(Circulation. 1999;100:1285-1290.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Prognostic Value of the Modified American College of Cardiology/American Heart Association Stenosis Morphology Classification for Long-Term Angiographic and Clinical Outcome After Coronary Stent Placement
From the Deutsches Herzzentrum and 1. Medizinische Klinik rechts der Isar, Technische Universität München, Munich, Germany.
Correspondence to Dr Adnan Kastrati, Deutsches Herzzentrum, Lazarettstraße 36, 80636 München, Germany. E-mail kastrati{at}dhm.mhn.de
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Abstract |
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Background—The modified American College of Cardiology/American Heart Association (ACC/AHA) lesion morphology criteria are predictive of early outcome after various coronary catheter interventions. Their potential prognostic value after stent implantation and, in particular, for restenosis and long-term clinical outcome has not been studied. We assessed the prognostic value of the modified ACC/AHA criteria for the long-term angiographic and clinical outcome of patients after coronary stenting.
Methods and Results—This study includes 2944 consecutive patients with symptomatic coronary artery disease treated with coronary stent placement. Modified ACC/AHA lesion morphology criteria were used to qualitatively assess the angiograms; type A and B1 lesions were categorized as simple, and type B2 and C lesions were designated complex. Primary end points were angiographic restenosis and 1-year event-free survival. Restenosis rate was 33.2% in complex lesions and 24.9% in simple lesions (P<0.001). It was 21.7% for type A, 26.3% for type B1, 33.7% for type B2, and 32.6% for type C lesions. One-year event-free survival was 75.6% for patients with complex lesions and 81.1% for patients with simple lesions (P<0.001). It was 85.2% for patients with type A, 79.4% for type B1, 75.9% for type B2, and 75.2% type C lesions. The higher risk for restenosis and an adverse outcome associated with complex lesions was also maintained after multivariate adjustment for other clinical and angiographic characteristics.
Conclusions—The modified ACC/AHA lesion morphology scheme has significant prognostic value for the outcome of patients after coronary stent placement. Lesion morphology is able to influence the restenosis process and thus the entire 1-year clinical course of these patients.
Key Words: stents • thrombosis • restenosis • lesion
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Introduction |
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The American College of Cardiology/American Heart Association (ACC/AHA) classification system for lesion morphology was intended to assist in the selection of patients most suitable for percutaneous coronary interventions and in the prediction of risk of procedure failure or complications.1 2 Indeed, previous studies have shown more complex lesions to be associated with a lower success rate and/or a higher incidence of complications after PTCA,3 directional atherectomy,4 and rotational atherectomy.5 Coronary catheter interventions in complex lesions have also been associated with higher costs.6 In addition, the classification system has been useful for evaluating the suitability for PTCA, directional atherectomy, rotational ablation, or CABG of patients needing coronary revascularization.7 8 Other studies, however, have questioned the value of this classification scheme as a decision-tree element in the selection of the most suitable coronary intervention in a given patient.9 10 At the same time, some studies could not demonstrate a substantial prognostic value for the ACC/AHA grading system.11 12 13 This role has been found to have vanished, particularly in the era of new devices for catheter interventions.14 We recently demonstrated a sustained predictive power of lesion complexity for the procedural success and early clinical outcome after coronary stent placement.15 Surprisingly, little attention has been paid to the assessment of the influence of lesion complexity according to the ACC/AHA criteria on long-term angiographic and clinical outcome of patients undergoing catheter interventions. A retrospective analysis of the Canadian Coronary Atherectomy trial (CCAT), the design of which excluded type C lesions, found no differences in 6-month angiographic late loss between type A and B lesions treated with either PTCA or atherectomy.9
The objective of this study was to assess, on the basis of prospectively collected data, the prognostic value of lesion complexity for the long-term angiographic and clinical outcome of patients after coronary stent placement.
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Methods |
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Patients
This study includes 2944 consecutive patients with symptomatic coronary artery disease who underwent coronary stent placement in Deutsches Herzzentrum and 1. Medizinische Klinik rechts der Isar der Technischen Universität München. Only patients who were treated with stenting in the setting of acute myocardial infarction were excluded from the study. Stent implantation was the intended procedure for all study patients.
Stent Placement and Poststenting Treatment
The protocol for stent placement and poststenting therapy is
described in detail elsewhere.16 17 Various stent types,
including Palmaz-Schatz (Johnson & Johnson Interventional Systems Co),
Inflow (Inflow Dynamics AG), PURA A (Devon Medical), NIR (a Medinol
Ltd product, Scimed Life Systems, Inc), and MULTI-LINK (Guidant,
Advanced Cardiovascular Systems, Inc.), were implanted.
