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.

Palmaz-Schatz stenting for treatment of focal vein graft stenosis: immediate results and long-term outcome.

OBJECTIVES: This study aimed to evaluate the effectiveness of Palmaz-Schatz stenting for the treatment of saphenous vein graft stenoses. BACKGROUND: Failure of saphenous vein grafts is a common cause of recurrent ischemia after coronary bypass surgery. A second bypass surgery carries more risk than the initial procedure, and balloon angioplasty of vein grafts has yielded disappointing results. It has been hoped that stenting might offer a better treatment option. METHODS: We examined the results of stent placement in 200 saphenous bypass graft lesions consecutively treated with either coronary (n = 146) or biliary (n = 54) Palmaz-Schatz stents. Immediate outcome and clinical follow-up (median 15.5 months) were examined in all patients. To document angiographic outcome, a second angiography was performed at 3 to 6 months for the first 120 consecutively stented lesions and was successfully obtained for 94 (78%). RESULTS: The mean graft age (+/- SD) was 8.7 +/- 4 years. Stent placement was successful in 197 (98.5%) of 200 lesions, reducing the mean diameter stenosis from 74 +/- 14% to 1 +/- 15%. In 164 procedures, there was one in-hospital death (0.6%), no emergency bypass operations and no Q wave myocardial infarctions. There was one acute stent thrombosis (0.6%) but no subacute thromboses. Vascular repair was required after 14 procedures (8.5%), with transfusion in 23 additional cases (14%). Angiographic restenosis (diameter stenosis > or = 50%) at 3- to 6-month follow-up was 17% (95% confidence interval 9% to 25%). By Kaplan-Meier estimates, however, the 2-year second revascularization rate was 49%, reflecting the predominant revascularization performed to treat progressive disease at other sites because failure at the stented site occurred in only 22% of lesions. CONCLUSIONS: Stenting resulted in excellent immediate and long-term angiographic results in this group of focally diseased, older saphenous vein grafts. Despite the high immediate success and very low (17%) angiographic restenosis rate at 6 months, approximately one half of these patients required further revascularization in the following 2 years, mainly because of disease progression at other sites.

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.

Peripheral vascular complications of directional coronary atherectomy and stenting: predictors, management, and outcome.

The hospital course of 688 patients consecutively treated with directional coronary atherectomy (375 procedures) or Palmaz-Schatz stenting (376 procedures) was evaluated to identify incidence, predictors, and outcome of major vascular complications. Major vascular complications (defined as surgical repair, major hematoma, or bleeding with a > 10-point hematocrit decrease requiring transfusion alone, or nonsurgically managed arteriovenous fistula, pseudoaneurysm, retroperitoneal hematoma or femoral neuropathy) occurred in 11.7% of procedures, and were more common after stenting than after directional coronary atherectomy (16.8% vs 6.7%, p < 0.001). In particular, surgical repair was required after 10.1% of stenting procedures, versus 5.1% of directional coronary atherectomies (p < 0.02). Multivariable analysis identified age > 70 years, coronary stenting, female gender, multiple procedures during the index hospitalization, and a low nadir platelet count as independent predictors of major vascular complications (all p < 0.03). In the stent subgroup, excessive anticoagulation, nadir platelet count, hypertension, and sheath removal protocol (other than a same-day, activated clotting time-guided protocol) were all independent predictors of vascular complications. Thus, the overall risk of vascular complications with new device procedures (stenting, directional atherectomy) is greater than that traditionally seen with balloon angioplasty alone, and is determined by patient-related factors, procedure type, and management parameters.

Elevation of the creatine kinase myocardial isoform following otherwise successful directional coronary atherectomy and stenting.

