Rationale and design of the MASS COMM trial: A randomized trial to compare percutaneous coronary intervention between MASSachusetts hospitals with cardiac surgery on-site and COMMunity hospitals without cardiac surgery on-site.

Background: Emergency surgery has become an increasingly rare event after percutaneous coronary intervention (PCI). There have been no randomized trials evaluating whether cardiac surgery services on-site are essential for patient safety and optimal outcomes during and after PCI.

Study Design: The MASS COMM trial (ClinicalTrials.

Influence of sex on long-term outcomes after percutaneous coronary intervention with the paclitaxel-eluting coronary stent: results of the "TAXUS Woman" analysis.

Objectives: We conducted the "TAXUS Woman" analysis to assess the influence of sex on long-term outcomes after percutaneous coronary intervention using paclitaxel-eluting stents (PES) in a broad spectrum of patients.

Background: Previous studies indicate that the sex gap suggesting worse outcomes in women has narrowed. However, limited data are available on long-term sex-based outcomes with drug-eluting stents despite their extensive use in current practice.

A technical and cognitive skills evaluation of performance in interventional cardiology procedures using medical simulation.

Introduction: Interventional cardiology, with large numbers of complex procedures and potentially serious complications, stands out as an obvious discipline in which to apply simulation to help prevent medical errors. The objective of the study was to determine whether it is feasible to develop a valid and reliable evaluation approach using medical simulation to assess technical and cognitive skills of physicians performing coronary interventions.

Methods: Clinical case scenarios were developed by a committee of subject matter experts, who defined key decision nodes, such as stent positioning, and introduced unanticipated complications, such as coronary perforation.

The clinical impact of routine angiographic follow-up in randomized trials of drug-eluting stents: a critical assessment of "oculostenotic" reintervention in patients with intermediate lesions.

Objectives: The aim of this study was to study the long-term clinical effects of routine angiographic follow-up and related reintervention after drug-eluting stenting.

Background: Prior stent trials have shown that protocol-mandated angiographic follow-up increases repeat interventions compared with clinical follow-up alone. The long-term clinical impact of this practice is unknown.

Long-term safety and efficacy with paclitaxel-eluting stents: 5-year final results of the TAXUS IV clinical trial (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent).

Objectives: The pivotal TAXUS IV (TAXUS IV-SR: Treatment of De Novo Coronary Disease Using a Single Paclitaxel-Eluting Stent) trial evaluated the long-term safety and effectiveness of the paclitaxel-eluting stent (PES) compared with an otherwise identical bare-metal stent (BMS) in a relatively uncomplicated population of patients with a single de novo lesion in a native coronary vessel, treated between March and July 2002.

Background: Long-term follow-up is required to determine whether the early safety and efficacy of drug-eluting stents are maintained.

Methods: The primary end point of this prospective, randomized, double-blind trial was 9-month ischemia-driven target vessel revascularization (TVR) for PES versus the BMS control.