Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial

Gregg W. Stone, MD; Mark Midei, MD; William Newman, MD; Mark Sanz, MD; James B. Hermiller, MD; Jerome Williams, MD; Naim Farhat, MD; Kenneth W. Mahaffey, MD; Donald E. Cutlip, MD; Peter J. Fitzgerald, MD, PhD; Poornima Sood, MD, MPhil; Xiaolu Su, MS; Alexandra J. Lansky, MD; for the SPIRIT III Investigators

JAMA. 2008;299(16):1903-1913.

Context  A thin, cobalt-chromium stent eluting the antiproliferative agent everolimus from a nonadhesive, durable fluoropolymer has shown promise in preliminary studies in improving clinical and angiographic outcomes in patients with coronary artery disease.

Objective  To evaluate the safety and efficacy of an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent.

Design, Setting, and Patients  The SPIRIT III trial, a prospective, randomized, single-blind, controlled trial enrolling patients at 65 academic and community-based US institutions between June 22, 2005, and March 15, 2006. Patients were 1002 men and women undergoing percutaneous coronary intervention in lesions 28 mm or less in length and with reference vessel diameter between 2.5 and 3.75 mm. Angiographic follow-up was prespecified at 8 months in 564 patients and completed in 436 patients. Clinical follow-up was performed at 1, 6, 9, and 12 months.

Interventions  Patients were randomized 2:1 to receive the everolimus-eluting stent (n = 669) or the paclitaxel-eluting stent (n = 333).

Main Outcome Measures  The primary end point was noninferiority or superiority of angiographic in-segment late loss. The major secondary end point was noninferiority assessment of target vessel failure events (cardiac death, myocardial infarction, or target vessel revascularization) at 9 months. An additional secondary end point was evaluation of major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization) at 9 and 12 months.

Results  Angiographic in-segment late loss was significantly less in the everolimus-eluting stent group compared with the paclitaxel group (mean, 0.14 [SD, 0.41] mm vs 0.28 [SD, 0.48] mm; difference, –0.14 [95% CI, –0.23 to –0.05]; P  .004). The everolimus stent was noninferior to the paclitaxel stent for target vessel failure at 9 months (7.2% vs 9.0%, respectively; difference, –1.9% [95% CI, –5.6% to 1.8%]; relative risk, 0.79 [95% CI, 0.51 to 1.23]; P < .001). The everolimus stent compared with the paclitaxel stent resulted in significant reductions in composite major adverse cardiac events both at 9 months (4.6% vs 8.1%; relative risk, 0.56 [95% CI, 0.34 to 0.94]; P = .03) and at 1 year (6.0% vs 10.3%; relative risk, 0.58 [95% CI, 0.37 to 0.90]; P = .02), due to fewer myocardial infarctions and target lesion revascularization procedures.

Conclusions  In this large-scale, prospective randomized trial, an everolimus-eluting stent compared with a paclitaxel-eluting stent resulted in reduced angiographic late loss, noninferior rates of target vessel failure, and fewer major adverse cardiac events during 1 year of follow-up.

Trial Registration  clinicaltrials.gov Identifier: NCT00180479

     

Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial

Context  In patients with de novo coronary lesions, drug-eluting stents have drastically reduced restenosis risk compared with bare metal stents and conventional balloon angioplasty. It is less clear whether drug-eluting stents are superior to conventional balloon angioplasty for the treatment of patients with in-stent restenosis. Objectives  To assess if drug-eluting stents are a more effective treatment of in-stent restenosis than conventional balloon angioplasty, and to assess the relative merits of 2 drug-eluting stents, a sirolimus-eluting stent and a paclitaxel-eluting stent. Design, Setting, and Participants  Randomized, open-label, active-controlled trial conducted among 300 patients with angiographically significant in-stent restenosis in 2 tertiary German centers from June 1, 2003, to October 20, 2003. Interventions  After pretreatment with 600 mg of clopidogrel for at least 2 hours before intervention, all patients were randomly assigned to 1 of 3 treatment groups: sirolimus stent, paclitaxel stent, or balloon angioplasty (100 patients in each group). Main Outcome Measures  Primary end point: angiographic restenosis (diameter stenosis 50%) at 6-month follow-up angiography based on "in-segment" analysis. Primary analysis was comparison between stent groups and balloon angioplasty groups; a secondary analysis compared sirolimus and paclitaxel stents. Results  Follow-up angiography was performed in 275 (92%) of 300 patients. The incidence of angiographic restenosis was 44.6% (41/92) in the balloon angioplasty group, 14.3% (13/91) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 21.7% (20/92) in the paclitaxel stent group (P = .001 vs balloon angioplasty). When compared with balloon angioplasty, receiving a sirolimus stent had a relative risk (RR) of angiographic restenosis of 0.32 (95% confidence interval [CI], 0.18-0.56); a paclitaxel stent had an RR of 0.49 (95% CI, 0.31-0.76). The incidence of target vessel revascularization was 33.0% (33/100) in the balloon angioplasty group, 8.0% (8/100) in the sirolimus stent group (P<.001 vs balloon angioplasty), and 19.0% (19/100) in the paclitaxel stent group (P = .02 vs balloon angioplasty). The secondary analysis showed a trend toward a lower rate of angiographic restenosis (P = .19) and a significantly lower rate of target vessel revascularization (P = .02) among sirolimus stent patients compared with paclitaxel stent patients. Conclusions  In patients with in-stent restenosis, a strategy based on sirolimus- or paclitaxel-eluting stents is superior to conventional balloon angioplasty for the prevention of recurrent restenosis. Sirolimus-eluting stents may be superior to paclitaxel-eluting stents for treatment of this disorder.      

Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial

Context  Compared with bare metal stents, sirolimus-eluting and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study. Objective  To compare the safety and efficacy of sirolimus-eluting vs paclitaxel-eluting coronary stents. Design  Prospective, randomized comparative trial (the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. Setting  Ninety hospitals in Europe, Latin America, and Asia. Patients  A total of 1386 patients (mean age, 62.6 years; 73.1% men; 28.0% with diabetes) with angina pectoris and 1 or 2 de novo lesions (2.25-3.00 mm in diameter) in native coronary arteries. Intervention  Patients were randomly assigned in a 1:1 ratio to receive a sirolimus-eluting stent (n = 701) or a paclitaxel-eluting stent (n = 685). Main Outcome Measures  The primary end point was in-lesion binary restenosis (presence of a more than 50% luminal-diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or non–Q-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization. Results  In-lesion binary restenosis at 8 months occurred in 86 patients (9.6%) with a sirolimus-eluting stent vs 95 (11.1%) with a paclitaxel-eluting stent (relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P = .31). For sirolimus- vs paclitaxel-eluting stents, respectively, the mean (SD) in-stent late loss was 0.09 (0.43) mm vs 0.31 (0.44) mm (difference, –0.22 mm; 95% CI, –0.26 to –0.18 mm; P<.001), mean (SD) in-stent diameter stenosis was 23.1% (16.6%) vs 26.7% (15.8%) (difference, –3.60%; 95% CI, –5.12% to –2.08%; P<.001), and the number of major adverse cardiac events at 1 year was 73 (10.7%) vs 76 (11.4%) (RR, 0.94; 95% CI, 0.69-1.27; P = .73). Conclusion  In this trial comparing sirolimus- and paclitaxel-eluting coronary stents, there were no differences in the rates of binary restenosis or major adverse cardiac events. Clinical Trial Registration  ClinicalTrials.gov Identifier: NCT00235092      

A prospective randomized antiplatelet trial of cilostazol versus clopidogrel in patients with bare metal stent

