[The immediate and long-term utility of rotational atherotomes: extraction atherectomy and rotational ablation atherectomy].
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The present study evaluated the acute and follow-up results of stenting following aggressive rotational atherectomy compared with stenting following less aggressive rotational atherectomy. Recent work has demonstrated that stenting following rotational atherectomy is a promising strategy for complex and calcified lesions. However, there is little information available regarding the optimal procedural technique of rotational atherectomy to be employed before stent implantation. Between May 1995 and February 1997, 162 lesions in 126 patients were stented following rotational atherectomy because of the presence of severe calcification on fluoroscopy or intravascular ultrasound (95%). The lesions were divided as to whether aggressive rotational atherectomy was performed or not. Aggressive rotational atherectomy, defined as the use of a final burr size > or =2.25 mm and/or final burr/vessel ratio > or =0.8, was performed in 56 lesions. A less aggressive rotational atherectomy strategy was performed in 106 lesions. Procedural Q-wave (8.9% vs. 1.9%, P<0.05) and non-Q-wave (11% vs. 1.9%, P<0.05) myocardial infarctions were observed more frequently after aggressive rotational atherectomy; there was no significant difference in the incidence of other procedural complications. Although there was no significant difference in minimal lumen diameter after the procedure (3.11+/-0.68 vs. 2.99+/-0.48 mm, NS), at follow-up a greater minimal lumen diameter was observed in the lesions treated with aggressive rotational atherectomy compared to those treated with less aggressive rotational atherectomy (2.12+/-1.31 vs. 1.56+/-0.89 mm, P<0.01). Restenosis rates were 50.0% in the lesions treated without aggressive rotational atherectomy and 30.9% in those treated with aggressive rotational atherectomy (P<0.05). There was no significant difference in the incidence of restenosis with a focal pattern between the two groups (25.0% vs. 21.4%, NS). In contrast, restenosis with a diffuse pattern was lower in lesions treated with aggressive rotational atherectomy than in those without aggressive rotational atherectomy (9.5% vs. 25.0%, P<0.05). Aggressive rotational atherectomy followed by stenting is a promising strategy to reduce the restenosis rate in calcified lesions. However, the aggressive strategy is associated with an increased risk of procedural myocardial infarction.
OBJECTIVES: The purpose of this study was to determine whether residual stenoses after excimer laser angioplasty and atherectomy were due to inefficient tissue ablation/removal or to undersized devices. BACKGROUND: Significant residual stenoses are commonly observed after use of laser and atherectomy devices. It is not known whether these residual stenoses are due to inefficient or undersized devices. METHODS: To determine the relative contribution of these factors, the minimal lumen diameter, percent diameter stenosis and normal reference diameter were measured immediately before and after coronary interventions in 696 lesions, including transluminal extraction atherectomy, high speed mechanical rotational atherectomy, excimer laser angioplasty and conventional balloon angioplasty. The ratio of the diameter of the device to the normal reference diameter (D/A, a measure of device sizing) and the ratio of the residual lumen diameter after use of the device to the device diameter (RLD/D, a measure of the efficiency of lumen enlargement) were calculated. RESULTS: Baseline diameter stenoses were similar for all interventions. The percent diameter stenoses were greater immediately after extraction atherectomy (60 +/- 21%), rotational atherectomy (54 +/- 23%) and excimer laser angioplasty (61 +/- 18%) compared with balloon angioplasty (26 +/- 12%, p < 0.001). The D/A ratio was smaller after extraction atherectomy (0.63 +/- 0.14), rotational atherectomy (0.59 +/- 0.17) and excimer laser angioplasty (0.51 +/- 0.11) compared with balloon angioplasty (1.05 +/- 0.13, p < 0.001). The RLD/D ratio was similar after extraction atherectomy (0.73 +/- 0.24) and balloon angioplasty (0.71 +/- 0.11) but was greater after rotational atherectomy (0.92 +/- 0.16, p < 0.001) and excimer laser angioplasty (0.85 +/- 0.30, p < 0.01) compared with balloon angioplasty. CONCLUSIONS: Residual stenoses after extraction atherectomy, rotational atherectomy and excimer laser angioplasty were more severe than after balloon angioplasty but were due to undersized devices (low D/A ratio), not to inefficient devices (low RLD/D ratio). Rotational atherectomy and excimer laser angioplasty were more efficient (higher RLD/D) than balloon angioplasty, whereas extraction atherectomy and balloon angioplasty were similar.
