Influence of diabetes mellitus on early and late clinical outcomes in saphenous vein graft stenting

OBJECTIVES: The purpose of this study was to compare early and late clinical outcomes in diabetic and nondiabetic patients after stent implantation in saphenous vein grafts (SVG). BACKGROUND: Patients with diabetes mellitus have less favorable acute and long-term outcomes after stent implantation in native coronary arteries. The impact of diabetes on SVG stenting, however, is not known. METHODS: We studied 908 consecutive patients (1,366 SVG lesions) treated with Palmaz-Schatz stents. In-hospital and late clinical outcomes (death, Q-wave myocardial infarction and repeat revascularization rates at one year) were compared between diabetic (n = 290) and nondiabetic (n = 618) patients. RESULTS: In-hospital mortality was significantly higher in diabetic as compared with nondiabetic patients (2.2% vs. 0.3%, p = 0.003). At one-year follow-up, target lesion revascularization (TLR) was 16.6% in diabetic and 12.3% in nondiabetic patients (p = 0.03). Overall cardiac event-free survival (freedom from death, Q-wave myocardial infarction and any coronary revascularization procedure) at one year was significantly lower in the diabetic (68%) compared with the nondiabetic patients (79%, p = 0.0003). By Cox regression analysis, diabetes mellitus was an independent predictor of both TLR (relative risk: 1.23; confidence interval: 0.96 to 1.58; p = 0.004) and late cardiac events (relative risk: 1.40; confidence interval: 1.05 to 1.86; p = 0.02). CONCLUSIONS: Patients with diabetes undergoing stent implantation in SVG have: 1) higher in-hospital and late mortality, 2) higher one-year TLR rates, and 3) significantly lower one-year cardiac event-free survival. Thus, diabetic patients have less favorable acute and late clinical outcomes after stent implantation in SVG lesions.     

Effect of bare metal stenting on angiographic and clinical outcomes in diabetic and nondiabetic patients undergoing percutaneous coronary intervention of nonacute occluded coronary arteries: a report from the Total Occlusion Study of Canada (TOSCA).

The outcome after PTCA and coronary stenting of nonacute total coronary occlusions in the diabetic population is unknown. The main objective of the present report was to compare the angiographic and 1-year clinical outcomes in the diabetic and nondiabetic patients who were enrolled in the Total Occlusion Study of Canada (TOSCA), a prospective randomized controlled multicenter trial of primary stenting versus PTCA alone in nonacute native coronary artery occlusions. Of the 410 patients enrolled, 68 (16.5%) were diabetics. At 6-month follow-up, stenting resulted in significant improvement in angiographic outcome compared to PTCA alone in both diabetic and nondiabetic populations. Angiographic restenosis was significantly reduced by stenting in the nondiabetic population (69.3% vs. 55.2%; P = 0.009). A reduction in restenosis of a similar magnitude was observed with stenting in the diabetic population (71.1% vs. 59.3%; P = NS). At 1-year clinical follow-up, composite adverse cardiac event rates were similar for both strategies regardless of diabetic status. Target vessel revascularization was reduced by stenting compared to PTCA in diabetics (20% vs. 31.6%) and nondiabetics (21.5% vs. 30%). A significant reduction for any vessel revascularization following stenting compared to PTCA was observed in the nondiabetic population (28.5% vs. 38.8%; P = 0.05) but not in the diabetic subgroup (36.7% vs. 42%; P = NS). In conclusion, stenting appeared to be superior to PTCA alone, resulting in similar magnitude of reduction in angiographic restenosis and target vessel revascularization rates in diabetics and nondiabetics. Restenosis rates in all groups remain high. This analysis forms an important background for future studies that are needed to examine the effect of stenting with drug-eluting stents in diabetics as well as nondiabetics with nonacute coronary occlusions.     

Clinical and angiographic outcome after sirolimus-eluting stent implantation in aorto-ostial lesions.