Background Cilostazol is a newly developed antiplatelet drug that has been widely applied for clinical use. Its antiplatelet action appears to be mainly related to inhibition of intracellular phosphodiesterase activity. Recently, cilostazol has been used for antiplatelet therapy after coronary bare metal stent implantation for thrombosis and restenosis prevention. This prospective randomized and double blind trial was designed to investigate the safety and efficacy of cilostazol for the prevention of late restenosis and acute or subacute stent thrombosis. Methods One hundred and twenty patients who underwent elective stent were randomly assigned to treatment group with cilostazol 200 mg/d (n = 60), clopidogrel 75 mg/d and aspirin 100 mg/d or to control group with clopidogrel treatment 75 mg/d (n = 60) and aspirin 100 mg/d. Follow-up coronary angiography was performed 6－9 months later.Results Nine months major adverse cardio-cerebral event (MACCE) were lower in treatment groups (P&lt;0.05). The quantitative coronary angiography (QCA) at 6 months follow-up showed that minimum lumen diameter (MLD) was higher in treatment group than that of control group [(2.14±0.52)mm vs (1.82±0.36)mm, P&lt;0.05]. Late lumen loss (LL) [(0.82±0.42)mm vs (1.31±0.58)mm; P&lt;0.01], restenosis rate (RR) (14% vs 32%; P&lt;0.05) and target lesion revascularizaion (TLR) rate (5% vs 17%; P&lt;0.05) were lower in treatment group than in control group.Conclusion Cilostazol therapy is an effective regimen for prevention not only stent thrombosis but also RR and TLR through reducing MLD without the risk of increasing bleeding.     

Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials

Context  Placement of sirolimus-eluting stents or paclitaxel-eluting stents has emerged as the predominant percutaneous treatment strategy in patients with coronary artery disease (CAD). Whether there are any differences in efficacy and safety between these 2 drug-eluting stents is unclear. Objective  To compare outcomes of sirolimus-eluting and paclitaxel-eluting coronary stents on the basis of data generated by randomized head-to-head clinical trials. Data Sources  PubMed and the Cochrane Central Register of Controlled Trials, conference proceedings from major cardiology meetings, and Internet-based sources of information on clinical trials in cardiology from January 2003 to April 2005. Study Selection  Randomized trials comparing the sirolimus-eluting stent with the paclitaxel-eluting stent in patients with CAD reporting the outcomes of interest (target lesion revascularization, angiographic restenosis, stent thrombosis, myocardial infarction [MI], death, and the composite of death or MI) during a follow-up of at least 6 months. Data Extraction  Two reviewers independently identified studies and abstracted data on sample size, baseline characteristics, and outcomes of interest. Data Synthesis  Six trials, including 3669 patients, met the selection criteria. No significant heterogeneity was found across trials. Target lesion revascularization, the primary outcome of interest, was less frequently performed in patients who were treated with the sirolimus-eluting stent (5.1%) vs the paclitaxel-eluting stent (7.8%) (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.49-0.84; P = .001). Similarly, angiographic restenosis was less frequently observed among patients assigned to the sirolimus-eluting stent (9.3%) vs the paclitaxel-eluting stent (13.1%) (OR, 0.68; 95% CI, 0.55-0.86; P = .001). Event rates for sirolimus-eluting vs paclitaxel-eluting stents were 0.9% and 1.1%, respectively, for stent thrombosis (P = .62); 1.4% and 1.6%, respectively, for death (P = .56); and 4.9% and 5.8%, respectively, for the composite of death or MI (P = .23). Conclusions  Patients receiving sirolimus-eluting stents had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stents. Rates of death, death or MI, and stent thrombosis were similar.      

紫杉醇药物涂层支架治疗左前降支病变临床研究

目的：探讨紫杉醇药物涂层支架（PES）治疗冠状动脉左前降支（LAD）病变的即刻疗效及预后。方法：2003年2月～2005年3月在本院造影证实连续LAD单支病变患者94例,共107处病变,按常规行经皮冠状动脉成形术加支架置入术,分析患者临床、X线影像学特征及手术成功率,并行随访。结果：94例患者中,29例置入PES,65例置入金属裸支架（BMS）,手术成功率100％。病变弥漫性30例（31．9％）,位于近段52例（55．3％）,中段12例（12．8％）。全部患者均完成术后6个月的随访并行造影复查。PES组术后6个月时造影复查2例（6,9％）发生再狭窄;BMS组1例1个月内因急性前壁心梗死亡,6个月时造影复查21例（32．3％）发生再狭窄。结论：PES置入治疗冠状动脉LAD病变安全有效,术后心源性猝死及非Q波性心肌梗死发生率与置入BMS者相似,支架内再狭窄发生率明显降低,因再狭窄需冠脉搭桥率也显著降低,术后6个月再狭窄率与文献报道冠脉搭桥术相近。     

