Impact of gender and antithrombin strategy on early and late clinical outcomes in patients with non-ST-elevation acute coronary syndromes (from the ACUITY trial).

Women with non-ST-elevation acute coronary syndrome are at increased risk for ischemic and bleeding complications compared with men. We examined the impact of gender and antithrombotic therapy for non-ST-elevation acute coronary syndrome on outcomes in patients in the ACUITY trial. Patients were randomized to heparin (unfractionated or enoxaparin) plus a glycoprotein IIb/IIIa inhibitor (GPI), bivalirudin plus a GPI, or bivalirudin alone.

Early stent thrombosis in patients with acute coronary syndromes treated with drug-eluting and bare metal stents: the Acute Catheterization and Urgent Intervention Triage Strategy trial.

Background: The clinical and angiographic predictors of early (<30 days) stent thrombosis (ST) have not been reported in high-risk patients with acute coronary syndromes.

Methods And Results: Qualitative and quantitative coronary angiographic analyses were performed in 3405 patients with moderate- and high-risk acute coronary syndromes in whom stents were implanted in the prospective randomized Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial, including 3043 patients (89.4%) in whom drug-eluting stents were implanted.

Treatment of left main and multivessel disease in the drug-eluting stent era.

For decades, the established standard of care for left main and multivessel coronary artery disease has been coronary artery bypass surgery because a significant survival advantage was found in patients revascularized with surgery compared with medical management. Although visions of less invasive strategies to manage this disease arose with the development of percutaneous coronary interventions, surgery proved to provide higher survival rates compared with balloon angioplasty and improved durability, with fewer required repeat revascularizations, compared with use of bare-metal stents. Drug-eluting stents revived hopes of an alternative treatment modality after trials demonstrated their safety and efficacy in other types of high-risk patients.

The Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: study design and rationale.

Background: Advances in coronary angioplasty and adjunct pharmacology have improved patient outcomes after primary percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI). However, several areas for improvement remain. Hemorrhagic complications, which are common in patients receiving intense anticoagulant and antiplatelet agents during primary PCI to suppress ischemia, have been strongly associated with early and late mortality.

Bivalirudin during primary PCI in acute myocardial infarction.

Background: Treatment with the direct thrombin inhibitor bivalirudin, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in similar suppression of ischemia while reducing hemorrhagic complications in patients with stable angina and non-ST-segment elevation acute coronary syndromes who are undergoing percutaneous coronary intervention (PCI). The safety and efficacy of bivalirudin in high-risk patients are unknown.

Methods: We randomly assigned 3602 patients with ST-segment elevation myocardial infarction who presented within 12 hours after the onset of symptoms and who were undergoing primary PCI to treatment with heparin plus a glycoprotein IIb/IIIa inhibitor or to treatment with bivalirudin alone.

Meta-analysis of the effects of paclitaxel-eluting stents versus bare metal stents on volumetric intravascular ultrasound in patients with versus without diabetes mellitus.

Diabetes mellitus is a strong predictor of in-stent restenosis after bare-metal stent placement because of exaggerated intimal hyperplasia (IH). In this study, serial intravascular ultrasound was used to evaluate the effects of polymer-based, paclitaxel-eluting stents (PES) on in-stent neointima formation in patients with and without diabetes. A volumetric IVUS meta-analysis of 956 patients randomized to PES or bare-metal stents in the TAXUS IV (n=268), TAXUS V (n=509), and TAXUS VI (n=179) trials was performed.

Safety and efficacy of drug-eluting stents: on-label and off-label perspectives.

Favorable outcomes in multiple randomized trials have resulted in the widespread adoption of drug-eluting stents (DES) during percutaneous coronary intervention (PCI). However, reports of increased stent thrombosis-possibly with increased rates of late death and myocardial infarction (MI)-along with the requirement of an extended course of clopidogrel with DES, have resulted in uncertainties as to which patients should receive DES instead of bare-metal stents (BMS). In most patient and lesion subsets, DES significantly reduce neointimal proliferation (resulting in decreased angiographic restenosis), recurrent angina and ischemia, and the need for subsequent revascularization procedures.

