Randomized Comparison of Angioplasty of Complex Coronary Lesions at a Single Center
Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study
Background The purpose of this study was to test whether coronary revascularization with ablation of either excimer laser or rotational atherectomy can improve the initial angiographic and clinical outcomes compared with dilatation (balloon angioplasty) alone.
Methods and Results At a single center, a total of 685 patients with symptomatic coronary disease warranting elective percutaneous revascularization for a complex lesion were randomly assigned to balloon angioplasty (n=222), excimer laser angioplasty (n=232), or rotational atherectomy (n=231). The primary end point was procedural success (diameter stenosis <50%, absence of death, Q-wave myocardial infarction, or coronary artery bypass surgery). The patients who underwent rotational atherectomy had a higher rate of procedural success than those who underwent excimer laser angioplasty or conventional balloon angioplasty (89% versus 77% and 80%, P=.0019), but no difference was observed in major in-hospital complications (3.2% versus 4.3% versus 3.1%, P=.71). At the 6-month follow-up, revascularization of the original target lesion was performed more frequently in the rotational atherectomy group (42.4%) and the excimer laser group (46.0%) than in the angioplasty group (31.9%, P=.013).
Conclusions Procedural success of rotational atherectomy is superior to laser angioplasty and balloon angioplasty; however, it does not result in better late outcomes. The role of plaque debulking before balloon dilatation in percutaneous coronary revascularization remains to be fully defined.
Excimer laser coronary angioplasty and high-speed PTRA may be more effective treatment modalities for certain unfavorable lesion morphologies than conventional PTCA, achieving higher rates of initial angiographic and clinical success with rates of restenosis comparable to that of balloon angioplasty.1 2 3 4 5 6 7
To test the hypothesis that debulking increases the success rate and because ELCA and PTRA are to some extent competitive debulking techniques with overlapping indications, we conducted a single-center prospective randomized trial in patients with type B or type C de novo stenoses in the native coronary arteries.
Coordinating Center and Investigators
The coordinating center was at the Red Cross Hospital (Frankfurt, Germany). All study procedures were carried out at the Red Cross Hospital by 1 of 14 experienced investigators. The ELCA and PTRA procedures were performed by investigators who had used these devices for >50 procedures. The study was approved by the institutional review board. The study was not sponsored.
Study patient enrollment began in October 1991 and was interrupted in August 1992 because of the market withdrawal of the Rotablator system. At that time, 450 patients had been enrolled (interim analysis). Patient enrollment was resumed in January 1993 and was completed (685 patients) in December 1993. The angiographic criteria for inclusion required that the target lesions and vessels were suitable for all three techniques. This was determined by the absence of specific angiographic exclusion criteria related to the characteristics of the lesion (stenosis angulation >60°, bend stenosis with an outwardly eccentric lumen, and bifurcational lesions requiring double guide wires) and the vessel (extreme proximal vessel tortuosity, saphenous bypass graft or presence of intraluminal thrombus [filling defect], and total occlusion deemed not traversable with guide wires). Patients with acute myocardial infarction and those who had undergone PTCA of any other vessel within the last 4 months were also excluded. Patients with multivessel coronary disease were eligible, but the culprit lesion was specified as the target before the coronary intervention began. Oral or written informed consent was obtained from every patient.
Randomization to one of the three treatment arms was carried out by means of sealed envelopes on the day of admission after clinical and angiographic eligibility had been confirmed by the investigators. The actual treatment assignments were cross-checked against a computer-generated randomization sequence.
All patients received aspirin (>160 mg/d) and oral nitrates beginning at least the day before the procedure. Heparin was administered as a bolus of 25 000 U, and heparin treatment after the procedure was restricted to patients with long spiral dissections only. Before and within 24 hours after the procedure, a 12-lead ECG was obtained, and creatine kinase levels with MB isoenzyme were measured 12 hours after the procedure in all patients (measurements repeated if elevated). After the procedure, aspirin (325 mg/d) was continued at least for 6 months.