冠脉内置入药物涂层支架与金属裸支架对冠心病患者血浆C反应蛋白水平的影响

目的:探讨冠脉内置入药物涂层支架(DES)和金属裸支架(BMS)对冠心病患者血浆C反应蛋白(CRP)水平的影响.方法:置入单个支架的稳定型心绞痛患者83例,其中成功置入DES 43例,成功置入BMS 40例,另选同期住院行冠脉造影检查显示冠状动脉不同程度狭窄而未行PCI的冠心病患者35例作对照,3组年龄、性别、身体状况、病变血管差异无统计学意义(P>0.05).分别于术前和术后48、72 h和2周取静脉血2 mL,测定血浆CRP水平.结果:术前3组血浆CRP水平差异无统计学意义(P>0.05),术后48、72 h DES和BMS组血浆CRP水平均较对照组升高,但DES组升高幅度较小(P<0.05).术后2周3组血浆CRP水平差异无统计学意义(P>0.05).结论:DES可能不会引发PCI术后的急性炎症反应.     

药物洗脱性支架和裸金属支架植入治疗冠状动脉狭窄的临床随访观察

目的探讨药物洗脱性支架(DES)和裸金属支架(BMS)治疗冠状动脉狭窄的远期疗效。方法对成功进行DES植入术患者2734例和BMS植入患者216例术后6个月、1年进行随访,观察其支架内再狭窄(ISR)发生率、急性心肌梗死发生率、冠状动脉旁路移植(CABG)或再次经皮冠状动脉介入治疗(PCI)治疗率、病死率,分析术后再狭窄的独立危险因素。结果术后6个月、1年时DES组ISR发生率均低于BMS组(9.58%vs 18.98%,18.32%vs 31.94%),差异有统计学意义(P<0.05);随访6个月时,急性心肌梗死发生率、CABG或再次PCI治疗率和病死率方面比较差异无统计学意义(P>0.05),但是随访1年后,其差异有统计学意义(P<0.05);多因素分析发现,支架直径≤3 mm、吸烟和年龄是支架植入术后发生再狭窄的独立危险因素。结论在冠状动脉狭窄的治疗中,DES的远期疗效优于BMS,但临床应用还需要进一步的循证医学研究证据。     

Effect of rimonabant on progression of atherosclerosis in patients with abdominal obesity and coronary artery disease: the STRADIVARIUS randomized controlled trial

