A clinical trial of abciximab in elective percutaneous coronary intervention after pretreatment with clopidogrel.

BACKGROUND: Whether the glycoprotein IIb/IIIa inhibitor abciximab is beneficial in patients undergoing elective percutaneous coronary intervention after pretreatment with clopidogrel is unknown. METHODS: We enrolled 2159 patients with coronary artery disease who underwent a percutaneous coronary intervention: 1079 patients were randomly assigned in a double-blind manner to receive abciximab and 1080 patients to receive placebo. All patients were pretreated with a 600-mg dose of clopidogrel at least two hours before the procedure. The primary end point of the trial was the composite of death, myocardial infarction, and urgent target-vessel revascularization within 30 days after randomization. RESULTS: The incidence of the primary end point was 4 percent (45 patients) in the abciximab group, as compared with 4 percent (43 patients) in the placebo group (relative risk, 1.05; 95 percent confidence interval, 0.69 to 1.59; P=0.82). Most adverse events were myocardial infarctions: the incidence was 4 percent (40 patients) in the abciximab group and 4 percent (41 patients) in the placebo group (P=0.91). Twelve patients (1 percent) in the abciximab group and eight patients (1 percent) in the placebo group had major bleeding complications (P=0.37). Profound thrombocytopenia occurred in 10 patients (1 percent) in the abciximab group but in none in the placebo group (P=0.002). CONCLUSIONS: Our data suggest that in patients at low-to-intermediate risk who undergo elective percutaneous coronary intervention after pretreatment with a high loading dose of clopidogrel, abciximab is associated with no clinically measurable benefit within the first 30 days.

Gender and myocardial salvage after reperfusion treatment in acute myocardial infarction.

OBJECTIVES: The aim of this study was to investigate whether there are gender-associated differences in the amount of myocardial salvage after primary percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI). BACKGROUND: Despite having a more adverse cardiovascular risk profile, women with AMI have similar or even better outcomes after primary PCI compared with men. The reasons for these findings are unclear. METHODS: In this study we included 202 women and 561 men with AMI who underwent primary PCI in the setting of three randomized trials. The primary end point of the study was myocardial salvage index (proportion of initial perfusion defect salvaged by reperfusion therapy), obtained by paired scintigraphic studies performed 7 to 10 days apart. RESULTS: The amount of myocardium at risk or initial perfusion defect (median [25th, 75th percentiles]) did not differ significantly between women and men (22.0% [12.0, 40.0] vs. 24.0% [14.0, 39.0] of the left ventricle [LV], p = 0.26). Final infarct size, measured in the follow-up scintigraphy, was significantly smaller in women than in men (6.0% [0.71, 18.7] vs. 10.0% [3.9, 21.8] of the LV, p = 0.001). Myocardial salvage index was 0.64 (0.35, 0.95) in women versus 0.50 (0.26, 0.77) in men (p < 0.001). After adjustment for baseline characteristics, female gender was an independent predictor of greater myocardial salvage after PCI (p = 0.002). CONCLUSIONS: The efficacy of primary PCI in patients with AMI appears to be gender-dependent. Myocardial salvage achieved by primary PCI is greater in women than in men.

Abciximab and angiographic restenosis after coronary stent placement. Analysis of the angiographic substudy of ISAR-REACT--a double-blind, placebo-controlled, randomized trial evaluating abciximab in patients undergoing elective percutaneous coronary interventions after pretreatment with a high loading dose of clopidogrel.

