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The SURTAVI trial demonstrated the noninferiority of transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) in patients with severe, symptomatic aortic stenosis at intermediate surgical risk. Most TAVI patients received an early generation device which is no longer commercially available. This analysis compares TAVI outcomes in patients that received the Evolut R valve to those of similar patients randomized to SAVR in the SURTAVI trial. The continued access study of SURTAVI (CAS) enrolled 290 patients. Of them, 252 were implanted with the 23, 26, or 29 mm Evolut R device. Propensity-score matching between this group and SURTAVI SAVR patients with annular diameter of 26 mm or less was based on 22 clinical characteristics, resulting in 197 matched pairs for analysis. The primary end point for comparison was the rate of all-cause mortality or disabling stroke at 1-year. The mean age for TAVI and SAVR patients in the propensity-score matched population was 79.1 years and STS-PROM was 4.0 ± 1.5% for TAVI and 3.9% ± 1.3% for SAVR. The rate of all-cause mortality or disabling stroke at 30-days significantly favored TAVI (0.5% vs 5.1%; p = 0.006). At 1-year TAVI was numerically favored (4.1% vs 8.2%; p = 0.082). In conclusion, compared with SAVR, TAVI using Evolut R had a favorable 30-day safety profile, significantly better hemodynamic performance, and a comparable 1-year rate of all-cause mortality or disabling stroke, suggesting this may be a preferred treatment for patients with severe, symptomatic aortic stenosis at intermediate surgical risk.

Transcatheter aortic valve implantation (TAVI) is approved for treatment of symptomatic aortic stenosis in patients at increased risk for surgical valve replacement, but outcomes data in patients with severe native aortic regurgitation (AR) treated with TAVI remain limited. The objective of this analysis was to evaluate outcomes among patients identified in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry who underwent TAVI for native AR with a commercially available self-expanding valve system. From January 2014 to December 2017, 230 patients in the TVT Registry underwent TAVI for primary severe native AR using a commercially available self-expanding valve (n = 81, CoreValve; n = 149, Evolut R). For inclusion, AR was either pure or mixed with predominantly moderate/severe AR and mean aortic valve gradient ≤20 mm Hg. Thirty-day outcomes were evaluated using time-to-event methods. Device success was reported in 81.7% of patients (CoreValve, 72.2%; Evolut R, 86.9%; p = 0.0.01). Thirty-day all-cause mortality was 13.3%. All patients presented with moderate/severe AR at baseline; at 30 days, 9.1% of implanted patients with data continued to have moderate and 1.4% severe AR. There was a significant reduction in residual moderate/severe AR from the CoreValve to Evolut R device (19.1% vs 6.3%, p = 0.02). Multivariable analysis revealed factors associated with 30-day all-cause mortality include number of valves used (hazard ratio [HR] 2.361, 1.643 to 3.391, p0.001), albumin3.3 mg/dL (HR 3.358, 1.551 to 7.273, p=0.002), and left ventricular ejection fraction (HR 0.978, 0.957 to 1.000, p = 0.047). Despite higher 30-day all-cause mortality, self-expanding TAVI may be an option in selected patients with AR who have no surgical options.

Transfemoral transcatheter aortic valve replacement (TF-TAVR) is mostly performed under general anesthesia (GA) in most US centers. We examined in-hospital and 30-day outcomes in patients who underwent TF-TAVR with a self-expanding bioprosthesis using local anesthesia (LA) or GA. Patients from the Transcatheter Valve Therapeutics Registry who underwent TF-TAVR from January 2014 to June 2016 with LA or GA were evaluated. Propensity matching was performed and procedural and clinical outcomes compared up to 30 days. A total of 11,006 patients were included (GA: 8,239 [74.9%] and LA: 2,767 [25.1%]). After propensity matching (n = 1,988 matched sets), device success was similar (94.5% vs 94.6%, p = 0.905). No differences in in-hospital stroke (2.7% vs 2.3%, p = 0.413) or paravalvular regurgitation grade (p = 0.113) were noted. Fewer LA patients were converted to open heart surgery (0.2% vs 0.6%, p = 0.076) or experienced an in-hospital major vascular complication (0.7% vs 1.4%, p = 0.026). Intensive care unit time (40.1 ± 58.4 vs 50.9 ± 72.1 hours, p0.001) and postprocedure length of stay (4.1 ± 3.6 vs 5.0 ± 4.5 days, p0.001) were significantly shorter with LA. In-hospital and 30-day all-cause mortality were lower in the LA cohort compared to the GA cohort ([1.1% vs 2.7%, p0.001] and [2.1% vs 3.9%, p = 0.001]). In conclusion, in the largest series of self-expanding bioprostheses for TF-TAVR, these propensity-matched cohorts demonstrate that LA is an acceptable alternative to GA with comparable success, lower safety outcomes, complications rates, and in-hospital and 30-day all-cause mortality.

This study was performed to determine if baseline aortic regurgitation (AR) affects the deleterious effects of postprocedure paravalvular leak following transcatheter aortic valve implantation (TAVI). We evaluated the effect of baseline AR on mortality in a large cohort of patients randomized to transcatheter or surgical aortic valve replacement (SAVR). The analysis cohort comprised 739 patients who underwent attempted TAVI (n = 386) or SAVR (n = 353) in the CoreValve US Pivotal High Risk Trial and had baseline AR measurements. Patients were stratified by the severity of baseline AR into those with none and/or trace and those with ≥mild AR. Echocardiographic measurements were assessed by an independent core laboratory. Of the 386 TAVI patients, 204 (52.9%) had none and/or trace at baseline AR; 182 (47.2%) had ≥mild AR. Of the 353 SAVR patients, 169 (47.9%) had none and/or trace and 184 (52.1%) ≥mild AR. The presence of ≥mild baseline AR was associated with lower all-cause mortality at 1 year following TAVI (9.4% vs 18.6%, p = 0.008) or SAVR (13.3% vs 24.4%, p = 0.009). Mortality remained lower in the ≥mild baseline AR patients at 3 years after SAVR (p = 0.011), but not TAVI. In conclusion, baseline AR appears to provide a protective effect on survival and quality of life in both TAVI and SAVR patients at 1 year; this effect persists out to 3 years in SAVR patients.

The impact of predilatation (Pre-Dil) on prosthesis hemodynamics and clinical outcomes of subjects who underwent transcatheter aortic valve implantation (TAVI) with a self-expanding prosthesis remains unclear. Two thousand seven hundred twenty-one subjects from the extreme- and high-risk CoreValve Continued Access Study (CAS) were included in the analysis. Subjects who underwent Pre-Dil before TAVI were compared with subjects who underwent TAVI without Pre-Dil. Clinical outcomes included death, stroke, myocardial infarction, acute kidney injury, and new permanent pacemaker implantation. Serial echocardiograms were analyzed to evaluate prosthesis hemodynamics, specifically paravalvular regurgitation, effective orifice area, and mean gradient. Two thousand one hundred eighteen and 603 subjects underwent TAVI with and without Pre-Dil, respectively. Subjects in the Pre-Dil cohort were more commonly male, while subjects in the no Pre-Dil cohort had higher rates of previous stroke and lower mean aortic valve gradients. Outcomes at 30 days were comparable between Pre-Dil and no Pre-Dil subjects, with no significant difference in mortality (5.5% vs 4.3%, p = 0.27), major stroke (2.6% vs 2.2%, p = 0.54), major vascular complications (6.9% vs 8.0%, p = 0.37), major bleeding (24.4% vs 26.1%, p = 0.40), and permanent pacemaker implantation (21.3% vs 23.4%, p = 0.36). There were no significant differences in the same outcomes at 12 months. Effective orifice area and mean gradient were comparable between Pre-Dil and no-Pre-Dil subjects at discharge, at 30 days, and at 12 months. In conclusion, when performing TAVI with the self-expanding CoreValve device, performing direct implantation without Pre-Dil maintains an acceptable safety profile and still achieves desired and consistent prosthesis hemodynamics.