Context  Abdominal obesity is associated with metabolic abnormalities and increased risk of atherosclerotic cardiovascular disease. However, no obesity management strategy has demonstrated the ability to slow progression of coronary disease. Objective  To determine whether weight loss and metabolic effects of the selective cannabinoid type 1 receptor antagonist rimonabant reduces progression of coronary disease in patients with abdominal obesity and the metabolic syndrome. Design, Setting, and Patients  Randomized, double-blinded, placebo-controlled, 2-group, parallel-group trial (enrollment December 2004-December 2005) comparing rimonabant with placebo in 839 patients at 112 centers in North America, Europe, and Australia. Interventions  Patients received dietary counseling, were randomized to receive rimonabant (20 mg daily) or matching placebo, and underwent coronary intravascular ultrasonography at baseline (n = 839) and study completion (n = 676). Main Outcome Measures  The primary efficacy parameter was change in percent atheroma volume (PAV); the secondary efficacy parameter was change in normalized total atheroma volume (TAV). Results  In the rimonabant vs placebo groups, PAV (95% confidence interval [CI]) increased 0.25% (–0.04% to 0.54%) vs 0.51% (0.22% to 0.80%) (P = .22), respectively, and TAV decreased 2.2 mm³ (–4.09 to –0.24) vs an increase of 0.88 mm³ (–1.03 to 2.79) (P = .03). In the rimonabant vs placebo groups, imputing results based on baseline characteristics for patients not completing the trial, PAV increased 0.25% (–0.04% to 0.55%) vs 0.57% (0.29% to 0.84%) (P = .13), and TAV decreased 1.95 mm³ (–3.8 to –0.10) vs an increase of 1.19 mm³ (–0.73 to 3.12) (P = .02). Rimonabant-treated patients had a larger reduction in body weight (4.3 kg [–5.1 to –3.5] vs 0.5 kg [–1.3 to 0.3]) and greater decrease in waist circumference (4.5 cm [–5.4 to –3.7] vs 1.0 cm [–1.9 to –0.2]) (P < .001 for both comparisons). In the rimonabant vs placebo groups, high-density lipoprotein cholesterol levels increased 5.8 mg/dL (4.9 to 6.8) (22.4%) vs 1.8 mg/dL (0.9 to 2.7) (6.9%) (P < .001), and median triglyceride levels decreased 24.8 mg/dL (–35.4 to –17.3) (20.5%) vs 8.9 mg/dL (–14.2 to –1.8) (6.2%) (P < .001). Rimonabant-treated patients had greater decreases in high-sensitivity C-reactive protein (1.3 mg/dL [–1.7 to –1.2] [50.3%] vs 0.9 mg/dL [–1.4 to –0.5] [30.9%]) and less increase in glycated hemoglobin levels (0.11% [0.02% to 0.20%] vs 0.40% [0.31% to 0.49%]) (P < .001 for both comparisons). Psychiatric adverse effects were more common in the rimonabant group (43.4% vs 28.4%, P < .001). Conclusions  After 18 months of treatment, the study failed to show an effect for rimonabant on disease progression for the primary end point (PAV) but showed a favorable effect on the secondary end point (TAV). Determining whether rimonabant is useful in management of coronary disease will require additional imaging and outcomes trials, which are currently under way. Trial Registration  clinicaltrials.gov Identifier: NCT00124332      

Platelet glycoprotein IIb/IIIa integrin blockade with eptifibatide in coronary stent intervention: the ESPRIT trial: a randomized controlled trial

CONTEXT: The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial showed the efficacy of adjunctive, double-bolus eptifibatide therapy in reducing ischemic complications of nonurgent coronary stent implantation at 48 hours and at 30 days. OBJECTIVE: To determine whether the beneficial effects of eptifibatide persist at 6 months after treatment. DESIGN: Follow-up study of a randomized, double-blind, placebo-controlled, crossover-permitted trial conducted from June 1999 through February 2000. SETTING: Ninety-two tertiary care centers in the United States and Canada. PARTICIPANTS: A total of 2064 patients scheduled to undergo nonurgent percutaneous coronary intervention with stent implantation. INTERVENTION: Patients were randomly assigned to receive placebo or eptifibatide (two 180-microg/kg boluses 10 minutes apart and continuous infusion of 2.0 microg/kg per minute), started immediately before stent implantation and continued for 18 to 24 hours. Complete follow-up data were available for 988 (95.0%) of 1040 patients given eptifibatide and 977 (95.4%) of 1024 patients given placebo. MAIN OUTCOME MEASURES: Composite rates of death or myocardial infarction (MI); death, MI, or target vessel revascularization; and their individual components 6 months after enrollment, compared between the 2 groups. RESULTS: By 6 months, the composite end point of death or MI had occurred in 7.5% of eptifibatide-treated patients and in 11.5% of placebo-treated patients (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.47-0.84; P =.002). The composite of death, MI, or target vessel revascularization was 14.2% in eptifibatide-treated patients vs 18.3% in placebo-treated patients (HR, 0.75; 95% CI, 0.60-0.93; P =.008). Most of this benefit accrued early (<48 hours after initiation of therapy) and was maintained through 6 months. Six-month mortality in the eptifibatide group was 0.8% vs 1.4% in the placebo group (HR, 0.56; 95% CI, 0.24-1.34; P =.19) and target vessel revascularization occurred in 8.6% of the eptifibatide group vs 9.4% of the placebo group (HR, 0.91; 95% CI, 0.68-1.22; P =.51). CONCLUSION: Adjunctive eptifibatide therapy during coronary stent implantation provides benefit through 6-month follow-up.     

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

Background  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 conduced 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.
Methods  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).
Results  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.
Conclusion  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.

