Stenting in small coronary arteries (SISCA) trial. A randomized comparison between balloon angioplasty and the heparin-coated beStent.

OBJECTIVES: The purpose of this study was to assess the clinical and angiographic benefits of elective stenting in coronary arteries with a reference diameter of 2.1 to 3.0 mm, as compared with traditional percutaneous transluminal coronary angioplasty (PTCA). BACKGROUND: The problems related to small-vessel stenting might be overcome using modern stents designed for small vessels, combined with effective antiplatelet therapy. METHODS: In five centers, 145 patients with stable or unstable angina were randomly assigned to elective stenting treatment with the heparin (Hepamed)-coated beStent or PTCA. Control angiography was performed after six months. The primary end point was the minimal lumen diameter (MLD) at follow-up. Secondary end points were the restenosis rate, event-free survival and angina status. RESULTS: At follow-up, there was a trend toward a larger MLD in the stent group (1.69 +/- 0.52 mm vs. 1.57 +/- 0.44 mm, p = 0.096). Event-free survival at follow-up was significantly higher in the stent group: 90.5% vs. 76.1% (p = 0.016). The restenosis rate was low in both groups (9.7% and 18.8% in the stent and PTCA groups, respectively; p = 0.15). Analyzed as treated, both the MLD and restenosis rate were significantly improved in patients who had stents as compared with PTCA. CONCLUSIONS: In small coronary arteries, both PTCA and elective stenting are associated with good clinical and angiographic outcomes after six months. Compared with PTCA, elective treatment with the heparin-coated beStent improves the clinical outcome; however, there was only a nonsignificant trend toward angiographic improvement.

Stenting small coronary arteries using two second-generation slotted tube stents: acute and six-month clinical and angiographic results.

This prospective study assessed the feasibility, safety, as well as clinical and angiographic outcome after 6 months in 96 patients (100 lesions) treated by stent implantation after a suboptimal balloon angioplasty result in coronary arteries < 3 mm and with a lesion length < 25 mm. The lesions were randomized to treatment with BeStent small or NIR-7. Final quantitative coronary angiography was performed off line. Baseline reference diameter was 2.58 +/- 0.22 mm. Complex lesions constituted 52%, and 23% had unstable angina. Angiographic and procedural success was achieved in 98% and 94%, respectively. At follow-up, 88.5% were free of major adverse cardiac events. The overall restenosis rate was 22.5% (89% angiographic follow-up). There were no statistically significant differences between the stents regarding predefined endpoints. Thus, provisional stent treatment of small coronary arteries using BeStent small or NIR-7 is feasible, safe, and has a favorable clinical and angiographic mid-term outcome.

Amlodipine versus slow release metoprolol in the treatment of stable exertional angina pectoris (AMSA).

OBJECTIVES: To compare the effects of amlodipine and slow release metoprolol on subjective symptoms and signs of ischaemia during bicycle ergometric exercise tests in patients with stable angina pectoris. DESIGN: A randomized double-blind comparison of the two drugs in patients with documented coronary disease required to have at least three attacks of angina per week and to perform a symptom-limited exercise test with significant signs of ischaemia in the ECG. RESULTS: Out of 127 patients, 117 completed the study. Both amlodipine and metoprolol significantly increased total exercise time, total workload, time to onset of angina and time to 1 mm ST-depression with no significant differences between the drugs. Amlodipine was significantly more efficient than metoprolol in reducing ST-depression at maximum workload. Diary data revealed no differences in patients' self-rating of drug effects. CONCLUSIONS: Judged by suppression of subjective symptoms and performance on exercise tolerance tests amlodipine represents a useful alternative to metoprolol as monotherapy in stable angina pectoris.

Safety of the transpulmonary ultrasound contrast agent NC100100: a clinical and haemodynamic evaluation in patients with suspected or proved coronary artery disease.