The MitraClip device for percutaneous mitral valve repair was approved by the Food and Drug Administration in the United States in October 2013. Few studies have evaluated national outcomes after this procedure in routine clinical practice. We identified adults aged ≥18 years who received percutaneous mitral valve repair from November 2013 to December 2014 in the Nationwide Readmissions Database, a publicly available administrative claims database. Procedural volumes, number of performing hospitals, individual hospital volumes, in-hospital mortality rate, and 30-day hospital readmission rate were determined. Patient demographics, clinical comorbidities, and hospital characteristics were analyzed using logistic regression to determine risk factors for in-hospital death and 30-day readmission. We identified 879 cases performed in the first 14 months after device approval (mean age ± SD, 75.0 ± 13.1 years; 45% women). The number of performing hospitals increased by 5.7-fold (23 to 132), although mean individual hospital volumes remained small (6.2 ± 10.4 cases per hospital). In-hospital all-cause mortality was 3.3% and was associated with higher number of clinical comorbidities. The rate of 30-day readmission was 14.6%, and 6.6% of patients died during rehospitalization. Increased procedural experience was associated with a nonsignificant trend toward reduced hospital readmission after multivariable adjustment (p = 0.08). In conclusion, use of percutaneous mitral valve repair in the United States early after approval increased steadily over time, although individual hospital volumes remained low. More than 1 in 7 patients who underwent this procedure are readmitted within 30 days of discharge.

Transcatheter aortic valve implantation with a bioprosthetic valve of insufficient size is associated with a higher risk of aortic regurgitation (AR). The 31-mm CoreValve and the next generation 34-mm Evolut R bioprostheses were designed to address the need for larger diameter aortic annuli. This analysis examined the clinical and hemodynamic outcomes following commercial transcatheter aortic valve implantation with the 31-mm CoreValve and 34-mm Evolut R in the Society of Thoracic Surgeons/the American College of Cardiology Transcatheter Valve Therapy Registry. Patients receiving a 31-mm CoreValve or 34-mm Evolut R valve for symptomatic severe native aortic stenosis from January 2014 to September 2017 in the Transcatheter Valve Therapy Registry underwent propensity score matching using baseline demographics, clinical and frailty measures, and procedural variables. Procedural characteristics, in-hospital and 30-day clinical and echocardiographic outcomes were compared. Of 4545 patients implanted with a 31-mm CoreValve and 3036 patients with a 34-mm Evolut R valve, matching resulted in 1813 patient sets. Most patients were male (>92%), elderly (∼80 years) with the Society of Thoracic Surgeons score of 6.6%. Use of the 34-mm versus 31-mm valve resulted in shorter median procedural time (113.0 [85.0, 150.0] vs 93.0 [71.0, 126.0] min, p

We sought to characterize the clinical outcomes and to identify predictors of mortality undergoing isolated tricuspid valve surgery in the United States. We identified 5,164 patients undergoing isolated tricuspid valve surgery from the Centers for Medicare and Medicaid Services Medicare Provider Analysis and Review data between January 2003 and December 2014. The primary outcome was all cause 1-year mortality. A backward elimination method was performed to identify predictors of 1-year mortality. Tricuspid valve repair was performed in 2,494 (48.3%) patients and tricuspid valve replacement was performed in 2,670 (51.7%) patients. Perioperative and 1-year mortality rates were 9.9% and 24.1%, respectively. Predictors of 1-year mortality were age (p0.001), chronic heart failure (p = 0.001, cirrhosis (p0.001), carcinoid syndrome (p0.001), chronic kidney disease (p = 0.001), secondary pulmonary hypertension (p = 0.023), endocarditis (p = 0.005), decubitus ulcer (p0.001), malnutrition (p0.001), replacement (p = 0.013), emergency procedure (p0.001), and preprocedural shock (p0.001). The C-statistic for 1-year mortality was 0.70 (95% confidence interval, 0.67 to 0.73). In conclusion, isolated tricuspid valve surgery is infrequently performed in the United States, and is associated with high 1-year mortality. Patients at higher risk for mortality can be identified based on the presence of a number of comorbidities at the time of surgery.

Patients with prior coronary artery bypass grafting (CABG) represent a high-risk cohort given associated medical conditions and worse outcome of saphenous vein graft compared with native vessel percutaneous coronary intervention (PCI). The goal of the current analysis was to compare clinical outcomes in 591 patients with and without prior CABG and multivessel coronary artery disease or unprotected left main disease and severely reduced left ventricular systolic function underwent Impella supported PCI from the PROTECT II randomized trial and the cVAD Registry. Patients with prior CABG surgery (n = 201) were compared with those without prior CABG surgery (n = 390). The primary end point of this analysis was overall mortality at 30 days. Patients with prior CABG surgery had greater Society of Thoracic Surgery mortality score compared with patients without prior CABG surgery, 7.6 ± 6.4 versus 5.1 ± 5.5, respectively, p0.001. Saphenous vein graft PCI was performed in 17% of patients with prior CABG surgery. Number of vessels treated was lower in patients with prior CABG surgery compared with patients without prior CABG surgery, 1.66 ± 0.56 versus 1.89 ± 0.64, respectively, p0.001. Achievement of TIMI 3 flow post PCI and overall PCI success was similar in the two groups. Overall mortality at 30 days was similar in patients with prior CABG surgery compared with patients without prior CABG surgery, 6.75% versus 6.61%, respectively, p = 1.0. In conclusion, in this high-risk cohort of patients underwent hemodynamically supported PCI, prior CABG surgery was not associated with worse outcome. The use of hemodynamic support appears to mitigate the increased risk of PCI associated with prior CABG.

