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Continuing Use of Prophylactic Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease Despite Evidence of No Benefit: Déjà Vu All Over Again

Continuing Use of Prophylactic Percutaneous Coronary Intervention in Patients With Stable... More than 50 million surgical procedures are performed annually in the United States1 and it has been estimated that nearly 1 million adverse cardiac events occur each year following noncardiac operations.2 In fact, cardiovascular complications are the leading cause of death within 30 days of noncardiac surgery.3 Multiple factors unique to the postoperative environment, such as sympathetic stimulation, hypercoagulable state, inflammation, hypotension, hypothermia, and tachycardia, are thought to contribute to occurrence of adverse cardiac events.3 Approximately half of patients who experience a perioperative myocardial infarction (MI) have evidence of plaque rupture (type 1 MI) with the remainder related to ischemia from supply/demand mismatch (type 2 MI).4 Given this high rate of postoperative ischemic complications, it is not surprising that prophylactic revascularization has been promoted as a potential solution. In a single-center 1984 study, Hertzer et al5 performed coronary angiography on 1000 patients with peripheral arterial disease in need of a vascular operation and found not surprisingly that 92% of vascular patients demonstrated some form of coronary artery disease (CAD). They found that the 216 patients who had prophylactic coronary artery bypass grafting (CABG) had a lower mortality rate (0.8%) following vascular surgery than those who did not have prophylactic revascularization. This finding was taken as face value evidence of the benefits of prophylactic revascularization without recognizing that the mortality rate of CABG was 5%. Taken together, the overall mortality rate was substantially higher in the group of patients getting prophylactic CABG (6%) compared with a 2% mortality overall. When a randomized clinical trial (RCT) of revascularization in the perioperative setting was performed, it showed no benefit to the strategy. The Coronary Artery Revascularization Prophylaxis (CARP) trial6 randomized 510 patients to either prophylactic coronary artery revascularization or no revascularization prior to elective vascular surgery, powered for the primary outcome of long-term mortality. Among the patients randomized to preoperative revascularization, percutaneous coronary intervention (PCI) was performed in 59% and CABG was performed in 41%. At a median follow-up of 2.7 years, there was no difference in mortality between the 2 groups—22% in the revascularization group and 23% in the no-revascularization group—and none for MI. The CARP trial clearly showed that a strategy of preoperative coronary artery revascularization prior to elective vascular surgery does not improve short- or long-term clinical outcomes. The CARP trial patients were not low-risk; 40% had angina, 40% had a prior MI and one-third had 3-vessel CAD. It is notable that, as the preoperative risk index increased, the risk of death and nonfatal MI also increased. But even in the high-risk subgroups there was no benefit to revascularization. For example, among 146 individuals with at least 2 risk factors for an adverse outcome who also demonstrated ischemia on a preoperative stress-imaging test, the incidence of death or nonfatal MI was the same (23%) with or without preoperative revascularization (P = .95).7 These important findings have shaped contemporary views of CAD.8 It is now understood that most MIs are caused by nonobstructive plaque.9 Preoperative CABG and PCI do not prevent the stresses of surgery that raise the risk for cardiac events, such as thrombosis, vasospasm, small-vessel disease, extreme increases in myocardial demand, or decreases in coronary blood flow due to hypotension. In the current issue of JAMA Internal Medicine, Schulman-Marcus et al10 present data on almost 200 000 patients from the National Cardiovascular Data Registry registry who underwent preoperative coronary angiography and the nearly 28 000 who underwent prophylactic PCI prior to noncardiac surgery from 2009 to 2014. The exact noncardiac surgical procedures and their outcomes are unknown. Prior to coronary angiography, approximately 80% of patients were either asymptomatic or had atypical chest pain considered unlikely to be ischemic, whereas 21% had stable angina. Following coronary angiography, PCI was recommended in 23% of the asymptomatic patients, 16% of patients with atypical symptoms, and 33% of patients with stable angina. Reminiscent of the study by Hertzer et al,5 there was a down side to preoperative PCI: 14 patients died, 83 experienced a stroke, and 473 had an MI before surgery. An example of the harms that occur after referral of a surgical patient for “routine preoperative” cardiac evaluation was illustrated in JAMA Internal Medicine last year in the Teachable Moments series.11 A preoperative workup that started with cardiac stress testing ordered to “clear” a patient for lower extremity bypass led to CABG with multiple complications that negatively affected his quality of life and led to him being considered too high risk for the planned vascular intervention to address his presenting symptom of claudication.11 Routine cardiac evaluation prior to noncardiac surgery receives a less is more designation, because it has associated harms, and lacks any evidence of benefit. This continued performing of