OBJECTIVES: This observational study evaluated the clinical and angiographic outcomes of patients with aorto-ostial coronary artery disease treated with sirolimus-eluting stents (SESs) or with bare metal stents (BMSs). BACKGROUND: The safety and effectiveness of SESs for the treatment of aorto-ostial lesions have not been demonstrated. METHODS: We identified 82 consecutive patients who underwent percutaneous coronary interventions in 82 aorto-ostial lesions using the SES (32 patients) or BMS (50 patients) and compared the two groups of patients. The incidence of major adverse cardiac events (MACE), including death or Q-wave myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR), were recorded in-hospital and at a 10-month follow-up. RESULTS: All stents were implanted successfully. There were no statistically significant differences regarding major in-hospital complications between the two groups. At 10-month follow-up, two (6.3%) patients in the SES group and 14 (28%) patients in the BMS group underwent TLR (p = 0.01); MACE were less frequent in the SES group compared to the BMS group (19% vs. 44%, p = 0.02). Angiographic follow-up showed lower binary restenosis rates (11% vs. 51%, p = 0.001) and smaller late loss (0.21 +/- 0.31 mm vs. 2.06 +/- 1.37 mm, p < 0.0001) in the SES group. CONCLUSIONS: The main finding of our study is that, compared to the BMS, implantation of the SES in aorto-ostial lesions appears safe and effective, with no increase in major in-hospital complications and a significant improvement in restenosis and late event rates at 10-month follow-up.     

Twelve-month outcomes after coronary stenting with the Genous™ bio-engineered R Stent™ in diabetic patients from the e-HEALING registry

Objectives: We compared 12‐month outcomes, regarding ischemic events, repeat intervention, and ST, between diabetic and nondiabetic patients treated with the Genous? EPC capturing R stent? during routine nonurgent percutaneous coronary intervention (PCI) using data from the multicenter, prospective worldwide e‐HEALING registry. Background: Diabetic patients have an increased risk for restenosis and stent thrombosis (ST). Methods: In the 4,996 patient e‐HEALING registry, 273 were insulin requiring diabetics (IRD), 963 were non‐IRD (NIRD), and 3,703 were nondiabetics. The 12‐month primary outcome was target vessel failure (TVF), defined as target vessel–related cardiac death or myocardial infarction (MI) and target vessel revascularization. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularization (TLR), and individual outcomes including ST. Cumulative event rates were estimated with the Kaplan–Meier method and compared with a log‐rank test. Results: TVF rates were respectively 13.4% in IRD, 9.0% in NIRD, and 7.9% in nondiabetics (P < 0.01). This was mainly driven by a higher mortality hazard in IRD (P < 0.001) and NIRD (P = 0.07), compared with nondiabetics. TLR rates were comparable in NIRD and nondiabetics, but significantly higher in IRD (P = 0.04). No difference was observed in ST. Conclusion: The 1‐year results of the Genous stent in a real‐world population of diabetics show higher TVF rates in diabetics compared with nondiabetics, mainly driven by a higher mortality hazard. IRD is associated with a significant higher TLR hazard. Definite or probable ST in all diabetic patients was comparable with nondiabetics. (J Interven Cardiol 2011;24:285–294)     

Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement

Objectives. The objectives of this study were to analyze the clinical and angiographic outcome of diabetic patients with successful coronary stent placement and to compare these results with those achieved after stenting in nondiabetic patients.

Background. The outcome of diabetic patients treated with stent placement due to coronary artery disease has not been assessed comprehensively.

Methods. This study analyzes a consecutive series of patients with successful stent placement comprising 715 patients with diabetes and 2,839 patients without diabetes. Clinical one year follow-up and angiographic control at 6 months were part of the protocol. Death, myocardial infarction and target lesion revascularization were considered as adverse events. An automated edge detection system was used for the angiographic assessment. The primary clinical endpoint was event-free survival at one year. The primary angiographic endpoint was restenosis rate at 6 months (≥50% diameter stenosis).

Results. Event-free survival was significantly lower in diabetic than in nondiabetic patients (73.1 vs. 78.5%, p < 0.001). Survival free of myocardial infarction was also significantly reduced in the diabetic group (89.9 vs. 94.4% in nondiabetics, p < 0.001). The incidence of both restenosis (37.5 vs. 28.3%, p < 0.001) and stent vessel occlusion (5.3 vs. 3.4%, p = 0.037) was significantly higher in diabetic patients. Diabetes was identified as an independent risk factor for adverse clinical events and restenosis in multivariate analyses.

Conclusions. Patients with diabetes mellitus have a less favorable clinical outcome at one year after successful stent placement as compared to the nondiabetic patients. The clinical follow-up was characterized by a higher incidence of death, myocardial infarction and reinterventions. Diabetic patients also demonstrated an increased risk for restenosis.     

