Letters
.56 for the type of stent used. Takagi et al also suggest that DES and bypass have similar mortality rates, referring to an obsolete meta-analysis that did not include the FREEDOM (Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease) trial2 or the long-term follow-up of SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial,3 the only 2 major randomized trials comparing DES with coronary artery bypass graft (CABG) in this setting. Instead, this meta-analysis by Yan et al4 included 11 observational studies, the results of which contradict substantially with gold-standard evidence from randomized trials and therefore are misleading. Rodriguez et al assert that we neglected to include 2 additional clinical trials in our meta-analysis, namely the Estudio Randomizado Argentino Angioplastia vs Cirugia (ERACI) II5 and the Coronary Artery Revascularization in Diabetes (VA CARDS)6 trials, and our results may therefore not be reliable. The ERACI-II trial from South America was a study with substandard clinical practice, with the lowest reported rate of arterial graft and stent use and the highest early surgical mortality among comparable trials.5 The trial did not meet the “>90% arterial graft use” and “>1 stent use in at least 70% of the cases” criteria for inclusion into meta-analysis and was therefore excluded from our meta-analysis.1 Nevertheless, we had stated the following in our article: “One well-known clinical trial from South America did not meet the study inclusion criteria because the frequency of the use of arterial grafts in the CABG arm and the frequency of stent use in the PCI [percutaneous coronary intervention] arm of this trial were too low.”1(p227) On the other hand, the results of the VA CARDS study became available in February 2013, after we performed our final literature search in December 2012, as stated in our article. VA CARDS is a prematurely stopped clinical trial enrolling only 25% of the intended sample size (N = 198). 6 Nevertheless, in this small trial, all-cause mortality was 5.0% for CABG and 21% for PCI (hazard ratio, 0.30; 95% CI, 0.110.80), supporting our main finding of increased mortality with stenting in multivessel coronary disease. In addition, Rodriguez et al claim that the superior survival with CABG is limited to patients with diabetes. I disagree. Our subgroup analysis of trials mostly including patients without diabetes shows a statistically significant reduced mortality with CABG compared with stenting (meta-analytic risk ratio, 0.72; 95% CI, 0.58-0.89 [P = .003]), with an interaction P value of .80 for comparison of effect in patients with diabetes vs patients without diabetes.1 Ilke Sipahi, MD
2. Farkouh ME, Domanski M, Sleeper LA, et al; FREEDOM Trial Investigators. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med. 2012;367(25):2375-2384. 3. Kappetein AP, Feldman TE, Mack MJ, et al. Comparison of coronary bypass surgery with drug-eluting stenting for the treatment of left main and/or three-vessel disease: 3-year follow-up of the SYNTAX trial. Eur Heart J. 2011;32 (17):2125-2134. 4. Yan TD, Padang R, Poh C, et al. Drug-eluting stents versus coronary artery bypass grafting for the treatment of coronary artery disease: a meta-analysis of randomized and nonrandomized studies. J Thorac Cardiovasc Surg. 2011;141(5): 1134-1144. 5. Rodriguez AE, Baldi J, Fernández Pereira C, et al; ERACI II Investigators. Five-year follow-up of the Argentine randomized trial of coronary angioplasty with stenting versus coronary bypass surgery in patients with multiple vessel disease (ERACI II). J Am Coll Cardiol. 2005;46(4):582-588. 6. Kamalesh M, Sharp TG, Tang XC, et al; VA CARDS Investigators. Percutaneous coronary intervention versus coronary bypass surgery in United States veterans with diabetes. J Am Coll Cardiol. 2013;61(8):808-816.
