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CLINICAL STUDY: PERCUTANEOUS CORONARY INTERVENTION

Predictive factors for early cardiac events and angiographic restenosis after coronary stent placement in small coronary arteries

J.örg Hausleiter, MD^*,*, Adnan Kastrati, MD^*, Julinda Mehilli, MD^*, Helmut Schühlen, MD^*, J.ürgen Pache, MD, Franz Dotzer, MD, Josef Dirschinger, MD and Albert Schömig, MD^*

^* Deutsches Herzzentrum München, Munich, Germany
1. Medizinische Klinik des Klinikums rechts der Isar, Technische Universität, Munich, Germany
Klinikum Garmisch-Partenkirchen, Garmisch-Partenkirchen, Germany

Manuscript received December 19, 2001; revised manuscript received April 26, 2002, accepted May 24, 2002.

^* Reprint requests and correspondence: Dr. Jörg Hausleiter, Deutsches Herzzentrum, Lazarettstr. 36, 80636 Munich, Germany.
hausleiter{at}dhm.mhn.de

	Abstract

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OBJECTIVES: The rationale of this study was to identify risk factors that predict early thrombotic events and angiographic restenosis after stenting in small coronary arteries.

BACKGROUND: Rates of cardiac complications and restenosis after percutaneous coronary intervention are higher in patients with small versus large coronary arteries. Because of discordant results, randomized studies comparing stent placement with balloon angioplasty could not establish the best interventional approach to use in this high-risk subset of patients. This study of predictive factors, with special focus on stent design, may provide particular help in this regard.

METHODS: Clinical, lesion-related, and procedural data of a large and unselected population of 3,156 consecutive patients were analyzed in a logistic regression model for both early and late complications. Repeat angiography at six months was performed in 80.8% of eligible patients.

RESULTS: The strongest risk factors for early thrombotic events (cumulative incidence of 4.2%) were the presence of an acute coronary syndrome and reduced left ventricular function. The stent design had no influence on early thrombotic complications. Restenosis (overall rate of 38.4%) was predominantly influenced by procedure-related variables, including the stent design and stented segment length. The incidence of restenosis varied from 29.6% to 55.8%, depending on the stent design used.

CONCLUSIONS: Clinical factors known before the procedure are predominant risk factors for early thrombotic complications, underscoring the need for potent antiplatelet regimens in these patients. In contrast, our findings suggest a major impact of procedural factors, including the choice of stent type, on restenosis.

Abbreviations and Acronyms   LV   left ventricular   MI   myocardial infarction   PTCA   percutaneous transluminal coronary angioplasty   TLR   target lesion revascularization

Several studies have assessed the predictive factors for major adverse cardiac events within the first 30 days, as well as for angiographic restenosis at six months after stent placement (8–11), but these findings may not be applicable to small coronary arteries owing to stent placement in large coronary arteries in the majority of patients. Furthermore, in most of the studies, the Palmaz-Schatz stent was the only type of stent used, and the impact of different stent designs on early and late outcomes in small coronary arteries is not known. A number of randomized trials have been undertaken to compare various stent models (12–15). Randomized trials often excluded patients with small coronary arteries and complex lesion morphologies. Therefore, their results may not be extrapolated to small coronary arteries. Studies focusing on this category of patients may help to explain the differences in the randomized stenting versus PTCA trials, resulting in a further refinement of the interventional approach.

In the present study, we analyzed the specific value of clinical, lesion-related, and procedural variables in predicting the risk of early thrombotic events and angiographic restenosis after stenting in a consecutive series of patients treated with various coronary stent designs in small coronary arteries.

	Methods

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Patients.   During a period of five years, coronary stent placement was performed in a consecutive series of 5,881 patients with symptomatic coronary artery disease. The population of the current study consisted of 3,156 patients with a reference vessel size <3.0 mm. Patients with unstable angina or acute myocardial infarction (MI) were included in this analysis. All patients were asked to undergo repeat angiography at six months, or earlier in the case of symptoms or objective signs of myocardial ischemia, as well as a clinical follow-up at 6 and 12 months. The protocol of routine clinical and angiographic follow-up studies has been approved by our institutional Ethics Committee.

Stent placement and post-stenting treatment
During the intervention, patients received heparin and aspirin intravenously. In addition, 37.7% of patients considered at higher risk of stent thrombosis (acute MI, persistent thrombus at the stent site, large residual dissections) also received a glycoprotein IIb/IIIa inhibitor (e.g., a bolus and 12-h infusion regimen of abciximab). Post-procedural therapy consisted in 250 mg ticlopidine plus 100 mg aspirin twice daily for four weeks; aspirin was taken indefinitely.

