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Supplemental Digital Content is available in the text. Background: For patients with severe aortic stenosis and coronary artery disease, the completely percutaneous approach to aortic valve replacement and revascularization has not been compared with the standard surgical approach. Methods: The prospective SURTAVI trial (Safety and Efficiency Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) enrolled intermediate-risk patients with severe aortic stenosis from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score (Synergy Between PCI with Taxus and Cardiac Surgery Trial) >22 was an exclusion criterion. Patients were stratified according to the need for revascularization and then randomly assigned to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention, whereas those in the SAVR group had coronary artery bypass grafting. The primary end point was the rate of all-cause mortality or disabling stroke at 2 years. Results: Of 1660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher Society of Thoracic Surgeons risk score for mortality (4.8±1.7% versus 4.4±1.5%; P <0.01) and were more likely to be male (65.1% versus 54.2%; P <0.01) than the 1328 patients not assigned to revascularization. After randomization to treatment, there were 169 patients undergoing TAVR and percutaneous coronary intervention, 163 patients undergoing SAVR and coronary artery bypass grafting, 695 patients undergoing TAVR, and 633 patients undergoing SAVR. No significant difference in the rate of the primary end point was found between TAVR and percutaneous coronary intervention and SAVR and coronary artery bypass grafting (16.0%; 95% CI, 11.1–22.9 versus 14.0%; 95% CI, 9.2–21.1; P =0.62), or between TAVR and SAVR (11.9%; 95% CI, 9.5–14.7 versus 12.3%; 95% CI, 9.8–15.4; P =0.76). Conclusions: For patients at intermediate surgical risk with severe aortic stenosis and noncomplex coronary artery disease (SYNTAX score ≤22), a complete percutaneous approach of TAVR and percutaneous coronary intervention is a reasonable alternative to SAVR and coronary artery bypass grafting. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01586910. [ABSTRACT FROM AUTHOR]

Background: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients.Methods: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods.Results: Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2).Conclusions: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.). [ABSTRACT FROM AUTHOR]

Objectives: This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. Background: Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. Methods: We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). Results: A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). Conclusions: TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902) [Copyright &y& Elsevier]

Background: We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery.Methods: We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing.Results: A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, -0.4; P<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke.Conclusions: In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement. (Funded by Medtronic; U.S. CoreValve High Risk Study ClinicalTrials.gov number, NCT01240902.). [ABSTRACT FROM AUTHOR]

The article presents a study that compared transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery. The study reveals increased surgical risk in patients with severe aortic stenosis and the association between TAVR with a self-expanding transcatheter aortic valve bioprosthesis and higher rate of survival.

The article presents clinical trials which examine the value of transcatheter aortic valve replacement (TAVR) in patients fitted for surgical aortic valve replacement (sAVR). The study reveals that death rates from any cause were 3.4% in the group of TAVR and 6.5% in the group of sAVR at 30 days. It shows that there is an important deviation in 2-year mortality between high-risk and moderate-risk groups, primarily attributable to an increased risk of noncardiac mortality in high-risk groups' patients.

Introduction: Although angiographic measures of restenosis, including late lumen loss, binary angiographic restenosis, and follow-up percent diameter stenosis have value in determining the efficacy of new drug- eluting stents (DES) designs, their ability to predict clinical events, including death, myocardial infarction, and target lesion revascularization (TLR) has been questioned. Methods: We reviewed the available literature and recent DES clinical trials to determine the relationship between clinical and angiographic markers of restenosis and late clinical outcomes after stent use. Results: Angiographic markers are useful surrogates for predicting differences in TLR between bare metal and DES. Due to the curvilinear relationship between late lumen loss and TLR and the skewedness of the late lumen loss distribution, late lumen loss as a single index has been less effective at predicting clinical differences between different DES when the absolute values of late lumen loss are low. Beyond predicting clinical restenosis, follow-up angiographic indices have been less predictive of other late clinical events, such as very late stent thrombosis or aneurysm formation. Conclusions: Angiographic markers of restenosis may be a useful surrogate for TLR in pilot studies of patients treated with DES, but their use as a surrogate marker for all clinical events after stent placement, including death, myocardial infarction, and stent thrombosis, may be confounded by the progression of atherosclerosis at remote sites and vagaries of the distribution of late lumen loss in patients treated with DES. [ABSTRACT FROM AUTHOR]

