Effect of glycoprotein IIb/IIIa receptor inhibition on angiographic complications during percutaneous coronary intervention in the ESPRIT trial.

OBJECTIVES: We sought to determine whether eptifibatide decreases the incidence of in-laboratory angiographic complications and to determine the relationship of angiographically evident complications to elevations of creatine kinase-MB (CK-MB) enzyme levels during percutaneous coronary intervention. BACKGROUND: In the Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial, eptifibatide during coronary intervention was associated with decreased ischemic complications at 48 h and 30 days. METHODS: Patients (n = 2,064) were randomized to placebo versus eptifibatide (two 180 microg/kg boluses 10 min apart and as a continuous infusion of 2 microg/kg per min) during percutaneous coronary stenting. Angiographic complications including major dissection, distal embolization, residual thrombus, abrupt closure, residual stenosis >50% and side-branch occlusion were prospectively recorded by the operator. Creatine kinase-MB levels were measured after the procedure and every 6 h thereafter. The incidence of angiographic complications and CK-MB elevation was determined for eptifibatide versus placebo groups. RESULTS: Eptifibatide-treated patients demonstrated nonsignificant trends toward fewer angiographic complications (10 vs. 12% for placebo patients, p = 0.13) and, for patients with angiographic complications, fewer subsequent CK-MB elevations (43 vs. 50% for placebo patients, p = 0.31). In patients without any angiographic complications, the incidence of CK-MB elevation >3 times the normal was 7% with placebo and 4% with eptifibatide (p = 0.003). CONCLUSIONS: Eptifibatide during nonurgent coronary stent intervention only minimally (and insignificantly) reduces the incidence of angiographic complications and subsequent CK-MB elevations in patients developing an angiographic complication. The greater effect is to reduce myocardial infarction in patients undergoing otherwise uneventful coronary stent implantation as well as in the overall study population.

Effectiveness of transluminal extraction atherectomy for debulking saphenous vein graft in-stent restenosis.

Treatment of in-stent restenosis in saphenous vein grafts often requires initial debulking, but transluminal extraction catheter (TEC) atherectomy is seldom used for this purpose, and most discussions omit this option. Our experience with 6 episodes of TEC used successfully for saphenous vein graft in-stent restenosis and review of 7 other reported cases suggests TEC may be safe and effective for debulking saphenous vein graft restenosis lesions.

The relative influence of lesion length and other stenosis morphologies on procedural success of coronary intervention.

As coronary interventional technology improves, the influence of lesion length (LL) on procedural success and device selection may vary. Thus, the authors prospectively analyzed 957 consecutive coronary interventions (CI) in 1,404 stenoses to ascertain the influence of lesion length on CI outcome. Stenosis morphology was prospectively classified by the AHA/ACC criteria. LL was analyzed both as dichotomous (S: < 10 mm, L: > 10 mm) variables and by the three-tiered AHA/ACC criteria (I: < 10 mm, II: 10-20 mm, III: > 20 mm). There was a significant univariate relationship between CI success and S stenosis (S: 95.8% vs L: 91.8%, p = 0.002 and I: 96.0%, II: 91.7%, III: 89.3%). Numerous interrelationships involving the morphologic characteristics were noted: lesion morphologies associated with S lesions were concentric (p = 0.0001) and had smooth contour (p = 0.0001), ostial location (p = 0.05) and little calcification (p = 0.0007), while irregular contour (p=0.0001), calcification (p=0.0076), eccentric (p=0.0001), thrombus (p = 0.0001), recent (p = 0.0001) or chronic (p = 0.001) total occlusion were associated with L lesions. When these relationships were taken into account by multiple logistic regression analysis, lesion length was not predictive of procedural outcome (p = 0.099). One morphologic type was associated with increased CI success: irregular contour (p = 0.022); recent (p < 0.0001) or chronic (< 0.0001) occlusions were associated with decreased CI success. Another factor considered was device selection: S lesions were associated with greater balloon angioplasty usage (p = 0.002), whereas more coronary stents (p = 0.024) and rotoblator (p = 0.018) devices were used in L lesions. More balloon angioplasty was performed in concentric (p < 0.0001) lesions; interventional devices were employed more often in eccentric (p < 0.0001) and irregular lesions (p < 0.0001). More complications were noted in lesions with thrombus (p = 0.0002), but lesion length was not predictive (p = NS). Lesion length is not a significant predictor of procedural success when adjusted for other lesion morphologies in the modern interventional era. The availability of new devices has improved the results in longer lesions since the AHA/ACC criteria were originally proposed.

