(Circulation. 1999;100:910-917.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Influence of Pre-PTCA Strategy and Initial PTCA Result in Patients With Multivessel Disease
The Bypass Angioplasty Revascularization Investigation (BARI)
From the Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pa (K.E.K., K.M.D); Montreal Heart Institute, Montreal, Canada (M.G.B.); Boston Medical Center, Boston, Mass (A.K.J.); Toronto Hospital, Toronto, Canada (L.S.); New York University Medical Center, New York, NY (F.F.); Stanford University Medical Center, Palo Alto, Calif (E.L.A.); University of Massachusetts Medical Center, Worcester, Mass (B.H.W.); New York Medical College, Valhalla, NY (M.B.W.); Maine Medical Center, Portland, Me (M.A.K.); Rhode Island Hospital, Providence, RI (B.L.S.); Cleveland Clinic Foundation, Cleveland, Ohio (A.D.); Duke University Medical Center, Durham, NC (R.H.J.); and the National Heart, Lung, and Blood Institute, Bethesda, Md (G.S.).
Correspondence to Kevin E. Kip, PhD, University of Pittsburgh, Graduate School of Public Health, 130 DeSoto St, 127 Parran Hall, Pittsburgh, PA 15261. E-mail kip{at}edc.gsph.pitt.edu
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Abstract |
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Background—In PTCA patients with multivessel coronary artery disease, incomplete revascularization (IR) is the result of both pre-PTCA strategy and initial lesion outcome. The unique contribution of these components on long-term patient outcome is uncertain.
Methods and Results—From the Bypass Angioplasty Revascularization Investigation (BARI), 2047 patients who underwent first-time PTCA were evaluated. Before enrollment, all significant lesions were assessed by the PTCA operator for clinical importance and intention to dilate. Complete revascularization (CR) was defined as successful dilatation of all clinically relevant lesions. Planned CR was indicated in 65% of all patients. More lesions were intended for PTCA in these patients compared with those with planned IR (2.8 versus 2.1). Successful dilatation of all intended lesions occurred in 45% of patients with planned CR versus 56% with planned IR (P<0.001). In multivariable analysis, planned IR (versus planned CR), initial lesions attempted (not all versus all intended lesions attempted), and initial lesion outcome (not all versus all attempted lesions successful) were unrelated to 5-year risk of cardiac death or death/myocardial infarction but were all independently related to risk of CABG.
Conclusions—Overall, a pre-PTCA strategy of IR in BARI-like patients appears comparable to a strategy of CR except for a higher need for CABG. Whether the use of new devices may attenuate the elevated risk of CABG in patients with multivessel disease and planned IR remains to be determined.
Key Words: angioplasty • coronary disease • revascularization
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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The effect of incomplete revascularization (IR) on clinical outcome in patients with multivessel coronary artery disease (CAD) treated with PTCA remains unclear.1 2 3 4 5 6 7 8 9 10 11 12 Early reports1 2 3 suggest higher rates of CABG and angina in patients incompletely versus completely revascularized with PTCA, whereas others, including those with adjustment for differences in pretreatment clinical profiles,4 7 report modest or no adverse effect associated with IR. Small patient cohorts and different analytic techniques and definitions of complete revascularization (CR) have contributed to the uncertainty.
Anatomic IR in patients with multivessel CAD can occur for several reasons, including untreated chronic total occlusions considered not amenable to PTCA; untreated, less-than-severe coronary narrowings (ie, 50% to 69%); untreated lesions supplying akinetic or dyskinetic left ventricular segments; and less frequently, unsuccessful lesion dilation.13 Thus, both pre-PTCA treatment strategy and initial outcome of treated lesions determine the patient's anatomic completeness of revascularization. Conceptually, when revascularization is anatomically incomplete, it can be subdivided by functional adequacy or inadequacy (ie, revascularization of all versus not all stenoses in arteries supplying viable myocardium), and this distinction appears to have prognostic significance.9 10 Hence, investigation of the effect of IR on clinical outcome requires consideration of pre-PTCA strategy, initial dilatation success, and functional significance of the myocardial territory revascularized.