Repetitive mechanical forces within the coronary artery may result in stent fracture after stent implantation, particularly in patients with complex coronary disease. This study sought to estimate the incidence of Cypher stent fracture in patients with moderately severe coronary disease and to identify the angiographic predictors of fractures in patients identified in a global Cypher fracture registry. Stent fracture analysis was performed in 305 patients treated with the Cypher stent in SIRIUS and in 39 patients with stent fractures reported in the Cypher fracture registry. Fractures were classified as isolated strut fractures (type 1, single-strut fracture; type 2, incomplete transverse fracture) and stent fracture (type 3, complete transverse fracture without displacement; type 4, transverse fracture with displacement). Isolated strut fractures were identified in 4 patients (1.3%) enrolled in SIRIUS (type 1 1.0%, type 2 0.3%); no stent fractures were identified. In 39 patients with 44 clinically reported Cypher fractures, isolated strut fractures were present in 15.4% (all type 2) and stent fractures were found in 84.6% (type 3 38.4%, type 4 46.2%). Compared with patients in SIRIUS, patients with clinically reported fractures had much greater lesion complexity, including extensive calcification, angulation ≥45°, lesion length ≥20 mm, proximal vessel tortuosity, total occlusions, and an ostial location. Clinically reported fractures were associated with a high rate of repeat target lesion revascularization (52.6%). In conclusion, stent fracture after Cypher stent placement occurs more often in patients with “ultra”-complex coronary anatomy, but is an uncommon event in patients treated with mild to moderate lesion complexity. [Copyright &y& Elsevier]

The article presents the results of clinical trials of drug-eluting stents in percutaneous coronary interventions (PCI). Coronary stents tested include bare metal stents (BMS), CYPHER stents, and TAXUS stents. The article also highlights the recommendations of the U.S. Food and Drug Administration (FDA) on future clinical trials.

Objectives: We sought to evaluate the relationship between angiographic late loss and clinical outcomes in the drug-eluting stent era. Background: The interrelationship between angiographic late loss, binary restenosis, and clinical recurrence (target lesion revascularization [TLR]) after coronary stent implantation has been incompletely evaluated. Methods: Using the angiographic substudy of the TAXUS-IV trial, in which 1,314 patients with de novo coronary lesions were randomized to either the paclitaxel-eluting TAXUS stent or to its bare-metal equivalent, we defined the relationship between in-stent and analysis segment late loss, the shape of the late loss histogram (variance and skewedness), and nine-month TLR. Results: Late loss by several measures was closely related to TLR (area under the receiver-operator curve >0.90). For individual vessels of the size in this study (2.8 ± 0.5 mm), the likelihood of TLR did not exceed 5% until analysis segment late loss was >0.5 mm, and did not exceed 10% until late loss was >0.65 mm. At greater late losses, the late loss TLR relationship was steep and nearly linear. For the overall patient cohort, the rate of TLR was related, however, not only to median late loss, but also to measures of its statistical distribution (TLR increased with lack of homogeneous biologic response [greater variance and greater right skewedness]). Similar relationships held for late loss measured within the confines of the stent itself. Conclusions: Coronary stents result in large lumens with “room” to accommodate up to ∼0.5 to 0.65 mm of tissue (angiographic analysis segment late loss) before the likelihood of clinical restenosis (TLR) exceeds 5% to 10%. These data have important implications toward understanding the absolute and relative efficacy of drug-eluting stents. [Copyright &y& Elsevier]

This chapter about antithrombotic therapy during percutaneous coronary intervention (PCI) is part of the seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence Based Guide-lines. Grade 1 recommendations are strong and indicate that the benefits do, or do not, outweigh risks, burden, and costs. Grade 2 suggests that individual patients' values may lead to different choices (for a full understanding of the grading, see Guyatt et al, CHEST 2004;126:179S-187S). Among the key recommendations in this chapter are the following: For patients undergoing PCI, we recommend pre- treatment with aspirin, 75 to 325 mg (Grade 1A). For long-term treatment after PCI, we recommend aspirin, 75 to 162 mg/d (Grade 1A). For long-term treatment after PCI in patients who receive antithrombotic agents such as clopidogrel or warfarin, we recommend lower-dose aspirin, 75 to 100 mg/d (Grade 1C+). For patients who undergo stent placement, we recommend the combination of aspirin and a thienopyridine derivative (ticlopidine or clopidogrel) over systemic anticoagulation therapy (Grade 1A). We recommend clopidogrel over ticlopidine (Grade 1A). For all patients undergoing PCI, particularly those undergoing primary PCI, or those with refractory unstable angina or other high-risk features, we recommend use of a glycoprotein (GP) IIb-IIIa antagonist (abciximab or eptifibatide) [Grade 1A]. In patients undergoing PCI for ST-segment elevation MI, we recommend abciximab over eptifibatide (Grade 1B). In patients undergoing PCI, we recommend against the use of tirofiban as an alternative to abciximab (Grade 1A). In patients after uncomplicated PCI, we recommend against routine postprocedural infusion of heparin (Grade 1A). For patients undergoing PCI who are not treated with a GP IIb-IIIa antagonist, we recommend bivalirudin over heparin during PCI (Grade 1A). In PCI patients who are at low risk for complications, we recommend bivalirudin as an alternative to heparin as an adjunct to GP IIb-IIIa antagonists (Grade 1B). In PCI patients who are at high risk for bleeding, we recommend that bivalirudin over heparin as an adjunct to GP IIb-IIIa antagonists (Grade 1B). In patients who undergo PCI with no other indication for systemic anticoagulation therapy, we recommend against routine use of vitamin K antagonists after PCI (Grade 1A). [ABSTRACT FROM AUTHOR]

