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Information about the impact of race/ethnicity on adverse outcomes after percutaneous coronary intervention (PCI) in the modern era is limited. Using consecutive patients from the National Heart, Lung, and Blood Institute Dynamic Registry, this study investigated differences in clinical presentation, treatment strategy, and acute and long-term outcomes in 3,669 white, 446 black, 301 Hispanic, and 201 Asian patients who underwent PCI. All comparisons were made to whites. Blacks were more likely than whites to be younger, women, and to present with a higher prevalence of cardiovascular risk factors (hypertension, diabetes, and smoking). Hispanics tended to be younger, hypertensive, diabetic, and to be undergoing their first cardiovascular procedure. Asians were, on average, younger, men, and presented more often with hypertension and diabetes than whites. Although the rate of stent implantation was significantly lower in blacks compared with whites (63% vs 74%, p <0.001), angiographic and procedural success rates were high (> or =95%) and did not differ by race/ethnicity. In-hospital mortality (0.2% vs 1.7%, p <0.05) and death/myocardial infarction (MI)/coronary artery bypass grafting (CABG) (3.1% vs 5.5%, p <0.05) were lower in blacks. All other in-hospital complications were similar to whites. At 1 year, there were no statistical differences in cumulative adverse event rates by ethnicity; however by 2 years there was a modestly higher mortality rate (adjusted RR 1.87; 95% confidence interval 1.15 to 3.04) and adverse event rate (death/MI, death/MI/CABG) among black patients. Thus, although differences in patient demographics, clinical presentation, angiographic characteristics and treatment strategies did not impact the incidence of acute and 1-year adverse outcomes of non-whites, there appears to be a significant reduction in event-free survival among blacks by 2 years. [ABSTRACT FROM AUTHOR]

Hypertrophic cardiomyopathy is a genetically determined disorder resulting in left ventricular hypertrophy. In a majority of the estimated 20 million people affected worldwide, left ventricular outflow obstruction is present at rest or with provocation. The presence and degree of obstruction influence the symptomatic presentation, treatment strategies and prognosis of affected individuals. Pharmacologic therapy with beta-adrenergic blocking drugs and calcium channel blockers is the principal treatment strategy in symptomatic patients with left ventricular outflow obstruction but is ineffective in many patients. When symptoms of exertional shortness of breath, chest pain and/or syncope prove refractory to medical therapy and there is persisting left ventricular outflow obstruction, or when there is drug intolerance, septal reduction strategies (surgical myectomy and alcohol septal ablation) are quite effective. Selection of the optimal septal reduction strategy for a given patient has become controversial and is determined largely by the medical system providing treatment strategies for the patient. Regretably, there are no randomized trials comparing myectomy and ablation and none are anticipated. The comprehensive Hypertrophic Cardiomyopathy Guideline Statements published in 2011 and 2014 differ significantly with the earlier statement favoring surgical myectomy and the more recent statement giving equal class I status to the two septal reduction strategies in adult patients with drug-refractory symptoms. Recently published studies of long-term follow-up of patients after alcohol septal ablation in Europe, where surgical myectomy is rarely performed, confirm long-term safety and effectiveness with survival free of cardiac events exceeding 96% at 15 years. The lesser degree of discomfort and more rapid recovery associated with the minimally invasive catheter-based alcohol ablation procedure coupled with the recently published long-term safety data favor an increased use of this strategy in symptomatic adult patients with hypertrophic obstructive cardiomyopathy (HOCM)., Competing Interests: Conflicts of Interest: The author has no conflicts of interest to declare., (2020 Cardiovascular Diagnosis and Therapy. All rights reserved.)

A 79-year-old woman had an atretic LIMA to LAD but without significant LAD stenosis, patent SVG to OM1, patent SVG to RCA, and severe tandem lesions in a very tortuous LCX for which she underwent PCI. Placement of a BMW coronary guidewire into the LCX resulted in the straightening of the vessel.

Background: The provisional approach for bifurcation stenting with side-branch balloon angioplasty is associated with dissections and suboptimal results requiring kissing balloon techniques or bailout stenting. We hypothesized that using a scoring balloon for the side branch and a drug-eluting stent for the main vessel might improve outcomes of true bifurcation lesions., Methods and Results: A total of 93 patients with complex bifurcations were enrolled in a multicenter, single-arm, prospective clinical trial. A drug-eluting stent was deployed in the main vessel following dilatation of the side-branch stenosis with a scoring balloon. The overall angiographic success rate was 93.5%, and procedural success rate was 91.4%. The final diameter stenosis was 13.9% ± 7.2% for the main vessel and 33.3% ± 22.9% for the side branch. Crossover to stent deployment in the side branch was required in 10.8%. The postscoring balloon dissection rate was 8.2% and 6% (all ≤ class C) for the main vessel and side branch respectively, which was reduced to 1.1 and 2.1% poststenting. At 9-month follow-up, the composite MACE rate [cardiac death, myocardial infarction, or target lesion revascularization (TLR)] was 5.4%, including a TLR rate of 3.3% (1.1% from hospital discharge to 9 months)., Conclusion: The 9-month results of the AGILITY trial support a simple provisional strategy for treating complex true bifurcation lesions with deployment of a drug-eluting stent in the main vessel after dilatation of the side-branch vessel with a scoring balloon. This strategy was associated with excellent and safe procedural results, a low rate of crossover to side-branch stenting, and favorable outcomes., (Copyright © 2013 Wiley Periodicals, Inc.)