     

Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial

Context  Exercise training for patients with Alzheimer disease combined with teaching caregivers how to manage behavioral problems may help decrease the frailty and behavioral impairment that are often prevalent in patients with Alzheimer disease. Objective  To determine whether a home-based exercise program combined with caregiver training in behavioral management techniques would reduce functional dependence and delay institutionalization among patients with Alzheimer disease. Design, Setting, and Patients  Randomized controlled trial of 153 community-dwelling patients meeting National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer Disease and Related Disorders Association criteria for Alzheimer disease, conducted between June 1994 and April 1999. Interventions  Patient-caregiver dyads were randomly assigned to the combined exercise and caregiver training progam, Reducing Disability in Alzheimer Disease (RDAD), or to routine medical care (RMC). The RDAD program was conducted in the patients' home over 3 months. Main Outcome Measures  Physical health and function (36-item Short-Form Health Survey's [SF-36] physical functioning and physical role functioning subscales and Sickness Impact Profile's Mobility subscale), and affective status (Hamilton Depression Rating Scale and Cornell Depression Scale for Depression in Dementia). Results  At 3 months, in comparison with the routine care patients, more patients in the RDAD group exercised at least 60 min/wk (odds ratio [OR], 2.82; 95% confidence interval [CI], 1.25-6.39; P = .01) and had fewer days of restricted activity (OR, 3.10; 95% CI, 1.08-8.95; P<.001). Patients in the RDAD group also had improved scores for physical role functioning compared with worse scores for patients in the RMC group (mean difference, 19.29; 95% CI, 8.75-29.83; P<.001). Patients in the RDAD group had improved Cornell Depression Scale for Depression in Dementia scores while the patients in the RMC group had worse scores (mean difference, -1.03; 95% CI, -0.17 to -1.91; P = .02). At 2 years, the RDAD patients continued to have better physical role functioning scores than the RMC patients (mean difference, 10.89; 95% CI, 3.62-18.16; P = .003) and showed a trend (19% vs 50%) for less institutionalization due to behavioral disturbance. For patients with higher depression scores at baseline, those in the RDAD group improved significantly more at 3 months on the Hamilton Depression Rating Scale (mean difference, 2.21; 95% CI, 0.22-4.20; P = .04) and maintained that improvement at 24 months (mean difference, 2.14; 95% CI, 0.14-4.17; P = .04). Conclusion  Exercise training combined with teaching caregivers behavioral management techniques improved physical health and depression in patients with Alzheimer disease.      

75岁以上冠心病患者冠状动脉内支架术的临床评估

目的　评估高龄因素对冠心病患者选择性冠状动脉内支架术成功率和安全性的影响。方法　将已进行选性冠状动脉内支架术的 1 9例冠心病患者的临床特点、支架术成功率、手术并发症及近期疗效进行回顾性对照分析 ,并与 1 5 0例非高龄患者作比较。结果　高龄组的支架术成功率为 94.7% ,非高龄组为 96.0 % ,两组比较无显著性差异 (P>0 .0 5 ) ;高龄组的冠状动脉血管并发症发生率为 5 .3 % ,外周血管并发症发生率为 5 .3 % ,术后近期硝酸酯类药物停用率为 44.4% ,非高龄分别为 6.6%、6.0 %及 42 .4% ,两组比较无显著性差异 (P >0 .0 5 )。结论　 75岁以上冠心病患者冠状动脉内支架术成功率和安全性均高 ,高龄因素对冠心病患者选性冠状动脉内支架术成功率和安全性无显著影响。     

75岁以上冠心病患者冠状动脉内支架术的临床评估

目的评估高龄因素对冠心病患者选择性冠状动脉内支架术成功率和安全性的影响.方法将已进行选性冠状动脉内支架术的19例冠心病患者的临床特点、支架术成功率、手术并发症及近期疗效进行回顾性对照分析,并与150例非高龄患者作比较.结果高龄组的支架术成功率为94.7%,非高龄组为96.0%,两组比较无显著性差异(P>0.05);高龄组的冠状动脉血管并发症发生率为5.3%,外周血管并发症发生率为5.3%,术后近期硝酸酯类药物停用率为44.4%,非高龄分别为6.6%、6.0%及42.4%,两组比较无显著性差异(P>0.05).结论 75岁以上冠心病患者冠状动脉内支架术成功率和安全性均高,高龄因素对冠心病患者选性冠状动脉内支架术成功率和安全性无显著影响.     