OBJECTIVE: To evaluate the clinical and haemodynamic safety of NC100100, a new transpulmonary ultrasound contrast agent intended for vascular use. DESIGN: Pulmonary artery pressures and gas exchange, left ventricular and systemic blood pressure and ECG were measured at baseline, after saline injection, and after each of two increasing doses of NC100100 injected intravenously. PATIENTS: 30 patients who were evaluated for suspected coronary artery disease. RESULTS: No change was detected in any of the haemodynamic variables, or in haematological or clinical chemical parameters. Blood gases were unchanged, as were heart rhythm and arterial oxygen saturation. No serious adverse reactions were reported. CONCLUSIONS: NC100100 appeared to be haemodynamically inert and safe in patients with coronary artery disease.

Sustained benefit of stenting chronic coronary occlusion: long-term clinical follow-up of the Stenting in Chronic Coronary Occlusion (SICCO) study.

OBJECTIVES: This study assessed the long-term clinical outcome of stenting chronic occlusions. BACKGROUND: In the Stenting in Chronic Coronary Occlusion (SICCO) study, patients were randomized to additional stent implantation (n = 58) or not (n = 59) after successful recanalization and dilation of a chronic coronary occlusion. Palmaz-Schatz stents were used with full anticoagulation. The previously published 6-month angiographic follow-up results showed reduction of the restenosis rate from 74% to 32%. METHODS: The primary end point was the occurrence of major adverse cardiac events (cardiac death, lesion-related acute myocardial infarction, repeat lesion-related revascularization or angiographic documentation of reocclusion). RESULTS: Late clinical follow-up was obtained in all patients at 33 +/- 6 months. Major adverse cardiac events occurred in 14 patients (24.1%) in the stent group compared with 35 patients (59.3%) in the percutaneous transluminal coronary angioplasty (PTCA) group (odds ratio 0.22, 95% confidence interval 0.10 to 0.49, p = 0.0002). Target vessel revascularization (including failed PTCA attempts) was performed in 24% of the stent group and in 53% of the PTCA group (p = 0.002). There were no events in the stent group after 8 months, whereas events continued to occur in the PTCA group. By multivariate analysis, allocation to the PTCA group, left anterior descending coronary artery lesion and lesion length were significantly related to the development of major adverse cardiac events. CONCLUSIONS: These data demonstrate the long-term safety and clinical benefit of stenting recanalized chronic occlusions. There is a continued risk of late clinical events related to nonstented lesions. Implantation of an intracoronary stent should therefore be considered after successful opening of a chronic coronary occlusion.

The Barath Cutting Balloon versus conventional angioplasty. A randomized study comparing acute success rate and frequency of late restenosis.

In a randomized multicenter study initial success rate and 6 months' follow-up were compared between coronary angioplasty performed with the Barath Cutting Balloon (group A, n = 32) and conventional balloons (group B, n = 32) in patients with type A or B lesions in native coronary arteries. The culprit lesion was not reached in one patient in group A. Initial success rates were similar with and without additional stenting (8 in group A and 10 in group B). Angiographic follow-up data (in 95%) revealed a non-significant improvement in minimal lumen diameter, diameter stenosis in group A. Restenosis developed in 16.7% of group A vs 25.8% of group B, (p = 0.57). A separate analysis of stented patients showed no restenosis in group A and restenosis in 4 out of 10 patients in group B (p = 0.10). A possible beneficial effect of the Cutting Balloon with respect to in-stent restenosis requires further studies.

Improvement in left ventricular ejection fraction and wall motion after successful recanalization of chronic coronary occlusions.