Effectiveness of drug-eluting stent implantation for patients with unprotected left main coronary artery stenosis.

This study was aimed to evaluate outcomes of patients with unprotected left main coronary artery (LMCA) stenosis who were treated with drug-eluting stents. Sixty-three consecutive patients with unprotected LMCA stenosis were treated with sirolimus-eluting stents in 52 (83%) patients and paclitaxel-eluting stents in 11 (17%) patients, in whom percutaneous intervention was considered the sole alternative because of high surgical risk and/or patient preference. Urgent percutaneous coronary intervention within 24 hours after angiography was performed in 6 (10%) patients.

Paclitaxel-eluting coronary stents in patients with diabetes mellitus: pooled analysis from 5 randomized trials.

Objectives: We sought to examine the safety and efficacy of paclitaxel-eluting stents (PES) in patients with diabetes mellitus (DM).

Background: Compared with patients without DM, patients with DM undergoing percutaneous coronary intervention are at increased risk for mortality and restenosis. The safety of drug-eluting stents in diabetic patients has recently been called into question by a published meta-analysis of randomized trials.

Short- and long-term outcomes after stent-assisted percutaneous treatment of saphenous vein grafts in the drug-eluting stent era.

Percutaneous treatment of saphenous vein graft (SVG) lesions has been associated with higher rates of periprocedural complications and restenosis compared with non-SVG lesions. Whether these outcomes are similar in contemporary clinical practice, particularly when drug-eluting stents are used, is unknown. We evaluated outcomes of 110 consecutive patients who were treated with stent-assisted percutaneous coronary intervention for 145 SVG lesions (drug-eluting stents used in 91.

Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management: one-year results from the ACUITY trial.

Context: At 30-day follow-up, patients with moderate- and high-risk acute coronary syndromes (ACS) undergoing early invasive treatment in the ACUITY trial with bivalirudin monotherapy vs heparin plus glycoprotein (GP) IIb/IIIa inhibitors had noninferior rates of adverse ischemic events with reduced rates of major bleeding. Deferred upstream use of GP IIb/IIIa inhibitors for selective administration to patients undergoing percutaneous coronary intervention (PCI) resulted in a significant reduction in major bleeding, although a small increase in composite ischemia could not be excluded.

Objective: To determine 1-year ischemic outcomes for patients in the ACUITY trial.

Gender-specific outcomes after sirolimus-eluting stent implantation.

Objectives: We examined the impact of gender on outcomes of patients undergoing percutaneous coronary intervention using sirolimus-eluting stents (SES).

Background: Although gender-specific differences in outcome after implantation of bare-metal stents (BMS) have been described, there are no data assessing outcomes of women treated with SES.

Methods: We performed a patient-level pooled analysis from 4 randomized SES versus BMS trials (RAVEL [Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent for Coronary Revascularization], SIRIUS [SIRolImUS-coated Bx Velocity balloon expandable stent in the treatment of patients with de novo coronary artery lesions], E-SIRIUS [Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries], and C-SIRIUS [Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries]) and analyzed outcomes as a function of gender.

The Anchor-Tornus technique: a novel approach to "uncrossable" chronic total occlusions.

Following successful guidewire passage, inability to cross a chronic total occlusion is the most frequent cause of procedural failure. While low-profile balloons, microcatheters, and specialty catheters such as the Tornus have been designed to facilitate lesion crossing, these devices require adequate guiding catheter support. We describe a novel application of the Tornus catheter combined with a balloon-anchored guide technique to successfully recanalize an otherwise difficult to cross chronic total occlusion.

An evaluation of fluoroscopy time and correlation with outcomes after percutaneous coronary intervention.

Objective: We evaluated short-term prognosis and resource utilization of consecutive patients treated with percutaneous coronary intervention (PCI) as a function of fluoroscopy time.

