Cypher Group Research Articles

Long-term clinical outcomes with biodegradable polymer sirolimus-eluting stents versus durable polymer sirolimus-eluting stents.

The purpose of this study was to compare the long-term outcomes of a biodegradable polymer, sirolimus-eluting stent (Orsiro) with a durable polymer, sirolimus-eluting stent (CYPHER) to determine if late failure of the CYPHER is caused by the polymer or sirolimus. A total of 447 patients who underwent percutaneous coronary intervention (PCI) with one of the study stents were retrospectively analysed. The composite of cardiac death, stent thrombosis, and clinically driven target lesion revascularisation (TLR) within two years after PCI occurred in 3.0% of the Orsiro group and 9.6% of the CYPHER group. Multivariable Cox regression results indicated that the Orsiro stent was a significant independent predictor of a lower occurrence of the composite outcome (adjusted HR 0.37, 95% CI: 0.14-0.87), stent thrombosis (adjusted HR 0.07, 95% CI: 0.00-0.65), clinically driven TLR (adjusted HR 0.26, 95% CI: 0.09-0.69), and stent failure (adjusted HR 0.26, 95% CI: 0.09-0.69) within two years after PCI. This study has demonstrated that late CYPHER failure is attributable more to its durable polymer than to the antiproliferative drug, sirolimus. This suggests that sirolimus-based, new-generation drug-eluting stents are relatively safe and are expected to show long-term outcomes superior to those of the CYPHER.

Acute and long-term outcomes of ostial stentings among bare-metal stents, sirolimus-eluting stents, and paclitaxel-eluting stents

The aim of this study is to evaluate the acute and long-term outcomes of ostial stentings among bare-metal stents (BMS), sirolimus-eluting stents, and paclitaxel-eluting stents. According to the CAPTAIN (Cardiovascular Atherosclerosis and Percutaneous TrAnsluminal INterventions) registry, from November 1995 to June 2011, 420 patients with ostial lesions were treated using BMS implantations (243 patients with 247 lesions), CYPHER implantations (77 patients with 77 lesions), or TAXUS implantations (100 patients with 104 lesions). Compared with the CYPHER and TAXUS groups, the BMS group had larger late loss (0.29±0.53, 0.64±0.78, and 1.30±0.79 mm, respectively, P=0.006) and restenosis rate (6, 8, and 33%, respectively, P<0.001). During the long-term follow-up, the BMS group had higher target lesion revascularization than the CYPHER and TAXUS groups (17, 4, and 6%, respectively, P=0.002). The cardiac event-free survival rate, as determined by the Kaplan-Meier analysis, was also lower in the BMS group than in the CYPHER and TAXUS groups (55, 86, and 76%, respectively, P<0.001). Intracoronary stenting with drug-eluting stent for ostial lesions was associated with lower angiographic restenosis and late loss, and a more favorable long-term clinical outcome than BMS.

Nobori Stent Shows Less Vascular Inflammation and Early Recovery of Endothelial Function Compared With Cypher Stent

The current study sought to examine inflammation at the stented segments of Nobori (Terumo Corporation, Tokyo, Japan) and Cypher (Cordis, Miami, Florida) drug-eluting stents (DES), as well as free radical production and endothelial function of the adjacent nonstented segments in a pig coronary model. Nobori is a novel DES, incorporating a biolimus A9-eluting biodegradable polymer coated only on the abluminal surface of the stent. These unique features may favorably affect inflammation and endothelial function, as compared to the currently marketed DES. Presently, pre-clinical data on direct comparison of the various generations of DES are not available. A total of 18 DES were implanted in pig coronary arteries and subsequently explanted at 1 month. Stented segments were assessed by angiography and histology. Ex vivo vasomotor function and superoxide production in segments proximal and distal to the stent were determined. The vasoconstriction, endothelial-dependent relaxation, and endothelial-independent relaxation of proximal and distal nonstented segments were measured. Histological evaluation revealed lower inflammatory response with Nobori than with Cypher DES. There is trend for lower angiographic percentage diameter stenosis in Nobori versus Cypher groups (p = 0.054). There was increased endothelium-dependent relaxation, decreased endothelin-1-mediated contraction, and less superoxide production in the vessel segments proximal and distal to Nobori versus Cypher stents. Our data show significantly lower inflammatory response in the stented segments, and rapid recovery of endothelial function of peristent segments in the Nobori group compared with Cypher DES group at 1 month in porcine coronary artery model.