Here, we evaluate the relative contributions of pre-PTCA strategy (planned CR versus planned IR), initial lesions attempted (whether or not all planned lesions were attempted), and initial lesion outcome on short- and long-term clinical outcome in patients with multivessel disease.
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Methods |
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Patient Population
A total of 2047 patients who underwent first-time PTCA were considered. This included 900 of 904 patients who were assigned to and received PTCA in the Bypass Angioplasty Revascularization Investigation (BARI) randomized trial, a randomized study of 1829 patients comparing initial PTCA versus CABG.14 15 Also included were 1147 of 1189 eligible patients who did not agree to participate in the randomized trial but consented to be followed in an observational registry and received initial PTCA within 3 months of study entry (Figure 1
). Recruitment and selection criteria of
BARI have been described elsewhere.14 15 16 Briefly,
eligibility required clinically severe angina or objective evidence of
ischemia requiring revascularization,
multivessel CAD suitable for both PTCA and CABG, and informed consent.
Ability to achieve CR was not required, although the protocol required
anticipated successful relief of the major areas of ischemia.
Patients were enrolled in 18 centers across North America between
August 1988 and August 1991.
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Forty-six patients who received initial PTCA were excluded (4 randomized and 42 registry patients) because of incomplete angiographic data. A central radiological laboratory interpreted angiograms from patients in the randomized trial; however, the same mechanism was not used in the observational registry. Therefore, clinical site readings were used for all patients.
Angiographic Definitions
Angiographically significant lesions were defined as 
50%
stenoses in a vessel 1.5 mm, as measured by electronic
calipers.17 The number of diseased vessels was determined
from the 3 major coronary perfusion territories (anterior,
lateral, and inferoposterior) supplied by a vessel with a significant
lesion. Lesion complexity was classified by use of American Heart
Association/American College of Cardiology consensus
panel criteria.18 Flow distal to each stenosis was
defined by TIMI flow criteria.19 A reduction in
stenosis of 20% with residual stenosis of <50% and
TIMI grade 3 flow defined successful lesion dilation.
Determination of Pre-PTCA Strategy and Initial Completeness of
Revascularization
Before patients entered the study, their angiograms were
reviewed by the PTCA operator to assess the clinical importance of each
significant lesion and its suitability for PTCA.20
Angiographically significant lesions were judged as culprit
(responsible, entirely or partially, for the patient's clinical
syndrome), important (contributed to patient's ischemic
syndrome), borderline (considered for
revascularization incidental to treatment of
culprit/important lesions), or unimportant (territory too small or
nonviable myocardium–ie, on the basis of evidence of
transmural infarction). For lesions considered culprit, important, or
borderline, the intention (yes versus no) to perform PTCA was
indicated. About 4% of all significant lesions were not rated for
clinical importance or intention. These lesions were generally
characterized as class C, excessively long or diffuse, and were assumed
to be unintended for PTCA.
CR was considered planned when all lesions deemed culprit, important, or borderline were designated by the PTCA operator as intended for revascularization. Otherwise, the patient had a pre-PTCA strategy of IR. Thus, the definition of planned CR refers to functionally adequate revascularization. When CR was planned and all intended lesions were successfully dilated, the patient was considered to be completely revascularized.
Data Collection
Details of the initial PTCA and follow-up clinical events,
including procedural and long-term mortality, recurrence of
angina, and repeated revascularization, were
recorded on standardized forms. Resting ECGs were collected at
study entry, before and after all coronary
revascularization procedures, at scheduled
follow-up, and for suspected myocardial infarction (MI) events. A
central ECG laboratory coded all Q-wave events. According to protocol,
cardiac enzymes were not used to define MI within 96 hours of
revascularization.14 21 Cause of death
was classified by an independent Mortality and Morbidity Classification
Committee.
Statistical Analysis
The patient population was analyzed by a 3x2 design.
