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(Circulation. 1997;96:3873-3879.)
© 1997 American Heart Association, Inc.

Articles

Long-term Angiographic and Clinical Outcome of Patients Undergoing Multivessel Coronary Stenting

Issam Moussa, MD; Bernhard Reimers, MD; Jeffrey Moses, MD; Carlo Di Mario, MD; Lucia Di Francesco, PhD; Massimo Ferraro, RN; ; Antonio Colombo, MD

From the Centro Cuore Columbus (B.R., C. Di M., L. Di F., M.F., A.C.), Milan, Italy, and Lenox Hill Hospital (I.M., J.M.), New York, NY.

Correspondence to Antonio Colombo, MD, Centro Cuore Columbus, Via M Buonarotti 48, 20145 Milan, Italy.

	Abstract

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Background Randomized clinical trials have shown that multivessel coronary angioplasty is feasible and provides similar long-term survival as bypass surgery in selected patients. However, the higher need for repeat intervention, in particular, coronary artery bypass graft surgery, remains a problem. The objective of this study was to test the hypothesis that multivessel stenting is safe and effective in reducing the need for repeat interventions, in particular, the need for bypass surgery.

Methods and Results Between March 1993 and June 1995, 100 consecutive patients (243 lesions) had multivessel coronary stenting. High-pressure stent optimization was used in all patients. Procedural success was achieved in 97% of lesions; 2 patients (2%) required emergency bypass surgery. Angiographic follow-up was obtained in 89% of patients at 5.2±2.5 months. Angiographic restenosis occurred in 22% of the lesions, but 37% of patients had 1 lesion with restenosis. Clinical follow-up was obtained in all patients at 21±10 months: target lesion revascularization was needed in 30 patients (30%), repeat angioplasty in 28 patients (28%) and coronary bypass surgery in 2 patients (2%); the overall survival rate was 96% (2% noncardiac death).

Conclusions Multivessel coronary stenting can be performed with high success rate and low need for emergency bypass surgery. Compared with historical results with multivessel percutaneous transluminal coronary angioplasty, patients who undergo multivessel stenting need less repeat interventions, in particular, less coronary bypass surgery and have similar long-term survival.

Key Words: angioplasty • revascularization • follow-up studies • stents

	Introduction

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Coronary artery bypass graft surgery, originally introduced in 1968,¹ results in longer survival and a better quality of life in a specific subgroup of patients with multivessel coronary artery disease compared with the use of an initial strategy of medical therapy.^2–5 Prospective, randomized clinical trials^6–11 have demonstrated that in patients with multivessel disease with an anatomy suitable for both PTCA and CABG, an initial strategy of PTCA results in a similar incidence of MI or death. However, the PTCA group had a higher incidence of recurrent angina and greater need for repeat revascularization secondary to higher restenosis rate. On the other hand, coronary stenting has been shown to be an effective device in two areas: bailout after failed PTCA¹² and reduction of restenosis in selected lesions.^13,14 In addition, improvements in deployment technique^15,16 and in pharmacological therapy^17,18 after stenting have increased its overall efficacy and cost effectiveness. Little data are available on the safety and long-term efficacy of coronary stenting without anticoagulation in patients with multivessel disease.

We performed this retrospective study to test the hypothesis that multivessel stenting without anticoagulation is safe and results in a reduced rate of angiographic restenosis and target lesion revascularization compared with historical results obtained with PTCA.

	Methods

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From March 30, 1993, through June 30, 1995, 988 consecutive patients with 1307 lesions underwent intracoronary stenting at Centro Cuore Columbus Hospital in Milan, Italy. One hundred patients with multivessel coronary disease (69 patients with two-vessel disease and 31 patients with three-vessel disease) with 243 lesions suitable for stent implantation underwent multivessel coronary stenting. All clinical, angiographic, and IVUS data were prospectively collected and entered into a dedicated database. Patients with stenting of unprotected left main coronary artery and patients with left ventricular ejection fraction of <35% were excluded from this analysis.

