Drug-Eluting Stents Versus Coronary Artery Bypass Grafting in Patients with Diabetes Mellitus

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1 CARDIOVASCULAR Drug-Eluting Stents Versus Coronary Artery Bypass Grafting in Patients with Diabetes Mellitus Yanai Ben-Gal, MD, Yaron Moshkovitz, MD, Nachum Nesher, MD, Gideon Uretzky, MD, Rony Braunstein, PhD, Alberto Hendler, MD, Einat Zivi, BmedSc, Itzhak Herz, MD, and Rephael Mohr, MD Departments of Cardiology and Cardiothoracic Surgery, Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Departments of Cardiology and Cardiac Surgery, Assuta Medical Center, Tel Aviv, and Center for Quality, Safety and Data, Hadassah Hebrew University Hospital, Ein Karem, Jerusalem, Israel Background. Reduction of restenosis and reinterventions was recently reported with percutaneous interventions (PCI) with drug-eluting stents (Cypher). This study compares results of Cypher (Cordis, Miami Lakes, FL) stenting and surgical revascularization in diabetic patients. Methods. From January 2002 to January 2005, 518 consecutive diabetic patients underwent myocardial revascularization; 176 by PCI incorporating Cyphers and 342 treated surgically. Single-vessel patients in the surgical group were treated with the left internal thoracic artery (ITA) and most multivessel patients were treated with two ITAs. After matching for age, sex, right system revascularization, and extent of coronary disease, two groups (86 patients each) were used to compare the two revascularization modalities. Results. Both groups were similar; however, left main, poor ejection fraction, total occlusion, and bifurcation lesions were more prevalent in the surgical group, and in-stent restenosis in the PCI group. The mean number of coronary vessels treated was higher in the surgical group (2.05 vs 1.6, p < 0.001). Mean follow-up was 18 months. Overall mortality (early and late) was 2.3% and 3.5% in the Cypher and surgical groups, respectively (p 0.65). Angina returned in 39.5% of the Cypher group and 15.1% of the surgical group, p < There were 25 reinterventions in the Cypher group compared with five in the surgical group (p 0.010). The Cox proportional hazard model revealed assignment to the Cypher group to be the only independent predictor of reangina (odds ratio [OR] 3.26, 95% confidence interval [CI] 1.63 to 6.53) and reintervention (OR 4.17, 95% CI 1.92 to 20.83). Conlusions. Despite improved results of PCI with Cyphers, midterm clinical outcome of diabetic patients treated surgically is better. (Ann Thorac Surg 2006;82:1692 7) 2006 by The Society of Thoracic Surgeons Surgical revascularization of the left anterior descending (LAD) with the internal thoracic artery (ITA) in patients with multivessel disease is still the only proven method of improving event-free survival [1, 2]. The use of both left and right ITAs has shown additional survival benefit over the use of only one ITA [3, 4]. Consequently, arterial myocardial revascularization using bilateral ITAs has become the preferred approach for various surgical groups. Historically, there were few retrospective clinical trials comparing percutaneous coronary interventions (PCI) and coronary artery bypass grafting (CABG). Better longterm survival for subgroups of diabetic patients treated with CABG was demonstrated in the Emory Angioplasty versus Surgery Trial [5], the Coronary Artery Bypass Revascularization Investigation [6], and the Bypass Angioplasty Revascularisation Investigation (BARI) [7, 8] studies. The BARI study showed that angioplasty in diabetic patients with multivessel coronary disease is associated with significantly increased rates of restenosis and reinterventions and lower survival, when compared with CABG. In the Arterial Revascularization Therapy Study (ARTS) [9], three-year survival of diabetic patients treated surgically was significantly better than that of diabetic patients treated with bare-metal stents. Recent reports from the TAXUS IV (Boston Scientific Corp, Natick, MA) and SIRIUS trials suggest a significant decrease of neointimal growth, in-stent restenosis, and improved clinical outcome with drug-eluting stents (DES), compared with bare metal stents. However, a trend toward a higher frequency of repeat interventions remained among the diabetic patients that were treated with DES [10, 11]. Arterial revascularization with skeletonized ITA (single or bilateral) is our preferred method of myocardial revascularization. We therefore decided to compare midterm outcome of ITA grafting in diabetic patients with those of PCI incorporating DES. Accepted for publication May 16, Address correspondence to Dr Mohr, Department of Cardiothoracic Surgery, Tel Aviv Sourasky Medical Center, 6 Weizman Street, Tel Aviv 64239, Israel; marion@tasmc.health.gov.il. Patients and Methods Between January 2002 and January 2005, 518 consecutive diabetic patients underwent myocardial revasculariza by The Society of Thoracic Surgeons /06/$32.00 Published by Elsevier Inc doi: /j.athoracsur

