[Percutaneous transluminal atherectomy for iliac artery stenosis].
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Angioplasty, Balloon↗
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[Nonsurgical recanalization of occluded femoral and popliteal arteries by a combination of the Dotter technic, angioscopy and atherectomy].
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Angioplasty, Balloon↗
Elective stent implantation after optimal debulking for complex coronary lesions: acute and mid-term results.
Between January 1995 to December 1997, 45 patients with complex lesions in coronary arteries were treated by using the strategy of initial debulking with an atherectomy device followed by elective stenting. Their age ranged from 35-73 years (mean +/- SD:53.9 +/- 9.1) and 93.3 percent were males. The lesion morphology was type B1 in 14 (31.1%), B2 in 16 (35.6%) and type C in 13 (28.9%) patients. The choice of atherectomy device, based primarily on the morphology of lesion, was rotational atherectomy in 23 (51.1%) and directional coronary atherectomy in 22 (48.9%) patients. While majority (73.9%) of the lesions treated by rotablation were long, diffuse and calcified, directional atherectomy was preferred for highly eccentric stenoses in large-sized arteries. All patients underwent elective stent implantation after optimal lesion debulking using a mean burr size of 1.74 +/- 0.2mm for rotablation and a 7Fr. atherocath in majority (90.9%) of patients treated by directional coronary atherectomy. Angiographic success was achieved in all, while clinical success was 97.8 percent. One patient died of acute-on-chronic renal failure during hospitalisation. There were no other major in-hospital adverse cardiac events. At a median follow-up of 13 months (range 1-36 months), recurrence of angina developed in 10 (22.7%), out in which target lesion revascularisation was required in 5 (11.4%) and elective coronary artery bypass graft surgery in one (2.2%) patient. The event-free survival as calculated by the Kaplan-Meier method was 85.8 percent at six, 77.2 at 12 71.7 percent at 18 months of follow-up. In conclusion, optimal debulking before stent implantation provides a larger lumen, and thus eliminates sub-acute stent thrombosis in complex coronary lesions. This strategy also resulted in a high incidence of event-free survival and a low frequency of target lesion revascularisation on mid-term follow-up.
Adult↗
Aortoiliac angioplasty: is there a need for other types of percutaneous intervention?
In a retrospective study, the authors compared results in 81 patients who underwent 117 percutaneous transluminal angioplasty (PTA) procedures in the iliac arteries and 21 patients who underwent iliac artery atherectomy. Both groups were similar with respect to symptoms and risk factors. The overall technical success rates were 97.4% for PTA and 100% for atherectomy. The initial clinical success was 92.8% for PTA and 100% for atherectomy. Complications requiring surgery occurred in four of 117 (3.4%) PTA and one of 21 (4.8%) atherectomy procedures. The 2-year patency rate for PTA was similar to that achieved with atherectomy in a smaller patient population. These results indicate that atherectomy does not offer any definite advantage over conventional PTA for the routine management of iliac lesions and make it difficult to justify the additional expense and complexity of this technique.
Angioplasty, Balloon↗
A New Approach to Plaque Removal: The Redha-Cut Device.
PURPOSE: To prospectively determine the safety, feasibility and efficacy of a new atherectomy device. Methods. Seventy patients with 93 symptomatic femoro-popliteal lesions underwent percutaneous atherectomy with Redha-cut, a metallic, flexible catheter. The device works on pull-back with two umbrella-like blades and enables cutting, retaining and removing of material. Quantitative analysis of the angiograms was performed. RESULTS: Obtaining of atherectomized samples was successful in all cases. The mean atherectomy time was 5 +/- 2 minutes. The stenoses were reduced from 74 +/- 2.3% before to 26 +/- 2% after atherectomy (p < 0.001). Subsequent PTA, which was performed to optimize the results, further decreased the degree of stenosis to 17% (p > 0.5). No perforations, acute closure or early re-thrombosis occurred. Cumulative patency rates according to the findings of non-invasiveive examinations were 83% at 6 months and 66% at 12 months. Conclusions. The Redha-cut device is a simple, safe and efficacious tool for biopsy sampling and atherectomy. Further studies randomizing patients either to balloon or atherectomy are planned to compare this technique with others in regard to long-term patency.
Journal Article↗
Frequency and Prognostic Importance of Creatine Phosphokinase Myocardial Isoforms after Successful Balloon and New Device Coronary Angioplasty.