BACKGROUND: ISAR-REACT was a trial designed to evaluate whether the glycoprotein IIb/IIIa inhibitor abciximab is beneficial in patients undergoing elective percutaneous coronary intervention (PCI) with stent placement after pretreatment with a 600 mg loading dose of clopidogrel. Objective for the angiographic substudy was to determine the impact of abciximab on angiographic restenosis after coronary stent placement. Previous analyses have suggested a reduction in the incidence of restenosis after the administration of abciximab. METHODS: The angiographic substudy comprises 1885 of 2159 patients enrolled in ISAR-REACT: 994 patients were randomly assigned to abciximab and 941 patients to placebo. All patients were scheduled for a routine angiographic follow-up after 6 months (performed in 80% of eligible patients). End points for the angiographic substudy were the rates of angiographic restenosis (> or = 50% diameter stenosis) and target lesion revascularization. RESULTS: The incidence of angiographic restenosis was 27% in the abciximab group and 29% in the placebo group (relative risk 0.92, 95% CI 0.79-1.06, P = .27). Late angiographic lumen loss was 0.95 +/- 0.68 and 0.99 +/- 0.70 mm, respectively (P = .25). Similar results were obtained in a subgroup analysis focusing on high-risk subsets. The rate of target lesion revascularization procedures was 22% in the abciximab group and 23% in the placebo group (relative risk 0.94, 95% CI 0.79-1.12, P = .52). CONCLUSIONS: In low- to intermediate-risk patients who undergo elective PCI after pretreatment with a high loading dose of clopidogrel >2 hours before PCI, the additional administration of the glycoprotein IIb/IIIa inhibitor abciximab is not associated with a significant reduction in angiographic restenosis.

Abciximab in patients with acute coronary syndromes undergoing percutaneous coronary intervention after clopidogrel pretreatment: the ISAR-REACT 2 randomized trial.

CONTEXT: No specifically designed studies have addressed the role of the glycoprotein IIb/IIIa inhibitor abciximab in patients with non-ST-segment elevation acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) after pretreatment with 600 mg of clopidogrel. OBJECTIVE: To assess whether abciximab is associated with clinical benefit in high-risk patients with ACS undergoing PCI after pretreatment with 600 mg of clopidogrel. DESIGN, SETTING, AND PATIENTS: International, multicenter, randomized, double-blind, placebo-controlled study conducted from March 2003 through December 2005, enrolling 2022 patients (mean age, 66 years) with non-ST-segment elevation ACS undergoing PCI. INTERVENTIONS: Patients were assigned to receive either abciximab (0.25 mg/kg of body weight bolus, followed by a 0.125-microg/kg per minute [maximum, 10 microg/min] infusion for 12 hours, plus heparin, 70 U/kg of body weight) or placebo (placebo bolus and infusion of 12 hours, plus heparin bolus, 140 U/kg). All patients received clopidogrel, 600 mg, at least 2 hours prior to the procedure, as well as 500 mg of oral or intravenous aspirin. MAIN OUTCOME MEASURES: The primary end point was a composite of death, myocardial infarction, or urgent target vessel revascularization occurring within 30 days after randomization; secondary end points were rates of in-hospital major and minor bleeding. RESULTS: Of 2022 patients enrolled, 1012 were assigned to abciximab and 1010 to placebo. The primary end point was reached in 90 patients (8.9%) assigned to abciximab vs 120 patients (11.9%) assigned to placebo, a 25% reduction in risk with abciximab (relative risk [RR], 0.75; 95% CI, 0.58-0.97; P = .03). Among patients without an elevated troponin level, there was no difference in the incidence of primary end point events between the abciximab group (23/499 patients [4.6%]) and the placebo group (22/474 patients [4.6%]) (RR, 0.99; 95% CI, 0.56-1.76; P = .98), whereas among patients with an elevated troponin level, the incidence of events was significantly lower in the abciximab group (67/513 patients [13.1%]) compared with the placebo group (98/536 patients [18.3%]), which corresponds to an RR of 0.71 (95% CI, 0.54-0.95; P = .02) (P = .07 for interaction). There were no significant differences between the 2 groups regarding the risk of major and minor bleeding as well as need for transfusion. CONCLUSIONS: Abciximab reduces the risk of adverse events in patients with non-ST-segment elevation ACS undergoing PCI after pretreatment with 600 mg of clopidogrel. The benefits provided by abciximab appear to be confined to patients presenting with an elevated troponin level. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00133003.

Stem cell mobilization by granulocyte colony-stimulating factor in patients with acute myocardial infarction: a randomized controlled trial.