2 Ann Thorac Surg BEN-GAL ET AL 2006;82: CYPHER STENTS VERSUS CABG Table 1. Extent of Coronary Disease and Number of Vessels Treated a Coronary Disease CABG (n 86) Cypher (n 86) p Left Main 13 (15.1%) 2 (2.3%) One-vessel disease 18 (20.9%) 18 (20.9%) Two-vessel disease 41 (47.7%) 41 (47.7%) Three-vessel disease 27 (31.4%) 27 (31.4%) Vessels Treated One-vessel treated 27 (31.4%) 44 (51.2%) Two-vessel treated a 32 (37.2%) 33 (38.4%) Three-vessel treated a 27 (31.4%) 9 (10.5%) RCA revascularization 22 (25.6%) 22 (25.6%) Incomplete revascularization 19 (22.1%) 41 (47.7%) Bifurcation lesion 16 (18.6%) 5 (5.8%) Total occlusion 23 (26.7%) 4 (4.7%) a Forty-five of the 60 (75%) multivessel treated patients were treated with two ITAs. CABG coronary artery bypass grafting; ITA internal thoracic artery; RCA right coronary artery. tion; 176 by PCI incorporating drug-eluting stents (Cypher) and 342 treated surgically. All single-vessel patients in the surgical group were treated with left ITA, and most of the multivessel patients were treated with two ITAs. Follow-up was obtained after Institutional Review Board approval and patients consent by telephone questionnaire and the national registry database. Follow-up was 100% complete. Preoperative characteristics of the two groups were different: CABG patients were older and had increased prevalence of triple-vessel disease (64% vs 35%, p 0.001). In order to control for these differences between surgical and PCI groups, we decided to compare results between the two treatment modalities after matching for age, sex, right coronary artery revascularization, and the extent of coronary artery disease (Table 1). Each of the two matched groups thus created contained 86 patients. Baseline characteristics of patients in both groups are depicted in Table 2. During the study period, selection criteria for surgery versus PCI were mainly technical. In principle, there was a preference to refer patients for surgery for the reasons detailed: (1) complex type C lesions (calcified coronary arteries, lesion length over 20 mm, twisted arteries, suspicion of a thrombus in an artery), or bifurcation lesion involving a major diagonal or marginal branch; (2) complete occlusion; (3) nonavailability of Cypher, including cases in which the patient was unable to fund a Cypher; and (4) patient s preference. In the percutaneous intervention group, stent implantation was performed after balloon angioplasty dilatation. All patients received aspirin (325 mg daily) before and after the procedure, and clopidogrel (Plavix; Sanofi, New York City, NY) (a loading dose of 300 mg the day before the procedure, and 75 mg daily for three months thereafter). During the procedure, all patients were treated intravenously with heparin. Intravenous platelet glycoprotein IIb/IIIa inhibitor (Integrilin [eptifibatide, Schering-Plough, Leuven, Belgium] or Aggrastat [Tirofiban, Merck, Sharp and Dohme, Haarlem, Holland]) were used only in four of the percutaneous intervention group. All LAD lesions in the percutaneous intervention group were treated with DES. In most patients, only one Cypher was used for the vessel treated. However, more than one Cypher was used if required (long lesion, dissection, bifurcation, etc). Drug-eluting stents or bare-metal stents or plain balloon angioplasty were used for non-lads. Twenty-nine patients were treated with two or more Cyphers. Bare stents were used in ten patients with tortuous or calcified coronary vessels. Percutaneous transluminal coronary angioplasty (PTCA) was used in seven patients with vessels smaller than 2.25 mm, or in patients with focal in-stent restenosis. Sixty-two of the patients treated surgically were operated on without extracorporeal circulation. All ITAs were dissected as skeletonized vessels and used preferentially for left-sided (LAD circumflex) arterial revascularization. In patients with single-vessel disease, we used in situ left ITA and in patients with multivessel disease we used the right ITA, either as an in situ graft or as a free graft attached end-to-side to the left ITA (composite T-graft). Right coronary system (posterior descending artery or posterolateral branch of the right coronary artery) revascularization was performed with saphenous vein graft in Table 2. Patient Characteristics Characteristics CABG (n 86) 1693 Cypher (n 86) p Age (27.9%) 25 (29.1%) Female 19 (22.1%) 19 (22.1%) 1.0 IDDM 8 (9.3%) 12 (14%) Hypertension 62 (72.1%) 59 (68.6%) Hyperlipidemia 53 (61.1%) 61 (70.9%) COPD 2 (2.3%) 7 (8.1%) CRF 4 (4.7%) 2 (2.3%) Peripheral vascular disease 8 (9.3%) 8 (9.3%) 1.0 Old myocardial infarction 30 (34.9%) 22 (25.6%) Acute MI (7 days) 11 (12.8%) 4 (4.7%) Ejection fraction (11.6%) 0 (0%) Prior PCI 34 (39.5%) 38 (44.2%) Prior PCI to LAD 15 (17.4%) 22 (25.6%) In-stent restenosis (LAD) 5 (5.8%) 16 (16.8%) Emergency 3 (3.5%) 1 (1.2%) Repeat operation 1 (1.2%) 4 (4.7%) Congestive heart failure 10 (11.6%) 6 (7%) IABP 2 (2.3%) 0 (0%) Obesity 22 (25.6%) 27 (31.4%) CABG coronary artery bypass grafting; COPD chronic obstructive pulmonary disease; CRF chronic renal failure (Cr 1.8); IABP intraaortic balloon pump; IDDM insulin treated diabetics; LAD left anterior descending; MI myocardial infarction; PCI percutaneous coronary intervention angioplasty or stent. CARDIOVASCULAR

