Journal of Vascular Surgery
Volume 49, Issue 1 , Pages 260-265, January 2009

The benefit of statins in non-cardiac vascular surgery patients

  • Anton F.H. Stalenhoef, MD, PhD

      Affiliations

    • Corresponding Author InformationReprint requests: Anton F. H. Stalenhoef, MD, PhD, FRCP, Professor of Medicine, Radboud University Nijmegen Medical Centre, 463 Department of General Internal Medicine, PO Box 9101, 6500 HB Nijmegen, The Netherlands

Department of Medicine, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands

Received 4 November 2008; accepted 6 November 2008.

Jan D. Blankensteijn, MD, PhD, Section Editor

Article Outline

There is overwhelming evidence that statins reduce morbidity and mortality in patients with coronary disease. Statins have also been shown to reduce the risk of (recurrent) stroke. Low-density lipoprotein (LDL)-cholesterol, which plays a causal role in the development of atherosclerotic disease, is the primary lipid target in prevention, and is effectively reduced by these agents. In this review, studies are summarized addressing the issues whether statins also directly influence the atherosclerotic process in peripheral arterial disease, carotid artery stenosis, and growth of abdominal aortic aneurysms, and whether statins have an effect on perioperative outcomes in vascular surgery patients. It appears that the evidence of statins on peripheral arterial disease is scarce and its effect on perioperative outcome inconclusive. Prospective randomized trials to answer these questions cannot be performed anymore, however, because all vascular patients should receive statin treatment as secondary prevention of cardiovascular disease.

 

HMG-CoA reductase inhibitors (or statins) effectively decrease serum cholesterol and there is ample evidence that cholesterol lowering with statins reduce morbidity and mortality in cardiovascular patients. The first large placebo-controlled trial was the 4S trial with simvastatin, which revolutionized clinical practice of cardiologists.1 This was followed by many other large trials in several categories of high-risk patients (diabetes, hypertension, elderly, or acute coronary syndrome) and comparisons with conventional and more intensive cholesterol-lowering therapy, which all gave a similar picture and indicated, in addition, that further lowering of serum cholesterol was associated with even more risk reduction. The largest of these trials is the Heart Protection Study (HPS), in which a large number of patients with peripheral vascular disease were also included.2 Based on placebo-controlled studies containing more than 90,000 patients, it has been shown that there is a strong proportional relationship between the degree of low-density lipoprotein (LDL)-cholesterol lowering and reduction in cardiovascular events.3, 4 There have been a few exceptions in this series of successful trials with neutral outcome: diabetic patients with endstage renal disease on dialysis5 and patients with heart failure,6 in whom vascular damage is apparently irreversible, or vascular disease so complex that treatment with statins is ineffective or has come too late.

The etiology of atherosclerotic vascular disease in the various parts of the arterial tree resulting in myocardial infarction, ischemic stroke, and peripheral disease is essentially the same. In addition, a considerable number of vascular patients present with manifestations of atherosclerosis in several parts of the arterial tree at the same time.7 Several intervention trials have indicated that statins not only prevent cardiac events in cardiovascular patients, but also ischemic stroke and peripheral arterial disease.2, 8 There is only one randomized trial in patients with a stroke or transient ischemic attack (TIA) without manifest coronary disease, aimed to specifically study the effect on recurrent stroke;9 this study using a high dose of 80 mg atorvastatin, showed a 16% reduction in fatal and non-fatal stroke and 26% reduction in total vascular events.

The purpose of this evidence-based review series is to look at the evidence that statins are also beneficial in preventing progression of atherosclerotic disease in other areas than the coronaries, ie, carotid arteries, abdominal aortic aneurysm, and peripheral arterial disease. Evidence that statins have direct beneficial effects on these parts of the arterial tree resulting in less clinical endpoints is scarce and difficult to obtain since all vascular patients are regarded as having high-risk and usually already treated with statins according to the current guidelines.

