Published online before print April 14, 2003, doi: 10.1161/01.CIR.0000066286.15621.98
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(Circulation. 2003;107:1848.)
© 2003 American Heart Association, Inc.
Brief Rapid Communications |
Statins Are Associated With a Reduced Incidence of Perioperative Mortality in Patients Undergoing Major Noncardiac Vascular Surgery
From the Departments of Cardiology (M.D.K., B.K., C.M.W., A.F.L.S., I.R.T., J.R.T.C.R., E.B.), Vascular Surgery (D.P., H.v.U.), and Anesthesiology (J.K.), Erasmus Medical Center, Rotterdam, The Netherlands; University Hospital Leiden, Department of Cardiology, Leiden, The Netherlands (J.J.B.); University of Amsterdam, Amsterdam, The Netherlands (P.J.L.); and Department of Anesthesiology, Johns Hopkins Hospital, Baltimore, Md (L.A.F.).
Correspondence to Don Poldermans, MD, PhD, Department of Vascular Surgery, Erasmus Medical Center, Room BA 300, Dr Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. E-mail d.poldermans{at}erasmusmc.nl
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Abstract |
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Background— Patients undergoing major vascular surgery are at increased risk of perioperative mortality due to underlying coronary artery disease. Inhibitors of the 3-hydroxy-3-methylglutaryl coenzyme A (statins) may reduce perioperative mortality through the improvement of lipid profile, but also through the stabilization of coronary plaques on the vascular wall.
Methods and Results— To evaluate the association between statin use and perioperative mortality, we performed a case-controlled study among the 2816 patients who underwent major vascular surgery from 1991 to 2000 at the Erasmus Medical Center. Case subjects were all 160 (5.8%) patients who died during the hospital stay after surgery. From the remaining patients, 2 controls were selected for each case and were stratified according to calendar year and type of surgery. For cases and controls, information was obtained regarding statin use before surgery, the presence of cardiac risk factors, and the use of other cardiovascular medication. A vascular complication during the perioperative phase was the primary cause of death in 104 (65%) case subjects. Statin therapy was significantly less common in cases than in controls (8% versus 25%; P<0.001). The adjusted odds ratio for perioperative mortality among statin users as compared with nonusers was 0.22 (95% confidence interval 0.10 to 0.47). Similar results were obtained in subgroups of patients according to the use of cardiovascular therapy and the presence of cardiac risk factors.
Conclusion— This case-controlled study provides evidence that statin use reduces perioperative mortality in patients undergoing major vascular surgery.
Key Words: statins • mortality • vasculature • surgery
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Introduction |
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Patients undergoing major vascular surgery experience a 30-day operative mortality of 5% to 6%, which arises principally from cardiac events.1 Myocardial infarction is the most frequent fatal complication. Although the understanding of the pathophysiology is not entirely clear, there is evidence that coronary plaque rupture, which leads to thrombus formation and subsequent vessel occlusion, is the dominant causative mechanism behind such complications, similar to myocardial infarctions occurring in the nonoperative setting.2 Inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (statins) may have a beneficial influence because of a direct effect on the vascular function, which results in coronary plaque stabilization.3 The current study aimed to examine the association between statin therapy and perioperative mortality in patients undergoing major vascular surgery.
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Methods |
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Study Design
We undertook a retrospective case-controlled study among the population of 2816 patients above the age of 15 years who underwent major vascular surgery between January 1, 1991, and December 31, 2000, in the Erasmus Medical Center, Rotterdam, the Netherlands. The computerized hospital information system was used to identify cases and controls. This system holds demographic data of all admitted patients and information on the perioperative course.
Selection of Cases and Controls
Case subjects were all 160 patients (5.8%) from this population who died because of any cause during surgery or during the hospital stay after surgery, excluding those patients who died after 30 days of continuous hospital stay. From the remaining patients, 2 controls were selected for each case. One control was operated on immediately before the case and one after the case, and they were stratified according to type of surgery.
Data Collection
For all cases and controls, the computerized hospital database, patient medical records, nurses reports, surgical reports, and discharge letters were manually screened to identify cardiac risk factors, and information on the duration of statin therapy, and ß-blocker use, and aspirin use before surgery. The most recent measurements of total cholesterol and low-density lipoprotein (LDL) cholesterol within 3 months of surgery were recorded. Patients were labeled as having raised cholesterol if the total cholesterol exceeded 5.5 mmol/L or the LDL-cholesterol exceeded 3.5 mmol/L.