Optimal final lumen area and predictors of target lesion revascularization after stent implantation in small coronary arteries

Despite similar early clinical events, patients who undergo treatment of small vessels are at an increased risk for target lesion revascularization (TLR) after coronary artery stenting. We sought to determine predictors of TLR after stent implantation in small coronary arteries. We identified 423 consecutive patients who underwent intravascular ultrasound (IVUS)-guided small vessel stenting procedures in 465 coronary lesions with an angiographic reference vessel diameter of <2.75 mm. Patients were divided into 2 groups based on a final IVUS lumen area of < or =6.0 mm2 (n=345 lesions, group I) and >6.0 mm2 (n=115, group II). Baseline patient characteristics and in-hospital outcomes were similar between the 2 groups, except for a higher rate of restenotic lesions in group I and bifurcation lesions in group II. Group I had higher TLR rates at 1 year compared with group II patients (39% vs 26%, p = 0.02). The TLR rate appeared to decrease with greater stent expansion, especially at >90% of the reference vessel area, as assessed by IVUS. By multivariate analysis, an IVUS final stent area of < or =6 mm2, diabetes, absence of prior myocardial infarction, and history of intervention were independent predictors of 1-year TLR in this population. Final stent area of >6.0 mm2 and greater stent expansion were associated with a decrease in TLR. Therefore, there does not appear to be any "downside" to aggressive stent implantation strategies in small vessels. In contrast, IVUS allows maximization of final lumen dimensions to minimize clinical restenosis.     

Favorable effect of gamma-radiation for in-stent restenosis: effect of diabetes on angiographic and clinical outcomes.

The purpose of this study was to examine the effect of vascular brachytherapy with gamma-radiation (gamma-RT) in patients with diabetes mellitus (DM) with coronary in-stent restenosis (ISR). In the Washington Radiation for In-Stent Restenosis (WRIST) trial, 130 patients with ISR were treated with (192)Ir or placebo. Of the patients enrolled, 44 (34%) had DM (18 of them treated with gamma-RT and 26 with placebo). Gamma-radiation therapy of ISR in diabetics resulted in similar procedural success and in-hospital outcome compared to nondiabetics. At 6-month follow-up, both DM and non-DM patients treated with gamma-RT had significantly lower target lesion revascularization (TLR), target vessel revascularization, and major adverse cardiac event rates compared to placebo. DM remains a powerful predictor of TLR and major adverse cardiac events even after treatment of ISR with gamma-RT.     

Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial

OBJECTIVES: We sought to determine the safety and efficacy of polymer-regulated site-specific delivery of paclitaxel in patients with diabetes mellitus undergoing stent implantation. BACKGROUND: Percutaneous coronary intervention in patients with diabetes is associated with high rates of restenosis and repeat revascularization due to excessive neointimal proliferation, a process that may be blunted with the site-specific delivery of paclitaxel. METHODS: In the TAXUS-IV trial, 1,314 patients were prospectively randomized to the slow rate-release polymer-based paclitaxel-eluting TAXUS stent or the bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). Medically treated diabetes was present in 318 patients (24%), 105 of whom required insulin. RESULTS: Among patients with diabetes, the TAXUS stent, compared to the bare-metal stent, reduced the rate of 9-month binary angiographic restenosis by 81% (6.4% vs. 34.5%, p < 0.0001), and reduced the 12-month rates of target lesion revascularization by 65% (7.4% vs. 20.9%, p = 0.0008), target vessel revascularization by 53% (11.3% vs. 24%, p < 0.004), and composite major adverse cardiac events by 44% (15.6% vs. 27.7%, p = 0.01). The one-year rates of cardiac death (1.9% vs. 2.5%), myocardial infarction (3.2% vs. 6.4%), and subacute thrombosis (0.6% vs. 1.2%) were comparable between the paclitaxel-eluting and control stents, respectively. In the insulin-requiring subgroup, the TAXUS stent reduced angiographic restenosis by 82% (7.7% vs. 42.9%, p = 0.0065), and reduced the one-year rate of target lesion revascularization by 68% (6.2% vs. 19.4%, p = 0.07), a relative reduction similar to patients without diabetes. CONCLUSIONS: The site-specific delivery of paclitaxel after coronary stent implantation is highly effective in reducing clinical and angiographic restenosis in patients with diabetes mellitus.     