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Methods 

From a literature search in PubMed, studies were selected evaluating the effect of treatment with statins on clinical endpoints in vascular (non-cardiac) patients. This was confined to three main vascular areas, carotid arteries, abdominal aorta, and peripheral (infrainguinal) arteries.

Both effects on clinical outcome in terms of progression of disease as well as on perioperative outcome have been reported.

Most strikingly, the majority of these studies are observational and retrospective in nature, of limited duration, usually conducted in complex patients with multiple pharmacological treatments without information about type of statin, dosing, exact duration of treatment, compliance, and levels of LDL- and high-density lipoproteins (HDL)-cholesterol. Many possible confounders are not controlled for and causal relationships are therefore not proven. There are a few exceptions.

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Results 

Carotid artery stenosis (Table I) 

Paraskevas et al10 have published an extensive review article in this journal about the effects of statins on carotid intima media thickness (IMT) and occurrence of cerebrovascular disease. There is evidence that the progression rate of IMT is reduced by statins, but controlled studies specifically on effect on carotid plaques are lacking. Perioperative outcome in symptomatic patients undergoing endarterectomy may be better in statin users but the level of evidence is not strong.

Table I. Clinical trials in patients with carotid artery stenosis undergoing carotid endarterectomy (CEA)
StudyStudy designPopulation/procedureNumber of patients (statin users/non users)OR or HR and (95% CI) vs non statin users⁎
Kennedy et al19Observational, retrospectiveCEA
n = 3360

Asymptomatic (665/587)

Symptomatic (815/1216)


In-hospital adverse outcome (death/stroke/cardiac events)

Asymptomatic: no difference

Symptomatic: death: OR 0.25 (0.07-0.90)

Stroke: OR 0.55 (0.32-0.95)

Cardiac events: no difference

McGirt et al20Observational, retrospectiveCEA
n = 1566

(42% symptomatic)

(657/909)


Perioperative outcome (mortality, stroke, myocardial infarction, cranial nerve injury, length of hospital stay)

Death: OR 0.20 (0.04-0.99)

Stroke: OR 0.35 (0.15-0.85)

Brooke et al21Case control, retrospectiveCEA
n = 1561

660 symptomatic (228/432)

901 asymptomatic (426/475)


Presence of symptomatic cerebrovascular disease at time of presentation for CEA

OR 0.72 (0.56-0.92)

OR, Odds ratio; HR, hazard ratio; CI, confidence interval; CEA, carotid endarterectomy.

⁎OR (and HR, or relative risk ratio): ratio of the odds (OR) or probability (HR) of an event occurring in the therapeutic group as compared to the odds (OR) or probability (HR) of it occurring in the control group. An OR or HR ratio greater than 1 indicates that the event is more likely in the first group and an OR/HR less than 1 indicates that the event is less likely in the first group.

Abdominal aortic aneurysm (AAA) (Table II) 

The number of subjects with AAA in the various studies is rather small and the studies are all observational in nature. In general, the growth rate of AAA may be reduced in patients using statins and mortality less, but the number of studies and evidence> are limited.

Table II. Clinical trials in patients with AAA
StudyStudy designPopulation/procedureNumber of patients (statin users/non users)OR or HR and (95% CI) vs non statin users⁎
Kertai et al22Observational, retrospectiveAAA elective surgical repairn=510(154/356)
All cause mortality and cardiovascular mortality

Median follow-up 4.7 years

All cause mortality HR 0.6 (0.5-0.9), cardiovascular mortality HR 0.7 (0.4-0.9)

Sukhija et al23Observational, prospectiveAAA surveillancen=130(75/55)
AAA growth rate

Follow-up 2 years

No change in statin users, increase from 45 to 53 mm in nonusers

Schouten et al24Observational, retrospectiveAAA surveillancen=150(59/91)
AAA growth rate

Follow-up 3.1 years

1.16 mm/year (0.33 to 1.99 mm) less growth in statin users compared with nonusers

Mosorin et al25Observational, retrospectiveAAA surveillancen=121(34/87)
AAA growth rate, survival from repair/rupture

Mean follow-up 3.6 years

Growth rate NS

Survival at 5 years in statin users 84% vs 59% in nonusers

Schlösser et al26Observational, prospectiveSmall AAA (30-55 mm) surveillancen=230(85/145)
Mortality, rupture rates, AAA growth rate

Median follow-up 3.3 years

7 ruptures (6 fatal)

Mortality NS

1.2 mm/year (2.34-0.060 mm/year) less growth in statin users compared with nonusers

AAA, Abdominal aortic aneurysm; OR, odds ratio; HR, hazard ratio; CI, confidence interval; NS, not significant.