Stents of various designs were inserted using either hand-crimped stents on conventional angioplasty balloons or the provided stent-delivery systems. The characteristics described subsequently for each stent type inserted in >100 patients in this series are those reported by the manufacturer. Most stent types had the slotted-tube design, including the classic Palmaz-Schatz stent (Johnson & Johnson Interventional Systems, Warren, New Jersey), the JO-Stent (JOMED International AB, Helsingborg, Sweden), and the Inflow stainless-steel stent (ID-Steel; Inflow Dynamics, Munich, Germany). The Inflow gold-plated stent (ID-Gold, Inflow Dynamics) is a stent with the same design as the ID-Steel stent, but it is plated with 0.005 mm of gold. The Pura-A stent (Devon Medical, Hamburg, Germany) has a slotted-tube design with longitudinal Y connections. The Multi-Link stent (Guidant, Advanced Cardiovascular Systems, Santa Clara, California) is made of a 0.050-mm stainless-steel wire that forms multiple rings connected with multiple links. The Multi-Link Duet stent (Guidant) also has an interconnected ring design, but the strut thickness is 0.140 mm. The NIR stent (Scimed, Boston Scientific Europe, Verviers, Belgium) has a continuous, uniform, multicellular design. Other stent types included the ACT-One and Paragon stents (Progressive Angioplasty Systems, Menlo Park, California), AVE GFX and Wiktor stents (Medtronic, Minneapolis, Minnesota), Crossflex and Crown stents (Johnson & Johnson Interventional Systems, Warren, New Jersey), Freedom stents (Global Therapeutics Inc., Broomfield, Colorado), ID Flex stents (Inflow Dynamics, Munich, Germany), Jomed graft stents (JOMED International AB, Helsingborg, Sweden), MAC and Omega stents (AMG, Raesfeld-Erle, Germany); all these stent types together were inserted in a total number of 118 patients.

Angiographic evaluation
Lesions were classified according to the modified American College of Cardiology/American Heart Association grading system (types A, B1, B2, and C). An automated edge-detection system (CMS version 4.0, Medis Medical Imaging Systems, Nuenen, The Netherlands) was used for off-line analysis of the digital angiograms. Matched views were selected for angiograms recorded before and immediately after the intervention and at follow-up. The variables obtained were lesion length, vessel size, minimal lumen diameter, diameter stenosis, and diameter of the maximally inflated balloon during stent placement. Late lumen loss was calculated as the difference in minimal lumen diameter measurements between after the procedure and at follow-up.

Definitions
Procedural success was defined as stent placement at the desired site, with a satisfactory angiographic result (i.e., final residual stenosis <30%) and Thombolysis in Myocardial Infarction distal flow grade 2. Residual dissections at the end of the procedure were defined as >5-mm-long dissections (8). An ejection fraction <50% was considered as reduced left ventricular (LV) function. The cumulative early thrombotic event rate was defined as death, nonfatal MI or documented stent occlusion, as demonstrated by angiography, occurring within the first 30 days after stent placement. The diagnosis of MI was based on typical chest pain combined with either new pathologic Q waves or a rise in creatine kinase >2 times the upper limit of normal (>160 U/l), with a concomitant increase in the MB isoenzyme. Target lesion revascularization (TLR) was performed in the presence of angiographic restenosis and typical chest pain or objective signs of myocardial ischemia. Patients with successful stent placement and without a major adverse cardiac event, including death, nonfatal MI, documented stent occlusion, or TLR within the first 30 days after stenting, were considered eligible for angiographic follow-up. Restenosis was defined as diameter stenosis 50% at follow-up angiography.

Statistical analysis
Results are expressed as the mean value ± SD or as proportions (%). Analysis of early clinical outcomes was performed on the entire patient population (n = 3,156), whereas analysis of late angiographic outcomes was done on patients eligible for repeat angiography. All variables were entered into a multivariate logistic regression model to test for their independent effects. Analysis of early thrombotic events was made per patient, whereas analysis of restenosis was lesion-based. To eliminate a potential clustering effect in patients with a multilesion intervention (16), bootstrapping with 1,000 replications was applied for the calculation of regression coefficients, odds ratios, and 95% confidence intervals for each co-variate in the model, as well as for model calibration and validation (17). To control the significance level when comparing different stent types (control for multiple comparisons), a closed-testing procedure was applied (18). In a step-down manner, it started with a test of the global null hypothesis at a full alpha level. In case of rejection, it proceeded with all null hypotheses on a lower stage, thus eliminating one group. If a null hypothesis could not be rejected, all hypotheses containing it were also rejected. With this test procedure, the significance alpha level can be controlled (18). Statistical significance was defined as p < 0.05.