3 CARDIOVASCULAR 1694 BEN-GAL ET AL Ann Thorac Surg CYPHER STENTS VERSUS CABG 2006;82: patients, with radial artery in nine, with the right ITA in two (distal end of the free graft), and with the right gastroepiploic artery in two patients. We treated all CABG patients with a high-dose intravenous infusion of isosorbide dinitrate ((Isoket) 4 to 20 mg/hour during the first postoperative 24 to 48 hours [12]. From the second postoperative day, the radial artery and right GEA patients were treated with calcium channel blockers (diltiazem, 90 to 180 mg/day orally). Definitions and Data Collection Patients data were analyzed according to American College of Cardiology/American Heart Association clinical data standards [13]. Diabetic patients included patients treated with insulin or oral hypoglycemic agents. Periprocedural myocardial infarction (MI) was defined as the postprocedure appearance of new Q-waves or S-T elevations of more than 2 mm on electrocardiogram, accompanied by creatine kinase (CPK)-MB greater than 50 mu/ml with or without regional wall motion abnormality, and major adverse cardiac events (MACE) were defined as the occurrence of a nonfatal MI, the need for revascularization, or cardiac mortality. Target vessel revascularization (TVR) was defined as revascularization in a vessel treated during the first procedure with Cypher or arterial bypass graft. Statistical Analysis Data are expressed as mean SD or proportions, as appropriate. The two groups were matched for age, sex, right system revascularization, and extent of coronary artery disease. The 2 test and Fisher exact test were used to compare discrete variables. The Cox proportional hazard model was used to evaluate risk factors for early return of angina and reintervention. Hazard ratio (HR) and 95% confidence interval (CI) were given. Postoperative angina-free survival, MACEfree survival and reintervention-free survival are expressed by the Kaplan-Meier method and comparison between groups is made by the log-rank test. All analyses were performed by SPSS 12 software (SPSS Inc, Chicago, IL). Results After matching for age, sex, right system revascularization, and extent of coronary artery disease (Table 1), the two groups were similar in most preoperative characteristics. However, left main (Table 1) and poor ejection fraction (EF 0.30) (Table 2) were more prevalent in the CABG group. In-stent restenosis (Table 2) was more prevalent among the Cypher group. On the other hand, more patients in the CABG group had complete occlusion or bifurcation lesion (Table 1). The average number of coronary vessels treated in the CABG and percutaneous intervention groups was vs , respectively (p 0.001). Despite the fact that groups were matched for the extent of coronary artery involvement, more patients in the CABG group had revascularization of three vessels, and more patients in the Cypher group (51.2%) had revascularization of only one vessel (Table 1), accounting for incomplete revascularization [14] in 47.7% of the Cypher group compared with 22.1% in the CABG group (p 0.001). Thirty-day mortality was 1.1% in the CABG and 0% in the Cypher groups (p 0.316). Early postprocedural complications in the Cypher group included the following: deterioration of renal functions (three patients) leading to chronic dialysis in one patient and two (2.3%) periprocedural MIs. In the CABG group, there were two perioperative MIs, one (1.1%) stroke, and two revisions for bleeding. Follow-up ranged between six and 51 months (mean, 18 months). There was one late death in the CABG group and two (2.3%) in the Cypher group (p not significant [NS]). Angina returned in 34 patients (39.5%) of the Cypher group compared with 13 (15.1%) in the CABG group (p 0.001). Thirty-nine patients of the Cypher group and 28 of the CABG group underwent postoperative thallium single-photon emission computed tomographic scintigraphy, which was found to be positive in 16 of the Cypher compared with three of the CABG group patients (p 0.001). During the follow-up period, 20 of the Cypher and seven of the CABG group patients were referred for coronary angiography. There were 25 (29.1%) reinterventions (two surgical and 23 PCI) in the Cypher group, including 15 to a Cypher-treated vessel, two to a vessel treated previously with bare-metal stents, and eight reinterventions in new coronary lesions. There were five (5.8%) reinterventions in the surgical group (p 0.001) (Cypher vs CABG). There were two late MIs in the CABG group and four in the Cypher group. Three of the five reinterventions in the surgical group were to vessels treated before with ITA, compared with 15 of the 25 interventions in the Cypher group that were in Cypher-treated vessels. This difference between groups in target vessel reintervention was statistically significant (p 0.002). Two-year angina-free survival (Kaplan-Meier) of