Percutaneous coronary intervention can be safely performed in patients with acute coronary syndromes (ACS), including those with non-ST-segment elevation myocardial infarction (MI), and unstable angina. Although there remains debate about whether an aggressive strategy involving early coronary arteriography and revascularization should be routinely performed in patients who present with non-ST-segment elevation MI and unstable angina, recent clinical trials suggest that an aggressive approach should be taken in both intermediate- and high-risk patients with ACS. There have been 4 clinical trials that have compared the outcomes of patients presenting with non-ST-segment elevation MI or unstable angina who were assigned to invasive or conservative strategies. The Thrombolysis in Myocardial Infarction (TIMI) IIIB trial and the Veterans Affairs Non-Q-Wave Infarction Strategies in Hospital (VANQWISH) trial failed to demonstrate a reduction in death or MI in patients assigned to an invasive approach, but it did demonstrate an important reduction in the frequency of rehospitalization. However, these studies were performed before the availability of coronary stents or the use of glycoprotein IIb/IIIa inhibitors. In contrast, the Fragmin and Fast Revascularisation During Instability in Coronary Artery Disease (FRISC) II and the Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy (TACTICS) trials demonstrated significant improvements in the rates of death or MI in patients with non-ST-segment elevation MI or unstable angina assigned to an invasive strategy. Event reductions were greatest in patients with non-ST-segment elevation MI or unstable angina at intermediate or high risk for an adverse outcome. Understanding that these subgroups comprise approximately 75% of patients presenting with non-ST-segment elevation MI or unstable angina, we believe that an invasive approach is indicated in most patients who develop non-ST-segment elevation MI or unstable angina. Regardless of the strategy used in ACS patients, lipid-lowering therapy is necessary to reduce recurrent ischemia events at the site of plaque instability and in atherosclerotic disease remote to the target lesion. [ABSTRACT FROM AUTHOR]

Recommends the use of antithrombotic therapy in patients undergoing percutaneous coronary intervention (PCI). Effect of antiplatelet agents on procedural outcome after coronary angioplasty; Evaluation of the safety of lower-dose heparin therapy during PCI.

Atherosclerosis is often asymptomatic, unrecognized, and undertreated. Lumen irregularities are important angiographic findings that should be addressed aggressively through risk factor modification, medical therapy, and coronary revascularization. Both angiographic and clinical benefits have been demonstrated with lipid reduction therapy in randomized clinical trials. Coronary revascularization is indicated for symptom relief and improvement in quality of life in patients with acute coronary syndromes at "intermediate" and "high" risk of subsequent death or myocardial infarction. In patients following percutaneous coronary intervention (PCI), future cardiac events may be related to lumen renarrowing or to progression of atherosclerotic disease at sites remote from the site of coronary revascularization. The time course of restenosis is relatively self-limiting, generally occurring within 6-12 months after the procedure. Clinical events occurring > 1 year after PCI generally relate to new lesions or progression of existing atherosclerotic disease. Patients with diabetes mellitus may be at higher risk for late coronary events than nondiabetic patients. In post-coronary artery bypass surgery (CABG) patients, the majority of late events relate to degeneration of saphenous vein grafts. Lipid lowering therapy after coronary revascularization has been shown to prevent clinical events related to plaque instability and inhibit progression of saphenous vein graft disease. Thus, there are 2 goals in management of patients with symptomatic coronary artery disease: (1) to relieve the flow-limiting stenosis, and (2) to prevent future clinical events with aggressive lipid lowering and modification of other risk factors. Patients, specialists, and primary care physicians each need to take accountability for this risk-factor modification. [ABSTRACT FROM AUTHOR]