Most stents were placed hand-crimped on conventional angioplasty
balloon catheters.
Angiographic Assessment
Lesions were classified according to the modified ACC/AHA
grading system3 as type A, B1, B2, or C. Left
ventricular function was assessed qualitatively on the
basis of biplane angiograms with a 7-segment division; the diagnosis of
reduced left ventricular function was established when 
2
segments were hypokinetic. Offline quantitative angiographic
analysis was performed with the use of digital angiograms taken
in matched views before and immediately after intervention and at
follow-up. Both qualitative (including lesion classification) and
quantitative analyses were done on the day of intervention by
experienced angiographers who were not involved in the procedure and
were unaware of patient outcome. The software used was the automated
edge-detection system CMS (Medis Medical Imaging Systems). The
angiographic parameters obtained were minimal lumen
diameter (MLD), interpolated reference diameter, diameter
stenosis, lesion length, and diameter of the maximally inflated
balloon during the procedure. Acute lumen gain was the difference
between final poststenting MLD and preprocedure MLD. Late lumen loss
was the difference between final poststenting MLD and MLD at follow-up.
Loss index was calculated as the ratio between late lumen loss and
acute lumen gain.
Definitions and Follow-Up
Lesions of ACC/AHA type B2 or C were considered complex; those
of type A or B1, simple. The absolute number of stents implanted was
recorded regardless of length. The length of the stented segment
was calculated as the sum of the length of all stents implanted in the
lesion. The procedure was considered successful when stent placement
was associated with a residual stenosis of <30% and TIMI flow
grade 2. Early stent thrombosis was defined as angiographically
proven stent vessel occlusion (TIMI flow grade 0 or 1) during the first
30 days after the procedure. Binary restenosis was defined as a
diameter stenosis of 50% at follow-up angiography. Death of
any cause, myocardial infarction, and target vessel
revascularization (TVR; PTCA or
aortocoronary bypass surgery) were considered major adverse
cardiac events. All deaths were considered to be due to cardiac causes
unless an autopsy established a noncardiac cause. The diagnosis of
myocardial infarction was established in the presence of a clinical
episode of prolonged chest pain and a rise in serum creatine kinase
(CK) levels to 2 times the upper normal limit or the appearance of
1 new pathological Q waves on the ECG. Serum CK levels were
determined at least once 8 to 24 hours after the intervention
regardless of symptoms and whenever a prolonged ischemic
episode was suspected during the hospital stay. We also recorded
the incidence of non–Q-wave myocardial infarction defined according to
the criteria applied in the EPISTENT (EPILOG Stent) trial (a value of
CK or its MB isoenzyme of 3 times the upper limit).18
TVR was indicated in the presence of angiographic restenosis
plus anginal symptoms or objective signs of ischemia. The
follow-up protocol included phone contact or a medical visit at the
outpatient clinic at 30 days and between 9 and 15 months after stent
placement, as well as a control angiography at 6 months. The 6-month
angiographic follow-up was scheduled for all patients who had no major
adverse cardiac events during the early 30-day period.
Primary end points of the study were angiographic restenosis at 6 months and event-free survival 1 year after intervention. Secondary end points were stent vessel occlusion and adverse clinical events during the first 30 days after the procedure.
Statistical Analysis
Data are expressed as mean±SD or as proportions. Comparisons
between patients with complex and those with simple lesions were made
with the 
2 test for categorical variables
and the 2-sided t test for continuous data. The test for
trend was used for analyzing categorical data and multiple group ANOVA
was used for continuous data among the 4 ACC/AHA types. In addition,
for the primary end points of the study, univariate
logistic regression analysis (angiographic restenosis)
and a Cox regression analysis (survival) were used to calculate
the differences in risk between 2 specific ACC/AHA types, accounting
for multiple group comparisons. The Kaplan-Meier method and log-rank
test were used to compare the 1-year event-free survival rates between
various groups. The potential independent role of lesion complexity in
late outcome was assessed with multivariate methods.
All clinical, angiographic, and procedural variables that differed
significantly between the 2 groups in monovariate analysis were
entered into the multivariate analysis
concomitantly with lesion complexity. Two models were constructed for 2
different outcome variables: a multiple logistic regression model
for binary restenosis and a Cox proportional-hazards model for
event-free survival. These models allowed calculation of the adjusted
risk of restenosis (odds ratio [OR] and 95% CI from logistic
regression analysis) and 1-year adverse outcome (hazard ratio
and 95% CI from Cox analysis) associated with lesion
complexity. Statistical significance was accepted for values of
P<0.05.