Moderate elevation of creatine kinase (CK) MB isoform is common following otherwise successful percutaneous coronary revascularization, and is frequently interpreted as evidence of a non-Q-wave myocardial infarction. It is not clear, however, whether elevation of CK MB isoform carries sufficient adverse clinical impact to be categorized as a "major" complication. We therefore explored the incidence and clinical consequence of elevation of CK MB isoform in a consecutive series of 565 patients who had otherwise successful directional coronary atherectomy (n = 274) or stenting (n = 291), and were followed for a mean of 2 years. Of this cohort, 11.5% had postprocedure elevation of the CK MB isoform above normal (10 IU/liter). These patients tended to be older and to have undergone atherectomy of a de novo lesion with adverse morphology (thrombus, calcification, eccentricity). Patients with elevation of CK MB isoform following otherwise successful revascularization generally showed no adverse long-term sequelae (death, recurrent myocardial infarction, repeat revascularization) compared with patients without elevation of CK MB isoform. Only 2.3% of the patients who had CK MB isoform release > 50 IU/liter demonstrated a trend (p = 0.08) toward decreased late survival, compared with patients without CK MB isoform elevation. While minor CK MB isoform elevation is common (11.5%) after successful coronary stenting or directional atherectomy, it generally has no adverse clinical consequences, and should not be considered a major complication.(ABSTRACT TRUNCATED AT 250 WORDS)

Effect of prior coronary restenosis on the risk of subsequent restenosis after stent placement or directional atherectomy.

Lesions that have developed restenosis after a prior intervention may be more likely to develop restenosis after subsequent percutaneous interventions. To determine if this is an independent effect, the clinical characteristics and immediate angiographic outcomes of 179 prior restenosis lesions were compared with those of 254 primary lesions after stenting or directional atherectomy. Six-month angiographic follow-up was obtained for 79% of successfully treated lesions. Univariable and multivariable logistic regression was used to determine how binary restenosis (defined as > or = 50% diameter stenosis at follow-up) was influenced by postprocedure luminal diameter, left anterior descending artery location, diabetes mellitus, as well as prior restenosis. At 6-month follow-up, prior restenosis lesions had a significantly smaller late diameter (1.77 vs 2.18 mm, p < 0.001), more absolute late loss (1.35 vs 1.14 mm, p = 0.051), a higher loss index (0.58 vs 0.45, p < 0.02), and a higher binary restenosis rate (37.3% vs 24.4%, p = 0.01). Whereas univariable analysis revealed that left anterior descending artery location, diabetes mellitus, postprocedure luminal diameter < 3.1 mm, and prior restenosis were each strong predictors of binary restenosis (all p < 0.02), multivariable analysis showed that after adjustment for left anterior descending artery location, diabetes, and postprocedure luminal diameter, prior restenosis was no longer an independent predictor of restenosis (odds ratio 1.57, 95% confidence interval 0.95-2.60, p = 0.073). In conclusion, although prior restenosis lesions do show more restenosis than primary lesions, much of this effect is due to preselection of a population enriched in other known factors that predispose to 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.

Comparative analysis of early and late angiographic outcomes using two quantitative algorithms in the Balloon versus Optimal Atherectomy Trial (BOAT).