Impact of treatment of coronary artery disease with sirolimus-eluting stents on outcomes of diabetic and nondiabetic patients

Patients with diabetes mellitus are at increased risk for repeat interventions and mortality after coronary angioplasty and stenting. The efficacy of sirolimus-eluting stents (SESs) to improve the outcomes of these patients is a focus of interest. In the first 1,407 patients treated with SESs at our institution, 492 were diabetic (insulin dependent diabetes mellitus [IDDM], n = 160 and non-insulin-dependent DM [NIDDM], n = 332). The in-hospital and 1- and 6-month clinical outcomes were compared with those of 915 patients without DM (non-DM). The baseline characteristics were similar, except for more women, obesity, previous myocardial infarction, coronary artery bypass grafting, and renal insufficiency in the DM group (p <0.001). Compared with non-DM patients, DM patients had higher in-hospital (p <0.05) and 1-month mortality (p = 0.02). IDDM patients had more in-hospital renal failure (p = 0.04) and Q-wave myocardial infarctions (1.6% vs 0%, p = 0.04) compared with NIDDM patients, and higher mortality (3.1% vs 0.8%, p = 0.04) and subacute stent thromboses (2.3% vs 0.5%, p = 0.07) than non-DM patients at 30 days. At 6 months, DM patients had a higher incidence of Q-wave myocardial infarction, target lesion revascularization-major adverse cardiac events, and composite of death and Q-wave myocardial infarction than non-DM patients (6.0% vs 2.7%, p = 0.01). Late outcomes between the IDDM and NIDDM groups were similar. Multivariate analysis showed diabetes and acute renal failure as independent predictors of target lesion revascularization-major adverse cardiac events. In conclusion, our data showed that, despite a reduction in repeat revascularization, coronary intervention with SESs in diabetic patients is limited by higher mortality at 1 month and a higher incidence of Q-wave myocardial infarction and target lesion revascularization-major adverse cardiac events at 6 months compared with non-DM patients. Careful surveillance is required in IDDM patients undergoing SES implantation.     

Comparison of clinical outcomes using stents versus no stents after percutaneous coronary intervention for proximal left anterior descending versus proximal right and left circumflex coronary arteries

Previous studies have demonstrated that proximal left anterior descending (LAD) stenoses have higher rates of restenosis after angioplasty than stenoses in other coronary segments. Stenting strategies may reduce this high rate of LAD restenosis. The study population included 1,289 patients with proximal coronary artery stenoses treated with percutaneous coronary interventions (PCI) with or without stents for single-vessel coronary disease between 1994 and 1999. Patients were divided into 4 groups: non-stent PCI in the proximal LAD artery (n = 168), non-stent PCI in proximal right/circumflex artery (n = 217), stent in the proximal LAD artery (n = 364), and stent to proximal right/circumflex artery (n = 540). Procedural success was higher in the stenting groups, but there were no significant differences in the major in-hospital events between the different lesion locations among the groups. At 1-year follow-up, there was no difference in mortality or myocardial infarction between the groups. There was no significant difference in the rate of target lesion revascularization (TLR) in the patients with proximal LAD stents compared with the patients with proximal right/circumflex coronary artery stents (10.1% vs 13.8%, p = 0.11). In the patients who did not receive stents with proximal narrowings, there was a significant increase in TLR in the LAD group compared with the right/circumflex group (21.1% vs 12.5%, p = 0.04). Thus, patients with proximal stenoses treated with non-stenting strategies have lower procedural success than those treated with stenting strategies; the patients with proximal LAD non-stent PCI have significantly higher rates of clinical restenosis than patients with proximal right and circumflex stenoses. A stenting strategy for proximal LAD stenoses appears to attenuate the differences of clinical restenosis noted after non-stent PCI.     

The effect of intracoronary radiation for the treatment of recurrent in-stent restenosis in patients with chronic renal failure