For the patients randomized to ELCA and PTRA, the procedural protocol required to debulk the target lesion with a device size not bigger than two thirds of the nominal vessel size. This approach of device sizing was recommended to maximize the likelihood of a safe outcome. Adjunctive low-pressure balloon dilatation (≤4 atm) was used to obtain <50% residual stenosis by visual assessment. The procedure was performed using 8F or 9F guiding catheters, depending on the size of the rotablator burr or the laser catheter. ELCA was performed with two different 308-nm xenon chloride excimer laser systems. The LAIS system (DYMER 200 Plus, Advance Interventional Systems, Inc), operated at a pulse duration of 210 nanoseconds and a pulse repetition rate of 20 to 30 Hz with multifiber over the wire catheters with diameters of 1.3, 1.6, 2.0, and 2.2 mm, and the 1.3 Z mm laser catheter and the eccentric laser catheter were used after their introduction in 1992. The energy was delivered at a fluence of 45 to 70 mJ/mm2. The Spectranetics system (CVX-300), operated at a pulse duration of 135 nanoseconds and a pulse repetition rate of 25 Hz with multifiber over the wire catheters with diameters of 1.4, 1.7, and 2.0 mm at 45 to 60 mJ/mm2, was used. During lasing, special attention was paid to keeping contrast medium out of the field, but no saline infusion protocol was used.
The Rotablator system (Heart Technology Inc) was used over a flexible 0.009-in guide wire with a rotational burr speed of 160 000 to 180 000 rpm. Burrs were available in sizes of 1.25, 1.5, 1.75, 2.0, 2.15, and 2.25 mm. The rotational ablation sequences were limited to 10 to 15 seconds; then, the burr was withdrawn from the lesion, and extended pauses were applied between each run to permit washout of particulate debris. A larger burr was used if the angiographic result was unsatisfactory (absence of luminal diameter gain) after several passages of the burr through the lesion. Balloon pressures >4 atm were applied only if the balloon was not fully inflated. The protective Teflon sheath over the drive shaft was flushed with saline (7 to 10 mL/min) containing a cocktail of 10 000 U heparin, 2 mg nitroglycerin, and 5 mg verapamil per 500-cm3 saline bag, which has been shown in our work to decrease the incidence of vasospasm to <10% and the slow-flow phenomenon to <1%.
Balloon angioplasty was performed by use of any approved rapid-exchange (monorail) balloon dilatation system (length, 20, 30, 35, and 40 mm). Perfusion balloons were permitted either as a primary or as a bailout device. The balloon size (recommended ratio of balloon size to vessel size, 1:1), length, and inflation protocols (incremental increase of balloon pressure by 1 atm per 10 to 15 seconds until full expansion recommended) were chosen by the operator to achieve optimal angiographic results. Stents were used as a bailout device if occlusive dissections could not be managed with prolonged inflations performed with perfusion balloons.
Laser angioplasty was chosen for crossover if a wire could be placed, but the balloon failed to reach or cross the stenosis. Rotational atherectomy was the preferred alternative if a balloon could not be fully inflated at high pressure or if neither laser catheter nor balloon could reach or cross the lesion.
Patients were advised to have clinical and angiographic follow-up studies as close to 6 months after the procedure as possible (range, 4 to 12 months). Patients eligible for follow-up angiography included those with angiographic success and without in-hospital death, bypass surgery, bailout stenting, or repeated angioplasty.
Quantitative Coronary Analysis
Quantitative angiographic analysis was performed immediately before and after intervention and at follow-up after intracoronary administration of 0.1 to 0.3 mg nitroglycerin by use of the view in which the initial stenosis appeared most severe. Vessel and lesion dimensions and lesion length (recorded along the diseased segment corresponding to 30% lumen narrowing) were obtained by use of electronic caliper measurements made on selected optically magnified cineframes with reference to the known diameter of the unfilled guiding catheter as previously described.8 9 The cineangiograms were analyzed in a central angiographic laboratory (Frankfurt am Main) by experienced angiographers.
The primary end point in the trial was the procedural success rate, defined as <50% stenosis without major in-hospital complications (death, myocardial infarction, or coronary artery bypass surgery). Myocardial infarction was defined as new Q waves in two or more contiguous leads and a total creatine kinase elevation of two or more times the upper limit of normal value and/or elevated creatine kinase–MB fraction to at least twice the upper limit of normal. Major complications and other secondary adverse events (bailout stent implantation, abrupt vessel reclosure, repeated intervention, and non–Q-wave myocardial infarction) were reviewed for adjudication by an independent committee. The investigators prospectively defined to analyze this composite (angiographic and clinical) primary end point of the trial according to the intention-to-treat principle before crossover (procedure result, assessed after the completed attempts of the assigned randomized therapy) or after crossover (procedure result, assessed after the attempts of an alternative therapy after failure of the assigned randomized treatment).