elective PCI prior to noncardiac surgery despite publication of a high-quality RCT data showing no benefit is reminiscent of the situation with regard to revascularization for patients in the nonoperative setting. An RCT, COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation)12 showed that revascularization does not lead to reduced rate of MI or death compared with medical therapy for patients with stable CAD. Resistance to changing practice after publication of the COURAGE trial has been documented13 and continues in clinical practice to this day. The source of the resistance is multifold. Referral bias, financial gain, poor understanding of pathophysiologic mechanisms, and individual physician belief of what might benefit the patient and patient perception of the potential benefit of the procedure unsubstantiated by data are possible although unproven reasons surrounding this overuse.14 The sense of irrationality surrounding this practice is so strong that the phenomenon has been coined the oculostenotic reflex (I see a stenosis; I stent it). The American College of Cardiology/American Heart Association15 Guidelines on perioperative cardiovascular evaluation and treatment of patients undergoing noncardiac surgery recommend that routine coronary revascularization not be performed before noncardiac surgery exclusively to reduce perioperative cardiac events. The persistence of unnecessary and potentially harmful PCI procedures should stimulate efforts to enhance translation and dissemination of the clinical science and improve compliance with these guidelines. At the same time, research efforts to find therapies that reduce the risk of perioperative cardiac events by interrupting the cascade of events triggered by the unique perioperative pathophysiologic mechanisms should be intensified. Back to top Article Information Correction: The byline of this article was corrected online May 2, 2016. Corresponding Author: Rita F. Redberg, MD, MSc, Department of Medicine, University of California, San Francisco, 505 Parnassus Ave, M1180, San Francisco, CA 94143-0124 (redberg@medicine.ucsf.edu). Published Online: March 28, 2016. doi:10.1001/jamainternmed.2016.0600. Conflict of Interest Disclosures: None reported. References 1. Patel AY, Eagle KA, Vaishnava P. Cardiac risk of noncardiac surgery. J Am Coll Cardiol. 2015;66(19):2140-2148.PubMedGoogle ScholarCrossref 2. Devereaux PJ, Goldman L, Cook DJ, Gilbert K, Leslie K, Guyatt GH. Perioperative cardiac events in patients undergoing noncardiac surgery: a review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk. CMAJ. 2005;173(6):627-634.PubMedGoogle ScholarCrossref 3. Devereaux PJ, Sessler DI. Cardiac complications in patients undergoing major noncardiac surgery. N Engl J Med. 2015;373(23):2258-2269.PubMedGoogle ScholarCrossref 4. Gualandro DM, Campos CA, Calderaro D, et al. Coronary plaque rupture in patients with myocardial infarction after noncardiac surgery: frequent and dangerous. Atherosclerosis. 2012;222(1):191-195.PubMedGoogle ScholarCrossref 5. Hertzer NR, Beven EG, Young JR, et al. Coronary artery disease in peripheral vascular patients: a classification of 1000 coronary angiograms and results of surgical management. Ann Surg. 1984;199(2):223-233.PubMedGoogle ScholarCrossref 6. McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery revascularization before elective major vascular surgery. N Engl J Med. 2004;351(27):2795-2804.PubMedGoogle ScholarCrossref 7. Garcia S, Moritz TE, Goldman S, et al. Perioperative complications after vascular surgery are predicted by the revised cardiac risk index but are not reduced in high-risk subsets with preoperative revascularization. Circ Cardiovasc Qual Outcomes. 2009;2(2):73-77.PubMedGoogle ScholarCrossref 8. Marzilli M, Merz CN, Boden WE, et al. Obstructive coronary atherosclerosis and ischemic heart disease: an elusive link! J Am Coll Cardiol. 2012;60(11):951-956.PubMedGoogle ScholarCrossref 9. Falk E. Plaque rupture with severe pre-existing stenosis precipitating coronary thrombosis: characteristics of coronary atherosclerotic plaques underlying fatal occlusive thrombi. Br Heart J. 1983;50(2):127-134.PubMedGoogle ScholarCrossref 10. Schulman-Marcus J, Feldman DN, Rao SV, et al. Characteristics of patients undergoing cardiac catheterization before noncardiac surgery: a report from the National Cardiovascular Data Registry CathPCI Registry [published online March 28, 2016]. JAMA Intern Med. doi:10.1001/jamainternmed.2016.0259.Google Scholar 11. Baxi SM, Lakin JR. Preoperative testing—a bridge to nowhere: a Teachable Moment. JAMA Intern Med. 2015;175(8):1272-1273.PubMedGoogle ScholarCrossref 12. Boden WE, O’Rourke RA, Teo KK, et al; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356(15):1503-1516.PubMedGoogle ScholarCrossref 13. Borden WB, Redberg RF, Mushlin AI, Dai D, Kaltenbach LA, Spertus JA. Patterns and intensity of medical therapy in patients undergoing percutaneous coronary intervention. JAMA. 2011;305(18):1882-1889.PubMedGoogle ScholarCrossref 14. Lin GA, Dudley RA, Redberg RF. Cardiologists’ use of percutaneous coronary interventions for stable coronary artery disease. Arch Intern Med. 2007;167(15):1604-1609.Google ScholarCrossref 15. Fleisher LA, Fleischmann KE, Auerbach AD, et al. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;130(24):e278-e333.PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Continuing Use of Prophylactic Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease Despite Evidence of No Benefit: Déjà Vu All Over Again

