HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Tomas A. Salerno Hooshang Bolooki Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Ferreira, A. C. Articles by de Marchena, E. Search for Related Content PubMed PubMed Citation Articles by Ferreira, A. C. Articles by de Marchena, E. Related Collections Coronary disease

Ann Thorac Surg 2003;75:485-489
© 2003 The Society of Thoracic Surgeons

---

Original article: cardiovascular

Clinical impact of drug-eluting stents in changing referral practices for coronary surgical revascularization in a tertiary care center

^a Department of Medicine, Division of Cardiology, University of Miami School of Medicine, Miami, Florida, USA
^b Department of Surgery, Division of Cardiothoracic Surgery, University of Miami School of Medicine, Miami, Florida, USA

Accepted for publication August 27, 2002.

* Address reprint requests to Dr Ferreira, PO Box 016960, Miami, FL 33101, USA
e-mail: aferreir{at}med.miami.edu

	Abstract

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
BACKGROUND: The long-term benefits of angioplasty are limited by the occurrence of restenosis. Drug-eluting stents with a projected restenosis rate of close to 0% are soon to become available. The short- and long-term consequences of this advance to the cardiac surgical volume remain unclear.

METHODS: A total of 196 consecutive coronary angiograms and medical records of patients referred for coronary bypass surgery were reviewed. Considering the hypothetical premise of having drug-eluting stents with a near zero restenosis rate, we reviewed each case to determine if surgical revascularization was still the preferred option for revascularization.

RESULTS: The mean age was 60 (±10.6) years. Seventy-two percent of patients were male. Considering the availability of drug-eluting stents 154 (79%) would still have been sent to surgery, representing a 21% decrease in the number of surgical revascularizations. Angiographic characteristics predicting coronary bypass revascularization were the presence of chronic total occlusion (odds ratio [OR]: 9.1; confidence interval [CI]: 2.1 to 39), left main coronary artery stenosis (OR: 9.6; CI: 1.27 to 73), and need for valvular surgery (OR: 7.38; CI: 1.3 to 157). The most common predictors of a change in clinical management from surgical to percutaneous revascularization if drug-eluting stents were available were diffuse coronary narrowing (OR: 15.78), restenotic lesions (OR: 27.86), and small coronary arteries (OR: 26).

CONCLUSIONS: Drug-eluting stents may have a significant impact on cardiac surgery volume (approximately a 21% decrease in our center). It may also direct patients with small vessels, diffuse narrowing, or restenotic lesions and diabetic patients to percutaneous therapy.

	Introduction

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
Currently percutaneous coronary interventions outnumber coronary bypass operations. The popularity of balloon angioplasty lies in its simplicity, safety, and relative patient friendliness. Direct comparison of angioplasty and coronary artery bypass surgery suggests that long-term survival rates are equivalent, albeit with more frequent repeat reinterventions among angioplasty patients [1, 2].

Stenting has been established as an effective procedure for reducing acute complications and long-term restenosis by means of a mechanical scaffolding and prevention of recoil and negative remodeling [3–5]. Two randomized clinical trials compared stent placement with coronary bypass surgery [6, 7]. The incidence of mortality and myocardial infarction was similar but the need for repeat revascularization was higher in the stented group at 1 year [8].

Restenosis remains the Achilles heel of percutaneousintervention and it is not unthinkable that, once restenosis is eliminated, coronary angioplasty might replace surgical revascularization for the great majority of patients [9].

Local drug delivery at the site of vascular injury through a polymeric-coated stent is an elegant approach to achieve effective local concentration of an antiproliferative agent to prevent restenosis [10–12]. As a result of initial clinical trials drug-coated stents with a projected restenosis rate of near 0% will likely become available in the North America in the foreseeable future [13, 14]. This retrospective study addresses the impact that drug-coated stents might have in the referral practices and coronary surgical volume in a tertiary care center.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
A total of 196 consecutive coronary angiograms and medical records of patients referred for coronary bypass surgery were reviewed from January 2001 to April 2002. These patients were referred for elective coronary bypass surgery by two independent high-volume interventional cardiologists who felt that the patient’s best option for revascularization was the surgical approach. Considering the hypothetical premise that drug-eluting stents were available with a near zero restenosis rate the referring cardiologists were asked to review the same patient medical records and coronary angiography and decide if surgical revascularization was still the preferred option for revascularization.