A periprocedural myocardial infarction, defined as the advent of new Q-waves or a creatine kinase-MB elevation >8× normal has been previously validated as predictive of subsequent mortality. We examined the effects of using this clinically relevant definition of periprocedural myocardial infarction instead of the original protocol definition on outcomes in the recent PROTECT II [A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP) in Patients Undergoing Non Emergent High Risk PCI] trial. In this trial, patients who were undergoing high-risk percutaneous coronary intervention (PCI) were randomized to either an intra-aortic balloon pump (IABP, n = 211) or a left ventricular assist device (Impella, n = 216). All eligible patients per study protocol were included in the analysis. Patient outcomes were compared up to 90 days, the longest available follow-up, on the composite end points of major adverse events (MAE) and major adverse cardiac and cerebral events (MACCE = death, stroke, myocardial infarction, and repeat revascularization). At 90 days, the rates of both composite end points were lower in the Impella group compared with the IABP group (MAE, 37% vs 49%, p = 0.014 respectively; MACCE, 22% vs 31%, p = 0.034 respectively). There were no differences in death or large myocardial infarction between the 2 arms. By multivariable analysis, treatment with Impella as opposed to IABP was an independent predictor for freedom from MAE (odds ratio = 0.75 [95% confidence interval 0.61 to 0.92], p = 0.007) and MACCE (odds ratio = 0.76 [95% confidence interval 0.61 to 0.96], p = 0.020) at 90 days postprocedure. In conclusion, hemodynamic support with Impella compared with IABP during high-risk PCI in the PROTECT-II trial resulted in improved event-free survival at 3-month follow-up; this finding was further supported by multivariate analyses.

The objective of this study was to compare outcomes in women after surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) using a self-expanding prosthesis in patients with severe aortic stenosis who were at high risk for SAVR. Although registries and meta-analyses have suggested that TAVR is of considerable benefit in women, perhaps even more so than in men, a rigorous evaluation of TAVR with a self-expanding valve versus SAVR in women from a randomized trial has not been performed. Patients with severe aortic stenosis were randomized 1:1 to either TAVR or SAVR. Outcomes at 1 year are reported. Treatment was attempted in a total of 353 women (183 TAVR and 170 SAVR). Baseline characteristics and predicted risk of the 2 groups were comparable, although the frequency of diabetes mellitus was lower in patients undergoing TAVR (33.3% vs 45.3%; p = 0.02). TAVR-treated patients experienced a statistically significant 1-year survival advantage compared with SAVR patients (12.7% vs 21.8%; p = 0.03). The composite all-cause mortality or major stroke rate also favored TAVR (14.9% vs 24.2%; p = 0.04). Quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire summary score, for both the TAVR and SAVR groups increased significantly from baseline to 1 year. In conclusion, female TAVR patients had lower 1-year mortality and lower 1-year all-cause mortality or major stroke compared with women undergoing SAVR, with both cohorts experiencing improved quality of life. Further studies specifically in women are warranted to validate these findings.

Treatment for severe symptomatic aortic stenosis has changed significantly in recent years due to advances in transcatheter aortic valve replacement (TAVR). Recent studies with the CoreValve prosthesis have demonstrated superior results compared with surgical aortic valve replacement in patients at increased risk for surgery, but there are limited data on gender-related differences in patient characteristics and outcomes with this device. We compared baseline characteristics and clinical outcomes in women and men undergoing TAVR with the CoreValve prosthesis. A total of 3,687 patients (1,708 women and 1,979 men) were included. At baseline, women tended to be slightly older and to have increased frailty, but they had fewer cardiac co-morbidities, higher left ventricular systolic function, less coronary artery disease, and fewer previous strokes. All-cause mortality was 5.9% for women and 5.8% for men at 30 days (p = 0.87) and 24.1% and 21.3%, respectively, at 1 year (p = 0.08). The incidence of stroke was 5.7% in women and 4.0% in men at 30 days (p = 0.02) and 9.3% and 7.7%, respectively, at 1 year (p = 0.05). Women had a higher incidence of bleeding, including more life-threatening bleeds, and a greater incidence of major vascular complications than men at 30 days. Device success was achieved in 86.9% of women and 86.1% of men (p = 0.50). In conclusion, although there were significant baseline differences and procedure-related complications between women and men undergoing TAVR with the CoreValve prosthesis, this analysis found no significant difference in 30-day or 1-year mortality.

Whether drug-eluting stents are effective and safe in patients with moderate renal insufficiency (RI) is unknown. We performed a pooled analysis of data from 3 blinded randomized trials of sirolimus-eluting stents (SESs) versus bare metal stents (BMSs; SIRIUS, C-SIRIUS, E-SIRIUS) that included 1,510 patients. Clinical and angiographic outcomes were stratified by the presence of RI defined by creatinine clearance calculated by the Cockcroft-Gault formula (normal ≥ 90, mild 60 to 89, moderate60 ml/min). Patients with baseline creatinine3.0 mg/dl were excluded from these trials. Baseline mild RI was present in 517 patients (34.7%, mean creatinine clearance 75.7 ml/min) and moderate RI in 228 patients (15.3%, mean creatinine clearance 47.2 ml/min). Treatment with SESs resulted in lower rates of 8-month angiographic restenosis rates in patients with RI (mild RI 6.7% vs 42.6%, p0.001; moderate RI 9.7% vs 39.7%, p0.001) and without baseline RI (7.7% vs 37.2%, p0.001). One-year target vessel revascularization rates were similarly decreased with SESs in patients with (mild RI 4.7% vs 24.2%, p0.001; moderate RI 5.5% vs 26.9%, p0.001) and without (8.1% vs 22.4%, p0.001) RI, and this benefit was maintained at 5 years. Compared to patients with normal or mild RI, patients with moderate RI had higher rates of overall mortality and cardiac death at 1 year and 5 years (death 2.6% vs 0.6%, p0.01, and 17.5% vs 6.3%, p0.01, at 1 year and 5 years, respectively; cardiac death 1.3% vs 0.2%, p = 0.05, and 6.6% vs 3.4%, p = 0.04, at 1 year and 5 years, respectively). However, there was no differential effect of SESs versus BMSs on any safety end point. In conclusion, patients with moderate RI have a nearly threefold increase in 5-year mortality after percutaneous coronary intervention compared to patients without RI. The effectiveness of SESs in decreasing restenosis compared to BMSs in patients with moderate RI was preserved and rates of death and myocardial infarction were not adversely affected.

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, angulationor =45 degrees , lesion lengthor =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.

We used intravascular ultrasound data after stent implantation from the TAXUS IV, V, and VI trials to determine predictors of angiographic stent edge restenosis. In the combined TAXUS IV, V, and VI trials, intravascular ultrasound was performed at implantation in 255 patients with bare metals stents (BMSs) and 276 patients with paclitaxel-eluting stents who underwent quantitative coronary angiography at 9 months. At follow-up, 6 BMSs (2.5%) had proximal edge and 6 BMSs (2.4%) had distal edge angiographic restenosis; 14 TAXUS stents (5.2%) had proximal edge and 1 TAXUS stent (0.4%) had distal edge angiographic restenosis. Although univariate analysis identified external elastic membrane, lumen areas, and plaque burden (external elastic membrane minus lumen/ external elastic membrane) as predictors of 9-month angiographic edge restenosis in the overall cohort and in BMS- and TAXUS-treated patients separately, only edge plaque burden was an independent predictor of 9-month angiographic edge restenosis. Receiver operator characteristic analysis showed that residual plaque burden, but not edge lumen area, was predictive of 9-month angiographic edge restenosis in BMS-treated patients (cutoff 47.7%, c = 0.70, p = 0.0244) and in TAXUS-treated patients (cutoff 47.1%, c = 0.69, p = 0.0137). In conclusion, residual edge plaque burden predicts stent edge restenosis after BMS or TAXUS stent implantation and the optimal plaque burden for stent edge landing zones are the same for BMSs and TAXUS stents, independent of vessel size and edge lumen dimensions.