JAMA Internal Medicine , Volume 176 (5) – May 1, 2016

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American Medical Association
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Copyright © 2016 American Medical Association. All Rights Reserved.
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2168-6106
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10.1001/jamainternmed.2016.0600
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Abstract

More than 50 million surgical procedures are performed annually in the United States1 and it has been estimated that nearly 1 million adverse cardiac events occur each year following noncardiac operations.2 In fact, cardiovascular complications are the leading cause of death within 30 days of noncardiac surgery.3 Multiple factors unique to the postoperative environment, such as sympathetic stimulation, hypercoagulable state, inflammation, hypotension, hypothermia, and tachycardia, are thought to contribute to occurrence of adverse cardiac events.3 Approximately half of patients who experience a perioperative myocardial infarction (MI) have evidence of plaque rupture (type 1 MI) with the remainder related to ischemia from supply/demand mismatch (type 2 MI).4 Given this high rate of postoperative ischemic complications, it is not surprising that prophylactic revascularization has been promoted as a potential solution. In a single-center 1984 study, Hertzer et al5 performed coronary angiography on 1000 patients with peripheral arterial disease in need of a vascular operation and found not surprisingly that 92% of vascular patients demonstrated some form of coronary artery disease (CAD). They found that the 216 patients who had prophylactic coronary artery bypass grafting (CABG) had a lower mortality rate (0.8%) following vascular surgery than those who did not have prophylactic revascularization. This finding was taken as face value evidence of the benefits of prophylactic revascularization without recognizing that the mortality rate of CABG was 5%. Taken together, the overall mortality rate was substantially higher in the group of patients getting prophylactic CABG (6%) compared with a 2% mortality overall. When a randomized clinical trial (RCT) of revascularization in the perioperative setting was performed, it showed no benefit to the strategy. The Coronary Artery Revascularization Prophylaxis (CARP) trial6 randomized 510 patients to either prophylactic coronary artery revascularization or no revascularization prior to elective vascular surgery, powered for the primary outcome of long-term mortality. Among the patients randomized to preoperative revascularization, percutaneous coronary intervention (PCI) was performed in 59% and CABG was performed in 41%. At a median follow-up of 2.7 years, there was no difference in mortality between the 2 groups—22% in the revascularization group and 23% in the no-revascularization group—and none for MI. The CARP trial clearly showed that a strategy of preoperative coronary artery revascularization prior to elective vascular surgery does not improve short- or long-term clinical outcomes. The CARP trial patients were not low-risk; 40% had angina, 40% had a prior MI and one-third had 3-vessel CAD. It is notable that, as the preoperative risk index increased, the risk of death and nonfatal MI also increased. But even in the high-risk subgroups there was no benefit to revascularization. For example, among 146 individuals with at least 2 risk factors for an adverse outcome who also demonstrated ischemia on a preoperative stress-imaging test, the incidence of death or nonfatal MI was the same (23%) with or without preoperative revascularization (P = .95).7 These important findings have shaped contemporary views of CAD.8 It is now understood that most MIs are caused by nonobstructive plaque.9 Preoperative CABG and