The 3 group components were determined from initial lesion outcome: (1)
all intended lesions were attempted and successful, (2) all intended
lesions were attempted but not all were successful, and (3) not all
intended lesions were attempted. Within these groups, patients were
dichotomized by pre-PTCA strategy (planned CR versus planned IR)
(Figure 2).
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Initially, baseline clinical and angiographic characteristics were
compared separately within the 3 and 2 group components. Subsequently,
in-hospital characteristics and complications were compared by planned
strategy (CR versus IR) within the 3 initial outcome groups (from the
above 3x2 design). Proportions were compared by
2 analysis; mean differences in
continuous variables were assessed by Student's t
tests.
The Kaplan-Meier method was used to estimate 5-year clinical event
rates. Additionally, a subset of 1830 patients (89.4% of total cohort)
who did not experience in-hospital death, MI, or CABG at the initial
PTCA were analyzed separately. At the data freeze, 95% of
surviving patients had 4 years of follow-up; 67% had 5 full years.
Patients with <5 years were censored at the last follow-up date.
Similarly, for estimates of cardiac mortality, deaths classified as
noncardiac were censored. Within the 3 initial outcome groups (groups 1
through 3), the log-rank statistic was used to compare hazard curves
between patients with planned CR and those with planned IR. Cox
regression analysis22 was used to estimate the
independent contribution of planned IR (versus planned CR), lesions
attempted (not all versus all intended lesions attempted), and lesion
outcome (not all versus all attempted lesions successfully dilated) on
5-year clinical outcome. A stepwise algorithm was used to adjust for
baseline clinical and angiographic variables associated with 5-year
clinical outcome. When the planned strategy and initial lesion outcome
variables did not step into the model, they were forced in at the
last stage of model development.
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Results |
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Baseline Clinical Characteristics and Completeness of Revascularization
Among the 3 columns of patients with planned CR (Figure 2
),
595 (45%) had all intended lesions successfully dilated. This compared
with 399 patients (56%) with planned IR (P<0.001). At
baseline, patients with planned IR had a worse clinical profile than
patients with planned CR (data not shown). This included older mean age
(62.2 versus 60.9 years, P=0.006) and history of MI (56%
versus 50%, P=0.01), congestive heart failure (9% versus
5%, P=0.002), treated diabetes (20% versus 15%,
P=0.004), and peripheral vascular disease (9%
versus 6%, P=0.02).
Baseline Angiographic Characteristics and Completeness of
Revascularization
Characteristics associated with planned IR included triple-vessel
disease, 4 significant lesions, diffuse lesions, presence of total
occlusions or class C lesions, and poor ejection fraction (Table 1, left). Most of these same
factors were also associated with failure to successfully dilate all
intended lesions (Table 1, right).
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Initial Procedural Outcome
Overall, the mean numbers of intended and attempted lesions were
higher in patients with planned CR compared with those with planned IR
(2.8 versus 2.1 and 2.2 versus 1.8, respectively; Table 2). Among patients with all intended
lesions successfully dilated (Table 2, left), in-hospital
death/Q-wave MI and repeated revascularization were
infrequent and were attributed to postdilatation complications,
including out-of-laboratory abrupt closure.
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Among patients without all intended lesions successfully dilated (Table 2, middle and right columns), in-laboratory abrupt closure
occurred 10% in each group but not differ by whether or not CR was
planned. Therefore, the reason that not all intended lesions were
attempted in some patients (Table 2, right) was not
attributed predominantly to acute vessel occlusion.
Finally, among patients with all intended lesions attempted but not all
successful (Table 2, middle), those with planned CR had a lower
incidence of in-hospital CABG than those with planned IR (9.9% versus
18.7%). In contrast, the incidence of in-hospital CABG among patients
without all intended lesions attempted (Table 2, right) did not
differ by pre-PTCA strategy but was frequent (
17%).
