Refractory angina pectoris in end-stage coronary artery disease: evolving therapeutic concepts

Refractory angina pectoris in coronary artery disease is defined as the persistence of severe anginal symptoms despite maximal conventional antianginal combination therapy. Further, the option to use an invasive revascularization procedure such as percutaneous coronary balloon angioplasty or aortocoronary bypass grafting must be excluded on the basis of a recent coronary angiogram. This coronary syndrome, which represents end-stage coronary artery disease, is characterized by severe coronary insufficiency but only moderately impaired left ventricular function. Almost all patients demonstrated severe coronary triple-vessel disease with diffuse coronary atherosclerosis, had had one or more myocardial infarctions, and had undergone aortocoronary bypass grafting (70% of cases). We present three new approaches with antiischemic properties: long-term intermittent urokinase therapy, transcutaneous and spinal cord electrical nerve stimulation, and transmyocardial laser revascularization.     

Coronary angioplasty versus repeat coronary artery bypass grafting for patients with previous bypass surgery

OBJECTIVES: We attempted to determine the relative risks and benefits of percutaneous transluminal coronary angioplasty (PTCA) and repeat coronary artery bypass grafting (re-CABG) in patients with previous coronary bypass surgery (CABG). BACKGROUND: Due to an expanding population of patients with surgically treated coronary artery disease and the natural progression of atherosclerosis, an increasing number of patients with previous CABG require repeat revascularization procedures. Although there are randomized comparative data for CABG versus medical therapy and, more recently, versus PTCA, these studies have excluded patients with previous CABG. METHODS: We retrospectively analyzed data from 632 patients with previous CABG who required either elective re-CABG (n = 164) or PTCA (n = 468) at a single center during 1987 through 1988. The PTCA and re-CABG groups were similar with respect to gender (83% vs. 85% male), age > 70 years (21% vs. 23%), mean left ventricular ejection fraction (46% vs. 48%), presence of class III or IV angina (70% vs. 63%) and three-vessel coronary artery disease (77% vs. 74%). RESULTS: Complete revascularization was achieved in 38% of patients with PTCA and 92% of those with re-CABG (p < 0.0001). The in-hospital complication rates were significantly lower in the PTCA group: death (0.3% vs. 7.3%, p < 0.0001) and Q wave myocardial infarction (MI) (0.9% vs. 6.1%, p < 0.0001). Actuarial survival was equivalent at 1 year (PTCA 95% vs. re-CABG 91%) and 6 years (PTCA 74% vs. re-CABG 73%) of follow-up (p = 0.32). Both procedures resulted in equivalent event-free survival (freedom from dealth or Q wave MI) and relief of angina; however, the need for repeat percutaneous or surgical revascularization, or both, by 6 years was significantly higher in the PTCA group (PTCA 64% vs. re-CABG 8%, p < 0.0001). Multivariate analysis identified age > 70 years, left ventricular ejection fraction < 40%, unstable angina, number of diseased vessels and diabetes mellitus as independent correlates of mortality for the entire group. CONCLUSIONS: In this nonrandomized series of patients with previous CABG requiring revascularization, an initial stategy of either PTCA or re-CABG resulted in equivalent overall survival, event-free survival and relief of angina. PTCA offers lower procedural morbidity and mortality risks, although it is associated with less complete revascularization and a greater need for subsequent revascularization procedures.     

