Commentary on highlighted late breaking trials in interventional cardiology at ESC, VIVA, TCT, and AHA 2013.

With the plethora of clinical trials, it is difficult for busy interventional cardiologists to stay up to date. Therefore, the SCAI publications committee concisely summarizes and provides editorial commentary on the most important trials from recent, large international meetings. The intent is to provide this summary every six months to allow quick assimilation of trial results into interventional practice.

Bioresorbable Scaffolds.

Percutaneous coronary intervention (PCI) has undergone major advances including the evolution in stent technology, from bare metal stents (BMS), to their drug eluting counterparts, to the development of bioresorbable scaffolds (BRS). The primary notion of BRS was to facilitate complete vascular healing and restore normal endothelial function following the resorption of stent scaffold while providing equivalent mechanical properties of a metallic drug eluting stents (DES) in the earlier stages. BRS provide attractive physiologic advancements over the existing DES and have shown promising results in initial clinical studies albeit with small sample sizes.

Balloon mitral valvuloplasty in the United States: a 13-year perspective.

Background: Incidence and prevalence of mitral stenosis is declining in the US. We performed this study to determine recent trends in utilization, complications, mortality, length of stay, and cost associated with balloon mitral valvuloplasty.

Methods: Utilizing the nationwide inpatient sample database from 1998 to 2010, we identified patients using the International Classification of Diseases, 9th Revision, Clinical Modification procedure code for "percutaneous valvuloplasty.

A random forest based risk model for reliable and accurate prediction of receipt of transfusion in patients undergoing percutaneous coronary intervention.

Background: Transfusion is a common complication of Percutaneous Coronary Intervention (PCI) and is associated with adverse short and long term outcomes. There is no risk model for identifying patients most likely to receive transfusion after PCI. The objective of our study was to develop and validate a tool for predicting receipt of blood transfusion in patients undergoing contemporary PCI.

Impact of multiple complex plaques on short- and long-term clinical outcomes in patients presenting with ST-segment elevation myocardial infarction (from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI] Trial).

It is not known whether the extent and severity of nonculprit coronary lesions correlate with outcomes in patients with ST-segment elevation myocardial infarction (STEMI) referred for primary percutaneous coronary intervention (PCI). We sought to quantify complex plaques in patients with STEMI referred for primary PCI and to determine their effect on short- and long-term clinical outcomes by examining the core laboratory database for plaque analysis from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction study. Baseline demographic, angiographic, and procedural details were compared between patients with single versus multiple complex plaques who underwent single-vessel PCI.

Percutaneous aortic balloon valvotomy in the United States: a 13-year perspective.

Background: We determined the contemporary trends of percutaneous aortic balloon valvotomy and its outcomes using the nation's largest hospitalization database. There has been a resurgence in the use of percutaneous aortic balloon valvotomy in patients at high surgical risk because of the development of less-invasive endovascular therapies.

Methods: This is a cross-sectional study with time trends using the Nationwide Inpatient Sample database between the years 1998 and 2010.

Impact of worsening renal dysfunction on the comparative efficacy of bivalirudin and platelet glycoprotein IIb/IIIa inhibitors: insights from Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

Background: Use of bivalirudin has been associated with a reduction in the incidence of bleeding in patients undergoing percutaneous coronary intervention. Patients with chronic kidney disease, a known predictor of post-percutaneous coronary intervention bleeding, are under-represented in clinical trials.

Methods And Results: We evaluated the outcome of 64,052 patients who underwent percutaneous coronary intervention from 2007 to 2009 at 33 hospitals in Michigan and were treated with bivalirudin (28,378) or with heparin and glycoprotein IIb/IIIa inhibitors (35,674).

Commentary on late breaking trials in interventional cardiology at ESC, VIVA, TCT, AHA (Fall 2012), and ACC 2013.

With the plethora of clinical trials, it is difficult for busy interventional cardiologists to stay up to date. Therefore, the Society for Cardiovascular Angiography and Interventions (SCAI) publications committee concisely summarized and provided editorial commentary on the most important trials from recent, large international meetings. The intent is to provide this summary every six months to allow quick assimilation of trial results into interventional practice.

Implications of myocardial reperfusion on survival in women versus men with acute myocardial infarction undergoing primary coronary intervention.

We evaluated the effects of myocardial perfusion after primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) on gender-based mortality rates. Research has demonstrated a gender-specific response of cardiomyocytes to ischemia and a potential increase in myocardial salvage in women compared with men. Myocardial blush grade (MBG), an angiographic surrogate of myocardial perfusion, is an independent predictor of early and late survival after AMI.