Objective: To determine the feasibility of a hybrid coronary revascularization (HCR) approach for the treatment of left main (LM) coronary artery stenosis., Background: The recommended therapy for significant LM stenosis is coronary artery bypass grafting (CABG). Percutaneous coronary intervention (PCI) of unprotected LM lesions is reserved for patients at high risk for complications with CABG. HCR in LM disease has not been studied., Methods: Twenty-two consecutive patients with LM stenosis >70% underwent staged HCR. Following a robotic or thoracoscopic-assisted minimally invasive left internal mammary artery (LIMA) to left anterior descending artery (LAD) coronary bypass, PCI of the LM, and non-LAD targets was performed after angiographic confirmation of LIMA patency. Intravascular ultrasound confirmed optimal stent deployment. Thirty-day adverse outcomes and long term follow up was obtained., Results: In the 22 patients with LM lesions, 6 were ostial, 5 mid, and 11 distal. LIMA patency was FitzGibbon A in all cases. LM stenting was successful in all patients with drug-eluting stents (DES) placed in 21 of 22 cases. Three patients underwent stent implantation in the right coronary artery. There were no 30-day major adverse cardiac or cerebrovascular events. At a mean of 38.8 ± 22 months postprocedure, 21 patients were alive without reintervention; one death occurred at 454 days., Conclusions: HCR for LM coronary disease is a feasible alternative to CABG and unprotected LM PCI. This approach combines the long-term durability of a LIMA-LAD bypass with the less invasive option of PCI in non-LAD targets with DES., (Copyright © 2011 Wiley-Liss, Inc.)

Intravascular ultrasound (IVUS) provides valuable information on the coronary vascular lumen and wall and has been an important tool in the cardiac catheterization laboratory for over 2 decades. The major utility of IVUS relates to optimizing stent deployment, particularly in complex lesions. In percutaneous coronary intervention with bare-metal stents, IVUS guidance reduces restenosis. In percutaneous coronary intervention with drug-eluting stents, IVUS guidance may reduce rates of stent thrombosis with little affect on restenosis. The benefit of IVUS guidance is most important in complex lesion subsets, such as left main and bifurcation lesions, where studies suggest that IVUS guidance may reduce mortality. Whereas IVUS luminal area measurements have been used to assess intermediate lesion severity, recent studies have demonstrated that IVUS accurately identifies nonischemic lesions for which percutaneous coronary intervention can be safely deferred, but cannot accurately predict hemodynamically significant lesions and should not solely be used to justify revascularization. In the current review, we focus on clinical applications of IVUS in interventional cardiology., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess, after 2 years of follow-up, the safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent (ZES) compared with a paclitaxel-eluting stent (PES) in patients with native coronary lesions., Background: Early drug-eluting stents were associated with a small but significant incidence of very late stent thrombosis (VLST), occurring >1 year after the index procedure. The ZES has shown encouraging results in clinical trials., Methods: The ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions), a randomized (1:1), single-blind, controlled trial (n = 1,548) compared ZES versus PES in patients with single de novo coronary lesions. Two-year follow-up was obtained in 96.0% of ZES and 95.4% of PES patients. The primary end point was target vessel failure (TVF), and safety end points included Academic Research Consortium-defined stent thrombosis. Economic end points analyzed included quality-adjusted survival, medical costs, and relative cost-effectiveness of ZES and PES., Results: The TVF at 2 years was similar in ZES and PES patients (11.1% vs. 13.1%, p = 0.232). There were fewer myocardial infarctions (MIs) in ZES patients (p = 0.022), due to fewer periprocedural non-Q-wave MIs and fewer late MIs between 1 and 2 years. Late MIs were associated with increased VLST (PES: 6 vs. ZES: 1; p = 0.069). Target lesion revascularization was similar comparing ZES with PES (5.9% vs. 4.6%; p = 0.295), especially in patients without planned angiographic follow-up (5.2% vs. 4.9%; p = 0.896). The cost-effectiveness of ZES and PES was similar., Conclusions: After 2 years of follow-up, ZES demonstrated efficacy and cost-effectiveness comparable to PES, with fewer MIs and a trend toward less VLST. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Despite significant advances in technology and technique, coronary restenosis remains the primary limitation of percutaneous transluminal coronary angioplasty (PTCA). Among patients undergoing PTCA, between 20% and 50% of patients who do not receive a stent and 10%-30% of those who do receive a stent develop restenosis within 6 months of the procedure. Drug-eluting stents, which release high local concentrations of antiproliferative or immunosuppressive agents directly into the vessel wall at the site of the lesion, have dramatically reduced the incidence of restenosis in patients undergoing PTCA. However, even with drug-eluting stents, a significant percentage of higher-risk patients develop in-stent restenosis. These data suggest that a role remains for effective, well-tolerated systemic pharmacologic therapies to further reduce the rate of restenosis. To date, the majority of systemic agents tested for restenosis prevention have failed to show significant benefit. Only 2 agents, probucol and cilostazol, have consistently demonstrated efficacy in preventing restenosis. In addition, the investigational agent AGI-1067 has demonstrated promising efficacy in early clinical trials. Together with drug-eluting stents, these therapies may for the first time reduce the rate of restenosis to near zero, even in high-risk patients, such as individuals with diabetes mellitus.

