(Circulation. 2000;102:2945.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
From the Division of Cardiology (D.O.W.), Rhode Island Hospital, Brown University, Providence, RI; the Department of Epidemiology (R.H., W.Y., S.F.K., H.A.V., K.M.D.), University of Pittsburgh, Pittsburgh; Lankenau Hospital (P.C.), Philadelphia, Pa; Montreal Heart Institute (M.G.B.), Montreal, Quebec, Canada; Cardiovascular Medical Associates (M.A-B.), Houston, Tex; Providence/St. Vincent Hospitals (P.C.B.), Portland, Ore; University of Pittsburgh Medical Center (H.C.), Pittsburgh, Pa; Medical College of Virginia (M.C.), Richmond, Va; Arizona Heart Institute (G.D.), Phoenix, Az; University of Southern California Medical Center (D.F.), Los Angeles, Calif; Mayo Clinic Foundation (D.R.H.), Rochester, NY; Boston University Medical Center (A.J.), Boston, Mass; Emory University Hospital (S.B.K. III), Atlanta, Ga; Seton Medical Center (R.M.), Daly City, Calif; St. Lukes/Roosevelt Hospital (J.S.), New York, NY; and Institute for Clinical and Experimental Medicine (V.S.), Prague, Czech Republic.
Correspondence to Katherine M. Detre, MD, DrPH, University of Pittsburgh/GSPH, 130 DeSoto St, 127 Parran Hall, Pittsburgh, PA 15261. E-mail Detre{at}edc.gsph.pitt.edu
| Abstract |
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Methods and ResultsBaseline features and in-hospital and 1-year outcomes of 1559 consecutive patients in the 19971998 Dynamic Registry who were having first coronary intervention were compared with 2431 patients in the 19851986 National Heart, Lung, and Blood Institute Registry. Compared with patients in the 19851986 Registry, Dynamic Registry patients were older (mean age, 62 versus 58 years; P<0.001) and more often female (32.1% versus 25.5%; P<0.001). In the Dynamic Registry, procedures were more often performed for acute myocardial infarction (22.9% versus 9.9%; P<0.001) and treated lesions were more severe (84.5% versus 82.5% diameter reduction; P<0.001), thrombotic (22.1% versus 11.3%; P<0.001) or calcified (29.5% versus 10.8%; P<0.001). Stents were used in 70.5% of Dynamic Registry patients, whereas 19851986 patients received balloon angioplasty alone. Procedural success was higher in the Dynamic Registry (92.0% versus 81.8%; P<0.001) and the rate of in-hospital death, myocardial infarction, and emergency coronary bypass surgery combined was lower (4.9% versus 7.9%; P=0.001) than in the 19851986 Registry. The 1-year rate for CABG was lower in the Dynamic Registry (6.9% versus 12.6%; P<0.001).
ConclusionsAlthough Dynamic Registry patients had more unstable and complex coronary disease than those in the 19851986 Registry, their rate of procedural success was higher whereas rates of complications and subsequent CABG were lower. Results of percutaneous coronary intervention have improved substantially over the past decade.
Key Words: angioplasty coronary disease arteries balloon stents
| Introduction |
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These trials, including Bypass Angioplasty Revascularization Investigation (BARI)2 and EAST,3 found that in most patients with multivessel coronary artery disease (CAD), balloon angioplasty did not compromise survival and proved to save costs slightly relative to CABG but many patients who received PTCA required repeat revascularization. Since that time, new devices have been developed as potential adjuncts or replacements for the balloon catheter.4 Although a few randomized clinical trials have helped to clarify the value of these new devices in limited patient subgroups,5 6 7 8 little is known of the extent of their use in overall clinical practice or of their effect on patient selection and outcomes.