Revascularization in patients with prior coronary bypass surgery

Increasingly over the past several years, patients have returned after coronary surgery for reintervention procedures. This reflects immediate postsurgical complications and the relentless progression of coronary artery disease in the native circulation and in the bypass grafts. Although there are randomized comparative data for coronary bypass surgery (CABG) versus percutaneous transluminal coronary angioplasty (PTCA) and medical therapy, these trials have always excluded patients with previous (GABG). OBJECTIVES: We attempted to compare the risks and benefits of percutaneous transluminal coronary angioplasty (PTCA) and repeat coronary artery bypass grafting (re-CABG) in patients with previous coronary bypass surgery (CABG). METHODS AND RESULTS: This study examines follow up data (15.4 +/- 11.0 months) from 130 patients with previous CABG, who required either PTCA (Group A, n = 73) or re-CABG (Group B; n = 57) at a single center from 1994 to 1997. Follow up data were obtained from subsequent office visits and telephone calls. The PTCA and re-CABG groups were similar with respect to gender (86% vs 94% males), mean age (62 +/- 9 vs 59 +/- 10 years), angina CCS classes 3 and 4 (73% vs 69%), diminished left ventricular function (23% vs 26%), risk factors such as diabetes (19% vs 17%), hypercolesterolemia (49% vs 45%) and smoking (48% vs 39%) and three-vessel native coronary artery disease (67% vs 72%). The symptomatic status prior to the revascularization procedure was similar in both groups. Complete and functional revascularization was achieved in 85% of the PTCA group and in 92% of those with re-CABG (p = NS). During the hospital stay the complication rates were lower in the PTCA group. Actuarial survival was different at follow up (p = 0.04). Both PTCA and re-CABG groups resulted in equivalent event-free survival (freedom from death, myocardial infarction, unstable angina and urgent revascularization). The need for repeat revascularization at follow up was significantly higher in the PTCA group (PTCA 28% vs re-CABG 10%, p < 0.01). CONCLUSIONS: In this non-randomized study of patients with previous CABG requiring revascularization procedures, PTCA resulted in lower procedural morbidity and mortality risks. At follow up, both PTCA or CABG were similar for event-free survival; PTCA offered lower overall mortality, although it is associated to a greater need for subsequent revascularization procedures.     

Coronary surgery without extracorporeal circulation. Indications, methods and results. Apropos of 224 cases

Coronary revascularization without cardiopulmonary bypass is evolving as an important technique. From January 1988 to September 1997, 224 patients underwent consecutively coronary artery bypass grafting without cardiopulmonary bypass in our institution. Indications for this type of revascularization were essentially: patients with a single coronary lesion and patients which presented an increased risk for extra-corporeal circulation. Follow-up was complete. The majority of patients were men (176) and the median age was 62 years. Most patients were in CCS III and IV (79%). Unstable angina was found in 19%, 4% had a recent trans mural infarction (< or = 48 hr), and 36% had an older infarct (> 48 hr). 8% were operated in emergency, 29% presented a restenosis following angioplasty, with 4% having a complication from angioplasty, and 0.8% were operated in cardiogenic shock. Redo surgery was seen in 4% of patients. 12% of patients had an ejection fraction less than 30%, 47% an ejection fraction between 30 et 49%, and 40% patients an ejection fraction greater than 50%. Mean Parsonnet score was 10. 185 patients (82.5%) underwent single bypass, and 39 patients (17%) multiple bypasses. Ten patients (4.4%) underwent hybrid revascularization with primarily surgical grafting followed by angioplasty. Postoperative outcome included: myocardial infarction in 16 patients (7.1%), 8 patients (3.5%) were reoperated for tamponade or bleeding, 2 patients (0.8%) developed a mediastinitis, and 1 patient (0.4%) had a neurological event. Hospital mortality was 4% (9 patients). Univariate and multivariate analysis identified two risks factors: age greater than 70 (OR 4.2, CI 1-18.4), and an ejection fraction less than 30% (OR 5, CI 1.2-21.6). Survival was 99.1% at 1 year, 94% at 3 years and 83.2% at 7 years. Post operative angina occurred in 33 patients, linked to a coronary anastomosis dysfunction in 9 patients (4.1%). A significant reduction of cost was found, compared to patients operated with extra-corporeal circulation. We conclude that coronary revascularization without cardiopulmonary bypass can provide satisfactory results, for patients with single coronary lesion, or for patients with an increased risk and multiple coronary lesions.     

Two- to three-year follow-up of patients with single-vessel coronary artery disease randomized to PTCA or medical therapy (results of a VA cooperative study). Veterans Affairs Cooperative Studies Program ACME Investigators. Angioplasty Compared to Medicine

Despite increasing use of percutaneous transluminal coronary angioplasty (PTCA) to treat stenotic coronary artery disease, there are relatively few prospective studies evaluating its long-term effectiveness. We prospectively randomized 212 stable patients with provocable myocardial ischemia and single-vessel subocclusive coronary disease to receive primary therapy with either PTCA or medical therapy. This report presents the clinical follow-up of these patients at a mean, after randomization, of 2.4 years for interview and 3.0 years for exercise testing. Of the 212 patients originally randomized, 175 received an extended follow-up interview, and 132 underwent exercise testing; 62% of patients in the PTCA group were angina free compared with 47% of patients in the medical group (p <0.05). Furthermore, exercise duration as measured by treadmill testing was prolonged by 1.33 minutes over baseline in the PTCA group, whereas it decreased by 0.28 minutes in the medical group (p <0.04). Although the angina-free time on the treadmill was not different (p=0.50), fewer patients in the medical group developed angina on the treadmill at 3 years than those in the PTCA group (p=0.04). By 36 months, excluding the initial randomized PTCA, use of PTCA and use of coronary artery bypass surgery were not different in the 2 treatment groups. These data indicate that some of the early benefits derived from PTCA in patients with single-vessel coronary artery disease are sustained, making it an attractive therapeutic option for these patients.     