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Results |
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Patient Characteristics
There were 264 patients with type A lesions, 634 with type B1, 1152 with type B2, and 894 with type C. Main baseline characteristics of the patients are listed in Tables 1
and 2. Patients with complex
lesions were older; were more likely to be men; and more frequently had
unstable angina, reduced left ventricular function,
multivessel disease, and more severe stenosis. Patients with
complex lesions were treated by use of a higher balloon pressure and a
larger number of stents and presented more frequently with
overlapping stents and uncovered residual dissections at the end of the
procedure. The procedure was successful in 97.6% of patients with
complex lesions and 98.9% of those with simple lesions
(P=0.02). Of the 2824 patients eligible for 6-month
angiographic follow-up, 2296 patients (81%) had control angiography at
a median of 187 days (interquartile range, 167 to 203 days) after the
procedure. The rate of angiographic follow-up was not associated with
lesion complexity; it was 82% in patients with complex lesions and
80% in those with simple lesions (P=0.2). Patients who
failed to have angiographic restudy were less likely to have
restenotic lesions (P<0.001) and had shorter
lesions (P=0.04) at baseline than patients who underwent
follow-up angiography, all other clinical, angiographic, and procedural
characteristics being similar.
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Early (30-Day) Outcome
Stent vessel occlusion occurred more often in complex lesions
(2.7% versus 1.3% in simple lesions, P=0.02). It occurred
in 0.8% of type A lesions, 1.6% of type B1, 1.7% of type B2, and
3.9% of type C (P<0.001, test for trend). The incidence of
death was 1.2% in patients with complex lesions and 0.7% in those
with simple lesions (P=0.21). Nonfatal Q-wave myocardial
infarction was observed in 1.4% of patients with complex and 0.6% of
patients with simple lesions (P=0.04). On the basis of CK
determinations during the first 24 hours after procedure (single
determination in 1424 patients and serial determinations every 8 hours
in 1520), the incidence of non–Q-wave myocardial infarction was 4.4%
in patients with complex and 2.2% in those with simple lesions
(P=0.004). The combined event rate of death, Q-wave
myocardial infarction, or TVR was 4.7% in patients with complex and
2.7% in patients with simple lesions (P=0.01). More
specifically, it was 2.6% in patients with type A lesions, 2.7% in
type B1, 3.7% in type B2, and 6.0% in type C (P<0.001,
test for trend).
Late Outcome
Table 3 shows the quantitative
results of the 6-month angiographic follow-up. All
parameters of lumen renarrowing were significantly less
favorable in complex lesions. Restenosis rate was 33.2% in
complex lesions and 24.9% in simple lesions (P<0.001). It
was 21.7% for type A lesions, 26.3% for type B1, 33.7% for type B2,
and 32.6% for type C (P<0.001, test for trend). Similarly,
the proportion of treated lesions found totally occluded at follow-up
angiography increased significantly with the increase in lesion
complexity: 1.5% in type A lesions, 2.4% in type B1, 4.3% in type
B2, and 3.9% in type C (P=0.048, test for trend). Late
lumen loss was also greater in complex lesions (P<0.001,
Figure 1). It was 0.90±0.72 mm for
type A lesions, 1.03±0.74 mm for type B1, 1.20±0.85 mm for
type B2, and 1.17±0.81 mm for type C (P<0.001).
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All variables for which univariate analysis yielded a significant difference (age, sex, unstable angina, reduced left ventricular function, multivessel disease, vessel location, abrupt closure before stenting, preprocedural diameter stenosis and lesion length, balloon pressure, number of stents, stented length, stent overlap, and large residual dissection) were entered into the multivariate logistic model as potential predictors of restenosis along with lesion complexity. The presence of complex lesions was associated with a 33% independent risk increase for restenosis (OR, 1.33; 95% CI, 1.07 to 1.64; P=0.009). Other significant independent risk factors for restenosis were lesion location in left anterior descending (P=0.008) or left circumflex (P=0.006) coronary artery, a tighter (P<0.001) and longer (P=0.03) stenosis before intervention, a greater number of stents implanted (P=0.02), and the presence of stent overlap (P=0.002). The independent predictive value of lesion complexity was further potentiated (P=0.004) when we included vessel size (P<0.001) in the multivariate model.