Background: The CREST trial demonstrated that after successful coronary stent implantation, the 6-month rate of target vessel revascularization (TVR) was similar (15.4% vs 16%, P = .90) for the 2 treatment groups, but restenosis rate was lower (22.0% vs 34.5%, P = .002) in cilostazol-treated patients. We sought to evaluate resource use, cost, and cost-effectiveness of cilostazol in CREST., Methods: A total of 705 patients were randomized to cilostazol 100 mg twice daily (n = 354) versus placebo (n = 351) for 6 months. Resources included rehospitalizations, medications, and outpatient services. Costs were determined from the Medicare fee schedule. Cilostazol was priced at 1.64 dollars a day. Base-case cost and cost-effectiveness analysis was performed for the entire population using TVR as a measure of effectiveness. Sensitivity analysis was conducted among 526 patients because restenosis data were available only for this patient population. A bootstrap resample approach (5000 samples) was used to obtain confidence intervals for cost differences., Results: For the entire population, costs of rehospitalizations, concomitant medications, outpatient tests, and physician or emergency department visits were lower during follow-up for cilostazol-treated patients. Overall, total 6-month follow-up costs remained 447 dollars lower for cilostazol (4178 dollars vs 4625 dollars), although this difference did not reach significance (95% CI -1458 dollars to 515 dollars). Cilostazol is likely a cost-saving strategy (similar rate of TVR and lower costs). Sensitivity analysis showed that cilostazol is likely a dominant strategy (lower restenosis rate and costs, 85% dominant, 88.9% <1000 dollars per restenosis averted)., Conclusions: Treatment with cilostazol is likely a cost-saving or dominant strategy in patients with successful coronary bare metal stent implantation. Cilostazol may offer a low-cost alternative to restenosis prevention in patients who do not receive drug-eluting stents.

The success of percutaneous coronary intervention (PCI) has historically been limited by a relatively high rate of restenosis, a response of the coronary artery to trauma induced during PCI. Bare-metal stents, by providing a supportive intravascular scaffolding, have significantly reduced the incidence of restenosis compared with traditional balloon PCI. However, significant loss of lumen within the bare-metal device (in-stent restenosis) occurs in 10-30% of patients within 6 months of the procedure. The recent introduction of drug-eluting stents, permitting local delivery of high concentrations of immunosuppressive or anti-proliferative agents, promises to prevent the processes underlying restenosis. Although these devices have been successful in providing an incremental reduction in rates of restenosis, they are expensive. To date, clinical trials of pharmacologic treatment have failed to demonstrate a clinically significant impact on restenosis. Recently, results of the Cilostazol for Restenosis (CREST) trial, a randomized, double-blind study, show that cilostazol reduces the risk of restenosis in patients who receive bare-metal stents, including high-risk patients. Effective adjunct pharmacologic therapy to prevent in-stent restenosis, therefore, remains desirable, particularly in patients receiving bare-metal stents, and potentially in patients receiving drug-eluting stents who are at high risk for restenosis (i.e., those with diabetes, long lesions, and small vessels).

Objective: To determine economic and quality of life outcomes for the Cilostazol for RESTenosis (CREST) trial, which is investigating the efficacy of cilostazol vs. placebo in preventing post-stent restenosis., Design: CREST is a prospective, multicenter, randomized, placebo-controlled, double-blind trial., Setting: 20 clinical sites; the Emory Center for Outcomes Research (ECOR) will serve as the economic and data coordinating center., Patients: 705 patients (>18 years) who have undergone successful, uncomplicated placement of an intracoronary stent in a native coronary artery., Intervention: Cilostazol (100 mg twice daily) or placebo for 6 months., Costs: Primary endpoint, total direct medical costs at 6 months; secondary endpoints, initial hospital costs and follow-up costs. QOL: Health-related quality of life (QOL) will be assessed using the EQ-5D and the Seattle Angina Questionnaire at baseline and at 1, 3, and 6 months. Cost-effectiveness analysis: Preliminary data show that cilostazol is clinically superior to placebo and if the mean cost for the cilostazol arm is higher than that for placebo, cost-effectiveness analysis will be determined for the cost per episode of restenosis prevented, the cost per episode of major clinical and angiographic endpoints averted, and the cost per quality-adjusted life-years gained.

Restenosis remains a major limitation of percutaneous transluminal coronary intervention. Stenting made an important contribution in restenosis reduction, but in-stent restenosis is becoming a growing problem. Although radiation therapy was traditionally used to kill relatively fast-growing tumor cells, it has also been used to clinically treat benign but problematic hyperplastic conditions. In addition, in vitro studies have shown that radiation inhibits serum-stimulated growth of arterial smooth muscle cells and fibroblasts, and decreases collagen synthesis by fibroblasts. The effects of radiation on neointimal inhibition after vascular injury were investigated in animal models using various catheter- and stent-based endovascular approaches (brachytherapy) as well as externally delivered x-irradiation. These studies have consistently shown that ionizing radiation delivered by the endoluminal approach results in remarkable suppression of neointima formation. However, animal studies also demonstrate altered vessel wall healing with increased thrombogenicity. The catheter-based approach with gamma- or beta-emitters showed feasibility and appears promising in early human clinical trials, whereas the strategy of using radiation stents is more problematic in the clinical arena. A number of randomized multicenter trials have been initiated and the results are eagerly awaited. More work needs to be done to define the optimal dosage, and to study the short- and long-term vascular biologic effects of brachytherapy. Additionally, if this form of therapy proves efficacious in the large, randomized, clinical trials, its cost-effectiveness will then need to be established. This review touches on some of the basic concepts involved in using the strategy of endovascular irradiation therapy for restenosis prevention after percutaneous coronary intervention and reviews the evidence of clinical efficacy and safety.