Furthermore each physician was asked to state the main reason why surgical revascularization was chosen over percutaneous multivessel angioplasty. Physicians were asked to identify in order of importance the main reason why surgical revascularization was recommended. Total coronary occlusion, left main artery stenosis, severe left ventricular dysfunction with ejection fraction less than 25%, small coronary arteries, diffuse coronary artery narrowing, lesion complexity (other than lesion length), proximal vessel tortuosity, angioplasty failure, or the need for a combined surgical procedure such as valvular surgery, left ventricular aneurysmectomy, or the presence of a ventricular septal defect (VSD) were all accepted reasons to favor surgical revascularization over percutaneous intervention.

The cases were reviewed to determine the main reasons why surgery had been recommended and to evaluate if revascularization strategies would be changed by ideal drug-eluting stents. Results are expressed as mean ± standard deviation or median with ranges, as indicated. Univariate analysis was performed using Fisher’s exact test. Odds ratios (OR) and confidence intervals(CI) for each variable are reported. All statistical analysis was performed using Epi Info 2002, Atlanta, Georgia. Approval was obtained from our Institutional Review Board.

	Results

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
A total of 196 patients angiograms and medical records were reviewed. The base line clinical characteristics of the overall population and the distribution of patients in relation to the preferred strategy (CABG vs coated stent) for each clinical characteristic are presented in Table 1. The mean age was 60.7 years (±10.6). Seventy-two percent were male. Forty-three percent of the patients were diabetic. Ninety-four percent of the patients were younger than 65 years of age. Hypertension was highly prevalent (94.7%).

Angiographic characteristics predicting coronary bypass revascularization, despite availability of drug-eluting stents, were the presence of chronic total occlusion (OR: 9.1; CI: 2.11 to 39; p = 0.000078), left main coronary artery stenosis(OR: 9.6; CI: 1.27 to 73; p = 0.0019), and the need for valvular surgery (OR: 7.38; CI: 1.3 to 157; p = 0.859). On the other hand, restenotic lesions (OR: 27.86; CI: 5.87 to 132; p = 0.0000003), small coronary arteries (OR: 26; CI: 3.05 to 224.86; p = 0.00019), and diffuse coronary narrowing (OR: 15.78; CI: 5.63 to 44.19; p = 0.000000015) were predictors of a change in clinical management from surgical to percutaneous revascularization if drug-eluting stents were available. The base line angiographic characteristics of the overall population and the distribution of patients in relation to the preferred strategy (CABG vs coated stent) for each angiographic characteristic are presented in Tables 2 and 3. Left ventricular dysfunction determined by ventriculography, coronary artery lesion complexity, and angioplasty failure were not predictors of utilization of either strategy.

	Comment

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

With the inception of stents fewer patients required emergent surgical interventions further jeopardizing surgical referrals. Many patients were still referred for surgery owing to either the occurrence or threat of stent restenosis. Stent restenosis occurs with an average frequency of approximately 20% to 30%. It is even higher among patients with diabetes mellitus, multivessel disease, complex lesions, and small vessels [17, 18].

Despite modern technical advances many physicians still refer patients with characteristics that predict high restenosis risk for surgical revascularization [15]. Recently developed drug-eluting stents may practically eliminate restenosis [13, 14]. Many have suggested that this advance will decrease dramatically the number of patients referred for coronary artery bypass surgery.

Our study demonstrated a potential decrease in surgical referrals by 21% when coated stents become available. Treatment of single-vessel and multivessel coronary disease with stents is frequently limited by anatomic variables and restenosis risk is only one of the issues considered by physicians when referring patients for surgical revascularization.

The presence of left main stenosis, chronic total occlusion, and the need for combined valvular surgery, which were present in 19.5%, 31.8%, and 12.8% of the patients respectively, predicted referral for surgical revascularization despite availability of coated stents (Table 3). Although the treatment of unprotected left main artery stenosis with a coated stent will not be limited by fear of possible sudden death due to silent restenosis, this study suggests that at least in our medical center these patients will continue to be referred for surgery. We believe that the initial experience of patients undergoing unprotected left main angioplasty, which demonstrated high procedural complications and early mortality, would still discourage our interventional cardiologists. We understand that this particular patient population may still be brought to the forefront of interventional cardiology if further refinement in technique and intervention allow a safer percutaneous approach for those patients [19].

