Randomised comparison of Micro Stent I with Palmaz-Schatz stent placement for the elective treatment of short coronary stenoses.

This randomised trial compared the Micro Stent I and the Palmaz-Schatz stent for the elective treatment of short (<8 mm long), new-onset coronary stenoses. The primary endpoints were restenosis rate and minimal luminal diameter at 6 mo angiographic follow-up. The secondary endpoints were angiographic and procedural success of stenting and a composite clinical endpoint at 6 mo (death, myocardial infarction, and target site revascularisation). A total of 93 patients were randomised. Clinical and angiographic characteristics of the two groups were comparable. Angiographic success of stenting was 96% in both groups, and there were no complications so that the procedural success was also 96% in both groups. The restenosis rate was 29% for Micro Stent I and 27% for the Palmaz-Schatz stent (P = NS). The minimal luminal diameter at 6 mo was 1.75 +/- 0.72 mm in the Micro Stent I group and 1.84 +/- 0.59 in the Palmaz-Schatz group (P = NS). At 6 mo, a clinical endpoint was reached by 21% of the patients in the Micro Stent I group and by 11% in the Palmaz-Schatz group (P = NS). In conclusion, the elective treatment of short coronary stenosis with the Micro Stent I or the Palmaz-Schatz stent resulted in similar early and late outcomes. In particular, the late angiographic results were very similar.

Early versus late coronary stenting following acute myocardial infarction: results of the STENTIM I Study (French Registry of Stenting in Acute Myocardial Infarction).

This study was undertaken to determine the feasibility and safety of coronary stenting in acute myocardial infarction (AMI). In AMI, primary percutaneous transluminal coronary angioplasty (PTCA) is accepted as the preferred method of reperfusion for patients presenting at highly experienced centres. Until recently, however, stenting has been avoided during AMI because of a potential high risk of thrombosis. This prospective observational study carried out in 20 centres and included 648 consecutive patients who underwent PTCA with stent implantation for AMI. Of these 648 patients, 269 (41.5%, Group 1) were dilated early (< 24 hr) after the onset of the symptoms (75% treated by direct PTCA) and 379 (58.5%, Group 2) were dilated between 24 hr and 14 days after AMI. Combined therapy with ticlopidin and aspirin was used after the procedure. Bailout stenting occurred more often in Group 1 than in Group 2 (17% vs. 9.5%)(P < 0.05). Angiographic successful stenting was similar in both groups of patients (96% vs. 97%). During the hospital follow-up period, stent thrombosis occurred in eight patients (3%) in Group 1 and in six patients (1.6%) in Group 2 (NS). There was 14 deaths (5.2%) in Group 1 and 11 deaths (3.9%) in Group 2 (NS). After multivariate analysis bailout stenting was identified as the sole predictor of stent thrombosis (P < 0.0001). Vascular access-site complications occurred in six patients (1%) with no difference between the two groups. This study indicates that patients who receive a coronary stent in AMI can be managed safely with antiplatelet therapy. Randomized studies are needed to determine the precise indication for coronary stenting as an adjunct to primary PTCA.

Comparison of 6F with 7F and 8F guiding catheters for elective coronary angioplasty: results of a prospective, multicenter, randomized trial.

A group of 460 patients was considered in our prospective study of assessment of the efficiency and safety of 6F (internal diameter 0.062 inches) guiding catheters to perform elective percutaneous coronary angioplasty by the femoral approach by using conventional balloon systems. The patients were randomly assigned either a 6F guiding catheter (first group, n = 231; 247 coronary lesions), or a 7F or 8F guiding catheter (second group, n = 229; 252 coronary lesions). The exclusion criteria were the ongoing myocardial infarction, the marked reduction of left ventricular function, and the decision to treat the lesion with a device not fitting the 6F guiding catheter. The angioplasty success rates (87% in the 6F group vs 88% in the 7F or 8F group) and the stent implantation rates (21% vs 25%) were similar in both groups. The ischemic complication rates (death, 2 vs 1 ) were also similar. The incidence of the femoral complications was significantly less important in the 6F group than in the 7/8F group (13.8% vs 23.5%; p < 0.01). Significant differences also were noted for the procedural time (36 +/- 22 vs 41 +/- 28 min; p < 0.01), the fluoroscopy time (11 +/- 10 vs 14 +/- 4 min; p < 0.05), the volume of contrast injected (136 +/- 68 ml vs 168 +/- 95 ml; p < 0.0001), and the time of femoral compression after the introducer sheath removal (11.7 +/- 9 vs 14.1 +/- 12 min; p < 0.01). Our data suggest that 6F guiding catheters for elective coronary angioplasty are more effective than are the larger diameter catheters. Besides a significant decrease of vascular complications, angioplasty with a 6F guiding catheter reduces the procedural time and the amount of contrast.

