One-year results of the ICON (Ionic versus non-ionic Contrast to Obviate worsening Nephropathy after angioplasty in chronic renal failure patients) Study.

BACKGROUND: Long-term clinical outcomes after exposure to non-ionic iso-osmolar contrast medium (IOCM) or ionic low-osmolar CM (LOCM) in patients with chronic kidney disease (CKD) undergoing coronary angiography are unclear. METHODS: The ICON trial was a prospective, double-blinded, multicentre study that randomly assigned 146 patients with CKD undergoing coronary angiography with or without percutaneous coronary intervention to the non-ionic IOCM Iodixanol or the ionic LOCM Ioxaglate. We report the 1-year clinical outcomes. RESULTS: After randomization, baseline and procedural characteristics were well-matched between the two groups. At 1 year, three deaths (4.1%) occurred in the ioxaglate and nine deaths in the iodixanol group (13.6%, P = 0.07). The cardiac death rate at 1 year was 2.7% in the ioxaglate group and 9.1% in the iodixanol group (P = 0.07). There were no significant differences in the rates of myocardial infarction (1.4% vs. 1.5%; P = 1.00) and repeated revascularization (6.8% vs. 9.1%; P = 0.75). CONCLUSIONS: The use of ionic LOCM ioxaglate was associated with a numerically lower mortality at 1 year as compared to iodixanol in patients who underwent cardiac catheterization. Future studies evaluating long-term safety following exposure to different types of CM are warranted.

Review of the 2005 American College of Cardiology, American Heart Association, and Society for Cardiovascular Interventions guidelines for adjunctive pharmacologic therapy during percutaneous coronary interventions: practical implications, new clinical data, and recommended guideline revisions.

In 2006, the American College of Cardiology, American Heart Association, and Society for Cardiovascular Interventions published the 2005 update of the evidence-based guidelines for the treatment of patients undergoing percutaneous coronary intervention (PCI). Together with procedural recommendations, these guidelines for percutaneous coronary intervention provide clinicians with guidance in the appropriate use of adjunctive pharmacologic therapy in patients undergoing PCI. However, there remain substantial variations in practice among clinicians and within and across institutions. Furthermore, the guidelines (being a static document) cannot incorporate additional evidence that has accumulated since their publication. Several landmark trials, notably Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment (ISAR-REACT 2) and Acute Catheterization and Urgent Intervention Triage strategY (ACUITY), have added substantially to the knowledge base about pharmacologic therapy since publication of the guidelines. This article is therefore intended to discuss implementation into clinical practice of the revised guidelines for antiplatelet and antithrombotic pharmacologic therapy during PCI and to evaluate recent clinical evidence and make recommendations for revision of the guidelines incorporating the outcomes of recently completed trials.

Safety of concomitant therapy with eptifibatide and enoxaparin in patients undergoing percutaneous coronary intervention: results of the Coronary Revascularization Using Integrilin and Single bolus Enoxaparin Study.

OBJECTIVES: This study was designed to assess whether use of enoxaparin during percutaneous coronary intervention (PCI) increased bleeding compared with unfractionated heparin, in addition to background therapy with eptifibatide. BACKGROUND: Data supporting the benefits of enoxaparin and the glycoprotein IIb/IIIa inhibitor eptifibatide evolved in parallel. Information on combining these two classes of medications is limited. METHODS: A total of 261 patients undergoing elective or urgent PCI were randomized to either eptifibatide plus enoxaparin or eptifibatide plus unfractionated heparin. RESULTS: The primary end point of the study, the bleeding index (change in hemoglobin corrected for blood transfusions), was 0.8 in the patients randomized to enoxaparin and 1.1 in patients randomized to unfractionated heparin (p = 0.15). The rate of vascular access site complications was 9.3% in the enoxaparin arm versus 9.8% in the unfractionated heparin arm (p = NS). The rate of bleeding complications was not significantly different between the two arms of the study, including in those patients who received vascular closure devices. The rate of angiographic complications was 6.3% in the enoxaparin group and 6.2% in the unfractionated heparin group (p = NS). Similarly, there were no significant differences in the composite of death, myocardial infarction, or urgent target vessel revascularization at 48 h or 30 days. CONCLUSIONS: Compared with unfractionated heparin plus eptifibatide, the combination of enoxaparin plus eptifibatide is not associated with an excess of bleeding or vascular complications, including in those receiving closure devices. Despite no monitoring of anticoagulation activity with enoxaparin, there was no apparent increase in angiographic or clinical complications.

Ionic low-osmolar versus nonionic iso-osmolar contrast media to obviate worsening nephropathy after angioplasty in chronic renal failure patients: the ICON (Ionic versus non-ionic Contrast to Obviate worsening Nephropathy after angioplasty in chronic renal failure patients) study.