The primary goal of the recently established Dynamic Registry is to characterize percutaneous coronary intervention in the new device era. The Registry provides the optimal design to assess and to compare with the 19851986 Registry the following: (1) contemporary patients and disease characteristics selected for percutaneous coronary intervention, (2) types of devices used in various settings, and (3) changes in interventional strategy as well as in-hospital and 1-year outcomes. The present report describes the findings from these comparisons.
| Methods |
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Data Collection
Registry research coordinators responsible for data
collection participated in a training session before patient
enrollment. Data collection included demographic information, medical
history, and risk factor profile. Coronary angiographic
information before and after intervention was obtained according to
definitions developed in previous registries and the Bypass Angioplasty
Revascularization
Investigation.1 9
Procedural strategy data included device use, procedural staging, and
success of each coronary lesion attempted. Successful lesion
dilatation was defined as an absolute 20% reduction in lesion severity
with final stenosis <50%. Angiographic success was classified
as either partial (some but not all attempted lesions successfully
treated) or total (all attempted lesions successfully treated).
Untoward events included death from any cause, myocardial infarction
(MI), or CABG. MI was defined as evidence of
2 of the following: (1)
typical chest pain >20 minutes not relieved by
nitroglycerin, (2) serial ECG recordings
showing changes from baseline or serially in ST-T and/or Q-waves in
2
contiguous leads, or (3) serum enzyme elevation of CK-MB>5% of total
CK (total CK>2x normal; LDH subtype 1>LDH subtype 2). Congestive
heart failure was defined as presence of paroxysmal nocturnal dyspnea,
dyspnea on exertion, or radiographic pulmonary
congestion. Risk for CABG was classified as low, moderate, high, or
inoperable according to judgment of the interventionist. Procedures
were classified according to clinical circumstances: emergent when
required immediately because of clinical instability, urgent when
required within 24 hours to minimize cardiac risk, and elective when
deferrable >24 hours without cardiac risk. Procedural success was
defined as achievement of either partial or total angiographic success
without death, Q-wave MI, or emergency CABG.
Statistical Methods
Differences between proportions were assessed by
2 test or Fishers Exact Test when the
number of patients in a group was small. Continuous variables were
compared by Students t test.
One-year outcomes were reported with Kaplan-Meier estimates and log
rank statistics. Standard stepwise procedures were used with Cox
proportional hazards models to obtain adjusted relative risks comparing
the 2 registries. Consent to collect follow-up information after
initial procedure hospitalization was not obtained for 253 of the 1559
Dynamic patients, who were censored at the time of hospital discharge
in analyses of 1-year event
rates.
| Results |
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Unstable angina was the most common procedural indication
for intervention in the Dynamic Registry
(Table 2
). Compared with the 19851986 Registry, procedures
were more likely to be performed for acute MI (22.9% versus 9.9%;
P<0.001) and less frequently
for stable angina. Also, interventions were more often emergent (13.0%
versus 5.8%; P<0.001) for
Dynamic than for 19851986 Registry patients. Among the 357 Dynamic
patients with AMI as indication for intervention, 48.7% had emergent
intervention. Glycoprotein IIb/IIIa receptor
inhibitors, not available in the 19851986 Registry, were
administered to 25.3% of Dynamic Registry patients.
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Comparison of interventional strategy revealed some interesting trends. Most patients had procedures attempted on only 1 lesion, and fewer Dynamic Registry patients had multilesion procedures than in the 19851986 Registry. Multivessel attempt was 9% in the Dynamic compared with 20.7% in the 19851986 Registry (P<0.001). Balloon angioplasty, the only percutaneous intervention at the time of the 19851986 Registry, was used as the sole device in 24.7% of Dynamic Registry patients, concomitantly with stent placement in 63.7%, rotational atherectomy in 3.1%, and both stent and rotational atherectomy in 5.9% of patients. (Directional atherectomy, extraction atherectomy, and laser each were used in <1% of patients.)
Although the left anterior descending coronary
artery was the most common location for an attempted lesion in both
registries, lesions in other locations were more often attempted in the
Dynamic compared with the 19851986 Registry
(Table 3
). Attempted lesion stenosis in the Dynamic
Registry was more severe, and lesions were more often total occlusions.
These differences were independent of sex of the patient or whether AMI
was the indication for intervention.
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Thrombus and calcification were reported far more frequently in the Dynamic Registry, yet angiographic success was achieved more often (93.7% versus 80.9%; P<0.001) and final lesion narrowing was less severe. Although abrupt artery closure was less common in the Dynamic Registry, side-branch occlusion and local coronary dissection were more common.