The secondary end points were (1) device (ELCA or PTRA) success, defined as the ability to cross the lesion or to improve the stenosis by ≥20% after device treatment alone on quantitative assessment; (2) angiographic success, defined as a reduction in diameter stenosis to <50% as assessed by quantitative angiography; (3) the absolute minimal luminal diameter of the target lesion before and after the procedure and at follow-up; (4) acute gain, defined as the minimal lumen diameter at the target lesion after the procedure relative to the baseline value before the procedure as assessed by quantitative analysis; (5) net gain, defined as the minimal lumen diameter at the treated coronary site at follow-up relative to the baseline value before the procedure as determined by quantitative angiography; (6) late loss, defined as the minimal lumen diameter at the treated site at follow-up relative to the minimal lumen diameter at the end of the procedure as determined by quantitative analysis; (7) the percent diameter stenosis net gain, defined as the percent diameter stenosis at the treated lesion at follow-up relative to the baseline value before the procedure as assessed by quantitative analysis; (8) restenosis rate, defined as a stenosis ≥50% at follow-up as determined by quantitative analysis; and (9) a composite clinical end point (0 to 360 days), prospectively defined as whichever of the following events occurred first: death, Q-wave myocardial infarction, target lesion revascularization defined as percutaneous intervention, or bypass surgery performed because of restenosis of the target lesion.
Power Calculations and Statistical Analysis
The size of the required sample (651 patients) was based on an assumed rate of procedural success of 75% in the PTCA group and an increase of that rate to 85% in either the ELCA or PTRA group (by a one-sided test with an α error of 0.05 and a power of 0.80). According to our experience, prior ERBAC work, and reports from the literature, there was strong evidence that PTRA and ECLA were superior to PTCA in complex lesions. This was the reason to use a one-sided test. To compensate for patient ineligibility (core laboratory determination versus investigator decision) and protocol violations, the sample list was enlarged to 685 patients.
Primary analysis of procedural angiographic and clinical outcomes was based on the intention-to-treat principle and involved all randomized patients.
Continuous variables are expressed as mean±SD and were compared by ANOVA (comparison of three groups) and the unpaired Student t test (comparison of two groups). Categorical data, which are presented as frequencies and percentages, were compared by the Kruskal-Wallis test or Pearson’s χ2 test (comparison of three groups) and Fisher’s exact test (comparison of two groups). The composite clinical end points and the need of target lesion revascularization were analyzed by means of Kaplan-Meier survival curves, with differences between the three treatment groups compared with the Wilcoxon test. All statistical tests were two tailed, and all statistical analyses were performed by means of the SPSS program. A probability of >95% was considered a significant difference between compared groups (P<.05). There were no prespecified hypotheses about subset differences.
Among the 685 patients enrolled between October 1991 and December 1993, 222 patients were randomly assigned to PTCA, 232 to ELCA, and 231 to PTRA. Table 1⇓ gives the baseline clinical and angiographic characteristics. According to the core laboratory analysis, 70 patients did not fulfill all inclusion criteria in retrospect but were included in the analysis (intention to treat).
Procedural Results and Periprocedural Clinical Outcomes
In the 222 patients randomly assigned to undergo PTCA, the procedure failed in 15 patients because of an inability to reach or cross the target lesion (6.8%). Nine of these patients were crossed over to PTRA (4.1%), and 1 patient crossed over to ELCA (0.5%). The mean maximal balloon size was 3.0±0.6 mm. The maximal balloon-size-to-vessel-size ratio was 1.05±0.26.
ELCA was attempted but failed in 43 of the 232 patients randomly assigned to undergo this procedure (18.5%) because of an inability to reach or cross entirely the lesion with the laser catheter. Of these 43 patients, 30 (12.9% of the total) were crossed over to PTCA, and 6 were crossed over to Rotablator (2.6% of the total). Overall, 93% of the ELCA group received adjunctive balloon dilatation to achieve the final angiographic result. The mean maximal balloon size was 3.0±0.5 mm. The mean laser-catheter-size-to-vessel-size ratio was 0.55±0.14. Before adjunctive balloon dilatation, an improvement of ≥20% was achieved in 88 lesions (37.9%).
PTRA was attempted but failed in 7 of the 231 patients randomly assigned to receive this treatment (3%) because of an inability to access or cross entirely the lesion. Of these 7 patients, 2 were crossed over to PTCA (0.9%) and 1 patient to ELCA (0.4%). Adjunctive PTCA was performed in 93% of the PTRA group. The mean maximal balloon size was 3.0±0.6 mm. We used 1.3 burrs per patient with a mean maximal burr-size-to-vessel-size ratio of 0.58±0.16. Before adjunctive balloon dilatation, an improvement of ≥20% was achieved in 81 lesions (35.1%).