Long-Term Clinical Outcome
Among patients with all intended lesions successfully dilated
(Table 3, left), the 5-year incidence of
death, cardiac death, and death/MI was similar regardless of whether or
not CR was planned. However, the prevalence of angina at 5 years was
higher in patients with planned IR (20.0% versus 14.8%,
P=0.04).
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In patients without all intended lesions attempted (Table 3,
right), 5-year mortality was higher in patients with planned IR
compared with those planned CR (14.2% versus 8.9%,
P=0.04). This higher mortality was also observed in patients
free of in-hospital death, MI, or CABG at the index PTCA (15.1% versus
7.1%, P=0.002). A similar trend was observed in these same
patients for cardiac mortality (7.8% versus 3.9%, P=0.06).
Among patients with all intended lesions attempted but not successfully
dilated (Table 3, middle), there was a suggestion of higher
5-year death and death/Q wave MI (Figure 3) in patients with planned IR compared
with those with planned CR (16.8% versus 9.6% and 25.9% versus
17.5%, respectively; P=0.06 for both comparisons).
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Finally, as shown in Table 3 and Figure 4A, 5-year incidence of CABG was markedly
higher in patients with planned IR. This excess risk occurred
regardless of whether or not all intended lesions were attempted and
successful and held true among patients free of initial in-hospital
death/MI/CABG (Figure 4B). Most CABGs were performed in the
first year of follow-up, with the excess risk associated with planned
IR observed within the first 2 years. Roughly 70% of patients who
underwent CABG had unstable angina and/or an urgent or emergent
revascularization priority (regardless of whether
CR was planned and among both randomized and registry patients).
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Multivariable Analysis
Pre-PTCA strategy (planned IR versus planned CR), lesions
attempted (not all versus all intended lesions attempted), and lesion
outcome (not all versus all attempted lesions successful) were not
independently associated with 5-year risk of cardiac death or
death/Q-wave MI (Figure 5). However, the
point estimate for planned IR and risk of death approached significance
(relative risk [RR], 1.36; 95% CI, 1.00 to 1.84; P=0.05).
In contrast, 5-year risk of CABG was independently associated with
planned IR (RR, 1.27; 95% CI, 1.01 to 1.60; P=0.04), not
attempting all intended lesions (RR, 1.50; 95% CI, 1.22 to 1.85;
P=0.0001), and unsuccessful dilatation of all attempted
lesions (RR, 1.48; 95% CI, 1.20 to 1.84; P=0.0003).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionReferences |
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In patients with multivessel CAD treated with PTCA, IR occurs frequently and is the result of both pre-PTCA strategy and initial lesion outcome. These components, coupled with varying definitions and the distinction between anatomic versus functional CR, have led to numerous yet equivocal reports on the influence of CR on clinical outcome.1 2 3 4 7 Among >2000 BARI patients treated with first-time PTCA during 1988 through 1991, we evaluated the relative contribution of pre-PTCA strategy (planned CR versus planned IR) and initial lesion outcome on clinical outcome. We considered a functional rather than anatomic definition of planned CR.
Initial PTCA Outcome
Overall, about one third of all patients had a planned strategy of
IR, and not unexpectedly, these patients had a higher prevalence of
triple-vessel disease and more significant stenoses. Patients
with planned CR were less likely to have all intended lesions
successfully dilated than patients with planned IR. This lower rate of
total angiographic success was probably the result of 2 factors. First,
patients with planned CR had, on average, more lesions intended for
PTCA. Thus, there was additional opportunity for failure of 1 lesion.
Second, although patients with planned CR had overall less extensive
CAD than patients with planned IR, more lesions were intended and
attempted in this group. This suggests a more aggressive approach,
perhaps including lesions difficult to treat with conventional PTCA.