Did Extra Resources or the Medical Home Model Improve Care? To the Editor In their study of the pilot program of the Rhode Island Chronic Care Sustainability Initiative, Rosenthal et al1 attributed the minimal (and with 1 exception, nonsignificant) improvements they observed to a specific model, the patientcentered medical home. In an accompanying Invited Commentary, Grumbach2 urges an even more positive interpretation of these results; he argues for the widespread adoption of the patient-centered medical home model.2 Both the study and the commentary ignore the extra $2 million (approximately $45 000 per physician) that insurers provided to the patient-centered medical home practices (but not to controls). Perhaps extra resources for primary care, not the adoption of the patient-centered medical home model per se, are what is important. David U. Himmelstein, MD Steffie Woolhandler, MD, MPH Author Affiliations: City University of New York, School of Public Health, New York. Corresponding Author: David U. Himmelstein, MD, City University of New York, School of Public Health, 255 W 90th St, Apt 12A, New York, NY 10024-1152 ([email protected]). Conflict of Interest Disclosures: None reported. 1. Rosenthal MB, Friedberg MW, Singer SJ, Eastman D, Li Z, Schneider EC. Effect of a multipayer patient-centered medical home on health care utilization and quality: the Rhode Island chronic care sustainability initiative pilot program. JAMA Intern Med. 2013;173(20):1907-1913. 2. Grumbach K. The patient-centered medical home is not a pill: implications for evaluating primary care reforms. JAMA Intern Med. 2013;173(20):1913-1914.
Author Affiliations: Department of Cardiology, Acibadem University Medical School, Istanbul, Turkey; Harrington Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio. Corresponding Author: Ilke Sipahi, MD, Department of Cardiology, Acibadem University Medical School, Acibadem Maslak Hospital, Buyukdere Cad 40, 34457 Istanbul, Turkey ([email protected]). Conflict of Interest Disclosures: None reported. 1. Sipahi I, Akay MH, Dagdelen S, Blitz A, Alhan C. Coronary artery bypass grafting vs percutaneous coronary intervention and long-term mortality and
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morbidity in multivessel disease: meta-analysis of randomized clinical trials of the arterial grafting and stenting era. JAMA Intern Med. 2014;174(2):223-230.
In Reply It is possible that the additional funds provided to practices in the patient-centered medical home pilot had a direct effect on the study outcomes that was not mediated by other changes. The establishment of a patient-centered medical home involves multiple changes to a practice. Thus, studying many variations of the changes would be needed to isolate the contribution of a single component, such as increased payments. We are unaware of evidence that increasing payments
JAMA Internal Medicine June 2014 Volume 174, Number 6
Copyright 2014 American Medical Association. All rights reserved.
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to primary care physicians without other changes is sufficient to increase the quality of primary care or to reduce the utilization of acute care. Meredith B. Rosenthal, PhD Mark W. Friedberg, MD, MPP Eric C. Schneider, MD, MSc Author Affiliations: Harvard School of Public Health, Harvard University, Boston, Massachusetts (Rosenthal); RAND Corporation, Boston, Massachusetts (Friedberg, Schneider); Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts (Friedberg, Schneider). Corresponding Author: Meredith B. Rosenthal, PhD, Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Ave, Boston, MA 02115 ([email protected]). Conflict of Interest Disclosures: None reported.
Comments Regarding “My Thyroid Story” To the Editor “My Thyroid Story”1 raised the important question of what should be done in the case of a young person with a very low-grade malignant neoplasm. To forgo surgery or ablative radiation therapy, it would be necessary to be able to distinguish cancers that have the potential to cause mortality or morbidity over 50 years (or more) from those that do not. If we lack that ability, what choice is there but to proceed with definitive treatment? For an otherwise healthy 30-year-old patient with a “generally benign” type of cancer, is watchful waiting ever really an alternative? The author also mentioned being required to eat a “zerosalt diet” prior to her postthyroidectomy follow-up scan, which she found unpleasant. Radioactive iodine scans are best performed after a period of reduced iodine ingestion, which promotes the uptake of the tracer (usually iodine 123) by functioning thyroid cells (malignant or benign).2 Patients are advised to avoid iodized salt; however, noniodized salt is commercially available3 and can be substituted to comply with iodine restriction while maintaining a palatable diet. David L. Keller, MD Corresponding Author: David L. Keller, MD, PO Box 14295, Torrance, CA 90503 ([email protected]).
