Drug-Eluting Stents Versus Coronary Artery Bypass Grafting in Patients with Diabetes Mellitus
2006; Elsevier BV; Volume: 82; Issue: 5 Linguagem: Inglês
10.1016/j.athoracsur.2006.05.080
ISSN1552-6259
AutoresYanai Ben‐Gal, Yaron Moshkovitz, Nachum Nesher, Gideon Uretzky, Rony Braunstein, Alberto Hendler, Einat Zivi, Itzhak Herz, Rephael Mohr,
Tópico(s)Cardiac Valve Diseases and Treatments
ResumoBackgroundReduction 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.MethodsFrom 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.ResultsBoth 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 < 0.001. 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).ConlusionsDespite improved results of PCI with Cyphers, midterm clinical outcome of diabetic patients treated surgically is better. 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. 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. 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 < 0.001. 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). Despite improved results of PCI with Cyphers, midterm clinical outcome of diabetic patients treated surgically is better. 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 [1Barner H.B. Swartz M.I. Mudd J.G. Tyras D.H. Late patency of the internal mammary artery as a coronary artery bypass conduit.Ann Thorac Surg. 1982; 34: 408-412Abstract Full Text PDF PubMed Scopus (130) Google Scholar, 2Loop F.D. Lytle B.W. Cosgrove D.M. et al.Influence of internal-mammary-artery-graft on 10-year survival and other cardiac events.N Engl J Med. 1986; 314: 1-6Crossref PubMed Scopus (2257) Google Scholar]. The use of both left and right ITAs has shown additional survival benefit over the use of only one ITA [3Buxton B.F. Komeda M. Fuller J.A. Gordon I. Bilateral internal thoracic artery grafting may improve outcome of coronary artery surgery: risk-adjusted survival.Circulation. 1998; 98: II1-II6PubMed Google Scholar, 4Lytle B.W. Blackstone E.H. Loop F.D. et al.Two internal thoracic artery grafts are better than one.J Thorac Cardiovasc Surg. 1999; 117: 855-872Abstract Full Text Full Text PDF PubMed Scopus (748) Google Scholar]. 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 long-term survival for subgroups of diabetic patients treated with CABG was demonstrated in the Emory Angioplasty versus Surgery Trial [5King S.B. Kosinski A.S. Guyton R.A. Lembo N.J. Weintraub W.S. Eight-year mortality in the Emory Angioplasty versus Surgery Trial (EAST).J Am Coll Cardiol. 2000; 35: 1116-1121Abstract Full Text Full Text PDF PubMed Scopus (261) Google Scholar], the Coronary Artery Bypass Revascularization Investigation [6Kurbaan A.S. Bowker T.J. Ilsley C.D. Sigwart U. Richards A.F. CABRI Investigators (Coronary Angioplasty versus Bypass Revascularization Investigation)Difference in the mortality of the CABRI diabetic and nondiabetic populations and its relation to coronary artery disease and the revascularization mode.Am J Cardiol. 2001; 87: 947-950Abstract Full Text Full Text PDF PubMed Scopus (106) Google Scholar], and the Bypass Angioplasty Revascularisation Investigation (BARI) [7BARI InvestigatorsComparison of coronary bypass surgery with angioplasty in patients with multivessel disease The Bypass Angioplasty Revascularization Investigation (BARI) Investigators.N Engl J Med. 1996; 335: 217-225Crossref PubMed Scopus (1543) Google Scholar, 8BARI InvestigatorsSeven-year outcome in the Bypass Angioplasty Revascularization Investigation (BARI) by treatment and diabetic status.J Am Coll Cardiol. 2000; 35: 1122-1129Abstract Full Text Full Text PDF PubMed Scopus (430) Google Scholar] 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) [9Abizaid A. Costa M.A. Centemero M. et al.Clinical and economic impact of diabetes mellitus on percutaneous and surgical treatment of multivessel coronary artery disease: insights from the Arterial Revascularization Therapy Study (ARTS) trial.Circulation. 2001; 104: 533-538Crossref PubMed Scopus (311) Google Scholar], 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 [10Hermiller J.B. Raizner A. Cannon L. et al.TAXUS-IV InvestigatorsOutcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus The TAXUS-IV trial.J Am Coll Cardiol. 