Our objective was to examine trends in outcome and cost of percutaneous coronary intervention (PCI) between 1990 and 1999. PCI has become the most common form of myocardial revascularization in recent years, rivaling the more established coronary artery bypass surgery. There has been increasing interest in improving outcome of PCI while also seeking to minimize cost. A total of 21,755 patients undergoing PCI were evaluated. Clinical data were gathered from the Emory Cardiovascular Database and financial data from the UB92 formulation of the hospital bill. Charges were reduced to cost using departmental cost-to-charge ratios. Costs were inflated to 1999 dollars using medical care inflation rates. Mortality varied without a significant trend from 0.63% to 0.44% (p = 0.64). The Q-wave myocardial infarction rate decreased from 0.68% to 0.40% (p = 0.0003). Emergent coronary surgery decreased from 3.50% to 1.25% (p <0.0001). Mean hospital inflation-adjusted cost decreased from $10,478 to $8,367 (p <0.0001). Length of stay after the procedure decreased from 2.8 to 1.8 days (p <0.0001). Outcome of PCI continues to improve, with a decrease in coronary surgery and Q-wave myocardial infarction but with no significant change in mortality. This was accomplished while also decreasing costs and length of stay. Whether these favorable trends will continue remains to be seen.

We describe a case of a coronary artery perforation involving the proximal right coronary artery that was successfully managed by percutaneous coil embolization. In the setting of a chronic coronary artery occlusion, this demonstrates the successful use of thrombogenic platinum alloy coils for a large proximal vessel perforation which has not been described previously., (Copyright 2001 Wiley-Liss, Inc.)

This study estimates the influence of age on outcomes (mainly survival) of 21,516 patients who underwent percutaneous transluminal coronary angioplasty (PTCA) between 1980 and 1996. We prospectively analyzed the patients in 5 age groups: <50, 50 to 59, 60 to 69, 70 to 79, and > or =80 years old. During the in-hospital period after PTCA, mortality increased from 0.28% in patients aged <50 to 3.45% in patients aged > or =80; Q-wave myocardial infarction was not significantly associated with age, and the 2 older groups were referred less often to coronary artery bypass graft surgery. During follow-up, lasting up to 10 years, the hazard of death was significantly influenced by age; Q-wave myocardial infarction was influenced by age, although the magnitude of the effect was relatively small and of questionable clinical significance; and coronary artery bypass graft surgery was performed less often in the 2 older age groups. Additional PTCA was similarly performed among the age groups. Age, diabetes mellitus, systemic hypertension, heart failure class, angioplasty in graft vessel, number of coronary vessels narrowed, and previous myocardial infarction were predictors of death over the 10-year follow-up. Age was the most important correlate of death after PTCA, with a 65% increase in the hazard of death for each 10-year increase in age. Age has an independent effect on early and late survival after PTCA.

OBJECTIVE: To provide information about the use of rotational atherectomy in octogenarians. MATERIAL AND METHODS: From 1993-1996, 26 octogenarians underwent coronary intervention with rotablator at Emory University Hospitals. The total number of lesions were 28 (57% of them in the left artery descending). Adjunctive balloon angioplasty was utilized in 26 lesions. The lesions were eccentric in 82%, calcified in 75%, with a mean length of 10.2Â+/-8.5 mm. RESULTS: The angiographic success rate was 96.2%. The only in-hospital complications was the death of 1 patient (3.8%) after an abrupt closure, and a dissection of 1 lesion of another patient, with a favorable subsequent outcome. The mean follow up was 1.3Â+/-0.4 years. The Kaplan-Meier survival rate at 1 year was 96.2% and at 2 years 78.3%. The freedom from death, myocardial infarction (MI), and coronary artery bypass graft (CABG) was 88.5% at 1 year and 59.7 % at 1.5 and 2 years. The freedom from death, MI, CABG, and percutaneous transluminal coronary angioplasty (PTCA) was 69.2% at one year and 36.3% at 1.5 and 2 years. CONCLUSIONS: In octogenarians with complex lesions, rotablator was performed in conjunction with balloon angioplasty, and showed a high rate of angiographic success, a relatively low complication rate, and a favorable 2 years survival rate. Nevertheless, the event free rates did not show the same favorable evolution after 1 year. If feasible, it would be useful to conduct randomized trials in the elderly to compare interventional procedures to medical treatment or surgery. (c)1999 by CVRR, Inc.

Historically, restenosis after coronary angioplasty has been assessed angiographically at about 6 months. The desirability of avoiding routine follow-up angiography as well as the recognition that angiographic and clinical assessments are not necessarily the same has prompted greater interest in following patients clinically after angioplasty. Clinical restenosis has been defined as the composite of death, myocardial infarction, coronary surgery, or additional angioplasty within 6 months of the index procedure. Clinical restenosis was observed in 2,340 of 11,473 patients (20.4%). The mortality at 6 months was only 1%. Although there were somewhat more acute myocardial infarctions and coronary surgical procedures, the most frequent event was additional angioplasty. Angiographic restenosis was noted in 30% of patients without clinical restenosis and in 87% of patients with clinical restenosis (p < 0.0001). Patients with clinical restenosis were less likely to be women, had more systemic hypertension, diabetes mellitus, more severe angina originally, fewer prior myocardial infarctions, more multivessel and left anterior descending artery disease, more multisite procedures, more branch site procedures, and longer and tighter stenoses both before and after the procedure. The year of the procedure did not correlate with restenosis. Clinical restenosis is less common than angiographic restenosis and the most common event is additional angioplasty. Although clinical restenosis is rarely fatal, it does result in inconvenience and additional resource consumption.