Clinical practice guidelines in unstable angina improve clinical outcomes by assuring early intensive medical treatment.

OBJECTIVES: To determine the influence of clinical practice guidelines on treatment patterns and clinical outcomes in unstable angina and the effectiveness of guideline reminders on implementing practice guidelines, two groups of medium and high risk patients with unstable angina were compared. BACKGROUND: New guidelines have been published by the Agency for Health Care Policy and Research (AHCPR) for evaluating and managing patients with unstable angina. The impact of these guidelines to improve the quality of care has never been tested. METHODS: Group 1 included 338 consecutive medium or high risk patients admitted before publication of the AHCPR guidelines, and group 2 consisted of 181 consecutive similar risk patients admitted after institution of the AHCPR guideline reminders at this institution. Dissemination of clinical practice guidelines was ensured by a grand rounds lecture and by posting guideline reminders on all group 2 patients' charts within 24 h of admission. RESULTS: The two groups were similar in terms of most baseline characteristics, including hypercholesterolemia, diabetes, hypertension, smoking history, baseline ST segment depression and previous coronary artery bypass graft surgery. Group 1 patients were older (68+/-13 vs. 63+/-16 years, p = 0.001) and more frequently had a previous myocardial infarction (39% vs. 22%, p = 0.001). Group 2 patients more frequently required intravenous nitroglycerin to control the index episode of chest pain (43% vs. 34%, p = 0.003). Group 2 patients more frequently received aspirin (96% vs. 88%, p = 0.009) during admission and underwent coronary angiography (71% vs. 58%, p = 0.006). More importantly, group 2 patients received oral beta-blockers (p = 0.008), aspirin and coronary angiography (p = 0.001) earlier than group 1 patients and experienced recurrent angina (29% vs. 54%) and myocardial infarction or death less frequently (3% vs. 9%, p = 0.028). CONCLUSIONS: In unstable angina, clinical practice guidelines were associated with greater use of aspirin and coronary angiography and greater use and earlier administration of beta-blockers. Variation in drug use over time was also reduced. Objective improvement in clinical outcome was also noted. Thus, practice guidelines improve the quality of care of patients with unstable angina.

Long-term safety of pravastatin-gemfibrozil therapy in mixed hyperlipidemia.

BACKGROUND: Combined HMG-CoA reductase inhibitor and fibric acid derivative therapy is often necessary for the effective reduction of concentrations of low-density lipoprotein (LDL) cholesterol and triglycerides in patients with mixed hyperlipidemia; however, the potential risk of myopathy has limited the use of these agents. HYPOTHESIS: This study evaluated long-term safety and efficacy of combined pravastatin and gemfibrozil therapy. METHODS: Eighty-three patients with hyperlipidemia were treated with combined pravastatin and gemfibrozil therapy for a median of 44 months (range 9-78 months). Plasma lipids, serum liver function tests, creatinine, and creatinine kinase (CK) levels were measured every 3 to 4 months. RESULTS: One patient developed myalgia with a normal CK level after 4 months of combination therapy. Three patients had transient elevations in CK levels that ranged from 3 to 5 times the upper limits of "normal" and that returned to normal upon repeat testing. Liver function tests did not change significantly from baseline. In a subset of 26 previously untreated patients, combined pravastatin (mean daily dose 22 mg) and gemfibrozil (mean daily dose 1,154 mg) therapy lowered total cholesterol by 25% (p < 0.001), triglycerides by 53% (p = 0.0001), LDL cholesterol by 14% (p = 0.24), and increased high-density lipoprotein (HDL) cholesterol by 20% (p = 0.012). CONCLUSION: Pravastatin and gemfibrozil therapy is safe and efficacious in patients with mixed hyperlipidemia. The long-term safety results are consistent with other reports on follow-up of shorter duration.