The influence of vessel size on clinical and angiographic outcomes after new device angioplasty has not been well documented. We reviewed clinical and angiographic outcomes of 2,044 patients undergoing new device angioplasty of native vessels enrolled in the New Approaches to Coronary Interventions (NACI) Registry. Quantitative angiography was performed using standard methods. Patients were divided into 3 groups according to reference vessel diameter (RVD) (<2.75, 2.75 to 3.25, and >3.25 mm). Patients with the smallest vessels had a higher incidence of diabetes (26% vs. 16%, p<0.01), multivessel disease (50% vs. 45%, p<0.01), left anterior descending coronary artery disease (61% vs. 39% p<0.01), and in general, more severe baseline lesion characteristics than patients with larger (>3.25 mm) vessels. Absolute baseline and final minimal lumen diameter (MLD) was also smaller in patients with RVD <2.75 mm despite similar final percent diameter stenosis. Although in-hospital events were similar, patients who underwent interventions in vessels <2.75 mm had an increased incidence of death (p<0.01), surgical revascularization (p<0.05), and target lesion revascularization (TLR) (p<0.01) at 1 year. Multivariate analysis by vessel size showed a stepwise increase in the risk of TLR by 1 year in patients with the smaller RVD (p = 0.0001) and the combined end point of 1 year death/Q wave-myocardial infarction/TLR (p = 0.02). Thus, despite similar early clinical events among patients undergoing new device angioplasty, patients who underwent treatment of smaller vessels had a significantly increased risk of major adverse clinical events and particularly TLR by 1 year after new device angioplasty of native coronary arteries. [ABSTRACT FROM AUTHOR]

Although substantial intersystem variability has been shown among several commercially available quantitative angiographic (QA) analysis algorithms, no previous study has compared the angiographic findings using 2 different QA systems performed at the same central angiographic laboratory. The purpose of this study was to compare the early and late QA results obtained with the CMS (MEDIS) and ARTREK (ImageComm) QA systems in the Balloon versus Optimal Atherectomy Trial. Directional atherectomy (n = 496) or balloon angioplasty (n = 490) was performed in 986 patients; late QA follow-up was available in 767 patients (77.7%). QA analysis was performed by 2 independent observers using the CMS and ARTREK systems. Correlation between the 2 QA systems for baseline measurements was good (Pearson's R = 0.78), although the CMS system resulted in larger baseline reference diameter (RD) (3.22 +/- 0.45 vs 3.07 +/- 0.40 mm; p <0.0001) and baseline minimal lumen diameters (MLD) (1.05 +/- 0.35 vs 0.92 +/- 0.32; mm p <0.0001) than the ARTREK system. The final and follow-up RD (+0.17 and +0.11 mm, respectively) were also larger using the CMS system. In contrast, the final and follow-up measurements of MLD and percent diameter stenosis were not significantly different using the 2 QA systems. The QA system did not affect the ability to detect a difference in restenosis rates (>50% follow-up diameter stenosis) between the 2 treatment groups (CMS, directional atherectomy [31.8%]; balloon angioplasty [40.5%]; p = 0.013 and ARTREK, directional atherectomy [33.9%], balloon angioplasty [41.3%]; p = 0.036). Only lesion irregularity contributed to the difference in baseline measurements of MLD and percent diameter stenosis. We conclude that important differences in measurements of RD, baseline MLD, and percent diameter stenosis were noted using the CMS and ARTREK systems. Both systems, however, were able to detect a treatment benefit associated with directional atherectomy in BOAT. The comparability of other angiographic systems will require similar evaluation in other studies. [ABSTRACT FROM AUTHOR]

Discusses the potential role of lipid-lowering therapy in the prevention of death and myocardial infarction following transluminal angioplasty and coronary artery bypass graft surgery. Ubiquity of atherosclerosis; Benefits of therapy; Angiographic studies; Plaque stability and coronary vasoreactivity; Clinical recurrence after revascularization.

Examines directional coronary atherectomy based from a report from the data library New Approaches to Coronary Intervention Registry in the United States. Angiographic core laboratory analysis; In-hospital outcomes; Predictors of in-hospital events, death and target lesion revascularization; Relation with other athrectomy studies.

Determines the frequency and predictors of major in-hospital ischemic complications after planned and unplanned procedures with new angioplasty devices based on data from the data library New Approaches to Coronary Intervention Registry in the United States. Procedural success of planned and unplanned procedures; Device-specific angiographic complications.

Assesses the general agreement of clinical site and angiographic core laboratory readings obtained in the database New Approaches to Coronary Intervention (NACI) Registry in the United States. Qualitative lesion morphology; Quantitative angiography; Influence of device used on quantitative measurements.