Objectives: This study sought to compare the outcome of percutaneous transluminal coronary angioplasty (PTCA) (n = 834) and coronary artery bypass graft surgery (CABG) (n = 1805) in diabetic patients with multivessel coronary disease from an observational database., Background: There is concern about selection of revascularization in diabetic patients with multivessel coronary artery disease., Methods: Data were collected prospectively and entered into a computerized database. Follow-up was by letter or telephone or additional events resulting in readmission., Results: After CABG there were more in-hospital deaths (0.36% vs. 4.99%, p < 0.0001) and a trend toward more Q wave myocardial infarctions than after PTCA. Five- and 10-year survival rates were 78% and 45% after PTCA and 76% and 48% after CABG, respectively (p = 0.47). At 5 and 10 years, insulin-requiring patients had lower survival rates of 72% and 31% after PTCA and 70% and 48% after CABG, respectively (p = 0.54). Multivariate correlates of long-term mortality were older age, low left ventricular ejection fraction, heart failure and hypertension. In the total group, insulin requirement was a correlate of long-term mortality. For the total group, choice of therapy had a multivariate hazard ratio close to 1. In the insulin-requiring subgroup, the multivariate hazard ratio was 1.35 (95% confidence interval 1.01 to 1.79) for PTCA versus CABG. Corrected for baseline differences, 5- and 10-year survival rates were 68% and 36% after PTCA and 75% and 47% after CABG, respectively, in the insulin-requiring subgroup. Nonfatal events were more common after PTCA, especially additional revascularization., Conclusions: This study reveals a high incidence of events in diabetic patients and raises further questions about angioplasty in insulin-requiring diabetic patients with multivessel disease.

Directional coronary atherectomy (DCA) with the Simpson coronary atherocath seeks to debulk rather than simply displace obstructive tissue and is a means of enlarging the stenotic coronary lumen. This report from the New Approaches to Coronary Intervention (NACI) registry describes the experience of 1,196 patients who underwent DCA as the sole treatment for either native vessel or vein graft lesions. Device success (post-DCA residual stenosis <50% and > or =20% improvement) was achieved in 87.8%, with a lesion success rate (postprocedural residual stenosis <50% and > or =20% improvement) of 94.0%. The mean resultant stenosis after all interventions (by core laboratory) was 19%. Significant in-hospital complications occurred in 2.8% of patients with DCA attempts, including death 0.6%, Q-wave myocardial infarction (MI) 1.5%, and emergent coronary artery bypass graft surgery (CABG) 2.8%. At 1-year follow-up, cumulative mortality was 3.6%, with repeat revascularization in 28% (repeat percutaneous transluminal coronary angioplasty, 20.1%; CABG, 10.6%). This reflected percutaneous or surgical revascularization of the original lesion (target lesion revascularization) in 22.6% of patients. Subgroup analysis showed a lower lesion success rate and an increased complication rate for unplanned use, vein graft treatment, and treatment of a de novo (vs a restenotic) lesion. Multivariate analysis shows that diabetes mellitus, unstable angina, treatment of a restenotic lesion, and greater residual stenosis after the initial procedure were independent predictors of the composite endpoint of death/Q-wave MI/target lesion revascularization by 1-year follow-up. Among these generally favorable acute and 1-year results, the NACI directional atherectomy data confirm the "bigger is better" hypothesis: that lesions with a lower residual stenosis after a successful procedure had significantly fewer target lesion revascularizations between 30 days and 1 year, with no increase in major adverse events.

Percutaneous treatment of saphenous vein graft (SVG) stenosis has been established as an alternative to repeat coronary artery bypass grafting. Intracoronary Palmaz-Schatz stent (PSS) and directional coronary atherectomy (DCA) have been suggested to provide better short- and long-term results than balloon angioplasty. Records of 840 patients with 931 SVG lesions treated with PSS (121 patients, 132 lesions), DCA (103 patients, 107 lesions), and balloon angioplasty (616 patients, 692 lesions) were reviewed. Inhospital and long-term outcome were compared among treated groups. The groups had similar clinical and angiographic baseline characteristics except for higher previously dilated grafts in the stent group and graft location among devices. Stent placement was angiographically successful in 99%, DCA in 95%, and balloon angioplasty in 93% of the lesions (p = 0.03). Quantitative angiography revealed a larger lumen diameter after procedure after PSS (3.2 mm) and DCA (3.1 mm) compared with 2.4 mm after balloon angioplasty (p = 0.0001). Angiographic complications (abrupt closure, severe dissections, or distal embolization) were evident in eight (6.1%) lesions after PSS placement, in 17 (15.9%) after DCA, and in 61 (8.8%) after balloon angioplasty. Serious in-hospital clinical complications (death, emergency coronary artery bypass grafting, or Q-wave myocardial infarction) were similar among devices. Survival rates were similar among the groups (p = 0.15). Repeat revascularization at follow-up was reported in 58 (60.4%) of patients after PSS, in 48 (51.1%) after DCA, and in 280 (49.4%) after balloon angioplasty. Correlates of additional revascularization at follow-up were older grafts, calcific lesions, previously dilated grafts, longer lesions, and patients with lower ejection fractions (odds ratio 1.06, 1.34, 1.43, 1.04, and 1.01, respectively). Correlates of mortality rate at follow-up were older patients, patients with lower ejection fractions, and distal embolization (odds ratio 1.04, 1.04, and 1.92, respectively). These data suggest that in patents with SVG stenosis the initial success and morbidity rates are similar when comparing PSS and DCA with balloon angioplasty. Although a larger lumen is obtained with PSS and DCA, patients who underwent balloon angioplasty had similar rates of cardiac events and requirements for additional procedures at follow-up.