2005; 45: 1172-1179Abstract Full Text Full Text PDF PubMed Scopus (235) Google Scholar, 11Moussa I. Leon M.B. Baim D.S. et al.Impact of sirolimus-eluting stents on outcome in diabetic patients: a SIRIUS (SIRolImUS-coated Bx velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) substudy.Circulation. 2004; 109: 2273-2278Crossref PubMed Scopus (377) Google Scholar]. 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. Between January 2002 and January 2005, 518 consecutive diabetic patients underwent myocardial revascularization; 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.Table 1Extent of Coronary Disease and Number of Vessels TreatedaForty-five of the 60 (75%) multivessel treated patients were treated with two ITAs.Coronary DiseaseCABG (n = 86)Cypher (n = 86)pLeft Main13 (15.1%)2 (2.3%)0.003 One-vessel disease18 (20.9%)18 (20.9%)1.000 Two-vessel disease41 (47.7%)41 (47.7%)1.000 Three-vessel disease27 (31.4%)27 (31.4%)1.000Vessels Treated One-vessel treated27 (31.4%)44 (51.2%)0.001 Two-vessel treatedaForty-five of the 60 (75%) multivessel treated patients were treated with two ITAs.32 (37.2%)33 (38.4%)0.875 Three-vessel treatedaForty-five of the 60 (75%) multivessel treated patients were treated with two ITAs.27 (31.4%)9 (10.5%)0.001 RCA revascularization22 (25.6%)22 (25.6%)1.000 Incomplete revascularization19 (22.1%)41 (47.7%)0.000 Bifurcation lesion16 (18.6%)5 (5.8%)0.010Total occlusion23 (26.7%)4 (4.7%)0.000CABG = coronary artery bypass grafting; ITA = internal thoracic artery; RCA = right coronary artery.a Forty-five of the 60 (75%) multivessel treated patients were treated with two ITAs. Open table in a new tab Table 2Patient CharacteristicsCharacteristicsCABG (n = 86)Cypher (n = 86)pAge >7024 (27.9%)25 (29.1%)0.866Female19 (22.1%)19 (22.1%)1.0IDDM8 (9.3%)12 (14%)0.341Hypertension62 (72.1%)59 (68.6%)0.616Hyperlipidemia53 (61.1%)61 (70.9%)0.197COPD2 (2.3%)7 (8.1%)0.087CRF4 (4.7%)2 (2.3%)0.406Peripheral vascular disease8 (9.3%)8 (9.3%)1.0Old myocardial infarction30 (34.9%)22 (25.6%)0.184Acute MI (7 days)11 (12.8%)4 (4.7%)0.059Ejection fraction 1.8); IABP = intraaortic balloon pump; IDDM = insulin treated diabetics; LAD = left anterior descending; MI = myocardial infarction; PCI = percutaneous coronary intervention angioplasty or stent. Open table in a new tab CABG = coronary artery bypass grafting; ITA = internal thoracic artery; RCA = right coronary artery. 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. 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 18 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 [12Gurevitch J. Miller H.I. Shapira I. et al.High-dose isosorbide dinitrate for myocardial revascularization with composite arterial grafts.Ann Thorac Surg. 1997; 63: 382-387Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar]. 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). Patients’ data were analyzed according to American College of Cardiology/American Heart Association clinical data standards [13Radford M.J. Arnold J.M. Bennett S.J. et al.ACC/AHA key data elements and definitions for measuring the clinical management and outcomes of patients with chronic heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Heart Failure Clinical Data Standards): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Failure Society of America.Circulation. 2005; 112: 1888-1916Crossref PubMed Scopus (168) Google Scholar]. 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. 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 χ2 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, MACE-free 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). 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 2.05 ± 0.82 vs 1.60 ± 0.63, 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 [14Salm T.J.V. Kip K.E. Jones R.H. et al.What constitutes optimal surgical revascularization? Answers from the Bypass Angioplasty Revascularization Investigation (BARI).J Am Coll Cardiol. 