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Journal of the American College of Cardiology Vol. 56, No. 25, 2010© 2010 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00Published by Elsevier Inc. doi:10.1016/j.jacc.2010.07.032

EDITORIAL COMMENT

moking Interventionshe Beginning of the Endr the End of the Beginning?*

lizabeth A. Jackson, MD, MPH,im A. Eagle, MD

nn Arbor, Michigan

eripheral artery disease (PAD) remains common amonghe adult population. Depending on the methods for detec-ion, the estimated prevalence of PAD among U.S. adultsanges from 2.5% in patients �60 years of age to 18.8% inatients �70 years of age (1,2). Using the Rose Claudica-ion Questionnaire, which can underestimate lower extrem-ty PAD (3), the age-specific annual incidence of intermit-ent claudication in the Framingham Heart Study rangedrom 6 per 10,000 men and 3 per 10,000 women for ages 30o 44 years and increased to 61 per 10,000 men and 54 per0,000 women for ages 65 to 74 years (4). Overall, anstimated 8 million Americans have PAD, and it remainsnderdiagnosed. In a large cross-sectional study of patientsrom 350 large-volume primary care practices in 25 Amer-can cities, among patients age 70 years or older, or patients0 to 69 years of age who smoked or had diabetes mellitus,he prevalence of PAD was 19% (5). Within this group,6% were observed to have both lower extremity PAD andt least 1 other form of atherosclerotic disease such asoronary artery disease. Despite the high prevalence of PADn this cohort, the diagnosis of PAD was new in 55% ofatients with PAD alone, and new in 33% of patients withoth lower extremity PAD and cardiovascular disease.

See page 2105

In addition to diabetes, hypertension, and hypercholes-erolemia, cigarette smoking is a significant risk factor forAD (3). In fact, smoking is a stronger predictor of PAD

han is coronary artery disease (2). Among patients withAD, an estimated 80% report currently smoking or haveeen a smoker (6,7). Risk of PAD among smokers is 3 to 6imes higher than among nonsmokers. Among the almost

Editorials published in the Journal of the American College of Cardiology reflect theiews of the authors and do not necessarily represent the views of JACC or themerican College of Cardiology.From the Division of Cardiovascular Medicine, Department of Internal Medicine,

aniversity of Michigan Health System, Ann Arbor, Michigan. The authors have

eported that they have no relationships to disclose.

,000 participants in the PARTNERS (PAD Awareness,isk and Treatment: New Resources for Survival) study, therevalence of tobacco use among subjects with PAD was7% for current smokers and 37% for former smokers (5).PAD is associated with significant morbidity and mor-

ality (8). An ankle-brachial index (ABI) �0.90 addsndependent prognostic value to the Framingham Riskcore in prediction of 10-year mortality (9). An ABI �0.90

s associated with double the risk of total mortality (9)! Aecline in ABI of �0.15 over a 10-year period is associatedith a 2.4� increased risk of total mortality and a 2.8�

ncreased risk for cardiovascular mortality (10).Although smoking rates have declined significantly over

he past several decades, an estimated 23% of men and 18%f women in the U.S. are current smokers (8). Increased usef smoking bans in the workplace and community haveontributed to the decline in smoking. Structured smokingessation programs have demonstrated success in assistingmokers to quit. Current guidelines recommend a combi-ation of behavioral intervention together with the use ofharmacological products for smoking cessation (11). Aeta-analysis of successful smoking cessation intervention

tudies suggests that factors associated with success includedace-to-face counseling, advice from both providers andonphysician counselors, and the number of sessions, withore being better (12). These aspects are key components

f the randomized clinical trial conducted by Hennrikus etl. (13) in this issue of the Journal.

Hennrikus et al. (13) reports a randomized trial using amoking cessation program for patients with PAD. Patientsith documented PAD who were identified as current

mokers were eligible for the study. Of the 687 outpatientsontacted, 124 were enrolled. Subjects were randomly as-igned to an intensive intervention consisting of physiciandvice to quit smoking in addition to smoking cessationreatment. Treatment included both behavioral and phar-acological components. Behavioral components includedethods found effective in prior trials, including selection ofquit date and behavioral and cognitive strategies for copingith urges to smoke. Use of pharmacologic agents was

ncouraged. Information on types of pharmacologic projectssed for smoking cessation was provided; however, subjectsere instructed to obtain these products through theirealth insurance and/or healthcare provider, as opposed toeing offered through the study. In addition, an addedomponent of the intervention was the identification of aerson from the subject’s social network who was contactedy the study counselor (by telephone) to discuss smokingessation strategies as they pertained to that particularubject. A total of 6 counseling sessions were planned over

5-month period; however, more sessions could be at-ended. The comparative arm of this randomized clinicalrial received a minimal intervention defined as receipt oferbal advice from their vascular provider to quit smoking

nd information on smoking cessation programs and re-

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2114 Jackson and Eagle JACC Vol. 56, No. 25, 2010Smoking Interventions December 14/21, 2010:2113–4

ources in the community provided by the study coordina-or. The investigators found participants in the intensiventervention arm were receptive to the counseling sessionsnd had higher rates of abstinence at 6 month as comparedo the minimal intervention group (21.3% vs. 6.8%; p �.02).The investigators are to be congratulated for the comple-

ion of a clinically relevant, detailed study. Their resultsuggest intensive counseling support together with providerdvice and pharmacological smoking cessation products canssist smokers to quit. However, this study highlights theotential difficulty of translating interventions tested in aesearch venue to the real-world setting; namely, is this aost-effective intervention? For many practitioners and pa-ients with PAD, the cost in time and resources to providend receive intensive counseling sessions is prohibitive. Inddition, currently many smoking cessation products are notovered by insurance; thus, smokers are often reluctant toay out-of-pocket for such products.For smoking cessation programs to reach the mainstream

f current therapeutics, several areas are in need of furthernderstanding. First, it is likely that smokers vary in theireeds during the quitting process (15). What components of

ntensive programs work the best and for which smokers?urrent guidelines suggest that a combination of behavioral

ntervention with pharmacologic assistance is most success-ul (11). The research present by Hennrikus et al. (13)upports this concept. Heavy smokers may also benefit morerom structured programs (15); this current study includedmokers who averaged at least a pack of cigarettes per day,nd 90% starting smoking soon after waking. In addition,he study population was predominately male.