The Emory Angioplasty versus Surgery Trial (EAST) showed that multivessel patients eligible for both percutaneous transluminal coronary angioplasty (PTCA) and coronary bypass surgery (CABG) had equivalent 3-year outcomes regarding survival, myocardial infarction, and major myocardial ischemia. Patients eligible for the trial who were not randomized because of physician or patient refusal were followed in a registry. This study compares the outcomes of the randomized and registry patients. Of the 842 eligible patients, 450 did not enter the trial. Their baseline features closely resembled those of the randomized patients and follow up was performed using the same methods. In the registry there was a bias toward selecting CABG in patients with 3-vessel disease (84%) and PTCA in patients with 2-vessel disease (54%). Three-year survival for the registry patients was 96.4%, which was better than the randomized patients, 93.4% (p = 0.044). Angina relief in the registry was equal for CABG and PTCA patients and was better for the PTCA registry (12.4%) than PTCA randomized patients (19.6%) (p = 0.079). Thus, the registry confirms that EAST is representative of all eligible patients and does not represent a low-risk subgroup. Since baseline differences were small, improved survival in the registry may be due to treatment selection. Physician judgment, even in patients judged appropriate for clinical trials, remains a potentially important predictor of outcomes.

Objectives: We sought to compare in-hospital and long-term outcome after angioplasty in patients with single-, double- and triple-vessel disease., Background: Coronary angioplasty is increasingly used in patients with multivessel disease., Methods: The source of data was the clinical data base at Emory University. Patients who had previous coronary revascularization or who underwent angioplasty in the setting of acute myocardial infarction were excluded., Results: Of 10,783 patients, 71% had one-vessel, 24% two-vessel and 5% three-vessel disease. Age, male gender, diabetes, hypertension, history of previous myocardial infarction, Canadian Cardiovascular Society class III or IV angina and congestive failure all increased with severity of disease. Complete revascularization was achieved in most patients with one-vessel disease, in a minority with two-vessel disease and rarely in those with three-vessel disease. Emergency coronary bypass surgery increased from 1.7% with one-vessel disease to 3.2% with three-vessel disease. Q wave myocardial infarctions could not be shown to vary significantly with severity of disease. The mortality rate increased from 0.2% with one-vessel disease to 1.2% with three-vessel disease. The number of vessels diseased was a multivariate correlate of in-hospital and long-term mortality. The 1-, 5- and 10-year survival was 0.99, 0.93 and 0.86 for one-vessel disease and 0.97, 0.89 and 0.76 for two-vessel disease, respectively. The 1-, 5- and 9-year survival was 0.95, 0.85 and 0.70 in three-vessel disease, respectively. Freedom from myocardial infarction, coronary bypass surgery and repeat angioplasty was also lower with more severe disease., Conclusions: Patients have increasing in-hospital and long-term mortality as the severity of disease increases. There is also an increased incidence of myocardial infarction and revascularization procedures with more severe disease.

Coronary embolization is a complication of coronary intervention procedures. The incidence, predictors, and clinical significance of this phenomenon during directional atherectomy were examined in 111 consecutive patients who underwent directional atherectomy to 120 lesions. Distal embolization occurred in 31 (28%) of the patients. It was noted mainly in the saphenous vein graft group of patients (12 [48%] of 25) versus the native coronary group (19 [22% of 86]; p = 0.01). Clinical predictors were age and de novo lesions. Morphologic predictors were larger artery size, larger postprocedure minimal luminal diameter, calcific lesions, and type C lesions. The only difference in clinical outcome was a longer hospitalization in the distal embolization group with 3.9 +/- 3.7 days versus the rest of the patients 2.4 +/- 2.4 days (p = 0.01). In the majority of patients there was no significant adverse clinical outcome.

Background: Although patients with diabetes mellitus constitute an important segment of the population undergoing coronary angioplasty, the outcome of these patients has not been well characterized., Methods and Results: Data for 1133 diabetic and 9300 nondiabetic patients undergoing elective angioplasty from 1980 to 1990 were analyzed. Diabetics were older and had more cardiovascular comorbidity. Insulin-requiring (IR) diabetics had diabetes for a longer duration and worse renal and ventricular functions compared with non-IR subjects. Angiographic and clinical successes after angioplasty were high and similar in diabetics and nondiabetics. In-hospital major complications were infrequent (3%), with a trend toward higher death or myocardial infarction in IR diabetics. Five-year survival (89% versus 93%) and freedom from infarction (81% versus 89%) were lower, and bypass surgery and additional angioplasty were required more often in diabetics. In diabetics, only 36% survived free of infarction or additional revascularization compared with 53% of nondiabetics, with a marked attrition in the first year after angioplasty, when restenosis is most common. Multivariate correlates of decreased 5-year survival were older age, reduced ejection fraction, history of heart failure, multivessel disease, and diabetes. IR diabetics had worse long-term survival and infarction-free survival than non-IR diabetics., Conclusions: Coronary angioplasty in diabetics is associated with high success and low complication rates. Although long-term survival is acceptable, diabetics have a higher rate of infarction and a greater need for additional revascularization procedures, probably because of early restenosis and late progression of coronary disease. The most appropriate treatment for these patients remains to be determined.

