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Bivalirudin is a new direct thrombin inhibitor. In patients undergoing PCI for stable coronary disease, bivalirudin and unfractionated heparin resulted in similar overall outcomes, but there was less major bleeding with bivalirudin. Bivalirudin is a new direct thrombin inhibitor. In patients undergoing PCI for stable coronary disease, bivalirudin and unfractionated heparin resulted in similar overall outcomes, but there was less major bleeding with bivalirudin. Percutaneous coronary intervention (PCI) is commonly used to treat patients with coronary artery disease. To minimize the risk of thrombotic complications during and shortly after the procedure, many different antithrombotic regimens have been investigated and are currently in use. Increasing evidence of the adverse consequences of periprocedural bleeding suggests that protection from thrombotic complications should not be the sole measure by which antithrombotic therapies are evaluated. 1 Aspirin, clopidogrel, and heparin are established antithrombotic drugs that are widely recommended according to current guidelines on PCI. 2 Pretreatment with 300 to 600 mg of clopidogrel increasingly is used before PCI because of mounting . . .

Reduced respiratory sinus arrhythmia, quantified as expiration-triggered sinus arrhythmia (ETA) from simultaneous electrocardiogram and respiration recordings, is a strong long-term mortality predictor in myocardial infarction survivors. Here, we investigated whether ETA also predicts mortality risk in the general elderly population. ETA was quantified from 30-min electrocardiogram and respiration recordings in 1788 general population subjects aged ≥60 years, who were then followed for a median of 4.0 years (median age 72 years, 58% female). Four-year all-cause mortality was 4.6%. Abnormal ETA using a predefined cutoff (≤0.19 ms) was associated with a 4-year mortality of 6.9%, compared to 3.7% in the remaining participants (p = 0.0022). ETA remained a significant mortality predictor in multivariable Cox analysis, also considering a modified Framingham score incorporating sex, age, smoking, cholesterol, blood pressure, antihypertensive medication, family history, diabetes and clinical atherosclerosis (multivariable hazard ratio 1.81; 95% confidence interval 1.17–2.81; p = 0.008). Combined risk prediction by ETA (using an optimized cutoff of ≤0.86 ms) and the Framingham score stratified patients into a low-risk (both parameters normal), an intermediate-risk (one parameter abnormal) and a high-risk group (both parameters abnormal), with 4-year mortality rates of 1.9%, 4.4% and 10.1%, respectively. We conclude that in elderly general population subjects, ETA is a mortality risk predictor that complements classical clinical risk stratification.

Routine 6-month follow-up angiography (FU angio) is the most sensitive tool to detect restenosis. Thus, FU angio protocols have been a pivotal part of trials on long-term efficacy of stents. However, it is unclear if such protocols supply data relevant for the prognosis of individual patients. The purpose of this study was to assess the impact of angiographic restenosis detected by FU angio on late mortality after coronary stent placement. We analyzed 2272 consecutive patients with successful stent placement performed from May 1992 through December 1996. All patients were scheduled for 6-month FU angio and contacted again after 4 years. FU angio was performed in 1958 patients. Of those, 557 patients (28.4%) had restenosis. After 4 years, 8.8% of patients with restenosis died, compared to 6.0% without ( P = .02). There were several significant differences in clinical and angiographic characteristics between the 2 groups. In a multivariate analysis including those characteristics plus restenosis, only older age and restenosis were independent risk factors for late mortality. In patients with severe restenosis (>75% of lumen diameter; n = 231), late mortality was 7.6% in those with target vascular revascularization, compared to 14.9% without ( P = not significant). In this analysis, mortality 4 years after stent placement was higher in patients with angiographic restenosis. Restenosis was an independent risk factor for late mortality, with a potential benefit after target vessel revascularization in severe restenoses. These data suggest that routine FU angio after stenting provides data relevant for long-term prognosis of patients.