PCI do not prevent the stresses of surgery that raise the risk for cardiac events, such as thrombosis, vasospasm, small-vessel disease, extreme increases in myocardial demand, or decreases in coronary blood flow due to hypotension. In the current issue of JAMA Internal Medicine, Schulman-Marcus et al10 present data on almost 200 000 patients from the National Cardiovascular Data Registry registry who underwent preoperative coronary angiography and the nearly 28 000 who underwent prophylactic PCI prior to noncardiac surgery from 2009 to 2014. The exact noncardiac surgical procedures and their outcomes are unknown. Prior to coronary angiography, approximately 80% of patients were either asymptomatic or had atypical chest pain considered unlikely to be ischemic, whereas 21% had stable angina. Following coronary angiography, PCI was recommended in 23% of the asymptomatic patients, 16% of patients with atypical symptoms, and 33% of patients with stable angina. Reminiscent of the study by Hertzer et al,5 there was a down side to preoperative PCI: 14 patients died, 83 experienced a stroke, and 473 had an MI before surgery. An example of the harms that occur after referral of a surgical patient for “routine preoperative” cardiac evaluation was illustrated in JAMA Internal Medicine last year in the Teachable Moments series.11 A preoperative workup that started with cardiac stress testing ordered to “clear” a patient for lower extremity bypass led to CABG with multiple complications that negatively affected his quality of life and led to him being considered too high risk for the planned vascular intervention to address his presenting symptom of claudication.11 Routine cardiac evaluation prior to noncardiac surgery receives a less is more designation, because it has associated harms, and lacks any evidence of benefit. This continued performing of elective PCI prior to noncardiac surgery despite publication of a high-quality RCT data showing no benefit is reminiscent of the situation with regard to revascularization for patients in the nonoperative setting. An RCT, COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation)12 showed that revascularization does not lead to reduced rate of MI or death compared with medical therapy for patients with stable CAD. Resistance to changing practice after publication of the COURAGE trial has been documented13 and continues in clinical practice to this day. The source of the resistance is multifold. Referral bias, financial gain, poor understanding of pathophysiologic mechanisms, and individual physician belief of what might benefit the patient and patient perception of the potential benefit of the procedure unsubstantiated by data are possible although unproven reasons surrounding this overuse.14 The sense of irrationality surrounding this practice is so strong that the phenomenon has been coined the oculostenotic reflex (I see a stenosis; I stent it). The American College of Cardiology/American Heart Association15 Guidelines on perioperative cardiovascular evaluation and treatment of patients undergoing noncardiac surgery recommend that routine coronary revascularization not be performed before noncardiac surgery exclusively to reduce perioperative cardiac events. The persistence of unnecessary and potentially harmful PCI procedures should stimulate efforts to enhance translation and dissemination of the clinical science and improve compliance with these guidelines. At the same time, research efforts to find therapies that reduce the risk of perioperative cardiac events by interrupting the cascade of events triggered by the unique perioperative pathophysiologic mechanisms should be intensified. Back to top Article Information Correction: The byline of this article was corrected online May 2, 2016. Corresponding Author: Rita F. Redberg, MD, MSc, Department of Medicine, University of California, San Francisco, 505 Parnassus Ave, M1180, San Francisco, CA 94143-0124 (redberg@medicine.ucsf.edu). Published Online: March 28, 2016. doi:10.1001/jamainternmed.2016.0600. Conflict of Interest Disclosures: None reported. References 1. Patel AY, Eagle KA, Vaishnava P. Cardiac risk of noncardiac surgery. J Am Coll Cardiol. 