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.

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.

Which groups of patients benefit from helicopter evacuation?

BACKGROUND: The evacuation of emergency cases by air, usually by helicopter, is controversial because of the cost of the programme, the possibility of an accident (especially in an urban area), and unproven benefit. But such evacuations cannot be studied by a random intervention (eg, air versus ground ambulance). We used an expert-panel approach to estimate the health outcome for patients transferred by emergency helicopter compared with the potential outcome if they had gone by surface ambulance. METHODS: The helicopter programme is based at the University Hospital of Tromsø in northern Norway. 370 case-reports of helicopter evacuation from rural areas were screened by anaesthetists for routine and case-specific data. Two expert panels assessed the cases for potential additional health benefit arising from the fact of helicopter evacuation. The panels used a modified Delphi technique to reach consensus in life-years gained. One panel met for cases aged under 15 and pregnant women, the other for older cases. FINDINGS: 240 of the 370 cases were male (65%); the age range for both sexes was 0-86 years. The most common diagnosis for the 55 cases aged under 15 was infection (49%); in older patients, cardiovascular disease dominated (50%). Trauma accounted for just under a fifth of cases in both groups. On average, the patients arrived 69 min (range 0-615) earlier in hospital than if they had gone by ground transport. For 283 cases, the initial screening by the anaesthetists indicated no additional benefit compared with that obtainable by ground-ambulance transport. The main reason was that no treatment was given during the flight or early on in hospital that could not have been given otherwise. 90 cases entered the expert panel system. Of these 90, 49 cases were judged to have received no additional benefit. This left 41 (11% of the total of 370 evacuated) who were judged to have benefited, gaining 290.6 life-years. 96% of the total number of life-years gained was achieved in nine patients, six of whom were aged below 7 (four were aged 0-7 months). The life-year-gain per adult patient with cardiovascular disease was 0.54. INTERPRETATION: We conclude that an emergency helicopter service can provide considerable health benefits for selected patients, at least in this rural setting. Given the costs and risks of such a service, the benefits for most patients are small.

Short-term treatment of Graves' disease with methimazole in high versus low doses.

OBJECTIVES: To compare the relapse rates in Graves' disease the first 2 years after methimazole 60 mg day-1 combined with thyroxine versus a titration regimen with methimazole alone, and to look for possible prognostic factors. DESIGN: A randomized, open, prospective study. Methimazole was given for 6 months in both groups, and thyroid status evaluated every 3rd month during the first year, and every 6th month during the second year. SETTING: The study was performed at our outpatient clinic with patients referred from primary care. SUBJECTS: Fifty-six patients were included. One became pregnant and one dropped out during the treatment period. Furthermore, nine patients in the high-dose and four in the low-dose group stopped the treatment because of side-effects. Thus, 19 patients in the high- and 22 in the low-dose group completed 6 months with methimazole. RESULTS: In those tolerating the treatment, the relapse rates in the high- and low-dose groups were 26.3 vs. 59.1% (P < 0.05), 42.1 vs. 77.3% (P < 0.02); and 57.9 vs. 77.3% (NS) after 3, 12 and 24 months, respectively. The corresponding relapse rates calculated on an 'intention to treat' basis were: 51.7 vs. 66.7%; 62.1 vs. 81.5%: 72.4 vs. 81.5% (NS). The thyroid volume was significantly (P < 0.05) larger in those that relapsed (17.8 +/- 2.9 vs. 11.6 +/- 1.2 mL; mean +/- SEM). CONCLUSIONS: In those tolerating the treatment, methimazole significantly reduced the relapse rate the 1st year when given in a high dose. However, the relapse rates in both groups, and the number of side-effects in the high-dose group, were unacceptably high.

Simvastatin and cholestyramine in the long-term treatment of hypercholesterolaemia.

After 6 weeks on a lipid-lowering diet, 20 outpatients with type II hyperlipoproteinaemia (18 type IIa) were randomized to treatment with cholestyramine 12 g b.i.d. (5 patients) or simvastatin (a new HMG-CoA reductase inhibitor) 40 mg q.p.m. (15 patients) for 12 weeks. From week 13 to week 20 nine patients in the simvastatin group and all patients in the cholestyramine group were treated with the combination of the two drugs. From week 21 to week 52 all patients were on monotherapy with simvastatin. Simvastatin treatment reduced low-density lipoprotein (LDL) cholesterol by 40% after 12 weeks, compared with 33% in the cholestyramine group. This difference was not significant. The total reductions of LDL-cholesterol on combination therapy were respectively 60% and 56% in each group. After 52 weeks LDL-cholesterol was still reduced by 36% (P less than 0.001) on monotherapy with simvastatin. Simvastatin also reduced triglycerides (TG) by 17% (P less than 0.05) and high-density lipoprotein (HDL) cholesterol was increased by 19% (P less than 0.01). No serious side effects were observed, and the new HMG-CoA reductase inhibitors may offer a new approach to the treatment of hypercholesterolaemia.