Effects of early high-dose streptokinase intravenously on left ventricular function in acute myocardial infarction.

One hundred seven patients who recently had acute myocardial infarction were randomly assigned either to standard heparin therapy or to intravenous streptokinase within 5 hours after the onset of symptoms in 7 hospitals without catheterization facilities. In the third week, the patients were referred to a university hospital, where the patency rate of the infarct-related artery was studied by selective coronary arteriography and left ventricular function by radionuclide angiography. Fifty-five patients received heparin and 52 streptokinase within a mean period of 190 minutes after the onset of symptoms. Seven patients in the heparin group and 4 in the streptokinase group died in hospital. The patency rate of the infarct-related artery was identical in both groups (69% in the heparin group vs 68% in the streptokinase group). Left ventricular ejection fraction was not statistically different (0.44 +/- 0.13 in the heparin group vs 0.45 +/- 0.12 in the streptokinase group). Left ventricular ejection fraction was significantly higher in patients with a patent infarct-related artery than in patients with an obstructed infarct-related artery (0.49 +/- 0.12 vs 0.41 +/- 0.15, p less than 0.01). In patients with inferior wall infarction, left ventricular ejection fraction was identical (0.50 +/- 0.10 in the heparin group vs 0.52 +/- 0.09, in the streptokinase group). In patients with anterior wall infarction, left ventricular ejection fraction was significantly higher in the streptokinase group than in heparin group (0.40 +/- 0.10 vs 0.33 +/- 0.09, p less than 0.05). Analysis of regional wall motion revealed that improvement occurred in the lateral wall of the left ventricle.(ABSTRACT TRUNCATED AT 250 WORDS)

[Intravenous streptokinase versus heparin in recent acute myocardial infarction. Randomized multicenter study in the Franche-Comté]. / Streptokinase intraveineuse versus héparine dans l'infarctus du myocarde aigu récent. Etude randomisée multicentrique franc-comtoise.

A multicentre randomised therapeutic trial was undertaken in 8 hospitals in the Franche-Comté department of France (Belfort, Besançon, Dole, Lons-le-Saunier, Luxeuil, Montbéliard, Vesoul, Pontarlier) in which 101 patients with acute primary myocardial infarction were treated within 5 hours of onset of symptoms with either intravenous streptokinase (1,500,000 U in 30 mn) or conventional heparin therapy. The results were assessed on the clinical outcome, arterial patency in the necrosed territory and global and regional ejection fractions (EF) at the 3rd week. After randomisation, 51 patients were given heparin and 50 received streptokinase. Seven patients died in the heparin group and 4 in the streptokinase group (NS). At the third week, the artery in the necrosed zone was patent in 69% of the heparin group and in 68% of the streptokinase group (NS). The EF was significantly higher in the patients with patent arteries in the necrosed zone than in those with occluded arteries (0.49 +/- 0.12 vs 0.41 +/- 0.15, p less than 0.01). There was no significant difference in EF between the heparin and streptokinase groups. The EF was significantly higher in patients with anterior infarction who received streptokinase than in those who received heparin (0.40 +/- 0.10 vs 0.33 +/- 0.09 p less than 0.05). Segmental wall motion was significantly better at the apex and free wall. There was no significant difference between the two groups in posterior infarction. These results show that reestablishment or maintenance of arterial patency in the necrosed zone improves left ventricular function and that patients with anterior wall infarction are the ones most likely to benefit from streptokinase therapy.