The Endeavor zotarolimus-eluting stent (ZES; Medtronic Vascular, Santa Rosa, CA) has been found to provide event-free clinical outcomes to 2 years for the treatment of symptomatic CAD by suppressing neointimal proliferation of the target lesion. The clinical outcomes of patients treated with the Endeavor ZES were evaluated at 4 years after implantation. One hundred consecutive patients with symptomatic ischemic heart disease due to de novo stenotic lesions of native coronary arteries were treated with the Endeavor ZES at 8 centers according to a standardized procedure. At 4 years, 3 patients were lost to follow-up analysis. The incidence of major adverse cardiac events (MACE; defined as death, myocardial infarction, emergent cardiac surgery, or repeat revascularization of the target lesion) was 2% at 4 months, 2% at 1 year, 3% at 2 years, 6.1% at 3 years, and 7.2% at 4 years. The difference in these rates was due to 4 deaths caused by cancer (metastatic melanoma, metastatic adenocarcinoma, small-cell cancer of the bladder, and lung carcinoma). From 2-4 years, there was an additional reported case of target lesion revascularization (TLR). A single case of stent thrombosis occurred at 10 days after the index procedure but no cases occurred thereafter. The treatment of patients with symptomatic CAD due to de novo lesions in native coronary arteries with the Endeavor ZES has sustained clinical benefits to 4 years, with very low rates of MACE and TLR.

Zotarolimus-eluting phosphorylcholine-coated cobalt-chromium alloy Driver stents (ZES) demonstrated significant reductions in target lesion revascularization rate with few apparent adverse events compared with bare metal stents (BMS; uncoated Driver stents) in a prospective, multicenter, double-blind, randomized controlled trial in de novo coronary lesions. The aim of this study was to examine detailed vascular responses to ZES compared with BMS using serial intravascular ultrasound analysis. A total of 343 patients (ZES n=178, BMS n=165) were enrolled in this formal, prespecified intravascular ultrasound substudy of the Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE Zotarolimus-Eluting Driver Coronary Stent in de Novo Native Coronary Artery Lesions (ENDEAVOR II), a prospective, multicenter, double-blind, randomized controlled trial to compare ZES and BMS in de novo native coronary artery lesions. Quantitative and qualitative intravascular ultrasound analyses were performed postprocedurally and at 8-month follow-up in stented and reference segments. ZES showed significantly less neointima, with a larger lumen than BMS at 8 months (percentage neointimal volume 17.6 ± 10.1% vs 29.4 ± 17.2%, p 2 , p

Both quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) are currently used to assess in-stent restenosis. This study aimed to use standardized imaging and clinical follow-up to compare QCA parameters with several IVUS parameters to evaluate their strengths and weaknesses for detecting in-stent restenosis in a drug-eluting stent population. A subset of patients from the TAXUS IV, V, and VI studies was evaluated. The subset, which included 216 TAXUS-treated patients and 191 bare-metal stent-treated patients, had complete IVUS and QCA performed at baseline and follow-up. As expected, all QCA and IVUS parameters were consistent with less intimal hyperplasia in TAXUS patients than controls. The overall incidence of QCA binary restenosis was 14.0%, which was 9.3% in TAXUS-treated patients and 19% in bare-metal stent-treated patients (p = 0.0008). Regression analysis showed that QCA late lumen loss and percentage of diameter stenosis correlated only moderately with the various IVUS measures of neointimal hyperplasia for the combined group of patients (TAXUS + bare-metal stent), as well as for the TAXUS-treated and bare-metal stent-treated patients separately. However, in general, correlations within the control (bare-metal stent) group tended to be stronger than within the TAXUS group. The strongest correlation was between QCA percentage of diameter stenosis and IVUS percentage of intimal hyperplasia in the overall group and the control group. The strongest IVUS predictor of QCA binary restenosis at 9 months was maximum percentage of intimal hyperplasia, with an overall C = 0.91 and p

Prospective follow-up at 2 years was obtained for 98.7% of the pooled 1,510 patients enrolled in SIRIUS, E-SIRIUS and C-SIRIUS, 3 randomized controlled trials that compared sirolimus-eluting stents (SESs) with bare metal stents (BMSs) to treat long stenoses in small coronary arteries. By 720 days, clinically driven target lesion revascularizations were performed in 5.7% of patients with SESs versus 22.6% of patients with BMSs (risk ratio 0.25, 95% confidence interval 0.18 to 0.35, p

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.

The results of the VeGAS 2 trial further extend knowledge of the AngioJet device and demonstrate benefits in success, safety, and greater convenience to the patient and physician due to a single, combined procedure for thrombus removal and definitive intervention in this high-risk patient group. AngioJet should be regarded as the therapy of choice for treatment of thrombotic SVGs or native coronary arteries.

To compare the efficacy of self-expanding (SE) and balloon-expandable (BE) stents in native coronary arteries, we randomly assigned 1,096 patients with new and restenotic lesions to receive either device. Baseline demographics and coronary angiographic characteristics were similar in the 2 groups. The incidence of major adverse cardiac events including death, myocardial infarction, bypass surgery, and repeat intervention was similar for both groups at 1 month (2.9% vs 3.1% for SE vs BE, respectively) and at 9 months (19.3% vs 20.1%, SE vs BE respectively). In a subgroup of patients who underwent follow-up angiography (n = 250), the binary restenosis rates (24.2% vs 18.7%, p = 0.30), late loss (0.98 vs 94 mm, p = 0.60), and loss index (0.55 vs 55, p = 0.95) were not significantly different for both groups. In 62 patients who underwent intravascular ultrasound examination (IVUS), there was a trend toward a lower incidence of edge tears in the SE group (6% vs 23%, p = 0.06). Follow-up IVUS analysis showed that the minimum stent area of the SE stent increased by 33% at 6 months, whereas no change occurred in the BE stents; this was accompanied by a greater degree of intimal proliferation in the SE stents compared with BE stents (3.1 +/- 2.0 vs 1.7 +/- 1.7 mm(2)). Thus, the SE stents had similar clinical and angiographic outcomes in patients with lesions in native coronary arteries.

The objectives of this analysis were to develop and validate simplified risk score models for predicting the risk of major in-hospital complications after percutaneous coronary intervention (PCI) in the era of widespread stenting and use of glycoprotein IIb/IIIa antagonists. We then sought to compare the performance of these simplified models with those of full logistic regression and neural network models. From January 1, 1997 to December 31, 1999, data were collected on 4,264 consecutive interventional procedures at a single center. Risk score models were derived from multiple logistic regression models using the first 2,804 cases and then validated on the final 1,460 cases. The area under the receiver operating characteristic (ROC) curve for the risk score model that predicted death was 0.86 compared with 0.85 for the multiple logistic model and 0.83 for the neural network model (validation set). For the combined end points of death, myocardial infarction, or bypass surgery, the corresponding areas under the ROC curves were 0.74, 0.78, and 0.81, respectively. Previously identified risk factors were confirmed in this analysis. The use of stents was associated with a decreased risk of in-hospital complications. Thus, risk score models can accurately predict the risk of major in-hospital complications after PCI. Their discriminatory power is comparable to those of logistic models and neural network models. Accurate bedside risk stratification may be achieved with these simple models.