Event-free survival (free of myocardial infarction or TVR) at 1 year
was 75.6% for patients with complex lesions and 81.1% for patients
with simple lesions (P<0.001; Figure 2). All variables mentioned above for
the model of restenosis were entered into the Cox model for
event-free survival. The presence of complex lesions was associated
with a 27% independent risk increase for an adverse outcome (hazard
ratio, 1.27; 95% CI, 1.06 to 1.52; P=0.01). Other
significant independent risk factors for an adverse outcome were lesion
location in left anterior descending (P=0.03) or left
circumflex (P=0.02) coronary artery and a tighter
(P=0.006) and longer (P=0.002) stenosis
before intervention. According to the specific ACC/AHA type, event-free
survival was 85.2% for patients with type A lesions, 79.4% for type
B1, 75.9% for type B2, and 75.2% for type C (P=0.003).
Patients with complex lesions showed a trend to decreased survival free
of myocardial infarction compared with patients with simple lesions
(94.1% versus 95.5%, P=0.11). The 1-year risk of death of
any cause was 3.7% for patients with complex lesions and 3.6% for
patients with simple lesions; mortality caused by noncardiac causes was
0.9% in both groups. Regardless of lesion complexity, the 1-year
mortality rate was 25% among those who incurred a Q-wave myocardial
infarction during the first 30 days after stenting, 13.6% in those
with non–Q-wave myocardial infarction, and 2.9% among patients
without myocardial infarction as an early complication
(P<0.001). The frequency of TVR was 20.7% in patients with
complex lesions and 15.4% in those with simple lesions
(P<0.001). It was 11.4% for type A lesions, 17.0% for
type B1, 20.7% for type B2, and 20.6% for type C
(P<0.001, test for trend). In patients who underwent TVR,
restenosis severity was comparable to that of the original
lesion, with diameter stenosis of 75.4±16.5% at follow-up
angiography compared with 75.6±14.3% before initial stent placement
procedure (P=0.83). In addition, in patients with complex
lesions, TVR was carried out in the presence of more severe
restenosis than in patients with simple lesions, with diameter
stenoses of 76.4±15.6% and 72.4±19.1%, respectively
(P=0.03).
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Table 4 summarizes the results of paired
comparisons among ACC/AHA types accounting for multiple groups. It
shows that significant risk differences are confined to the comparisons
between type C and B2 lesions on 1 side and type A and B1 lesions on
the other side.
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Discussion |
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The present study demonstrates that the modified ACC/AHA lesion morphology classification system has significant independent prognostic value for the outcome of patients after coronary stent placement. Interestingly, lesion complexity influenced not only the early but also the long-term outcome through its negative impact on restenosis.
Lesion Morphology and Early Outcome
In 350 patients, Ellis et al3 found a steady increase
in complication rate with higher grades of lesion complexity. It was
2.4% for type A lesions, 8% for type B1, 10% for type B2, and 17.5%
for type C.3 Our 30-day results relative to the incidence
of stent thrombosis and adverse clinical events confirm that lesions
with more complex morphology continue to be a major source of
complications even after coronary stenting. The usefulness of
the ACC/AHA modified classification scheme has also been documented for
newer devices such as directional and rotational
atherectomy.4 5 Our study expands the case for using these
classification criteria to assess risk in patients undergoing
coronary stent placement. This is in apparent contrast to a few
recent studies that assessed the prognostic value of ACC/AHA lesion
morphology criteria for interventions performed in the 1990s and found
no significant differences in the rate of complications among type A,
B, and C lesions.10 11 12 13 These studies concur, however, in
the conclusion that advances in technology and the advent of new
devices in interventional cardiology have reduced the
overall incidence of complications after percutaneous
coronary interventions.10 12 13 The overall event
rate varied from 3% to 3.8% in these studies10 12 13
compared with 8.6% in the study of Ellis et al.3 The
current decline in adverse clinical events is also evident from the
results of the present study. An inevitable side effect of the
decreased untoward event rate after coronary catheter
interventions is a power reduction of the studies aimed at assessing
the role of lesion morphology.
Lesion Morphology and Late Outcome
This study demonstrates for the first time the protraction of the
influence of lesion morphology on outcome beyond the first month after
coronary stent implantation. Event-free survival was
significantly lower in patients with complex lesions even after
controlling for other risk factors. It is reassuring that the combined
incidence of death and myocardial infarction in patients with complex
lesions was not significantly higher than that verified for patients
with simple lesions. Thus, our data may not refute the usefulness of
stenting in the presence of lesions with more complex morphology. Most
of the difference in event-free survival between the groups with
complex and simple lesions was produced by a more frequent need of TVR
in patients with complex lesions. This is to be attributed to the
higher restenosis rate in this group of patients. Intravascular
ultrasound studies have found that plaque burden before intervention
was a powerful risk factor for restenosis,19 and
plaque burden is expected to be greater in complex lesions. We found
significant differences between type B2 and B1 lesions, which indicate
that type B as originally defined in the ACC/AHA criteria1
contains 2 distinct groups of lesions with different risks for
restenosis. Therefore, our findings constitute further support
for the modification made to the ACC/AHA scheme.3 Although
there was a stepwise increase in early event rates as lesion complexity
went from type A to C, significant differences in long-term outcome
measures were seen mostly between 2 groups of lesions composed of types
A and B1 and types B2 and C. Thus, for simplicity, the 4 types of the
modified ACC/AHA classification scheme can be further condensed into 2
types, simple and complex lesions, in the same way that was used often
in this study to present the results. The findings of our study
relative to the significant association between lesion complexity and
long-term outcome after coronary stent placement legitimize the
recommendation that modified ACC/AHA criteria should become integral
part of the list of factors that serve for risk assessment of patients
undergoing coronary stent placement.
