Randomized trial comparing intravenous nitroglycerin and heparin for treatment of unstable angina secondary to restenosis after coronary artery angioplasty.

BACKGROUND: The treatment of unstable angina targets the specific pathophysiological thrombotic process at the site of the active culprit lesion. In unstable angina due to a restenotic lesion, smooth muscle cell proliferation and increased vasoreactivity may play a more important role than thrombus formation. Therefore, the relative benefits of nitroglycerin and heparin might differ in unstable angina associated with restenosis compared with classic unstable angina. METHODS AND RESULTS: We randomized 200 patients hospitalized for unstable angina within 6 months after angioplasty (excluding those with intracoronary stents) to double-blind administration of intravenous nitroglycerin, heparin, their combination, or placebo for 63+/-30 hours. Recurrent angina occurred in 75% of patients in the placebo and heparin-alone groups, compared with 42.6% of patients in the nitroglycerin-alone group and 41.7% of patients in the nitroglycerin-plus-heparin group (P<0.003). Refractory angina requiring angiography occurred in 22.9%, 29.2%, 4. 3%, and 4.2% of patients, respectively (P<0.002). The odds ratios for being event free were 0.24 (95% CI, -0.13 to 0.45, P=0.0001) for nitroglycerin versus no nitroglycerin and 0.98 (95% CI, -0.55 to 1. 73, P=NS) for heparin versus no heparin. No patient died or suffered myocardial infarction. CONCLUSIONS: Intravenous nitroglycerin is highly effective in preventing adverse ischemic events (recurrent or refractory angina) in patients with unstable angina secondary to restenosis, whereas heparin has no effect.

Double vessel occlusions after balloon angioplasty treated by stenting and subsequently by abciximab infusion.

Stent thrombosis is a serious complication after percutaneous coronary intervention. A patient is presented with a double vessel occlusion after balloon angioplasty and subsequent stenting. He was then managed by abciximab therapy alone. Control angiography showed complete resolution of the thrombotic occlusions. His subsequent clinical course was uneventful.

Outcome of children with atrial septal defect considered too small for surgical closure.

There are few studies providing information on the natural course of hemodynamically insignificant atrial septal defect (ASD). To review the outcome of patients with secundum ASD, we retrospectively reviewed the charts of patients who had initially not been considered for surgical closure after age 1 year, and who had either a follow-up of at least 10 years or documented closure. Thirty patients, 22 females and 8 males, fulfilled our inclusion criteria. Mean age at diagnosis was 1.3 year and mean follow-up duration was 11.5 years. Seventeen patients had spontaneous closure of the ASD at a mean age of 8.4 years. There were 7 asymptomatic patients whose ASD was still patent at the last visit (mean age 14.1 years, mean follow-up 13.2), with defect dimensions on echocardiography ranging from 1 to 6 mm. The remaining 6 patients were considered to require surgical closure on the basis of an apparent increase in size of the ASD and secondary clinical and hemodynamic manifestations. These results (1) confirm that not all secundum ASDs need to be treated surgically because they can still spontaneously close past the age of 5, and (2) suggest that in a minority of cases the size of the defect could increase.

Intravenous diltiazem in acute myocardial infarction. Diltiazem as adjunctive therapy to activase (DATA) trial.