2002; 39: 565-572Abstract Full Text Full Text PDF PubMed Scopus (120) Google Scholar] 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 = 0.0001, 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 three-vessel disease (odds ratio [OR] 3.43, 95% CI 1.04 to 11.23), and peripheral vascular disease (OR 3.75 95% 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).Fig 2Reintervention-free survival of Cypher versus coronary artery bypass grafting (CABG) groups (p = 0.04, log-rank test).View Large Image Figure ViewerDownload (PPT) 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). 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 [15Ho K.K.L. Senerchia C. Rodriguez O. Chauhan M.S. Kuntz R.E. Predictors of angiographic restenosis after stenting pooled analysis of 1197 patients with protocol-mandated angiographic follow-up from five randomized stent trials.Circulation. 1998; 98: 1-362PubMed Google Scholar, 16Kobayashi Y. De Gregorio J. Kobayashi N. et al.Stented segment length as an independent predictor of restenosis.J Am Coll Cardiol. 1999; 34: 651-659Abstract Full Text Full Text PDF PubMed Scopus (257) Google Scholar, 17Elezi S. Kastrati A. Pache J. et al.Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement.J Am Coll Cardiol. 1998; 32: 1866-1873Abstract Full Text Full Text PDF PubMed Scopus (473) Google Scholar, 18Schofer J. Schluter M. Rau T. Hammer F. Haag N. Mathey D.G. Influence of treatment modality on angiographic outcome after coronary stenting in diabetic patients: a controlled study.J Am Coll Cardiol. 2000; 35: 1554-1559Abstract Full Text Full Text PDF PubMed Scopus (90) Google Scholar, 19Stone G.W. Ellis S.G. Cox D.A. et al.A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease.N Engl J Med. 2004; 350: 221-231Crossref PubMed Scopus (2631) Google Scholar, 20Serruys P.W. Kay I.P. Disco C. Deshpande N.V. de Feyter P.J. Periprocedural quantitative coronary angiography after Palmaz-Schatz stent implantation predicts the restenosis rate at six months; results of a meta-analysis of the Belgian Netherlands Stent Study (BENESTENT) I, BENESTENT II pilot, BENESTENT II and MUSIC trials. Multicenter Ultrasound Stent In Coronaries.J Am Coll Cardiol. 1999; 34: 1067-1074Abstract Full Text Full Text PDF PubMed Scopus (162) Google Scholar, 21Cutlip D.E. Chauhan M.S. Baim D.S. et al.Clinical restenosis after coronary stenting; perspectives from multicenter clinical trials.J Am Coll Cardiol. 2002; 40: 2082-2089Abstract Full Text Full Text PDF PubMed Scopus (353) Google Scholar, 22Mercado N. Boersma E. Wijns W. et al.Clinical and quantitative coronary angiographic predictors of coronary restenosis: a comparative analysis from the balloon-to-stent era.J Am Coll Cardiol. 2001; 38: 645-652Abstract Full Text Full Text PDF PubMed Scopus (145) Google Scholar, 23Kasaoka S. Tobis J. Akiyama T. et al.Angiographic and intravascular ultrasound predictors of in-stent restenosis.J Am Coll Cardiol. 1998; 32: 1630-1635Abstract Full Text Full Text PDF PubMed Scopus (241) Google Scholar]. 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 [24Sim I. Gupta M. McDonald K. Bourassa M. Hlatky M.A. A meta-analysis of randomized trials comparing coronary artery bypass grafting with percutaneous transluminal coronary angioplasty in multi-vessel coronary artery disease.Am J Cardiol. 1995; 76: 1025-1029Abstract Full Text PDF PubMed Scopus (85) Google Scholar]. In the present era, comparable long-term survival was demonstrated in most patients, with the exception of diabetics [7BARI InvestigatorsComparison of coronary bypass surgery with angioplasty in patients with multivessel disease The Bypass Angioplasty Revascularization Investigation (BARI) Investigators.N Engl J Med. 1996; 335: 217-225Crossref PubMed Scopus (1543) Google Scholar, 8BARI InvestigatorsSeven-year outcome in the Bypass Angioplasty Revascularization Investigation (BARI) by treatment and diabetic status.J Am Coll Cardiol. 2000; 35: 1122-1129Abstract Full Text Full Text PDF PubMed Scopus (430) Google Scholar, 25Weintraub W.S. Stein R. Kosinski A. et al.Outcome of coronary bypass surgery versus coronary angioplasty in diabetic patients with multivessel coronary artery disease.J Am Coll Cardiol. 