Objective: To discuss adjunctive pharmacologic agents for acute myocardial infarction, to critique their initial effects in clinical trials, and to review their potential for improving the clinical conditions of patients with acute myocardial infarction.Data Sources: Relevant studies reported from January 1985 to December 1990 were identified through a MEDLINE search of the English-language literature and through a manual search of the bibliographies of all identified articles.Study Selection: Peer-reviewed experimental and clinical studies evaluating the role of pharmacologic adjuncts to thrombolytic therapy in experimental models of coronary occlusion and clinical trials of patients with acute myocardial infarction were selected for review.Data Extraction and Synthesis: The data presented were abstracted by the investigators. Differences with a univariate P value of less than 0.05 were considered to be statistically significant.Conclusions: Current clinical data suggest that adjunctive pharmacologic therapy to thrombolytic agents should include aspirin, at least 160 mg administered as soon as possible after the onset of symptoms; intravenous heparin; and, in selected patients without contraindications, intravenous beta-blockading agents. [ABSTRACT FROM AUTHOR]

Because coronary angioplasty is being increasingly used as a treatment for coronary artery disease, the proper evaluation and management of patients after the procedure are important issues. Although coronary angioplasty is a complex technical procedure, the methods routinely used to evaluate its results have many shortcomings. Although the initial results of the procedure are assessed most commonly by the visual interpretation of video images and coronary angiograms, quantitative angiography, trans-stenotic pressure gradients, and coronary flow reserve measurements have also been used. In the period after coronary angioplasty, success can be evaluated by patients' clinical improvement in symptoms and their stress responses to various functional tests. The management of the patient during the first 24 hours after angioplasty should focus on the prevention, detection, and, if necessary, treatment of acute vessel closure. During the subsequent 6 months, the emphasis should shift to the evaluation of recurrent symptoms and prevention of restenosis. We discuss the methods used to assess the results of coronary angioplasty and suggest guidelines for managing patients after the procedure. [ABSTRACT FROM AUTHOR]

Background: For patients with severe aortic stenosis (AS) and coronary artery disease (CAD), the completely percutaneous approach to aortic valve replacement and revascularization has not been compared to the standard surgical approach.Methods: The prospective SURTAVI trial enrolled intermediate-risk patients with severe AS from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score >22 was an exclusion criterion. Patients were stratified according to need for revascularization and then randomized to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in the TAVR group underwent percutaneous coronary intervention (PCI), while those in the SAVR group had coronary artery bypass grafting (CABG). The primary endpoint was the rate of all-cause mortality or disabling stroke at two years.Results: Of 1,660 subjects with attempted aortic valve implants, 332 (20%) were assigned to revascularization. They had a higher STS risk score for mortality (4.8±1.7% vs 4.4±1.5%; p<0.01) and were more likely to be male (65.1% vs 54.2%; p<0.01) than the 1,328 patients not assigned to revascularization. After randomization to treatment, there were 169 TAVR and PCI patients, 163 SAVR and CABG patients, 695 TAVR patients, and 633 SAVR patients. No significant difference in the rate of the primary endpoint was found between TAVR and PCI and SAVR and CABG (16.0%; 95% CI 11.1 - 22.9 vs. 14.0%; 95% CI 9.2 - 21.1; p=0.62), or between TAVR and SAVR (11.9%; 95% CI 9.5 - 14.7 vs. 12.3%; 95% CI 9.8 - 15.4; p=0.76).Conclusions: For patients at intermediate surgical risk with severe AS and non-complex CAD (SYNTAX score ≤ 22), a complete percutaneous approach of TAVR and PCI is a reasonable alternative to SAVR and CABG.Clinical Trial Registration: URL: www.clinicaltrials.gov Unique Identifier: NCT01586910. [ABSTRACT FROM AUTHOR]