OBJECTIVES: This study compared and contrasted the randomized trials of directional atherectomy and coronary angioplasty for de novo native coronary artery lesions. BACKGROUND: The results of two randomized trials, the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT) and the Canadian Coronary Atherectomy Trial (CCAT), comparing initial and intermediate-term outcome of directional coronary atherectomy and conventional coronary angioplasty in de novo native vessels, have been reported. In CAVEAT any coronary artery segment that could be treated by either technique was included; in CCAT only nonostial proximal left anterior descending coronary artery stenoses were studied. METHODS: The primary end point was 6-month angiographic restenosis. Clinical outcome end points at 6 months included death, myocardial infarction, emergency bypass surgery and abrupt closure. RESULTS: Initial angiographic success rates were significantly improved with directional coronary atherectomy compared with conventional angioplasty (89% vs. 80% for CAVEAT; 98% vs. 91% for CCAT). Also, the initial improvement in minimal lumen diameter and final immediate postprocedural residual diameter stenosis were better with atherectomy. In CCAT, there was no difference in initial complications; in CAVEAT, non-Q wave myocardial infarction rates and abrupt closure were increased with atherectomy. Despite improved success rates and better lumen achieved with atherectomy, in CCAT there was no difference in angiographic restenosis (46% for directional atherectomy vs. 43% for angioplasty). In CAVEAT, in a prespecified subset analysis involving the proximal left anterior descending coronary artery, restenosis was both significantly and clinically less for directional atherectomy (51% vs. 63%). For non-left anterior descending coronary artery segments, there was no difference. CONCLUSIONS: These studies document the difference between achievement of an excellent initial angiographic result and the longer term issue of clinical restenosis. Widespread use of directional coronary atherectomy to treat lesions that would be well treated by angioplasty in an attempt to decrease restenosis rates substantially does not appear indicated by the data. In individual lesions, directional atherectomy should be selected with the view toward optimizing initial results. Further trials are needed to determine whether more aggressive or better targeted directional coronary atherectomy may improve not only the initial gain but the long-term outcome as well.
OBJECTIVES: This study sought to determine whether preprocedural lesion morphology differentially affects the outcome of directional coronary atherectomy versus standard balloon angioplasty. BACKGROUND: Despite previous studies (Canadian Coronary Atherectomy Trial [CCAT]/Coronary Angioplasty Verus Excisional Atherectomy Trial [CAVEAT]), directional coronary atherectomy continues to be recommended on the basis of lesion-specific features, although the validity of this approach has never been proved. METHODS: A retrospective, subgroup analysis of the CCAT data base (group average +/- SD) was performed. RESULTS: In the long term (6 months), both procedures were equally successful in the proximal left anterior descending coronary artery (directional atherectomy 0.62 +/- 0.70 mm vs. coronary angioplasty 0.70 +/- 0.72 mm, p = NS), with atherectomy tending to perform best in relatively "simple" lesions (American College of Cardiology/American Heart Association [ACC/AHA] type A: atherectomy 0.57 +/- 0.70 mm vs. angioplasty 0.50 +/- 0.77 mm; ACC/AHA type B1: atherectomy 0.65 +/- 0.68 mm vs. angioplasty 0.60 +/- 0.68 mm) and those with moderate dystrophic calcification (atherectomy 0.79 +/- 0.56 mm vs. angioplasty 0.45 +/- 0.73 mm). Although greatest minimal lumen diameter gains were seen in larger (> 3 mm) coronary arteries (atherectomy 0.76 +/- 0.62 mm vs angioplasty 0.80 +/- 0.72 mm, p = NS) and those with severe obstruction (preprocedural minimal lumen diameter < 1.0 mm: atherectomy 0.80 +/- 0.62 mm vs. angioplasty 0.84 +/- 0.63 mm, p = NS), neither technique was superior, and eccentric stenoses (symmetry index < 0.5) had similar outcomes (atherectomy 0.59 +/- 0.49 mm vs. angioplasty 0.62 +/- 0.65 mm, p = NS). CONCLUSIONS: These data refute many preconceptions regarding the choice of directional coronary atherectomy on the basis of anatomic criteria.
