A randomized, controlled, multi-center trial comparing the safety and efficacy of zotarolimus-eluting and paclitaxel-eluting stents in de novo lesions in coronary arteries: final results of the ZoMaxx II trial.

Background/objectives: The purpose of this prospective, randomized, single-blind controlled clinical trial was to compare the effectiveness of a zotarolimus-eluting stent (ZoMaxx™) with a paclitaxel-eluting coronary stent (Taxus™ Express(2)™) in patients with angina pectoris and a single native coronary artery lesion between 10-28 mm in length and 2.5-3.75mm in diameter.

Comparison of vascular response to zotarolimus-eluting stent vs paclitaxel-eluting stent implantation: pooled IVUS results from the ZoMaxx I and II trials.

Background: The ZoMaxx I and II trials were randomized controlled studies of the zotarolimus-eluting, phosphorylcholine-coated, TriMaxx stent for the treatment of de novo coronary lesions. The aim of this study was to compare the vessel response between zotarolimus- (ZES) and paclitaxel-eluting stents (PES) using intravascular ultrasound (IVUS).

Methods And Results: Data were obtained from the ZoMaxx I and II trials, in which a standard IVUS parameter was available in 263 cases (baseline and 9-months follow up).

A randomized comparison of the Endeavor zotarolimus-eluting stent versus the TAXUS paclitaxel-eluting stent in de novo native coronary lesions 12-month outcomes from the ENDEAVOR IV trial.

Objectives: The ENDEAVOR IV (Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial evaluated the safety and efficacy of the zotarolimus-eluting stent (ZES) compared with the paclitaxel-eluting stent (PES).

Background: First-generation drug-eluting stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. A second-generation drug-eluting stent, which delivers zotarolimus, a potent antiproliferative agent, via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut stent has shown promising experimental and early clinical results.

Late safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent compared with a paclitaxel-eluting stent in patients with de novo coronary lesions: 2-year follow-up from the ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions).

Objectives: The aim of this study was to assess, after 2 years of follow-up, the safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent (ZES) compared with a paclitaxel-eluting stent (PES) in patients with native coronary lesions.

Background: Early drug-eluting stents were associated with a small but significant incidence of very late stent thrombosis (VLST), occurring >1 year after the index procedure. The ZES has shown encouraging results in clinical trials.

Frequency and clinical consequences associated with sidebranch occlusion during stent implantation using zotarolimus-eluting and paclitaxel-eluting coronary stents.

Background: Myocardial infarction (MI) after drug-eluting stent placement has been associated with an unfavorable late prognosis. Although the etiology of periprocedural MI is multifactorial, sidebranch occlusion may be an important contributing factor. We sought to identify the incidence of sidebranch occlusion during zotarolimus-eluting stent (ZES) and paclitaxel-eluting stent (PES) placement and to relate sidebranch occlusion to the occurrence of periprocedural MI.

Clinical and angiographic outcomes in diabetics from the ENDEAVOR IV trial: randomized comparison of zotarolimus- and paclitaxel-eluting stents in patients with coronary artery disease.

Objectives: The aim of this study was to examine outcomes related to the use of the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) compared with the TAXUS paclitaxel-eluting stent (PES) (Boston Scientific Corp., Natick, Massachusetts) in the 477 patients with diabetes mellitus (DM) enrolled in the randomized ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial.

Background: Percutaneous coronary intervention (PCI) in diabetic patients is associated with increased rates of restenosis-related end points compared with PCI in nondiabetic patients.

First human experience with local delivery of novel antisense AVI-4126 with Infiltrator catheter in de novo native and restenotic coronary arteries: 6-month clinical and angiographic follow-up from AVAIL study.

Background: A novel antisense phosphorodiamidate morpholino oligomer, AVI-4126, was shown to be effective in reducing neointimal formation in different animal models following delivery by pluronic gels, porous balloon catheters, and coated stents. The purpose of the AVAIL study was to investigate both the safety and the efficacy of AVI-4126 delivered locally via Infiltrator catheter after percutaneous coronary intervention in humans.

Methods: The AVAIL trial is a prospective, evaluator-blinded, randomized study including clinical follow-up at 30 days and 6 months after intervention and 6-month angiographic and intravascular ultrasound (IVUS) follow-up.

Final results of the Can Routine Ultrasound Influence Stent Expansion (CRUISE) study.