their accelerated diagnostic protocol. Such an interpretation of this study would be misleading. The safety of the protocol relies on combining the accelerated diagnostic protocol with expedited outpatient cardiac testing. All the low-risk patients in the experimental arm discharged from the ED underwent a functional cardiac study within 72 hours (most within 24 hours). The importance of such testing is highlighted by the single missed MACE in the experimental group, a patient discharged from the ED whose acute myocardial infarction followed an unrecognized abnormal outpatient stress test result. This MACE rate could be presented as 2.2%, well above the accepted miss rate,4 given that only 46 low-risk patients in the experimental arm were ultimately discharged directly from the ED. The authors unfortunately did not report how many outpatient stress test findings lead to subsequent cardiovascular interventions. In their earlier observational study, 18.3% of the low-risk population had therapeutic interventions and 2.0% went on to have revascularization procedures.2 It is difficult to argue that these therapies did not mitigate the number of 30-day MACE in both studies. We also wonder if the difference in rates of rapid ED discharge was driven less by the accelerated diagnostic protocol and more by the ability to reliably secure expedited outpatient stress testing, an option which was apparently not available to clinicians in the control arm. This is strongly suggested by the fact that the gaps in length of stay between the 2 groups persist consistently out to 16 hours, well beyond any efficiency gained in ruling out acute myocardial infarction with a 2-hour approach. These nuances should encourage clinicians and administrators to mobilize resources toward improving emergency physician access to outpatient stress testing appointments instead of focusing on marginally accelerated troponin testing. Though the Invited Commentary by Rahko5 asserts that most medical centers have the capacity for immediate stress testing or coronary computed tomography, it is our opinion that this is almost exclusively an office-hours phenomenon and accordingly contributes little to reducing hospital admissions or alleviating ED overcrowding during “off” (and often peak-volume) hours.
Conflict of Interest Disclosures: None reported. 1. Redberg RF. My thyroid story. JAMA Intern Med. 2013;173(19):1769. 2. ThyCa: Thyroid Cancer Survivors' Association Inc website. http://www.thyca .org/pap-fol/lowiodinediet/. Accessed October 28, 2014. 3. Amazon.com website. Sodium Chloride, Salt USP, 1 Cup, $10.39. http://www .amazon.com/Sodium-Chloride-Salt-USP-Cup/dp/B004SOZI2O/ref=sr_1_3?s=hpc& ie=UTF8&qid=1382980457&sr=1-3&keywords=non-iodized+salt. Accessed October 28, 2013.
Low-Risk Chest Pain in the Emergency Department: Should We Be Focusing on Better Follow-up Instead of Accelerated Testing? To the Editor We would like to thank Than and colleagues1-3 for their efforts to safely streamline the emergency department (ED) evaluation of low-risk patients with chest pain. We are concerned, however, that their data could be read to suggest that 30-day major adverse cardiac events (MACEs) can be safely excluded in emergency department (ED) patients with possible acute coronary syndrome based purely on low-risk results using
Dustin G. Mark, MD David R. Vinson, MD Author Affiliations: Department of Emergency Medicine, Kaiser Permanente, East Bay, Oakland, California (Mark); Department of Emergency Medicine, Kaiser Permanente, Roseville, Roseville, California (Vinson). Corresponding Author: Dustin G. Mark, MD, Department of Emergency Medicine, Kaiser Permanente, East Bay, 280 W Macarthur Blvd, Oakland, CA 94611 ([email protected]). Conflict of Interest Disclosures: None reported. 1. Than M, Aldous S, Lord SJ, et al. A 2-hour diagnostic protocol for possible cardiac chest pain in the emergency department: a randomized clinical trial. JAMA Intern Med. 2014;174(1):51-58. 2. Than M, Cullen L, Aldous S, et al. 2-Hour accelerated diagnostic protocol to assess patients with chest pain symptoms using contemporary troponins as the only biomarker: the ADAPT trial. J Am Coll Cardiol. 2012;59(23):2091-2098. 3. Cullen L, Mueller C, Parsonage WA, et al. Validation of high-sensitivity troponin I in a 2-hour diagnostic strategy to assess 30-day outcomes in emergency department patients with possible acute coronary syndrome. J Am Coll Cardiol. 2013;62(14):1242-1249.