Introduction: Reduced stroke volume index (SVI) and LVEF are associated with increased mortality after aortic valve replacement (AVR) in patients with severe AS. Their interaction with the AVR strategy has not been thoroughly investigated. Hypothesis: Our aim was to assess the impact of SVI and LVEF on 1-year mortality after surgical (S)AVR and transcatheter (T)AVR. Method: The analysis cohort comprised 742 patients of the multicenter, randomized (1:1) CoreValve US Pivotal High Risk Trial, implanted with the CoreValve self-expanding aortic bioprosthesis (n=389) or a surgical aortic bioprosthetic valve (n=353). SV and LVEF were measured as a part of comprehensive echocardiography analysis by an independent core lab. Normal SVI was ≥ 35 mL/m2 and preserved LVEF was ≥ 50%. Mortality rates were Kaplan-Meier estimates. Results: Baseline reduced SVI was present in 35.8% of TAVR and 31.3% of SAVR patients. Compared to patients with normal SVI, TAVR patients with reduced SVI were more often male (61.6% vs. 47.3%, p = 0.01), had AF (55.6% vs. 32.6%, p < 0.001) and a higher logEuroSCORE (20.9 ± 15.7% vs. 15.7 ± 10.6%, p = 0.001). For SAVR, male sex (62.5% vs. 49.3%, p = 0.03), AF (55.2% vs. 42.2%, p = 0.03), logEuroSCORE (20.6 ± 14.9% vs. 16.9 ± 11.0%, p = 0.04) and coronary artery disease (84.4% vs. 72.0%, p = 0.02) were more prevalent in patients with reduced SVI. Baseline reduced LVEF was present in 18.1% of TAVR and 19.6% of SAVR patients. In patients with reduced LVEF (left panel), 1- year mortality was higher with reduced SVI after AVR without treatment interaction. In patients with preserved LVEF (right panel), there was a clinically significant interaction between 1-year mortality and treatment, without any impact of SVI status on the mortality within the same AVR strategy. Conclusions: In high-risk patients with severe AS, there is a clinically significant interaction between AVR strategy and 1-year survival when LVEF is ≥ 50% and between SVI status and 1-year survival when LVEF <50%. [ABSTRACT FROM AUTHOR]

Background: Subclinical leaflet thrombosis has been reported after bioprosthetic aortic valve replacement, characterized using 4-dimensional computed tomographic imaging by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM). The incidence and clinical implications of these findings remain unclear.Objectives: The aim of this study was to determine the frequency, predictors, and hemodynamic and clinical correlates of HALT and RLM after aortic bioprosthetic replacement.Methods: A prospective subset of patients not on oral anticoagulation enrolled in the Evolut Low Risk randomized trial underwent computed tomographic imaging 30 days and 1 year after transcatheter aortic valve replacement (TAVR) or surgery. The primary endpoint was the frequency of HALT at 30 days and 1 year, analyzed by an independent core laboratory using standardized definitions. Secondary endpoints included RLM, mean aortic gradient, and clinical events at 30 days and 1 year.Results: At 30 days, the frequency of HALT was 31 of 179 (17.3%) for TAVR and 23 of 139 (16.5%) for surgery; the frequency of RLM was 23 of 157 (14.6%) for TAVR and 19 of 133 (14.3%) for surgery. At 1 year, the frequency of HALT was 47 of 152 (30.9%) for TAVR and 33 of 116 (28.4%) for surgery; the frequency of RLM was 45 of 145 (31.0%) for TAVR and 30 of 111 (27.0%) for surgery. Aortic valve hemodynamic status was not influenced by the presence or severity of HALT or RLM at either time point. The rates of HALT and RLM were similar after the implantation of supra-annular, self-expanding transcatheter, or surgical bioprostheses.Conclusions: The presence of computed tomographic imaging abnormalities of aortic bioprostheses were frequent but dynamic in the first year after self-expanding transcatheter and surgical aortic valve replacement, but these findings did not correlate with aortic valve hemodynamic status after aortic valve replacement in patients at low risk for surgery. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283). [ABSTRACT FROM AUTHOR]

Abstract Background The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality–risk patients. Objectives The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. Methods Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. Results A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. Conclusions This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902) Central Illustration [ABSTRACT FROM AUTHOR]

A response by Dr. Greg Stone to a letter to the editor about his article comparing paclitaxel-eluting stents to brachytherapy and in-stent restenosis from a previous issue is presented.

Discusses the case of a 70-year old man with unstable angina, highlighting therapeutic challenges for acute coronary syndromes. Primary goals of therapy; Reasons for prescribing angiotensin-converting enzyme inhibitors; Aggressive risk-factor modification.

Introduces a series of articles pertaining to the roles of medical therapy and percutaneous coronary intervention in patients with acute coronary syndromes. Oxidative, inflammatory and remodeling processes in the vascular wall during atherosclerosis; Role of inflammation in the pathogenesis of atherosclerotic disease; Techniques for visualization of plaque.

Background: Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk.Methods: We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement.Results: A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group.Conclusions: TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .). [ABSTRACT FROM AUTHOR]

The article discusses Transcatheter aortic valve implantation (TAVI) as the greatest advance in interventional cardiology. It mentions that superiority of the technique in comparison to medical therapy can be observed from the controlled trials results. It also focuses on the excellent acute and long term outcomes of the well established procedure of conventional aortic valve replacement (AVR).