AIMS: This study assessed changes in left ventricular ejection fraction and regional radial shortening after successful angioplasty of chronic coronary occlusions. METHODS: We studied 95 patients with angina pectoris or exercise-induced ischaemia with a successfully recanalized chronic (median duration 4.3 months) coronary occlusion. Intracoronary stents were implanted in 71%. Left ventriculograms were obtained at baseline and after 6.7 +/- 1.4 months. Left ventricular ejection fraction and regional radial shortening were determined by a computer-assisted method. RESULTS: Left ventricular ejection fraction increased from 0.62 +/- 0.13 at baseline to 0.67 +/- 0.11 at follow-up (P < 0.001). The change in left ventricular ejection fraction in patients with a patent artery and in patients with reocclusion (n = 8) was 0.05 +/- 0.06 and 0.01 +/- 0.04, respectively (P = 0.04). Regional radial shortening in the territory of the recanalized artery increased by 16% (from 0.28 +/- 0.11 to 0.32 +/- 0.11, P < 0.001) in patients with a patent artery at follow-up, but was unchanged in patients with reocclusion. CONCLUSION: Long-term patency after recanalization of old, chronic coronary occlusions in patients with angina pectoris is associated with improvement in global and regional left ventricular function. This may be a result of recovery of hibernating myocardium and supports the strategy of recanalizing chronic coronary occlusions.

Predictors for restenosis after angioplasty of chronic coronary occlusions.

BACKGROUND: The Stenting In Chronic Coronary Occlusion (SICCO) study assessed the effects of additional intracoronary stenting (Palmaz-Schatz) after successful percutaneous transluminal coronary angioplasty (PTCA) of chronic coronary occlusions and showed a significant reduction of restenosis in stented patients. METHODS: Univariate and logistic regression analyses were used to assess clinical, angiographic and procedure related predictors for restenosis (>50% diameter stenosis at follow-up) and Major Adverse Clinical Events (MACE=cardiac death, lesion-related acute myocardial infarction, repeat lesion-related angioplasty, bypass surgery involving the treated segment or angiographic documentation of reocclusion in non-revascularized patients) in the 114 SICCO patients with an angiographic end-point and 300 days clinical follow-up. RESULTS: By 6 months the restenosis rate was 53%, and after 300 days MACE had occurred in 39%. Both the rates of restenosis and MACE was significantly reduced by stenting. The restenosis rate was improved by stenting also in patients with a 'stentlike' result after the initial PTCA. In the multivariate model the risk of restenosis was increased by a history of unstable angina, a long lesion and a non-tapering occlusion stump. LAD location was associated with a threefold increased risk of MACE. CONCLUSION: Stent implantation should always be considered in successfully opened chronic occlusions.

Stenting in Chronic Coronary Occlusion (SICCO): a randomized, controlled trial of adding stent implantation after successful angioplasty.

OBJECTIVES: This study investigated whether stenting improves long-term results after recanalization of chronic coronary occlusions. BACKGROUND: Restenosis is common after percutaneous transluminal coronary angioplasty (PTCA) of chronic coronary occlusions. Stenting has been suggested as a means of improving results, but its use has not previously been investigated in a randomized trial. METHODS: We randomly assigned 119 patients with a satisfactory result after successful recanalization by PTCA of a chronic coronary occlusion to 1) a control (PTCA) group with no other intervention, or 2) a group in which PTCA was followed by implantation of Palmaz-Schatz stents with full anticoagulation. Coronary angiography was performed before randomization, after stenting and at 6-month follow-up. RESULTS: Inguinal bleeding was more frequent in the stent group. There were no deaths. One patient with stenting had a myocardial infarction. Subacute occlusion within 2 weeks occurred in four patients in the stent group and in three in the PTCA group. At follow-up, 57% of patients with stenting were free from angina compared with 24% of patients with PTCA only (p < 0.001). Angiographic follow-up data were available in 114 patients. Restenosis (> or = 50% diameter stenosis) developed in 32% of patients with stenting and in 74% of patients with PTCA only (p < 0.001); reocclusion occurred in 12% and 26%, respectively (p = 0.058). Minimal lumen diameter (mean +/- SD) at follow-up was 1.92 +/- 0.95 mm and 1.11 +/- 0.78 mm, respectively (p < 0.001). Target lesion revascularization within 300 days was less frequent in patients with stenting than in patients with PTCA only (22% vs. 42%, p = 0.025). CONCLUSIONS: Stent implantation improved long-term angiographic and clinical results after PTCA of chronic coronary occlusions and is thus recommended regardless of the primary PTCA result.