The frequency and prognostic importance of subclinical myocardial necrosis after new device coronary intervention is not known. To identify the frequency of CPK-MB release after balloon and single new device angioplasty in native coronary arteries, we reviewed the course of 810 patients who underwent successful single lesion, native vessel angioplasty using balloon angioplasty (N=174), Gianturco-Roubin stent placement for suboptimal angioplasty results (N=31), Palmaz-Schatz stent deployment (N=320), directional coronary atherectomy (N=102), or rotational atherectomy (N=183). All patients had serial measurements of CPK-MB isoenzymes 6 and 18Ð24 hours after coronary intervention; absolute CPK-MB levels were determined by radioimmunoassay (normal assay < 4 ng/ml). CPK-MB isoenzymes were > 2 times normal (> 8 ng/dl) in 15.6% of procedures, > 3 times normal (³ 12 ng/ml) in 11.5% of procedures, > 4 times normal (³ 16 ng/ml) in 8.6% of procedures, and > 5 times normal (³ 20 ng/ml) in 7.7% of procedures. CPK-MB elevation > 2 times normal was more common in those undergoing directional atherectomy (20.8%) and Gianturco-Roubin stent placement (34,4%) than in those undergoing balloon angioplasty (11.7%). No significant differences were noted in patients undergoing rotational atherectomy (13.2%) or Palmaz-Schatz stent placement (15.6%) than in those undergoing balloon angioplasty. CPK-MB > 5 times normal occurred after 7.7% of procedures, but did not vary significantly among the devices used in this study. We conclude that CPK-MB elevations > 2 times normal are highest in patients undergoing directional coronary atherectomy and ÒbailoutÓ use of the Gianturco-Roubin stent. No significant differences in CPK-MB elevation were seen in patients undergoing balloon angioplasty, Palmaz-Schatz stent deployment, or rotational atherectomy. Identification of the prognostic importance of these CPK-MB elevations is currently under study.
Journal Article↗
[Coronary angioplasty with a rotary atherotome].
Several new coronary dilatation systems, including those using laser energy, atherectomy devices and stent implantation, are being developed as alternative or complementary procedures to coronary artery balloon angioplasty. We report our initial experience performing coronary angioplasty with a new rotational atherectomy device, the transluminal extraction catheter, which simultaneously cut and aspirate fragments from the atherosclerotic plaque. The components of the whole system are a special guidewire to cross the stenosis, the atherectomy catheter and the conduction-control unit. This unit, connected when the atherectomy catheter is positioned across the lesion, produces rotation of the conical bladder located in the catheter distal tip and simultaneous aspiration of residual particles. The procedure was performed in 11 patients in whom 13 lesions were dilated. All patients were male (mean age 55 +/- 23 years, range 45-77). The reason for the angioplasty was stable angina in 2 patients and unstable angina in the remaining seven. Initial success (residual stenosis less than 50% of vessel diameter) was obtained in 10 of 13 lesions. In two, conventional balloon angioplasty was required to improve atherectomy result. The only unsuccessful procedure was in a proximal right coronary artery venous graft, in which a large dissection occurred. Patient had angina but no myocardial infarction. Pathologic examination of aspirated material revealed fibrous tissue in 12 cases and cholesterol crystals in four. We conclude, with the limitation of a preliminary study, that rotational atherectomy with the transluminal extraction catheter is a useful procedure to relief coronary stenosis of the coronary arteries.
Aged↗
Relation between estrogen replacement therapy and restenosis after percutaneous coronary interventions.
OBJECTIVES: We attempted to determine the relation between estrogen replacement therapy and the rate of restenosis after coronary angioplasty and atherectomy. BACKGROUND: Although estrogen replacement therapy in women has been associated with a reduction in cardiovascular events and improvement in endothelial function, no study has examined whether estrogen reduces restenosis rates after percutaneous coronary interventions. METHODS: A total of 204 women enrolled in the Coronary Angioplasty Versus Excisional Atherectomy Trial with angiographic follow-up were contacted, and their menopausal and estrogen replacement status was determined. Late loss in minimal lumen diameter, late loss index, minimal lumen diameter, rate of restenosis > 50% and actual percent of stenosis were compared in estrogen users and nonusers by quantitative coronary angiography at 6-month follow-up. RESULTS: Late loss in minimal lumen diameter was significantly less in women using estrogen than in nonusers (-0.13 vs. -0.46 mm, p = 0.01). A regression analysis of the determinants of late loss in minimal lumen diameter revealed that estrogen use was the single most important predictor of subsequent late loss (F = 13.38, p = 0.0006). Formal testing revealed a highly significant interaction between the use of estrogen and intervention (angioplasty or atherectomy). Women undergoing atherectomy who received estrogen had a significantly lower late loss index (0.06 vs. -0.63, p = 0.002), less late loss (0.06 vs. -0.61 mm, p = 0.0006), larger minimal lumen diameter (p = 0.044) and lower restenosis rates (p = 0.038 for > 50% stenosis) than those not using estrogen. In contrast, estrogen had minimal effects on restenosis end points after angioplasty. CONCLUSIONS: This study demonstrates the potential for estrogen replacement therapy to reduce angiographic measures of restenosis in postmenopausal women after coronary intervention, particularly in those undergoing atherectomy.