Excimer laser angioplasty versus balloon angioplasty in functional and total coronary occlusions

Registries of excimer laser coronary angioplasty have reported good results in the treatment of complex coronary artery disease, including total or subtotal coronary occlusions. One hundred three patients (103 lesions) with a functional or total coronary occlusion were included in a randomized trial (Amsterdam-Rotterdam [AMRO] trial, total of 308 patients), 49 patients were allocated to laser angioplasty and 54 patients to balloon angioplasty. The primary clinical end points were death, myocardial infarction, coronary bypass surgery, or repeated coronary angioplasty of the randomized segment during a 6-month follow-up period. The primary angiographic end point was the minimal lumen diameter at follow-up in relation to the baseline value (net gain), as determined by an automated contour-detection algorithm. Laser angioplasty was followed by balloon angioplasty in all procedures. The angiographic success rate was 65% in patients treated with excimer laser-assisted balloon angioplasty compared with 61% in patients treated with balloon angioplasty alone. No deaths occurred. There were no significant differences between the laser angioplasty group and the balloon angioplasty group in the incidence of myocardial infarctions (1 patient vs 3, respectively, p = 0.36), coronary bypass surgery (4 patients vs 2, respectively, p = 0.34), repeat angioplasty (10 patients vs 8, respectively, p = 0.46) or primary clinical end point (15 patients vs 12, respectively, p = 0.34). The net gain in minimal lumen diameter and restenosis rate (>50% diameter stenosis at follow-up) were 0.81 +/- 0.74 mm and 66.7%, respectively, in patients treated with laser angioplasty compared with 1.04 +/- 0.68 mm and 48.5%, respectively, in patients treated with balloon angioplasty (p = 0.59 and p = 0.15, respectively). Excimer laser-assisted balloon angioplasty demonstrated no benefit over balloon angioplasty with respect to initial and long-term clinical and angiographic outcome in the treatment of patients with functional or total coronary occlusions of >10 mm in length.     

Third angioplasty, and after that?

The authors studied retrospectively a series of 39 patients with a documented second restenosis after coronary angioplasty between January 1987 and November 1992, 33 of whom (31 men, 2 women) underwent a third procedure. The artery dilated was the left anterior descending (n = 17 including 9 proximal stenoses), the right coronary (n = 10), the left circumflex or its branches (n = 5) and the left main stem (n = 1). The lesions were confirmed to one vessel in 25 cases (75%) and affected two vessels in 8 cases (25%). The third angioplasty procedure was performed on a single artery in all cases. The average left ventricular ejection fraction was 60% (43%-75%). The diameter of the dilated artery was over 3.25 mm in 24% of cases (8/33). The primary success rate was 100% without any complications. The average period between the first and second angioplasties was 16 +/- 10 weeks, and between the second and third angioplasties 19 +/- 12 weeks. Angioplastic controls of the 3rd angioplasty were performed in 25 cases (75%). A third restenosis (n = 7) was treated by surgical bypass (n = 1), repeat angioplasty (n = 4), endocoronary stenting (n = 1) or medically (n = 1), with a global follow-up of 22 months (2-56 months), 2 patients underwent coronary bypass grafting, 2 have residual angina (contralateral lesion which could not be dilated), 1 had an infarct in the territory of an undilated artery, and 28 (85%) were asymptomatic. The restenosis rate after the third angioplasty procedure was 28% (7/25).(ABSTRACT TRUNCATED AT 250 WORDS)     

An evaluation of the use made of cosmetic and functional prostheses by unilateral upper limb amputees