Safety and Efficacy of the XIENCE V Everolimus-Eluting Stent Compared to First-Generation Drug-Eluting Stents in Contemporary Clinical Practice

Data from randomized clinical trials have shown the safety and efficacy of the XIENCE V in selected populations. However, limited data are available comparing the XIENCE V to the first-generation CYPHER sirolimus-eluting stent. This study aimed to assess the long-term safety and clinical efficacy of the XIENCE V everolimus-eluting stent compared to first-generation stents in an unselected patient population. This retrospective analysis included 6,069 patients treated with CYPHER, TAXUS, and XIENCE stents from 2003 to 2009 at our institution. The patients were followed up for ≥1 year after the index procedure. The baseline characteristics were generally comparable among the 3 groups, with the exception of a significantly greater prevalence of diabetes mellitus, systemic hypertension, and a history of angioplasty and coronary bypass surgery among the XIENCE patients. The XIENCE patients also had a twofold greater rate of type C lesions. One-year follow-up data were available for 82% of the patients. The 1-year major adverse cardiovascular events rate was 9.3% for the XIENCE stent versus 9.8% for the CYPHER stent and 11.5% for the TAXUS stent (p = 0.11). Mortality was lower in the XIENCE group than in the CYPHER and TAXUS groups (3.6% vs 4.9% vs 7.2%, respectively, p <0.001), and target lesion revascularization was similar (5.9% vs 5.2% vs 5.6%, respectively; p = 0.34). Stent thrombosis was lower in the XIENCE patients (0.2% vs 1.2% vs 0.7%, p = 0.007). In conclusion, in a contemporary United States clinical practice with an unselected patient population, use of the XIENCE V stent was associated with an improved safety profile and reduction of all-cause mortality and stent thrombosis compared to first-generation drug-eluting stents. The XIENCE V failed to demonstrate superiority for overall major adverse cardiovascular events, Q-wave myocardial infarction, and revascularization rates.

Angioscopy study from a large patient population comparing sirolimus‐eluting stent with biodegradable versus durable polymer

This study aimed to compare the neointimal coverage (NIC), subclinical thrombus, color of plaque underneath the stent at 9-month after implantation of sirolimus-eluting stent (SES) either with durable or with biodegradable polymer (BDPM). A total of 175 patients were assigned as Cypher (n = 81, 97 stents with durable polymer) and Excel (n = 94, 112 stents with BDPM) stent at 9-month after indexed procedure. NIC was classified from grade 0-3. Color of plaque was divided into white, light-yellow, yellow, and dark yellow. Thrombus was diagnosed as white or red material with cotton-like or ragged appearance. Incomplete NIC (grade 0/1) circled by a blush was termed by "inflaming." There were significant differences in unstable angina (90.5 vs. 52.4%, P = 0.015), previous myocardial infarction (33.3 vs. 4.0%, P = 0.045) and left ventricular eject fraction (55.2 ± 7.8 vs. 62.6 ± 6.3%, P = 0.021) between the Excel and Cypher groups. The minimal- and maximal-NIC grades in the Cypher group were 0.67 ± 0.58 and 2.29 ± 0.46, respectively, when compared with 1.45 ± 0.67 (P < 0.001) and 2.64 ± 0.49 (P = 0.023) in the Excel group. The percentage of yellow plaque, thrombus, "inflaming" and NIC grade of 0 in the Excel and Cypher groups, respectively, were as follows: 8.0 vs. 26.8% (P = 0.031), 9.8 vs. 32.9% (P = 0.024), 8.0 vs. 38.1% (P = 0.017), and 38.1 vs. 0% (P < 0.001). Of the stents with "inflaming," 63.6% had thrombus when compared with 20.1% of the non-erosion stents (P < 0.001). Overlapping segments had the lowest NIC grades and more "inflaming" demonstrating a significant difference between Cypher vs. Excel stents. NIC grade was positively correlated with thrombus. SES with BDPM has improved NIC resulting in less yellow plaque, thrombus, and "inflaming." Overlapping segments had the lowest NIC grade and more "inflaming."