Aged↗
Growth factors released into the coronary circulation after vascular injury promote proliferation of human vascular smooth muscle cells in culture.
OBJECTIVES: This study sought to 1) assess in vivo release of platelet-derived growth factor (PDGF) and basic fibroblast growth factor (bFGF) into the coronary circulation after vascular injury in human subjects; and 2) evaluate mitogenic effects of PDGF and bFGF on the patient's own vascular smooth muscle cells (VSMCs). BACKGROUND: Circumstantial evidence suggests involvement of PDGF and bFGF peptides in the neointimal response to vascular injury. To date, no study has shown biologically active growth factors within the coronary circulation after vascular injury in human subjects. METHODS: In 18 patients, plasma PDGF AB, platelet factor 4 (PF4) and beta-thromboglobulin (beta-TG) levels were measured in coronary sinus blood obtained before and up to 30 min after angioplasty. In five patients undergoing atherectomy, coronary sinus serum was added to cultured VSMCs derived from atherectomy tissue to assess the mitogenic potential of the serum. Mitogenicity attributable to PDGF and bFGF was determined using neutralizing antibodies to these factors. PDGF A, PDGF B and bFGF were localized within the atherectomy tissue using immunocytochemical analysis. RESULTS: Before angioplasty, PDGF AB, PF4 and beta-TG levels were elevated threefold in patients scheduled for angioplasty compared with those in control patients (p < 0.01). Within 5 min of angioplasty, PDGF AB levels increased twofold and returned toward preangioplasty levels at 30 min; PF4 and beta-TG levels remained elevated. Serum obtained at 30 min after atherectomy showed a sixfold increase in mitogenicity compared with preatherectomy serum (p = 0.01). This increase in mitogenicity was reduced by 20%, 40% and 65% in the presence of neutralizing antibodies to PDGF, bFGF and PDGF + bFGF, respectively. PDGF A, PDGF B and bFGF were visualized within the intima of the atherectomy tissue. CONCLUSIONS: The change in plasma PDGF level is consistent with first-phase release of PDGF after vascular injury. The increase in mitogenicity of serum suggests that PDGF and bFGF are biologically active.
Adult↗
Evolving trends in interventional device use and outcomes: results from the National Cardiovascular Network Database.
BACKGROUND: Although multiple new coronary interventional devices have been approved for marketing in the United States, use of these technologies in general clinical practice and their associated outcomes have not been reported. METHODS AND RESULTS: Using the National Cardiovascular Network's Coronary Interventional Database, we examined temporal trends in the use and outcomes of coronary stents, lasers, directional atherectomy, and rotational atherectomy devices at 12 US hospitals between January 1994 and December 1997 (n = 76,904). Over this period, the percentage of cases involving coronary stents rose more than 12-fold (from 5.4% in 1994 to 69.0% in 1997). In contrast, use of atherectomy-type devices declined significantly. Device selection was strongly influenced by the patient's coronary anatomy and procedural indication, but less by age, sex, or race. Device use also varied significantly among individual centers (4-fold variation among sites in stent use and 6-fold variation in atherectomy use) even after adjusting for patient characteristics. Although overall mortality rates were unchanged during this 4-year period, procedural success rates have improved and complication rates have declined significantly. Lengths of postprocedure hospital stay also fell significantly for all patients undergoing coronary intervention in this time period. CONCLUSIONS: Percutaneous interventional strategies are rapidly changing with the explosive growth of coronary stent use and the decline in use of atherectomy devices. Patient outcomes, including complication rates and postprocedure lengths of stay, have also improved as the new interventional strategies have been refined in clinical practice.
Angioplasty, Balloon, Coronary↗
Plaque removal prior to stent implantation in native coronary arteries: why? When? And how?