OBJECTIVES: This study was defined as a pilot investigation of the usefulness and safety of intravenous diltiazem as adjunctive therapy to tissue plasminogen activator in acute myocardial infarction, followed by oral therapy for 4 weeks. BACKGROUND: Experimental studies have documented that calcium antagonists protect the myocardial cell against the damage caused by coronary artery occlusion and reperfusion, yet no benefits have been conclusively demonstrated in acute myocardial infarction (AMI) in humans. METHODS: In this pilot study, 59 patients with an AMI treated with tissue-type plasminogen activator (t-PA) were randomized, double blinded, to intravenous diltiazem or placebo for 48 h, followed by oral therapy for 4 weeks. The primary objective was to detect an effect on indices of regional left ventricular function and perfusion. Patients were also closely monitored for clinical events, coronary artery patency and indices of infarct size and of left ventricular function. RESULTS: Creatine kinase elevation, Q wave score, global and regional left ventricular function and coronary artery patency at 48 h were not significantly different between the diltiazem and placebo groups. A greater improvement observed in regional perfusion and function with diltiazem was likely explained by initial larger defects. Diltiazem, compared to placebo, reduced the rate of death, reinfarction or recurrent ischemia at 35 days from 41% to 13% (p=0.027) and prevented the need for an urgent intervention. The rate of death or myocardial infarction was reduced by 65% (p=0.15). These benefits could not be explained by differences in baseline characteristics such as age, site and extent of infarction, time of inclusion or concomitant therapy. Heart rate and blood pressure were reduced throughout the study with active diltiazem treatment. Side effects of diltiazem were bradycardia and hypotension that required transient or permanent discontinuation of the study drug in 27% of patients, vs. 17% of patients with placebo. CONCLUSIONS: A protective effect for clinical events related to early postinfarction ischemia and reinfarction was suggested in this study, with diltiazem administered intravenously with t-PA followed by oral therapy for 1 month, with no effect on coronary artery patency and left ventricular function and perfusion.

Probucol and multivitamins in the prevention of restenosis after coronary angioplasty. Multivitamins and Probucol Study Group.

BACKGROUND: Oxidizing metabolites generated at the site of coronary angioplasty can induce chain reactions that may lead to restenosis. Antioxidants may counter oxidative stress and modify neointimal formation and vascular remodeling. Experimental data and small clinical studies have suggested that antioxidants may prevent restenosis after angioplasty. In a double-blind, randomized trial, we studied whether drugs with antioxidant properties decrease the incidence and severity of restenosis after angioplasty. METHODS: One month before angioplasty, 317 patients were randomly assigned to receive one of four treatments: placebo, probucol (500 mg), multivitamins (30,000 IU of beta carotene, 500 mg of vitamin C, and 700 IU of vitamin E), or both probucol and multivitamins-all given twice daily. Patients were treated for four weeks before and six months after angioplasty. Patients received an extra 1000 mg of probucol, 2000 IU of vitamin E, both probucol and vitamin E, or placebo 12 hours before angioplasty, according to their treatment assignments. Base-line and follow-up angiograms were interpreted by blinded investigators using a quantitative approach. RESULTS: The mean (+/-SD) reduction in luminal diameter six months after angioplasty was 0.12 +/- 0.41 mm in the probucol group, 0.22 +/- 0.46 mm in the combined-treatment group, 0.33 +/- 0.51 in the multivitamin group, and 0.38 +/- 0.50 mm in the placebo group (P = 0.006 for those receiving vs. those not receiving probucol, and P = 0.70 for those receiving vs. those not receiving vitamins. Restenosis rates per segment were 20.7 percent in the probucol group, 28.9 percent in the combined-treatment group, 40.3 percent in the multivitamin group, and 38.9 percent in the placebo group (P = 0.003 for probucol vs. no probucol). The rates of repeat angioplasty were 11.2 percent. 16.2 percent, 24.4 percent, and 26.6 percent, respectively (P = 0.009 for probucol vs. no probucol). CONCLUSIONS: The antioxidant probucol is effective in reducing the rate of restenosis after balloon coronary angioplasty.

Angiographic features of vein grafts versus ungrafted coronary arteries in patients with unstable angina and previous bypass surgery.

