Long-term results of directional coronary atherectomy: predictors of restenosis.

OBJECTIVES: This study was performed to obtain better understanding of the long-term clinical efficacy of directional coronary atherectomy. BACKGROUND: Although this procedure yields favorable acute results, its acceptance has been limited by the perception that late results (that is, freedom from restenosis) are no better than those of conventional angioplasty. METHODS: A total of 225 atherectomies performed in 190 patients between August 1988 and July 1991 were examined. Minimal lumen diameter of the treated segments was measured on angiograms obtained before, after and 6 months after intervention. RESULTS: Although most lesions (97%) had one or more characteristics predictive of unfavorable short- or long-term results after conventional angioplasty, atherectomy was successful in 205 lesions (91%) with a mean residual stenosis of 7 +/- 16%. After subsequent balloon angioplasty in 16 unsuccessful atherectomy attempts, procedural success was 98%. There were no deaths or Q wave myocardial infarctions, and one patient (0.5%) underwent emergency bypass surgery. Six-month angiographic follow-up was obtained in 77% of the eligible patients. The overall angiographic restenosis rate was 32%. Predictors of a lower restenosis rate included a postprocedure lumen diameter > 3 mm (24% vs. 39%, p = 0.047), serum cholesterol < or = 200 mg/dl (18% vs. 40%, p = 0.018) and recent myocardial infarction (16% vs. 37%, p = 0.034). Life-table analysis showed a 2% mortality rate and a 26% incidence of other events (myocardial infarction, repeat revascularization) within the 1st year. The annual 5% mortality rate and 7% incidence of other events during years 2 and 3 were related in large part to the existence or progression of disease at other locations. CONCLUSIONS: Six-month angiographic follow-up of patients who underwent directional coronary atherectomy during the 1st 3 years of our experience shows an overall restenosis rate of 32%, with lower rates in patients with a postatherectomy lumen diameter > or = 3 mm, cholesterol level < or = 200 mg/dl or a recent myocardial infarction. Few if any events relating to the site of atherectomy developed after the 1st year of follow-up.

Angiographic and clinical outcome of intracoronary stenting: immediate and long-term results from a large single-center experience.

OBJECTIVES: The purpose of this study was to determine the immediate and long-term angiographic and clinical results of coronary stenting. BACKGROUND: Although preliminary trials of endovascular stenting have demonstrated promising results, lack of long-term follow-up has limited the critical evaluation of the role of coronary stenting in the treatment of obstructive coronary artery disease. METHODS: A total of 250 procedures using the Palmaz-Schatz stent, performed in 220 patients between June 1988 and July 1991, were examined. Minimal lumen diameter of the treated segments was measured on angiograms obtained before, after and 6 months after intervention. RESULTS: Stent placement was successful in 246 (98%) of 250 lesions, reducing diameter stenosis from 77% to -2.5%. There were no deaths or Q wave myocardial infarctions. One patient (0.4%) required emergency bypass surgery and one (0.4%) developed subacute thrombosis. Femoral vascular complications occurred in 36 patients (16%). Six-month angiographic follow-up was obtained in 91% of eligible patients. The overall angiographic restenosis rate (stenosis greater than or equal to 50%) was 25%. By univariable analysis, the rate of restenosis was significantly higher for stents in the left anterior descending versus the right coronary artery (44% vs. 12%; p = 0.002); in diabetic patients (56% vs. 20%; p = 0.006), and in vessels with post-stent lumen diameter less than 3.31 mm (34% vs. 16%; p = 0.05). Stenting of the left anterior descending artery was the strongest predictor (p = 0.01) of restenosis in a multivariable model. Total survival was 97% and event-free survival (freedom from death, myocardial infarction or revascularization) was 70% at 36 months. CONCLUSIONS: Palmaz-Schatz stents can be placed successfully with a low incidence of major complications. The angiographic restenosis rate was 25%, and 70% of patients remained free of cardiovascular events at 3 years. Diabetes, small postprocedure lumen diameter and stenting of the left anterior descending artery are associated with higher rates of restenosis.