Impact of bivalirudin and paclitaxel-eluting stents on outcomes in patients undergoing primary percutaneous coronary intervention of the left anterior descending artery.

Patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) of the left anterior descending artery (LAD) are at increased risk for cardiovascular events compared with patients undergoing non-LAD PCI. We assessed the impact of bivalirudin and paclitaxel-eluting stenting (PES) in patients with STEMI who underwent LAD PCI. In the HORIZONS-AMI trial, 1,445 patients had LAD PCI and 1,884 patients had non-LAD PCI.

Short-term outcomes of balloon angioplasty versus stent placement for patients undergoing primary percutaneous coronary intervention: Implications for patients requiring early coronary artery bypass surgery.

Background: In patients with acute ST-elevation myocardial infarction (STEMI) needing early coronary artery bypass graft (CABG) surgery, it is unknown whether primary percutaneous balloon angioplasty (PTCA)-without stent implantation-allows safe transition to subsequent CABG.

Methods: We examined acute STEMI patients enrolled in the Stent-PAMI and CADILLAC trials to study the differences in the early clinical events between those treated with primary PTCA (n = 1494) or primary stenting (n = 1488).

Results: Baseline clinical and pre- and post-procedural angiographic features including post-intervention TIMI 3 flow rates were similar in the 2 groups with the exception of higher median infarct-artery residual stenosis in the PTCA group (26% [IQR 19%-34%] vs.

Safety and efficacy of high- versus low-dose aspirin after primary percutaneous coronary intervention in ST-segment elevation myocardial infarction: the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial.

Objectives: This study sought to examine the relationship between the aspirin dose prescribed at hospital discharge and long-term outcomes after ST-segment elevation myocardial infarction in patients treated with primary percutaneous coronary intervention (PCI).

Background: Patients with ST-segment elevation myocardial infarction who undergo primary PCI are prescribed maintenance aspirin doses that vary between 75 and 325 mg daily. Whether the dose of aspirin affects long-term patient outcomes is unknown.

A pooled analysis of the effect of endovascular cooling on infarct size in patients with ST-elevation myocardial infarction.

Aims: Prior evaluations of endovascular cooling during primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) have suggested variability in treatment effect related to core temperature at the time of reperfusion, to infarct location and time from symptom onset to reperfusion. Recent results from a randomised feasibility study suggest rapid induction of hypothermia in primary PCI results in a significant reduction in infarct size (IS).

Methods And Results: Outcomes from two randomised trials of hypothermia in primary PCI were pooled to examine IS as a percentage of left ventricular myocardium assessed by SPECT or magnetic resonance imaging.

Current percutaneous treatment strategies for saphenous vein graft disease.

Coronary artery bypass graft surgery remains one of the most widely performed surgical procedures in North America and aortocoronary saphenous vein grafts (SVG) are the most frequently used surgical conduits. SVG disease (SVGD) remains the leading cause of symptomatic coronary artery disease postcoronary artery bypass graft. When optimal medical therapy is ineffective, repeat surgery is associated with higher mortality combined with less favorable clinical and angiographic results, thus percutaneous revascularization on SVG is currently the standard of care for the revascularization of SVGD.

Comparison of abciximab versus eptifibatide during percutaneous coronary intervention in ST-segment elevation myocardial infarction (from the HORIZONS-AMI trial).

There are limited safety and effectiveness data comparing glycoprotein IIb/IIIa inhibitors in the setting of primary percutaneous coronary intervention. In this substudy of the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, the clinical and bleeding outcomes of eptifibatide versus abciximab were evaluated in patients with ST-segment elevation myocardial infarction who underwent percutaneous coronary intervention. Three-year clinical outcomes of patients in the heparin plus glycoprotein IIb/IIIa inhibitor arm were compared according to treatment with abciximab (n = 907) versus eptifibatide (n = 803).

Mortality in patients with ST-segment elevation myocardial infarction who do not undergo reperfusion.

Reperfusion therapy reduces mortality in patients presenting with ST-segment elevation myocardial infarctions (STEMI). However, some patients may not receive thrombolytic therapy or undergo primary percutaneous coronary intervention. The decision making and clinical outcomes of these patients have not been well described.

Revascularization Strategies in Women with Stable Cardiovascular Disease: What do the Trials Reveal?

Cardiovascular disease (CAD) is the leading cause of death worldwide in both women and men. Although the prevalence of CAD is less in women, those women affected by CAD die more often than men. Women are underrepresented in cardiovascular studies, making it difficult to determine the outcomes of different revascularization strategies.