Reproducibility of quantitative coronary analysis, Assessment of variability due to frame selection, different observers, and different cinefilmless laboratories.

Because of limited storage capacity for digital images, angiographic laboratories without cinefilm are dependent on locally performed quantitative coronary angiography (QCA) in clinical studies. In the present study the intra- and interobserver variability, as well as variability between different laboratories and variability due to frame selection was analyzed. A total of 20 coronary lesions were studied in two different laboratories 12 +/- 8 days apart. Images were analyzed on-line and after being transferred to a Cardiac Work Station (CWS). There was no significant difference between the measurement situations. For minimal luminal diameter (MLD) precision (SD of signed errors) ranged from 0.12 mm to 0.20 mm, for reference diameter (RD) from 0.15 mm to 0.28 mm, and for percent diameter stenosis (DS) from 4.2% to 5.8%. Overall relative precision was obtained by normalizing the QCA parameters, as well 11.9% for MLD, 7.0% for RD and 8.5% for DS (p < 0.001, Rd and DS compared to MLD). The overall variability in the interobserver and in the interlaboratory comparisons was 11.2% and 10.4%, respectively (n.s) (n.s.). Thus the variability of QCA performed in cinefilmless, digital laboratories is small, and within a range making it an useful tool for clinical practice and group comparisons in clinical studies. However, the error range of QCA measurements must be taken into consideration when judging results from individual patients.

[Treatment with ticlodipine after intracoronary stent implantation]. / Behandling med tiklopidin etter intrakoronar stentimplantasjon.

Complications were registered prospectively in 100 patients who had had a successful intracoronary stent implantation as assessed by quantitative angiography. The reference diameter of the vessels was 3.29 +/- 0.52 mm. Instead of the traditional treatment with dextran, heparin, warfarin, acetylsalicylic acid (ASA) and dipyridamol, all patients received the platelet antagonist ticlopidine 250 mg twice daily for 28 days together with ASA 160 mg daily. In the first 50 patients low molecular weight heparin was injected for three days. There was no incidence of stent occlusion within one month after the stent implantation. Only one patient needed surgical repair because of groin haematoma, whereas three patients needed prolonged compression in the groin because of bleeding. Ticlopidine was withdrawn because of side effects in 11 patients. No serious haematological side effect was seen. In the patients who received low molecular weight heparin the stay in hospital was 5.3 +/- 1.0 days, whereas the remaining 50 patients stayed in the hospital for 2.8 +/- 1.9 days. Thus, compared with traditional anticoagulation therapy, treatment with ticlopidine and ASA after stent implantation prevented stent occlusion, groin complications were few, and the need for hospitalization was reduced.

[Atherectomy. A new catheterization method for coronary revascularization]. / Aterektomi. En ny katetermetode for koronar revaskularisering.

Intimal atheroma con be excised and removed by coronary atherectomy. We describe our experience from the use of this method in the first 42 patients. The procedure was successful in 40 patients, in 16 cases after adjunct percutaneous transluminal coronary angioplasty. Two patients required bypass surgery because of catheter-related injury to the coronary vessel. One of these suffered a myocardial infarction, the only infarction in the material. In-hospital complications were minor, and the average stay in hospital after the procedure was 1.6 days. Angiography in 20 patients after a median follow-up period of 116 days showed restenosis in 30%, all of whom were treated successfully with PTCA. Symptomatic improvement was reported by 74% of the patients after a median observation time of 16 months. One patient died, probably from infarction, three months after the initial treatment, one patient suffered a non-fatal infarction, and one patient underwent bypass surgery. We conclude that atherectomy is an effective and safe treatment of coronary heart disease in selected cases, mainly eccentric stenoses and ostial lesions.