Directional coronary atherectomy was developed with the hope that it would lower the risk of acute closure and restenosis by leaving a larger smoother lumen and fewer dissections than angioplasty. To evaluate this hypothesis, we compared the clinical and angiographic results of directional coronary atherectomy with those of percutaneous transluminal coronary angioplasty in well-matched groups. We studied 126 consecutive atherectomies and 127 angioplasties performed on similar lesions. Procedural results were evaluated with regard to dissections, complications, acute closure, and residual stenosis. Each patient's clinical course was followed, and each patient was contacted at 6 months for evaluation of recurrent angina, need for repeat catheterization, and angiographic rate of restenosis. Baseline clinical and angiographic characteristics of the two groups were well matched and met the criteria established as being appropriate for atherectomy. The angiographic success rate was 98% after angioplasty and 99% after atherectomy. There were fewer dissections after atherectomy (13%) compared with the number after angioplasty (22%; p = 0.03). Residual stenosis was 8.3 +/- 9% after atherectomy compared with 15 +/- 12% after angioplasty (p = 0.0001). However, there were more complications after atherectomy (p = 0.03). There was no significant difference between the two groups in the recurrence rate of angina or in the angiographic restenosis rate at 6 months. It was concluded that when lesion characteristics and vessel size are appropriate for atherectomy, the procedural success rate of either atherectomy or angioplasty is extremely high. Although atherectomy leads to a larger residual lumen and fewer dissections, the complication rate after atherectomy is higher than that after angioplasty. There is a trend toward more occlusions after atherectomy.(ABSTRACT TRUNCATED AT 250 WORDS)
BACKGROUND: Transluminal extraction coronary (TEC) atherectomy is a relatively new device that has recently been approved by the Food and Drug Administration. Because of its ability to aspirate clot and atheromatous material, TEC atherectomy may be useful in patients with stenoses in saphenous vein bypass grafts. METHODS AND RESULTS: TEC atherectomy was performed on 158 saphenous vein graft lesions in 146 consecutive patients with a mean age of 65 +/- 8 years (78% men). Clinical indications for atherectomy included stable angina (37%), unstable angina (54%), and postinfarction angina after recent (< 1 month) myocardial infarction (8%). Patients with acute myocardial infarction and target vessels < 2 mm in diameter were excluded. The mean age of the bypass graft was 8.3 +/- 3.0 years, and 17% were diffusely diseased and degenerated. Complex lesion morphology included total occlusion (6%), eccentricity (64%), ulceration (18%), and thrombus (28%). The TEC atherectomy cutter was successfully advanced through 144 lesions (91%), but technical failures occurred in 14 lesions (9%), and these were subsequently managed by successful balloon angioplasty. Quantitative angiography revealed an increase in lumen diameter from 0.9 +/- 0.5 mm, to 1.5 +/- 0.7 mm after TEC atherectomy, to 2.3 +/- 0.8 mm after percutaneous transluminal coronary angioplasty (PTCA) (P < .001), which corresponded to decreases in diameter stenosis from 75 +/- 14%, to 58 +/- 20% after TEC atherectomy, to 36 +/- 22% after PTCA (P < .001). Device success was achieved in 39.2% (post-TEC atherectomy decrease in diameter stenosis > or = 20%), and procedural success was achieved in 84% (final diameter stenosis < 50% in the absence of a major complication). Angiographic complications were evident in 33 lesions (20.7%) immediately after TEC atherectomy and in 8 lesions (5%) after PTCA, including distal embolization (11.9%), no-reflow (8.8%), and abrupt closure (5.0%), but no perforations. Adjunctive PTCA (and other medical therapy) successfully managed 61% of angiographic complications. Serious clinical complications included in-hospital death in 3 patients (2.0%), emergency bypass surgery in 1 patient who died (0.7%), Q wave myocardial infarction in 3 patients (2.0%), non-Q wave myocardial infarction in 4 patients (2.7%), vascular injury requiring surgical repair and/or blood transfusion in 9 patients (6.1%), and hemorrhagic cerebral infarction in 4 patients (2.7%). Using a composite clinical end point defined as in-hospital death, emergency bypass surgery, or myocardial infarction, the strongest independent correlate (P < .001) of a severe clinical complication was the development of one or more serious angiographic complications (no-reflow, distal embolization, or abrupt closure) immediately after TEC atherectomy. Complete clinical follow-up was available in 118 (92%) of 128 eligible patients at an interval of 6.0 +/- 2.5 months after discharge. Late cardiac outcome included recurrent angina treated with medical therapy (18%), repeat