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.56 for the type of stent used. Takagi et al also suggest that DES and bypass have similar mortality rates, referring to an obsolete meta-analysis that did not include the FREEDOM (Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease) trial2 or the long-term follow-up of SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial,3 the only 2 major randomized trials comparing DES with coronary artery bypass graft (CABG) in this setting. Instead, this meta-analysis by Yan et al4 included 11 observational studies, the results of which contradict substantially with gold-standard evidence from randomized trials and therefore are misleading. Rodriguez et al assert that we neglected to include 2 additional clinical trials in our meta-analysis, namely the Estudio Randomizado Argentino Angioplastia vs Cirugia (ERACI) II5 and the Coronary Artery Revascularization in Diabetes (VA CARDS)6 trials, and our results may therefore not be reliable. The ERACI-II trial from South America was a study with substandard clinical practice, with the lowest reported rate of arterial graft and stent use and the highest early surgical mortality among comparable trials.5 The trial did not meet the “>90% arterial graft use” and “>1 stent use in at least 70% of the cases” criteria for inclusion into meta-analysis and was therefore excluded from our meta-analysis.1 Nevertheless, we had stated the following in our article: “One well-known clinical trial from South America did not meet the study inclusion criteria because the frequency of the use of arterial grafts in the CABG arm and the frequency of stent use in the PCI [percutaneous coronary intervention] arm of this trial were too low.”1(p227) On the other hand, the results of the VA CARDS study became available in February 2013, after we performed our final literature search in December 2012, as stated in our article. VA CARDS is a prematurely stopped clinical trial enrolling only 25% of the intended sample size (N = 198). 6 Nevertheless, in this small trial, all-cause mortality was 5.0% for CABG and 21% for PCI (hazard ratio, 0.30; 95% CI, 0.110.80), supporting our main finding of increased mortality with stenting in multivessel coronary disease. In addition, Rodriguez et al claim that the superior survival with CABG is limited to patients with diabetes. I disagree. Our subgroup analysis of trials mostly including patients without diabetes shows a statistically significant reduced mortality with CABG compared with stenting (meta-analytic risk ratio, 0.72; 95% CI, 0.58-0.89 [P = .003]), with an interaction P value of .80 for comparison of effect in patients with diabetes vs patients without diabetes.1 Ilke Sipahi, MD
2. Farkouh ME, Domanski M, Sleeper LA, et al; FREEDOM Trial Investigators. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med. 2012;367(25):2375-2384. 3. Kappetein AP, Feldman TE, Mack MJ, et al. Comparison of coronary bypass surgery with drug-eluting stenting for the treatment of left main and/or three-vessel disease: 3-year follow-up of the SYNTAX trial. Eur Heart J. 2011;32 (17):2125-2134. 4. Yan TD, Padang R, Poh C, et al. Drug-eluting stents versus coronary artery bypass grafting for the treatment of coronary artery disease: a meta-analysis of randomized and nonrandomized studies. J Thorac Cardiovasc Surg. 2011;141(5): 1134-1144. 5. Rodriguez AE, Baldi J, Fernández Pereira C, et al; ERACI II Investigators. Five-year follow-up of the Argentine randomized trial of coronary angioplasty with stenting versus coronary bypass surgery in patients with multiple vessel disease (ERACI II). J Am Coll Cardiol. 2005;46(4):582-588. 6. Kamalesh M, Sharp TG, Tang XC, et al; VA CARDS Investigators. Percutaneous coronary intervention versus coronary bypass surgery in United States veterans with diabetes. J Am Coll Cardiol. 2013;61(8):808-816.
