Usefulness of Nisoldipine for prevention of restenosis after percutaneous transluminal coronary angioplasty (results of the NICOLE study). NIsoldipine in COronary artery disease in LEuven.

The NIsoldipine in COronary artery disease in LEuven (NICOLE) study investigates (1) whether nisoldipine, a dihydropyridine calcium antagonist, reduces the progression of minor coronary arterial lesions in the long term, and (2) whether it reduces the restenosis rate after successful percutaneous transluminal coronary angioplasty (PTCA). The NICOLE study is a single-center, randomized, double-blind trial in 826 patients, who underwent a successful PTCA. Nisoldipine 40 mg coat-core or placebo was started the morning after the procedure and continued for 3 years. All coronary arterial segments were measured on preprocedural angiogram and on the second follow-up angiogram at 3 years. On the first follow-up angiogram at 6 months only the dilated segments were measured. Although the study is still ongoing until the primary end point is reached, we report in this study the angiographic restenosis data as well as the clinical events observed at 6-month follow-up. The per-protocol population consisted of 646 patients. Restenosis, defined as a > or =50% loss of the initial gain (National Heart, Lung, and Blood Institute criterion IV) occurred in 49% and 55% of the 308 nisoldipine-treated and the 338 placebo-treated patients, respectively (p = NS). At follow-up, the rates of death and myocardial infarction were low and similar in both groups, but in the nisoldipine group, less patients required early coronary angiography (18% vs 26%, p = 0.006) and subsequent revascularization procedures (32% vs 41%, p = 0.057). Thus, nisoldipine did not significantly reduce the angiographic restenosis rate after PTCA, but reduced the number of repeat revascularization procedures, which may be due to its antianginal action.

"Back-squeezing" of the clot: an unusual complication of primary coronary angioplasty.

Distal coronary embolism of thrombotic material is quite common in the setting of primary coronary angioplasty for evolving acute myocardial infarction. Embolization to another coronary artery is, however, much more uncommon. We report on a case in which a large thrombus migrated from the proximal left anterior descending artery (LAD) to the proximal left circumflex artery (CX) during inflation of the dilatation balloon. The putative mechanism was retrograde expulsion of the thrombus by the deploying balloon.

Comparison of clinical complications, angiographic results, and device usage of coronary angioplasty using low- and high-compliance balloons.

We randomized 800 patients in a prospective study comparing the angiographic results, device usage and in-hospital outcome of balloon angioplasty of primary stenoses of native coronary vessels with low-compliant and highly compliant balloons. The cumulative incidence of prespecified clinical endpoints was 8.0% in both treatment groups. The primary angiographic success rates were 83.9% and 78.9% in the high- and low-compliance group, respectively (P = 0.05). For the lesions dilated with one study balloon only, the quantitative angiographic findings were virtually identical in the two treatment groups. The total number of dissections was slightly but not significantly higher in the lesions treated with a highly compliant balloon. The global usage of angioplasty balloons was similar in both treatment groups. We conclude that, in general, there is no objective reason to prefer one balloon material to another on the basis of its compliance characteristics.

Apical ballooning of the left ventricle: first series in white patients.

BACKGROUND: A cardiac syndrome of "apical ballooning" was recently described, consisting of an acute onset of transient extensive akinesia of the apical and mid portions of the left ventricle, without significant stenosis on the coronary angiogram, accompanied by chest symptoms, ECG changes, and a limited release of cardiac markers disproportionate to the extent of akinesia. Until now, this syndrome has been reported only in Japanese patients. OBJECTIVE: To describe 13 white patients who presented with this syndrome over the previous four years. RESULTS: All but one of the patients were women with a mean age of 62 years. Eight of them presented with chest pain, of whom six had cardiogenic shock. In nine patients a triggering factor was identified: emotional stress in three, trauma in one, pneumonia in one, asthma crisis in one, exercise in two, and cerebrovascular accident in one. In all patients left ventriculography showed very extensive apical akinesia ("apical ballooning") in the absence of a significant coronary artery stenosis, not corresponding with the perfusion territory of a single epicardial coronary artery. Mean maximal creatine kinase MB and troponin rise were 27.4 microg/l (range 5.2-115.7 microg/l, median 16.6 microg/l) and 18.7 microg/l (range 2.0-97.6 microg/l, median 14.5 microg/l), respectively. Six patients were treated with intra-aortic balloon counterpulsation. One patient died of multiple organ failure. On necropsy, no myocardial infarction was found. In the 12 survivors, left ventricular systolic function recovered completely within three weeks. CONCLUSIONS: This is the first series of "apical ballooning" to be reported in white patients. Despite dramatic initial presentation, left ventricle function recovered completely within three weeks in the survivors.