OBJECTIVES: This randomized, prospective, double-blind, multicenter study compared nephrotoxicity of the nonionic iso-osmolar contrast media (CM) iodixanol versus the ionic low-osmolar CM ioxaglate in patients with chronic renal insufficiency undergoing coronary angiography. BACKGROUND: The properties of iodinated CM might contribute to the incidence of contrast-induced nephropathy (CIN). METHODS: Patients with renal impairment undergoing coronary angiography were randomly assigned to iodixanol (n = 72) or ioxaglate (n = 74). RESULTS: Baseline characteristics were well-matched between the 2 groups. The predicted risk score for CIN was similar in the iodixanol and in the ioxaglate groups (11.9 +/- 4.1 vs. 11.8 +/- 4.1), as was the use of N-acetylcysteine (70% vs. 73%). The primary end point of the study, median peak increase of serum creatinine from day 0 through day 3 after angiography, did not differ between the iodixanol (0.09 mg/dl; interquartile range 0.00 to 0.30 mg/dl) and the ioxaglate (0.15 mg/dl; interquartile range 0.00 to 0.40 mg/dl; p = 0.07) groups. The percentages of patients with a peak increase of serum creatinine >or=0.5 mg/dl (15.9% in iodixanol vs. 18.2% in ioxaglate), >or=1.0 mg/dl (1.4% vs. 4.5%), and >or=25% or >or=0.5 mg/dl (15.9% vs. 24.2%, respectively) also did not differ significantly between the 2 groups. CONCLUSIONS: In high-risk patients undergoing coronary angiographic procedures, use of the nonionic iso-osmolar CM iodixanol does not reduce renal deterioration in patients with renal impairment, compared with the ionic low-osmolar CM ioxaglate. Given that the study was underpowered to compare nephrotoxicity of the 2 groups under the active medical protection of CIN, a larger randomized study is warranted that will enroll patients with higher risks of CIN under a strict control of hydration regimens and adjunctive medications.

Real-world safety and efficacy of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention.

BACKGROUND: Large randomized clinical trials have demonstrated differences in the efficacy and safety of glycoprotein (GP) IIb/IIIa inhibitors, but little has been published regarding comparisons of these agents in a "real-world" setting. PURPOSE: This study evaluated the safety and efficacy of GP IIb/IIIa inhibitors in a large population of patients who underwent percutaneous coronary intervention (PCI) during a 5-year period. METHODS: Patients undergoing PCI from 2000 through 2004 were eligible for inclusion if they received any single GP IIb/IIIa inhibitor. Patients with significant comorbidities were included. Patients were excluded if they received more than one GP IIb/IIIa inhibitor or underwent catheterization without PCI. Target activated clotting time was 200-250 seconds. RESULTS: Of 5,055 patients undergoing PCI, 4,321 (85%) received a single GP IIb/IIIa inhibitor (abciximab, 1,178; eptifibatide, 1,698; tirofiban, 1,445). Major bleeding complications were rare, ranging from 1.9-3.1%, and transfusion rates were low, ranging from 0.8-2.1%, with no significant differences among the agents evaluated. No significant differences in 1-year mortality, myocardial infarction, urgent target vessel revascularization or composite endpoint rates were identified among the therapeutic agents. CONCLUSIONS: In this large study of PCI patients, GP IIb/IIIa inhibition was associated with a low incidence of major bleeding complications and requirement of transfusion. With appropriate management, GP IIb/IIIa inhibitor use can benefit patients undergoing PCI, with minimal risk of bleeding complications.

Restenosis after Angioplasty.

Angiographic restenosis occurs in 30% to 50% of patients after percutaneous transluminal coronary angioplasty (PTCA) with 20% to 30% target vessel revascularization at one year, and is associated with increased morbidity, mortality and health care costs. Intracoronary stents are the first line of therapy against restenosis after angioplasty. Depending on lesion morphology and location, stents can reduce restenosis and target lesion revascularization (TLR) by 20% to 30%. Obstructive coronary lesions in vessels with a diameter larger than 3.0 mm should be stented. The benefit of stenting in vessels smaller than 3.0 mm is controversial, with the BESMART (Bestent in Small Arteries) and ISAR-SMART (Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries) studies demonstrating conflicting results. Chronically occluded and subtotal vessels should be stented after PTCA. Obstructive lesions in saphenous vein grafts should be stented. It is preferable to stent ostial lesions after PTCA. Restenosis can occur in 15% to 25% of patients within 6 months of stent placement. Initial approach to focal in-stent restenosis is to repeat PTCA. Patients with diffuse restenosis may require debulking prior to PTCA to improve acute results. "Stenting within-stent" has not proven beneficial unless there is diffuse in-stent restenosis, neointimal prolapse or vessel dissection during PTCA. There are no pharmacologic therapies approved by the Food and Drug Administration available to treat restenosis at present. Brachytherapy, gamma or beta, is an effective adjunctive therapy that can reduce recurrent in-stent restenosis by 40% to 70%. Patients at high risk for recurrent in-stent restenosis (proliferative or total occlusion pattern) can be considered for brachytherapy to treat the first episode of in-stent restenosis. Patients with focal in-stent restenosis should be treated with brachytherapy after multiple recurrences of in-stent restenosis. Emerging therapies for treatment of restenosis include antiproliferative-coated stents and photoangioplasty.