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(Circulation. 1997;96:91-98.)
© 1997 American Heart Association, Inc.
Articles |
Randomized Comparison of Angioplasty of Complex Coronary Lesions at a Single Center
Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study
From Herzzentrum Frankfurt (Germany).
Correspondence to Nicolaus Reifart, MD, Herzzentrum Frankfurt, PO Box 10 10 63, D-60010 Frankfurt am Main, Germany.
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Abstract |
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 Top Abstract IntroductionMethodsResultsDiscussionAppendix 1References |
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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.
Key Words: angioplasty • lasers • atherectomy
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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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.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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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.
Patient Selection
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
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.
Revascularization Procedures
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.
Follow-up
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.
End Points
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 
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 
2 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.
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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Study Population
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).
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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).
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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%).
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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.
Angiographic Results
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).
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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).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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In-Hospital Results
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).
Follow-up Results
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.
Study Limitations
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.
Conclusions
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.
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Selected Abbreviations and Acronyms |
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Appendix 1 |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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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.
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References |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix 1References |
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1. Ryan TJ, Bauman WB, Kennedy JW, Kereiakes DJ, King SB III, McCallister BD, Smith SC Jr, Ullyot DJ. Guidelines for percutaneous transluminal coronary angioplasty: a report of the American Heart Association/American College of Cardiology Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on Percutaneous Transluminal Coronary Angioplasty). Circulation.. 1993;88:2987-3007.
2.
Ellis SG, Vandormael MG, Cowley MJ, Di Sciascio G,
Deligonul U, Topol EJ, Bulle TM. Coronary morphologic
and clinical determinants of procedural outcome with angioplasty for
multivessel coronary disease: implications for patient
selection. Circulation.. 1990;82:1193-1202.
3. Myler RK, Shaw RE, Stertzer SH, Hecht HS, Ryan C, Rosenblum J, Cumberland DC, Murphy MC, Hansell HN, Hidalgo B. Lesion morphology and coronary angioplasty: current experience and analysis. J Am Coll Cardiol.. 1992;19:1641-1652.[Abstract]
4. Litvack F, Eigler N, Margolis J, Rothbaum D, Bresnahan JF, Holmes D, Untereker W, Leon M, Kent K, Pichard A, King S, Ghazzal Z, Cummins F, Krauthamer D, Palacios I, Block P, Hartzler GO, O'Neill W, Cowley M, Roubin G, Klein LW, Frankel PS, Adams C, Goldenberg T, Laudenslager J, Grundfest WS, Forrester JS. Percutaneous excimer laser coronary angioplasty: results in the first consecutive 3,000 patients: the ELCA Investigators. J Am Coll Cardiol.. 1994;23:323-329.[Abstract]
5.
Ellis SG, Popma JJ, Buchbinder M, Franco I, Leon MB,
Kent KM, Pichard AD, Satler LF, Topol EJ, Whitlow PL. Relation
of clinical presentation, stenosis morphology, and
operator technique to the procedural results of rotational atherectomy
and rotational atherectomy-facilitated angioplasty.
Circulation.. 1994;89:882-892.
6. Warth DC, Leon MB, O'Neill W, Zacca N, Polissar NL, Buchbinder M. Rotational atherectomy multicenter registry: acute results, complications and 6-month angiographic follow-up in 709 patients. J Am Coll Cardiol.. 1994;24:641-648.[Abstract]
7.
Baumbach A, Oswald H, Kvasnicka J, Fleck E,
Geschwind HJ, Ozbek C, Reifart N, Bertrand ME, Karsch KR.
Clinical results of coronary excimer laser angioplasty: report
from the European Coronary Excimer Laser Angioplasty
Registry. Eur Heart J.. 1994;15:89-96.
8.
Uehata A, Matsuguchi T, Bittl JA, Orav J, Meredith IT,
Anderson TJ, Selwyn AP, Ganz P, Yeung AC. Accuracy of electronic
digital calipers compared with quantitative angiography in measuring
coronary arterial diameter.
Circulation.. 1993;88:1724-1729.
9. Reiber JH, Kooijman CJ, Den Boer A, Serruys PW. Assessment of dimensions and image quality of coronary contrast catheters from cineangiograms. Cathet Cardiovasc Diagn. 1985;11:521-531.[Medline] [Order article via Infotrieve]
10. Deckelbaum LI, Natarajan MK, Bittl JA, Rohlfs K, Scott J, Chisholm R, Bowman KA, Strauss BH. Effect of intracoronary saline infusion on dissection during excimer laser coronary angioplasty: the Percutaneous Excimer Laser Coronary Angioplasty (PELCA) Investigators. J Am Coll Cardiol.. 1995;26:1264-1269.[Abstract]
11. Bittl JA, Sanborn TA, Tcheng JE, Siegel RM, Ellis SG. Clinical success, complications and restenosis rates with excimer laser coronary angioplasty: the Percutaneous Excimer Laser Coronary Angioplasty Registry. Am J Cardiol.. 1992;70:1533-1539.[Medline] [Order article via Infotrieve]
12.
Topol E, Leya F, Pinkerton C, Whitlow P, Hofling B,
Simonton C, Masden R, Serruys P, Leon M, Williams D, King III S, Mark
D, Isner J, Holmes D, Ellis S, Lee K, Keeler G, Berdan L, Hinohara T,
Califf R. A comparison of directional atherectomy with
coronary angioplasty in patients with coronary artery
disease: the CAVEAT Study Group. N Engl J
Med.. 1993;329:221-227.
13.
Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch
W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, Belardi
J, Sigwart U, Colombo A, Goy JJ, van den Heuvel P, Delcan J, Morel
M. A comparison of balloon-expandable stent implantation with
balloon angioplasty in patients with coronary artery
disease. N Engl J Med.. 1994;331:489-495.
14.
Fischman DL, Leon MB, Baim DS, Schatz RA, Savage
MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, Cleman M, Heuser
R, Almond D, Teirstein PS, Fish RD, Colombo A, Brinker J, Moses J,
Shaknovich A, Hirshfeld J, Bailey S, Ellis S, Rake R, Goldberg
S. A randomized comparison of coronary-stent placement
and balloon angioplasty in the treatment of coronary artery
disease: Stent Restenosis Study Investigators.
N Engl J Med.. 1994;331:496-501.
15. Appelman YEA, Piek JJ, Strikwerda S, Tijssen JGP, De Feyter PJ, David GK, Serruys PW, Margolis JR, Koelemay, MJ, Montauban van Swijndregt EWJ, Koolen JJ. Randomised trial of excimer laser angioplasty versus balloon angioplasty for treatment of obstructive coronary artery disease. Lancet.. 1996;347:79-84.[Medline] [Order article via Infotrieve]
16.
Ghazzal ZMB, Hearn JA, Litvack F, Goldenberg T, Kent
KM, Eigler N, Douglas JS, King SB III. Morphological predictors of
acute complications after percutaneous excimer laser
coronary angioplasty. Circulation.. 1992;86:820-827.
17.
Mintz GS, Kovach JA, Javier SP, Pichard AD, Kent KM,
Popma JJ, Salter LF, Leon MB. Mechanism of lumen enlargement
after excimer laser coronary angioplasty: an intravascular
ultrasound study. Circulation.. 1995;92:3408-3414.
18. Schwarz F, Störger H, Preusler W, Reifart N, Baier T, Schlotzer P, Neubauer A, Heinsen S. Langzeiterfolg der Koronarangioplastie nach wiederholten Eingriffen. Dtsch Med Wochenschr.. 1990;115:1779-1782.[Medline] [Order article via Infotrieve]
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