The efficacy and safety in using a new low-profile perfusion balloon catheter (PBC) as the initial balloon in percutaneous coronary angioplasty (PTCA) was assessed retrospectively in 61 patients: 43 males, mean age 62 +/- 12 years. Thirty-three patients (54%) had unstable angina. PTCA was performed using an improved PBC in the following vessels: LAD 40%; CX 21%; RCA 24%. Lesion morphology was: Type A 21%; Type B1 18%; Type B2 40%; Type C 21%. Mean artery size was 3.01 +/- 0.53 mm. Mean PBC size was 3.14 +/- 0.45 mm. The mean number of inflations used was 2.85 +/- 2.0. The mean longest inflation was 415 +/- 213 sec and the total inflation time was 663 +/- 342 sec to a mean maximum pressure atmosphere of 7.85 +/- 2.0 bars. The number of balloons used per procedure was 1.2 +/- 0.44. In 50 patients (82%) only one balloon was used during the PTCA. PTCA was successful (< 50% diameter stenosis without major complications) in 60 patients (98.4%). Mean diameter stenosis at baseline was 82 +/- 9.5% and post-angioplasty 13 +/- 10.6%. A mild intimal tear occurred in 6 patients (9.8%). A stent was implanted in 3 patients (4.9%) due to severe dissection. In hospital reocclusion occurred in one patient (1.6%). There were no deaths or emergency bypass surgery. A low profile PBC is safe and effective as an initial balloon in PTCA. It may reduce the number of balloons used and inflations per procedure.

Objectives: This study compares in-hospital and long-term outcome after angioplasty in women and men., Background: The recognition that coronary artery disease is the most common cause of death in women has increased interest in outcome studies of coronary artery disease in women., Methods: Patients who had previous coronary revascularization and those who underwent angioplasty in the setting of acute myocardial infarction were excluded. Angioplasty was performed with standard methods. Clinical data were retrieved from a clinical data base and analyzed with standard statistical methods., Results: There were 2,845 women and 7,940 men. The women were older (62 +/- 11 vs. 57 +/- 10 years) and had more hypertension (54.5% vs. 40.1%), diabetes (19.3% vs. 11.7%), grade III to IV angina (71.5% vs. 58.4%) and congestive failure (4.3% vs. 2.1%) than men (all p < 0.0001). More men had a previous myocardial infarction (35.4% vs. 31.0%) and were taller and weighed more (all p < 0.0001). The men had lower ejection fractions and more multivessel disease (31.0% vs. 25.2%) (both p < 0.0001). In women there was a trend toward more Q wave myocardial infarctions (1.1% vs. 0.75%, p = 0.10), and hospital mortality was higher (0.7% vs. 0.1%, p < 0.0001). Angina at follow-up was more common in women 40.2% vs. 26.7%, p < 0.0001). The multivariate correlates of in-hospital death were short stature, reduced ejection fraction and multivessel disease, with trends for older age and female gender. Five-year survival was 95% in men and 92% in women (p = 0.0002). However, female gender was not a multivariate correlate of long-term survival and was accounted for by other characteristics, primarily age. The multivariate correlates of long-term survival were older age, congestive failure, reduced ejection fraction, multivessel disease, diabetes, hypertension and a trend for severe angina. No difference between women and men was noted in long-term freedom from myocardial infarction. There were more additional procedures in men than in women., Conclusions: Despite higher in-hospital mortality, long-term mortality and clinical outcome were similar in both genders when age and body habitus were accounted for.

Surgical correction of anomalous coronary arteries may result in late conduit or anastamotic stenosis. In this case report, we describe the use of coronary angioplasty to dilate a stenosis at the aortic ostium of an intrapulmonary tunnel created to correct an anomalous left coronary artery from the pulmonary artery.

The purpose of this study was to determine whether in patients with 2 sites dilated by percutaneous transluminal coronary angioplasty (PTCA), the sites undergo restenosis independently. Although restenosis remains a critical limitation after PTCA, there is little information separating site- and patient-dependent determinants of restenosis. In particular, if patients with 2 sites dilated have restenosis at 0 or 2 sites more frequently and at 1 site less frequently than expected by random chance, then patient-related factors may be important in the restenosis process. The source of data was the clinical data base at Emory University. Patients who had previously coronary surgery or PTCA, and those who underwent PTCA in the setting of acute myocardial infarction were excluded. In all, 515 patients with 2 sites dilated undergoing angiographic restudy at 4 months to 1 year after PTCA formed the study population. Site 1 was the first site dilated. At site 1, 224 of 515 sites (45%) were restenotic, and at site 2, 193 (33%) were restenotic. Multiple clinical and angiographic variables were analyzed as possible correlates of restenosis. The most powerful univariate and multivariate correlate of restenosis at either site 1 or 2 was the behavior of the other site. If site 2 was patent, then site 1 was restenotic 28% of the time compared with 69% if site 2 was restenotic. If site 1 was patent, site 2 was restenotic 20% of the time compared with 60% if site 1 was restenotic. This relation was stronger if the 2 sites were in the same coronary artery.(ABSTRACT TRUNCATED AT 250 WORDS)