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. Methods: This is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES. The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. Results: Among a total of 1,548 patients assigned to ZES (n = 773) or PES (n = 775), at 9 months, ZES was noninferior to PES with rates of target vessel failure 6.6% versus 7.1%, respectively (pnoninferiority ≤ 0.001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs. 2.2%; p = 0.007), whereas at 12 months, there were no significant differences between groups in rates of cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis. Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES (15.3% vs. 10.4%; p = 0.284), rates of 12-month target lesion revascularization were similar (4.5% vs. 3.2%; p = 0.228), especially in patients without planned angiographic follow-up (3.6% vs. 3.2%; p = 0.756). Conclusions: These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions. (ENDEAVOR IV Clinical Trial; NCT00217269) [Copyright &y& Elsevier]

Objectives: The goal of this research was to assess non-inferiority of the next-generation TAXUS Liberté stent (Boston Scientific Corp., Natick, Massachusetts) versus the TAXUS Express stent (Boston Scientific Corp.). Background: The introduction of drug-eluting stents (DES) has shifted clinical practice towards more complex lesion subsets, prompting the need for more deliverable DES. TAXUS Liberté was designed to combine the established polymer-based, paclitaxel-elution TAXUS technology with the more advanced Liberté stent platform. Methods: The TAXUS ATLAS study is a global, prospective, single-arm trial evaluating outcomes in de novo coronary lesions visually estimated to be 10 to 28 mm in length in vessels 2.5 to 4.0 mm in diameter. The control group is an entry-criteria-matched population of TAXUS Express patients from the TAXUS IV and V trials. The primary end point is non-inferiority of TAXUS Liberté versus TAXUS Express for 9-month target vessel revascularization. Results: Despite similar inclusion criteria, quantitative coronary angiography-determined baseline lesion characteristics were significantly more complex for TAXUS Liberté than TAXUS Express. The primary non-inferiority end point was met with the 1-sided 95% confidence bound of 2.98% less than the pre-specified non-inferiority margin of 3% (p = 0.0487). Conclusions: Despite the treatment of more complex lesions with TAXUS Liberté, the primary end point was met, demonstrating that TAXUS Liberté is non-inferior to TAXUS Express. The successful transfer of the proven TAXUS technology to the more advanced TAXUS Liberté platform was demonstrated. (TAXUS ATLAS: TAXUS Liberté-SR Stent for the Treatment of De Novo Coronary Artery Lesions; http://www.clinicaltrials.gov/ct/show/NCT00371709?order=1; NCT00371709) [Copyright &y& Elsevier]

Objectives: This trial examined the relative clinical efficacy, angiographic outcomes, and safety of zotarolimus-eluting coronary stents (ZES) with a phosphorylcholine polymer versus sirolimus-eluting stents (SES). Background: Whether a cobalt-based alloy stent coated with the novel antiproliferative agent, zotarolimus, and a phosphorylcholine polymer may provide similar angiographic and clinical benefit compared with SES is undetermined. Methods: A prospective, multicenter, 3:1 randomized trial was conducted to evaluate the safety and efficacy of ZES (n = 323) relative to SES (n = 113) in 436 patients undergoing elective percutaneous revascularization of de novo native coronary lesions with reference vessel diameters between 2.5 mm and 3.5 mm and lesion length ≥14 mm and ≤27 mm. The primary end point was 8-month angiographic in-segment late lumen loss. Results: Angiographic in-segment late lumen loss was significantly higher among patients treated with ZES compared with SES (0.34 ± 0.44 mm vs. 0.13 ± 0.32 mm, respectively; p < 0.001). In-hospital major adverse cardiac events were significantly lower among patients treated with ZES (0.6% vs. 3.5%, p = 0.04). In-segment binary angiographic restenosis was also higher in the ZES cohort (11.7% vs. 4.3%, p = 0.04). Total (clinically and non-clinically driven) target lesion revascularization rates at 9 months were 9.8% and 3.5% for the ZES and SES groups, respectively (p = 0.04). However, neither clinically driven target lesion revascularization (6.3% zotarolimus vs. 3.5% sirolimus, p = 0.34) nor target vessel failure (12.0% zotarolimus vs. 11.5% sirolimus, p = 1.0) differed significantly. Conclusions: Compared with SES, treatment with a phosphorylcholine polymer-based ZES is associated with significantly higher late lumen loss and binary restenosis at 8-month angiographic follow-up. (The Endeavor III CR; http://clinicaltrials.gov/ct/show/ NCT00265668?order=1?) [Copyright &y& Elsevier]