percutaneous intervention on the original target lesion (26%), repeat coronary artery bypass surgery (5%), Q wave myocardial infarction (4%), and late cardiac death (7%). Angiographic follow-up in 105 (80%) of 132 eligible lesions revealed a restenosis rate of 69% (defined as a diameter stenosis > 50%), including 30 lesions (29%) with total occlusion of the original lesion. CONCLUSIONS: In patients with stenoses in saphenous vein bypass grafts, TEC atherectomy is limited by the frequent need for adjunctive balloon angioplasty to achieve adequate lumen enlargement and to manage TEC atherectomy-induced complications. Although the incidence of serious clinical complications is similar to that of other percutaneous interventions in vein grafts, there is a high incidence of restenosis and late vessel occlusion. Prospective randomized studies are needed to determine the best revascularization strategy for high-risk patients with old degenerated vein
BACKGROUND: Directional coronary atherectomy and percutaneous transluminal coronary angioplasty have both been used in symptomatic patients with coronary saphenous vein bypass graft stenoses. The relative merits of plaque excision and removal versus balloon dilatation remain uncertain. We compared outcomes after directional coronary atherectomy or angioplasty in patients with de novo bypass graft stenoses. METHODS AND RESULTS: Fifty-four North American and European sites randomized 305 patients with de novo vein graft lesions to atherectomy (n = 149) or angioplasty (n = 156). Quantitative coronary angiography at a core laboratory assessed initial and 6-month results. Initial angiographic success was greater with atherectomy (89.2% versus 79.0%), as was initial luminal gain (1.45 versus 1.12 mm, P < .001). Distal embolization was increased with atherectomy (P = .012), and a trend was shown toward more non-Q-wave myocardial infarction (P = .09). Although the 6-month net minimum luminal diameter gain was 0.68 mm for atherectomy and 0.50 mm for angioplasty, the restenosis rates were similar, 45.6% for atherectomy and 50.5% for angioplasty (P = .491). At 6 months, there was a trend toward decreased repeated target-vessel interventions for atherectomy (P = .092); in addition, 13.2% of patients treated with atherectomy versus 22.4% of the angioplasty patients (P = .041) required repeated percutaneous intervention of the initial target lesion. CONCLUSIONS: Atherectomy of de novo vein graft lesions was associated with improved initial angiographic success and luminal diameter but also with increased distal embolization. There was no difference in 6-month restenosis rates, although primary atherectomy patients tended to require fewer target-vessel revascularization procedures.
BACKGROUND: Directional atherectomy is a frequently used percutaneous revascularization strategy, but its long-term outcomes have not previously been compared with those of balloon angioplasty in a prospective trial. METHODS AND RESULTS: The 1012 patients enrolled in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT I) were followed for at least 1 year after randomization. Analyses of predetermined end points were performed, including a detailed analysis of the 14 patients who died. At 1 year, 11 patients had died in the atherectomy group compared with 3 in the angioplasty group (2.2% versus 0.6%, P = .035), with an excess of out-of-hospital deaths (2.2% versus 0.2%, P = .01) and late cardiac deaths (1.6% versus 0%, P = .01). Univariate predictors of death included age, abrupt closure, periprocedural enzyme elevation, and peripheral vascular complications. There was no evidence that the excess of deaths after atherectomy was linked to perforation, ectasia, or deep resection. Cumulative rates of myocardial infarction were higher in those who had been randomized to atherectomy than in those randomized to angioplasty (8.9% versus 4.4%, P = .005) with a trend toward excess Q-wave and non-Q-wave infarctions. By multivariate analysis, atherectomy was the only variable predictive of the combined end point of death or myocardial infarction. No clinical or angiographic characteristics added to this index. Rates of repeat percutaneous intervention at the target site (24.4% after atherectomy versus 25.9% after angioplasty), coronary artery bypass surgery (9.3% versus 9.1%), hospitalization (50% versus 47.1%), and stroke (1% in both groups) were not significantly different. CONCLUSIONS: Long-term follow-up of the 1012 patients randomized to atherectomy or angioplasty has revealed a statistically significant excess of deaths after directional atherectomy that was not evident at 6 months. This difference could be due to the chance occurrence of a low mortality rate in those randomized to angioplasty. The excess of myocardial infarctions after atherectomy remains statistically significant at 1 year. Further investigation is warranted to improve the safety of atherectomy.