Data from a real-world sample of U.S. adults, the Adultse of Tobacco Survey, suggests a significant number of

mokers attempt to quit without using a structured program15). Among smokers who attempted to quit over a 10-yeareriod, 47.5% of smokers who attempted to quit on theirwn were successful, compared with 23.6% of smokers whosed a cessation program. The 23.6% success rate of thoseho used a structured program in this report is consistentith the efficacy of other formal cessation programs thatefine success as 1 year of smoking cessation. Thus, forany smokers, an intensive program may not be preferable

r feasible. Hennrikus et al. (13) did find subjects randomlyllocated to the intensive intervention arm attended aignificant number of sessions, suggesting excellent accep-ance of the multiple counseling sessions. The overall 20%uit rate at 6 months for the intensive intervention programikely translates into an even lower quit rate at 12 months,learly a limited effect of the intervention.

Given the logistical and financial difficulties in creating anntensive program in practice, exploring other interventionsuch as social media and on-line programs to supplementace-to-face counseling is warranted. In addition, providingharmacologic products free or at reduced cost is likely to

ssist in quit rates. These aspects of smoking cessation

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rograms have to be addressed before the widespreadranslation of intensive intervention to the community.mong populations such as patients with PAD, the high

ates of cardiovascular disease and the resulting morbiditynd mortality suggest the worth of continued research in therea of smoking cessation. However, our idea that one sizets all is both naïve and also biologically implausible.

eprint requests and correspondence: Dr. Kim A. Eagle, Uni-ersity of Michigan Cardiovascular Center, 1500 East Medicalenter Drive, Suite 2131, Ann Arbor, Michigan 48109-5852.-mail: keagle@umich.edu.

EFERENCES

1. Kannel WB. The demographics of claudication and the aging of theAmerican population. Vasc Med 1996;1:60–4.

2. Criqui MH, Denenberg JO, Langer RD, Fronek A. The epidemiologyof peripheral arterial disease: importance of identifying the populationat risk. Vasc Med 1997;2:221–6.

3. Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA 2005 practiceguidelines for the management of patients with peripheral arterialdisease (lower extremity, renal, mesenteric, and abdominal aortic): acollaborative report from the American Association for VascularSurgery/Society for Vascular Surgery, Society for Cardiovascular An-giography and Interventions, Society for Vascular Medicine andBiology, Society of Interventional Radiology, and the ACC/AHATask Force on Practice Guidelines (Writing Committee to DevelopGuidelines for the Management of Patients With Peripheral ArterialDisease). J Am Coll Cardiol 2006;47:1–192.

4. Kannel WB, Skinner JJ Jr., Schwartz MJ, Shurtleff D. Intermittentclaudication. Incidence in the Framingham study. Circulation 1970;41:875–83.

5. Hirsch AT, Criqui MH, Treat-Jacobson D, et al. Peripheral arterialdisease detection, awareness, and treatment in primary care. JAMA2001;286:1317–24.

6. Meyers DG, Neuberger JS, He J. Cardiovascular effect of bans onsmoking in public places: a systematic review and meta-analysis. J AmColl Cardiol 2009;54:1249–55.

7. Smith GD, Shipley MJ, Rose G. Intermittent claudication, heartdisease risk factors, and mortality. The Whitehall study. Circulation1990;82:1925–31.

8. Lloyd-Jones D, Adams RJ, Brown TM, et al. Heart disease and strokestatistics—2010 update: a report from the American Heart Associa-tion. Circulation 2010;121:e46–215.

9. Fowkes FG, Murray GD, Butcher I, et al. Ankle brachial indexcombined with Framingham Risk Score to predict cardiovascularevents and mortality: a meta-analysis. JAMA 2008;300:197–208.

0. Criqui MH, Ninomiya JK, Wingard DL, Ji M, Fronek A. Progressionof peripheral arterial disease predicts cardiovascular disease morbidityand mortality. J Am Coll Cardiol 2008;52:1736–42.

1. Fiore MC, Jaen CR, Baker TB, et al. Treating Tobacco Use andDependance: 2008 Update. Rockville, MD: U.S. Department ofHealth and Human Services, Public Health Service, 2008.

2. Kottke TE, Battista RN, DeFriese GH, Brekke ML. Attributes ofsuccessful smoking cessation interventions in medical practice. Ameta-analysis of 39 controlled trials. JAMA 1988;259:2883–9.

3. Hennrikus D, Joseph AM, Lando HA, et al. Effectiveness of asmoking cessation program for peripheral artery disease in patients: arandomized controlled trial. J Am Coll Cardiol 2010;56:2105–12.

4. Monso E, Campbell J, Tonnesen P, Gustavsson G, Morera J.Sociodemographic predictors of success in smoking intervention.Tobac Control 2001;10:165–9.

5. Fiore MC, Novotny TE, Pierce JP, et al. Methods used to quitsmoking in the United States. Do cessation programs help? JAMA1990;263:2760–5.

ey Words: clinical trials y peripheral artery disease y smokingessation.