OBJECTIVES: This study was designed to analyze the in-hospital and six-month clinical and angiographic outcomes of patients with chronic renal failure (CRF) treated with intracoronary radiation for the prevention of recurrence of in-stent restenosis. BACKGROUND: Patients with CRF are at a higher risk than the general population for accelerated atherosclerotic cardiovascular disease and for restenosis after percutaneous coronary intervention. Previous studies have shown the effectiveness of both beta and gamma radiation in preventing recurrent restenosis in patients with in-stent restenosis. METHODS: We studied the in-hospital and six-month clinical and angiographic outcomes of 118 patients with CRF and 481 consecutive patients without CRF who were treated with intracoronary radiation for the prevention of recurrence of in-stent restenosis in native coronaries and saphenous vein grafts. RESULTS: Patients with CRF were usually older, women, hypertensive and diabetic, with multivessel disease and with reduced left ventricular function. In-hospital outcome for patients with CRF was marred by a higher incidence of death, non-Q-wave myocardial infarction and major vascular and bleeding complications. At six-month follow-up, the mortality rate was higher in patients with CRF, 7.6% compared with 1.9% in non-CRF patients (p = 0.003). Restenosis, target lesion revascularization (TLR) and target vessel revascularization (TVR) rates were similar in the two groups. In patients with CRF, radiation therapy compared to placebo reduced restenosis (53.8% vs. 22.6%, p = 0.04), TLR (71.4% vs. 15.3%, p < 0.0001) and TVR (78.6% vs. 23.7%, p = 0.0002). CONCLUSIONS: Intracoronary radiation for the prevention of recurrence of in-stent restenosis achieved similar rates of restenosis and revascularization procedures in patients with and without CRF. Despite this benefit, patients with renal dysfunction continued to have significantly higher in-hospital and six-month adverse outcomes.     

Latin American randomized trial of balloon angioplasty vs coronary stenting for small vessels (LASMAL): immediate and long-term results

PURPOSE: To assess the potential role of coronary stent to improved acute success and reduce late restenosis in lesions with reference diameter <2.9 mm using a bare metal stent specifically designed for small coronary vessels. There is controversy on the results among previous studies comparing bare metal stent implantation with conventional balloon percutaneous transluminal coronary angioplasty (PTCA). Differences in baseline characteristics, inclusion and exclusion criteria, and stent design may account for these discrepancies. METHODS: The population of this multicenter, multinational randomized study (LASMAL) consisted of 246 patients undergoing percutaneous coronary intervention of small vessel reference diameter. They were randomized into 2 strategies of percutaneous revascularization: elective primary stent (n = 124) or conventional balloon PTCA with provisional stenting (n = 122) in the presence of acute, threatened closure or flow-limiting dissections. RESULTS: The clinical success rate was significantly better for the stent group (98.3% vs 91.8%; P = 0.038). At 30 days follow-up, requirements of target vessel revascularization (TVR) (6.6% vs 0.8%; P = 0.018) and incidence of major adverse cardiac and cerebrovascular events (MACCE) (9.8% vs 2.4%; P = 0.01) was significantly lower in the stent strategy. Postpercutaneous coronary intervention minimal luminal diameter (MLD) was significantly larger in the stent group (2.3 +/- 0.2 mm vs 2.2 +/- 0.2 mm; P = 0.003). At follow-up, MLD in the stent group was larger than with PTCA (1.7 +/- 0.7 mm vs 1.5 +/- 0.7 mm, respectively; P = 0.035). Net gain was also significantly better with stent strategy (1.1 +/- 0.7 mm vs 0.8 +/- 0.7 mm, respectively; P = 0.002). Stenting resulted in a significant lower angiographic binary restenosis (20% vs 31%; P = 0.02) than PTCA. Furthermore, patients treated with stent were more frequently free from MACCE at 9-month follow-up (death, acute myocardial infarction [AMI], stroke, repeat revascularization procedures) than those treated initially with PTCA (82.2% vs 72% of PTCA, P = 0.046). CONCLUSIONS: The use of a specifically designed bare metal coronary phosphoril choline-coated stent as primary device during percutaneous interventions in small coronary arteries was associated with high procedural success and low in-hospital and 30-day follow-up complications. At long-term follow-up, patients initially treated with stents had lower angiographic restenosis rate and were more frequently free from major adverse cardiac events.     