Although substantial intersystem variability has been shown among several commercially available quantitative angiographic (QA) analysis algorithms, no previous study has compared the angiographic findings using 2 different QA systems performed at the same central angiographic laboratory. The purpose of this study was to compare the early and late QA results obtained with the CMS (MEDIS) and ARTREK (ImageComm) QA systems in the Balloon versus Optimal Atherectomy Trial. Directional atherectomy (n = 496) or balloon angioplasty (n = 490) was performed in 986 patients; late QA follow-up was available in 767 patients (77.7%). QA analysis was performed by 2 independent observers using the CMS and ARTREK systems. Correlation between the 2 QA systems for baseline measurements was good (Pearson's R = 0.78), although the CMS system resulted in larger baseline reference diameter (RD) (3.22 +/- 0.45 vs 3.07 +/- 0.40 mm; p <0.0001) and baseline minimal lumen diameters (MLD) (1.05 +/- 0.35 vs 0.92 +/- 0.32; mm p <0.0001) than the ARTREK system. The final and follow-up RD (+0.17 and +0.11 mm, respectively) were also larger using the CMS system. In contrast, the final and follow-up measurements of MLD and percent diameter stenosis were not significantly different using the 2 QA systems. The QA system did not affect the ability to detect a difference in restenosis rates (>50% follow-up diameter stenosis) between the 2 treatment groups (CMS, directional atherectomy [31.8%]; balloon angioplasty [40.5%]; p = 0.013 and ARTREK, directional atherectomy [33.9%], balloon angioplasty [41.3%]; p = 0.036). Only lesion irregularity contributed to the difference in baseline measurements of MLD and percent diameter stenosis. We conclude that important differences in measurements of RD, baseline MLD, and percent diameter stenosis were noted using the CMS and ARTREK systems. Both systems, however, were able to detect a treatment benefit associated with directional atherectomy in BOAT. The comparability of other angiographic systems will require similar evaluation in other studies.

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.

Methods to limit reinfarction and ischemia after thrombolytic therapy.

Thrombolytic therapy has greatly influenced the long-term outcome of thousands of patients suffering AMI. The incidence of reocclusion and recurrent ischemia are continuing problems that need to be confronted if thrombolytic therapy is to have its full impact on the care of these patients. Clinical studies are providing more information on the best adjunctive therapy to accompany thrombolysis. Nursing has the potential to improve the outcome of patients by assuring the methods of preventing reocclusion we have available are skillfully implemented. If reocclusion occurs, nurses can identify the event and initiate treatment before substantial myocardium is lost. In the future, noninvasive methods to identify which patients will reocclude may be available. Thrombolytic "cocktails" or medications such as antiplatelet antibodies may be useful and may abolish reocclusion completely.

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.

Bleeding complications in the patient with cardiac disease following thrombolytic and anticoagulant therapies.

Thrombolytic and anticoagulant therapies are used frequently in the cardiac patient. Bleeding complications and other coagulation defects, such as heparin-induced thrombocytopenia (HITP), can occur following the administration of these drugs. Nurses caring for the cardiac patient need to be aware of the potential for bleeding and know how to safely and effectively care for the patient who experiences a bleeding event.

Thrombolytic therapy: a review of the literature on streptokinase and tissue plasminogen activator with implications for practice.

Thrombolytic therapy has had a major impact on the outcome of AMI patients. For the first time, medicine has a means of interrupting the process of myocardial necrosis and limiting the potential size of the infarction. For those patients who can receive thrombolytic therapy and who seek medical attention within the first few hours of infarction, the impact of successful thrombolysis on ventricular function is most substantial. Also, in some patients with continuing symptoms, benefit may be seen beyond the 3- to 6-hour time limit. However, the therapy is not yet perfect. No thrombolytic agent has consistently been able to attain reperfusion in more than 75 per cent of those treated. There are significant bleeding risks associated with these medications, and the best adjunctive therapy to prevent reocclusion has not been established. Nursing has also been significantly affected by the addition of thrombolysis to the coronary care and emergency units. The role of identifying appropriate patients, caring for the patient during thrombolysis, and dealing with complications of the therapy has added a new dimension to the nursing care of the infarction patient. In the era of nursing shortages, these additional tasks may be difficult to welcome with enthusiasm. However, when the possibility of discharging a patient from the coronary care unit with little or no myocardial damage is entertained, the additional burden of thrombolytic therapy seems well worth the effort.

A predictive method for estimating the late angiographic results of coronary intervention despite incomplete ascertainment.