Statistical Analysis
Unconditional logistic regression analyses were applied to evaluate the relation between statin use and perioperative mortality. Stratified analyses were performed according to a number of clinically important baseline characteristics. To reveal a possible heterogeneity in odds ratios between subgroups of patients, interaction terms between the stratification characteristic and statin use were included in the models. Interaction was considered statistically significant at the classic 0.05 probability level. We adjusted for the stratification factors calendar year and type of surgery, and for a number of potential confounding factors, including age, gender, history of cardiovascular or cerebrovascular disease, and cardiovascular therapy. Individual factors were omitted from the regression models when stratification made adjustment inappropriate. We only report the adjusted odds ratios and corresponding 95% confidence intervals.
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Results |
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Baseline clinical characteristics of cases and controls are presented in Table 1. A vascular complication during the perioperative phase was the primary cause of death in 104 (65%) case subjects; 88 (56%) had a fatal myocardial infarction, and 14 (9%) had a fatal stroke. The most common nonvascular causes of death were bleeding complications (21 cases [13%]) and sepsis (30 cases [19%]).
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Statin use was significantly less common in cases than in controls (12 cases [8%] and 81 controls [25%]; P<0.001). The risk of perioperative mortality among statin users was reduced 4.5 times compared with nonusers (adjusted odds ratio 0.22 and 95% confidence interval 0.10 to 0.47). This variation in statin use was accompanied by a difference in the level of total cholesterol before surgery, which was higher in cases than in controls (the median values and interquartile ranges were 6.1 [4.9 to 7.2] and 5.7 [4.8 to 6.6] mmol/L, respectively), although statistical significance was not reached (P=0.052). A similar difference was observed among statin users in cases and controls (6.3 [5.5 to 6.8] and 5.7 [4.9 to 6.7] mmol/L; P=0.15). In addition, among statin users, the duration of statin therapy was apparently shorter in cases (median and interquartile range 4 [1 to 14] months) than in controls (11 [4 to 22] months), although statistical significance was not reached (P=0.054). Among 21 patients with a fatal bleeding complication, there was no relation to statin use (19 non-statin users [13%] versus 2 statin users [17%]; P=0.67).
There was no evidence of a heterogeneity in the mortality reduction among statin users as compared with nonusers between subgroups of patients according to clinically important baseline characteristics or type of surgery, with the exception of age; perioperative mortality reduction by statins was stronger in patients below the age of 70 years as compared with the elderly (Table 2).
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Aspirin was more frequently used in cases than in controls (51 cases [32%] and 73 controls [23%]; P=0.003). However, it should be taken into account that, according to the Erasmus Medical Center surgical protocol, aspirin was discontinued 10 days before elective major vascular surgery. Additionally, aspirin use was associated with a high prevalence of cardiovascular disease, including myocardial infarction and stroke. After adjustment for these differences, aspirin use was no longer associated with an increased risk of perioperative mortality. Importantly, there was no interaction between the use of statins and (previous) aspirin use with regard to perioperative mortality (Table 2).
ß-blocker therapy was less common in cases than in controls (31 cases [19%] and 114 controls [36%]; P<0.001), and the risk of perioperative mortality among ß-blocker users was 2.3 times reduced compared with nonusers (adjusted odds ratio 0.43 and 95% confidence interval 0.26 to 0.72). There was no significant interaction between the use of statins and ß-blockers with regard to perioperative mortality, which implies that both agents have an additional effect (Table 2). These findings were similar in several strata according to the number of cardiac risk factors.
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Discussion |
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In this case-controlled study we found that statin use reduced perioperative mortality in patients undergoing major vascular surgery. As compared with nonusers, patients on statin therapy had a more than 4-fold reduced risk. This result was consistent in subgroups of patients according to the type of surgery, cardiac risk factors, and cardiovascular therapy, including aspirin and ß-blockers.