OBJECTIVES: The aim of the study was to compare the angiographic features of culprit coronary lesions located in grafts with those in native coronary arteries in patients with unstable angina and previous coronary artery bypass graft surgery (CABG). BACKGROUND: Deterioration of angina in patients with previous CABG is usually due to progression of atherosclerosis in coronary arteries or in vein grafts, but the relative importance of graft versus native coronary artery disease as well as the morphologic features of the culprit lesions in unstable angina have not been systematically assessed. METHODS: Disease progression and angiographic features of vein grafts and ungrafted and grafted coronary arteries were assessed in 95 consecutive patients admitted with unstable angina or non-Q wave myocardial infarction with CABG > 6 months previously. All patients were receiving aspirin and heparin, and 46 had received streptokinase during the acute phase in a doubleblind, placebo-controlled study. Coronary and vein angiography was performed within 8 days after admission (mean [+/- SD] 5 +/- 2 days). The most recent angiogram served to assess disease progression by quantitative angiography. RESULTS: The culprit lesion was located in a vein graft in 51 patients, an ungrafted coronary artery in 17 and a grafted artery (proximal and distal to the site of graft insertion) in 9 and was of undetermined site in the remaining 18. The proportion of grafts accounting for acute disease increased to 85% with CABG > or = 5 years. Total occlusion occurred in 25 vein grafts and 4 ungrafted coronary arteries (49% vs. 24%, p = 0.02). Intravessel thrombus was found in 18 culprit vein grafts but in only 2 ungrafted coronary arteries (37% vs. 12%, p = 0.04). Both intravessel thrombus and total occlusion were demonstrated in six culprit vein grafts but in none of the ungrafted coronary arteries (12% vs. 0%, p = NS). The prevalence of total occlusion and thrombus was not influenced by trial medication, streptokinase or placebo. CONCLUSIONS: Unstable angina in patients with previous CABG is most often due to graft disease and is associated with more frequent thrombi that are more refractory to medical therapy.

Intravascular ultrasound for diagnosis of left main coronary artery stenosis.

Coronary angiography has many limitations for the assessment of coronary artery disease. Intracoronary ultrasound imaging may overcome some of these limitations by providing direct visualization of the luminal area. This report describes a case where intracoronary ultrasound imaging was useful for correct assessment of left main coronary artery disease which enabled avoidance of coronary artery bypass grafting in this patient. Intravascular ultrasound may be a good complement to coronary angiography in selected cases of left main coronary artery lesion.

[Does gender affect long-term results of coronary angioplasty in patients with multivessel disease?]. / Influence du sexe sur les résultats à long terme de l'angioplastie coronaire chez les patients pluritronculaires?

Multivessel coronary angioplasty, defined as angioplasty of 2 or 3 main coronary vessels performed during the same procedure, was performed in 203 selected patients between 1981 and 1986. The results in men (n = 159, group I) were compared with those in women (n = 44, group II). The angiographic appearances were comparable in the two groups, but the women were older, more often hypertensive and diabetic, and more symptomatic than the men (82% vs 57% in grades 3 or 4 of the Canadian Cardiovascular Society (CCS) Classification; p < 0.009). Complete revascularisation with angioplasty of all stenoses > 50% was attempted during the same session. The primary success rate per lesion was comparable in the two groups (90% in men, 93% in women; NS), as was the number of segments successfully dilated per patient (2.2 +/- 0.7 in group I and 2.2 +/- 0.8 group II; NS). Angioplasty was complicated by myocardial infarction and/or emergency coronary bypass surgery in 11 men and 2 women (NS). Clinical follow-up was obtained for an average of 71 +/- 22 months in the men and 70 +/- 22 months in the women in 96% of cases. The global seven year survival rate without recurrent infarction or cardiovascular death was 81% in men and 83% in women (NS). The number of repeat revascularisation procedures was comparable in the two groups (46% in women and 43% in men; NS) as was the number and duration of hospital admissions during follow-up (8.4 +/- 12.3 days in the women and 6.7 +/- 8.4 days in the men; NS). The functional status at the end of follow-up was the same in the two groups with 84% of men and 81% of women being asymptomatic or grade 1 of the CCS classification. The authors conclude that the long-term results of multivessel angioplasty are good and comparable in men and women. This revascularisation procedure should be considered as an alternative to surgery in women and men.

Aneurysm of the membranous ventricular septum and accessory valvular tissue causing obstruction of the pulmonary outflow tract in corrected transposition.

Aneurysm of the membranous portion of the ventricular septum and accessory valvular tissue are two infrequent congenital lesions. This case illustrates a rare association of aneurysm of the membranous septum and accessory valvular tissue originating from the mitral valve, causing right-sided ventricular outflow tract obstruction in a patient with corrected transposition. Multiplane transesophageal echocardiography allowed for determination of the dual nature of the obstruction.

Aspirin versus heparin to prevent myocardial infarction during the acute phase of unstable angina.