BACKGROUND: Investigations of coronary restenosis typically use late (4-6-month) angiographic end points. Since only 50-80% of patients generally undergo repeat angiography, however, restenosis for the population as a whole is usually estimated by assuming that nonrestudied and restudied patients are similar. If restudied and nonrestudied patients differ, incomplete angiographic follow-up can yield an erroneous estimate of restenosis. No suitable method has yet been devised to detect and correct these errors. METHODS AND RESULTS: We studied the clinical indications for angiographic restudy in an actual series of 301 treated lesions in 267 consecutive patients who underwent either Palmaz-Schatz stenting (126 patients) or directional coronary atherectomy (141 patients) at our institution. While only 249 (83%) treated segments underwent 4-6-month angiographic follow-up, all had clinical follow-up that described whether specific indications for restudy were present. Patients who had no clinical indications for such restudy were designated as having elective follow-up. In contrast, patients who had recurrent symptoms or positive exercise studies and were scheduled for repeat angiography at the independent recommendation of their referring cardiologist were designated as having nonelective follow-up. Mean late percent stenosis or binary restenosis rate (> 50% diameter stenosis) was determined for elective versus nonelective lesions that underwent follow-up angiography. These values were then used to input the behavior of the nonrestudied lesions according to their clinical status. From these imputations, a "predictive" model was developed to estimate the mean restenosis values that would have been found had the entire population actually undergone angiographic follow-up. Comparisons between the estimates of this predictive method and the traditional method that uses only the actual angiographic data demonstrate how alterations in various parameters influence the selection bias caused by incomplete angiographic follow-up. Of the 301 lesions available for follow-up, 100 of the 103 (97%) nonelective versus 149 of the 198 (75%, p < 0.001) elective lesions actually underwent angiographic follow-up. Mean follow-up percent stenosis (50% versus 27%) and the binary restenosis rate (53% versus 13%) differed significantly for the nonelective versus the elective lesions, respectively (both p < 0.001). Even at the fairly high (83%) angiographic follow-up rate, elective versus nonelective status was thus a confounder that caused differences between the restenosis rate estimated by the traditional (29.1%; 95% CI: 23.4, 34.7) and the predictive methods (26.3%; 95% CI: 21.4, 31.1). Larger (and even statistically significant) differences may be present under the conditions that exist in many current studies. CONCLUSIONS: Restenosis trials with < 90% angiographic follow-up suffer from selection bias. Traditional methods that analyze only the restudied patients fail to correct for the important confounding influence of the clinical status of the nonrestudied patients. By using this readily available clinical information about the nonrestudied patients, a predictive method may be developed that provides a closer estimate of the true restenosis behavior for the population as a whole.

Inter-series differences in the restenosis rate of Palmaz-Schatz coronary stent placement: differences in demographics and post-procedure lumen diameter.

Restenosis rates following Palmaz-Schatz stenting vary between 13 and 36%. To determine whether the nearly three-fold interseries difference in restenosis rates reflects systematic factors (demographic and procedural variables such as post-treatment lumen diameter) rather than random variation, we pooled 486 lesions treated with the Palmaz-Schatz coronary stent in the U.S. Multicenter Registry (n = 259) with the single-center Beth Israel Hospital experience (n = 227) and analyzed the combined series using a continuous geometric model of restenosis. A greater proportion of lesions (66 vs. 50%; P < 0.001) in the Multicenter cohort represented restenosis after a prior intervention. The Multicenter experience also showed a smaller minimum lumen diameter following stent placement (2.61 vs. 3.43 mm; P < 0.001), higher post-stent percent stenosis (16 vs. -2%; P < 0.001), and less acute gain (1.79 vs. 2.67 mm; P < 0.001) than lesions treated in the Beth Israel cohort. At 6-month follow-up, the angiographic restenosis rate (> or = 50% diameter stenosis) was significantly higher in the Multicenter group (35 vs. 27%; P = 0.05), despite the development of less absolute late loss (0.96 vs. 1.32 mm; P < 0.001). Multivariable modeling, however, showed that the only independent predictors of restenosis were a post-procedure lumen diameter < 2.80 mm (odds ratio = 1.57; P = 0.04), diabetes mellitus (odds ratio = 3.55; P < 0.001), and prior restenosis (odds ratio = 1.84; P = 0.008).(ABSTRACT TRUNCATED AT 250 WORDS)