Study Limitations
Although all data were prospectively collected with the objective
of assessing the potential association between lesion complexity and
long-term outcome after stenting, the study lacks a fully prospective
design with a well-defined prior hypothesis, and this should be
considered a limitation. In addition, 20% of patients equally
distributed between our study groups failed to undergo angiographic
follow-up. The complete 1-year clinical follow-up achieved in this
study, however, may attenuate the limitation caused by this level of
missing angiographic restudy. Conventional angioplasty, with or without
intracoronary stents, remains the dominant treatment strategy
in current coronary interventional practice. The major
limitation of the present study lies in the fact that while
providing evidence about the importance of lesion morphology in
determining the early and long-term outcome after coronary
stent placement, it is a monodevice study that does not offer direct
help for defining the best interventional strategy for complex lesions.
Randomized studies have already proven the advantages of stenting over
plain PTCA for the treatment of patients with coronary artery
disease,20 but the results were confined primarily to
relatively simple lesions. The present study further underscores
the need to compare stenting with other catheter interventions,
especially conventional PTCA, for the treatment of patients with
complex lesions. Interpretation of the results of the present study
should also take into account the interobserver and intraobserver
variabilities in grading of coronary lesions according to
ACC/AHA criteria.21
Conclusions
This study demonstrates that the modified ACC/AHA lesion
morphology scheme has significant prognostic value for outcome after
coronary stent placement. This value is not confined to the
early postinterventional period only. Lesion morphology is able to
influence the restenosis process and thus the entire 1-year
clinical course of patients treated with intracoronary
stenting. Therefore, the modified ACC/AHA grading system should be
considered a useful prognostic index for risk assessment in patients
undergoing coronary stent placement.
Received March 24, 1999; revision received June 14, 1999; accepted June 23, 1999.
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J. Mehilli, A. Kastrati, H. Bollwein, A. Dibra, H. Schuhlen, J. Dirschinger, and A. Schomig Gender and restenosis after coronary artery stenting Eur. Heart J., August 2, 2003; 24(16): 1523 - 1530. [Abstract] [Full Text] [PDF]
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O. Gorchakova, W. Koch, N. von Beckerath, J. Mehilli, A. Schomig, and A. Kastrati Association of a genetic variant of endothelial nitric oxide synthase with the 1 year clinical outcome after coronary stent placement Eur. Heart J., May 1, 2003; 24(9): 820 - 827. [Abstract] [Full Text] [PDF]
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S. C. Smith Jr, J. T. Dove, A. K. Jacobs, J. Ward Kennedy, D. Kereiakes, M. J. Kern, R. E. Kuntz, J. J. Popma, H. V. Schaff, D. O. Williams, et al. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines): A report of the American College of Cardiology/ American Heart Association Task Force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions J. Am. Coll. Cardiol., June 15, 2001; 37(8): 2239 - 2239. [Full Text] [PDF]
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W. Maier, O. Mini, J. Antoni, M. B. Wischnewsky, and B. Meier ABC Stenosis Morphology Classification and Outcome of Coronary Angioplasty : Reassessment With Computing Techniques Circulation, March 6, 2001; 103(9): 1225 - 1231. [Abstract] [Full Text] [PDF]
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J. Mehilli, A. Kastrati, J. Dirschinger, H. Bollwein, F.-J. Neumann, and A. Schomig Differences in Prognostic Factors and Outcomes Between Women and Men Undergoing Coronary Artery Stenting JAMA, October 11, 2000; 284(14): 1799 - 1805. [Abstract] [Full Text] [PDF]
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J. Al Suwaidi, P. B. Berger, and D. R. Holmes Jr Coronary Artery Stents JAMA, October 11, 2000; 284(14): 1828 - 1836. [Abstract] [Full Text] [PDF]
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