Patients with peripheral vascular disease often have extensive coronary artery disease, characterized by the presence of asymptomatic but vulnerable atherosclerotic plaques, which may rupture because of the stress of surgery.1 The progression of these plaques during surgery is not predictable by the current imaging techniques.4,5 Therefore, a systemic medical therapy for plaque stability is an attractive option. Statins may provide such systemic effect because of the antiinflammatory action and the reversal of endothelial dysfunction.3 All these factors may induce a shift from pro-thrombosis and vasospasm to more stable thrombo-resistant conditions and vasodilation, thereby reducing perioperative myocardial ischemia.
Aspirin has shown benefits in patients with established coronary artery disease. In the present study, no such benefit was observed. In fact, aspirin use was associated with an increased mortality risk. However, it should be noted that aspirin was discontinued at least 10 days before elective surgery, and aspirin users had a higher prevalence of cardiac risk factors. Importantly for our study, there was no interaction between the beneficial effects of statins and aspirin use (Table 2).
Besides the beneficial effect of statins, our data confirmed the cardioprotective effect of ß-blockers. Furthermore, the effect of statins on perioperative mortality was similar in ß-blocker users and nonusers. Indeed, ß-blockers may particularly influence the myocardial supply/demand mismatch, whereas statins may mainly affect the coronary plaque stabilization. Nevertheless, it should be realized that interactions between these drugs might exist that are simply missed because of lack of statistical power. A difference was observed in mortality reduction among younger patients and those with a history of heart failure. A large prospective randomized study showed no difference in the effect of statins in these subgroups on late cardiovascular events in patients with or at risk for coronary artery disease, and showed a beneficial effect in patients with peripheral vascular disease with low or normal cholesterol levels.6 Therefore, future investigations should be considered to evaluate this issues in more detail.
Among statin users, the duration of therapy was apparently shorter in cases than in controls. This observation is in accordance with evidence from large prospective studies, in which the beneficial effects of statins on cardiovascular events usually appear after long-term treatment.7 Nonetheless, the possibility of a beneficial effect after a short period of statin treatment should not be excluded.8
Our study has several limitations that are common with any study relying on retrospective data collection. Most importantly, information on statin use might have been missed, and probably differently so in cases and controls because of observer bias. Our estimate of the beneficial effect of statin therapy may therefore be overoptimistic. Thus, although our results indicate a strong reduction of perioperative mortality by statins, this early evidence needs confirmation through a series of large-scale, randomized clinical trials.
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Conclusion |
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Preoperative statin therapy is associated with a reduction of perioperative mortality. Although the possible mechanisms of the effect of statins remain unclear, further investigation of early treatment with statins in this population is strongly recommended.
Received December 31, 2002; revision received February 20, 2003; accepted February 25, 2003.
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References |
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Preoperative statin treatment is associated with reduced postoperative mortality and morbidity in patients undergoing cardiac surgery: an 8-year retrospective cohort study. J. Thorac. Cardiovasc. Surg., March 1, 2006; 131(3): 679 - 685.
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 K. Hindler, C. S. Cleeland, E. Rivera, and C. D. Collard The Role of Statins in Cancer Therapy. Oncologist, January 1, 2006; 11(3): 306 - 315. [Abstract] [Full Text] [PDF]
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 M. Kikura, T. Takada, and S. Sato Preexisting Morbidity as an Independent Risk Factor for Perioperative Acute Thromboembolism Syndrome Arch Surg, December 1, 2005; 140(12): 1210 - 1217. [Abstract] [Full Text] [PDF]