The presence of a chronic total occlusion of a coronary artery and the inability to achieve complete revascularization were important factors that led to the referral of patients for surgical intervention. Although restenosis rates are higher after recanalization of a total occlusion restenosis is only one aspect of those challenging interventions.

Despite improvement of success rates of revascularization of total occlusions over time attempted revascularization does not come without risks. Major adverse cardiac events are high and success rates are still low. Failure to recanalize a total occlusion is associated with worse outcomes and those patients will likely remain in the surgeon’s realm [20, 21].

Valvular surgery, usually for ischemic mitral insufficiency and less frequently ventricular septal rupture and mechanical complications of ischemic heart disease, are frequently dealt with at the time of surgical revascularization and there is little to be offered by the interventional cardiologist at this time.

On the other hand, small vessel and diffuse coronary disease (Table 2), mainly in diabetic patients (43% of our patients), were predictors for utilization of the medicated stents in our study. In previous clinical trials stents consistently failed to decrease restenosis in small (<2.7 mm) vessels [22, 23]. Diabetes, also a predictor for restenosis, is frequently associated with small and diffusely diseased vessels [24]. The possibility of eliminating restenosis will make this population an inviting target for percutaneous intervention.

Interventional cardiologists throughout the country expect a 50% decrease in cardiac surgery volume, which is more than twice our presumptive projection of 21% (or 24.5% when patients requiring combined surgery were excluded). An increase of 75% in percutaneous coronary revascularization has also been estimated. It is important to indicate that long-term results of drug-eluting stents are not yet available and its short-term impact in surgical volume will only hold after long-term clinical results prove its efficacy and safety.

The concern for restenosis is only one of the many reasons for referring patients for surgical revascularization. We believe that a restenosis-free stent will decrease the coronary artery bypass surgery referral by approximately 21% to 24.5% in our tertiary care center. Extrapolation of these results to other institutions will depend on their particular characteristics and settings as well as on the expertise of their interventionist and surgical teams. Generalization of our results will need far more extensive review of surgical referrals in other medical centers in different US regions.

Often characteristics such as diffuse disease, chronic total occlusion, and complex coronary artery anatomy still limit the application of transvascular coronary revascularization and those limitations will not be transcended by drug-eluting stents. Patients undergoing surgical revascularization frequently have left main coronary artery stenosis or total coronary occlusion and many require combined valvular surgery or have complex anatomy, which favor surgical revascularization. Drug-eluting stents may have a significant impact on the cardiac surgery volume that is lower than has been proposed by some interventionists. It may also direct more patients with small vessels, diffuse coronary narrowing, or restenotic lesions and diabetic patients to percutaneous therapy [25–31].

	Acknowledgments

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 
This study was supported in part by the Tomas Curtis Research Fund.

	References

Top Abstract Introduction Patients and methods Results Comment Acknowledgments References

 