Long term effects of nisoldipine on the progression of coronary atherosclerosis and the occurrence of clinical events: the NICOLE study.

BACKGROUND: Earlier angiographic studies have suggested that calcium antagonists may prevent the formation of new coronary lesions and the progression of minimal lesions. Conversely, a meta-analysis suggested that these drugs may increase cardiovascular mortality and morbidity in patients with coronary heart disease. OBJECTIVE: To investigate whether nisoldipine retards the progression of coronary atherosclerosis or reduces the occurrence of clinical events. DESIGN AND SETTING: The NICOLE study (NIsoldipine in COronary artery disease in LEuven) is a single centre, randomised, double blind, placebo controlled trial with coronary angiography at baseline, six months, and three years of follow up. PATIENTS: 826 patients who had undergone successful coronary angioplasty were randomised to nisoldipine 40 mg once daily or placebo. The intention to treat and per protocol population consisted of 819 and 578 patients, respectively. RESULTS: In the per protocol population, 625 of the nisoldipine treated and 655 of the placebo treated patients (NS) showed angiographic progression in at least one coronary arterial segment, defined as an increase in diameter stenosis of > or = 13%. The average minimum luminal diameter of the non-dilated lesions decreased by 0.163 mm and 0.167 mm in the nisoldipine and placebo groups, respectively (NS). The respective numbers of new lesions detected were 7 and 13 (NS). In the intention to treat population, the rates of death, stroke, and acute myocardial infarction were similar in both treatment groups. However, nisoldipine use was associated with fewer revascularisation procedures and thus the percentage of patients with any clinical event was lower (44.6% v 52.6%, p = 0.02). CONCLUSIONS: Nisoldipine has no demonstrable effect on the angiographic progression of coronary atherosclerosis or the risk of major cardiovascular events but its use is associated with fewer revascularisation procedures.

Relation between different methods for analysing ST segment deviation and infarct size as assessed by positron emission tomography.

OBJECTIVE: To study the relation between resolution of ST segment deviation and infarct size using positron emission tomography. METHODS: 45 patients with ST segment elevation acute myocardial infarction treated with thrombolysis or percutaneous coronary intervention were studied prospectively. An ECG was taken before and at (mean (SD)) 100 (45) min after reperfusion therapy. ECGs were analysed by three methods. Residual ST segment deviation, obtained from the ECG immediately after completion of reperfusion therapy, was defined by summation for each of the three methods. Relative resolution of ST segment deviation was defined as the absolute resolution divided by the ST segment deviation score at baseline x 100 (%). After 29 (14) hours, myocardial blood flow was measured with 13NH3. For each patient, the regions with a myocardial blood flow < 80% of normally perfused myocardium ( = hypoperfusion) and < 50% ( = no reflow) were automatically delineated. RESULTS: Substantial differences were found between different ECG analysis methods. There were moderate correlations between the area with myocardial hypoperfusion and ST segment deviation scores at baseline and after reperfusion therapy. After reperfusion therapy, residual ST segment deviation in the single lead with maximum ST segment deviation was as good at discriminating between tertiles of myocardial damage as summed ST segment elevation. Relative ST segment resolution did not discriminate between different degrees of myocardial damage. CONCLUSIONS: In the individual patient, residual ST segment deviation after reperfusion in the single lead with maximum ST segment deviation is at least as good as summed ST elevation in predicting final myocardial damage.