BACKGROUND: Antiplatelet therapy with aspirin and antithrombotic therapy with heparin both prevent the complications of unstable angina; however, no definitive data exist on the relative clinical efficacy of the two drugs. METHODS AND RESULTS: Aspirin (325 mg bid) or heparin (5000-U intravenous bolus followed by a perfusion titrated to the APTT) were compared in a double-blind randomized trial of 484 patients in two cohorts enrolled sequentially. The study was initiated at admission to hospital at a mean of 8.3 +/- 7.8 hours after the last episode of pain. End points were assessed 5.7 +/- 3.3 days later, when the decision for long-term management was made. Myocardial infarction occurred in 2 (0.8%) of the 240 patients randomized to heparin and in 9 (3.7%) of the 244 randomized to aspirin (P = .035), an odds ratio of 0.22 and a risk difference of 2.9% (95% confidence limits, 0.3% to 5.6%) with heparin. The only death resulted from a myocardial infarction in an aspirin patient. Survival curves with Cox logistic regression analysis showed that the improvement in survival without myocardial infarction with heparin (P = .035) was independent of other baseline characteristics. CONCLUSIONS: This study documents that heparin prevents myocardial infarction better than aspirin during the acute phase of unstable angina.

Five- to ten-year outcome after multivessel percutaneous transluminal coronary angioplasty.

The early and late outcome of patients who underwent multivessel percutaneous transluminal coronary angioplasty (PTCA) in a 1-stage procedure are described, and the predictors for clinical event and new revascularization procedure are identified. Of 1,937 patients treated by PTCA between 1981 and 1986, 203 (10.4%) had multivessel PTCA in a 1-step procedure. A follow-up extending to 71 +/- 23 months was obtained in 195 patients (96%). Primary success was achieved in 91% of 494 attempted sites, and complete revascularization in 65% of 203 patients. There were no in-hospital deaths. Acute complications occurred in 13 patients (6.4%), including non-Q-wave (n = 8) and Q-wave (n = 5) infarction, and urgent coronary artery bypass surgery (n = 3). Before PTCA, 126 patients (62%) were in class III or IV of the Canadian Cardiovascular Society classification; at follow-up, 84% were angina-free or in class I. Death occurred in 14 patients and nonfatal myocardial infarction in 18. Angiographic restenosis was diagnosed in 37.2% of dilated lesions in 96 patients (60% of 159 restudied). A repeat revascularization procedure for restenosis or progression of disease, or both, was needed in 92 symptomatic patients (47%). The survival rate at 7 years without the need for surgery or PTCA was 53%, and cardiac survival without myocardial infarction was 85.5%. The only independent predictor of cardiac death was ejection fraction (p < 0.001). The rate of restenosis per patient was primarily determined by the number of segments dilated, whereas progression of disease was related to the number of nonsignificant coronary artery stenoses (< 50%) at baseline (p < 0.02).(ABSTRACT TRUNCATED AT 250 WORDS)

Symptom-limited versus low level exercise testing before hospital discharge after myocardial infarction.

OBJECTIVE: This study was undertaken to compare a low level and a symptom-limited test performed before hospital discharge after an uncomplicated myocardial infarction. BACKGROUND: Exercise testing after myocardial infarction provides useful prognostic information. Usually either a low level test is performed before hospital discharge or a symptom-limited test is performed at 3 weeks. METHODS: The study group comprised 202 patients with an uncomplicated myocardial infarction; 58 patients had a non-Q wave infarction and 115 patients had received thrombolytic therapy. Both a low level and a symptom-limited exercise test were performed in 200 of the 202 study patients in randomized order on consecutive days, a mean of 7.4 +/- 2.3 days after infarction. RESULTS: The symptom-limited test required a considerably greater effort than the low level test: exercise duration was 554 +/- 209 versus 389 +/- 125 s (p less than 0.0001), and peak work load was 5.7 +/- 1.8 versus 4.2 +/- 1.1 METs (p less than 0.0001). The peak heart rate was higher during the symptom-limited test (121 +/- 20 vs. 108 +/- 14 beats/min, p less than 0.0001), as was the rate-pressure product. The number of patients who developed ST segment depression greater than or equal to 1 mm increased from 56 during the low level test to 89 during the symptom-limited test (p less than 0.0001). ST segment depression greater than or equal to 2 mm occurred in 22 patients during the low level test and in 41 patients during the symptom-limited test, an 86% increase (p less than 0.0001). The number of patients with either angina or ST depression greater than or equal to 1 mm increased from 66 to 105 (p less than 0.0001) with the symptom-limited test. Exercise test results were similar for patients with a Q wave or a non-Q wave infarction. Exercise duration was longer and exercise-induced ST depression less frequent in patients who had received thrombolytic therapy. CONCLUSIONS: A symptom-limited exercise test performed before hospital discharge after uncomplicated myocardial infarction provides a significantly greater cardiovascular stress than does a low level test and is associated with an ischemic response nearly twice as frequently. The prognostic significance of a positive response at higher work loads has not been defined.