Table 2⇓ gives the procedural outcomes and complications that occurred during hospitalization. The procedural success rate (primary end point) was 79.7% in the PTCA group, 77.2% in the ELCA group, and 89.2% in the PTRA group (P=.0019). There was a higher crossover rate in the ELCA group than in the PTCA and PTRA groups (15.5% versus 5.0 and 1.3%, P<.001). After crossover, the procedural success rates increased to 83.3% in the PTCA group, 90.5% in the ELCA group, and 90.5% in the PTRA group (P=.025). The incidence of major in-hospital events (composite of death, coronary bypass surgery, and Q-wave myocardial infarction) was similar in the three groups: 3.1% in the PTCA group, 4.3% in the ELCA group, and 3.2% in the PTRA group; P=.71). There was no difference in the incidence of other complications, including non–Q-wave myocardial infarction, bailout stenting, and the need for acute reintervention, among the three groups. During hospitalization, 92.8% of the patients in the PTCA group, 94.4% of the patients in the ELCA group, and 93.1% of the patients in the PTRA group remained free of any adverse event (Table 2⇓).
Angiographic evidence for dissections at any stage during the procedure was detected in 46.7% of lesions after PTCA, 56.7% of lesions after ELCA, and 39.8% of lesions after PTRA (P<.001). Severe dissections (Thrombolysis in Myocardial Infarction flow <3, residual stenosis ≥50%, and length >10 mm) were detected after ELCA alone before adjunctive PTCA in 6.9% of lesions and after PTRA alone in 0.9% of lesions (P<.001). The final angiogram demonstrated a severe dissection in 9.9% of lesions in the PTCA group, 13.8% in the ELCA group, and 5.2% in the PTRA group (P=.007). In the laboratory, acute occlusion at the angioplasty site was not seen in the PTCA group, occurred in 3 ELCA patients (1.3%), and was seen in 2 patients (0.9%) treated with PTRA. Coronary artery perforation occurred in 1 patient (0.5%) in the PTCA group, in 3 patients (1.3%) in the ELCA group, and in 2 patients (0.9%) in the PTRA group. Perforation resulted in clinical events in 1 patient (bypass surgery) in the ELCA group and in 1 patient (bypass surgery and death) in the PTRA group. Slow-flow or no-flow phenomenon was observed in 2 patients (0.9%) of the PTRA group. The procedure was accompanied by transient coronary spasm in 1 patient (0.5%) treated with PTCA, in 28 patients (12.1%) treated with ELCA, and in 24 patients (10.4%) treated with PTRA.
Late Clinical Follow-up
Clinical follow-up data were available for 607 of the 615 patients (98.7%) fulfilling the inclusion criteria according to core laboratory analysis after primary treatment. Table 3⇓ and Fig 1⇓ show the cumulative clinical outcomes (0 to 360 days). A clinical end point (death, Q-wave myocardial infarction, coronary bypass surgery, or repeated angioplasty) was reached in 70 patients (36.6%) randomized to PTCA versus 101 patients (47.9%) randomized to ELCA and 94 patients (45.9%) assigned to PTRA (P=.057 for the three-group comparison; P=.015 for PTCA versus ELCA; P=.04 for PTCA versus PTRA). The proportion of patients who were Canadian Cardiovascular Society angina class 0-I at follow-up was similar in the three groups (PTCA, 63.6%, versus ELCA, 62.1%, versus PTRA, 62.7%).
Of the 70 patients who did not fulfill the inclusion criteria, 66 (94.3%) had a late follow-up with similar results: a clinical event (Q-wave myocardial infarction, repeated PTCA, coronary artery bypass surgery, or death) occurred in 5 of the 24 patients (20.8%) after PTCA, in 7 of 20 patients (35%) after ELCA, and in 10 of 22 patients (45.5%) after PTRA.
Table 1⇑ shows the luminal dimensions at baseline and immediately after the procedure. At baseline and after the procedure, there was no difference in the reference diameter or the severity of stenosis between the three groups. The procedures resulted in a similar acute gain in the luminal diameter and percent diameter stenosis, with best results for PTRA. Angiographic follow-up data were obtained for 397 of the 526 eligible patients (75.5%): 109 of 155 patients (70.3%) in the PTCA group, 143 of 187 patients (76.5%) in the ELCA group, and 145 of 184 patients (78.8%) in the PTRA group. Table 4⇓ and Fig 2⇓ give the quantitative angiographic data of these patients. The luminal diameter and percent diameter stenosis at follow-up were similar, with no difference in the luminal diameter net gain between the three groups. However, there was a trend toward a larger mean reduction in the luminal diameter in the ELCA group than in the PTCA and PTRA groups (0.77±0.73 versus 0.55±0.68 and 0.62±0.77 mm; P=.052; ELCA versus PTCA group, P<.05).