Background: Percutaneous transluminal coronary angioplasty (PTCA) of aorto-ostial stenosis has been associated with a lower rate of acute success, a high risk of vessel closure, and late restenosis. The purpose of this report is to document a prospective multicenter trial of excimer laser coronary angioplasty (ELCA) of aorto-ostial stenosis involving the coronary arteries and saphenous vein grafts., Methods and Results: Between December 1989 and May 1992, 206 aorto-ostial ELCA procedures were performed on 209 stenoses in 200 patients. Canadian Cardiovascular Society class III or IV angina was present in 76%. The distribution of stenosis locations was left main coronary (LM) in 26 (12%), right coronary (RCA) in 124 (59%), and vein grafts (VG) in 59 (28%). Adjunctive PTCA was performed in 72%. Procedure success defined as < or = 50% diameter stenosis without major complications was achieved in 90% (LM, 92%; RCA, 89%, VG, 90%). Quantitative angiographic analysis documented an improvement in stenosis diameter from 0.8 +/- 0.5 mm or 76 +/- 14% at baseline to 2.1 +/- 0.6 mm or 36 +/- 15% at completion (P < .01). The majority of the acute gain in diameter (1.0 +/- 0.6 mm) resulted from ELCA. A major complication during hospitalization occurred in 3.9% (death, 0%; Q-wave myocardial infarction, 0.5%; bypass surgery, 3.4%). The only logistic regression univariate and multivariate predictor of procedure failure was female gender. Six-month angiographic follow-up, available in 51% of eligible patients, documented an average lumen diameter of 1.7 +/- 1.0 mm and mean diameter stenosis of 46 +/- 26%. Restenosis (> 50% diameter stenosis) occurred in 39% (LM, 64%; RCA, 35%; VG, 35%). Restenosis was less likely when residual stenosis was < or = 35% (28% versus 53%, P < .05). Clinical events at follow-up were death, 2.7%; bypass surgery, 6.5%; myocardial infarction, 2.2%; and repeat angioplasty, 16.2%. Of the remainder, 78% were asymptomatic, class I or II for anginal symptoms. An adverse event during follow-up was more than twice as likely in the group with LM (50.0% versus 21.1%, P < .02)., Conclusions: ELCA is acutely effective and safe therapy in patients with aorto-ostial stenosis. Six-month restenosis, adverse-event rates were higher and functional status was poorer in the group with LM stenosis. ELCA may be considered as an alternative to bypass surgery in carefully selected patients with isolated aorto-ostial stenosis of the RCA and saphenous vein grafts.

Background: Acute occlusion after balloon coronary angioplasty is associated with an increased risk of angina, emergency coronary artery bypass grafting (CABG), myocardial infarction (MI), and death. Stents offer a way of restoring patency and avoiding these complications., Methods and Results: One hundred sixteen patients underwent attempted stent placement for imminent or total acute closure after PTCA. In 103 patients (110 stents, 105 procedures) the stent was successfully deployed (89%). Angiographic success (final diameter stenosis of < 50%) was achieved in 94 placements (85%). Seventy-one phase 2 procedures (CABG optional, n = 96; phase 1, CABG required, n = 9) were angiographically successful without complications of death, Q-wave myocardial infarction, or CABG (clinical success 74%). Stent placement was associated with resolution of ST-segment deviation and angina in 84% of patients. Five deaths and 5 Q-wave MIs occurred during hospitalization. Two deaths were related to pulmonary insufficiency from chronic lung disease and one patient died after rescue stent placement for left main coronary artery occlusion during routine angiography. Another patient died after CABG was followed by right ventricular MI. The last death occurred in an elderly patient who suffered a stroke while on intravenous heparin. During hospitalization nine patients developed reocclusion after stent placement (8.6% of procedures) and six had repeat PTCA. CABG was performed after 29 stent procedures (28%). The first nine patients underwent CABG as a mandate of the phase 1 protocol. In addition, nine patients had CABG after stenting with a good angiographic result but with a large amount of myocardium at risk. Clinical follow-up was obtained in all patients at a median of 14 months (range, 2 to 43). There were three late deaths (3%), two Q-wave myocardial infarctions (2%), 16 repeat PTCAs (16%), and 15 CABG procedures (15%). Angiographic restenosis (percent diameter > or = 50%) using caliper measurements was found in 30 of 57 patients (53%) at a median of 4 months (93% of patients eligible). A total of 41 procedures were successful and unaccompanied by death, emergency or elective coronary artery bypass grafting, or angiographic restenosis in follow-up. Restenosis and/or clinical events (death, MI, CABG, repeat PTCA) were associated with non-Q MI, hypertension, diabetes, left circumflex coronary artery stenting, saphenous vein graft stenting, smaller caliber artery stenting, higher balloon to artery ratios, and shorter inflation times., Conclusions: Coronary artery stenting for acute closure after PTCA relieves myocardial ischemia and provides an alternate means of treatment. This series includes early learning curve experience; 70% (67 of 96) of patients were spared emergency coronary artery bypass graft surgery when this adverse outcome occurred. Certain clinical and angiographic subsets are at increased risk for restenosis and future cardiac events.