[Immediate and mid-term results of percutaneous pulmonary valvotomy in adults. Apropos of 10 cases]. / Résultats immédiats et à moyen terme de la valvulotomie pulmonaire percutanée chez l'adulte. A propos de 10 cas.

Percutaneous pulmonary valvulotomy (PPV) is the treatment of choice for isolated congenital pulmonary stenosis of infancy. However, experience with this technique in the adult is much more limited. From November 1983 to November 1990, PPV was performed in 10 adults in our Institute. The mean age was 40 +/- 19 years (range 21 to 71 years). Before PPV, 4 patients were in functional Class II and 6 in functional Class III of the NYHA classification. All procedures were successful with no complications. The right ventricular systolic pressure decreased from 98 +/- 35 to 57 +/- 30 mmHg (p less than 0.01) and the mean pulmonary gradient decreased from 57 +/- 30 to 23 +/- 15 mmHg (p less than 0.01). The cardiac output was unchanged: 5.3 +/- 2.8 and 5.9 +/- 2.6 l/mn (not significant). Pulmonary valve area increased from 0.59 +/- 0.3 to 1.15 +/- 0.5 cm2 (p less than 0.01). The post-dilatation infundibular gradient was less than 10 mmHg in all patients. After an mean follow-up period of 29 +/- 26 months all but one patient (Class II) were in functional Class I. Exercise capacity was 6.9 +/- 2 Mets. Doppler echocardiography indicated a stable mean pulmonary gradient of 16.5 +/- 6.8 mmHg after PPV and 15.0 +/- 7.0 mmHg during follow-up. Pulmonary regurgitation was less than Grade I in all cases. In conclusion, PPV is an effective treatment for adult pulmonary stenosis and carries a low risk. The mid term results are excellent.

Influence of fibrinolysis and percutaneous transluminal coronary angioplasty on the frequency of ventricular premature complexes.

This study evaluated the aggressive management of acute myocardial infarction to determine how it modifies the incidence of ventricular arrhythmias and of other determinants of prognosis during recovery. The population consisted of 344 consecutive survivors of acute myocardial infarction admitted to the hospital with chest pain and ST-segment elevation on the electrocardiogram. Three groups constituted the study population: 168 control patients treated conservatively or in whom fibrinolysis was unsuccessful, 73 patients successfully reperfused with intravenous streptokinase and 103 patients with both successful fibrinolysis and successful percutaneous transluminal coronary angioplasty (PTCA) of the artery responsible for the infarct. Early spontaneous angina occurred in 47 control patients (28%), 25 streptokinase patients, (34%) and, in significantly fewer number, 20 PTCA patients (19%, p less than 0.05). Similarly, exercise-induced ST-segment depression on the predischarge exercise treadmill test was less frequent with PTCA (p less than 0.05). The number of ventricular premature complexes (VPCs) on a 24-hour Holter recording was 40 +/- 123/hr in the control group and significantly less in the streptokinase (21 +/- 64, p less than 0.05) and PTCA groups (17 +/- 61, p less than 0.05). Three or more VPCs/hr were observed in 50% of the control patients, compared with 29% of the streptokinase and 27% of the PTCA patients (p less than 0.005). Mean radionuclide ejection fraction was greater than 40% and similar in the 3 study groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Multiple coronary angioplasty: a model to discriminate systemic and procedural factors related to restenosis.