Novel Approaches for Preventing or Limiting Events in Diabetic Patients (Naples-Diabetes) Trial

Background— To expand the paucity of data on the efficacy of various drug-eluting stents in diabetic patients. Methods and Results— Type 2 diabetic patients treated in our institution from October 2005 to January 2007 presenting with of de novo lesions in native coronary arteries were randomly assigned to sirolimus-eluting stents (Cypher group; n=76); paclitaxel-eluting stents (Taxus group; n=75); and everolimus-eluting stents (Endeavor group; n=75). Poor metabolic control (HbA1c &gt;7% and low-density lipoprotein cholesterol &gt;100 mg/dL) and microvascular complications (retinopathy and/or nephropathy) were assessed. The primary end point was the 3-year composite of major adverse cardiac events (MACE), including death of any cause, myocardial infarction, and clinically driven target vessel revascularization. MACE-free survival was 86.8% in the Cypher group, 82.5% in the Taxus group, and 64.4% in the Endeavor group ( P =0.006 by log-rank test). The post hoc comparisons showed no significant difference between Cypher versus Taxus groups (adjusted P =1.0) but a higher MACE rate in the Endeavor group versus both the Cypher group (adjusted P =0.012) and the Taxus group (adjusted P =0.075). Independent predictors of 3-year MACE at Cox analysis were treatment by Endeavor versus Cypher stent (2.35 [95% confidence interval, 1.07 to 5.41]; P =0.030), multivessel disease (hazard ratio, 1.78 [95% confidence interval, 1.06 to 2.66]; P =0.031), diabetic retinopathy (hazard ratio, 1.60; [95% confidence interval, 1.03 to 2.76]; P =0.038), and poor metabolic control (hazard ratio, 1.60; [95% confidence interval, 1.02 to 2.52]; P =0.048). Conclusions— The present pilot study suggests that in diabetic patients, the Endeavor stent is associated with a higher 3-year MACE rate when compared with Cypher and Taxus stents.

E0506 Application of overlapped sirolimus-eluting stents in treatment of long coronary arteries lesion

ObjectiveTo evaluate the clinical efficacy of overlapped Excel and Cypher stents in treatment for long coronary arteries lesion.Method374 patients with de-novo long coronary arteries lesion who performed 2 Excel or...

E0639 Clinical study of Endeavour stent in patients with coronary heart disease and diabetes

ObjectiveTo evaluated the safety and efficacy of Endeavor Stent in patients with coronary heart disease (CHD) and diabetes performed percutaneous coronary intervention (PCI) via trans-radial artery approach for de novo...

Tacrolimus-eluting carbon-coated stents versus sirolimus-eluting stents for prevention of symptom-driven clinical end points

Coating of stents has been shown to minimize the interactions between platelets, stent surface and vascular response following stent implantation. The aim of our study was to compare the tacrolimus-eluting carbon-coated JANUS(®) stent with sirolimus-eluting CYPHER(®) stent for the prevention of symptom-driven clinical end points in a real world clinical setting. This prospective registry with a follow-up period of 24 months was conducted in 90 consecutive patients undergoing coronary artery stenting receiving CYPHER(®) (n = 48) or JANUS(®) (n = 42) stents. The primary end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction and target vessel revascularisation, and the secondary end point was clinically driven in-stent restenosis. The primary combined endpoint occurred in 38% of patients (n = 16) in the JANUS(®) group compared to 10% (n = 5) in the CYPHER(®) group. The relative risk increase of the composite end point was therefore 63% higher in patients receiving JANUS(®) stents compared to the CYPHER(®) stents (crude HR = 1.63, 95% CI = 1.17-2.28, p = 0.004; adjusted HR = 1.79, CI = 1.26-2.55, p = 0.001). Interestingly, 75% of events in the JANUS(®) group occurred during the first 6 months after stent implantation. Similarly, the rate of clinically driven in-stent restenosis was higher in patients receiving JANUS(®) stent (n = 10, 2%) compared to the CYPHER(®) stent (n = 2, 4%). Concordantly, the relative risk for clinically driven in-stent restenosis was 81% higher in the JANUS(®) group compared to the CYPHER(®) group (crude HR = 1.81, 95% CI = 1.08-3.02, p = 0.02; adjusted HR = 2.24, CI = 1.26-3.96, p = 0.006). The use of tacrolimus-eluting carbon coated JANUS(®) stent was associated with worse clinical outcome compared to the sirolimus-eluting CYPHER(®) stent in clinical routine use.