1. Bypass Angioplasty Revascularization Investigation (BARI). Comparison of coronary bypass surgery with angioplasty in patients with multivessel disease. N Engl J Med 1996;335:217-225.[Abstract/Free Full Text]
2. Rodriguez A., Mele E., Peyregne E., et al. Three year follow up of the Argentine randomized trial of percutaneous transluminal coronary angioplasty versus coronary artery bypass surgery in multivessel disease (ERACI). J Am Coll Cardiol 1996;27:1178-1184.[Abstract]
3. Serruys P.W., de Jaegere P., Kiemeneij F., et al. A comparison of ballon-expandable stent implantation with ballon angioplasty in patients with coronary artery disease. N Engl J Med 1994;331:489-495.[Abstract/Free Full Text]
4. Fischman D.L., Leon M.B., Baim D., et al. A randomized comparison of coronary stent placement and ballon angioplasty in the treatment of coronary artery disease. N Engl J Med 1994;331:496-501.[Abstract/Free Full Text]
5. Serruys P.W., de Bruyne B., Carlier S., et al. Randomized comparison of primary stenting and provisional balloon angioplasty guided by flow velocity measurement. Doppler Endpoints Balloon Angioplasty Trial Europe (DEBATE) II Study Group. Circulation 2000;102:2930-2937.[Abstract/Free Full Text]
6. Windecker S., Meier B. Intervention in coronary artery disease. Heart 2000;83:481-490.[Free Full Text]
7. Serruys P, Unger F, van Hout BA, et al. The ARTS study (Arterial Revascularization Therapies Study). Semin Intervent Cardiol 1999;4:209–19
8. van den Brand M.J.B.M., Rensing B.J.W.M., Morel M.A.M., et al. The effect of completeness of revascularization on event free survival at one year in the ARTS trial. J Am Coll Cardiol 2002;39:559-564.[Abstract/Free Full Text]
9. Beyar R, Roguin A. The sirolimus coated stent: will the Achilles heel of interventional cardiology finally be cured [Editorial]? Eur Heart J 2001;22:2054–7
10. Fox R.A., Barker P., Guy D., et al. The use of 188Re to treat in-stent restenosis of coronary arteries. Aust Phys Eng Sci Med 2001;24:160-165.
11. Camenzind E., Kint P.P., Di Mario C., et al. Intracoronary heparin delivery in humans. Acute feasibility and long-term results. Circulation 1995;92:2463-2472.[Abstract/Free Full Text]
12. Drachman D.E., Eldeman E.R., Seifert P., et al. Neointimal thickening after stent delivery of paclitaxel: change in composition and arrest of growth after six months. J Am Coll Cardiol 2000;36:2325-2332.[Abstract/Free Full Text]
13. Rensing B.J., Vos J., Smits P.C., et al. Coronary restenosis elimination with a sirolimus eluting stent—first European human experience with 6-month angiographic and intravascular follow-up. Eur Heart J 2001;22:2125-2130.[Abstract/Free Full Text]
14. Sousa J.E., Costa M.A., Abizaid A.C., et al. Sustained suppression on neointimal proliferation by sirolimus-eluting stents. One year angiographic and intravascular ultrasound follow-up. Circulation 2001;104:2007-2011.[Abstract/Free Full Text]
15. Holmes D.R., Hirshfeld J., Faxon D., et al. ACC expert consensus document on coronary artery stents. J Am Coll Cardiol 1998;32:1471-1482.[Free Full Text]
16. Loubeyre C., Morice M.C., Berzin B., et al. Emergency coronary artery bypass surgery following coronary angioplasty and stenting: results of a French multicenter registry. Catheter Cardiovasc Interv 1999;47:441-448.[Medline]
17. Williams D.O., Holubkov R., Yeh W., et al. Percutaneous coronary interventions in the current era compared with 1985-1986: the National Heart, Lung, and Blood Institute registries. Circulation 2000;102:2945-2951.[Abstract/Free Full Text]
18. Mehran R., Dangas G., Mintz G.S., et al. Patterns of in-stent restenosis: angiographic classification and implications for long-term clinical outcome. Circulation 1999;100:1872-1878.[Abstract/Free Full Text]
19. Park S.J., Hong M.K., Lee C.W., et al. Elective stenting of unprotected left main coronary artery stenosis. J Am Coll Cardiol 2001;38:1054-1060.[Abstract/Free Full Text]
20. Tsuchikane E., Otsuji S., Awatw N., et al. Impact of pre-stent plaque debulking for chronic coronary total occlusions on restenosis reduction. J Invas Cardiol 2001;13:584-589.[Medline]
21. Suero J.A., Marso S.P., Jones P.G., et al. Procedural outcomes and long term surgical among patients undergoing percutaneous coronary intervention of a chronic total occlusion in native coronary arteries: a 20-year experience. J Am Coll Cardiol 2001;38:409-414.[Abstract/Free Full Text]
22. Muramatsu T., Tsukahara R., Ho M., et al. Clinical outcome of stent implantation in small coronary artery arteries. J Invas Cardiol 2001;13:634-639.[Medline]
23. Schunkert H., Harrell L., Palacios I.F. Implications of small reference vessel diameter in patients undergoing percutaneous coronary revascularization. J Am Coll Cardiol 1999;34:40-48.[Abstract/Free Full Text]
24. Moer R., Myreng Y., Molstad P., et al. Stenting in Small Coronary Arteries (SISCA) trial. J Invas Cardiol 2001;38:1597-1607.
25. Morice MC, Serruys PW, Sousa JE, et al, for the RAVEL Study Group. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;23:1773–80
26. Abizaid A., Costa A., Centemero M., et al. Clinical and economic impact of diabetes mellitus on percutaneus and surgical treatment of multivessel coronary disease patients. Circulation 2001;104:533-538.[Abstract/Free Full Text]
27. Hidalgo M., Rowinsky E.K. The rapamycin-sensitive signal transduction pathway as a target for cancer therapy. Oncogene 2000;19:6680-6686.[Medline]
28. Chen D., Krasinki K., Chen D., et al. Down regulation of cyclin-dependent kinase 2 activity and cyclin A promoter activity in VSMC by p27, an inhibitor of neointima formation in the rat carotid artery. J Clin Invest 1997;99:2334-2341.[Medline]
29. Braun-Dullaeus R.C., Mann M.J., Seay U., et al. Cell cycle protein in expression in vascular smooth muscle cells in vitro and in vivo is regulated through phosphatidylinositol 3-kinase and mammalian target of rapamycin. Aterioscler Thromb 2001;21:1152-1159.[Abstract/Free Full Text]
30. Serruys P.W., de Jaegere P., Kiemeneij F., et al. A comparison of ballon-expandable-stent implantation with ballon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med 1994;331:489-495.
31. Serruys P.W., van Hout B., Bonnier H., et al. Randomized comparison of implantation of heparin-coated stents with ballon angioplasty in selected patients with coronary artery disease (Benestent II). Lancet 1998;352:673-681.[Medline]