Background: Intravascular ultrasound (IVUS) can assess stent geometry more accurately than angiography. Several studies have demonstrated that the degree of stent expansion as measured by IVUS directly correlated to clinical outcome. However, it is unclear if routine ultrasound guidance of stent implantation improves clinical outcome as compared with angiographic guidance alone.

Long-term survival with use of percutaneous extracorporeal life support in patients presenting with acute myocardial infarction and cardiovascular collapse.

Up to 10% of patients who arrive at the hospital with acute myocardial infarction (AMI) present with or develop cardiogenic shock. Some patients, despite inotropes and intra-aortic balloon pump (IABP) placement, are not hemodynamically stable enough to undergo emergent revascularization. The use of percutaneous extracorporeal life support (ECLS) can stabilize patients to allow effective therapy.

Clinical and angiographic follow-Up after primary stenting in acute myocardial infarction: the Primary Angioplasty in Myocardial Infarction (PAMI) stent pilot trial.

Background: Restenosis has been reported in as many as 50% of patients within 6 months after PTCA in acute myocardial infarction (AMI), which necessitates repeat target-vessel revascularization (TVR) in approximately 20% of patients during this time period. Routine (primary) stent implantation after PTCA has the potential to further improve late outcomes.

Methods And Results: Primary stenting was performed as part of a prospective study in 236 consecutive patients without contraindications who presented with AMI of <12 hours' duration at 9 international centers.

Stents in acute myocardial infarction.

It has been widely reported throughout studies comparing mechanical reperfusion by primary percutaneous transluminal coronary angioplasty (PTCA) with thrombolytic therapy in acute myocardial infarction (AMI) that PTCA results in reduced rates of in-hospital mortality, reinfarction, recurrent ischemia, and stroke, allowing earlier hospital discharge with similar total costs. The attraction of primary PTCA is its relative simplicity and predictability with operators who have a wide range of experience with PTCA. With these results, it is legitimate to wonder what, if any, possible advantages other reperfusion approaches, such as stenting, might offer compared with primary PTCA.

Long-term outcome after primary angioplasty: report from the primary angioplasty in myocardial infarction (PAMI-I) trial.

Objectives: This study sought to compare the two-year outcome after primary percutaneous coronary angioplasty or thrombolytic therapy for acute myocardial infarction.

Background: Primary angioplasty, that is, angioplasty without antecedent thrombolytic therapy, has been shown to be an effective reperfusion modality for patients suffering an acute myocardial infarction. This report reviews the two-year clinical outcome of patients randomized in the Primary Angioplasty in Myocardial Infarction trial.

Prospective, multicenter study of the safety and feasibility of primary stenting in acute myocardial infarction: in-hospital and 30-day results of the PAMI stent pilot trial. Primary Angioplasty in Myocardial Infarction Stent Pilot Trial Investigators.

Objectives: The goals of this study were to examine the safety and feasibility of a routine (primary) stent strategy in acute myocardial infarction (AMI).

Background: Limitations of reperfusion by primary percutaneous transluminal coronary angioplasty (PTCA) in AMI include in-hospital recurrent ischemia or reinfarction in 10% to 15% of patients, restenosis in 37% to 49% and late infarct-related artery reocclusion in 9% to 14%. By lowering the residual stenosis and sealing dissection planes created by PTCA, primary stenting may further improve short- and long-term outcomes after mechanical reperfusion.

Excimer laser coronary angioplasty: the New Approaches to Coronary Intervention (NACI) experience.

In the New Approaches to Coronary Intervention (NACI) registry, 887 patients were electively treated with excimer laser coronary angioplasty (ELCA) for coronary artery disease. The Advanced Interventional System (AIS) system was used in 487 cases; the Spectranetics system, in 400. The mean age was 63.

Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts. Saphenous Vein De Novo Trial Investigators.

Background: Treatment of stenosis in saphenous-vein grafts after coronary-artery bypass surgery is a difficult challenge. The purpose of this study was to compare the effects of stent placement with those of balloon angioplasty on clinical and angiographic outcomes in patients with obstructive disease of saphenous-vein grafts.

Methods: A total of 220 patients with new lesions in aortocoronary-venous bypass grafts were randomly assigned to placement of Palmaz-Schatz stents or standard balloon angioplasty.

Analysis of the relative costs and effectiveness of primary angioplasty versus tissue-type plasminogen activator: the Primary Angioplasty in Myocardial Infarction (PAMI) trial. The PAMI Trial Investigators.