To assess the interrelation of clinical and procedural factors responsible for restenosis, 119 patients undergoing coronary arteriography were studied a mean of 5.8 +/- 3 months after successful multiple percutaneous transluminal coronary angioplasty. In all clinical, angiographic and procedural variables, the 119 patients undergoing repeat catheterization were similar to the 87 patients that did not. Overall, restenosis occurred in 74 (34%) of 215 lesions. Sixty-three patients had no restenosis, 44 had at least one restenosis and 12 had restenosis at all angioplasty sites. The statistical distribution of restenoses did not follow a binomial model, suggesting that restenosis is more than a lesion-specific phenomenon. Of all the clinical and procedural variables assessed by multivariate logistic regression analysis, only percent stenosis before angioplasty (p less than 0.01), diabetes mellitus (p less than 0.01) and percent stenosis after angioplasty (p less than 0.05) were predictive of restenosis in the entire group. Patients with no restenosis and patients with restenosis at all sites were not different with respect to procedural variables; however, patients with restenosis at all sites more often (p less than 0.05) had diabetes and recent onset angina. In contrast, patients with no restenosis differed from patients with isolated restenosis with respect to procedural variables: severity of stenosis before and after angioplasty, balloon/artery lumen ratio and maximal inflation pressure. Thus, procedural factors may be more related to isolated restenosis, but patient-related factors such as diabetes and recent onset angina may play a more important role in patients with multiple restenoses.

Restenosis and progression of coronary atherosclerosis after coronary angioplasty.

The relation between restenosis and progression of atherosclerosis in other coronary segments after angioplasty was studied in 98 consecutive patients with 110 coronary stenoses successfully treated with angioplasty. At early angiographic restudy (5 +/- 2 months after angioplasty) 37 patients (38%) had restenosis (defined as a stenosis greater than or equal to 50% of the luminal diameter or loss of greater than or equal to 50% of the gain achieved by angioplasty); progression of atherosclerosis was observed in 4 patients with and 7 without restenosis (13 versus 11%, p = NS). Ninety of the 98 patients underwent a late angiographic restudy a mean of 34 +/- 11 months after angioplasty. Late restenosis was found in one patient. Progression of coronary artery disease (defined as a greater than or equal to 20% decrease in the diameter of a vessel initially narrowed by greater than or equal to 50% or a greater than or equal to 30% decrease when the initial stenosis was less than 50%) was examined in relation to restenosis in 85 of the 90 patients. It occurred in 9 of 27 patients with and 22 of 58 patients without restenosis (33 versus 38%, p = NS). Restenosis developed more rapidly than did progression of disease. Diameter stenosis increased from 35 +/- 8 to 73 +/- 11% at the early restudy in lesions with restenosis; in lesions with disease progression it increased from 9 +/- 18 to 20 +/- 28% (p less than 0.001) at the early restudy to 53 +/- 21% (p less than 0.001) at the late restudy.(ABSTRACT TRUNCATED AT 250 WORDS)

Early results, complications and restenosis rates after multilesion and multivessel percutaneous transluminal coronary angioplasty.

Initial results, complications, restenosis rates and clinical outcomes were compared in 78 patients undergoing multilesion and 128 patients undergoing multivessel percutaneous transluminal coronary angioplasty (PTCA). Multilesion PTCA was defined as a procedure in which a proximal PTCA site had to be crossed to dilate a distal severe narrowing and multivessel PTCA as multiple dilatations without having to cross 1 severe narrowing to dilate another. The clinical and angiographic features of the 2 groups were similar. More sites per patient were attempted among those who underwent multilesion PTCA. Primary success rate per lesion was 86% (236 of 274) among those who underwent multivessel and 73% (155 of 211) among those who underwent multilesion PTCA (p less than 0.001). A success rate of 81% (101 of 124) for proximal lesions among those with multilesion PTCA was not significantly worse than that for those with multivessel PTCA; however, lesions distal to proximal sites had a success rate of only 62% (54 of 87), worse than either those with proximal stenoses or multivessel PTCA (p less than 0.005). Arterial diameter, severity of stenosis or procedural variables did not account for this difference. Complication rates were similar in the 2 groups. Despite a poorer success rate among patients with multilesion PTCA, clinical improvement to functional class 0 or 1 occurred in more than 70% of patients in both groups and was equal in patients with and without successful distal dilatations. Restenosis rates per lesion in patients with multivessel (31%) and multilesion (30%) PTCA were similar.(ABSTRACT TRUNCATED AT 250 WORDS)