The NIR stent is a novel second generation tubular stent that was designed to overcome some of the limitations of the earlier Palmaz-Schatz (PS) stent design. The NIR Vascular Advanced North American (NIRVANA) trial randomized 849 patients with single coronary lesions to treatment with the NIR stent or the PS stent. The study was an "equivalency" trial, designed to demonstrate that the NIR stent was not inferior to (i.e., equivalent or better than) the PS stent, for the primary end point of target vessel failure (defined as death, myocardial infarction, or target vessel revascularization) by 9 months. Successful stent delivery was achieved in 100% versus 98.8%, respectively, with a slightly lower postprocedural diameter stenosis (7% vs. 9%, p = 0.04) after NIR and PS stent placement, respectively. Major adverse cardiac events (death, myocardial infarction, repeat target lesion revascularization) were not different at 30 days (4.3% vs. 4.4%). The primary end point of target vessel failure at 9 months was seen in 16.0% of NIR versus 17.2% of PS patients, with the NIR proving to be equal or superior to the PS stent (p0.001 by test for equivalency). Angiographic restudy in 71% of a prespecified cohort showed no significant difference in restenosis (19.3% vs 22.4%). Thus, the NIR stent showed excellent deliverability with slightly better acute angiographic results and equivalent or better 9-month target vessel failure rate when compared with the PS stent.

Although patients with end-stage renal disease (ESRD) are at high risk for restenosis that requires repeat revascularization after balloon angioplasty, their restenosis rate after coronary stenting is still unknown. Over a 4-year period, we performed coronary stenting on 40 lesions in 34 patients with ESRD. We compared these lesions with 80 lesions from patients without renal disease who underwent coronary stenting in the STARS and WINS clinical trials, matched for treatment site, diabetes, lesion length, and reference vessel diameter. Quantitative coronary angiography was performed on all lesions and clinical outcomes were assessed at 9-month follow-up. Clinical and angiographic characteristics were well matched between the 2 groups and acute clinical success rates were similar. Despite comparable initial angiographic results over the 9-month follow-up period, repeat target lesion revascularization was twice as frequent in the ESRD group compared with the control group (35% vs 16%, p

The cumulative experience of 4 clinical trials using the MULTI-LINK coronary stent design was analyzed. Multivariable logistic regression identified postprocedure in-stent minimum lumen diameter (p = 0.0001), stent length (p = 0.0038), smoking (p = 0.0105). and diabetes (p = 0.0803) as the most important predictors of in-stent restenosis at late (6- to 9-month) angiographic follow-up.

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.

To identify luminal dimension changes occurring within the stent alone and within the stent + margin segment, we reviewed the quantitative angiographic results obtained from the Scripps Coronary Radiation to Inhibit Proliferation Post Stenting (SCRIPPS) trial, a prospective randomized trial assessing the effect of iridium-192 (Ir-192) on the prevention of stent restenosis. Fifty-five patients were randomly assigned to receive Ir-192 or placebo sources after successful intervention. Procedural and 6-month follow-up cineangiograms were quantitatively reviewed in 52 patients to identify changes within the stent and the stent + margin segment. The percent diameter stenosis was lower within the stent than within the stent + margin segment after the procedure (6 +/- 22% vs 21+/- 15%, p0.0001) and at follow-up (28 +/- 29% vs 42 +/- 21%, p0.0001). As a result, a lower restenosis rate was found within the stent than within the stent + margin (25% vs 37%, p0.0001); isolated stent margin restenosis occurred in 11.5% of lesions. Treatment with Ir-192 reduced restenosis within the stent (8% vs 39%; p = 0.010) and within the stent + margin segment (17% vs 54%; p = 0.010); the reduction in restenosis at the margin only (8.3% vs 14.3%, p = 0.503) was not significant. The lowest relative risk for restenosis resulting from Ir-192 occurred within the stent (0.21; 95% confidence interval [CI] 0.05 to 0.86) compared with the stent + margin segment (0.31; 95% CI 0.12 to 0.81) or the stent margin (0.58; 95% CI 0.12 to 2.91). In the SCRIPPS trial, 32% of restenosis occurred at the stent margins. Treatment with Ir-192 reduced restenosis primarily within the stent rather than the margin. Whether extending the treatment length to fully include the stent margins will further reduce restenosis requires further study.

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; p0.0001) and baseline minimal lumen diameters (MLD) (1.05 +/- 0.35 vs 0.92 +/- 0.32; mm p0.0001) 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.

In phase 1 of this study, 60 patients undergoing coronary angioplasty were randomized to receive saline, dopamine, or aminophylline; the overall incidence of contrast-induced renal failure was 38%, without difference among the 3 groups. In phase 2 of this study, 72 patients with established contrast-induced renal failure were randomized to receive saline or dopamine; dopamine had a deleterious effect on the severity of renal failure, prolonging the course.

In-stent restenosis has become a significant clinical problem. In 1997 alone, it is estimated that up to 100,000 patients world-wide with in-stent restenosis were treated. Serial intravascular ultrasound (IVUS) analysis has shown that tubular-slotted stents almost never chronically recoil and that neointimal hyperplasia is responsible for in-stent restenosis. With the rapid recent explosion in stent use, information about in-stent restenosis has lagged behind, especially on the impact of new stent designs. For example, the true prevalence of in-stent restenosis (1) varies with the lesion and patient subset, being much higher in the "real world" than in the selected patients typically enrolled in many studies; and (2) depends on its definition (i.e., clinical vs angiographic, intralesion vs in-stent). "Conventional" catheter-based treatments have included percutaneous transluminal coronary angioplasty (PTCA), rotational atherectomy, excimer laser coronary angioplasty, directional coronary atherectomy, and additional stent implantation. Rates of recurrence with these approaches are not known and vary considerably among series; however, certain lesions seem likely to recur regardless of the treatment modality. Recently, brachytherapy has emerged as the most promising way to treat in-stent restenosis.

Despite the success of coronary interventions in the treatment of stenosis due to coronary atherosclerosis, it behooves cardiologists to treat the underlying disease by decreasing patients' cholesterol levels. Intravascular ultrasound has made it possible to detect plaque accumulation not visible on angiography. Although advanced lesions that are fibrous and calcific can be treated with atherectomy and lasers, it is the soft, lipid-laden plaque that is particularly vulnerable to rupture and leads to coronary events. Therefore, attention must also focus on decreasing atherosclerotic progression in patients who have undergone coronary interventions. Studies have clearly shown the value of cholesterol reduction in decreasing coronary events. However, a review of cardiologists' practices shows that more aggressive lipid-lowering therapy is needed. One way to achieve this goal is to treat and monitor patients who have undergone revascularization procedures and to encourage patients to become more involved in their own care.