Comparison of long-term clinical and angiographic outcomes following implantation of bare metal stents and drug-eluting stents in aorto-ostial lesions

Percutaneous coronary intervention (PCI) to aorto-ostial (AO) lesions is technically demanding and associated with high revascularization rates. The aim of this study was to assess outcomes after bare metal stent (BMS) compared to drug-eluting stent (DES) implantation after PCI to AO lesions. A retrospective cohort analysis was conducted of all consecutive patients who underwent PCI to AO lesions at 2 centers. Angiographic and clinical outcomes in 230 patients with DES from September 2000 to December 2009 were compared to a historical control group of 116 patients with BMS. Comparison of the baseline demographics showed more diabetics (32% vs 16%, p = 0.001), lower ejection fractions (52.3 ± 9.7% vs 55.0 ± 11.5%, p = 0.022), longer stents (17.55 ± 7.76 vs 14.37 ± 5.60 mm, p <0.001), and smaller final stent minimum luminal diameters (3.43 ± 0.53 vs 3.66 ± 0.63 mm, p = 0.001) in the DES versus BMS group. Angiographic follow-up (DES 68%, BMS 66%) showed lower restenosis rates with DES (20% vs 47%, p <0.001). At clinical follow-up, target lesion revascularization rates were lowest with DES (12% vs 27%, p = 0.001). Cox regression analysis with propensity score adjustment for baseline differences suggested that DES were associated with a reduction in target lesion revascularization (hazard ratios 0.28, 95% confidence interval 0.15 to 0.52, p <0.001) and major adverse cardiac events (hazard ratio 0.50, 95% confidence interval 0.32 to 0.79, p = 0.003). There was a nonsignificantly higher incidence of Academic Research Consortium definite and probable stent thrombosis with DES (n = 9 [4%] vs n = 1 [1%], p = 0.131). In conclusion, despite differences in baseline characteristics favoring the BMS group, PCI with DES in AO lesions was associated with improved outcomes, with lower restenosis, revascularization, and major adverse cardiac event rates.     

One‐year clinical outcome in an unselected patient population treated with the Genous™ endothelial progenitor cell capturing stent

Objective : We assessed the 1‐year clinical outcome in a large cohort of unselected patients treated with an endothelial progenitor cell (EPC) capturing coronary stent. Background : The novel EPC capturing stent is coated with CD34+ antibodies that bind circulating EPCs to the stent surface, thereby accelerating endothelialization of the stent struts; it is hypothesized that this may prevent restenosis and stent thrombosis. Methods : A total of 405 unselected patients were treated percutaneously with the EPC capturing stent. The majority of patients had complex lesions with an estimated high risk of restenosis. Results : The primary endpoint defined as the composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) at 1‐year was 13.3%, mainly attributable to TLR which was 10.9%. The occurrence of definite and probable ST was low, 0.5 and 0.7%, respectively. Based on the risk of restenosis, in patients with an estimated high risk of restenosis (n = 249), the composite primary endpoint was 16.1% versus 9.0% in patients with an estimated low risk (n = 155). Moreover, the 1 year clinical outcomes in diabetic patient compared well with the nondiabetic patients. Conclusion : In this single‐center study, the 1‐year clinical follow‐up in a “real‐world” population treated with the EPC capturing stent showed good results. Currently, large randomized studies are conducted to evaluate the long‐term safety and efficacy of this stent. © 2011 Wiley‐Liss, Inc.     

雷帕霉素涂层支架治疗老年人冠心病的疗效及再狭窄的随访分析

目的 观察雷帕霉素涂层冠状动脉Cypher支架治疗老年冠心病患者的临床疗效及再狭窄情况。方法 2002年11月至2005年5月在我院心导管室接受Cypher支架治疗的328例60岁以上的老年冠心病患者，观察术后即刻效果，随访6个月记录心脏性死亡、心肌梗死、再次血管重建事件，并进行冠状动脉造影复查。328例中，ST段抬高的急性心肌梗死66例，非ST段抬高的急性心肌梗死21例，不稳定心绞痛149例，稳定型心绞痛92例。结果 支架植入成功率99．1％（325／328），住院期间无死亡。随访6个月出现急性和亚急性血栓各1例，晚期血栓致心肌梗死2例，心力衰竭死亡1例，进行血管重建术7例。住院其间主要心脏不良事件发生率0．6％（2／328），6个月心脏不良事件发生率3．7％（12／328）。术后6个月84例患者冠状动脉造影复查显示，再狭窄率为8．3％（7／84），支架内为2．4％（2／84），靶病变重建率为5．9％（5／84）。结论 应用Cypher支架治疗老年人冠心病是安全和有效的，主要心脏不良事件发生率低，支架内再狭窄率和靶病变重建率明显低于普通金属支架。     

Predictive factors of cardiac events after implantation of sirolimus-eluting stents for treatment of in-stent restenosis