2015;66(19):2140-2148.PubMedGoogle ScholarCrossref 2. Devereaux PJ, Goldman L, Cook DJ, Gilbert K, Leslie K, Guyatt GH. Perioperative cardiac events in patients undergoing noncardiac surgery: a review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk. CMAJ. 2005;173(6):627-634.PubMedGoogle ScholarCrossref 3. Devereaux PJ, Sessler DI. Cardiac complications in patients undergoing major noncardiac surgery. N Engl J Med. 2015;373(23):2258-2269.PubMedGoogle ScholarCrossref 4. Gualandro DM, Campos CA, Calderaro D, et al. Coronary plaque rupture in patients with myocardial infarction after noncardiac surgery: frequent and dangerous. Atherosclerosis. 2012;222(1):191-195.PubMedGoogle ScholarCrossref 5. Hertzer NR, Beven EG, Young JR, et al. Coronary artery disease in peripheral vascular patients: a classification of 1000 coronary angiograms and results of surgical management. Ann Surg. 1984;199(2):223-233.PubMedGoogle ScholarCrossref 6. McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery revascularization before elective major vascular surgery. N Engl J Med. 2004;351(27):2795-2804.PubMedGoogle ScholarCrossref 7. Garcia S, Moritz TE, Goldman S, et al. Perioperative complications after vascular surgery are predicted by the revised cardiac risk index but are not reduced in high-risk subsets with preoperative revascularization. Circ Cardiovasc Qual Outcomes. 2009;2(2):73-77.PubMedGoogle ScholarCrossref 8. Marzilli M, Merz CN, Boden WE, et al. Obstructive coronary atherosclerosis and ischemic heart disease: an elusive link! J Am Coll Cardiol. 2012;60(11):951-956.PubMedGoogle ScholarCrossref 9. Falk E. Plaque rupture with severe pre-existing stenosis precipitating coronary thrombosis: characteristics of coronary atherosclerotic plaques underlying fatal occlusive thrombi. Br Heart J. 1983;50(2):127-134.PubMedGoogle ScholarCrossref 10. Schulman-Marcus J, Feldman DN, Rao SV, et al. Characteristics of patients undergoing cardiac catheterization before noncardiac surgery: a report from the National Cardiovascular Data Registry CathPCI Registry [published online March 28, 2016]. JAMA Intern Med. doi:10.1001/jamainternmed.2016.0259.Google Scholar 11. Baxi SM, Lakin JR. Preoperative testing—a bridge to nowhere: a Teachable Moment. JAMA Intern Med. 2015;175(8):1272-1273.PubMedGoogle ScholarCrossref 12. Boden WE, O’Rourke RA, Teo KK, et al; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356(15):1503-1516.PubMedGoogle ScholarCrossref 13. Borden WB, Redberg RF, Mushlin AI, Dai D, Kaltenbach LA, Spertus JA. Patterns and intensity of medical therapy in patients undergoing percutaneous coronary intervention. JAMA. 2011;305(18):1882-1889.PubMedGoogle ScholarCrossref 14. Lin GA, Dudley RA, Redberg RF. Cardiologists’ use of percutaneous coronary interventions for stable coronary artery disease. Arch Intern Med. 2007;167(15):1604-1609.Google ScholarCrossref 15. Fleisher LA, Fleischmann KE, Auerbach AD, et al. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;130(24):e278-e333.PubMedGoogle ScholarCrossref

Journal

JAMA Internal MedicineAmerican Medical Association

Published: May 1, 2016

Keywords: myocardial infarction,percutaneous coronary intervention,coronary angiography,coronary artery bypass surgery,coronary arteriosclerosis,perioperative cardiovascular risk,coronary revascularization,health services misuse,physician's practice patterns,unnecessary procedures,vascular surgical procedures,coronary heart disease,prophylactic surgery,perioperative myocardial infarction

References