VIPER-2: a prospective, randomized single-center comparison of 2 different closure devices with a hemostatic wound dressing for closure of femoral artery access sites.

PURPOSE: To report the outcome of a prospective randomized safety and performance trial of 2 access site closure devices versus a wound dressing. METHODS: Between October 2005 and July 2006, 852 consecutive patients (605 men; mean age 67 years) undergoing diagnostic or interventional catheterization procedures thru a 5- or 6-F femoral sheath were randomized to one of the 3 closure methods: a collagen plug device (Angio-Seal), a clip (StarClose), or a wound dressing (D-Stat Dry). The efficacy of the devices was assessed, as well as the complications occurring at the puncture site during the hospital stay. The primary endpoint of the study was the cumulative incidence of access site pseudoaneurysm, major access site bleeding requiring transfusion, access site vascular surgery, or death from all causes. RESULTS: There were no significant differences in baseline characteristics between the 3 treatment groups. The primary endpoint was reached in 20 (7.1%) of 281 patients treated with D-Stat Dry and in 11 (1.9%) of 571 patients treated with the mechanical closure devices (p<0.0001). There was no significant difference among the mechanical closure devices concerning the incidence of the primary endpoint (Angio-Seal 1.1% versus StarClose 2.8%; p = 0.13). CONCLUSION: The collagen plug device had the lowest rates of major and minor access site-related complications after removal of 5- or 6-F femoral sheaths. The difference between the mechanical closure devices concerning the incidence of the primary endpoint did not reach statistical significance. The wound dressing showed significantly higher major and minor complication rates.     

Relation of hyperglycemia to ST-segment resolution after reperfusion for acute myocardial infarction (from Observatoire des Infarctus de Côte-d'Or Survey [RICO])

Hyperglycemia has been shown to be a powerful predictor of worse outcome after ST-segment-elevation myocardial infarction (STEMI), which could be related to impaired myocardial reperfusion. This study investigated the association between hyperglycemia and ST-segment resolution (STR) after thrombolysis. From the French regional Observatoire des Infarctus de C?te-d'Or survey, admission glucose in 371 patients with STEMIs who were treated by lysis<12 hours was analyzed. The single worst lead electrocardiogram before and 90 minutes after lysis was analyzed, and patients were divided into 3 groups according to the degree of STR: none (<30%), partial (30% to 70%), or complete (>or=70%). Of the 371 patients, 101 (27.2%) had no STR, 124 (33.4%) had partial STR, and 146 (39.4%) had complete STR. STR decreased with increasing glycemia (p=0.029), and patients with hyperglycemia (glycemia>or=11 mmol/L) were more likely to have no STR. Moreover, hyperglycemia was an independent predictor of incomplete STR even after adjustment for potential confounders (odds ratio 2.348, 95% confidence interval 1.212 to 4.547). In conclusion, the present study suggests a strong association between hyperglycemia and electrocardiographic signs of reperfusion in patients with STEMIs after lysis and suggests the usefulness of evaluating early glycemic control in the setting of reperfusion for acute myocardial infarction.     

Non-revascularisation of acute coronary syndrome with ST elevation

National therapeutic strategies in acute coronary syndromes (ACS) required revaluation, especially with regards to reperfusion. RICO is an observatory of ACS in the C?te d'Or district. Between January 1st 2001 and April 31st 2003, the cases of 706 patients with ACS and persistent ST elevation or appearances of left bundle branch block eligible for revascularisation (admitted < 12 hours after onset of symptoms and no contra-indications to thrombolysis), were reviewed. The number of revascularised patients was 488 (69%) and 218 (31%) were not revascularised. Thrombolysis was the most commonly used method of revascularisation (66%) in this district: 34% underwent primary angioplasty. Multivariate analysis showed only three independent predictive factors of non-reperfusion during the acute phase. They were: age (> or = 75 years) (p < 0.001), left bundle branch block (p = 0.002) and hospital admission > or = 6 hours after onset of symptoms (p < 0.001). These results confirm the utility of developing networks to improve the efficacy of management and reduce the delay before hospital admission. They also identify specific population groups, the elderly for example, who require specific therapeutic strategies for coronary revascularisation in ACS.     

Beneficial effects of statin therapy on survival in hypertensive patients with acute myocardial infarction: data from the RICO survey

BACKGROUND: Randomized studies have shown a reduction in cardiovascular events associated with low doses of statin among hypertensive patients at only moderate cardiovascular risk. The hypothesis of the present study was that statin therapy initiated during hospitalization could improve the long-term outcome after acute myocardial infarction (MI) in hypertensive patients. METHODS: From the French regional obserRvatoire des Infarctus de C?te d'Or (RICO) survey, 1076 patients with a history of hypertension, surviving acute MI were included. Patients on statin therapy initiated before their hospitalization were excluded from the study. Patients were categorized into two groups based on whether or not statin treatment was initiated during the hospital stay. RESULTS: Patients in the statin group were younger (70 years [range, 58 to 77 years] v 75 years [range, 65 to 82 years], P < .001) and were more likely to have hypercholesterolemia (42% v 28 %, P < .001). No differences were observed between the two groups for LDL-cholesterol levels on admission. At 1-year follow-up, cardiovascular mortality and rehospitalization for heart failure were lower in the statin group (respectively, 5% v 15%, P < .001; 5% v 7%, P < .001). Multivariate analysis showed that statin therapy was associated with decreased mortality (hazard ratio [95% confidence interval; CI]: 0.58 [0.32-0.98], P = .035) independently of either hypercholesterolemia, the use of beta-blockers, angiotensin-converting enzyme inhibitors, or diuretics, but not with a decreased incidence of heart failure (hazard ratio [95% CI]: 0.88 [0.55-1.23], P = .152). CONCLUSIONS: In this observational study, the long-term benefits of statin therapy initiated in-hospital in hypertensive patients after acute MI was demonstrated. These findings may have implications for treatment optimization of hypertensive patients in secondary prevention.     

Hypersomnolence with beta-adrenergic blockers

An elderly, mildly demented, hypertensive male patient developed hypersomnolence on administration of propranolol for treatment of hypertension; no other cause for hypersomnolence was detected. Upon replacement of propranolol with atenolol, he felt better but continued to be quite somnolent. When atenolol was discontinued, he reported to have lack of sleep. On readministration of subtherapeutic doses of the same beta-adrenergic blocking agents, he once again experienced excessive sleepiness. By discontinuing beta-blocking agents and introducing captopril, he felt much better, became pleasant and talkative, and blood pressure was well controlled. Beta antagonists are important drugs in the management of many cardiovascular problems. Propranolol, a lipophilic beta-blocking agent, and atenolol, a hydrophilic beta-blocking agent, are two of the major agents currently used clinically in the United States. Numerous neuropsychiatric side-effects of the beta-adrenergic blocking drugs have been reported, but hypersomnolence is not readily recognized as one of them.