The safety and therapeutic efficacy for application of biodegradable stent excel with biodegradble polymer combined with firofiban in patients with acute coronary syndrom

Objective To evaluate the safety, and the brief-and prolongedterm therapeutic efficacy for im-plantation of biodegradable stent Excel combined with Tirofiban made in China into patients with acute coronary syndrome(ACS). Method A total of 301 patients were divided into Excel group (n = 100), Cypher group (n =102) and bare metal stem(BMS) (n = 99). The Tirofiban used in three groups was administered intravenously during and after operation.The loading dose of Tirofiban was 10 μg/kg given within 3 min followed by a Tirofiban intravenous maintenance infusion in 0.15 μg/(kg·min) with micro pump for 48 hours. Safety and efficacy were compared among three groups after stents implantation by the observation of TIMI flow, complication of bleeding, changes of platelet count, haematoglobin and hematocrit, incidence of angina, acute and subacute thrombosis inner stent and major adverse cardiac events (MACE) (cardiac death, nonfatal myocardial infarction and target ves-sel revascularization). Follow-up information got from out-patient clinic and telephone call including incidence of angina, MACE and rehospitalization were comapared sucessively 1 month, 6 monthes and 12 monthes after dis-charge. Results Among there groups,there were no significant differences in demographics,and physical and lab-oratory findings before treatment. Successful rate of implantation was 100 percent and the TIMI flow of class Ⅲ was found in all patients. There was no complication of stroke and massive hemorrhage of gastrointestinal tract, and no significant differences in complication of bleeding, platelet count, hemoglobin and hematocrit after implantation. Incidence rates of acute thrombosis were 0, 0.98 and 1.01 percent in three groups, and there was no significant difference in acute thrombosis inner stent among three groups (P >0.05). The rates of angina, sub.acute stent thrombosis, MACE and rehospitalization among three groups had no differences at 1 month and 6 monthes follow-up(P > 0.05), but significant differences were not found until 12 monthes follow-up (P < 0.05). Conclusions Drug-eluting stent Excel with biodegradable polymer combined with Tirofiban made in China implanted in patients with ACS were capable of preventing acute and later thrombosis inner stent. This procedure had favourable safety, and brief-term and proionge-term therapeutic efficacy. Key words: Drng-eluting stent; Biodegradable stent; Coronary artery disease; Tirofiban; Transluminal; Percutaneous,angioplasty; Acute coronary syndrom

Serial Intravascular Ultrasound Analysis of Peri-Stent Remodeling and Proximal and Distal Edge Effects After Sirolimus-Eluting or Paclitaxel-Eluting Stent Implantation in Patients With Diabetes Mellitus