Objectives: We sought to determine the relative cost and effectiveness of two different reperfusion modalities in patients with acute myocardial infarction (AMI).

Background: Recent studies have found superior clinical outcomes after reperfusion by primary percutaneous transluminal coronary angioplasty (PTCA) compared with thrombolytic therapy. The high up-front costs of cardiac catheterization may diminish the relative advantages of this invasive strategy.

Program Operation and Technical Aspects of a Regional Primary PTCA Program.

In this section of the symposium, we will divide the discussion into two parts: the hypothesis, and the background and operation of a regional primary angioplasty program with review of the results in our location in West Texas. A brief discussion of the technical aspects in the performance of primary angioplasty will be detailed. We will review the practical aspects of the performance of primary percutaneous transluminal coronary angioplasty with outlines for implementation of the angiogram, conducting angioplasty, giving adjunctive mechanical and chemical therapies, care of the patient after the intervention and the potential need for subsequent coronary bypass surgery.

Outcome of different reperfusion strategies in patients with former contraindications to thrombolytic therapy: a comparison of primary angioplasty and tissue plasminogen activator. Primary Angioplasty in Myocardial Infarction (PAMI) Investigators.

High-risk patients have been excluded from most thrombolytic trials because of concern over hemorrhagic complications or lack of efficacy. However, based on several recent studies suggesting that patients with relative thrombolytic contraindications may also benefit from reperfusion, recommendations have been made to broadly expand the eligibility criteria for thrombolytic therapy, despite higher absolute complication rates. Primary percutaneous transluminal coronary angioplasty (PTCA) may be an attractive alternative for patients presenting at appropriately equipped hospitals who would otherwise remain at high risk after thrombolytic therapy.

Influence of acute myocardial infarction location on in-hospital and late outcome after primary percutaneous transluminal coronary angioplasty versus tissue plasminogen activator therapy.

In the Primary Angioplasty in Myocardial Infarction trial, 395 patients with acute myocardial infarction (AMI) were prospectively randomized to tissue plasminogen activator (tPA) or primary percutaneous transluminal coronary angioplasty (PTCA). In 138 patients with anterior wall AMI, in-hospital mortality was significantly reduced by treatment with PTCA compared with tPA (1.4% vs 11.

Immediate results and late outcomes after stent implantation in saphenous vein graft lesions: the multicenter U.S. Palmaz-Schatz stent experience. The Palmaz-Schatz Stent Study Group.

Objectives: This study reports the multicenter registry experience evaluating the safety and efficacy of the Palmaz-Schatz stent in the treatment of saphenous vein graft disease.

Background: Saphenous vein graft angioplasty is associated with frequent periprocedural complications and a high frequency of restenosis. Stent implantation has been shown to reduce restenosis, with improved long-term outcomes in the treatment of native coronary artery disease.

Implications of recurrent ischemia after reperfusion therapy in acute myocardial infarction: a comparison of thrombolytic therapy and primary angioplasty.

Objectives: The purpose of this study was to examine the incidence and implications of recurrent ischemia after different reperfusion strategies in acute myocardial infarction.

Background: The rates and effects of recurrent ischemia after reperfusion with thrombolytic therapy and with primary percutaneous transluminal coronary angioplasty have not been compared.

Methods: At 12 centers 395 patients presenting within 12 h of the onset of acute myocardial infarction were prospectively randomized to receive recombinant tissue-type plasminogen activator (rt-PA) or primary coronary angioplasty.

Comparison of in-hospital outcome in men versus women treated by either thrombolytic therapy or primary coronary angioplasty for acute myocardial infarction.

At 12 centers, 395 patients, including 288 men (73%) and 107 women (27%) with acute myocardial infarction (AMI), were prospectively randomized to treatment with tissue plasminogen activator (t-PA) or primary percutaneous transluminal coronary angioplasty (PTCA). Compared with men, women were older (65.7 vs 57.

Regional flow adjusted hemoperfusion during coronary angioplasty: circulatory support/myocardial protection.

Routine percutaneous transluminal coronary angioplasty catheters are adequate and demonstrate high success rates in balloon angioplasty with stable patients. Active hemoperfusion seems to offer an advantage in patients with hemodynamic instability. Active hemoperfusion provides myocardial protection during coronary interventions and can be applied in conjunction with routine angioplasty equipment.