Drug-eluting coronary-artery stents are more effective than bare-metal stents in reducing the frequency of coronary restenosis in patients with diabetes. In a randomized, controlled trial in patients with diabetes, the sirolimus-eluting stent was associated with a smaller extent of late luminal loss than was the paclitaxel-eluting stent, suggesting that the risk of restenosis was also reduced. In patients with diabetes, the sirolimus-eluting stent was associated with a smaller extent of late luminal loss than was the paclitaxel-eluting stent, suggesting that the risk of restenosis was also reduced. Coronary artery disease is a major cause of complications and death among patients with diabetes mellitus. 1 In particular, patients with diabetes are prone to a diffuse and rapidly progressive form of atherosclerosis, which increases their likelihood of requiring revascularization. 2 – 4 Percutaneous coronary intervention and aortocoronary bypass surgery are recommended revascularization strategies for such patients. However, because of the increased risk of restenosis after percutaneous coronary interventions in these patients, 5 – 7 aortocoronary bypass surgery has been considered to be the preferred revascularization strategy for many. 8 , 9 Drug-eluting stents markedly reduce the incidence of restenosis as compared with bare-metal stents, both in . . .

A number of stent-versus-stent trials have not been able to disclose differences in stent performance. It has been hypothesized that the selection of patient subsets with simple lesion morphologies may have masked differences among the stent designs under testing. The randomized Intracoronary Stenting and Angiographic Results Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO) trial has shown that a reduced stent strut thickness is associated with a reduced risk for restenosis. The rationale of this study was to investigate the role of lesion complexity on the capacity of a stent-versus-stent trial to distinguish between superior and inferior stents. In the ISAR-STEREO trial, 651 patients were randomly assigned to receive either a thin-strut (n = 326) or a thick-strut stent (n = 325) with a comparable stent design. Restenosis, defined as a ≥50% diameter stenosis at follow-up angiography, was analyzed according to the lesion complexity, which was assessed with the use of the American College of Cardiology/American Heart Association classification system. The restenosis rate did not differ between stent designs in patients with noncomplex lesions (type A or B 1; restenosis rate: 16.7% vs 16.7%, P = 1.0 for thin-strut vs thick-strut stents). In patients with complex lesions (type B 2 or C), there was a significant reduction in restenosis in the thin-strut stent group (restenosis rate: 14.5% vs 29.0%; P < .01 for thin-strut vs thick-strut stents). The results of this study suggest that the potential to detect differences in the risk for restenosis in stent-versus-stent trials is strongly dependent on the inclusion of patients with complex lesions. These findings may be relevant when planning new stent-versus-stent trials.

It is not known whether there exists a sex-dependent difference in the clinical benefit of abciximab in patients with acute coronary syndromes (ACS) undergoing a percutaneous coronary intervention (PCI). We performed this retrospective analysis of 2022 patients (498 women) with ACS enrolled in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 2 trial and randomized to receive abciximab or placebo during a PCI procedure. The incidence of major adverse cardiac events (MACE) during the 30 days after PCI was the primary end point of the study. Among men, the 30-day incidence of MACE was 8.6% in the abciximab group compared with 12.6% in the placebo group, relative risk (RR) 0.69 (95% confidence interval [CI] 0.50-0.94), P = .01. The 30-day incidence of MACE in women was 9.7% in the abciximab group compared with 9.9% in the placebo group, RR 0.98 (95% CI, 0.56-1.72), P = .97. After adjustment for baseline clinical and angiographic characteristics, there was no significant interaction between sex and abciximab ( P = .71); adjusted RR was 0.70 (95% CI, 0.34-1.34) in women and 0.60 (95% CI, 0.40-0.90) in men. The incidence of major bleeding was significantly greater in women (3.6%) than in men (0.7%), RR 5.5 (95% CI, 2.54-11.9), P < .001, without any dependence on the form of therapy received. In patients with non-ST elevation ACS undergoing a PCI, the benefit with abciximab is greater in men than in women. This is apparently the result of sex-based differences in risk profile.

Antiplatelet therapy is used as an adjunct in patients undergoing coronary angioplasty and stenting in order to reduce the incidence of ischemic complications and improve the outcome. In this study of elective coronary stenting, patients were pretreated with aspirin and clopidogrel and then randomly assigned to receive the glycoprotein IIb/IIIa inhibitor abciximab or placebo. Abciximab added no benefit to the combination of aspirin and clopidogrel. A trial of aspirin and clopidogrel and then abciximab. Progress in the field of adjunctive antithrombotic therapy has had a decisive role in improving the outcome of percutaneous coronary interventions. 1 Dual antiplatelet therapy with aspirin and a thienopyridine has strikingly improved both the efficacy and the safety of coronary-artery stenting. 2 , 3 Thienopyridines act by blocking one of the three adenosine 5'-diphosphate (ADP) receptors. 4 – 6 An important limitation of ticlopidine is its delayed onset of action: maximal inhibition of ADP-induced platelet aggregation is achieved several days after administration. 4 , 7 – 9 Although the use of large loading doses of clopidogrel results in a more rapid onset of action than that of . . .