The fact that about one fourth of all patients with planned CR had 1
class C lesion supports this contention. Previous studies have reported
the difficulty in achieving CR in attempts to revascularize chronic
total occlusions.6 23
When all planned lesions were not attempted or successfully dilated, the incidence of abrupt closure and Q-wave MI was similar by pre-PTCA strategy. Thus, incident abrupt closure, which precipitated a substantial proportion of the major in-hospital complications, was not influenced by whether or not CR was planned. Moreover, abrupt closure alone was not the primary reason why not all intended lesions were attempted. Thus, other factors, such as suboptimal result (but not acute occlusion) and poor patient tolerance of PTCA, may be important contributors to the reason that less revascularization is attempted compared with what is initially intended.
Long-Term Clinical Outcome
In unadjusted analyses, planned IR (versus planned CR) was
associated with higher mortality and a trend toward higher cardiac
mortality in patients in whom all intended lesions were not attempted
and/or successfully dilated. However, after statistical adjustment,
5-year risk of cardiac death and death/MI was similar in patients by
pre-PTCA strategy. These results are consistent with reports
suggesting comparable mid-term survival with and without CR after
PTCA.4 5 7 Our data suggest that clinically appropriate
use of planned IR by experienced angioplasty operators is a reasonable
strategy in patients with multivessel disease.
However, there was still an excess independent risk of CABG in patients with planned IR and among those with a suboptimal result. These findings support previous reports1 3 4 6 8 and the contention that IR, whether by intention or suboptimal PTCA result, is associated with higher risk of CABG. These findings persist even among patients initially free of major in-hospital complications and are particularly prominent in the first year after PTCA. In essence, among patients with multivessel CAD not suitable for CR via PTCA, the angioplasty operator may ultimately be more inclined to "give up" and triage to CABG those patients with subsequent need for repeated revascularization.
Study Limitations
All PTCA procedures were performed in 1988 through 1991 without
the use of new devices, including stents. The excess risk of CABG
observed in relation to both pre-PTCA strategy and suboptimal result
with conventional PTCA might have been attenuated had stents been used
and similarly may be less prominent today.
Our definition of CR is study specific and based on angiographic
criteria and PTCA operator judgments of the importance and suitability
of significant stenoses for PTCA. Possibly, a more
physiologically relevant definition of CR, such
as successful treatment of lesions 70% stenosis (as opposed
to 50%), could have been used. Similarly, quantitative evaluation of
patient atherosclerotic burden was not derived from a core laboratory.
There may have been site variability in determining which patients were
intended to undergo and those who achieved CR. With random variation
within centers assumed, the misclassification of planned and achieved
CR would likely be nondifferential and would tend to bias study results
toward the null.
Finally, although patients from the randomized trial and observational registry met the same clinical eligibility criteria, differences exist between the cohorts. Specifically, registry patients were more often white; were more educated with a higher self-rated quality of life; and had a less frequent history of MI, diabetes, and smoking.24 These differences, however, do not appear to be influential here because, remarkably, the percentages of patients with planned CR (65%) and those with actual CR achieved (29%) were identical between the 2 cohorts. This suggests that PTCA operators were equally motivated to achieve CR in both populations.
Conclusions
Among >2000 patients with multivessel CAD treated with first-time
PTCA, about one third had a pre-PTCA strategy of functional IR, 50%
had all intended lesions attempted and successfully dilated, and only
29% were completely revascularized. Triple-vessel disease, 4
significant lesions, and difficult lesions for conventional PTCA (ie,
class C lesions) were associated with planned IR and suboptimal PTCA.
Abrupt closure strongly precipitated major in-hospital complications
but was unrelated to whether or not CR was planned. In
multivariable analysis, planned IR and failure to
successfully dilate all intended lesions were unrelated to long-term
risk of cardiac death or cardiac death/MI. However, risk of CABG,
particularly within the first year following PTCA, was higher in
patients with planned IR and among those with a suboptimal initial
result.
Overall, a pre-PTCA strategy of IR in BARI-like patients appears comparable to a strategy of CR, except for a higher need for CABG. Whether or not the use of new devices may attenuate this elevated risk of CABG in similar patients remains to be determined.
Received January 25, 1999; revision received June 1, 1999; accepted June 9, 1999.
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