CONTEXT: Experimental studies and early phase clinical trials suggest that transplantation of blood-derived or bone marrow-derived stem cells may improve cardiac regeneration and neovascularization after acute myocardial infarction. Granulocyte colony-stimulating factor (G-CSF) induces mobilization of bone marrow stem cells. OBJECTIVE: To assess the value of stem cell mobilization by G-CSF therapy in patients with acute myocardial infarction. DESIGN, SETTING, AND PATIENTS: Randomized, double-blind, placebo-controlled trial of patients diagnosed with ST-segment elevation acute myocardial infarction who had successful reperfusion by percutaneous coronary intervention within 12 hours after onset of symptoms in Germany between February 24, 2004, and February 2, 2005. INTERVENTIONS: Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days. MAIN OUTCOME MEASURES: The primary end point was reduction of left ventricular infarct size according to technetium Tc 99m sestamibi scintigraphy performed at baseline and at 4 to 6 months after randomization. Secondary end points included improvement of left ventricular ejection fraction measured by magnetic resonance imaging and the incidence of angiographic restenosis. RESULTS: Of the 114 patients, 56 were assigned to receive treatment with G-CSF and 58 were assigned to receive placebo. Treatment with G-CSF produced a significant mobilization of stem cells. Between baseline and follow-up, left ventricular infarct size according to scintigraphy was reduced by a mean (SD) of 6.2% (9.1%) in the G-CSF group and 4.9% (8.9%) in the placebo group (P = .56) and left ventricular ejection fraction was improved by 0.5% (3.8%) in the G-CSF group and 2.0% (4.9%) in the placebo group (P = .14). Angiographic restenosis occurred in 19 (35.2%) of 54 patients in the G-CSF group and in 17 (30.9%) of 55 patients in the placebo group (P = .79). The most common adverse event among patients assigned to G-CSF was mild to moderate bone pain and muscle discomfort. CONCLUSION: Stem cell mobilization by G-CSF therapy in patients with acute myocardial infarction and successful mechanical reperfusion has no influence on infarct size, left ventricular function, or coronary restenosis. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00126100.

Randomized clinical trial of abciximab in diabetic patients undergoing elective percutaneous coronary interventions after treatment with a high loading dose of clopidogrel.

BACKGROUND: Diabetic patients are at increased risk of adverse outcomes after percutaneous coronary interventions. Although subset analyses suggest particular benefit from the administration of abciximab in diabetic patients, no dedicated large randomized trials have been performed in diabetic patients undergoing percutaneous coronary intervention, and certainly not after pretreatment with a high loading dose of clopidogrel. METHODS AND RESULTS: This study (Intracoronary Stenting and Antithrombotic Regimen: Is Abciximab a Superior Way to Eliminate Elevated Thrombotic Risk in Diabetics [ISAR-SWEET] Study) enrolled 701 diabetic patients with coronary artery disease who underwent an elective percutaneous coronary intervention after pretreatment with a 600-mg dose of clopidogrel >2 hours before the procedure: 351 patients were randomly assigned to abciximab and 350 patients to placebo. The primary end point of the trial was the composite incidence of death and myocardial infarction at 1 year. The frequency of angiographic restenosis (diameter stenosis > or =50%) was the secondary end point. The incidence of death or myocardial infarction was 8.3% in the abciximab group and 8.6% in the placebo group (P=0.91), with a relative risk of 0.97 (95% CI, 0.58 to 1.62). The incidence of angiographic restenosis was 28.9% in the abciximab group and 37.8% in the placebo group (P=0.01), with a relative risk of 0.76 (95% CI, 0.62 to 0.94). The incidence of target lesion revascularization was 23.2% in the abciximab group and 30.4% in the placebo group (P=0.03). CONCLUSIONS: The findings of this study do not support a significant impact of abciximab on the risk of death and myocardial infarction in diabetic patients undergoing percutaneous coronary interventions after pretreatment with a 600-mg loading dose of clopidogrel at least 2 hours before the procedure. The present findings suggest, however, that abciximab reduces the risk of restenosis in diabetic patients receiving coronary bare metal stents.