This article has been cited by other articles:

				M. Fouda Coronary Artery Bypass Surgery with On-Pump Beating-Heart Technique Asian Cardiovasc Thorac Ann, October 1, 2007; 15(5): 392 - 395. [Abstract] [Full Text] [PDF]

				B. P. Choudhary, C. Antoniades, A. F. Brading, A. Galione, K. Channon, and D. P. Taggart Diabetes Mellitus as a Predictor for Radial Artery Vasoreactivity in Patients Undergoing Coronary Artery Bypass Grafting J. Am. Coll. Cardiol., September 11, 2007; 50(11): 1047 - 1053. [Abstract] [Full Text] [PDF]

				A. Jalal An objective method for grading of distal disease in the grafted coronary arteries Interactive CardioVascular and Thoracic Surgery, August 1, 2007; 6(4): 451 - 455. [Abstract] [Full Text] [PDF]

				C. K. Haan, S. O'Brien, F. H. Edwards, E. D. Peterson, and T. B. Ferguson Trends in emergency coronary artery bypass grafting after percutaneous coronary intervention, 1994-2003. Ann. Thorac. Surg., May 1, 2006; 81(5): 1658 - 1665. [Abstract] [Full Text] [PDF]

				L. W. Klein Are Drug-Eluting Stents the Preferred Treatment for Multivessel Coronary Artery Disease? J. Am. Coll. Cardiol., January 3, 2006; 47(1): 22 - 26. [Abstract] [Full Text] [PDF]

				D. G. Pennington The Impact of New Technology on Cardiothoracic Surgical Practice Ann. Thorac. Surg., January 1, 2006; 81(1): 10 - 18. [Full Text] [PDF]

				M. Zimarino, A. M. Calafiore, and R. De Caterina Complete myocardial revascularization: between myth and reality Eur. Heart J., September 2, 2005; 26(18): 1824 - 1830. [Abstract] [Full Text] [PDF]

				A. S. Cordeiro da Rocha, N. P. Rodrigues Dassa, F. J. Monassa Pittella, O. N. Barbosa, J. O. Reis Brito, B. Tura, and P. R. Dutra da Silva High Mortality Associated With Precluded Coronary Artery Bypass Surgery Caused by Severe Distal Coronary Artery Disease Circulation, August 30, 2005; 112(9_suppl): I-328 - I-331. [Abstract] [Full Text] [PDF]

				B. D. Powell, C. S. Rihal, M. R. Bell, K. J. Zehr, and D. R. Holmes Jr Anticipated Impact of Drug-Eluting Stents on Referral Patterns for Coronary Artery Bypass Graft Surgery: A Population-Based Angiographic Analysis Mayo Clin. Proc., June 1, 2004; 79(6): 769 - 772. [Abstract] [PDF]

				P. H Chong and J. W. Cheng Early Experiences and Clinical Implications of Restenosis and Drug-Eluting Stents: Part 2 Ann. Pharmacother., May 1, 2004; 38(5): 845 - 852. [Abstract] [Full Text] [PDF]

This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Tomas A. Salerno Hooshang Bolooki Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Ferreira, A. C. Articles by de Marchena, E. Search for Related Content PubMed PubMed Citation Articles by Ferreira, A. C. Articles by de Marchena, E. Related Collections Coronary disease