Patients with diabetes have an increased risk of in-stent restenosis after coronary stent implantation. Serial intravascular ultrasound was used to study chronic arterial responses and edge effects after implantation of Cypher (Cordis, Johnson & Johnson, Miami Lakes, Florida) or Taxus (Boston Scientific, Maple Grove, Minnesota) stents in diabetic patients. Seventy-four diabetic patients were randomly assigned to Cypher or Taxus stent implantation. Intravascular ultrasound of 5-mm long segments immediately proximal and distal to the stent was performed after the procedure and at the 8-month follow-up. The increase in peri-stent external elastic membrane (EEM) volume was more pronounced in the Taxus group (292.4 +/- 132.6 to 309.5 +/- 146.8 mm(3)) than in the Cypher group (274.4 +/- 137.2 to 275.4 +/- 140.1 mm(3); p = 0.005). Peri-stent plaque volume increased in the Taxus group (152.5 +/- 73.7 to 166.1 +/- 85.1 mm(3)), but was unchanged in the Cypher group (153.5 +/- 75.5 to 151.5 +/- 75.8 mm(3); p = 0.002). In proximal and distal reference segments, mean lumen area decreased within the entire 5-mm edge segment (proximal and distal) because of plaque progression (distal, 5.5 +/- 3.6 to 5.8 +/- 3.7 mm(2); p = 0.097; proximal, 8.1 +/- 2.7 to 8.7 +/- 2.9 mm(2); p = 0.006) without remodeling (change in EEM) in the Taxus group. Conversely, there were no significant changes in reference-segment EEM or plaque areas in the Cypher group. In conclusion, in diabetic patients, Taxus stent implantation was associated with increased (1) peri-stent EEM volume and peri-stent plaque, and (2) stent edge plaque progression accompanied by lumen reduction without remodeling. These findings were not seen in Cypher stents.

An Intravascular Ultrasound Study of Cypher, Taxus, and Endeavor Stents on Relation between Neointimal Proliferation and Residual Plaque Burden

Studies on balloon angioplasty, atherectomy, and bare metal stent have shown a direct relation between residual plaque burden and restenosis. We investigated the relation between residual plaque burden and neointimal proliferation after drug-eluting stent (DES) implantation. Over a period of 12 months, 65 patients (Cypher, n = 25; Taxus, n = 28; Endeavor, n = 12) from two centers underwent intravascular ultrasound (IVUS) examination at 8.2 (interquartile range 6.8-9.5) months after coronary stent implantation in native de novo coronary arteries. IVUS images were acquired with motorized pullback at 0.5 mm/s, and cross-sectional measurements were performed within the stents at 1-mm intervals. The following measurements were obtained: (1) lumen area (LA), (2) stent area (SA), (3) external elastic membrane area (EEMA), (4) percent neointimal hyperplasia area (SA-LA/SA) x 100, and (5) percent residual plaque area (EEMA-SA)/EEMA x 100. The analysis of 1,173 cross sections (Cypher, n = 436; Taxus, n = 532, Endeavor, n = 205) using mixed model to account for intrasubject correlation showed an absence of relation between percent residual plaque area and percent neointimal hyperplasia area (P = 0.189). Mean residual plaque burden outside the stent for Cypher, Taxus, and Endeavor groups was similar (45.7%, 44.8%, and 42.4%, respectively). Mean percent neointimal hyperplasia area for the Cypher, Taxus, and Endeavor groups was 12.0%, 15.0%, and 16.2%, respectively (P = 0.163). In patients after first-generation DES implantation and without significant in-stent restenosis, late in-stent neointimal proliferation is not related to the amount of residual plaque burden after stent implantation. This suggests against routine plaque removal before DES implantation to reduce neointimal proliferation.

Comparison of the Sirolimus-Eluting Versus Paclitaxel-Eluting Coronary Stent in Patients With Diabetes Mellitus: The Diabetes and Drug-Eluting Stent (DiabeDES) Randomized Angiography Trial