Coronary stenting has significantly reduced restenosis in focal de novo coronary lesions, but its impact in complex lesions has been less pronounced. Recent data suggest a possible role for pre-intervention plaque burden in exacerbating neo-intimal hyperplasia after stent implantation. These observations formed the basis for the hypothesis that plaque removal prior to stent implantation, using directional atherectomy in non-calcified lesions and rotational atherectomy in calcified lesions, may reduce restenosis. The currently available non-randomized experience that used this approach has shown its feasibility and favourable long-term outcome when applied in selected patients. However, the incidence of non-Q-wave myocardial infarction is increased with both rotational and directional atherectomy compared to PTCA or stent alone. The utilization of potent antiplatelet agents and/or the development of new atherectomy devices that produce lower embolization rate may decrease the incidence of these ischaemic complications. In addition, considering the increased procedural time and cost, this approach will have to be applied in selected patient subsets where debulking or stenting as a stand-alone strategy is associated with a high restenosis rate. Randomized clinical trials testing the usefulness of this approach, with both rotational and directional atherectomy, are currently in progress.
Angioplasty, Balloon, Coronary↗
Optimal treatment of nonaorto ostial coronary lesions in large vessels: acute and long-term results.
Percutaneous interventions of nonaorto ostial coronary lesions are usually complex, often requiring a combined approach of debulking and stenting, insertion of multiple guidewires and long procedure duration. Debulking with atherectomy device preserves side-branch patency by reducing plaque shift while coronary stenting minimizes vessel recoil and restenosis. We retrospectively evaluated the acute and long-term results of rotational atherectomy (group R, n = 94), coronary stenting (group S, n = 39), and combination of rotational atherectomy and stenting (group R-S, n = 59) in a total of 192 patients with nonaorto ostial lesions. The number of patients with diabetes mellitus and rest angina was significantly higher in groups S and R-S. Clinical success rates were high and procedural complication rates were low and comparable in all three groups. Despite the similar reference vessel size and preprocedure minimal lumen diameter (MLD), postprocedure MLD showed a trend toward larger lumen in groups S (3.15 +/- 0.18 mm) and R-S (3.21 +/- 0.16 mm). Group S had significantly higher incidence of side-branch narrowing (30.7%), requiring intervention (15.4%). At long-term follow-up (mean of 9 +/- 4 months), target lesion revascularization rate was significantly lower in groups R-S (11.9%) and S (15.4%) compared to group R (28.9%; P = 0.02). Our nonrandomized data suggest that stenting with or without rotational atherectomy provides the best long-term approach for the interventional treatment of nonaorto ostial coronary lesions. The clinical benefit and cost effectiveness of performing rotational atherectomy before stent implantation to reduce the incidence of side-branch closure requires further study.
Aged↗
Independent predictors of restenosis after percutaneous coronary revascularization in haemodialysis patients.
BACKGROUND: Percutaneous balloon angioplasty has become a well-established and routine procedure for coronary revascularization of haemodialysis patients with coronary artery disease. However, the incidence of restenosis after balloon angioplasty is significantly higher in haemodialysis patients than in the general population. We performed a retrospective study comparing balloon angioplasty with coronary stenting in haemodialysis patients. We evaluated the long-term clinical and angiographic outcome after successful percutaneous coronary revascularization in haemodialysis patients. METHODS: A total of 103 consecutive haemodialysis patients (123 lesions) underwent procedurally and clinically successful percutaneous revascularization. Patients were treated with three different strategies: (i) balloon angioplasty in 55 patients (69 lesions); (ii) coronary stenting with balloon angioplasty in 23 patients (25 lesions); and (iii) coronary stenting with rotational atherectomy in 25 patients (29 lesions) who had severely calcified stenotic coronaries. RESULTS: The rates of in-hospital mortality were similar in the three groups. The 1-year incidence of overall events and major adverse cardiac events (MACE) were significantly higher in the balloon group than in the stent with/without rotational atherectomy groups (75% vs 36 and 28%, P<0.01; 71% vs 32 and 28%, P<0.01). Use of coronary stenting (relative risk=0.006, P<0.001) and the presence of calcified coronary lesion (relative risk=68.2, P<0.001) were independent predictors of the 1-year MACE-free survival after percutaneous revascularization. The 3-year MACE-free survival rate was significantly lower in the balloon group than in the stent with/without rotational atherectomy groups (11% vs 33 and 47%, P<0.005 and P<0.001). CONCLUSIONS: This study shows that coronary stenting reduces the incidence of MACE in haemodialysis patients with/without calcified coronary lesions. Moreover, coronary stenting reduces the restenosis rate of both complex and restenotic lesions, and rotational atherectomy prior to coronary stenting reduces the restenosis rate of the severely calcified coronary lesions. These results suggest that coronary stenting with/without rotational atherectomy has led to an improved long-term outcome in the haemodialysis patients with coronary artery disease.