Recent histopathologic and intravascular ultrasound (IVUS) data indicate that inadequate compensatory enlargement of atherosclerotic lesions contributes to the development of significant arterial stenoses. Such lesions may contain less plaque, which may have implications for atheroablative interventions. In this study, we compared lesions with (group A, n = 16) and without inadequate compensatory enlargement (group B, n = 30) as determined by IVUS. The acute results and the follow-up lumen dimensions of angiographically successful directional coronary atherectomy procedures were compared. Inadequate compensatory enlargement was considered present when the preintervention arterial cross-sectional area at the target lesion site was smaller than that at the (distal) reference site. Three-dimensional IVUS analysis and quantitative angiography were performed in 46 patients before and after intervention. IVUS measurements included the arterial, lumen, and plaque (arterial minus lumen) cross-sectional areas at the target lesion site (i.e., smallest lumen site) and the (distal) reference site. Angiographic follow-up was performed in 42 patients. Preintervention and postintervention angiographic measurements and IVUS lumen cross-sectional area measurements were similar in both groups. However, at follow-up, the angiographic minimum lumen and reference diameters were significantly smaller in group A compared with group B (1.71 +/- 0.47 mm vs 2.14 +/- 0.73 mm, p

High-speed rotational atherectomy (RA) is a new percutaneous procedure for treatment of coronary stenoses that operates by the unique mechanism of plaque abrasion. This article reports acute (in-hospital) outcomes and 1-year follow-up in a large cohort of patients treated with this device by NACI investigators. A total of 525 patients with 670 lesions treated with RA form the substrate of this report. Patients tended to be older (mean age 64.8 years) than those in previously reported series of percutaneous transluminal coronary angioplasty (PTCA), with more extensive disease and more complex lesions. Calcification was present in 54% of lesions, and eccentricity in 41%. Balloon angioplasty postdilation was performed after RA in 88% of cases. Angiographic and procedural success (angiographic success without death, Q-wave myocardial infarction [MI] or emergency coronary artery bypass graft [CABG] surgery) rates were 89% and 88%, respectively. Acute in-hospital events included 4 deaths (1%) and 1 emergency CABG surgery (0.4%). MI occurred in 6% of patients, consisting predominantly of non-Q-wave MI (5%). After RA, angiographic complications included coronary dissection (12%), abrupt closure (5%), side branch occlusion (3%), and distal embolization (3%). Most of these were resolved after postdilation except for coronary dissection, which was present in 15% of lesions treated. Mean length of stay was 3 days. At 1-year follow-up, 27% of patients required target lesion revascularization and 30% had experienced death, Q-wave MI, or target lesion revascularization. Preprocedural characteristics that independently predicted 1-year death, Q-wave MI, or target lesion revascularization were male gender, high risk for surgery, target lesions that were proximal to or in bifurcations, eccentric, long, or highly stenosed. RA, even when applied to lesions of traditionally unfavorable morphology, appears to provide reasonable procedural and angiographic success rates. Restenosis and progression of disease contribute to subsequent clinical and procedural events.

The randomized Stent Restenosis Study (STRESS) and Belgium Netherlands Stent (Benestent) trials established that elective use of Palmaz-Schatz stents (PSSs) in native coronary arteries with de novo lesions is associated with increased procedural success and reduced restenosis. However there are other clinical indications for which stents are commonly used (unplanned use, vein grafts, restenosis lesions) that are not addressed in these studies. From 1990-1992, 688 lesions in 628 patients were treated with PSSs in the New Approaches to Coronary Intervention (NACI) registry. Angiographic core laboratory readings were available for 543 patients (595 lesions, of which 106 were stented for unplanned indications, 239 were in saphenous vein bypass grafts, and 296 were previously treated). The cohort of patients in whom stents were placed for unplanned indications had more women, current smokers, and had a higher incidence of recent myocardial infarction (MI). Patients who underwent stenting of saphenous vein grafts were older, had a higher incidence of diabetes mellitus, unstable angina, prior MI, and congestive heart failure. Lesion success was similar in all cohorts (98%), but procedural success was significantly higher for planned stenting (96% vs 87%; p0.01). Predictors of adverse events in-hospital were presence of a significant left main stenosis and stenting for unplanned indication. The incidence of target lesion revascularization by 30 days was significantly higher for patients undergoing unplanned stenting due to a higher risk for stent thrombosis. Recent MI, stenting in native lesion, and small postprocedural minimum lumen diameter independently predicted target lesion revascularization at 30 days. Independent predictors of death, Q-wave myocardial infarction, or target lesion revascularization at 1 year included severe concomitant disease, high risk for surgery, left main disease, stenting in the left main coronary artery, and low postprocedure minimum lumen diameter.

To assess the agreement of clinical site and angiographic core laboratory readings obtained in the New Approaches to Coronary Intervention (NACI) registry, we reviewed the angiographic results obtained in 787 lesions assessed both by the sites and the core laboratory, including 135 lesions analyzed twice (or =2 months apart) by the angiographic core laboratory. Although moderate agreement was demonstrated between the clinical site and angiographic core laboratory for qualitative lesion morphology such as lesion calcium (kappa [kappa] = 0.42), only fair agreement was found between site and core laboratory estimation of lesion ulceration (kappa = 0.33); thrombus (kappa = 0.30); and eccentricity (kappa = 0.27); with poor agreement for angulation (kappa = 0.16); and proximal vessel tortuosity (kappa = 0.03). Agreement for qualitative morphology was better for repeated core laboratory readings of lesion eccentricity (kappa = 0.75); angulation (kappa = 0.72); thrombus (kappa = 0.68); proximal vessel tortuosity (kappa = 0.66); and calcification (kappa = 0.64). Quantitative angiographic measurements correlated moderately between the clinical site using the digital caliper method and the core laboratory using the automated edge-detection method, including preprocedural percentage diameter stenosis (intraclass correlation [R] = 0.50) and postprocedural percentage diameter stenosis (R = 0.63). Repeated core laboratory readings had almost perfect agreement, with R ranging from 0.88 for postprocedural percentage diameter stenosis to 0.93 for reference vessel diameter and pre- and postprocedural minimal lumen diameters. Repeated angiographic core laboratory readings provided highly consistent quantitative and qualitative morphologic results in the NACI registry, but the core laboratory readings varied substantially from those obtained at the clinical site. More standardized angiographic analytic criteria and core laboratory feedback to investigators may improve agreement between the clinical sites and the angiographic core laboratory in subsequent studies.