The restenosis rate was 47% (51 of 109 patients) in the PTCA group, 59% (85 of 143 patients) in the ELCA group, and 57% (82 of 145 patients) in the PTRA group (P=.14 for the three-group comparison; P=.039 for PTCA versus ELCA).
Our primary goal was to test the hypothesis that debulking with ELCA or PTRA before PTCA would increase the success rate and lower the complication rate in complex coronary lesions (type B or C). The results of this first randomized comparison of PTCA with two competitive techniques revealed a significantly higher success rate with PTRA compared with PTCA (89% versus 80%) and ELCA (89% versus 77%). The superiority of PTRA was due mainly to a lower technical failure rate (to reach and cross entirely the target lesion) and an increased ability to achieve a <50% diameter stenosis after adjunctive PTCA. We found a lower incidence of Q-wave myocardial infarction and no-reflow phenomenon in the PTRA group compared with registry data.6 Several modifications of the technique might be responsible: smaller burr sizes than recommended, short runs (10 to 15 seconds) with intervals to allow the debris to be flushed off, and a continuous infusion with nitroglycerin and verapamil to ensure maximal vasodilation of the coronary bed. Stents were used only as bailout devices; a more liberal use might have increased the success rate, especially in the PTCA group. On the other hand, during the trial period, the standard medical treatment after stenting was full anticoagulation, a strategy that caused considerable bleeding and subacute stent thrombosis. Additionally, early and late results of stents in complex coronary lesions have not yet been evaluated in randomized trials. Noteworthy, laser and rotablator techniques have been further refined after our study was completed. The use of saline flushing during laser ablation reduces the formation of vapor bubbles and may have a beneficial impact on success and complications.10 A more careful control of the rotational burr speed (drop ≤5000 rpm) should avoid heat generation and thus reduce restenosis, and the use of inflations at very low balloon pressures (≤2 bar) after rotablation might avoid vessel traumatization with impact on early and late outcome.
Considerably higher success rates and similar complication rates for ELCA have been reported in earlier series.4 11 Our less favorable findings may be explained by patient selection (high proportion of calcified lesions and exclusion of restenotic lesions and short concentric stenoses) and by the general observation that the success rates of randomized core laboratory–controlled studies are 5% to 10% lower compared with reports of observational data12 13 14 and as recently confirmed for ELCA.15 Our lower laser success rate resulted mainly from a significantly higher rate of technical failure (the inability to reach or cross entirely the lesion), often because the vessel was tortuous or the lesion calcified.
It is true that Ghazzal et al16 identified the degree of eccentricity as the most powerful predictor of complications after laser procedures. Our inclusion criterion, however, was “suitability for all three techniques,” and we therefore avoided very eccentric lesions and angulation >60°.
Unexpectedly, the rate of adverse events in the hospital was similar in the three groups. The failure to prove an advantage of debulking might be due to the fact that the procedural results and the incidence of complications with balloon angioplasty were better than those reported in earlier nonrandomized series in the literature for similar complex lesion morphology.1 2 3 Furthermore, the results in our PTCA group compare favorably with the results of other randomized trials in which complex lesions were excluded.5 6 7
Although the study was not powered for subgroup analysis, the advantage of PTRA (higher procedural success rate) appeared more striking in type B2 and C lesions compared with B1 lesions (in type B2/C lesions: PTCA, 74%; ELCA, 75%; and PTRA, 87%, P<.01; in type B1 lesions: PTCA, 96%; ELCA, 88%; and PTRA, 100%, P=.05).
Although the primary focus of this trial was on the comparison of immediate results, we were able to prospectively collect clinical follow-up in 98.7% of patients, and the frequency with which follow-up angiography was performed was relatively high in the three groups (75.5% of eligible patients). Comparison of the late angiographic and clinical outcomes of the three techniques revealed that the initial advantage of PTRA in procedural success rate did not translate into a superior long-term clinical outcome mainly because of an increased need for additional percutaneous intervention. This excess of need for additional revascularization was similarly observed in the ELCA group and confirms the findings of Appelman et al.15 The composite analysis of clinical end points, however, did not show a difference among the three groups for the rates of death, Q-wave myocardial infarction, and coronary bypass surgery.
