Stephen G. Ellis

Treatment of in-stent restenosis is generally considered low risk, and it is not clear if adjunctive use of abciximab is beneficial in this low-risk population. We determined the effect of adjunctive abciximab during percutaneous coronary intervention (PCI) for treatment of in-stent restenosis. Two hundred and ninety-three patients with in-stent restenosis underwent PCI at the Cleveland Clinic between January 1996 and December 1998. Patients undergoing directional atherectomy, laser treatment and brachytherapy were excluded (9 patients). Of the remaining 284, seventy-nine patients received abciximab during PCI and 205 were treated without abciximab. The groups were similar with respect to age, gender, left ventricular function, number of vessels involved, history of prior coronary artery bypass grafting and unstable symptoms at presentation. There were more diabetics, hypertensives, and patients with elevated cholesterol in the abciximab-treated group. At 1-year follow-up, there was a significantly lower incidence of myocardial infarction (2.5% versus 5.3%; p < 0.05) and lower mortality (1.2% versus 5.8%; p < 0.01) in the abciximab-treated group. There was no difference in the incidence of revascularization. The findings of a lowered mortality and myocardial infarction rate with abciximab warrants further prospective study in patients with in-stent restenosis.

Background —The currently used American College of Cardiology/American Heart Association lesion classification scheme dates from an era when balloon angioplasty was the only percutaneous treatment available and major complications occurred in ≈7% of patients. Major advances in treatment options would suggest that this scheme may be outmoded, but the schemes that have been suggested to update lesion classification have not been widely accepted. Methods and Results —Four thousand one hundred eighty-one consecutive patients (6676 lesions) formed a training set and 2146 patients (4231 lesions) formed a validation set treated from 1995 to 1997 at a single center used by 3 hospital groups. Twenty-seven pretreatment candidate variables were analyzed with the use of stepwise proportional logistic regression, and 9 (nonchronic total occlusion with TIMI flow 0, degenerated vein graft, vein graft age >10 years, lesion length ≥10 mm, severe calcium, lesion irregularity, large filling defect, angulated ≥45 degrees plus calcium, and eccentricity) were independently correlated ( P P =0.010 vs old scheme), respectively. Conclusions —Appreciation of these contemporary risk factors for complications of coronary intervention may assist in patient selection and in risk adjustment for comparison of outcomes between providers.

Background Coronary artery bypass surgery (CABG) has been considered the therapy of choice for patients with unprotected left main (ULMT) coronary stenoses. Selected single-center reports suggest that the results of percutaneous intervention may now approach those of CABG. Methods and Results To assess the results of percutaneous ULMT treatment from a wide variety of experienced interventional centers, we requested data on consecutive patients treated after January 1, 1994, from 25 centers. One hundred seven patients were identified who were treated either electively (n=91) or for acute myocardial infarction (n=16). Of patients treated electively, 25% were considered inoperable, and 27% were considered high risk for bypass surgery. Primary treatment included stents (50%), directional atherectomy (24%), and balloon angioplasty (20%). Follow-up was 98.8% complete at 15±8 months. Results varied considerably, depending on presentation and treatment. For patients with acute myocardial infarction, technical success was achieved in 75%, and survival to hospital discharge was 31%. For elective patients, technical success was achieved in 98.9%, and in-hospital survival was strongly correlated with left ventricular ejection fraction ( P =.003). Longer-term event (death, infarction, or bypass surgery) -free survival was correlated with ejection fraction ( P <.001) and was inversely related to presentation with progressive or rest angina ( P <.001). Surgical candidates with ejection fractions ≥40% had an in-hospital survival of 98% and a 9-month event-free survival of 86±5%, whereas patients with ejection fractions Conclusions While results for selected patients appear promising, until early post–hospital discharge cardiac death can be better understood and minimized, percutaneous revascularization of ULMT stenosis should not be considered an alternative to bypass surgery for most patients. When percutaneous revascularization of ULMT is required, directional atherectomy and stenting appear to be the preferred techniques, and follow-up angiography 6 to 8 weeks after treatment is probably advisable.

Background Although an inverse relation between physician caseload and complications has been conclusively demonstrated for several surgical procedures, such data are lacking for percutaneous coronary intervention, and the ACC/AHA guidelines requiring ≥75 cases per year for operator “competency” are considered by some physicians to be arbitrary. Methods and Results From quality-controlled databases at five high-volume centers, models predictive of death and the composite outcome of death, Q-wave infarction, or emergency bypass surgery were developed from 12 985 consecutively treated patients during 1993 through 1994. Models had moderate to high discriminative capacity (area under ROC curves, 0.65 to 0.85), were well calibrated, and were not overfitted by standard tests. These models were used for risk adjustment, and the relations between both yearly caseload and years of interventional experience and the two adverse outcome measures were explored for all 38 physicians with ≥30 cases per year. The average physician performed a mean±SD of 163±24 cases per year and had been practicing angioplasty for 8±5 years. Risk-adjusted measures of both death and the composite adverse outcome were inversely related to the number of cases each operator performed annually but bore no relation to total years of experience. Both adverse outcomes were more closely related to the logarithm of caseload (for death, r =.37, P =.01; for death, Q-wave infarction, or bypass surgery, r =.58, P <.001) than to linear caseload. Conclusions In this analysis, high-volume operators had a lower incidence of major complications than did lower-volume operators, but the difference was not consistent for all operators. If these data are validated, their implications for hospital, physician, and payer policy will require exploration.