society of Internal Medicine (ACP-ASIM) Guidelines for the Management of Patients With Chronic Stable Angina, which were published in June 1999, have now been updated. The full-text guideline incorporating the updated material is available on the Internet (www.acc.org or www.americanheart.org) in both a track-changes version showing the changes in the 1999 guideline in strike-out (deleted text) and highlighting …

2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

Jonathan L. Halperin, MD, FACC, FAHA, Chair Glenn N. Levine, MD, FACC, FAHA, Chair-Elect Sana M. Al-Khatib, MD, MHS, FACC, FAHA Kim K. Birtcher, PharmD, MS, AACC Biykem Bozkurt, MD, PhD, FACC, FAHA Ralph G. Brindis, MD, MPH, MACC, FAHA Joaquin E. Cigarroa, MD, FACC Lesley H. Curtis, PhD,

Health status predicts long-term outcome in outpatients with coronary disease

Background—Although patient-reported health status measures have been used as end points in clinical trials, they are rarely used in other settings. Demonstrating that they independently predict mortality and hospitalizations among outpatients with coronary disease could emphasize their clinical value. Methods and Results—This study evaluated the prognostic utility of the Seattle Angina Questionnaire (SAQ), a disease-specific health status measure for patients with coronary artery disease. Patients were enrolled in a prospective cohort study from 6 Veterans Affairs General Internal Medicine Clinics. All patients reporting coronary artery disease who completed a SAQ and had 1 year of follow-up were analyzed (n=5558). SAQ predictor variables were the physical limitation, angina stability, angina frequency, and quality-of-life scores. The primary outcome was 1-year all-cause mortality, and a secondary outcome was hospitalization for acute coronary syndrome (ACS). Lower SAQ scores were associated with increased risks of mortality and ACS admissions. Prognostic models controlling for demographic and clinical characteristics demonstrated significant independent mortality risk with lower SAQ physical limitation scores; odds ratios for mild, moderate, and severe limitation were 1.5, 2.0, and 4.0 versus minimal limitation (P <0.001). Odds ratios for mild, moderate, and severe angina frequency were 0.8, 1.2, and 1.6 (P =0.078). The odds ratios for ACS admission among those with mild, moderate, and severe angina frequency were 1.4, 2.0, and 2.2, respectively (P =0.016). Conclusions—SAQ scores are independently associated with 1-year mortality and ACS among outpatients with coronary disease and may serve a valuable role in the risk stratification of such patients.

A general method of compliance assessment using centralized pharmacy records. Description and validation.

The prescription refill records of centralized pharmacies are a potential source of information about patient compliance with long-term medications. We developed a method for assessing compliance in such settings and validated our measures using pharmacy data and clinical information from patients with seizure disorders and hypertension. For patients taking the anticonvulsant medication phenytoin, compliance with the drug correlated significantly with mean plasma phenytoin level. For patients on antihypertensive medications, compliance with the treatment regimen correlated with control of diastolic blood pressure. Many patients (15% in the phenytoin validation, and 33% in the blood pressure validation) obtained substantial oversupplies of medications; for these patients, the direct relationship between compliance and drug effect was not evident. A majority of seizure patients with “subtherapeutic” mean plasma phenytoin levels were identified as noncompliant using our measures. We conclude that our method of assessing compliance in obtaining medications is feasible in “managed care” settings, appears to be a valid correlate of drug effects, and may be useful in research and patient care.