Lesions at the ostium of the left anterior descending coronary artery constitute a distinct group because of suboptimal results and higher restenosis rate after balloon angioplasty. Several non-balloon devices have been used to improve the outcome of dilatation of such lesions. We retrospectively compared the in-hospital and follow-up results of directional coronary artherectomy and stents for the treatment of ostial lesions of the left anterior descending artery. Out of 37 patients, 12 underwent directional coronary atherectomy and 25, stent implantation. The two strategies were deployed at different periods over the past five years. The baseline clinical and angiographic characteristics were comparable in the two groups. Directional coronary atherectomy was done using 7Fr atherocath with adjunctive balloon angioplasty in all. All the stents were deployed using moderate to high pressure balloon inflation after adequate predilatation. While the pre-procedure luminal diameter stenosis was similar in the two groups (87.3 +/- 8.8% vs 89.3 +/- 7.2%; p = NS), the residual stenosis was significantly lower in the stent group (5 +/- 2.8%) compared to directional coronary atherectomy (18.7 +/- 9.8; p = 0.02). There was no significant difference in the primary success rate between the two devices (91.6% directional coronary atherectomy vs 100% stent; p = NS). One patient in the directional coronary atherectomy group developed acute closure followed by emergency coronary artery bypass graft surgery and death. No major complication was observed in the stent group. Over a mean follow-up of 9.9 +/- 11.6 months following directional coronary atherectomy and 8.6 +/- 4.4 months after stenting, significantly higher number of patients (60%) developed recurrence of angina or any event following directional coronary atherectomy compared to stent (15.8%; p < 0.02). There was no myocardial infarction, coronary artery bypass graft surgery or death in either group on follow-up. The need for target lesion revascularisation was significantly higher in the directional coronary atherectomy group (50%) compared to stenting (10.5%; p < 0.02). Comparing directional coronary atherectomy with stent, the event-free survival was 80 percent vs 94.7 percent at three months and 50 percent vs 84.7 percent, both at six and nine months, respectively. In conclusion, stenting of the left anterior descending artery ostial lesion results in a significantly lesser post-procedure residual stenosis, improved in-hospital outcome, a lesser need for target lesion revascularisation and much improved event-free survival on follow-up as compared to directional coronary atherectomy. Therefore, stenting appears to be a more favourable treatment option compared to directional coronary atherectomy for the treatment of ostial lesions in the left anterior descending artery.
Our objectives were to determine procedural success, clinical complications, and follow-up restenosis rates after rotational burr and transluminal extraction atherectomy of coronary artery and saphenous vein graft ostial stenoses. Balloon angioplasty of ostial lesions has been associated with low rates of success and high rates of clinical complications and restenosis compared to nonostial lesions. Atherectomy, due to its ability to excise (extraction atherectomy) or pulverize (rotational atherectomy) atheroma and the internal elastic lamina, may result in improved procedural outcome. We retrospectively studied 101 patients with ostial stenoses treated by rotational burr and transluminal extraction atherectomy over a 3-yr period. Quantitative angiography and clinical follow-up were reviewed to determine success, complication, and restenosis rates. Rotational burr (n = 29) and transluminal extraction (n = 72) atherectomy were associated with high procedural success (93% and 90%, respectively) and a low incidence of complications (6.9% and 4.2%, respectively). Post-atherectomy angiographic success was low (52% and 69%, respectively) and required adjunctive balloon angioplasty in 85% of patients overall. This lower success rate likely reflects device undersizing as the overall post-atherectomy artery to device ratio was near unity (0.95). The rates of angiographic ostial restenosis remain high (39.1% and 65.9%, respectively, P < 0.05). The high rate of restenosis after transluminal extraction atherectomy was due to the higher rate of restenosis in saphenous vein grafts (80%) compared to TEC treated coronary arteries (59%). When only coronary artery lesions were compared, there was no significant difference between atherectomy device groups with respect to restenosis rates or late loss.(ABSTRACT TRUNCATED AT 250 WORDS)