[Should older patients be admitted for coronary evaluation and treatment? With special emphasis on a survey and catheter-based revascularization of patients over 70 years of age]. / Bør eldre henvises til koronar utredning og behandling? Saerlig omtale av utredning og kateterbasert revaskularisering av pasienter over 70 år.

A three year survey of patients undergoing diagnostic left heart catheterization and PTCA treatment is presented from Feiringklinikken. Data on patients over and under 70 years have been analysed separately. The fraction of patients over 70 years admitted for catheterization increased significantly from 18.8% to 23.4% during the survey period. Angiography was associated with a low mortality of 0.04% and incidence of cerebrovascular complications with 0.1%, with no increased risk in patients over 70 years. The proportion of patients treated with PTCA increased significantly during the survey from 25% to 39% for patients over 70 years and from 31% to 42% for patients under 70 years (p < 0.01). The initial success rate of PTCA was 89% and 92% for patients over and under 70 years respectively (not significant). The rate of serious complications was low in both age groups, 3.2% and 1.0% in patients over and under 70 years respectively (p < 0.01). Older patients can be examined invasively with low risk of complications. A substantial number of patients, also among the elderly, can be treated safely with PTCA with good initial results. Thus, elderly patients should be offered the benefit of invasive diagnosis and treatment for coronary heart disease.

[Intracoronary stents. Experience from the Feiring clinic]. / Intrakoronar stentbehandling. Erfaringer fra Feiringklinikken.

There are two major problems connected to percutaneous transluminal coronary angioplasty (PTCA): acute closure of the vessel during the procedure and a high rate of late restenosis. Deployment of intracoronary stents has emerged as a procedure that can counteract these difficulties. At the Feiring Clinic 158 patients were treated with intracoronary stents in 1992 and 1993. In 87% of the patients no in-hospital cardiac events occurred. The overall mortality rate was 1.8%. Thrombosis of the stent occurred in 5.7% of the patients and acute myocardial infarction in 5.1%. Emergency bypass operation was performed in 5.1%. The most important predictor for clinical success was a good angiographic appearance after deployment of stent. It is concluded that stent deployment has improved the immediate outcome of a complicated PTCA procedure, and it is likely that it also will reduce the rate of restenosis.

Prognostic significance of type and location of a first myocardial infarction.

The prognostic significance of type (Q-wave versus non-Q-wave) and location of infarction (anterior versus infero-posterior) was assessed in 350 patients with a first myocardial infarction followed for 3 years. A baseline multivariate Cox model was constructed from variables assessable at entry of the index infarction. The prognostic significance of site and type of infarction was evaluated when added to this model. Both Q-wave infarction and anterior location were significant with a risk ratio of 1.91 (95% confidence interval 1.14-3.18) and 1.70 (95% confidence interval 1.11-2.61) respectively. However, when the model also included the size of infarction. Q-wave infarction was no longer formally significant, while anterior location still was associated with adverse outcome (risk ratio 1.56, 95% confidence interval 1.02-2.39). It is inferred from the results that this effect of anterior infarction is due to a larger damage to the left ventricle for identical infarct sizes compared to infero-posterior infarctions.

The effect of magnesium versus verapamil on supraventricular arrhythmias.

Magnesium has previously been used in the treatment of various arrhythmias, but few randomized and prospective studies are available. In a single-blind study, the efficacy and safety of intravenous magnesium sulfate (bolus doses of 5 + 5 mmol followed by infusion of 0.04 mmol/min) versus verapamil (5 + 5 mg followed by 0.1 mg/min) was evaluated in 57 patients with supraventricular arrhythmias (supraventricular tachycardia, atrial fibrillation, and atrial flutter) of recent onset (less than 1 week). Fifteen (58%) of the patients receiving magnesium (n = 26) converted to sinus rhythm within 4 h, and 16 (62%) within 24 h. Verapamil caused a lower ventricular rate, but only six (19%) of the patients (n = 31) converted to sinus rhythm within 4 h (p < 0.01) and 16 (52%) within 24 h (NS). No side effects were observed during magnesium infusion, whereas six patients receiving verapamil had to be withdrawn from further study medication due to symptomatic side effects (hypotension in three, cardiac failure in three). Magnesium appears to be an effective and safe drug for the treatment of supraventricular arrhythmias. The overall efficacy for conversion to sinus rhythm is at least as effective as with verapamil, and its action is more rapid.