Aged↗
Immediate results of interventional devices for coronary ostial narrowing with angina pectoris.
Angioplasty of aorto-ostial lesions has had suboptimal results. This study reports on the immediate results of new debulking devices (atherectomy, excimer laser) in the treatment of aorto-ostial disease. Thirty-one vessels (29 patients) with an ostial lesion treated with a new device (group I) were compared with 15 vessels (13 patients) with an ostial lesion treated with angioplasty alone during the preceding 24 months (group II). Both groups were similar in their clinical characteristics. A larger proportion of vessels in group I (64%) compared with group II (7%) had unfavorable features for angioplasty. Procedural success was similar: 28 vessels in group I (91%) and 14 in group II (93%). Among the new devices, success was also similar: atherectomy in 8 arteries (89%), rotablator in 4 (100%) and excimer laser in 17 (94%). The acute gain was more significant with new devices: absolute reduction in percent stenosis was 66% for directional atherectomy, 67% for rotational atherectomy (p = 0.016 compared with angioplasty), 52% for excimer laser (p = 0.09) and 46% for angioplasty. In group I, 2 patients (6%) required emergency bypass surgery during our early experience; no deaths or Q-wave myocardial infarctions occurred. Group II had no complications. Therefore in aorto-ostial lesions, despite a much higher prevalence of unfavorable angiographic characteristics, new devices had (1) a success rate of > or = 90%, (2) a significantly larger acute gain compared with angioplasty alone, and (3) an acceptable complication rate. Larger studies with complete angiographic follow-up are needed to assess restenosis.
Aged↗
Correlation between clinical and morphologic findings in unstable angina.
This study was undertaken to verify the hypothesis that the discrepant findings in published reports on the prevalence of thrombus in unstable angina depend on the inclusion of different clinical subsets in the various studies. We therefore correlated the clinical characteristics of patients included under the label of unstable angina with the morphologic features assessed by coronary angiography and intravascular ultrasound, and with histopathologic findings of atherectomy specimens. Fifty-eight patients with unstable angina (class B of the Braunwald classification) undergoing coronary arteriography followed by either coronary angioplasty (n = 20) or directional coronary atherectomy (n = 38) were studied. Fifteen patients were in class IB and 43 were in class II to IIIB. Among these 43 patients with angina at rest, 28 had ST-segment elevation during pain, and 15 had ST-segment depression, and 26 developed negative T waves on the baseline electrocardiogram (ECG) as a result of prolonged or repeated episodes of resting chest pain. Intravascular ultrasound examination of the culprit lesion was performed in 43 patients before the interventional procedure, and histopathologic analysis of atherectomy specimens was performed in 38 patients. Complex lesion morphology by angiography was observed in 31 patients (53%) without any significant relation to various clinical subsets. Patients in Braunwald class IB had more calcific plaques than patients in class II to IIIB (p < 0.001). Among patients with angina at rest, those with negative T waves on the baseline ECG, as well as those with transient ST elevation during pain, had a significantly higher incidence of noncalcific lesions (p = 0.001 for both). Analysis of atherectomy specimens revealed acute coronary lesions (thrombus and/or intraplaque hemorrhage) in 18 patients (47%). The incidence of acute coronary lesions was significantly higher in patients with than without negative T waves on the baseline ECG (p = 0.005), and increased further when negative T waves were combined with ST elevation during pain (p = 0.001). Multivariate analysis revealed that the presence orf negative T waves on the baseline ECG was the only explanatory variable related to the presence of acute coronary lesions by histology (p = 0.03). Patient subsets included in the broad spectrum of unstable angina have different morphologic features and incidence of acute coronary lesions by histology. These data provide an explanation for the discrepant findings in published reports on the relevance of thrombus formation in the pathogenesis of unstable angina.
Angina, Unstable↗
Mechanical debulking versus balloon angioplasty for the treatment of diffuse in-stent restenosis.