Patients with acute myocardial infarction benefit markedly from the restoration of coronary blood flow in the infarct-related vessel, and myocardial salvage is the principal mechanism of this benefit. 1 The unequivocal demonstration of the advantages of early fibrinolysis in patients with acute myocardial infarction 2 , 3 led to the widespread use of this reperfusion strategy. Subsequently, randomized trials indicated that primary percutaneous transluminal coronary angioplasty (PTCA) may be superior to fibrinolysis with regard to the early 4 – 6 and late 7 , 8 clinical outcomes. However, the only randomized study that specifically assessed myocardial salvage found a small but nonsignificant difference in favor of primary . . .

Patients with acute myocardial infarction might benefit from the addition of glycoprotein IIb/IIIa inhibitors to fibrinolytic or mechanical reperfusion strategies. We compared two strategies, stenting and fibrinolysis, both combined with abciximab, in terms of their ability to salvage myocardium in patients with acute myocardial infarction. We enrolled 162 patients with acute myocardial infarction within 12 h of onset of symptoms, assigning 81 stenting plus abciximab and 81 alteplase plus abciximab. Technetium-99m sestamibi scintigraphy was done at admission and after a median of 11 days to calculate initial perfusion defect, final infarct size, and degree of myocardial salvage. The primary endpoint was the salvage index (the ratio of the degree of myocardial salvage to the initial perfusion defect). Major adverse clinical events within 6 months from randomisation were also compared between the two treatments. Paired scintigraphic measurements were available for 70 patients in the stent group and 71 in the alteplase group. Stenting was associated with greater myocardial salvage than alteplase (median 13.6% [IQR 5.9-23.9] vs 8.0% [2.5-16.0] of the left ventricle; p=0.007). Salvage index was greater in the stent group than in the alteplase group (median 0.60 [0.37-0.82] vs 0.41 [0.13-0.58]; p=0.001). The 6-month mortality rate was 5% (four deaths) in the stent group and 9% (seven deaths) in the alteplase group (relative risk 0.56 [95% CI 0.17-1.88]; p=0.35). In patients with acute myocardial infarction, a reperfusion strategy based on stenting with abciximab produced more myocardial salvage than the combination of fibrinolysis plus abciximab. Larger studies are needed to assess whether these effects translate into clinical benefit.

Myocardial salvage assessed by (99m)Tc-sestamibi scintigraphy is a marker of myocardial tissue reperfusion in patients with acute myocardial infarction. The prognostic value of myocardial salvage index in patients with acute myocardial infarction after reperfusion therapy has not, however, been investigated. We analyzed 765 patients with acute myocardial infarction randomized to treatment by coronary stenting (383 patients), primary coronary angioplasty (251 patients), or thrombolysis (131 patients) in the setting of 3 randomized trials. Initial (before reperfusion therapy) and follow-up (7-14 d after reperfusion therapy) scintigraphic examinations were performed to assess the initial perfusion defect, final infarct size, and salvage index. Patients were categorized into 2 groups defined by the median salvage index (0.5): the group with salvage index < 0.5 (374 patients) and the group with salvage index >or= 0.5 (391 patients). The primary endpoint of the study was mortality at 6 mo after the index event. Six-month mortality was 5.1% (19 deaths) in the group with salvage index < 0.5, compared with 1.0% (4 deaths) in the group with salvage index >or= 0.5 (odds ratio, 5.1; 95% confidence interval, 1.9-13.3; P = 0.001). Salvage index (median [25th, 75th percentiles] was significantly smaller in nonsurvivors than in survivors (0.19 [0.05, 0.37] vs. 0.50 [0.26, 0.80], P = 0.0004). The Cox proportional hazards model showed that myocardial salvage index (P = 0.0007), initial perfusion defect (P = 0.0007), and age (P = 0.04) were independently associated with 6-mo mortality. Myocardial salvage achieved by reperfusion therapy predicts mortality in patients with acute myocardial infarction. Our findings support the use of salvage index as a surrogate of mortality in clinical trials designed to test the efficacy of reperfusion therapies among patients with acute myocardial infarction.