PURPOSE: To review the available data on the treatment of chronic stable angina and formulate a rational approach to the use of pharmacologic therapy, percutaneous transluminal coronary angioplasty (PTCA), and coronary artery bypass graft surgery (CABG). DATA SOURCES: A MEDLINE search of English-language literature published between 1976 and 1996 and the bibliographies of relevant articles. STUDY SELECTION: Primary research articles, meta-analyses, and meeting abstracts related to the management of chronic stable angina with an emphasis on comparisons of medical therapy, PTCA, and CABG. DATA EXTRACTION: Three trials comparing medical therapy with PTCA, seven trials comparing medical therapy with CABG, and nine trials comparing PTCA with CABG. DATA SYNTHESIS: Low-risk patients with single-vessel coronary artery disease and normal left ventricular function had greater alleviation of symptoms with PTCA than with medical treatment; mortality rates and rates of myocardial infarction were unchanged. In high-risk patients (risk was defined by severity of ischemia, number of diseased vessels, and presence of left ventricular dysfunction), improvement of survival was greater with CABG than with medical therapy. In moderate-risk patients with multivessel coronary artery disease (most had two-vessel disease and normal left ventricular function), PTCA and CABG produced equivalent mortality rates and rates of myocardial infarction. CONCLUSIONS: In low-risk patients, a strategy of initial medical therapy is reasonable. In moderate-risk patients, PTCA and CABG produce similar mortality rates and rates of myocardial infarction but PTCA-treated patients require more revascularization procedures. In high-risk patients, CABG is usually preferred.     

Procedural results and late clinical outcomes following multivessel coronary stenting

OBJECTIVES: To evaluate in-hospital and long-term clinical outcomes in a large consecutive series of patients undergoing percutaneous multivessel stent intervention. BACKGROUND: High restenosis and recurrent angina rates have limited the clinical outcomes of multivessel coronary angioplasty before stents were available to improve angioplasty results. METHODS: We evaluated in-hospital and long-term clinical outcomes (death, Q-wave myocardial infarction [MI], and repeat revascularization rates at one year) in 398 consecutive patients treated with coronary stents in two (94% of patients) or three native arteries, compared to 1,941 patients undergoing stenting procedure in a single coronary artery between January 1, 1994 and August 29, 1997. RESULTS: Overall procedural success was obtained in 96% of patients with two- or three-vessel stenting and in 970% of patients with single-vessel stent intervention (p = 0.36). Procedural complications were also similar (3.8% for multivessel versus 2.9% for single vessel, p = 0.14). During follow up, target lesion revascularization was 15% in multivessel and 16% in single-vessel interventions (p = 0.38), and repeat revascularization (calculated per treated patient) was also similar for both groups (20% vs. 21%, p = 0.73). There was no difference in death (1.4% vs. 0.7%, p = 0.26), and Q-wave MI (1.2% vs. 0%, p = 0.02) was lower following multivessel interventions. Overall cardiac event-free survival was similar for both groups (p = 0.52). CONCLUSIONS: Unlike previous conventional angioplasty experiences, multivessel stenting has (1) similar in-hospital procedural success and major complication rates and (2) similar long-term (one year) clinical outcomes compared with single-vessel stenting. Thus, stents may be a viable therapeutic strategy in carefully selected patients with multivessel coronary disease.     

Late results of percutaneous transluminal coronary angioplasty of two or more major native coronary arteries

Of 613 consecutive patients with multivessel coronary artery disease (CAD) undergoing revascularization, 521 patients (85%) underwent primary management with percutaneous transluminal coronary angioplasty (PTCA). To examine long-term outcome in a series of patients often referred for coronary artery bypass graft (CABG) surgery, all patients undergoing multivessel dilations were identified for late follow-up analysis (n = 161). Mean age was 65 years; 54 patients (34%) were women. Four hundred fifty-five of 502 lesions (90.6%) were successfully dilated. Major in-hospital procedural complications occurred in 6 patients (3.7%), including death in 3 (1.9%), nonfatal Q-wave myocardial infarction in 2 (1.2%), and CABG in 1 (0.6%). Final follow-up data were available in 159 patients (99%) at a mean of 39 +/- 18 months. Including in-hospital events, actuarial 3-year survival was 93%, and 3-year infarct-free survival was 90%. At final follow-up, 143 of 146 patients alive (98%) were angina free. Crossover to CABG was required in 25 patients (16%). Repeat PTCA was performed in 67 patients (42%) (mean 1.7 PTCAs/patient, range 1 to 7). PTCA is an effective therapeutic alternative in the management of most patients with multivessel CAD requiring revascularization. A strategy using multiple repeated PTCA procedures when necessary results in prolonged infarct-free survival, with long-term freedom from angina and limited crossover to CABG.     