OBJECTIVES: This study sought to determine whether adjunctive balloon angioplasty after rotational atherectomy and excimer laser angioplasty provides better lumen enlargement ("facilitated angioplasty") than angioplasty alone. BACKGROUND: Adjunctive angioplasty is often used immediately after atherectomy and laser angioplasty to further enlarge lumen dimensions, but it is not known whether this practice is superior to angioplasty alone. METHODS: Balloon angioplasty was performed in 1,266 native coronary lesions alone (n = 541) or after extraction atherectomy (n = 277), rotational atherectomy (Rotablator) (n = 211) or excimer laser angioplasty (n = 237). Quantitative angiographic analysis included final lumen diameter, final diameter stenosis and efficiency of balloon-mediated lumen enlargement. RESULTS: Compared with angioplasty alone (33 +/- 12% [mean +/- SD]), final diameter stenosis was higher for adjunctive angioplasty after extraction atherectomy (37 +/- 16%, p < 0.001) and excimer laser angioplasty (37 +/- 16%, p < 0.001) and lower after rotational atherectomy (27 +/- 15%, p < 0.001). However, there was significant undersizing of balloons after all three devices. To correct for differences in balloon size, the efficiency index (final lumen diameter/balloon diameter ratio) was calculated and was higher for adjunctive angioplasty after the Rotablator (0.78 +/- 0.14, p < 0.001) than after angioplasty alone (0.69 +/- 0.12). The efficiency indexes suggested facilitated angioplasty after rotational atherectomy for ostial, eccentric, ulcerated and calcified lesions and lesions > 20 mm long. Facilitated angioplasty was also observed after extraction atherectomy and excimer laser angioplasty for ostial lesions, but not for any other lesion subsets. CONCLUSIONS: Rotational atherectomy, extraction atherectomy and excimer laser angioplasty can facilitate the results of balloon angioplasty. However, the extent of facilitated angioplasty is dependent on the device and baseline lesion morphology, consistent with the need for lesion-specific coronary intervention.
OBJECTIVES: This study aimed to evaluate the prevalence and time course of wall motion abnormalities associated with rotational coronary atherectomy. BACKGROUND: Although initial clinical studies found evidence of transient wall motion abnormalities after rotational coronary atherectomy, the prevalence and duration of these wall motion abnormalities are unknown. METHODS: Using simultaneous echocardiography, we prospectively evaluated 22 patients undergoing rotational atherectomy and compared their wall motion abnormalities with those of 10 patients undergoing coronary angioplasty alone. The extent of wall motion abnormality was quantified and plotted against time to produce curves of abnormal wall motion development and recovery for the two groups. RESULTS: The cumulative ischemic time was similar for the two groups ([mean +/- SD] 10.3 +/- 6 min for rotational atherectomy vs. 9.6 +/- 4.2 min for coronary angioplasty, p = 0.73). The rate of return to baseline function was significantly lower in the rotational atherectomy group than in the coronary angioplasty group (rotational atherectomy rate constant 0.069 +/- 0.079/min vs. coronary angioplasty rate constant 1.250 +/- 0.47/min, p = 0.0001). The mean time to recovery of baseline wall motion in the rotational atherectomy group (153 min, 95% confidence interval [CI] 6.5 to 3,600) was significantly longer than in the coronary angioplasty group (2.6 min, 95% CI 1.3 to 5.5, p = 0.0001). Rotational atherectomy burr time was longer in the patients who developed myocardial infarction than in those without myocardial infarction (4.7 +/- 2.4 vs. 3 +/- 1.4 min, p = 0.045). CONCLUSIONS: Transient wall motion abnormalities are common after rotational coronary atherectomy and have a longer duration than those observed after coronary angioplasty. This disparity may be a consequence of differences in the mechanisms by which rotational coronary atherectomy and coronary angioplasty produce their effect.