Like all device trials in interventional cardiology, this is an unblinded study. In addition, patients were enrolled only in a single, high-volume center that might have a unique patient referral pattern and interventional technique.
After randomization and treatment, the core laboratory analysis identified 70 patients who did not fulfill inclusion criteria (16 type A lesions, 13 restenoses, 6 stenoses <50%, 12 bypass grafts, 6 various protocol violations, 2 films not suitable for analysis, and 15 interventions in patients enrolled in a different study). They were included in the evaluation of the acute results (intention to treat) but did not influence the outcome (primary success/severe complications) of those who met the inclusion criteria: PTCA (n=195; 80%/3.1%), ELCA (n=212; 77%/3.7%), and PTRA (n=208; 90%/2.5%).
Creatine kinase enzymes were measured 12 hours after the procedure. We might have missed some early and smaller enzyme rises considered non–Q-wave infarctions by some investigators.
We used an exceedingly high dose of 25 000 U heparin during the procedure, which has been documented in our laboratory to raise and maintain the activated clotting time >350 seconds during the overall duration of the procedure in 100% of 300 consecutive patients, thus reducing the rate of abrupt closure to <3% with an acceptable rate of bleeding complications (2.7%).
Although ELCA and PTRA are to some extent competitive techniques, there might be less overlap than assumed in 1992. Despite the theoretical potential of ELCA being able to ablate calcified tissue, we found a low procedural success rate in that subgroup (68%) that has been confirmed recently17 that contrasts with an 89% procedural success rate of calcified lesions in the PTRA group.
Another limitation of the trial was that the decision for a second intervention was left to the physician’s judgment on the basis of clinical information and the coronary anatomy at follow-up angiography. However, the vast majority of second intervention was substantiated on the basis of recurrent angina or objective evidence of ischemia (PTCA, 79.1%; ELCA, 73%; PTRA, 80.9%).
Our strategy to limit the size of the new devices used in this trial to approximately two thirds of the reference vessel size proved to be safe, as demonstrated by a very low rate of vessel perforation, major dissections requiring bailout stenting, no-reflow phenomenon, and severe coronary spasm requiring therapy. However, this rather conservative debulking approach, which often required adjunctive PTCA to obtain an acceptable residual stenosis, may also explain why quantitative analysis of angiographic results failed to demonstrate a significant difference between the three treatment arms in the postprocedural and follow-up minimum luminal diameter and residual percent diameter stenosis. The hypothesis that more debulking (more aggressive burr sizing) will result in a lower restenosis and repeated revascularization rate without increasing major complications needs further investigation.
Our results indicate that in patients with complex type B or C lesions, procedural success (<50% diameter stenosis by quantitative coronary analysis without major in-hospital complications) is higher in patients treated with PTRA than with PTCA or ELCA.
The incidence of restenosis (diameter stenosis ≥50%) was high in all three groups (PTCA, 47%; ELCA, 59%; and PTRA, 57%) and only significantly different between ELCA (59%) and PTCA (47%).
At present, the role of rotational atherectomy in the therapeutic arena may be viewed optimistically if restenosis is considered a benign disease that is easily treated with a second PTCA18 and that rotational atherectomy provides the means to expand the indication for percutaneous coronary interventions. Further evaluations are warranted to clarify whether the long-term results of complex lesions can be improved by more aggressive debulking, stenting, or a combined approach.
Selected Abbreviations and Acronyms
|ELCA||=||excimer laser coronary angioplasty|
|ERBAC||=||Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison|
|PTCA||=||percutaneous transluminal coronary angioplasty|
|PTRA||=||rotational atherectomy with rotablator system|
The following operators participated in the ERBAC study: N. Reifart, W. Preusler, F. Schwarz, J.W. Klöpper, M. Hofmann, H. Störger, E. Silberer, D. Witte, R. Wolf, M. Pieper, J. Haase, S. Müller, M. Vandormael, and B. Troger.
Angiographic core laboratory: M. Vandormael, J. Haase, S. Müller, B. Troger, R. Agrawal, and P. Kerkar.
Data coordination and analysis: M. Vandormael, M. Krajcar, S. Göhring, G. Groth, M. Hoyer, K. Kruse, T. Mehrling, M. Nowatzyk, A. Piotraschke, M. Sauermilch, and N. Semmler.
- Received October 24, 1996.
- Revision received January 16, 1997.
- Accepted February 2, 1997.
- Copyright © 1997 by American Heart Association
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