Previous studies have shown a high rate of repeat intervention after treating diffuse in-stent restenosis with percutaneous transluminal coronary angioplasty (PTCA) alone. It is not clear whether debulking with atherectomy is more effective in this condition. Between January 1994 and February 1997, we treated 60 consecutive patients with diffuse in-stent restenosis of a native coronary artery using conventional PTCA (n=30) or debulking (with rotational or directional atherectomy) plus adjunctive PTCA (n=30). Paired angiograms were analyzed by quantitative angiography, and clinical follow-up was obtained in all patients at 1 month, 6 months, and 1 year after revascularization. The mean lesion lengths were 13.5+/-8.3 and 18.4+/-13.2 mm in the debulking and PTCA groups, respectively (p=0.09). Acute procedural success was 100% in both cohorts, with no major complications in either group. Treatment with atherectomy plus adjunctive PTCA resulted in lower postprocedure stenoses (18+/-10 vs 26+/-13%, p=0.01) than treatment with balloon angioplasty alone. At 1-year follow-up, repeat target vessel revascularization was required in 28% of patients in the debulking group compared with 46% in the PTCA group (p=0.18). Independent predictors of the need for repeat target vessel revascularization were longer lesion lengths, diabetes mellitus, and smaller postprocedure lumen diameter. Thus, the strategy of atherectomy and adjunctive PTCA for diffuse in-stent restenosis is safe, improves acute angiographic results compared with PTCA alone, and may decrease the need for target vessel revascularization.
Angioplasty, Balloon, Coronary↗
Mechanical debulking versus balloon angioplasty for the treatment of true bifurcation lesions.
OBJECTIVES: The purpose of this study was to compare the immediate angiographic and long-term results of debulking versus balloon angioplasty for treatment of true bifurcation lesions. BACKGROUND: Previous studies have shown true bifurcation lesions to be a high risk morphological subset for percutaneous transluminal coronary angioplasty (PTCA). Although atherectomy devices have been used to treat bifurcation lesions, no studies have compared the outcomes of these alternative treatment modalities. METHODS: Between January 1992 and May 1997, we treated 70 consecutive patients with true bifurcation lesions (defined as a greater than 50% stenosis in both the parent vessel and contiguous side branch) with conventional PTCA (n = 30) or debulking (with rotational or directional atherectomy) plus adjunctive PTCA (n = 40). Paired angiograms were analyzed by quantitative angiography, and clinical follow-up was obtained in all patients. RESULTS: Acute procedural success was 73% in the PTCA group and 97% in the debulking group (p = 0.01). Major in-hospital complications occurred in two patients in the PTCA group and one in the debulking group. Treatment with atherectomy plus PTCA resulted in lower postprocedure residual stenoses than PTCA alone (16+/-15% vs. 33+/-17% in the parent vessel, and 6+/-15% vs. 39+/-22% in the side branch; p < 0.001 for both comparisons). At 1 year follow-up, the incidence of target vessel revascularization (TVR) was 53% in the PTCA group as compared with 28% in the debulking group (p = 0.05). Independent predictors of the need for repeat TVR were side branch diameter >2.3 mm, longer lesion lengths, and treatment with PTCA alone. CONCLUSIONS: For the treatment of true bifurcation lesions, atherectomy with adjunctive PTCA is safe, improves acute angiographic results, and decreases target vessel revascularization compared to PTCA alone. The benefits of debulking for bifurcation lesions were especially seen in lesions involving large side branches.
Aged↗
New technologies in interventional cardiology.
The limitations of balloon angioplasty have led to the introduction of new devices designed to improve the short- and long-term efficacy of percutaneous revascularization techniques. Preliminary single-operator experience and registry data have suggested that these devices may be useful in particular anatomical situations. Last year saw the beginning of the next phase of device assessment, the randomized study, directly comparing the new devices with coronary angioplasty either in the total angioplasty patient population or in selected subgroups. Two major randomized studies, the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT) and the Canadian Coronary Atherectomy Trial (CCAT), directly compared directional coronary atherectomy with balloon angioplasty and suggested that coronary atherectomy offers no particular advantage over balloon angioplasty. This year will see the publication of the Belgium Netherlands Stent (BENESTENT) and Stent Restenosis Study (STRESS) randomized trials, which compared coronary stents with balloon angioplasty; further studies comparing balloon angioplasty with other devices are currently under way. We are now entering a new era where randomized studies will directly assess the safety and efficacy of the new devices compared with balloon angioplasty and demonstrate, in a scientific manner, the validity (or otherwise) of their superiority over balloon angioplasty.
Angioplasty, Balloon, Coronary↗