Eosinophil chemotactic activity in bronchoalveolar lavage fluid obtained from Toxocara canis-infected rats

Angioplasty of the internal mammary artery (IMA) bypass graft has been shown to be a safe and effective revascularization procedure. However, angiographic and long term clinical outcomes in the high-risk group of patients presenting with rest angina has not been well documented. We report the results of IMA angioplasty in 20 patients with rest angina out of 614 (3.2%) who received a left IMA graft at our institution between April 1987 and September 1994. All patients were admitted with rest angina, 12 patients demonstrated persistent ischemia despite medical therapy, two patients were in heart failure, and one patient was in cardiogenic shock. Balloon angioplasty was successful in 15 of 20 patients (75%). Failed angioplasty was associated with either severe IMA tortuousity (three patients) or inability to cross the anastomotic stenosis with the guide wire (two patients). Each of these five patients required angioplasty of either the native left anterior descending artery or other saphenous vein grafts for clinical stabilization. No patient suffered a major complication (myocardial infarction, emergent coronary bypass surgery, death). Clinical follow-up was obtained in all 20 patients (6 months, 7 years, mean 27 months). Twelve patients (60%) were asymptomatic or had stable angina at follow-up, and 8 returned with anginal symptoms. Four patients required repeat angioplasty for disease in other vessels, two were treated medically for angina, one underwent repeat CABG, and cardiac transplantation was performed in one patient for refractory heart failure. Angiographic follow up was obtained in 10/15 (66%) successful angioplasty patients, and only one patient demonstrated restenosis at the treated site (10%). During follow up one patient developed an IMA stenosis at a previous dissection site in the body of the graft that was treated with angioplasty. These results suggest that IMA angioplasty in patients with rest angina is associated with excellent long term patency and clinical efficacy, as well as low procedural risk.     

Effects of different protective agents on the phototoxicity of fluoranthene to Daphnia magna

OBJECTIVE: To determine if a risk prediction model for patients with unstable angina would predict resource utilization. METHODS AND RESULTS: Four hundred sixty-five consecutive patients admitted for unstable angina to a tertiary care university-based medical center were prospectively evaluated from June 1, 1992, to June 30, 1995. The proportion of patients receiving coronary angiography, coronary angioplasty, and coronary artery bypass grafting were analyzed according to four risk groups on the basis of a previously published model: Group 1, <2% risk of major complication; Group 2, 2.1% to 5% risk; Group 3, 5.1 % to 15% risk; and Group 4, >15.1 % risk. Hospital length of stay and estimated cost of hospitalization based on DRG and specific payer ratio of cost-to-charge were also compared between groups. Multiple linear regression analysis was used to determine the influence of estimated risk and procedures on hospital costs. The four groups were well matched for gender, hypertension, tobacco history, and previous percutaneous transluminal coronary angioplasty and myocardial infarction. Group 4 had a higher incidence of previous coronary bypass grafting (35% vs 10%, p=0.001) and triple vessel or left main coronary artery disease compared with Group 1 (44% vs 13%, p=0.041). Group 4 patients were more likely to be admitted to the coronary care unit compared with Group 2 or Group 1 patients (80% vs Group 1: 51% [p= 0.001]; and vs Group 2: 53% [p=0.001]), more likely to receive heparin (87% vs 71%, p=0.007), and more likely to receive a beta-blocker or calcium channel blocker (89% vs 74%, p=0.008) than Group 1. Coronary angioplasty rates were similar for all groups, but Group 4 patients were more likely to receive coronary bypass grafting than Group 2 or Group 1 (27% vs Group 2: 12%, p=0.004 and vs Group 1: 8%, p=0.002). Hospital length of stay was highest in Group 4 and lowest for Group 1. Average hospital costs were significantly less in Group 3 than in Group 4, but higher than in Group 1. Multivariate analysis determined a dependency of costs on risk group with Group 2 having costs 31.4% (95% CI=9.8 to 57.2), Group 3 46.7% (24, 3 to 73.1), and Group 4 75% (46.9 to 110.7) higher than Group 1. The use of procedures also significantly increased costs, with PTCA-treated patients having a 44.9% (26.7 to 65.7) increase in costs compared with medically treated patients, and surgically treated patients having a 204.7% increase in costs. CONCLUSION: Resource utilization as assessed by the use of revascularization procedures, length of stay, and hospital costs are influenced by patient acuity estimated from a prediction model on the basis of estimated risk of cardiac complications. The model exerts independent influence on cost even after adjustment for various procedures. The use of revascularization procedures, especially coronary artery surgery, remains a large determinant of hospital cost.     