Digitalis in patients after myocardial infarction.

For more than two centuries digitalis has been used in the treatment of cardiac disease. Despite this long clinical experience with the drug, controversy still exists as to its clinical effect and impact on survival, especially in patients after myocardial infarction. In the last decade a number of studies have addressed the problem of assessing the clinical effect of digitalis in patients with sinus rhythm and left ventricular dysfunction. An overall conclusion from these studies seems to indicate that a modest clinical beneficial effect can be expected from the drug. Regarding the effect of digitalis on the mortality in patients after a myocardial infarction controversy still prevails. All studies show an increased mortality in patients using digitalis, but opinions differ as to whether this is due solely to baseline imbalances between the populations or that a harmful effect of digitalis itself exists as well. This question cannot be answered with certainty until the results from a large, randomized study are available. In the meantime digitalis can probably be used as a first line therapy in patients with atrial fibrillation and left ventricular dysfunction. In patients with sinus rhythm and heart failure, however, it is probably wise to reserve digitalis to those that are still symptomatic after diuretics, nitrates and ACE inhibitors have been tried.

Left atrial myxoma and systemic AL-amyloidosis.

A case of left atrial myxoma with systemic AL-amyloidosis is described. Localized myxomas have the peculiar property of giving rise to constitutional symptoms, indicating a systemic disease process. The coexistence of AL-amyloidosis and an atrial myxoma in the same patient makes it tempting to suggest that an immunological defect is involved in the development of both diseases.

Hemodynamic evaluation of the CarboMedics prosthetic heart valve in the aortic position: comparison of noninvasive and invasive techniques.

Seventy-three patients with a CarboMedics aortic bileaflet valve prosthesis were examined by Doppler ultrasonography, and 27 of them were also assessed by transseptal catheterization. The ultrasonic mean systolic gradient was 17.1 +/- 5.6 mm Hg for valve size 19 mm, falling gradually with increasing valve size to 6.8 +/- 2.5 mm Hg for size 27 mm. The catheter mean systolic gradient was consistently smaller than the ultrasonic gradient (4.3 +/- 4.8 mm Hg), but Tobit regression analysis showed a significant association between the two methods. In all patients both methods revealed negligible to small amounts of retrograde leakage, which is assumed to be a normal finding for this valve. The effective flow areas of the valves calculated from the ultrasonic data were similar to the in vitro calculated flow areas. The hemodynamic potential of this valve is therefore completely utilized in vivo. The effective orifice area corrected for body surface area increased with increasing valve size, which demonstrates a moderate valve-patient mismatch.

First myocardial infarction in smokers.

In 484 patients with a first myocardial infarction 155 were smokers at the time of infarction. Their unadjusted survival was superior to the non-smokers at 3 months follow-up, with a relative risk of 0.36 (95% confidence interval 0.22-0.59). Major baseline differences existed between the two populations. When these inequalities were taken into account through a multivariate Cox regression the relative risk was increased to 0.55 (95% confidence interval 0.33-0.93), but was still significantly lower than in non-smokers (P = 0.017). No difference in rate of reinfarction was observed between the two populations. The smokers tended to have a 'less serious infarction' than the non-smokers. However, adding variables that accounted for this into the Cox model did not cancel the impact of smoking. From the results it is suggested that the reduced mortality in smokers is due to a thrombus occurring at an earlier stage of the coronary artery disease. Thus, at the time of infarction smokers' left ventricular function tends to be less affected, and this is reflected in the improved survival rate among smokers in the first months after an acute myocardial infarction.