The aim of the present study was to evaluate angiographic late luminal loss after the implantation of sirolimus-eluting Cypher stents and paclitaxel-eluting Taxus stents in patients with diabetes. The study was a Danish multicenter, open-label, randomized trial. One hundred fifty-three patients with diabetes with coronary artery disease were randomized to Cypher (n = 76) or Taxus (n = 77) stent implantation. All patients were followed for 8 months. The primary end point was 8-month angiographic in-stent late luminal loss. This primary end point was reduced in the Cypher group compared with the Taxus group (0.23 +/- 0.54 vs 0.44 +/- 0.52 mm, p = 0.025). Angiographic in-segment restenosis at 8-month follow-up, a secondary end point, was present in 16 patients (Cypher, n = 6; Taxus, n = 10; p = 0.24). Target lesion revascularization was performed in 5 patients (6.5%) and 9 patients (11.8%) in the Cypher and Taxus groups, respectively (p = 0.25). Definite stent thrombosis was observed in 2 patients (in the Taxus group), no patients had probable stent thrombosis, and 1 patient in each group had possible stent thrombosis. Major adverse cardiac events (cardiac death, myocardial infarction, definite stent thrombosis, or target lesion revascularization) were observed in 17 patients (Cypher, n = 6; Taxus, n = 11; p = 0.19). In conclusion, angiographic in-stent late luminal loss is significantly reduced in patients with diabetes by use of the sirolimus-eluting Cypher stent compared with the paclitaxel-eluting Taxus stent.

Incidence of thrombosis after implantation of drug-eluting stents in patients with coronary artery disease

Randomized clinical trials have demonstrated equivalent safety to bare-metal stents after drug-eluting stents (DES) implantation. However, the DES thrombosis in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications. This study sought to assess the incidence of DES thrombosis after implantation of DES in patients with real world coronary artery disease (CAD) in China. From December 2001 to April 2007, 8190 consecutive patients received the treatment with DES, 5412 patients completed one year follow-up: 2210 with sirolimus-eluting stent Cypher, 1238 with paclitaxel-eluting stent Taxus and 1964 with Chinese sirolimus-eluting stent Firebird. After two years of follow-up, there were 2176 patients (1245 Cypher, 558 Taxus and 373 Firebird). All patients were treated with aspirin and clopidogrel over at least 9 months. Among 8190 patients, 17 patients had acute stent thrombosis (0.24%): 7 in the Cypher group, 4 Taxus and 6 Firebird; 23 patients had subacute stent thrombosis: 8 Cypher, 6 Taxus and 9 Firebird. The incidence of acute and subacute thrombosis was 0.49%: 0.50% Cypher, 0.63% Taxus and 0.41% Firebird. The incidence of late thrombosis at one year followup was 0.63%: 0.63% Cypher, 0.88% Taxus and 0.46% Firebird; at two year follow-up the incidence was 0.74%: 0.72% Cypher, 0.90% Taxus and 0.54% Firebird. There was no significant difference among three groups at 1 year and 2 years follow-up. The first generation DES in the treatment of complex lesions are safe and effective if patients are aggressively treated with dual antiplatelet agents.

Novel bioabsorbable salicylate‐based polymer as a drug‐eluting stent coating

Permanent polymers used in current drug-eluting stents (DES) can trigger chronic inflammation and hypersensitivity reactions, which may contribute to the increased risk of late thrombosis and rebound restenosis. Therefore, optimal polymer selection and the use of completely absorbable but biocompatible polymers are expected to minimize these risks. We sought to evaluate a novel, potentially innately anti-inflammatory, bioabsorbable salicylate-based polymer as a DES coating, in a clinically relevant animal model. Four types of stents were implanted in pig coronary arteries using QCA to optimize stent apposition: bare metal stents (BMS); salicylic acid/adipic acid bioabsorbable polymer-only coated metal stents (SA/AA); biostable polymeric sirolimus-eluting stents (Cypher); and metal stents coated with salicylic acid/adipic acid bioabsorbable polymer containing sirolimus (SA/AA + S). The dose density of sirolimus was 8.3 microg/mm of stent length (similar to Cypher) with in vitro studies demonstrating elution over 30 days and complete polymer degradation in 37 days. Animals underwent angiographic restudy and were terminated at 1 month for complete histopathologic and histomorphometric analyses. Both SA/AA + S and Cypher stents had significantly lower angiographic % stenosis when compared with BMS and SA/AA polymer-only groups (6 +/- 4% and 5 +/- 4% vs. 15 +/- 7% and 16 +/- 5%, respectively, P < 0.001). Intimal thickness was lower for SA/AA + S and Cypher than for BMS (0.14 +/- 0.06 and 0.13 +/- 0.04 mm vs. 0.23 +/- 0.05 mm, respectively, P < 0.001). Histologic % area stenosis was also lower for SA/AA + S and Cypher when compared with BMS (22 +/- 7% and 23 +/- 6% vs. 33 +/- 5%, respectively, P < 0.001). There was a strong trend toward reduced inflammatory response in the SA/AA and SA/AA + S when compared with BMS and Cypher groups (P = 0.072). This study shows favorable vascular compatibility and efficacy for a novel bioabsorbable salicylate-based polymer as a DES coating, and supports further research and development of this unique class of polymer materials for applications in cardiovascular devices.