Did Extra Resources or the Medical Home Model Improve Care? To the Editor In their study of the pilot program of the Rhode Island Chronic Care Sustainability Initiative, Rosenthal et al1 attributed the minimal (and with 1 exception, nonsignificant) improvements they observed to a specific model, the patientcentered medical home. In an accompanying Invited Commentary, Grumbach2 urges an even more positive interpretation of these results; he argues for the widespread adoption of the patient-centered medical home model.2 Both the study and the commentary ignore the extra $2 million (approximately $45 000 per physician) that insurers provided to the patient-centered medical home practices (but not to controls). Perhaps extra resources for primary care, not the adoption of the patient-centered medical home model per se, are what is important. David U. Himmelstein, MD Steffie Woolhandler, MD, MPH Author Affiliations: City University of New York, School of Public Health, New York. Corresponding Author: David U. Himmelstein, MD, City University of New York, School of Public Health, 255 W 90th St, Apt 12A, New York, NY 10024-1152 ([email protected]). Conflict of Interest Disclosures: None reported. 1. Rosenthal MB, Friedberg MW, Singer SJ, Eastman D, Li Z, Schneider EC. Effect of a multipayer patient-centered medical home on health care utilization and quality: the Rhode Island chronic care sustainability initiative pilot program. JAMA Intern Med. 2013;173(20):1907-1913. 2. Grumbach K. The patient-centered medical home is not a pill: implications for evaluating primary care reforms. JAMA Intern Med. 2013;173(20):1913-1914.
Author Affiliations: Department of Cardiology, Acibadem University Medical School, Istanbul, Turkey; Harrington Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio. Corresponding Author: Ilke Sipahi, MD, Department of Cardiology, Acibadem University Medical School, Acibadem Maslak Hospital, Buyukdere Cad 40, 34457 Istanbul, Turkey ([email protected]). Conflict of Interest Disclosures: None reported. 1. Sipahi I, Akay MH, Dagdelen S, Blitz A, Alhan C. Coronary artery bypass grafting vs percutaneous coronary intervention and long-term mortality and
1008
morbidity in multivessel disease: meta-analysis of randomized clinical trials of the arterial grafting and stenting era. JAMA Intern Med. 2014;174(2):223-230.
In Reply It is possible that the additional funds provided to practices in the patient-centered medical home pilot had a direct effect on the study outcomes that was not mediated by other changes. The establishment of a patient-centered medical home involves multiple changes to a practice. Thus, studying many variations of the changes would be needed to isolate the contribution of a single component, such as increased payments. We are unaware of evidence that increasing payments
JAMA Internal Medicine June 2014 Volume 174, Number 6
Copyright 2014 American Medical Association. All rights reserved.
Downloaded From: http://archinte.jamanetwork.com/ by a Western University User on 06/06/2015
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to primary care physicians without other changes is sufficient to increase the quality of primary care or to reduce the utilization of acute care. Meredith B. Rosenthal, PhD Mark W. Friedberg, MD, MPP Eric C. Schneider, MD, MSc Author Affiliations: Harvard School of Public Health, Harvard University, Boston, Massachusetts (Rosenthal); RAND Corporation, Boston, Massachusetts (Friedberg, Schneider); Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts (Friedberg, Schneider). Corresponding Author: Meredith B. Rosenthal, PhD, Department of Health Policy and Management, Harvard School of Public Health, 677 Huntington Ave, Boston, MA 02115 ([email protected]). Conflict of Interest Disclosures: None reported.
Comments Regarding “My Thyroid Story” To the Editor “My Thyroid Story”1 raised the important question of what should be done in the case of a young person with a very low-grade malignant neoplasm. To forgo surgery or ablative radiation therapy, it would be necessary to be able to distinguish cancers that have the potential to cause mortality or morbidity over 50 years (or more) from those that do not. If we lack that ability, what choice is there but to proceed with definitive treatment? For an otherwise healthy 30-year-old patient with a “generally benign” type of cancer, is watchful waiting ever really an alternative? The author also mentioned being required to eat a “zerosalt diet” prior to her postthyroidectomy follow-up scan, which she found unpleasant. Radioactive iodine scans are best performed after a period of reduced iodine ingestion, which promotes the uptake of the tracer (usually iodine 123) by functioning thyroid cells (malignant or benign).2 Patients are advised to avoid iodized salt; however, noniodized salt is commercially available3 and can be substituted to comply with iodine restriction while maintaining a palatable diet. David L. Keller, MD Corresponding Author: David L. Keller, MD, PO Box 14295, Torrance, CA 90503 ([email protected]).