BACKGROUND: The factors associated with recurrent restenosis after SES implantation for in-stent restenosis are unknown. This study aimed to assess the clinical outcome and to analyse predictive factors of cardiac events in patients with in-stent restenosis treated with Sirolimus-eluting stent (SES). METHODS: In 3 centers, consecutive patients (n = 100) with elective indication to percutaneous coronary intervention (PCI) for in-stent restenosis (n = 110) were treated with SES: 28 lesions were focal, 40 diffuse, 17 proliferative, and 15 showed total occlusion. RESULTS: SES implantation was successful in all patients, without complication during the first hospital stay. The mean follow-up was 15 (10-24) months. A cardiac event related to the target vessel occurred in 24 (24%) patients, and was associated with dialysis status (p < 0.05), lower ejection fraction (p < 0.05) and revascularization without SES in another site (p < 0.0001). A cardiac event related to the SES occurred in 11 (11%) patients, secondary to an acute or sub-acute thrombosis of the SES (2%), to a late occlusion of the target vessel (4%) or to a non-occlusive restenosis of the SES (5%), and was associated with unstable angina (p < 0.01), multivessel disease (p < 0.03) and revascularization without SES in another site (p < 0.03). No cardiac event related to the SES occurred in patients with direct stenting. Target lesion revascularization for in-SES restenosis or occlusion of the target vessel was performed in 7 (7%) patients, and was associated with unstable angina (p < 0.01) and revascularization without SES in another site (p < 0.01). Target vessel revascularization was needed in 20 patients (20%), related to dialysis status (p < 0.01) and a revascularization without SES in another site (p < .0001). CONCLUSIONS: SESs are effective in the treatment of high risk patients with complex in-stent restenosis. Most of cardiac events during follow-up are related to a revascularization without SES in another site.     

Treatment of saphenous vein graft lesions with drug-eluting stents: immediate and midterm outcome

OBJECTIVES: The purpose of the present report was to evaluate clinical and angiographic outcomes of drug-eluting stent (DES) implantation in saphenous vein graft (SVG) lesions. BACKGROUND: The safety and efficacy of DES implantation for the treatment SVG lesions remains uncertain. METHODS: We evaluated in-hospital and six-month outcomes in 61 consecutive patients treated with DES in SVG lesions from March 2002 to March 2004 (DES group), as compared to 89 consecutive patients treated with bare-metal stents (BMS) in the 24 months immediately before the introduction of DES (BMS group). Major adverse cardiac events (MACE) including death, myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR) were recorded in-hospital and at six-month follow-up. RESULTS: The rate of in-hospital MACE was similar between the two groups (6.6% vs. 5.6%, p = 1.0). Cumulative MACE at six months was 11.5% in the DES group and 28.1% in the BMS group (p = 0.02). The DES group had a significantly lower incidence of in-segment restenosis (10.0% vs. 26.7%, p = 0.03), TLR (3.3% vs. 19.8%, p = 0.003), and TVR (4.9% vs. 23.1%, p = 0.003). By Cox regression analysis, diabetes (hazard ratio [HR]: 3.03; 95% confidence interval [CI]: 1.33 to 6.90; p = 0.008), usage of BMS (HR: 2.53; 95% CI: 1.07 to 5.97; p = 0.03), and age of SVG (HR: 1.10; 95% CI: 1.02 to 1.19; p = 0.02) were identified as predictors of MACE at six-month follow-up. CONCLUSIONS: Compared to BMS implantation, DES implantation in SVG lesions appears safe with favorable and improved mid-term outcomes.     

Impact of stenting and abciximab in patients with diabetes mellitus undergoing primary angioplasty in acute myocardial infarction (the CADILLAC trial)

We sought to determine the benefits of stent implantation and abciximab in patients with diabetes mellitus and acute myocardial infarction (AMI) who underwent primary angioplasty. In a 2-by-2 factorial design, 2,082 patients with AMI were randomly assigned to balloon angioplasty versus stenting, with or without abciximab. Diabetes was present in 346 patients (16.6%). The primary end point was the composite incidence of death, disabling stroke, reinfarction, and ischemic target vessel revascularization (TVR). The primary end point at 1 year occurred significantly more frequently in diabetic than nondiabetic patients (21.9% vs 16.8%, p <0.02), driven by increased rates of death (6.1% vs 3.9%, p = 0.04) and TVR (16.4% vs 12.7%, p = 0.07). Among patients with diabetes, TVR at 1 year was significantly reduced with routine stenting compared with balloon angioplasty (10.3% vs 22.4%, p = 0.004), with no differences in death, reinfarction, or stroke. Angiographic restenosis was also greatly reduced in diabetics randomized to stenting (21.1% vs 47.6%, p = 0.009). No beneficial effects were apparent with abciximab in diabetic patients at 1 year. Despite the improved outcomes with stenting in patients with diabetes, 1-year mortality remained increased in diabetic patients who received stents compared with nondiabetics (8.2% vs 3.6%, p = 0.005). Thus, routine stent implantation in diabetic patients with AMI significantly reduces restenosis and enhances survival free from TVR, independent of abciximab use, although survival remains reduced compared with survival in nondiabetic patients regardless of reperfusion modality.     