Therapy-dependent influence of time-to-treatment interval on myocardial salvage in patients with acute myocardial infarction treated with coronary artery stenting or thrombolysis.

BACKGROUND: The relationship between myocardial salvage and time-to-treatment interval in patients with acute myocardial infarction (AMI) treated with coronary artery stenting or thrombolysis has not been studied. METHODS AND RESULTS: This study analyzed 264 patients with AMI randomized to coronary stenting (133 patients) or thrombolysis (131 patients) in the setting of 2 randomized trials. Patients were divided into the following 3 groups defined by tertiles of the time-to-treatment interval: lower tertile (<165 minutes), middle tertile (165 to 280 minutes), and upper tertile (>280 minutes). Paired scintigraphic examinations were performed to obtain salvage index, which was the primary end point of the study. In the group with thrombolysis, the salvage index (median [25th; 75th] percentile) was 0.45 (0.16; 0.83) in the lower, 0.29 (0.17; 0.48) in the middle, and 0.20 (0.04; 0.46) in the upper tertile (P=0.03). In the group with stenting, the salvage index was 0.56 (0.49; 0.75) in the lower, 0.57 (0.36; 0.73) in the middle, and 0.57 (0.32; 0.75) in the upper tertile (P=0.59). In patients treated with stenting, the salvage index was greater than in patients treated with thrombolysis in the lower (0.56 versus 0.45, P=0.09), middle (0.57 versus 0.29, P=0.0003), and upper (0.57 versus 0.20, P=0.0005) tertiles of the time-to-treatment interval. CONCLUSIONS: The influence of the time-to-treatment interval on the myocardial salvage in patients with AMI depends on the type of reperfusion therapy. Coronary artery stenting was superior to thrombolysis independent of the time-to-treatment intervals, and the difference in benefit increased with more prolonged time from symptom onset.

A randomized trial comparing myocardial salvage achieved by coronary stenting versus balloon angioplasty in patients with acute myocardial infarction considered ineligible for reperfusion therapy.

OBJECTIVES: We assessed myocardial salvage achieved by reperfusion with percutaneous coronary interventions (PCI) and compared stenting with balloon angioplasty (PTCA) in patients with acute myocardial infarction (AMI) ineligible for thrombolysis. BACKGROUND: A substantial proportion of patients with AMI are currently considered ineligible for thrombolysis, and reperfusion treatment is frequently not recommended for them. It is not known whether these patients benefit from PCI. METHODS: The Stent or PTCA for Occluded Coronary Arteries in Patients with Acute Myocardial Infarction Ineligible for Thrombolysis (STOPAMI-3) trial, a randomized, open-label study, included 611 patients with AMI who were ineligible for thrombolysis (lack of ST-segment elevation on the electrocardiogram, late presentation >12 h after symptom onset, and contraindications to thrombolysis). Patients were randomly assigned to receive either coronary artery stenting (n = 305) or PTCA (n = 306). Scintigraphic myocardial salvage index (proportion of the initial myocardial perfusion defect that was salvaged by reperfusion) was the primary end point of the study. RESULTS: A considerable myocardial salvage was achieved with both stenting and PTCA. In patients assigned to receive stenting, the median size of the salvage index was 0.54 (25th and 75th percentiles, 0.29 and 0.87), as compared with a median of 0.50 (25th and 75th percentiles, 0.26 and 0.82) in the group assigned to receive PTCA (p = 0.20). Mortality at six months was 8.2% in the group of patients assigned to receive stenting and 9.2% in the group of patients assigned to receive PTCA (p = 0.69). CONCLUSIONS: Patients with AMI who are currently considered ineligible for thrombolysis by conventional guidelines may greatly benefit from primary PCI. The benefit seems to be comparable when a strategy of stenting is compared with a strategy of PTCA in these patients.

Influence of treatment duration with a 600-mg dose of clopidogrel before percutaneous coronary revascularization.