Stent Implantation Procedure
IVUS-guided intracoronary stenting was performed using techniques previously described.¹⁶ Indications for coronary stenting were elective in 189 lesions (79%), including 16 restenotic lesions and 16 chronic total occlusions; suboptimal result after PTCA in 26 lesions (10%); and threatened or acute vessel closure in 28 lesions (11%). The Palmaz-Schatz coronary stent (Johnson & Johnson Interventional Systems) was the stent most commonly used (133 lesions). Other stents included Gianturco-Roubin Flexstent (Cook Inc) in 26 lesions, Wiktor stent (Medtronic Interventional Vascular) in 27 lesions, AVE (Applied Vascular Engineering, Inc) in 13 lesions, Cordis stent in 9 lesions, Wallstent (Schneider) in 16 lesions, and a combination of the Palmaz-Schatz stent and other stents in 19 lesions. Several different stent types were used because of the complex anatomy (proximal tortousity, lesions on a bend, long lesions, and so on), which required different stent designs and lengths to be used.

Coronary Angiography and IVUS Imaging
Coronary angiography was done in a routine manner. Angiographic measurements were done with digital electronic calipers (Brown and Sharp) from an optically magnified image in the view that shows the most severe narrowing. All angiograms were analyzed by an experienced angiographer who was not involved in the intervention and who was blinded to the IVUS measurements. Previous studies have shown that digital calipers correlate closely with computer-assisted methods, with low interobserver and intraobserver variabilities.¹⁹ In our laboratory, interobserver reproducibility was assessed by two experienced angiographers who performed blinded measurements of randomly selected coronary segments (n=20). Intraobserver reproducibility was based on blinded measurements performed at a different time. Intraobserver correlation coefficient (r) was .98 (P<.0001; 95% CI, .96 to .99) for reference measurements and .91 (P<.0001; 95% CI, .71 to .97) for intrastent minimal luminal diameter. Interobserver correlation coefficient was .95 (P<.0001; 95% CI, .87 to .98) for reference measurements and .90 (P<.0001; 95% CI, .68 to .97) for intrastent minimal luminal diameter. Lesions were classified according to the modified American College of Cardiology– American Heart Association (AHA-ACC) classification.²⁰

IVUS imaging was performed using the Cardiovascular Imaging System (CVIS) with a 3.2F or 2.9F catheter. Validation of quantitative measurements and pathological correlation with ultrasound measurements have been reported.^21,22 Online quantitative measurements were performed during the procedure. In our laboratory, the intraobserver and interobserver variabilities of IVUS measurements inside the stent and in the reference segments have been previously reported.¹⁶ The cross section with the smallest lumen area inside the stent was selected for measurements for each pass of the IVUS catheter. Measurements in the reference segment were obtained proximal and distal to the stented segment in the closest, most normal-appearing segments. The average reference vessel and lumen cross-sectional areas were calculated as the average of the proximal and distal reference vessel and lumen cross-sectional areas, respectively.

Definitions
Angiographic Definitions
A clinically important lesion was defined as a stenosis of 50% of the diameter of a vessel with a reference diameter of >2.0 mm as measured with electronic calipers.

Clinical Events
Death was defined as any death regardless of cause. A Q-wave MI was defined as new pathological Q waves (>0.4 second) on an ECG in conjunction with elevation in creatine kinase to greater than twice the upper limit of normal. A non–Q-wave MI was defined by an elevation of the cardiac enzymes to greater than twice the upper limit of normal without the development of new pathological Q waves. Emergency CABG was defined as CABG involving immediate transfer of the patient from the catheterization laboratory to the operating room or within 24 hours of the procedure. Elective CABG was defined as CABG performed >24 hours after a stent procedure for procedural failure in the absence of ischemia or evolving MI. Acute thrombosis was defined as angiographically documented occlusion with TIMI grade 0 or I flow at the stent site occurring within 24 hours of the stent procedure. Subacute thrombosis events were angiographically documented occlusions with TIMI grade 0 or I flow at the stent site occurring >24 hours after the stent procedure. Repeat angioplasty was defined as nonemergency angioplasty performed for symptomatic restenosis.

Follow-up
Short-term follow-up was performed through telephone conversation with the patient at 1 month. Angiographic follow-up was planned at 6 months, but patients who had recurrent symptoms or an event were studied earlier. Long-term clinical follow-up was performed through telephone conversation with the patient or the referring physician.

Statistical Analysis
Normally distributed data that are continuous are expressed as mean±1 SD. Comparisons of continuous variables between groups was performed with unpaired student's t test. Subgroup comparison of categorical variables was performed with ² analysis. Differences were considered statistically significant at P<.05. The contribution of clinical, angiographic, and procedural variables to the outcome variable (restenosis and target lesion revascularization) was evaluated with logistic regression analysis. First, univariate analysis was performed to independently evaluate the contribution of each relevant variable; then, variables that were found to be significant in univariate analysis were entered into a multivariate logistic regression model to test the relative contribution of each of these variables to the outcome variable. Values of P<.05 were considered significant.