1998; 31: 10-19Abstract Full Text Full Text PDF PubMed Scopus (226) Google Scholar]. Similar findings were reported later on in the subgroup of 208 diabetic patients treated with stents from the ARTS trial [9Abizaid A. Costa M.A. Centemero M. et al.Clinical and economic impact of diabetes mellitus on percutaneous and surgical treatment of multivessel coronary artery disease: insights from the Arterial Revascularization Therapy Study (ARTS) trial.Circulation. 2001; 104: 533-538Crossref PubMed Scopus (311) Google Scholar]. Three-year survival of diabetic patients who underwent CABG was better than that of diabetics who underwent myocardial revascularization with stents [9Abizaid A. Costa M.A. Centemero M. et al.Clinical and economic impact of diabetes mellitus on percutaneous and surgical treatment of multivessel coronary artery disease: insights from the Arterial Revascularization Therapy Study (ARTS) trial.Circulation. 2001; 104: 533-538Crossref PubMed Scopus (311) Google Scholar]. Significant improvement of clinical and angiographic outcome of PCI in diabetic patients was recently reported with the use of DES [10Hermiller J.B. Raizner A. Cannon L. et al.TAXUS-IV InvestigatorsOutcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus The TAXUS-IV trial.J Am Coll Cardiol. 2005; 45: 1172-1179Abstract Full Text Full Text PDF PubMed Scopus (235) Google Scholar, 11Moussa I. Leon M.B. Baim D.S. et al.Impact of sirolimus-eluting stents on outcome in diabetic patients: a SIRIUS (SIRolImUS-coated Bx velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) substudy.Circulation. 2004; 109: 2273-2278Crossref PubMed Scopus (377) Google Scholar]. 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 [26Kimura T. Nosaka H. Yokoi H. Iwabuchi M. Nobuyoshi M. Serial angiographic follow-up after Palmaz-Schatz stent implantation: comparison with conventional balloon angioplasty.J Am Coll Cardiol. 1993; 21: 1557-1563Abstract Full Text PDF PubMed Scopus (161) Google Scholar], 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 [10Hermiller J.B. Raizner A. Cannon L. et al.TAXUS-IV InvestigatorsOutcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus The TAXUS-IV trial.J Am Coll Cardiol. 2005; 45: 1172-1179Abstract Full Text Full Text PDF PubMed Scopus (235) Google Scholar, 11Moussa I. Leon M.B. Baim D.S. et al.Impact of sirolimus-eluting stents on outcome in diabetic patients: a SIRIUS (SIRolImUS-coated Bx velocity balloon-expandable stent in the treatment of patients with de novo coronary artery lesions) substudy.Circulation. 2004; 109: 2273-2278Crossref PubMed Scopus (377) Google Scholar, 18Schofer J. Schluter M. Rau T. Hammer F. Haag N. Mathey D.G. Influence of treatment modality on angiographic outcome after coronary stenting in diabetic patients: a controlled study.J Am Coll Cardiol. 2000; 35: 1554-1559Abstract Full Text Full Text PDF PubMed Scopus (90) Google Scholar, 27Herz 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: 88-92Abstract Full Text Full Text PDF PubMed Scopus (11) Google Scholar]. This is a nonrandomized comparison. Despite the use of multivariate methods, there may be residual confounders, and also differences between groups due to 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 [28Vimani R. Farb A. Guagliumi G. Kolodgie F.D. Drug-eluting stents; caution and concerns for long-term outcome.Coron Artery Dis. 2004; 15: 313-318Crossref PubMed Scopus (219) Google Scholar, 29McFadden E.P. Stabile E. Regar E. et al.Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy.Lancet. 2004; 364: 1519-1521Abstract Full Text Full Text PDF PubMed Scopus (1325) Google Scholar]. 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” [30SOS InvestigatorsCoronary 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: 961-962Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar] between surgery and percutaneous interventions may further be reduced by more extensive use of DES for complete revascularization. WithdrawalThe Annals of Thoracic SurgeryVol. 84Issue 2PreviewBen-Gal Y, Moshkovitz Y, Nesher N, Uretzky G, Braunstein R, Hendler A, Zivi E, Herz I, Mohr R. Drug-eluting stents versus coronary artery bypass grafting in patients with diabetes mellitus. Ann Thorac Surg 2006;82:1692–7. Full-Text PDF
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