OBJECTIVES: We examined clinical outcomes in the Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment (ISAR-REACT) trial based on the duration of pretreatment with a 600-mg loading dose of clopidogrel. BACKGROUND: The influence of the treatment duration with a 600-mg dose of clopidogrel before percutaneous coronary revascularization on early outcomes remains uncertain. METHODS: Among 2,159 patients with coronary disease who underwent percutaneous coronary intervention (PCI) in the ISAR-REACT trial, we examined clinical outcomes relative to the duration of pretreatment with a 600-mg dose of clopidogrel: (2 to 3 h, 3 to 6 h, 6 to 12 h, or >12 h). Patients were randomly assigned to adjunctive therapy with abciximab or placebo at the beginning of the study. The primary end point was a composite of death, myocardial infarction, or urgent revascularization within 30 days after randomization. RESULTS: No significant differences were observed between patient groups regarding the duration of pretreatment, irrespective of assignment to abciximab or placebo (p = 0.27 for interaction among abciximab/clopidogrel and placebo/clopidogrel treatment at each time interval). Occurrence of major bleeding also did not differ according to time of initial clopidogrel dosing. CONCLUSIONS: For low-to-intermediate risk patients treated with a 600-mg loading dose of clopidogrel before PCI, incremental clinical benefit within the first 30 days from durations of pretreatment >2 to 3 h was not evident.

Prognostic value of impaired fasting glucose for outcomes of patients with stable angina pectoris treated with percutaneous coronary interventions.

The prognostic value of the newly defined impaired fasting glucose (IFG) range (100 to 109 mg/dl) for the outcomes of patients undergoing percutaneous coronary interventions is unknown. We assessed the composite of death or myocardial infarction at 1 year of follow-up in 189 patients with IFG and 801 patients with a normal fasting glucose (<100 mg/dl), all with stable angina. The 1-year cumulative rate of death or myocardial infarction was 10.3% in the IFG group and 4.4% in the normal fasting glucose group (p = 0.002). In the multivariate model, IFG was an independent predictor of the occurrence of death or myocardial infarction (adjusted hazard ratio 2.30, 95% confidence interval 1.29 to 4.08, p = 0.005). An IFG of 100 to 109 mg/dl in patients with stable angina who undergo percutaneous coronary intervention may identify a patient subset with an increased risk of death or myocardial infarction.

Sex-associated differences in clinical outcomes after coronary stenting in patients with diabetes mellitus.

PURPOSE: It has been suggested that the influence of diabetes on cardiovascular mortality is sex dependent. We undertook this study to determine whether there were sex-related differences in 1-year clinical outcomes following coronary artery stenting in diabetic patients. METHODS: The study included 4460 consecutive patients (1084 women) who underwent coronary artery stenting for stable or unstable angina, of whom 970 (22%) had diabetes. Six-month follow-up angiography was performed in 3452 patients (77.4%). The primary endpoint was the combined incidence of major adverse cardiac events (death, myocardial infarction, and target vessel revascularization). RESULTS: Diabetes was associated with a significant increase in the combined incidence of death, myocardial infarction, and target vessel revascularization at 1 year in women; this incidence was greater in diabetic women than in nondiabetic women (26.9% [84/312] vs. 18.9% [146/772]; odds ratio [OR] = 1.5; 95% confidence interval [CI]: 1.2 to 2.0; P = 0.002). The primary endpoint appeared to be similar in men regardless of diabetes status (24.6% [162/658] with diabetes vs. 23.3% [634/2718] without diabetes; OR = 1.07; 95% CI: 0.90 to 1.27; P = 0.43). There was a significant interaction between diabetes and sex in both unadjusted (P = 0.03) and adjusted (P = 0.04) analyses, with diabetes having a greater negative effect in women than in men for major adverse cardiac events after coronary stenting. CONCLUSION: In patients who underwent coronary artery stenting, the increased risk of adverse cardiac events associated with diabetes was more pronounced in women than in men.

A randomized evaluation of the effects of glucose-insulin-potassium infusion on myocardial salvage in patients with acute myocardial infarction treated with reperfusion therapy.