Neointimal hyperplasia after sirolimus-eluting and paclitaxel-eluting stent implantation in diabetic patients: The Randomized Diabetes and Drug-Eluting Stent (DiabeDES) Intravascular Ultrasound Trial

Patients with diabetes have increased risk of in-stent restenosis after coronary stent implantation owing to neointimal hyperplasia (NIH). The aim of the study was to evaluate the extent and distribution of NIH with intravascular ultrasound (IVUS) after coronary artery stenting with sirolimus-eluting (Cypher) or paclitaxel-eluting (Taxus) stents in diabetic patients. One hundred and thirty diabetic patients were randomized to Cypher or Taxus stent implantation. IVUS was performed at 8 month follow-up. NIH volume was significantly reduced in the Cypher group when compared with the Taxus group: median (inter-quartile range) 0.0 (0.0-0.0) vs. 8.0 mm(3) (0.1-33.0), P < 0.001. Per cent NIH volume was also significantly lower in Cypher stents compared with Taxus stents: median (inter-quartile range) 0.0 (0.0-0.0) vs. 7.5% (0.1-27.0), P < 0.001. NIH was covering 5.4% of the stent length in the Cypher stents compared with 46.1% in the Taxus stents (P < 0.001). The incidence of diffuse NIH was significantly higher for Taxus than for Cypher stents (42.9 vs. 3.5%, P < 0.001). Taxus stents had more often NIH at the proximal stent edge compared with Cypher stents (45.1 vs. 7%, P < 0.001) and no Cypher stents had NIH at the distal stent edge compared with 35.5% of the Taxus stents (P < 0.001). In diabetic patients, the Cypher stent, compared with the Taxus stent, inhibited NIH more effectively and had a more focal NIH pattern including less involvement of the stent edges.

Comparison of in-hospital and long-term outcomes between a Cypher stent and a Taxus stent in Chinese diabetic patients with coronary artery disease

The sirolimus and paclitaxel distribution patterns and tissue residence time may be modified in atherosclerotic lesions for patients with diabetes, and the biological mechanisms of action for these agents differ significantly. Previous clinical trials have yielded discrepant results of major adverse cardiac events and restenosis between a sirolimus-eluting stent and a paclitaxel-eluting stent in coronary artery disease. Therefore, this study was conducted to compare in-hospital and long-term clinical outcomes between patients receiving sirolimus-eluting stent (Cypher or Cypher Select stent) and paclitaxel-eluting stent (Taxus Express stent) after percutaneous intervention (PCI) in Chinese patients with diabetes. One hundred and sixty-four consecutive diabetic patients underwent PCI in Fuwai Hospital from April 2004 to December 2004. Of them, 101 patients received Cypher or Cypher Select stents (Cypher group, 145 stents) and 63 patients received Taxus Express stents (Taxus group, 129 stents). Repeat coronary angiography was performed at 6-month and clinical outcomes were evaluated at 1- and 3-year follow-up. Stent thrombosis was classified according to Academic Research Consortium (ARC). The two groups did not differ significantly with respect to cardiac death, recurrent myocardial infarction (re-MI), target vessel revascularization (TVR) and occurrence of major adverse cardiac events (MACE). And the MACE-free cumulative survival at 1- and 3-year follow-up and early, late and very late thrombosis rates were also similar in the two groups (all P > 0.05). There was a trend favoring PES over SES with regard to reducing cardiac death (0 vs 2.0%, P = 0.524), re-MI (0 vs 2.0%, P = 0.524), the composite of the cardiac death and re-MI (0 vs 4.0%, P = 0.299) and very late thrombosis (0 vs 3.0%, P = 0.295) between 1-year and 3-year follow-up. The study indicates that PCI with either Cypher or Taxus stents is associated with similar efficacy and safety in the small population of Chinese diabetic patients during long-term follow-up.