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J. Scarlett, N. Hahn, E. Jacobsohn, and M. S. Avidan The Evidence That Deep Anesthesia Impacts Long Term Mortality Is Not Compelling Anesth. Analg., December 1, 2005; 101(6): 1880 - 1880. [Full Text] [PDF]
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S. E. Hoeks, J. J. Bax, and D. Poldermans Should the ACC/AHA guidelines be changed in patients undergoing vascular surgery? Eur. Heart J., November 2, 2005; 26(22): 2358 - 2360. [Full Text] [PDF]
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 L. G. Futterman and L. Lemberg The Expanding Role of the HMG-CoA Reductase Inhibitor, The Most Widely Prescribed Drug in the World Am. J. Crit. Care., November 1, 2005; 14(6): 555 - 558. [Full Text] [PDF]
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 D. M. Kent Improved Perioperative Outcomes From Carotid Endarterectomy: Yet Another Statin Side Effect? Stroke, October 1, 2005; 36(10): 2058 - 2059. [Full Text] [PDF]
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J. Kennedy, H. Quan, A. M. Buchan, W. A. Ghali, and T. E. Feasby Statins Are Associated With Better Outcomes After Carotid Endarterectomy in Symptomatic Patients Stroke, October 1, 2005; 36(10): 2072 - 2076. [Abstract] [Full Text] [PDF]
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 P.J. Devereaux, L. Goldman, S. Yusuf, K. Gilbert, K. Leslie, and G. H. Guyatt Surveillance and prevention of major perioperative ischemic cardiac events in patients undergoing noncardiac surgery: a review Can. Med. Assoc. J., September 27, 2005; 173(7): 779 - 788. [Abstract] [Full Text] [PDF]
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H.-J. Priebe Perioperative myocardial infarction--aetiology and prevention Br. J. Anaesth., July 1, 2005; 95(1): 3 - 19. [Abstract] [Full Text] [PDF]
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R. G. Depalma Association Between Long-term Statin Use and Mortality after Successful Aneurysm Surgery Perspectives in Vascular Surgery and Endovascular Therapy, June 1, 2005; 17(2): 173 - 174. [Abstract] [PDF]
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I. S. Ali and K. J. Buth Preoperative statin use and in-hospital outcomes following heart surgery in patients with unstable angina Eur. J. Cardiothorac. Surg., June 1, 2005; 27(6): 1051 - 1056. [Abstract] [Full Text] [PDF]
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B. Subramaniam, F. Pomposelli, D. Talmor, and K. W. Park Perioperative and Long-Term Morbidity and Mortality After Above-Knee and Below-Knee Amputations in Diabetics and Nondiabetics Anesth. Analg., May 1, 2005; 100(5): 1241 - 1247. [Abstract] [Full Text] [PDF]
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 M. D. Kertai, E. Boersma, J. Klein, H. van Urk, and D. Poldermans Optimizing the Prediction of Perioperative Mortality in Vascular Surgery by Using a Customized Probability Model Arch Intern Med, April 25, 2005; 165(8): 898 - 904. [Abstract] [Full Text] [PDF]
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I. Malik JournalScan Heart, March 1, 2005; 91(3): 414 - 416. [Full Text] [PDF]
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K. O'Neil-Callahan, G. Katsimaglis, M. R. Tepper, J. Ryan, C. Mosby, J. P.A. Ioannidis, and P. G. Danias Statins decrease perioperative cardiac complications in patients undergoing noncardiac vascular surgery: The Statins for Risk Reduction in Surgery (StaRRS) study J. Am. Coll. Cardiol., February 1, 2005; 45(3): 336 - 342. [Abstract] [Full Text] [PDF]
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 Y. Birnbaum, Y. Ye, S. Rosanio, S. Tavackoli, Z.-Y. Hu, E. R. Schwarz, and B. F. Uretsky Prostaglandins mediate the cardioprotective effects of atorvastatin against ischemia-reperfusion injury Cardiovasc Res, February 1, 2005; 65(2): 345 - 355. [Abstract] [Full Text] [PDF]
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M. Moscucci and K. A. Eagle Coronary Revascularization before Noncardiac Surgery N. Engl. J. Med., December 30, 2004; 351(27): 2861 - 2863. [Full Text] [PDF]
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J. F. Eidt Effect of Simvastatin Versus Placebo on Treadmill Exercise Time Until the Onset of Intermittent Claudication in Older Patients With Peripheral Arterial Disease at Six Months and at One Year After Treatment Perspectives in Vascular Surgery and Endovascular Therapy, December 1, 2004; 16(4): 334 - 336. [Abstract] [PDF]