BACKGROUND: Intravenous glucose-insulin-potassium (GIK) may have a positive metabolic influence in patients with acute myocardial infarction (AMI) who receive reperfusion therapy. The objective of this randomized trial was to assess for the first time whether GIK improves myocardial salvage in patients with AMI. METHODS: The Reevaluation of Intensified Venous Metabolic Support for Acute Infarct Size Limitation (REVIVAL) trial is a randomized, open-label study conducted among 312 patients with AMI. Patients were randomly assigned to either the GIK therapy group (n = 155) or the control group (n = 157). All patients were intended to receive reperfusion treatment, which was given in all but 5 patients (1.6%). The primary end point of the study was salvage index, measured as the proportion of initial perfusion defect (acute technetium-99m sestamibi scintigraphy) salvaged by therapy (follow-up scintigraphy performed after 7 to 14 days). RESULTS: The primary end point of the study, the salvage index, was in median 0.50 (25th, 75th percentiles: 0.18, 0.87) in the GIK group and 0.48 (25th, 75th percentiles: 0.27, 0.78) in the control group (P =.96). By 6 months, the mortality rate was 5.8% in the GIK group and 6.4% in the control group (P =.85; relative risk, 0.92; 95% CI, 0.37 to 2.26). Subgroup analyses showed that GIK therapy was associated with increased salvage index only among diabetic patients (mean difference, 0.19; 95% CI, 0.01 to 0.37). CONCLUSIONS: The routine use of GIK therapy in patients with AMI is not associated with enhanced myocardial salvage. This therapy appears to improve myocardial salvage only among diabetic patients.

Evaluation of prolonged antithrombotic pretreatment ("cooling-off" strategy) before intervention in patients with unstable coronary syndromes: a randomized controlled trial.

CONTEXT: In unstable coronary syndromes, catheter intervention is frequently preceded by antithrombotic treatment to reduce periprocedural risk; however, evidence from clinical trials to support antithrombotic pretreatment is sparse. OBJECTIVE: To test the hypothesis that prolonged antithrombotic pretreatment improves the outcome of catheter intervention in patients with acute unstable coronary syndromes compared with early intervention. DESIGN, SETTING, AND PATIENTS: Randomized controlled trial conducted from February 27, 2000, to April 8, 2002, and including patients admitted to 2 German tertiary care centers with symptoms of unstable angina plus either ST-segment depression or elevation of cardiac troponin T levels. INTERVENTIONS: Patients were randomly allocated to antithrombotic pretreatment for 3 to 5 days or to early intervention after pretreatment for less than 6 hours. In both groups, antithrombotic pretreatment consisted of intravenous unfractionated heparin (60-U/kg bolus followed by infusion adjusted to maintain partial thromboplastin time of 60 to 85 seconds), aspirin (500-mg intravenous bolus followed by 100-mg twice-daily oral dose), oral clopidogrel (600-mg loading dose followed by 75-mg twice-daily dose), and intravenous tirofiban (10- microg/kg bolus followed by continuous infusion of 0.10 microg/kg per min). MAIN OUTCOME MEASURE: Composite 30-day incidence of large nonfatal myocardial infarction or death from any cause. RESULTS: Of the 410 patients enrolled, 207 were allocated to receive prolonged antithrombotic pretreatment and 203 to receive early intervention. Elevated levels of cardiac troponin T were present in 274 patients (67%), while 268 (65%) had ST-segment depression. The antithrombotic pretreatment and the early intervention groups were well matched with respect to major baseline characteristics and definitive treatment (catheter revascularization: 133 [64.3%] vs 143 [70.4%], respectively; coronary artery bypass graft surgery: 16 [7.7%] vs 16 [7.9%]). The primary end point was reached in 11.6% (3 deaths, 21 infarctions) of the group receiving prolonged antithrombotic pretreatment and in 5.9% (no deaths, 12 infarctions) of the group receiving early intervention (relative risk, 1.96 [95% confidence interval, 1.01-3.82]; P =.04). This outcome was attributable to events occurring before catheterization; after catheterization, both groups incurred 11 events each (P =.92). CONCLUSION: In patients with unstable coronary syndromes, deferral of intervention for prolonged antithrombotic pretreatment does not improve the outcome compared with immediate intervention accompanied by intense antiplatelet treatment.