Prophylactic abciximab in elective coronary stenting: results of a randomized trial

BACKGROUND: The use of abciximab (c7E3 Fab; ReoPro , Eli Lilly & Company, Indianapolis, Indiana) during percutaneous coronary intervention (PCI) decreases the incidence of early (30-day) and late (6-month to 1 year) adverse cardiac ischemic events. In a high-risk population, abciximab also reduced the need for target lesion revascularization. PCI of lesions with complex morphology, particularly long lesions, is associated with more complicated outcomes. The use of multiple and/or long intracoronary stents to cover long coronary lesions may lower the incidence of acute or subacute occlusion, but is still limited by a high late restenosis rate. We characterized patients undergoing elective implantation of long or multiple overlapping coronary stents and determined the impact of abciximab administration on clinical and angiographic outcomes. METHODS AND RESULTS: In a prospective, single-center randomized trial, a total of 107 patients undergoing elective implantation of long or multiple overlapping coronary stents were randomly assigned to receive either standard-dose heparin (n = 53) or abciximab plus low-dose heparin (n = 54). The use of abciximab was not associated with an increased incidence of bleeding or vascular complications compared to standard heparin regimen (3.7% versus 3.8%, respectively; p = NS). A 68% reduction in composite in-hospital cardiac events (i.e., death, myocardial infarction, urgent revascularization) was observed in the abciximab group (3.7% versus 11.5%, p = 0.1). At 6-month follow-up, a 48% reduction of target lesion revascularization (11% versus 21%; p = 0.1) and a decrease in binary angiographic restenosis were observed for abciximab-treated patients (17% versus 34%; p < 0.05). CONCLUSION: The peri-procedural use of abciximab during implantation of long or multiple overlapping coronary stents is safe and effective, as it does not increase bleeding or vascular complications compared to standard heparin anticoagulation and reduces the incidence of in-hospital adverse cardiac events; moreover, abciximab improves 6-month clinical and angiographic outcomes in such a complex setting.     

Outcome of nonobstructive residual dissections detected by intravascular ultrasound following percutaneous coronary intervention

The purpose of this study was to assess the outcome of nonobstructive (or non-flow-limiting) residual dissection (RD) after percutaneous coronary intervention. Results of 124 consecutive native coronary lesions with angiographic nonobstructive RD in 97 patients (RD group) were compared with outcomes of 124 lesions without RD in 100 patients (non-RD group), whose characteristics were matched with those of the RD group. RD occurred after stent implantation (81 of 124 lesions, 65%) or balloon angioplasty (43 of 124 lesions, 35%). Angiographic types of RD were type A in 8 lesions (6%), B in 101 (82%), and C in 15 (12%). Stents were implanted in 65% of the lesions in each group. Clinical success (94% in RD group vs 95% in non-RD group, p = 0.77) and the in-hospital major adverse cardiac event rates were found to be similar in the 2 groups (6% vs 3%, respectively; p = 0.33). The late angiographic and clinical outcomes were also comparable. By intravascular ultrasound (IVUS) evaluation of the dissections in the RD group, area stenosis correlated with the incidence of in-hospital major adverse cardiac events (p = 0.023), whereas the final minimal lumen area correlated inversely with the occurrence of restenosis (p = 0.011). An area stenosis > or =58% was the best predictor for the incidence of in-hospital major adverse cardiac events (sensitivity 0.68, specificity 0.68). Most nonobstructive RDs are "favorable" and do not need stent implantation. IVUS evaluation identifies "unfavorable" nonobstructive (or non-flow-limiting) dissections that might be prone to acute occlusion. Nonobstructive dissections can be left untreated when final IVUS reveals an area stenosis of < 60% at the site of a dissection.