Higher complication rates and lower success rates for treatment of women compared with men have been reported in prior studies of coronary angioplasty and in most early reports of outcome with new coronary interventional devices. In multivariate analysis this has been attributed largely to older age and other unfavorable clinical characteristics. These results are reflected in the current guidelines for coronary angioplasty. Women in prior studies have also had different distributions of vessel and lesion characteristics, but the influence of these differences on the outcome of new-device interventions have not been adequately evaluated. This article evaluates the influence of gender on clinical and angiographic characteristics, interventional procedure and complications, angiographic success, and clinical outcomes at hospital discharge and 1-year follow-up, as observed in the New Approaches to Coronary Intervention (NACI) registry. The NACI registry methodology has been reported in detail elsewhere in this supplement. This study focuses on the 90% of patients-975 women and 1,880 men-who had planned procedures with a single new device and also had angiographic core laboratory readings. Women compared with men were older, had more recent onset of coronary ischemic pain that was more severe and unstable, and had more frequent histories of other adverse clinical conditions. The distributions of several but not all angiographic characteristics before intervention were considered more favorable to angioplasty outcome in women. Differences were observed in device use and procedure staging. Angiographically determined average gain in lumen diameter after new-device intervention, with or without balloon angioplasty, was significantly less in women (1.38 mm) than in men (1.53 mm; p0.001); this 0.15 mm difference is consistent with the 0.16-mm smaller reference vessel lumen diameter of women. However, final percent diameter stenoses and TIMI flow and lesion compliance characteristics were similar. Among procedural complications, only treatment for hypotension, blood transfusion, and vascular repair occurred more often in women. More women than men were clinically unstable (2.1% vs 1.1%) or went directly to emergent coronary artery bypass graft surgery (CABG; 1.2% vs 0.6%) on leaving the interventional laboratory. However, in-hospital death (1.4% vs 1.1%), Q-wave myocardial infarction (MI) (0.9% vs 1.1%), and emergent CABG (1.5% vs 1.0%, for women and men, respectively) were not significantly different. Nonemergent CABG was more frequent in women (1.8% vs 0.9%; p0.05) and length of hospital stay after device intervention was longer (4.4 days vs 3.8 days in men; p0.01). In both univariate and multivariate analyses gender did not emerge as a significant variable in relation to the combined endpoint, death, Q-wave MI, or emergent CABG at hospital discharge. At 1-year follow-up more women than men reported improvement in angina (70% vs 62%) and fewer women than men had had repeat revascularization (32% vs 36%). Similar proportions were alive and free of angina, Q-wave MI and repeat revascularization (46% of women vs 45% of men). Although several procedure-related complications were more frequent in women than men after coronary interventions with new devices, no important disadvantages were observed for women in the rates of major clinical events at hospital discharge and at 1-year clinical follow-up. Additional studies are needed to evaluate the complex interplay of clinical, vessel, and lesion characteristics on success and complications of specific interventional techniques and to determine whether gender, per se, is a risk factor and whether gender specific interventional strategies may be beneficial.

Women have an increased mortality after coronary interventions compared with men, which may be partly explained by differences in comorbid clinical conditions. However, whether women also have quantitative differences in coronary atherosclerosis is not known. Preinterventional intravascular ultrasound (IVUS) was used to study de novo, nonostial native coronary lesions in 169 women and 549 men with chronic angina. The external elastic membrane (EEM), lumen, and plaque + media (P + M) areas, plaque burden, plaque eccentricity, and calcium were measured at the target lesion and at a proximal reference site. All cross-sectional IVUS measures were also corrected for body surface area. Results are reported as mean +/- 1 SD. Women had significantly smaller reference site EEM (16.5 +/- 5.3 vs 19.4 +/- 6.3 mm2, p

Restenosis continues to be the “Achilles' heel” of transcatheter interventions. While attempts to reduce restenosis by inhibiting cellular proliferation through pharmacologic or mechanical means have been unsuccessful, stents, which inhibit acute recoil and chronic remodeling, have been shown convincingly to reduce restenosis in 2 randomized clinical trials. Intravascular ultrasound (IVUS) allows transmural, tomographic imaging of coronary arteries in humans in vivo to subdivide restenosis into the two basic underlying components: tissue proliferation and arterial remodeling. In studies performed at the Washington Hospital Center, in nonstented lesions 73% of late lumen loss was due to arterial remodeling (a decrease in arterial, or external elastic membrane cross-sectional area) and 27% was due to tissue growth (an increase in plaque plus media cross-sectional area). These findings were confirmed by 2 other studies: the Optimal Atherectomy Restenosis Study (OARS) and the Serial Ultrasound analysis of REstenosis (SURE) Trial. IVUS was also used to study the mechanisms by which stents reduce restenosis. Stents created a larger final lumen cross-sectional area and, for all practical purposes, abolished arterial remodeling to offset a stent-related increase in neointimal tissue accumulation. Neointimal hyperplasia is solely responsible for in-stent restenosis and therefore appears to be a pure model for studying strategies to limit tissue proliferation. (Am J Cardiol 1996;78(suppl 3A):18–22)

Using sonoreflective endovascular targets of known length (stainless steel tubular slotted stents), we have validated in vivo the accuracy and reproducibility of intravascular ultrasound length measurements using a system incorporating motorized transducer pullback through a stationary imaging sheath. The correlation was r = 0.936, with a measurement error of only +/- 5.2%, minimal intraobserver variability, and variability of sequential measurements of only +/- 4.8%.

The angiographic and clinical outcomes of 115 patients (129 lesions) treated at 11 clinical centers using a decremental diameter (tapered) balloon catheter were evaluated. The presence of marked tapering of the reference vessel, lesion location involving a bifurcation or anastomosis of a saphenous vein graft, or total coronary occlusion where estimation of the distal vessel size was difficult were indications for this device. The tapered balloon was used as the initial dilatation device in 62 patients (73 narrowings), and as a secondary device in 53 patients (56 narrowings). Lesions selected for tapered balloon angioplasty were generally complex (95% had > or = 1 and 60% had > or = 2 adverse morphologic features). Vessel diameters were larger in the proximal reference segments (3.07 +/- 0.52 mm) than in distal ones (2.48 +/- 0.45 mm) (p

This study evaluated the safety and efficacy of a dexamethasone-eluting stent with a special high dexamethasone-loading dose for treatment of de novo coronary lesions in 30 patients. Eight patients had in-stent restenosis (restenosis rate 31%) at 6-month follow-up, and the in-stent late lumen loss was 0.96 +/- 0.63 mm due to an average intimal hyperplasia area obstruction of 32 +/- 21%, indicating that high-dose dexamethasone-loaded stents do not significantly reduce neointimal proliferation.

To determine the reliability of geometric (edge-detection) quantitative coronary angiographic analysis (QCA) of restenosis within a new Cordis tantalum stent, QCA and intracoronary ultrasound (ICUS) measurements were compared in both an experimental restenosis model and in the clinical follow-up of patients. In the experimental series, Plexiglas phantom vessels with concentric stenosis channels ranging from 0.75 to 3.0 mm in diameter and with a reference diameter of 3.0 mm were imaged both before and after their insertion in tantalum stents. In the clinical series, the agreement of QCA and ICUS measurements were studied in 23 patients who had undergone coronary implantation of the new tantalum stent and in 23 patients who had undergone balloon angioplasty 6 months previously. The reliability of QCA declined in the presence of the radiopaque stent (accuracy of QCA decreased from -0.07 to -0.12 mm), whereas the reliability of lumen measurements by ICUS was independent of the presence of the radiopaque stent (-0.12 and -0.13 mm). Without the stent, the average minimal luminal diameter (MLD) obtained by QCA of the 1.00 mm Plexiglas vessel was 1.00 +/- 0.01 mm, and the 3.00 mm reference vessel diameter was 2.81 +/- 0.05 mm, providing a 64 +/- 1% diameter stenosis. After introduction of the stent, the average MLD and reference vessel diameter were 0.99 +/- 0.06 and 3.36 +/- 0.17 mm, respectively, providing a diameter stenosis of 71 +/- 2%. ICUS measurements (2.77 mm) of the reference vessel diameter (3.00 mm) were unaffected by the presence of the stent. (ABSTRACT TRUNCATED AT 250 WORDS)