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 M. T. Montero, J. Matilla, E. Gomez-Mampaso, and M. A. Lasuncion Geranylgeraniol Regulates Negatively Caspase-1 Autoprocessing: Implication in the Th1 Response against Mycobacterium tuberculosis J. Immunol., October 15, 2004; 173(8): 4936 - 4944. [Abstract] [Full Text] [PDF]
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A. F. Hernandez, D. J. Whellan, S. Stroud, J. L. Sun, C. M. O'Connor, and J. G. Jollis Outcomes in heart failure patients after major noncardiac surgery J. Am. Coll. Cardiol., October 6, 2004; 44(7): 1446 - 1453. [Abstract] [Full Text] [PDF]
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W. Pan, T. Pintar, J. Anton, V.-V. Lee, W. K. Vaughn, and C. D. Collard Statins Are Associated With a Reduced Incidence of Perioperative Mortality After Coronary Artery Bypass Graft Surgery Circulation, September 14, 2004; 110(11_suppl_1): II-45 - II-49. [Abstract] [Full Text] [PDF]
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A. F. Hernandez, L. K. Newby, and C. M. O'Connor Preoperative Evaluation for Major Noncardiac Surgery: Focusing on Heart Failure Arch Intern Med, September 13, 2004; 164(16): 1729 - 1736. [Abstract] [Full Text] [PDF]
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R. B. Cavalcanti Does perioperative lipid-lowering therapy reduce in-hospital mortality after major noncardiac surgery? Can. Med. Assoc. J., August 17, 2004; 171(4): 328 - 328. [Full Text] [PDF]
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C. J. Vaughan and A. M. Gotto Jr Update on Statins: 2003 Circulation, August 17, 2004; 110(7): 886 - 892. [Full Text] [PDF]
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D. Mukherjee and K. A. Eagle Ischemia, revascularization, and perioperative troponin elevation after vascular surgery J. Am. Coll. Cardiol., August 4, 2004; 44(3): 576 - 578. [Full Text] [PDF]
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 H. L. Lazar Role of statin therapy in the coronary bypass patient Ann. Thorac. Surg., August 1, 2004; 78(2): 730 - 740. [Abstract] [Full Text] [PDF]
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 S R Johnson, P J Harvey, J S Floras, M Iwanochko, D Ibanez, D D Gladman, and M Urowitz Impaired brachial artery endothelium dependent flow mediated dilation in systemic lupus erythematosus: preliminary observations Lupus, August 1, 2004; 13(8): 590 - 593. [Abstract] [PDF]
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H.-J. Priebe Triggers of perioperative myocardial ischaemia and infarction Br. J. Anaesth., July 1, 2004; 93(1): 9 - 20. [Abstract] [Full Text] [PDF]
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S. J. Howell and J. W. Sear Perioperative myocardial injury: individual and population implications Br. J. Anaesth., July 1, 2004; 93(1): 3 - 8. [Abstract] [Full Text] [PDF]
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M. Zaugg, M. C. Schaub, and P. Foex Myocardial injury and its prevention in the perioperative setting Br. J. Anaesth., July 1, 2004; 93(1): 21 - 33. [Abstract] [Full Text] [PDF]
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 P. K. Lindenauer, P. Pekow, K. Wang, B. Gutierrez, and E. M. Benjamin Lipid-Lowering Therapy and In-Hospital Mortality Following Major Noncardiac Surgery JAMA, May 5, 2004; 291(17): 2092 - 2099. [Abstract] [Full Text] [PDF]
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M. Schillinger, M. Exner, W. Mlekusch, J. Amighi, S. Sabeti, M. Muellner, H. Rumpold, O. Wagner, and E. Minar Statin therapy improves cardiovascular outcome of patients with peripheral artery disease Eur. Heart J., May 1, 2004; 25(9): 742 - 748. [Abstract] [Full Text] [PDF]
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D. E. Newby and A. F. Nimmo Editorial II: Prevention of cardiac complications of non-cardiac surgery: stenosis and thrombosis Br. J. Anaesth., May 1, 2004; 92(5): 628 - 632. [Full Text] [PDF]
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 G. W. Smetana, S. L. Cohn, and V. A. Lawrence Update in Perioperative Medicine Ann Intern Med, March 16, 2004; 140(6): 452 - 461. [Full Text] [PDF]
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B.A. in 't Veld, M.S. Arbous, D. Poldermans, M. Kertai, B. Krenning, C. M. Westerhout, A. F.L. Schinkel, I. R. Thomson, P. J. Landsberg, L. Fleisher, et al. Statins and Incidence of Perioperative Mortality in Patients Undergoing Major Noncardiac Vascular Surgery * Response Circulation, November 25, 2003; 108 (21): e151 - e151. [Full Text] [PDF]
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