⁎OR (and HR, or relative risk ratio): ratio of the odds (OR) or probability (HR) of an event occurring in the therapeutic group as compared to the odds (OR) or probability (HR) of it occurring in the control group. An OR or HR ratio greater than 1 indicates that the event is more likely in the first group and an OR/HR less than 1 indicates that the event is less likely in the first group.

Peripheral artery disease (PAD) (Table III) 

The studies looking at the clinical effect of statins in patients with claudication or after infrainguinal bypass surgery are all observational and provide a variable picture, but the majority reports a beneficial effect on walking performance, patency, and survival in the statin users. The two largest studies showed improved survival: Feringa et al11 compared 481 statin users with 893 non users with ankle brachial index (ABI) ≤0.90 during a mean follow-up of 6.4 years and found reduced mortality, cardiac death, and kidney failure per 10% increase in statin dose and 10 mg/dL lower LDL-cholesterol. Schanzer et al12 made use of the Project of Ex-vivo vein graft Engineering via Transfection III (PREVENT III) cohort of 1404 patients undergoing lower extremity bypass grafting (testing the efficacy of edifoligide to reduce neointimal hyperplasia, which did not confer benefit). This study (636 statin users vs 768 non users) revealed no effect on patency, but improved survival 1 year after surgical revascularization.

Table III. Clinical trials in patients with PAD
StudyStudy designPopulation/procedureNumber of patients (statin users/non users)OR or HR and (95% CI) vs non statin users⁎
McDermott et al27Observational, retrospective cross sectionalABI <0.90 vs ABI 0.90-1.50
n = 392 (177/215)

n = 249 (75/174)

Better walking performance in statin users
Mohler et al28Randomized, double blind, parallel design, placebo, 10 mg and 80 mg atorvastatinIntermittent claudication
n = 354

placebo 114

10 mg 120

80 mg 120


Change in treadmill exercise, patient-reported physical activity and quality of life questionnaire

Follow-up 1 year

No difference in maximal walking time, pain-free walking time improved in 80 mg group

Mondillo et al29Randomized, placebo controlled, double blind 40 mg simvastatin vs placeboIntermittent claudication, Cholesterol >5.69 mmol/Ln = 86 (43/43)
Treadmill test, ABI at 3 and 6 months follow-up

More increase in pain-free walking distance (90 m) and total walking distance (116 m) and small increase in ABI in the simvastatin group.

Schillinger et al30Observational, prospectiveSevere PAD, percutaneous catheter interventionn = 515 (269/246)
All cause mortality, composite of myocardial infarction and death

Median follow-up 21 months

Mortality: HR 0.52 (0.30-0.91)

Myocardial infarction and death; HR 0.48 (0.29-0.79)

Henke et al31Observational, retrospectivePAD infrainguinal bypassn = 293 (164/129)
Graft patency, limb salvage, mortality

Mean follow-up 17 months.

Graft patency: OR 3.7 (2.1-6.4)

Amputation rate: OR 0.34 (6.15-0.77)

Mortality: NS

Abbruzzese et al32Observational, retrospectivePAD infrainguinal bypassn = 172 (189 procedures) (94/95)
Graft patency, limb salvage, mortality

Mean follow-up 17.5 months.

Patency rates: NS

Limb salvage: NS

Mortality: NS

Ward et al33Observational, retrospectivePAD infrainguinal bypassn = 446 (72/374)
Perioperative complications (all cause mortality, cardiovascular mortality, myocardial infarction, stroke, major peripheral vascular complications); long-term survival

Mean follow-up 5.5 years.

