Randomized, controlled trial of secondary prevention of coronary sclerosis in normocholesterolemic patients using pravastatin: final 5-year angiographic follow-up of the Prevention of Coronary Sclerosis (PCS) study

BACKGROUND: The potential benefit of cholesterol-lowering therapy for normocholesterolemic patients with coronary artery disease (CAD) has not been clarified. The Prevention of Coronary Sclerosis (PCS) Study was designed to evaluate the effect of pravastatin on secondary prevention of progression of CAD in normocholesterolemic patients for a period of 5 years. METHODS: A total of 329 patients with CAD were enrolled. Normocholesterolemic patients were defined by a serum total cholesterol (TC) level of 180-219 mg/dl. Patients in this group were randomized into pravastatin and dietary control groups. Patients whose serum TC level fell outside the normal range were divided into a high-cholesterol reference group (TC > or = 220 mg/dl) and a low-cholesterol reference group (TC < 180 mg/dl). Patients in the pravastatin and high-cholesterol groups received pravastatin 10 mg/day. Coronary angiography was performed at baseline, 2 years, and 5 years and analyzed by quantitative coronary arteriography. Angiographic coronary progression was evaluated by minimum obstruction diameter (MOD) and mean segment diameter (MSD). RESULTS: At 5 years, change in MOD was significantly (change, P=0.033; change/years, P=0.032) less in the pravastatin group (-0.04 +/- 0.17 mm) than in the dietary control group (-0.16 +/- 0.27 mm). Although a similar trend was observed in the MSD results, the differences were not significant. CONCLUSION: Long-term angiographic data show that cholesterol-lowering therapy by pravastatin prevents progression of coronary atherosclerosis in normocholesterolemic patients with CAD.     

Limitations of a QRS scoring system to assess left ventricular function and prognosis at hospital discharge after myocardial infarction

The value of a QRS scoring system derived from 12 lead electrocardiograms to estimate left ventricular ejection fraction was assessed in a prospective study of 285 hospital survivors of myocardial infarction. In these patients both the QRS score and ejection fraction were measured by radionuclide ventriculography at discharge. The correlation between ejection fraction and QRS score was weak. In 22 patients who died during six to 12 months follow up the ability of the ejection fraction and QRS score to predict mortality was assessed in terms of sensitivity, specificity, predictive value of a positive and negative test, and efficiency. For ejection fraction less than 40% and a QRS score greater than or equal to 6 sensitivity was respectively 73% and 64%, specificity 73% and 56%, predictive value of a positive test 18% and 11%, predictive value of a negative test 97% and 95%, and efficiency 73% and 56%. Both ejection fraction and QRS score may be used to identify patients at low and high risk during one year follow up, but, contrary to initial expectations, the QRS score appears to be of little value in estimating ejection fraction and is less accurate than ejection fraction in predicting late survival in hospital survivors of myocardial infarction.     

Evidence‐based chronic ulcer care and lower limb outcomes among Pacific Northwest veterans

Evidence‐based ulcer care guidelines detail optimal components of care for treatment of ulcers of different etiologies. We investigated the impact of providing specific evidence‐based ulcer treatment components on healing outcomes for lower limb ulcers (LLU) among veterans in the Pacific Northwest. Components of evidence‐based ulcer care for venous, arterial, diabetic foot ulcers/neuropathic ulcers were abstracted from medical records. The outcome was ulcer healing. Our analysis assessed the relationship between evidence‐based ulcer care by etiology, components of care provided, and healing, while accounting for veteran characteristics. A minority of veterans in all three ulcer‐etiology groups received the recommended components of evidence‐based care in at least 80% of visits. The likelihood of healing improved when assessment for edema and infection were performed on at least 80% of visits (hazard ratio [HR] = 3.20, p = 0.009 and HR = 3.54, p = 0.006, respectively) in patients with venous ulcers. There was no significant association between frequency of care components provided and healing among patients with arterial ulcers. Among patients with diabetic/neuropathic ulcers, the chance of healing increased 2.5‐fold when debridement was performed at 80% of visits (p = 0.03), and doubled when ischemia was assessed at the first visit (p = 0.045). Veterans in the Pacific Northwest did not uniformly receive evidence‐based ulcer care. Not all evidence‐based ulcer care components were significantly associated with healing. At a minimum, clinicians need to address components of ulcer care associated with improved ulcer healing.     

Association of plasma lipid levels with apolipoprotein E polymorphism in Type 2 diabetes

OBJECTIVE: To evaluate the distribution of apolipoprotein E polymorphism in patients with Type 2 diabetes and their impact on plasma lipid levels. Subjects: Unrelated Type 2 diabetic patients (n = 298) treated by diet and sulfonylurea and not receiving lipid-lowering regimens, elderly (n = 98) and young (n = 101)unrelated healthy control subjects in Hungary. METHODS: Apolipoprotein E genotypes were identified by PCR amplification and subsequent restriction endonuclease digestion. RESULTS: The distribution of the most frequent genotypes in the diabetes group was E2/3 8.7%, E3/3 78.2%, E3/4 12.8%, in the elderly group E2/3 9.2%, E3/3 78.6%, E3/4 12.2% and in the young group E2/3 11.9%, E3/3 62.4%, E3/4 24.8%. The frequencies of allele e4 in the diabetes and in the elderly control group were significantly lower than in the young control group (both P < 0.05). Associations were found between the e4 allele and increased triglyceride level in the diabetes group, the e2 allele and decreased total cholesterol and LDL-cholesterol levels both in the elderly and young control groups (both P < 0.01). CONCLUSION: The lower frequency of allele e4 in both the elderly and diabetes groups, may be explained by an increased morbidity and mortality in middle-aged carriers of apo e4 allele. The increased risk of e4 carriers in Type 2 diabetes may be partly mediated by a higher triglyceride level.     

Low restenosis rate of the NIR coronary stent: results of the Danish multicenter stent study (DANSTENT)--a randomized trial comparing a first-generation stent with a second-generation stent

Background Larger studies evaluating the angiographic results of second-generation stents are scarce. The objectives of this study were to assess current standards of angiographic and clinical outcomes after implantation of the second-generation stainless steel stent, NIR (Medinol Ltd, Tel Aviv, Israel), and to compare the outcomes with those of the first-generation Palmaz-Schatz (PS) stent (Johnson & Johnson, Warren, NJ). Methods Patients having coronary artery lesions that could be covered by a stent of 15 mm in length were randomly assigned to receive the NIR or the PS. Procedural success, 6-month angiographic findings, and 1-year clinical outcomes were determined. Results In 424 patients included in the study, the overall procedural success rate was high (NIR 98%, PS 99%, P = .90). Follow-up angiography was conducted in 91% of the patients. The overall rate of angiographic restenosis was low in both groups (NIR 9.9%, PS 12.6%, P = .35). We found a low restenosis rate in vessels with a minimal lumen diameter >3.1 mm after the procedure, particularly in the NIR group (<6%). The rate of target lesion revascularization after 1 year did not differ (NIR 12%, PS 10%, P = .47). Conclusions The angiographic and clinical outcomes after implantation of the second-generation stainless steel stent were not significantly better than those of the first-generation stent. The low restenosis rates, particularly in patients with the largest minimal lumen diameters after stent implantation, warrants circumspection when planning the evaluation of newer stent technologies that aim to further reduce coronary restenosis. (Am Heart J 2003;145:e5.)