	Results

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Patient Characteristics and Procedural Variables
Patients' clinical characteristics are shown in Table 1, and baseline angiographic characteristics are shown in Table 2. Eleven lesions (5%) had a thrombus, 38 lesions (16%) were located at bifurcations, and 25 lesions (10%) were located in vessels with severe proximal tortousity. The mean number of stents implanted per patient was 3.4±1.7 stents. Coronary stenting was performed in two vessels in 84 patients (84%) and three vessels in 14 patients (14%). Two patients (2%) had only one vessel stented (because of stent delivery failure to the other vessel). The mean number of lesions stented per patient was 2.4±0.8 with the following distribution: 2 lesions in 66 patients (66%), 3 lesions in 24 patients (24%), 4 lesions in 5 patients (5%), and 5 lesions in 3 patients (3%). The mean number of stents implanted per lesion was 1.4±0.9 with the following distribution: for 10 lesions (4%), one-half Palmaz-Schatz stent was implanted; for 147 lesions (60%), 1 stent was implanted; for 60 lesions (25%), 2 stents were implanted; and for 24 lesions (10%), 3 stents were implanted. The balloon-to-vessel ratio used for final stent expansion was 1.13±0.17 with a maximal balloon inflation pressure of 16±3 atm. Initial stent implantation was angiographically successful in 235 lesions (97%). Of the study population, 6 patients had 6 additional lesions (not included in this analysis) for which PTCA was performed only because they were judged unsuitable for stent implantation.

View this table: [in this window] [in a new window]   Table 1. Baseline Clinical Characteristics

View this table: [in this window] [in a new window]   Table 2. Baseline Lesion Characteristics

Angiographic and IVUS Analysis
Baseline and postprocedural angiographic measurements are shown in Table 3. IVUS interrogation after stenting was performed in 207 lesions (85%). Postprocedural intrastent minimum lumen diameter was 2.80±0.56 mm, and intrastent minimum lumen cross-sectional area was 7.40±2.88 mm², which is larger than the distal reference lumen cross-sectional area of 6.90±3.08 mm² (P=.008).

View this table: [in this window] [in a new window]   Table 3. Quantitative Angiographic Measurements

Procedural and In-Hospital Events
As shown in Table 4, there were no procedural deaths. Two patients (2%) underwent emergency CABG: 1 for vessel rupture and the second for acute closure that was managed with stenting but with suboptimal results. Six patients (6%) had non–Q-wave MI, and 2 other patients (2%) had Q-wave MI.

View this table: [in this window] [in a new window]   Table 4. Procedural Complications and Postprocedural Clinical Events

In-hospital events occurred in 3 patients (3%); 1 patient had acute stent thrombosis 16 hours after the procedure that was managed with urgent PTCA without further clinical events. A second patient developed arterial thrombosis at the puncture site. This patient underwent surgical embolectomy but had a complicated course with sepsis that resulted in the patient's death. A third patient underwent elective CABG 24 hours after the procedure because of a suboptimal result after multivessel bailout stenting of the left main and left anterior descending coronary artery.

Postprocedural Pharmacological Regimen and Early Events
Ninety-five patients (95%) were treated with only antiplatelet medications: ticlopidine and aspirin in 68 patients (68%) and aspirin alone in 27 patients (27%). Five patients (5%) received a standard anticoagulation regimen consisting of short-term heparin, warfarin for 1 month, and aspirin indefinitely. This latter group included 1 patient with thrombus and slow flow after the procedure, a second patient with suboptimal final IVUS results, a third patient with inadequate lesion coverage because of the inability to deliver the stent, and 2 patients who were receiving chronic anticoagulants for other indications. Early events within 1 month after hospital discharge occurred in 1 patient (1%) who had subacute stent thrombosis with angiographic documentation and died in the catheterization laboratory before intervention.