Combined complications: OR 0.36 (0.14-0.93)

Long-term survival: OR 0.52 (0.32-0.84)


Feringa et al11

Observational, prospectivePAD (ABI ≤0.90)n = 1374 (481/893)
All cause mortality, cardiac death, progression to kidney failure

Mean follow-up 6.4 years

Per 10% increase in statin dose and 10 mg/dl lower LDL-cholesterol:

mortality: HR 0.71 (0.62-0.80)

cardiac death: HR 0.76 (0.67 -0.82)

kidney failure: HR 0.69 (0.54-0.89)

Schanzer et al12Observational, analysis of PREVENT III CohortPAD infrainguinal bypassn = 1401 (636/768)
30-day MACE, death, 1-year graft patency and mortality

30-day: MACE and death: NS

1 year graft patency: NS

1 year mortality: HR 0.71 (0.52-0.98)

OR, Odds ratio; HR, hazard ratio; CI, confidence interval; PAD, peripheral artery disease; NS, not significant; MACE, major adverse cardiovascular events; ABI, ankle brachial index.

⁎OR (and HR, or relative risk ratio): ratio of the odds (OR) or probability (HR) of an event occurring in the therapeutic group as compared to the odds (OR) or probability (HR) of it occurring in the control group. An OR or HR ratio greater than 1 indicates that the event is more likely in the first group and an OR/HR less than 1 indicates that the event is less likely in the first group.

Combined peripheral vascular disease (carotid artery, aorta, and lower extremity) (Table IV) 

Earlier retrospective studies investigated the perioperative mortality and in-hospital complications of major vascular surgery and found less complications in statin users, whereas myocardial infarction/death were not significantly different;13 Poldermans et al14 reported in a retrospective case-controlled study reduced perioperative mortality. The same group reported improved short- and long-term survival in patients with PAD and chronic obstructive pulmonary disease on intensified doses of statins.15

Table IV. Clinical trials in patients with peripheral vascular disease (combined carotid, aorta and lower extremity)
StudyStudy designPopulation/procedureNumber of patients (statin users/non users)OR or HR and (95% CI) vs non statin users⁎
Poldermans et al14Case controlled, retrospectiveMajor vascular surgery (non-cardiac)
n = 2816

160 cases, 320 controls (12/160; 81/320)


Perioperative mortality

OR 0.22 (0.10-0.47)

O'Neil-Callahan et al13Observational, retrospectiveCEA, aortic surgery, lower limb revascularization
n = 997, (1163 hospitalizations) (526/637)


Total in-hospital complications (death, myocardial infarction, myocardial ischemia, congestive heart failure, ventricular tachyarrhythmia)

Complications: OR 0.56 (0.39-0.79)

Myocardial infarction/death: NS


Heart Protection

Study (HPS)

Collaborative Group16

Randomized, placebo controlled double blind (40 mg simvastatin/placeboClaudication, revascularization, amputation, aneurysm repair (Subgroup in HPS)n = 6748 (3384/3364)
MACE, coronary event, stroke, revascularization, first PAD events Mean follow-up 5 years.

MACE: HR 0.76 (0.72-0.81)

Coronary events: HR: 0.73 (0.67-0.79)

Stroke: HR 0.75 (0.66-0.85)

Revascularization: HR 0.76 (0.70-0.83)

First PAD events: 16% (5-25) relative reduction

Van Gestel et al15Observational, retrospective
Elective surgery for AAA, CEA, lower limb arterial reconstruction with and without COPD

n = 3371 (810/2561)
30-day and 10-year mortality

30-day: OR 0.45 (0.27-0.75)

10 year: HR 0.72 (0.60-0.85)

COPD: 30-day: OR: 0.48 (0.23-1.00)

10-year: HR 0.67 (0.52-0.86)

OR, Odds ratio; HR, hazard ratio; CI, confidence interval; CEA, carotid endarterectomy; HPS, hyperperfusion syndrome; AAA, abdominal aortic aneurysm; NS, not significant; MACE, major adverse cardiovascular events; COPD, chronic obstructive pulmonary disease.