Revascularization of Left Anterior Descending Artery With Drug-Eluting Stents: Comparison With Minimally Invasive Direct Coronary Artery Bypass Surgery

The proximal left anterior descending artery (LAD) is a challenging area for percutaneous interventions; therefore, coronary artery bypass grafting is often considered and sometimes performed even in patients with single-vessel disease involving the proximal LAD. This study compares mid-term results of LAD revascularization using drug-eluting stents (Cypher) with minimally invasive direct coronary artery bypass grafting (MIDCAB). From May 2002 to December 2003, 376 consecutive patients underwent myocardial revascularization of the LAD, 272 by Cypher and 104 by MIDCAB. After matching for age, sex, and extent of coronary artery disease, two groups of 83 patients each were used to compare the two revascularization modalities. The groups were similar; however, ejection fraction of less than 0.35 was more prevalent in the MIDCAB group and prior percutaneous coronary intervention in the Cypher group. Thirty-day mortality was 1.1% in the MIDCAB and 0% in the Cypher group. Mean follow-up was 22.5 months. Two late cardiac deaths occurred in the MIDCAB group and one in the Cypher group (p = NS). Angina returned in 35% of the Cypher group and in 8.4% of the MIDCAB group (p < 0.001). There were 14 (16.8%) reinterventions in the Cypher compared with three (3.6%) in the surgical group (p = 0.005). Cox proportional hazard model showed that assignment to the Cypher group was the only independent predictor of reangina (hazard ratio [HR], 6.17, 95% confidence interval [CI], 2.46 to 15.4). Treatment with Cypher was also an independent predictor of reintervention (HR 8.26, 95% CI, 1.68 to 40). Despite improved results of percutaneous interventions with Cypher to the LAD, mid-term clinical outcome of patients treated with MIDCAB was better.

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

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.

RETRACTED: Drug-eluting stents versus arterial myocardial revascularization in patients with diabetes mellitus

The introduction of drug-eluting stents significantly reduced restenosis and reinterventions in patients undergoing percutaneous coronary interventions. This study compares results of Cypher stenting with those of surgical arterial revascularization in patients with diabetes mellitus. From May 2002 through May 2005, 523 consecutive diabetic patients underwent myocardial revascularization: 244 underwent percutaneous coronary interventions incorporating drug-eluting stents, and 279 were treated surgically. All single-vessel patients in the surgical group were treated with the left internal thoracic artery, and most multivessel patients were treated with 2 internal thoracic arteries. After propensity score matching, 2 groups (93 patients each) were used to compare the 2 revascularization modalities. The number of coronary vessels treated per patient was higher in the surgical group (2.72 vs 1.75, P < .001). Follow-up ranged between 6 and 42 months (mean, 19 months). Overall mortality (early and late) was 3.2% in the surgical group and 2.2% in the Cypher group (P = .65). Two-year angina-free survival and reintervention-free survival (Kaplan-Meier) of the surgical group were 88% and 95%, respectively, compared with 47.8% (P = .001) and 83.6% (P = .01), respectively, in the percutaneous coronary intervention group. Cox proportional hazards modeling revealed assignment to the Cypher group to be the only predictor of reintervention (odds ratio, 3.86; 95% confidence interval, 1.25-11.9). Assignment to the Cypher group (hazard ratio, 5.92; 95% confidence interval, 2.96-11.87) and insulin treatment (hazard ratio, 2.06; 95% confidence interval, 1.06-4.02) were independent predictors of angina recurrence. The midterm clinical outcome of diabetic patients who underwent surgical arterial revascularization is better than that of patients undergoing percutaneous coronary intervention treated with drug-eluting stents.