	Results

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The analyzed variables were grouped into three categories: clinical, lesion-related, and procedural. In Tables 1 and 2, these variables are summarized for all patients.

Multivariate analysis for early thrombotic events
Figure 1 depicts eight clinical, lesion-related, and procedure-related variables that were identified as independent risk factors for the occurrence of thrombotic events. The strongest independent predictors were the clinical variables: the presence of an acute coronary syndrome and reduced LV function (Table 3). Among the procedure-related variables, the presence of a residual dissection at the end of the intervention was a strong predictor of thrombotic events. Female patients, as well as patients with complex, de novo, or long stented lesions, also had an increased risk of a major early adverse event. The stent design had no significant influence on early thrombotic events (p = 0.38).

View larger version (19K): [in this window] [in a new window]   Figure 1 Significant and independent factors for thrombotic events occurring within the first 30 days, as derived from the multivariate model, displayed with their relative risk and 95% confidence interval. The confidence interval for the continuous variable "stented segment length" was calculated for the first versus third quartile: 10 vs. 25 mm. LV = left ventricular.

Multivariate analysis for angiographic restenosis
Figure 2A presents nine clinical, lesion-related, and procedure-related variables as independent risk factors for restenosis. The stent design had the strongest independent influence among the procedural variables (Table 4). Additional predictive factors included, in the order of significance, vessel size, stented segment length, lesion complexity, stenosis severity before the intervention, gender, balloon-to-vessel ratio, diabetes mellitus, and lesion length.

View larger version (13K): [in this window] [in a new window]   Figure 2 (A) Significant and independent factors for angiographic restenosis at six months, as derived from the multivariate model, displayed with their relative risk and 95% confidence interval. For continuous variables, these were calculated for the first versus third quartile (lesion length: 7.4 vs. 15.3 mm; small vessel size: 2.25 vs. 2.94 mm; stenosis severity before the intervention: 65.7% vs. 89.9%; balloon/vessel ratio: 1.02 vs. 1.14; and stented segment length: 15 vs. 25 mm). (B) Adjusted risk (with odds ratio and 95% confidence interval) for restenosis associated with each stent type, as derived from the multivariate model. The risk was calculated using the Palmaz-Schatz stent as a reference.

View larger version (21K): [in this window] [in a new window]   Figure 3 Graph showing the strength (i.e., chi-square value) of the logistic regression models for thrombotic events and angiographic restenosis. Each top solid bar is for the full model, including clinical, lesion-related, and procedural variables; the other open bars are for the respective partial models. The graph illustrates the dominant influence of clinical factors on thrombotic events, as opposed to the dominant influence of procedural factors on restenosis.

	Discussion

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Although stent placement was initially approved by the U.S. Food and Drug Administration for use only in large coronary arteries (i.e., >3.0 mm), patients with smaller arteries constitute a large group of those treated with percutaneous coronary interventions in daily practice. Consequently, the outcome of patients with elective stent placement in small coronary arteries has been compared with the outcome of those treated with balloon angioplasty in several recent randomized trials (4–7). As only two of four studies have shown a significant long-term benefit of routine stent placement (4,5), the advantage of a strategy of routine stent placement in small coronary arteries remains to be better studied. In the present study, we provide a comprehensive analysis of the risk of early thrombotic events after stenting and angiographic restenosis in a large population that had stent placement in small coronary arteries, including many patients with acute coronary syndromes who had been excluded from most previous trials.

Predictors of early thrombotic events.   In this analysis, a large number of factors were included: baseline clinical and lesion-related characteristics available before the intervention, as well as procedural factors describing the intervention and the final results. Eight factors were identified as significant and independent predictors of the occurrence of early thrombotic events. The most significant factors were two variables available before the intervention: the presence of an acute coronary syndrome and reduced LV function. In addition, the presence of a postprocedural dissection contributed significantly to the risk of thrombotic events. Our analysis of risk is in keeping with the results from previous analyses of larger vessels (8,9). These studies identified the influence of the aforementioned clinical variables, along with procedural factors, including lesion complexity and length of the stented segment, as risk factors for the occurrence of early stent thrombosis. The importance of clinical risk factors identifiable before the interventional procedure indicates a need for individual risk stratification and a refined interventional approach (e.g., with an intensified antithrombotic regimen with potent glycoprotein IIb/IIIa inhibitors in a high-risk subset of patients).