Objectives: The purpose of this research was to determine the relative safety and efficacy of multiple (≥2) overlapping Cypher sirolimus-eluting stents (SES) (Johnson & Johnson, New Brunswick, New Jersey). Background: Overlapping coronary stents are common. The periprocedural and late clinical and angiographic consequences of overlapped coronary stents are not clearly defined, particularly for drug-eluting stents. Methods: All patients enrolled into five clinical trials of the SES were analyzed. Three of these trials were prospective randomized comparisons of the SES to the bare-metal stent (BMS), and two were prospective non-randomized trials of SES-treated patients with historical controls. All clinical and angiographic outcomes in overlap-stent–treated patients were compared by stent type and with single-stent–treated patients for the same stent device. Results: In all, 575 patients with stent overlap (337 SES, 238 BMS) and 1,162 patients with single stents (697 SES, 465 BMS) were analyzed. Stent overlap was associated with a greater late lumen loss in stent and more frequent angiographic restenosis regardless of stent type. Among overlap-stent–treated patients, the SES provided similar magnitude of restenosis benefit as observed for single-stent–treated patients. Overlapped SES was not associated with an increase in myocardial infarction. Conclusions: The strategy of SES overlap, when required, is both safe and efficacious in reducing restenosis with no increase in the incidence of myocardial infarction or major adverse cardiovascular events, when compared with a bare metal coronary stent prosthesis. [Copyright &y& Elsevier]

Selection of coronary stent length varies from covering only the zone of maximum obstruction to stenting from normal- to normal-appearing vessels. With bare metal stenting, for any given lesion there is a high restenotic risk associated with longer stent length. With drug-eluting stents, the relation between stent length and restenosis has not been evaluated. In the angiographic follow-up cohort of the SIRIUS trial that compared the sirolimus-eluting Bx Velocity stent with the standard Bx Velocity stent (n = 699), we constructed a multiple regression model to predict 8-month percent diameter stenosis using the main effects of lesion length and excess stent length beyond the lesion length and adjusting for known predictors of restenosis. Stent length exceeded lesion length in 94% of lesions overall. Mean difference in length was 8.3 ± 8.3 mm (mean lesion length 14.6 ± 5.9 mm, mean stent length 22.9 ± 9.6 mm). Stented lesion length and excess stent length were associated with absolute increases in percent diameter stenosis per 10 mm of 9.1% (p &#60;0.0001) and 3.6% (p = 0.053) in the bare metal arm and 3.5% (p = 0.047) and 2.1% (p = 0.040) in the sirolimus-eluting stent arm. Although the effects of lesion length and excess stent length on restenosis were markedly decreased with sirolimus-eluting stents (vs bare metal stents), a small restenotic penalty is still paid for excessive stent length. Longer stent-to-lesion length strategies should be used only when a shorter stent is likely to result in incomplete lesion coverage and edge dissection, a strong determinant of stent thrombosis. [Copyright &y& Elsevier]

Distal balloon occlusion was approved as a means of embolic protection during saphenous vein graft intervention based on its ability to decrease major adverse clinical events (MACEs) by 42% in the 801-patient Saphenous Vein Graft Angioplasty Free of Emboli Randomized (SAFER) trial. However, the cost and technical complexity of this device have limited its widespread use and prompted some to avoid its use in cases that appear at “low risk” for complications. If predictors of MACEs and their potential decrease by distal balloon occlusion could be identified, this would have important clinical implications in this challenging population. We therefore used standard demographic and angiographic variables and 2 new angiographic markers (extent of graft degeneration and estimated volume of plaque in the target lesion) to construct multivariable logistic regression models of 30-day of MACEs in the SAFER trial. Independent correlates of increased 30-day MACEs were more extensive vein graft degeneration (p = 0.0001) and bulkier lesions (larger estimated plaque volume, p = 0.0005). Use of a distal balloon occlusion device was independently predictive of lower 30-day rates of MACE (p = 0.01), with uniform benefit across risk strata (no significant interaction between device use and independent angiographic risk factors). Thus, the risk of 30-day MACEs after percutaneous intervention in aortocoronary saphenous vein grafts is increased in more diffusely diseased grafts and in bulkier lesions, but a significant benefit of the GuardWire was seen across all levels of MACE risk rather than just those perceived to be at highest risk. [Copyright &y& Elsevier]

In this retrospective review of 5,234 cardiac catheterizations and percutaneous coronary interventions, the rate of vascular complications was highest in extremely thin and morbidly obese patients and lowest in moderately obese patients, consistent with the previously reported “obesity paradox.” The use of transradial access and arterial access closure devices was associated with reduced vascular complications in the population of obese patients. [Copyright &y& Elsevier]