Frequency and outcome of chest pain after two new coronary interventions (atherectomy and stenting).

Between June 1988 and July 1991, 464 new device interventions (Palmaz-Schatz stent or Simpson directional atherectomy) were performed in 410 patients. Chest pain occurred within 72 hours after the procedure in 94 patients (23%). All patients were evaluated with electrocardiograms and cardiac isoenzymes on the day after the procedure, and urgent repeat coronary angiography was performed in 29 chest pain patients (31%). Whereas all 14 patients with abnormal findings on repeat angiography had electrocardiographic changes, 6 of the 20 restudied patients (30%) with electrocardiographic changes had no angiographic explanation for chest pain. Non-Q-wave myocardial infarction occurred in 22 patients (5%) (10 of 35 [29%] with chest pain and electrocardiographic changes, 3 of 44 [7%] with chest pain and no electrocardiographic change, and 9 of 316 [3%] without chest pain). Factors associated with chest pain after new device intervention included a decreased residual percent stenosis (p = 0.05), incomplete revascularization (p = 0.005) and the presence of multivessel disease (p = 0.001). Vessel dissection after stenting but not atherectomy was associated with postprocedure chest pain. Chest pain is common (23%) after new device intervention. Electrocardiographic changes are a sensitive marker of angiographic abnormality and confer a higher risk of non-Q-wave myocardial infarction, but no increase of in-hospital mortality. Determinants of postprocedure chest pain are lower residual percent stenosis, incomplete revascularization and the presence of multivessel disease. Patients with chest pain but no electrocardiographic changes early after successful stent placement or atherectomy need not routinely undergo urgent recatheterization.

Acute and long-term results of coronary stents and atherectomy in women and the elderly.

AIM: To determine the efficacy of new coronary interventions in women and the elderly. PATIENTS AND METHODS: We studied 504 patients who underwent a total of 567 procedures, comprising 275 directional coronary atherectomy and 292 Palmaz-Schatz stents over a 2 1/2 year period; 18% were women and 23% were aged > or = 70 years (elderly). RESULTS: High rates of success were obtained with these procedures in women and the elderly, although the rates were lower in women than in men (89 versus 96%, P = 0.005), and similarly lower in the elderly than in younger patients (91 versus 96%, P = 0.06). In addition to the lower success rates, there was a higher incidence of procedure-related non-Q myocardial infarction and vascular complications in both the women and the elderly, independently. The degree of angiographic restenosis (> or = 50% diameter stenosis), however, was similar in women (36 versus 28% in men, P = 0.22) and in the elderly (28 versus 29% in patients ages < 70 years, P = 0.8). There were no sex-related differences in survival, late myocardial infarction, or repeat revascularization. In the elderly, although the incidence of repeat revascularization was not increased, there was a decrease in late survival (P < 0.001) and an increase in the incidence of late myocardial infarction (P = 0.02), probably reflecting the presence of other co-morbid variables. CONCLUSION: Both directional coronary atherectomy and coronary stenting can be performed safely and effectively in women and the elderly with good long-term clinical results, despite a somewhat lower rate of success and similarly higher rates of acute complications.

Highlights from the past decade of interventional device research.

The last decade of research and implementation in the interventional device arena has brought about an unprecedented improvement in the ability to safely and effectively treat coronary artery disease. This explosion of technology is not over; there remain questions to be answered and patient subsets whose care can be improved upon. Our understanding of the restenosis process has helped guide research in the appropriate directions, and by 2010 restenosis after a coronary intervention will most likely be of historic interest only. With the addition of thrombus removal catheters and protection devices, treatment of problematic high-risk lesions will also be improved upon. The effect of these devices on acute patient care and long-term outcomes, including quality of life, will be profound.