In-hospital mortality was not significantly different
between the registries
(Table 4
), whereas MI and need for emergent CABG were
significantly lower in the Dynamic Registry. Both total angiographic
success and procedural success were achieved significantly more often
in the Dynamic Registry. In addition, mean length of hospital stay
decreased significantly, from 4.1 to 2.7 days. Overall incidence of
repeat revascularization during initial
hospitalization was 5.6% (4.2% repeat percutaneous
intervention and 1.5% CABG).
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Crude mortality during 1 year of follow-up was higher in the
Dynamic Registry compared with the 19851986 Registry (1-year rate,
5.4% versus 3.6%), whereas 1-year death or MI rate was similar
(Figure 1
). After controlling for important baseline
differences between registries
(Table 5
), death rates became comparable. Lower adjusted
mortality was not significant, although the 30% lower 1-year risk for
combined-endpoint death or MI achieved significance. Similarly, 1-year
CABG and repeat percutaneous procedure rates were
significantly lower in the Dynamic Registry both before and after
adjustment for baseline inequalities
(Figure 2
). These findings were uniform regardless of number
of lesions or vessels attempted during the initial
procedure.
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Within the Dynamic Registry, differences were seen in unadjusted 1-year event rates within several clinically important subgroups. Women had higher 1-year mortality (7.6% versus 4.4%; P<0.05) and need for CABG (9.5% versus 5.6%; P<0.05) than men. Patients whose indication for intervention was AMI had higher 1-year mortality (9.2% versus 4.3%; P<0.001) than those with other indications, primarily due to higher in-hospital mortality (5.9% versus 0.7%; P<0.001). Use of GP IIb/IIIa receptor inhibitor was associated with increased 1-year MI rate (9.5% versus 4.0%; P<0.001), due in part to more in-hospital events (5.1% versus 2.0%; P<0.001). No differences were seen in 1-year death, MI, or revascularization by stent use during initial procedure.
| Discussion |
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Coronary intervention was more often performed in the setting of unstable coronary disease in the Dynamic Registry. In fact, AMI was reported as the primary indication for intervention more than twice as often as in 19851986. Because coronary angioplasty can be performed quickly and as an immediate adjunct to coronary angiography, it is particularly well suited for coronary syndromes in which rapid revascularization is essential.13 14 These findings may indicate that percutaneous intervention has become an established treatment for patients with acute coronary syndromes and may reflect a preference for a catheterization-based approach over medical or surgical alternatives.15 16 17 18
Substantial differences were found in revascularization strategy at both the lesion and patient levels. Calcification of attempted lesions was nearly 3-fold greater than in 19851986. The increase in lesions determined to be calcified may reflect more attention paid to this factor because of availability of rotational atherectomy and improved visibility of modern X-ray equipment and not necessarily a true increase in calcification.
Nearly twice as many attempted lesions showed evidence of thrombus, and attempted lesions had on average more severe stenosis. Lesion access was more difficult in the Dynamic Registry because more lesions were located in arteries other than the left anterior descending. All of these observations indicate that although operators now attempt fewer lesions, they attempt substantially more challenging lesions than in the past. The feasibility of treating more advanced coronary disease by percutaneous techniques has expanded the scope of patients eligible for this approach and is probably a reflection of improvements in angioplasty techniques and equipment.
Remarkably, although most Dynamic Registry patients had multivessel coronary disease and averaged nearly 3 significant lesions each, two-thirds had only 1 lesion attempted. Similarly, more than two thirds of patients with multivessel disease had a single vessel or graft targeted for revascularization. This shift to a more selective revascularization strategy was seen among patients treated outside of the AMI setting as well as among AMI patients, for whom initial intervention is usually performed to reestablish perfusion of the infarct-related artery rather than to achieve complete revascularization.15 A potential explanation for this observation is that some lesions may cause more ischemia than others19 and that operators place strategic emphasis in treating these lesions rather than others that may be of less functional significance. Operators may now also be more astute at identifying these "culprit" lesions. Certainly, the selective use of angioplasty in the Dynamic Registry was not based on a strategy of avoiding complex lesions, which were attempted more often than in the 19851986 Registry.