the CABG patients was 87 4% compared with 55 7% in the PCI patients (p , log-rank test) (Fig 1). Two-year reintervention-free survival of the CABG patients was 94 3% compared with 76 6% in the Cypher group (p 0.04, log-rank test) (Fig 2). In the CABG group, multivariate (Cox) and univariate analysis did not identify any specific preoperative (Table 2) or operative (Table 1) characteristics, including the use of the off-pump technique and the number of vessels treated, to be associated with increased risk of reangina. Independent predictors of reintervention were preoperative use of intraaortic balloon pump IABP (odds ratio [OR] 10.3, 95% CI 1.06 to 100) and chronic renal failure (OR 9.64, 95% CI 1.59 to 51.3). On the other hand, in the percutaneous intervention group, independent predictors of angina recurrence were threevessel disease (odds ratio [OR] 3.43, 95% CI 1.04 to

4 Ann Thorac Surg BEN-GAL ET AL 2006;82: CYPHER STENTS VERSUS CABG Fig 1. Angina-free survival of Cypher versus coronary artery bypass grafting (CABG) groups (p , log-rank test) ), and peripheral vascular disease (OR % CI 1.53 to 9.19) and the only independent predictor of reintervention was left main disease (OR 6.9, 95% CI 3.98 to11.95). During the follow-up period, the occurrence of MACE (cardiac mortality, myocardial infarction, or reintervention) was significantly higher in the Cypher group (23.2% [20 events] vs 9.3% [8 events] [p 0.01]). However, none of the confounding parameters, including assignment to the Cypher group was found to be associated with an increased risk of MACE (Cox model). To determine whether the difference between groups in reangina and reinterventions is affected by the difference in preoperative characteristics, we performed multivariable analysis (Cox model) with patient group (PCI or CABG) as an independent variable. We first included the variables to be controlled: left main, poor EF, total occlusion, bifurcation lesion, and preprocedure in-stent restenosis, and then the treatment group. The Cox model showed that after controlling for the above risk factors, the only independent predictor for reangina was assignment to the PCI group (Cypher group [OR 3.26, 95% CI, 1.63 to 6.53). Assignment to the PCI group was also an independent predictor for reintervention (OR 4.17, 95% CI 1.92 to 20.83). stents from the ARTS trial [9]. Three-year survival of diabetic patients who underwent CABG was better than that of diabetics who underwent myocardial revascularization with stents [9]. Significant improvement of clinical and angiographic outcome of PCI in diabetic patients was recently reported with the use of DES [10, 11]. However, the reported occurrence of MACE and reinterventions among diabetics was still higher than that in nondiabetic patients. This study describes our initial experience in diabetic patients treated with Cypher stents and compares the early and midterm results to those of CABG employing left-sided arterial revascularization. In order to control for differences between groups in preoperative characteristics, treatment groups were compared only after matching for age, sex, right system revascularization, and extent of coronary artery disease, and the Cox proportional hazard model was used to define independent predictors of adverse outcome events like reangina, reintervention, and MACE. After a mean follow-up of 18 months, which is long enough for the development of in-stent restenosis [26], survival was similar; however, less than 60% of the Cypher patients were angina free and 16 of them (18.6%) required one or two reinterventions. Target vessel reintervention in the Cypher-treated group was 17.4% compared with 3.5% in the CABG group. There were more MACE events in the Cypher group; however, assignment to the Cypher group was not found to be an independent predictor of MACE. Assignment to the Cypher group was an independent predictor of angina recurrence and reintervention. These results of the Cypher group are much worse than what was previously published in nondiabetic patients [10, 11, 18, 27]. Study Limitations 1695 This is a nonrandomized comparison. Despite the use of multivariate methods, there may be residual confounders, and also differences between groups due to CARDIOVASCULAR Comment Numerous reports of PCI results have persistently demonstrated the association of diabetes mellitus, with an increased prevalence of adverse outcome events such as MACE, target vessel revascularization (TVR), and the need for reinterventions [15 23]. Randomized trials comparing multivessel PCI with CABG have demonstrated similar occurrence of death and MI, but higher rates of reinterventions and early return of angina in PCI patients [24]. In the present era, comparable long-term survival was demonstrated in most patients, with the exception of diabetics [7, 8, 25]. Similar findings were reported later on in the subgroup of 208 diabetic patients treated with Fig 2. Reintervention-free survival of Cypher versus coronary artery bypass grafting (CABG) groups (p 0.04, log-rank test).