their accelerated diagnostic protocol. Such an interpretation of this study would be misleading. The safety of the protocol relies on combining the accelerated diagnostic protocol with expedited outpatient cardiac testing. All the low-risk patients in the experimental arm discharged from the ED underwent a functional cardiac study within 72 hours (most within 24 hours). The importance of such testing is highlighted by the single missed MACE in the experimental group, a patient discharged from the ED whose acute myocardial infarction followed an unrecognized abnormal outpatient stress test result. This MACE rate could be presented as 2.2%, well above the accepted miss rate,4 given that only 46 low-risk patients in the experimental arm were ultimately discharged directly from the ED. The authors unfortunately did not report how many outpatient stress test findings lead to subsequent cardiovascular interventions. In their earlier observational study, 18.3% of the low-risk population had therapeutic interventions and 2.0% went on to have revascularization procedures.2 It is difficult to argue that these therapies did not mitigate the number of 30-day MACE in both studies. We also wonder if the difference in rates of rapid ED discharge was driven less by the accelerated diagnostic protocol and more by the ability to reliably secure expedited outpatient stress testing, an option which was apparently not available to clinicians in the control arm. This is strongly suggested by the fact that the gaps in length of stay between the 2 groups persist consistently out to 16 hours, well beyond any efficiency gained in ruling out acute myocardial infarction with a 2-hour approach. These nuances should encourage clinicians and administrators to mobilize resources toward improving emergency physician access to outpatient stress testing appointments instead of focusing on marginally accelerated troponin testing. Though the Invited Commentary by Rahko5 asserts that most medical centers have the capacity for immediate stress testing or coronary computed tomography, it is our opinion that this is almost exclusively an office-hours phenomenon and accordingly contributes little to reducing hospital admissions or alleviating ED overcrowding during “off” (and often peak-volume) hours.
Conflict of Interest Disclosures: None reported. 1. Redberg RF. My thyroid story. JAMA Intern Med. 2013;173(19):1769. 2. ThyCa: Thyroid Cancer Survivors' Association Inc website. http://www.thyca .org/pap-fol/lowiodinediet/. Accessed October 28, 2014. 3. Amazon.com website. Sodium Chloride, Salt USP, 1 Cup, $10.39. http://www .amazon.com/Sodium-Chloride-Salt-USP-Cup/dp/B004SOZI2O/ref=sr_1_3?s=hpc& ie=UTF8&qid=1382980457&sr=1-3&keywords=non-iodized+salt. Accessed October 28, 2013.
Low-Risk Chest Pain in the Emergency Department: Should We Be Focusing on Better Follow-up Instead of Accelerated Testing? To the Editor We would like to thank Than and colleagues1-3 for their efforts to safely streamline the emergency department (ED) evaluation of low-risk patients with chest pain. We are concerned, however, that their data could be read to suggest that 30-day major adverse cardiac events (MACEs) can be safely excluded in emergency department (ED) patients with possible acute coronary syndrome based purely on low-risk results using
Dustin G. Mark, MD David R. Vinson, MD Author Affiliations: Department of Emergency Medicine, Kaiser Permanente, East Bay, Oakland, California (Mark); Department of Emergency Medicine, Kaiser Permanente, Roseville, Roseville, California (Vinson). Corresponding Author: Dustin G. Mark, MD, Department of Emergency Medicine, Kaiser Permanente, East Bay, 280 W Macarthur Blvd, Oakland, CA 94611 ([email protected]). Conflict of Interest Disclosures: None reported. 1. Than M, Aldous S, Lord SJ, et al. A 2-hour diagnostic protocol for possible cardiac chest pain in the emergency department: a randomized clinical trial. JAMA Intern Med. 2014;174(1):51-58. 2. Than M, Cullen L, Aldous S, et al. 2-Hour accelerated diagnostic protocol to assess patients with chest pain symptoms using contemporary troponins as the only biomarker: the ADAPT trial. J Am Coll Cardiol. 2012;59(23):2091-2098. 3. Cullen L, Mueller C, Parsonage WA, et al. Validation of high-sensitivity troponin I in a 2-hour diagnostic strategy to assess 30-day outcomes in emergency department patients with possible acute coronary syndrome. J Am Coll Cardiol. 2013;62(14):1242-1249.
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