Background: Advances in interventional cardiology are reflected in the growing complexity of PCI leading to an increasing use of fluoroscopic guidance. The relationship between fluoroscopy time and in-hospital outcomes after PCI has not been addressed.

Impact of baseline platelet count in patients undergoing primary percutaneous coronary intervention in acute myocardial infarction (from the CADILLAC trial).

Despite the well-recognized role of platelets in the pathogenesis of acute myocardial infarction (AMI) and in the vascular responses to angioplasty, the relation between platelet count and outcomes after primary percutaneous coronary intervention (PCI) in AMI is unknown. We therefore determined the effect of baseline platelet count on clinical and angiographic outcomes of patients with AMI undergoing primary PCI. In the prospective, randomized CADILLAC trial, platelet count on admission was available in 2,021 of 2,082 patients (97.

Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial.

Background: The aim of this study was to assess anticoagulation with the direct thrombin inhibitor bivalirudin during percutaneous coronary intervention in individuals with moderate and high-risk acute coronary syndromes.

Methods: 13,819 individuals in the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial were prospectively randomly assigned to receive heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibitors, bivalirudin plus glycoprotein IIb/IIIa inhibitors, or bivalirudin alone. Of these individuals, 7789 underwent percutaneous coronary intervention after angiography.

Routine upstream initiation vs deferred selective use of glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: the ACUITY Timing trial.

Context: In patients with moderate- and high-risk acute coronary syndromes (ACS) who undergo an early, invasive treatment strategy, current guidelines recommend administration of platelet glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibitors, either upstream to all patients prior to angiography or deferred for selective use in the catheterization laboratory just prior to angioplasty. The preferred approach is undetermined.

Objective: To determine the optimal strategy for the use of Gp IIb/IIIa inhibitors in patients with moderate- and high-risk ACS undergoing an early, invasive treatment strategy.

Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents.

Background: The safety of drug-eluting stents has been called into question by recent reports of increased stent thrombosis, myocardial infarction, and death. Such studies have been inconclusive because of their insufficient size, the use of historical controls, a limited duration of follow-up, and a lack of access to original source data.

Methods: We performed a pooled analysis of data from four double-blind trials in which 1748 patients were randomly assigned to receive either sirolimus-eluting stents or bare-metal stents and five double-blind trials in which 3513 patients were randomly assigned to receive either paclitaxel-eluting stents or bare-metal stents; we then analyzed the major clinical end points of the trials.

Bivalirudin for patients with acute coronary syndromes.

Background: Current guidelines for patients with moderate- or high-risk acute coronary syndromes recommend an early invasive approach with concomitant antithrombotic therapy, including aspirin, clopidogrel, unfractionated or low-molecular-weight heparin, and glycoprotein IIb/IIIa inhibitors. We evaluated the role of thrombin-specific anticoagulation with bivalirudin in such patients.

Methods: We assigned 13,819 patients with acute coronary syndromes to one of three antithrombotic regimens: unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin alone.

Drug-eluting stents in the treatment of intermediate lesions: pooled analysis from four randomized trials.

Objectives: To address the safety and efficacy of drug-eluting stents (DES) in the treatment of intermediate lesions, we performed a pooled analysis of four randomized DES versus bare-metal stent (BMS) trials and assessed outcomes among patients with intermediate lesions.

Background: Before the introduction of DES, intermediate coronary lesions were commonly managed based on physiologic or anatomic assessment of lesion severity. The DES may challenge this paradigm.

Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial.

Context: Restenosis within bare-metal stents is often treated with repeat percutaneous coronary intervention, although subsequent recurrence rates are high, with vascular brachytherapy (VBT) affording the best results. The effectiveness of drug-eluting stents in this setting has not been established.

Objective: To investigate the safety and efficacy of the polymer-based, slow-release paclitaxel-eluting stent in patients with restenotic lesions after prior stent implantation in native coronary arteries.