The appropriateness of performing coronary angiography and coronary artery revascularization in a Swedish population

OBJECTIVE: To evaluate the appropriateness of performing coronary angiography and revascularization in a Swedish population. DESIGN: Prospective population study of questionnaires and medical records. SETTING: All the hospitals in southwestern Sweden that perform coronary angiography and revascularization. PATIENTS: Random sample of 831 patients (with chronic stable angina) on the waiting list for coronary angiography or revascularization in southwestern Sweden in September 1990. MAIN OUTCOME MEASURE: Percentage of patients referred for coronary angiography or revascularization for appropriate, uncertain, or inappropriate indications. RESULTS: Of the patients referred for angiography, 89% were classified as appropriate, 9% as uncertain, and 2% as inappropriate. The percentages are similar for patients referred for coronary artery bypass graft surgery and for angioplasty (91% and 86%, respectively, classified as appropriate). The majority of patients had chest pain rated as Canadian Cardiovascular Society classes II through IV (93%), despite maximum anti-ischemic therapy in 90% of these patients. CONCLUSIONS: Few patients were referred for coronary angiography or revascularization for inappropriate or uncertain indications. The percentage of these patients who are from southwestern Sweden is similar to the percentage recently reported from New York State.     

The effect of pravastatin on prevention of restenosis after successful percutaneous transluminal coronary angioplasty

Numerous attempts have been made to prevent late restenosis after successful percutaneous transluminal coronary angioplasty (PTCA), but there is still no effective treatment. This report describes the effect of an oral lipid-lowering agent, pravastatin, on restenosis after successful PTCA. Sixty-six patients who underwent successful elective PTCA were assigned to a pravastatin-treated group (Group 1, n = 29) or an untreated group (Group 2, n = 37) in a prospective and randomized fashion. Pravastatin (5 mg or 10 mg twice a day) was given to Group 1 patients from day 3 after the procedure. Selective coronary angiography was repeated 3 to 5 months later, or sooner if the patient developed angina pectoris. The serum cholesterol level was decreased significantly in Group 1 (from 215.7 +/- 44.3 mg/dl to 181.2 +/- 30.3 mg/dl, p < 0.001), but not in Group 2 (from 191.9 +/- 30.8 mg/dl to 191.8 +/- 33.3 mg/dl, p = ns), at the time of repeat coronary angiography. However, there were no differences between the groups with regard to the recurrence of angina, the need for repeat PTCA, or restenosis, as assessed by quantitative analysis of coronary cineangiograms. These results suggest that oral pravastatin therapy does not effectively prevent late restenosis after successful PTCA by this mode of administration.     

Complications prior to revascularization among patients waiting for coronary artery bypass grafting and percutaneous transluminal coronary angioplasty

AIM: To describe the occurrence of death, development of acute myocardial infarction and need for hospitalization among patients on the waiting list for coronary artery bypass grafting and percutaneous transluminal coronary angioplasty. PATIENTS AND METHODS: All the patients on the waiting list for possible coronary revascularization in September 1990 in western Sweden. RESULTS: Of 718 patients waiting for either coronary artery bypass grafting or percutaneous transluminal coronary angioplasty, 15 (2.1%) died between the actual week in September 1990 and prior to revascularization and 12 (1.7%) developed a non-fatal acute myocardial infarction during the same period. All 15 patients who died before undergoing revascularization died a cardiac death. Death and/or the development of an acute myocardial infarction was significantly more frequent among the elderly, among patients with a low ejection fraction and among patients with a history of diabetes mellitus. In all, 29% required hospitalization prior to the procedure. The most common reason was symptoms of angina pectoris requiring hospitalization in 23% of the patients. CONCLUSION: Among patients on the waiting list before either coronary artery bypass grafting or percutaneous transluminal coronary angioplasty, 15 (2.1%) died prior to the procedure and 1.7% developed a non-fatal acute myocardial infarction. The risk of either death or developing an acute myocardial infarction was highest among patients in the older age groups, among patients with a history of diabetes mellitus and among patients with a lower ejection fraction.     