Gender and restenosis after coronary artery stenting.

AIMS: To examine the impact of sex on restenosis in a large cohort of consecutive patients undergoing coronary stenting and systematic angiographic and clinical follow-up. METHODS AND RESULTS: The study includes a cohort of 4374 consecutive patients (1025 women and 3349 men), undergoing coronary stenting for stable or unstable angina. Follow-up angiography at 6 months was performed in 80% of patients. Clinical events were assessed for a period of 1 year after the procedure. Main end-points of the study were angiographic and clinical restenosis at follow-up. Compared to men, women were older, presented more often with diabetes, smaller vessel size and shorter lesions. Clinical restenosis (need for reintervention) was found in 14.8% of women and 17.5% of men (P=0.048). The incidence of angiographic restenosis was significantly lower in women then in men (28.9% vs 33.9%, respectively, P=0.01). After adjustment for other covariates, women presented a 23% reduction of the risk of restenosis: odds ratio 0.77 (95% confidence interval 0.63 to 0.93). While a small vessel size was a risk factor for restenosis in both sexes, the influence of diabetes on restenosis was mostly confined to women. CONCLUSION: Compared with men, women present a lower risk of restenosis after coronary stenting despite a more preponderant presence of two major risk factors for restenosis, diabetes and small vessel size. There are sex-based differences in predictive factors of restenosis with diabetes having a particularly strong impact in women.

Predictive value of basal C-reactive protein levels for myocardial salvage in patients with acute myocardial infarction is dependent on the type of reperfusion treatment.

AIMS: To evaluate whether C-reactive protein (CRP) levels on admission are predictive of myocardial salvage achieved with different reperfusion strategies in patients with acute myocardial infarction (AMI). METHODS AND RESULTS: Patients with AMI treated with stenting plus abciximab (n=125) and thrombolysis alone (n=54) or with abciximab (n=71) were prospectively studied. CRP levels were measured by a high sensitivity assay. The threshold of the upper quartile (12 mg/l) was used to divide patients into two groups: 60 patients with high CRP (>12 mg/l) and 190 patients with low CRP (< or =12 mg/l). Myocardial salvage was measured by technetium (Tc)-99(m)sestamibi scintigraphy. Patients in the high CRP group had a significantly lower salvage index (0.35+/-0.42 vs 0.48+/-0.34, p=0.01) and higher 18-month mortality (11.7 vs 3.2%, p=0.03) compared to those in the low CRP group. While basal CRP was not related to myocardial salvage in patients treated with stenting plus abciximab (p=0.89) or thrombolysis plus abciximab (p=0.43), a high CRP on admission was associated with a significantly lower salvage index (0.09+/-0.48 vs 0.42+/-0.37 in the low CRP group, p=0.006) among patients treated with thrombolysis alone. CONCLUSION: CRP levels on admission may predict the efficacy of reperfusion in patients with AMI. The predictive ability is dependent on the form of reperfusion therapy.

Intracoronary stenting and angiographic results: Restenosis after direct stenting versus stenting with predilation in patients with symptomatic coronary artery disease (ISAR-DIRECT trial).

The objective of this randomized study was to assess whether direct stenting leads to less restenosis than does conventional stenting (CS) with predilation in clinical practice. We included 910 patients who were randomly assigned to undergo either direct stenting (DS; n = 456) or CS (n = 454). No significant difference was observed in the incidence of angiographic restenosis (primary endpoint): 23.6% for DS and 21.0% for CS (P = 0.41; relative risk = 1.1; 95% CI = 0.8-1.5). The incidence of target vessel revascularization was 17.3% among DS and 14.8% among CS patients (P = 0.29; relative risk = 1.2; 95% CI = 0.8-1.6). The combined incidence of death or myocardial infarction at one year was 9.0% in the DS group and 7.0% in the CS group (P = 0.28). In conclusion, direct stenting is not associated with any reduction of thrombotic and restenotic complications as compared to the conventional stenting.