T hird-party payors, state regulators, and patients secking to identify sources of quality medical care frequently attempt to compare the outcomes of treatment provided by one institution or by one physician with those of others. Moreover, as part of its quality improvement activities, a responsible institution must evaluate its outcomes and those of its individual physicians against accepted standards. The complexity of such comparisons is often not initially apparent. Consequently, their fairness and accuracy have been a source of controversy.’ Detailed comparison data of outcomes of both balloon and new-device coronary angioplasty are often sought but arc not readily available from most providers. Lacking more accurate indicators of quality in the performance of these percutaneous transluminal coronary rcvascularization (PTCR) procedures, evaluators frequently resort to equating the volume of patients treated with quality. Some data are available to support this assumption.2,3 In fact, based on this premise, the joint Task Force of the American Heart Association (AHA) and the American College of Cardiology (ACC) has recommended that individual physicians perform 275 procedures annually to remain qualified to perform PTCR and that institutions should offer the service only if they pcrform 2200/year.4 These volume-related guidelines have been criticized as intrinsically flawed and unsupported by outcome data. Even if the general concept is correct, individual “low-volume” operators may be quite skillful and individual “high-volume” operators may not be. Thus, outcome data need to be developed to allow comparisons of individual physicians or institutions. We describe some of the methodological complexities involved and some obstacles to be overcome in developing such data.

IVUS measurements of stent and reference lumen dimensions and cross-sectional areas are highly reproducible. Furthermore, paramedical personnel can be trained to perform these measurements accurately. Thus, IVUS measurements may become the gold standard for the acute, chronic, and serial assessment of stent implantation procedures.

Preintervention intravascular ultrasound (IVUS) imaging was performed in 313 target lesions in 301 patients. Revascularization strategy intended before imaging was compared with the treatment actually performed; there was a change in therapy in 124 lesions (40%) in 121 patients (40%). This included: (1) assessment of lesion severity leading to revascularization when none had been planned (n = 20, 6%), (2) avoiding surgery or catheter-based revascularization that had originally been planned (n = 21, 7%), and (3) assessment of lesion composition leading to a change in revascularization strategy (n = 20, 6%) or for selecting the revascularization strategy (n = 63, 20%). Nine of these 121 patients were referred for coronary artery bypass graft surgery. IVUS minimal lumen diameter correlated well with angiography (r = 0.83); however, a disagreement was the reason for deciding to perform or not to perform revascularization in 41 lesions (13%). IVUS assessment of target lesion calcification, eccentricity and unusual morphology were the reasons for changing or selecting specific devices: (1) concentric and eccentric lesions with significant superficial calcium were treated with rotational atherectomy, excimer laser angioplasty or surgery; (2) eccentric lesions that did not contain significant superficial calcium were treated with directional atherectomy; (3) dissections and true aneurysms were treated with stent placement even if calcified; (4) thrombus-containing lesions in vein grafts were treated with thrombolytic therapy or extraction atherectomy, or both; and (5) fibrotic vein graft lesions were treated with balloon angioplasty or stent placement.

To assess clinical and angiographic outcome after directional coronary atherectomy, the clinical course of 306 patients undergoing this procedure was reviewed. Directional atherectomy was successful in 290 (94.8%) procedures; complications developed in 8 (2.6%) patients. After atherectomy, percent diameter stenosis was reduced from 71 ± 14 to 14 ± 14% (p 30%. Intravascular ultrasound was also performed in 57 patients after directional atherectomy and demonstrated that a significant amount of residual plaque mass remained in lesions with a calcium arc ≥90° (17 ± 5 mm2 vs 12 ± 5 mm2 in lesions without calcium; p = 0.007). During the 11 ± 6 month follow-up period, 69 (28.3%) patients developed recurrent clinical events (death, 5; Q wave myocardial infarction, 8; coronary bypass surgery, 31; coronary angioplasty, 36). Using a proportional hazards model, independent predictors of late clinical events included diabetes mellitus (relative risk [RR] = 1.95; p

The clinical and angiographic outcome of patients undergoing rotational coronary atherectomy after unsuccessful balloon angioplasty was evaluated using quantitative angiographic methods to provide insight into this procedure's mechanism of benefit. During the study period, 41 patients (50 lesions) were referred for rotational atherectomy after standard balloon angioplasty was unsuccessful. After rotational atherectomy, percent diameter stenosis was reduced from 72 +/- 14% to 41 +/- 16% (p0.001); adjunct balloon angioplasty was performed in 44 lesions (88%), resulting in a 25 +/- 17% final diameter stenosis (p0.001). The acute gain in minimal lumen diameter was 1.20 +/- 0.59 mm. In lesions needing adjunct balloon dilatation, lesion stretch was 73 +/- 27%, and elastic recoil was 22 +/- 18%, with no variation by etiology of the initial balloon failure. Overall angiographic success (50% residual diameter stenosis) was obtained in 49 lesions (98%). Procedural success, defined as50% residual diameter stenosis and the absence of major in-hospital complications (death, Q-wave myocardial infarction or emergency bypass surgery), was obtained in 37 of 41 procedures (90%); complications developed in 3 patients (7%), including 2 who needed emergency bypass surgery after development of delayed abrupt closure. It is concluded that rotational coronary atherectomy may be used in selected patients when standard balloon angioplasty is unsuccessful. Its mechanism of benefit appears related, at least in part, to changes in plaque compliance resulting from partial atheroma ablation.

The incidence and predictors of major adverse cardiac events after percutaneous coronary intervention of saphenous vein grafts have not been evaluated in the era of routine embolic protection device (EPD) use and the current standards of antiplatelet therapy. The Assessment of the Medtronic AVE Interceptor Saphenous Vein Graft Filter System (AMEthyst) is the largest randomized trial of vein graft intervention comparing the Interceptor EPD and either the GuardWire or FilterWire EPD as the control. The baseline demographic, procedural, and clinical characteristics and the 30-day major adverse cardiac events ([MACE] death, myocardial infarction, and repeat revascularization [either surgery or percutaneous coronary intervention] of the target vessel) were recorded for 748 patients who had undergone vein graft intervention with distal embolic protection. At 30 days, MACE had occurred in 58 patients (7.8%). The univariate predictors of MACE at 30 days included plaque volume (odds ratio 1.005/mm(3), p0.0001), target lesion length (odds ratio 1.046/mm, p0.001), vein graft degeneration score (odds ratio 1.631, p = 0.001), coronary narrowing classification (odds ratio 1.697, p = 0.004), reference vessel diameter (odds ratio 1.689, p = 0.004), and male gender (odds ratio 2.406, p = 0.046) and was independent of device type (p = 0.74). The plaque volume was the most important and only multivariate predictor of MACE. The highest quartile of plaque volume defined a subset at particular risk, despite EPD use (MACE 15.8% vs 5.0%, p0.001). In conclusion, in a patient population in which EPD and preprocedure thienopyridine therapy were uniformly implemented, MACE occurred with an incidence of 7.8% at 30 days. An increasing plaque volume was the most important determinant of MACE and defined a population at particular risk.