Although it has been demonstrated that a coiled stent design may have a significant impact on the incidence of subacute stent thrombosis within the first month after stenting (13), our analysis did not identify the use of various noncoiled stent designs as an independent predictor of thrombotic events in this patient cohort with small coronary arteries.

Predictors of restenosis
The predictive model for binary restenosis identified nine independent factors: female gender, diabetes mellitus, lesion complexity, long lesions, small vessel size, stenosis severity before the intervention, high balloon/vessel ratio, long stented segment, and stent design (Fig. 2A). Small vessel size, which was the second strongest risk factor in the current analysis, is a well-known potent predictor of restenosis after PTCA, as well as after stent placement (19–22). Elezi et al. (20) demonstrated that the risk of restenosis after stent placement may vary from 29.6% to 53.5% in patients with small coronary arteries (i.e., diameter <2.8 mm), depending on the presence of additional risk factors, such as complex lesion morphology and diabetes mellitus.

Most of the other identified predictors of restenosis are in keeping with earlier reports. However, the results of the earlier studies were confined to the sole use of the Palmaz-Schatz stent, and the influence of stent design has not been incorporated into the previous statistical models. In this series of patients with small coronary arteries, we used eight different stent designs of various slotted-tube and interconnected ring designs. In the current analysis, stent design was identified as a strong independent predictor of angiographic restenosis. This influence of stent design was also apparent in the analysis of angiographic late lumen loss and the need of TLR. The results are in agreement with four recent randomized clinical trials demonstrating that stent design (12,13), stent coating (23) and stent strut thickness (24) may determine restenosis-free survival. In most of these studies, patients with small coronary arteries and complex lesion morphologies were included. In contrast, several other randomized trials that excluded patients with small coronary arteries or complex lesion morphologies have failed to detect differences between different stent designs (14,15). Therefore, the results of our analysis suggest that the exclusion of patients with small coronary arteries may have masked differences among the tested stent designs in some previous trials.

When comparing elective stent placement with conventional PTCA in patients with small coronary arteries, two of four randomized trials have shown a significantly reduced restenosis rate after placement of a dedicated small vessel stent—the BeStent Small (Medtronic, Minneapolis, Minnesota) (4,5). Dedicated stents for small arteries have fewer struts, cells, or loops per circumference, compared with large-vessel stents, and/or they have thinner stent struts to reduce the metal coverage and load relative to the circumference of the vessel wall. The Intracoronary Stenting or Angioplasty for Restenosis Reduction in Small Arteries Trial (ISAR-SMART), in which the Multi-Link stent was used, demonstrated an almost identical clinical and angiographic long-term outcome in patients randomized to either treatment regimen (6). Although the current study supports the hypothesis that a potential cause for the divergent trial results could be the use of different stent designs, our study also demonstrates that the design of the nondedicated Multi-Link stent is associated with the lowest restenosis rate in small coronary arteries, compared with the other stent designs used in this study. Therefore, it is unlikely that the differences in stent design between the BeStent Small and Multi-Link stent are the sole cause for the divergent trial results. Recently, we demonstrated a strong relationship between the residual stenosis grade after PTCA and restenosis reduction after stenting in a meta-analysis of stent versus PTCA trials in small coronary arteries (25). Consequently, the residual stenosis grade achieved with PTCA has also been considered as a plausible explanation for the divergent trial results. Finally, relevant differences in patient and lesion characteristics, including lesion complexity and stented segment length, may also provide an additional explanation for the discrepancy of the study results.

Study limitations
Although all data were prospectively collected with the objective of assessing the short- and long-term outcomes after stenting, the analysis was performed retrospectively. Of note, our main outcome measure—angiographic restenosis—was based on quantitative angiographic evaluations by operators blinded to the actual stent type used. However, additional randomized trials are required to establish the definite role of the stent type in restenosis development after stenting of small coronary arteries.

An additional limitation of the study is the absence of the BeStent Small, which has been used in three randomized trials comparing stenting with PTCA in small coronary arteries (4,5,7). Finally, we acknowledge the limitation related to the availability of follow-up angiographic studies in 80.8% of patients. Previous trials of restenosis have also shown the impossibility of achieving higher rates because of patient refusal in an inevitable proportion of cases.

Conclusions
Early thrombotic complications occurred in a low percentage of patients in this large, unselected population of 3,156 patients with stent placement in small coronary arteries. The predictors of early complications are predominantly clinical factors, including the presence of an acute coronary syndrome and reduced LV function, indicating the need for pre-interventional risk stratification, with an intensified antithrombotic regimen for high-risk patients. The development of angiographic restenosis is primarily influenced by procedural variables, particularly stent design. Therefore, judicious selection of stent designs is required before stenting of small coronary arteries.

	References

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