Cataract extraction rates in Olmsted County, Minnesota, 1980 through 1994

Management of Q-wave acute myocardial infarction (AMI) has been shown to differ between the United States and Canada, with more catheterization and revascularization procedures performed in the United States, but with little or no apparent difference in clinical outcomes. No previous studies have evaluated management differences for the acute coronary syndromes of unstable angina pectoris and non-Q-wave AMI. We therefore compared treatments and outcomes between 14 United States and 4 Canadian tertiary care centers participating in an observational registry of all consecutive admissions for unstable angina or non-Q-wave AMI between 1990 and 1993. A random, stratified sample was selected for detailed assessment and follow-up. There were 1,733 patients enrolled in United States centers and 642 in Canadian ones. In United States centers patients were less likely to receive intravenous nitroglycerin, heparin, beta blockers, calcium antagonists, or > or = 2 anti-ischemic agents. Coronary arteriography during index hospitalization was equally frequent in both countries (63.4% vs 66.9%, p = 0.781), but at 6 weeks and 1 year coronary arteriography was slightly less frequent in the United States patients. Revascularization by coronary angioplasty or bypass surgery was equivalent at 6 weeks and 1 year; however, there were trends toward less angioplasty and more bypass surgery in the United States than in Canada. Patients at United States centers stayed in the hospital fewer days than patients at Canadian centers (mean 8.2 vs 12.1 days, p <0.001). Death or AMI by 6 weeks was not different (4.8% vs 4.4%, p = 0.633), nor was it different at 1 year (10.0% vs 10.2%, p = 0.836). The combined outcome of death, AMI, or recurrent ischemia was more common in United States than in Canadian patients at 6 weeks (18.4% vs 13.9%, p = 0.004). Our findings indicate that United States physicians and hospitals did not consistently utilize more resources and were not more aggressive than their Canadian counterparts when treating acute coronary syndromes during this period.     

A clinical trial comparing primary stenting of the infarct-related artery with optimal primary angioplasty for acute myocardial infarction: results from the Florence Randomized Elective Stenting in Acute Coronary Occlusions (FRESCO) trial

OBJECTIVES: This study sought to compare stenting of the primary infarct-related artery (IRA) with optimal primary percutaneous transluminal coronary angioplasty (PTCA) with respect to clinical and angiographic outcomes of patients with an acute myocardial infarction. BACKGROUND: Early and late restenosis or reocclusion of the IRA after successful primary PTCA significantly contributes to increased patient morbidity and mortality. Coronary stenting results in a lower rate of angiographic and clinical restenosis than standard PTCA in patients with angina and with previously untreated, noncomplex lesions. METHODS: After successful primary PTCA, 150 patients were randomly assigned to elective stenting or no further intervention. The primary end point of the trial was a composite end point, defined as death, reinfarction or repeat target vessel revascularization as a consequence of recurrent ischemia within 6 months of randomization. The secondary end point was angiographic evidence of restenosis or reocclusion at 6 months after randomization. RESULTS: Stenting of the IRA was successful in all patients randomized to stent treatment. At 6 months, the incidence of the primary end point was 9% in the stent group and 28% in the PTCA group (p=0.003); the incidence of restenosis or reocclusion was 17% in the stent group and 43% in the PTCA group (p=0.001). CONCLUSIONS: Primary stenting of the IRA, compared with optimal primary angioplasty, results in a lower rate of major adverse events related to recurrent ischemia and a lower rate of angiographically detected restenosis or reocclusion of the IRA.     

Heart and Estrogen/progestin Replacement Study (HERS): design, methods, and baseline characteristics

The Heart and Estrogen/progestin Replacement Study (HERS) is a randomized, double-blind, placebo-controlled trial designed to test the efficacy and safety of estrogen plus progestin therapy for prevention of recurrent coronary heart disease (CHD) events in women. The participants are postmenopausal women with a uterus and with CHD as evidenced by prior myocardial infarction, coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, or other mechanical revascularization or at least 50% occlusion of a major coronary artery. Between February 1993 and September 1994, 20 HERS centers recruited and randomized 2763 women. Participants ranged in age from 44 to 79 years, with a mean age of 66.7 (SD 6.7) years. Most participants were white (89%), married (57%), and had completed high school or some college (80%). As expected, the prevalence of coronary risk factors was high: 62% were past or current smokers, 59% had hypertension, 90% had serum LDL-cholesterol of 100 mg/dL or higher, and 23% had diabetes. Each woman was randomly assigned to receive one tablet containing 0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate daily or an identical placebo. Participants will be evaluated every 4 months for an average of 4.2 years for the occurrence of CHD events (CHD death and nonfatal myocardial infarction). We will also assess other major CHD endpoints, including revascularization and hospitalization for unstable angina. The primary analysis will compare the rate of CHD events in women assigned to active treatment with the rate in those assigned to placebo. The trial was designed to have power greater than 90% to detect a 35% reduction in the incidence of CHD events, assuming a 50% lag in effect for 2 years and a 5% annual event rate in the placebo group. The design, analysis, and conduct of the study are controlled by the Steering Committee of Principal Investigators and coordinated at the University of California, San Francisco. HERS is the largest trial of any intervention to reduce the risk of recurrent CHD events in women with heart disease and is the first controlled trial to seek evidence of the efficacy and safety of postmenopausal hormone therapy to prevent recurrent CHD events.     