⁎OR (and HR, or relative risk ratio): ratio of the odds (OR) or probability (HR) of an event occurring in the therapeutic group as compared to the odds (OR) or probability (HR) of it occurring in the control group. An OR or HR ratio greater than 1 indicates that the event is more likely in the first group and an OR/HR less than 1 indicates that the event is less likely in the first group.

The best evidence comes from the Heart Protection Study.2, 16 In this randomized, placebo controlled, double blind study, a subgroup of 6748 patients with PAD were included and allocated to either 40 mg of simvastatin or placebo during a mean of 5 years. There was a significant 22% relative reduction in the rate of first major vascular events. Overall, there was a significant 16% reduction in the rate of first peripheral vascular events. Around 2700 patients with PAD had no pre-existing coronary artery disease at baseline and achieved similar proportional benefits as those with coronary artery disease and PAD.16

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Discussion 

This review summarizes the evidence for the beneficial effects of statins in non-cardiac vascular surgery patients with respect to clinical symptoms and/or perioperative outcome. Since patients with symptomatic PAD have frequently co-existing coronary disease and a high risk to develop cardiovascular events, they should be treated with statins according to current guidelines. This will make future randomized controlled studies impossible to conduct. The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial, with high dose of atorvastatin, has shown to reduce the risk of recurrent fatal and non-fatal strokes in patients with a history of ischemic stroke or TIA, but without manifest coronary disease (secondary prevention). A difference in LDL-cholesterol of 1.4 mmol/L was associated with a significant absolute 5-year risk reduction of fatal and non-fatal stroke of 2.2%, whereas the risk of major cardiovascular events was reduced by 3.5%.9 It was already known that stroke or TIA should be regarded as “coronary heart disease risk equivalent” for which secondary more aggressive prevention guidelines apply. The studies summarized in this review also suggest beneficial effect on the progression of PAD, but hard clinical evidence for these peripheral beds is scarce due to the non-randomized nature of most studies with many possible confounders and comes mainly from the hyperperfusion syndrome (HPS). Furthermore, although some studies suggest benefit with respect to perioperative complications, mortality, and clinical outcome, the protective effect of statins are not proven in these situations. Biccard17 provides useful recommendations for perioperative statin use, so that meta-analysis in the future may provide an answer whether statins will reduce perioperative complications. The same holds true for the effect of statins on the progression rate of AAAs: there is no conclusive evidence that these drugs prevent growth and ruptures of AAA.

It has been suggested that the statins exert their effect as anti-inflammatory agents independent of their cholesterol lowering effect. Statins are indeed known to lower high sensitive C-reactive protein (hs-CRP).18 It remains to be seen, however, whether these effects are really cholesterol-independent, because the clinical effects of statins are proportionally (one-to-one) related to the degree of LDL-cholesterol lowering.3, 4 The clinical relevance of this so called pleiotropic effect has not been proven so far. In conclusion, life style measures, smoking cessation, and cholesterol lowering remain of utmost importance to influence favorably (cardiovascular) outcome in vascular patients. Despite the relative shortcomings in direct clinical evidence for the beneficial effect of statins in particular parts of the vascular tree, statins have become, beyond a doubt, an essential instrument in the management of the vascular patient.

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Author contributions 


Conception and design: AS

Analysis and interpretation: AS

Data collection: AS

Writing the article: AS

Critical revision of the article: AS

Final approval of the article: AS

Statistical analysis: Not applicable

Obtained funding: Not applicable

Overall responsibility: AS

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References 

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 Competition of interest: none.

PII: S0741-5214(08)02009-0

doi:10.1016/j.jvs.2008.11.070

Refers to erratum:

  • Correction , 13 February 2009

    Journal of Vascular Surgery April 2009 (Vol. 49, Issue 4, Page 1091)

Journal of Vascular Surgery
Volume 49, Issue 1 , Pages 260-265, January 2009

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