Despite treatment of older, less stable patients with more severe and complex lesions, procedural success rates were substantially higher in the Dynamic Registry than the 19851986 Registry. Coronary stenosis was relieved in a larger proportion of patients in the Dynamic registry, and magnitude of improvement was also much greater. Importantly, the increased lesion success was not achieved at the expense of additional risk.
Although angiographic dissection was observed more often, abrupt artery closure was substantially reduced in the Dynamic Registry. Although the reason for more dissection in contemporary practice is not readily apparent, potential explanations include more aggressive balloon angioplasty due to availability of stents or perhaps a change in threshold for declaring when dissection is present.
In-hospital mortality was not significantly different from the 19851986 Registry, and incidence of periprocedural MI and emergency CABG were significantly lower than a decade ago. With the increased rate of side-branch closure, probably as a result of stent use, a higher rate of periprocedural MI might have been expected. Because this effect was not observed, side-branch occlusion was probably limited to small arterial branches or transient.
Important differences in late outcome were also observed. Although 1-year crude mortality was higher in the new Registry, this difference was explained entirely by baseline differences between the 2 cohorts. Need for additional revascularization, either percutaneous or surgical, was 41% lower during 1-year follow-up in the Dynamic Registry. CABG reduction is explained mostly by lower procedural complications in the Dynamic Registry, whereas repeat procedure rates are gradually reduced over the entire follow-up period, which indicates important reductions in restenosis. Thus, current techniques have not only enhanced safety of percutaneous coronary revascularization, but also have augmented durability of the intervention.
Others have suggested that use of intracoronary stents may be responsible for improved results with contemporary percutaneous intervention.20 21 Our analysis found no difference in outcome between stented and nonstented patients. Accordingly, a significant percentage of patients may achieve a favorable clinical outcome without routine stent use. On the other hand, we cannot exclude a beneficial effect of stents. Because stent use is based on clinical judgment, stents were probably deployed in the Dynamic Registry patients most likely to benefit from stenting. Patients who did not receive stents may have been at low risk for complications or restenosis. Also, improved clinical outcome has been observed in trials of IIb/IIIa receptor antagonists.22 23 24 The present study does not support this effect and in fact demonstrated a higher MI rate among patients who received this therapy. However, proper interpretation of our finding requires acknowledgment that patients who received IIb/IIIa receptor blockade were more likely to have features associated with increased risk of complication. Outcomes for these patients might have been worse had this therapy not been administered. Finally, other factors, including more aggressive medical therapy and philosophies regarding indications for surgical revascularization, may have affected both in-hospital and 1-year outcomes.
Certain limitations must be acknowledged in interpretation of our findings. First, although the Dynamic Registry included a broad representation of clinical centers, most Registry investigators operated at large referral centers and were experienced interventional cardiologists. Whether the results achieved in the Registry apply to other types of institutions or given less experienced operators is unknown. Second, to permit meaningful comparison with the 19851986 Registry, Dynamic Registry patients who had had prior coronary intervention were not included in this analysis. These patients will be included in subsequent reports.
In summary, the Dynamic Registry has documented the substantial changes that have taken place in the field of percutaneous coronary intervention in the past decade. Patients now more often present with unstable coronary syndromes. Although revascularization strategy is somewhat more conservative than in 19851986, substantially more complex lesions are now being attempted. Rates of success are higher and acute complications lower compared with prior experience. Of particular importance is the documentation of the striking reduction in need for subsequent repeat surgical or percutaneous procedures. These results support use of percutaneous coronary interventions as effective means for achieving coronary revascularization.
| Acknowledgments |
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| Footnotes |
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| Appendix 1 |
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Personnel from the Coordinating Center, University of Pittsburgh, Pittsburgh, Pa, included the following: K. Detre, MD, DrPH (Director); S. Kelsey, PhD, R. Holubkov, PhD (Codirectors); M. Brooks, PhD, W. Yeh, H. Vlachos (Statisticians); V. Niedermeyer (Project Manager); S. Lawlor (Director, Data Management); E. Passano (Data Manager); J. Bondi and T. Ledneva (Data Entry); and N. Reck (Project Secretary).
NHLBI Project Office personnel included G. Sopko, MD, and P. Desvigne-Nickens, MD.
Received May 22, 2000; revision received July 20, 2000; accepted July 25, 2000.
| References |
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