Secondary prevention of ischemic heart disease after coronary revascularization

This study was aimed to assess the compliance with policies for secondary prevention of coronary heart disease (CHD) one year after coronary artery revascularization with special attention to the management of hyperlipidemia. One year after coronary revascularization during the year 1994, patients were contacted by letter to determine the modification of their risk factors, the treatment patterns for hypercholesterolemia and to have their plasma lipid level and blood pressure measured. Of the 245 consecutive patients contacted (110 after coronary artery bypass grafting, and 135 after percutaneous transluminal coronary angioplasty), 186 (76%) provided the information required for further analysis. Excluding the patients older than 65 years, only 29 out of 97 patients (30%) with a total cholesterol of more than 5.2 mmol/l, and only 20 out of 52 patients (38%) with a total cholesterol of more than 6.2 mmol/l were receiving lipid lowering therapy 1 year after coronary artery revascularization. In contrast, 97% (n = 180) of the entire population studied were taking antiplatelet drugs and/or coumadine. Participation in an in-house rehabilitation program yielded a positive influence on smoking, but not on treatment of hypercholesterolemia. In conclusion, only a small proportion of patients with documented CHD and hypercholesterolemia were being treated for their lipid disorder 1 year after coronary artery revascularization. In contrast, the great majority of patients received antiplatelet and/or coumadine therapy: These results indicate that the compliance with published treatment guidelines for hyperlipidemia in patients with CHD is still highly inadequate, irrespective of the participation in a rehabilitation program.     

Randomized trial of direct coronary angioplasty versus intravenous streptokinase in acute myocardial infarction

OBJECTIVES: The objective of this study was to obtain preliminary data on the relative clinical utility of direct coronary angioplasty compared with that of intravenous thrombolytic therapy for patients with acute myocardial infarction. BACKGROUND: The relative merits of intravenous thrombolytic therapy and direct coronary angioplasty as treatment for acute myocardial infarction are incompletely understood, and randomized trials of these treatments have been extremely limited. METHODS: One hundred patients with ST segment elevation presenting to a single high volume interventional center within 6 h of the onset of chest pain were randomized to receive either streptokinase (1.2 million U intravenously over 1 h) or immediate catheterization and direct coronary angioplasty. Patients were excluded for age > or = 75 years, prior bypass surgery, Q wave infarction in the region of ischemia or excessive risk of bleeding. All patients were then treated with aspirin (325 mg orally/day) and heparin (1,000 U intravenously/h) for 48 h until catheterization was performed to determine the primary study end point, namely, infarct-related artery patency at 48 h. Secondary end points were in-hospital death, left ventricular ejection fraction at 48 h and time to treatment. RESULTS: There was no difference in the baseline characteristics of the two treatment groups. Overall patient age was 56 +/- 10 years, 83% of patients were male, 11% had prior infarction, 40% had anterior infarction and 97% were in Killip class I or II. Although time to treatment was delayed in the angioplasty group (238 +/- 112 vs. 179 +/- 98 min, p = 0.005), there was no difference in 48-h infarct-related artery patency or left ventricular ejection fraction (patency 74% vs. 80%; ejection fraction 59 +/- 13% vs. 57 +/- 13%; angioplasty vs. streptokinase, p = NS for both). There were no major bleeding events, and the mortality rate with angioplasty (6%) and streptokinase (2%) did not differ (p = NS). CONCLUSIONS: These results suggest that intravenous thrombolytic therapy might be preferred over coronary angioplasty for most patients because of the often shorter time to treatment.