Final results of the Balloon vs Optimal Atherectomy Trial (BOAT)

BACKGROUND: Previous directional coronary atherectomy (DCA) trials have shown no significant reduction in angiographic restenosis, more in-hospital complications, and higher 1-year mortality than conventional balloon angioplasty (percutaneous transluminal coronary angioplasty [PTCA]). DCA, however, has subsequently evolved toward a more "optimal" technique (larger devices, more extensive tissue removal, and routine postdilation to obtain diameter stenosis <20%). METHODS AND RESULTS: The Balloon vs Optimal Atherectomy Trial (BOAT) was conducted to evaluate whether optimal DCA provides short- and long-term benefits compared with balloon angioplasty. One thousand patients with single de novo, native vessel lesions were randomized to either DCA or PTCA at 37 participating centers. Lesion success was obtained in 99% versus 97% (P=.02) of patients to a final residual diameter stenosis of 15% versus 28% (P<.0001) for DCA and PTCA, respectively, the latter including stents in 9.3% of the patients. There was no increase in major complications (death, Q-wave myocardial infarction, or emergent coronary artery bypass graft surgery [2.8% versus 3.3%]), although creatine kinase-MB >3X normal was more common with DCA (16% versus 6%; P<.0001). Angiographic restudy (in 79.6% of eligible patients at 7.2+/-2.6 [median, 6.9] months) showed a significant reduction in the prespecified primary end point of angiographic restenosis by DCA (31.4% versus 39.8%; P=.016). Clinical follow-up to 1 year showed nonsignificant 13% to 17% reductions in the DCA arm of the study for mortality rate (0.6% versus 1.6%; P=.14), target-vessel revascularization (17.1% versus 19.7%; P=.33), target-site revascularization (15.3% versus 18.3%; P=.23), and target-vessel failure (death, Q-wave myocardial infarction, or target-vessel revascularization, 21.1% versus 24.8%; P=.17). CONCLUSIONS: Optimal DCA provides significantly higher short-term success, lower residual stenosis, and lower angiographic restenosis than conventional PTCA, despite failing to reach statistical significance for reducing late clinical events compared with PTCA with stent backup.

'Optimal' directional coronary atherectomy: final results of the Optimal Atherectomy Restenosis Study (OARS).

BACKGROUND: Previous clinical trials of directional coronary atherectomy (DCA) have failed to show significant improvement in early or late outcomes compared with balloon angioplasty (PTCA). The present study tested the hypothesis that more aggressive "optimal" atherectomy could be performed safely to produce larger initial lumen diameters and a lower late restenosis rate. METHODS AND RESULTS: The present study was a prospective multicenter registry of consecutive patients undergoing optimal DCA of de novo or restenotic lesions in 3.0- to 4.5-mm native coronary arteries. Optimal DCA was defined as using a 7F atherectomy device and adjunctive PTCA if necessary to achieve a < 15% residual stenosis. Six-month angiographic and 1-year clinical follow-up was planned in all patients. A total of 199 patients with 213 lesions met eligibility criteria for enrollment. Short-term procedural success was achieved in 97.5%, with a major complication rate (death, emergency bypass surgery, or Q-wave myocardial infarction [MI]) of 2.5%. There were no early deaths. Non-Q-wave MI (CK-MB > 3 times normal) occurred in 14% of patients. Mean reference vessel diameter was 3.28 mm. Mean diameter stenosis was reduced from 63.5% to a final stenosis of 7%. Late 1-year clinical follow-up revealed one cardiac death and a target lesion revascularization rate of 17.8%. The angiographic restenosis rate at 6 months was 28.9%, with the major predictor of restenosis being a smaller postprocedure lumen diameter. CONCLUSIONS: Optimal DCA produced a low residual percent diameter stenosis and a lower restenosis rate than seen in previous trials without an increase in early or late major adverse events.