PURPOSE: Directional atherectomy is an endovascular interventional technique for excision and removal of obstructive arterial lesions. To evaluate whether atherectomy would provide better results than conventional balloon angioplasty (BA) in symptomatic femoropopliteal disease, a prospective randomized study comparing the early and late outcomes of these techniques was conducted. The rate of restenosis or occlusion was assessed by use of color-flow duplex scanning during the follow-up period. METHODS: Seventy-three patients were randomized between atherectomy (38 patients) and BA (35 patients). All patients had segmental lesions of the femoropopliteal arteries amenable to either technique. The median follow-up duration was 13 months (range 1 to 39). Follow-up comprised regular clinical and hemodynamic assessment and color-flow duplex examinations. Restenosis was defined on the basis of a peak systolic velocity ratio of 2.5 or greater, and occlusion of the treated segment was diagnosed if flow signals were absent, that is, loss of patency. RESULTS: Residual stenoses (> or = 30% diameter reduction) resulted in five patients (13%) undergoing atherectomy and three patients (9%) undergoing BA. At 1 month clinical and hemodynamic improvement by Society for Vascular Surgery/International Society for Cardiovascular Surgery criteria for lower limb ischemia was observed in 34 patients (89%) treated with atherectomy and in 34 (97%) treated with BA. By life-table analysis the cumulative rate of clinical and hemodynamic success at 2 years was 52% in patients treated with atherectomy and 87% in patients treated with BA (p = 0.06). The patency rate at 2 years of treated segments was 34% in the atherectomy group and 56% in patients treated with BA (p = 0.07). In patients with lesions greater than 2 cm, the 1-year patency rate of AT was significantly lower than BA (p = 0.03). CONCLUSIONS: Atherectomy does not result in an improved clinical and hemodynamic outcome. Furthermore atherectomy of segmental atherosclerotic femoropopliteal disease does not result in a better patency rate than BA, and, in lesions with greater length than 2 cm, the atherectomy results are significantly worse.
An attempt was made to assess the mechanism of directional coronary atherectomy using different methods of analysis. Quantitative coronary angiography was used as the gold standard to assess the immediate results of atherectomy, and a comparative quantitative analysis of atherectomy and balloon angioplasty was made. To determine whether the post-atherectomy cross-sectional area is close to a circle, we compared the area measurements obtained by edge detection with those obtained by videodensitometry. Finally, the extent of a 'Dotter' effect was established by quantitative angiography following crossing the stenosis with the atherectomy device. For the purpose of this study, the results of the first 113 successful atherectomy procedures were reviewed. In matched lesions, directional atherectomy induced a greater increase in minimal luminal diameter than balloon angioplasty (1.6 mm vs 0.8 mm; P < 0.0001). However, this luminal improvement is due to a substantial 'Dotter' effect induced by the bulky atherectomy device. Following atherectomy, only a slight difference in cross-sectional area measurements between edge detection and videodensitometry (mean difference: 0.28 mm2) was found. Histologic examination of an atherectomized coronary artery showed a near-circular postatherectomy area geometry. In conclusion, directional atherectomy is a very effective device with a substantially better initial result than balloon angioplasty. However, insertion of this bulky device itself causes an important 'Dotter' effect.
Directional coronary atherectomy has been introduced as an alternative to conventional balloon angioplasty when treating coronary artery stenoses with complex lesion morphology. To determine the immediate efficacy of coronary atherectomy in patients with such lesions, the first 113 attempts at directional atherectomy in two centres using quantitative angiography were reviewed in 105 patients. The lesions were classified as complex stenosis since 95% had a symmetry index less than 1.0, a length of 6.83 +/- 2.55 mm on average and an area of plaque of 9.77 +/- 6.69 mm2. Procedural success defined as a residual stenosis less than or equal to 50% after tissue retrieval was obtained in 90 (85.7%) of 105 patients. The primary angioplastic success rate, combining atherectomy and balloon angioplasty in case of failed attempt of atherectomy was 95.2%. Coronary atherectomy was unsuccessful in five patients; three were referred for emergency coronary artery bypass grafting. Major complications (death, emergency surgery and transmural infarction) were encountered in 5.7% of the patients. Assessed by quantitative coronary analysis, a residual minimal luminal diameter of 2.42 +/- 0.52 mm and a diameter stenosis of 26 +/- 12% were obtained immediately after directional coronary atherectomy. We conclude that directional coronary atherectomy is particularly suitable for the treatment of stenosis with complex lesion morphology and is associated with acceptable complication rates. Randomized trials comparing atherectomy with balloon angioplasty are warranted to clarify the role of atherectomy in the treatment of lesions in the proximal part of the three major epicardial coronary arteries.