5 CARDIOVASCULAR 1696 BEN-GAL ET AL Ann Thorac Surg CYPHER STENTS VERSUS CABG 2006;82: unblinding of both the patients and physicians. In addition, important covariates (mainly technical), such as vessel diameter and lesion length, were not included in the analysis. These technical parameters, which are less important in the surgical group, may affect restenosis, reangina, and reintervention in the PCI group. Larger prospective multicenter studies are required to determine their importance in patients selected for PCI or surgery in this evolving era of DES. Another limitation of this study is the relatively short follow-up period (mean, 19 months). There is growing evidence that DES may develop delayed thrombosis related to delayed endothelialization, hypersensitivity to the stent polymer, or discontinuation of antiplatelet treatment [28, 29]. Longer follow-up is therefore required. In conclusion, midterm clinical outcome of diabetic patients treated surgically is still better than that of patients treated with Cyphers. However, the reangina and reintervention gap [30] between surgery and percutaneous interventions may further be reduced by more extensive use of DES for complete revascularization. References 1. Barner HB, Swartz MI, Mudd JG, Tyras DH. Late patency of the internal mammary artery as a coronary artery bypass conduit. Ann Thorac Surg 1982;34: Loop FD, Lytle BW, Cosgrove DM, et al. Influence of internal-mammary-artery-graft on 10-year survival and other cardiac events. N Engl J Med 1986;314: Buxton BF, Komeda M, Fuller JA, Gordon I. Bilateral internal thoracic artery grafting may improve outcome of coronary artery surgery: risk-adjusted survival. Circulation 1998; 98(suppl 2):II Lytle BW, Blackstone EH, Loop FD, et al. Two internal thoracic artery grafts are better than one. 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6 Ann Thorac Surg BEN-GAL ET AL 2006;82: CYPHER STENTS VERSUS CABG plantation: comparison with conventional balloon angioplasty. J Am Coll Cardiol 1993;21: Herz I, Moshkovitz Y, Hendler A, et al. Revascularization of left anterior descending artery with drug-eluting stents: comparison with off-pump surgery. Ann Thorac Surg 2005;79: Vimani R, Farb A, Guagliumi G, Kolodgie FD. Drug-eluting stents; caution and concerns for long-term outcome. Coron Artery Dis 2004;15: McFadden EP, Stabile E, Regar E, et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet 2004;364: SOS Investigators. Coronary artery bypass surgery versus percutaneous coronary intervention with stent implantation in patients with multivessel coronary artery disease (the Stent or Surgery trial): a randomised controlled trial. Lancet 2002;360: CARDIOVASCULAR Notice From the American Board of Thoracic Surgery The 2006 Part I (written) examination will be held on Monday, December 4, It is planned that the examination will be given at multiple sites throughout the United States using an electronic format. The closing date for registration was August 1, Those wishing to be considered for examination must apply online at To be admissible to the Part II (oral) examination, a candidate must have successfully completed the Part I (written) examination. A candidate applying for admission to the certifying examination must fulfill all the requirements of the Board in force at the time the application is received. Please address all communications to the American Board of Thoracic Surgery, 6333 N St. Clair St, Suite 2320, Chicago, IL 60611; telephone: (312) ; fax: (312) ; info@abts.org by The Society of Thoracic Surgeons Ann Thorac Surg 2006;82: /06/$32.00 Published by Elsevier Inc