Effects of antibiotic therapy on outcomes of patients with coronary artery disease: a meta-analysis of randomized controlled trials

Context  Although Chlamydia pneumoniae infection has been associated with the initiation and progression of atherosclerosis, results of clinical trials investigating antichlamydial antibiotics as adjuncts to standard therapy in patients with coronary artery disease (CAD) have been inconsistent. Objective  To conduct a meta-analysis of clinical trials of antichlamydial antibiotic therapy in patients with CAD. Data Sources  The MEDLINE and Cochrane Central Register of Controlled Trials databases were searched from 1966 to April 2005 for English-language trials of antibiotic therapy in patients with CAD. Bibliographies of retrieved articles were searched for further studies. Presentations at major scientific meetings (2003-2004) were also reviewed. Search terms included antibacterial agents, myocardial infarction, unstable angina, and coronary arteriosclerosis. Study Selection  Eligible studies were prospective, randomized, placebo-controlled trials of antichlamydial antibiotic therapy in patients with CAD that reported all-cause mortality, myocardial infarction, or unstable angina. Of the 110 potentially relevant articles identified, 11 reports enrolling 19 217 patients were included. Data Extraction  Included studies were reviewed to determine the number of patients randomized, mean duration of follow-up, and end points. End points of interest included all-cause mortality, myocardial infarction (MI), and a combined end point of MI and unstable angina. Data Synthesis  Event rates were combined using a random-effects model. Antibiotic therapy had no impact on all-cause mortality among treated vs untreated patients (4.7% vs 4.6%; odds ratio [OR], 1.02; 95% confidence interval [CI], 0.89-1.16; P = .83), on the rates of MI (5.0% vs 5.4%; OR, 0.92; 95% CI, 0.81-1.04; P = .19), or on the combined end point of MI and unstable angina (9.2% vs 9.6%; OR, 0.91; 95% CI, 0.76-1.07; P = .25). Conclusion  Evidence available to date does not demonstrate an overall benefit of antibiotic therapy in reducing mortality or cardiovascular events in patients with CAD.      

经桡动脉冠状动脉腔内支架植入术治疗老年女性冠心病

目的 比较经桡动脉与股动脉途径行冠状动脉介入治疗老年女性冠心病的时间、治疗成功率和并发症.方法 回顾性分析80例行介入治疗的60岁以上的老年女性冠心病患者资料,其中经桡动脉介入(transradial coronary intervention,TRI)组40例,经股动脉介入(transfemoral coronary intervention,TFI)组40例.随访30 d,观察两组穿刺成功率、手术成功率及并发症.结果 两组患者手未成功率相似(95%及97.5%,P=0.556);经皮冠状动脉介入治疗时间分别为(61±16)min与(61±10)min,两组间差异无显著性(P=0.999).但TRI组的术后并发症及住院时间显著低于TFI组.结论 经桡动脉途径与股动脉途径介入治疗冠状动脉病变时间及成功率相似,但前者术后并发症明显减少.     

Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial

Context  Although low levels of high-density lipoprotein cholesterol (HDL-C) increase risk for coronary disease, no data exist regarding potential benefits of administration of HDL-C or an HDL mimetic. ApoA-I Milano is a variant of apolipoprotein A-I identified in individuals in rural Italy who exhibit very low levels of HDL. Infusion of recombinant ApoA-I Milano–phospholipid complexes produces rapid regression of atherosclerosis in animal models. Objective  We assessed the effect of intravenous recombinant ApoA-I Milano/phospholipid complexes (ETC-216) on atheroma burden in patients with acute coronary syndromes (ACS). Design  The study was a double-blind, randomized, placebo-controlled multicenter pilot trial comparing the effect of ETC-216 or placebo on coronary atheroma burden measured by intravascular ultrasound (IVUS). Setting  Ten community and tertiary care hospitals in the United States. Patients  Between November 2001 and March 2003, 123 patients aged 38 to 82 years consented, 57 were randomly assigned, and 47 completed the protocol. Interventions  In a ratio of 1:2:2, patients received 5 weekly infusions of placebo or ETC-216 at 15 mg/kg or 45 mg/kg. Intravascular ultrasound was performed within 2 weeks following ACS and repeated after 5 weekly treatments. Main Outcome Measures  The primary efficacy parameter was the change in percent atheroma volume (follow-up minus baseline) in the combined ETC-216 cohort. Prespecified secondary efficacy measures included the change in total atheroma volume and average maximal atheroma thickness. Results  The mean (SD) percent atheroma volume decreased by -1.06% (3.17%) in the combined ETC-216 group (median, -0.81%; 95% confidence interval [CI], -1.53% to -0.34%; P = .02 compared with baseline). In the placebo group, mean (SD) percent atheroma volume increased by 0.14% (3.09%; median, 0.03%; 95% CI, -1.11% to 1.43%; P = .97 compared with baseline). The absolute reduction in atheroma volume in the combined treatment groups was -14.1 mm³ or a 4.2% decrease from baseline (P<.001). Conclusions  A recombinant ApoA-I Milano/phospholipid complex (ETC-216) administered intravenously for 5 doses at weekly intervals produced significant regression of coronary atherosclerosis as measured by IVUS. Although promising, these results require confirmation in larger clinical trials with morbidity and mortality end points.      

Long-term outcome of patients of over 85 years old with acute coronary syndrome undergoing percutaneous coronary stenting: a comparison of bare metal stent and drug eluting stent

Background Patients aged over 85 years have been under-represented in percutaneous coronary intervention （PCI） trials despite an increase in referrals for PCI. The long-term safety and efficacy of percutaneous coronary stenting in patients aged over 85 years with acute coronary syndrome （ACS） remain unclear. Moreover it is unknown whether there are differences between bare metal stent （BMS） and drug eluting stent iDES） in this special population.
Methods A total of 80 patients with ACS aged over 85 years undergoing stenting （BMS group n=21 vs DES group n=59） were retrospectively studied. In-hospital, one year and overall clinical follow-up （12-36 months） of major adverse cardiac events （MACEs） including cardiac deaths, myocardial infarction, target lesion revascutarization （TLR） and target vessel revascularization （TVR） as well as stroke and other major bleeding were compared between the two groups.
Results In the entire cohort, the procedure success rate was 93.8% with TIMI-3 coronary flow post-PCI in 93.8% of the vessels and the procedure related complication was 17.5%. The incidence of in-hospital MACEs in BMS group was higher （14.3% vs 6.8%, P=0.30）. The 1-year incidence of MACEs in DES group was 7.0% while there was no MACE in the BMS group. Clinical follow-up for 12-36 months showed that the overall survival free from MACE was 82.9% and the incidence of MACE in the BMS group was lower （5.3% vs 21.1%, P=0.20）. Multivariate regression analysis showed that the creatinine level （OR：. 1.013; 95%CI： 1.006-1.020; P=0.004） and hypertension （OR; 3.201; 95%CI： 1.000-10.663; P=0.04） are two major factors affecting the long-term MACE.
Conclusions Percutaneous coronary stenting in patients aged over 85 years is safe and provides good short and tona-term efficacy. Patients with renal dvsfunction and hvoertension may have a relatively hiah incidence of MACE.     

碎片状QRS波诊断冠心病的意义

目的 探讨心电图中碎片状QRS复合波(fQRS)的出现对诊断陈旧性心肌梗死的意义.方法 选择2009～2010年在新乡医学院第一附属医院心血管内科住院并接受冠状动脉造影、心电图检查的患者369例作为研究对象.结果ST-T改变诊断冠心病的敏感性、特异性、阴性预测值分别为:62.5%,45.6%,48.8%;fQRS分别为:49.5%,66.3%,50.8%;ST-T和/或fQRS分别为:75.5%,71.6%,69.7%.结论 心电图中fQRS波的出现与ST-T改变的联合分析能显著提高冠心病诊断的敏感性及特异性.