Incidence and Predictors of Angiographic Restenosis
Eighty-four of 94 eligible patients (89%) with 226 lesions (89%) had angiographic follow-up at a mean duration of 5.2±2.5 months (range, 2.1 to 30 months). The overall incidence of restenosis expressed on a per-lesion basis was 22%, but 31 patients (37%) had 1 lesion with restenosis. As shown in Table 5, restenotic lesions were located in smaller vessels and had smaller postprocedural minimum lumen diameter as determined with angiography and IVUS. There was no significant difference in stent type, stent indication, number of stents per lesion, balloon-to-vessel ratio, or maximal pressure used for stent optimization. Table 6 shows predictors of restenosis as evaluated with univariate and multivariate logistic regression analyses.

View this table: [in this window] [in a new window]   Table 5. Comparison Between the Restenosis and No-Restenosis Groups in the Total Cohort

View this table: [in this window] [in a new window]   Table 6. Predictors of Angiographic Restenosis by Logistic Regression Analysis

Repeat Interventions and Long-term Clinical Events
Clinical follow-up was achieved in all patients at 21±10 months. Repeat revascularization at the target lesion site was required in 30 patients (30%), PTCA was required in 28 patients (28%), and CABG was required in 2 patients (2%). Predictors of the need for target lesion revascularization are shown in Table 7. Other events included 1 patient (1%) who underwent CABG after failed angioplasty for a new lesion and 2 patients (2%) had nonfatal MI. In addition, 2 patients (2%) died; the first occurred 8 months after the procedure secondary to MI, and the second patient died 1 year after the procedure secondary to pulmonary embolism. Of 89 patients who were alive and free from CABG at long-term follow-up, 8 patients had angina (9%). There were 75 patients (84%) who had treadmill stress tests, and 3 of these patients (4%) had objective evidence of ischemia.

View this table: [in this window] [in a new window]   Table 7. Predictors of Target Lesion Revascularization by Logistic Regression Analysis

	Discussion

Top Abstract Introduction Methods Results Discussion References

 
Scope of the Problem: Lessons Learned From Prospective, Randomized Clinical Trials
The results of several prospective, randomized clinical trials have recently shed light on an issue that has been under debate for a decade—the value of PTCA compared with CABG in treatment of patients with multivessel coronary disease. Table 8 lists the results of these trials. In patients who were randomized to PTCA, the need for in-hospital CABG ranged from 5% to 10.1% (emergency CABG ranged from 4.3% to 9.6%). At long-term follow-up, the need for target lesion revascularization ranged from 37% to 55% (with the need for CABG ranging from 16% to 22.5%), and cumulative mortality ranged from 2.2% to 13.7%. These results were later confirmed in a large meta-analysis of eight randomized trials in which PTCA was compared with CABG in single and multivessel disease.²³ In a subset of this analysis (patients with multivessel disease, not including BARI), a total of 1336 patients who were randomized to PTCA were compared with 1303 patients randomized to CABG. Among patients randomized to PTCA, 4.6% required emergency CABG, 18.3% required additional CABG within 1 year, and in subsequent years the need for additional CABG was 2% per year. Data from these trials indicate that patients randomized to an initial strategy of PTCA had an equivalent incidence of nonfatal MI and death compared with patients undergoing CABG but a higher recurrence of angina and repeat interventions. This led to a better quality of life in the CABG group at 3 years follow-up after the initial morbidity caused by the procedure. In addition, the escalating costs of repeat interventions over 5-year follow-up in the PTCA group led to similar costs as for CABG in patients with three-vessel disease.²⁴

View this table: [in this window] [in a new window]   Table 8. Randomized Trials of PTCA vs CABG for Treatment of Multivessel Coronary Artery Disease

In light of these data, it becomes clear that for catheter-based coronary interventions to gain an edge in the treatment of this important cohort of patients, an improvement in these results is needed. Coronary stenting has been shown to be an effective device for bailout after failed PTCA, reducing the need for emergency CABG.²⁵ In addition, coronary stenting has expanded the therapeutic window to more complex lesions, such as chronic total occlusions,^26–28 ostial lesions,^29,30 and calcified lesions,³¹ with more favorable immediate- and long-term outcomes compared with PTCA. With this background, our experience in the treatment of multivessel coronary artery disease with coronary stenting can be put into better perspective.

Present Study: `The Stenting Alternative'
Multivessel Stenting: Procedural Safety, Outcome, and Completeness of Revascularization
It has been shown that procedural safety and outcome in catheter-based coronary interventions are influenced by vessel size, lesion length, lesion location, and overall lesion complexity.^32,33 In this study, 42% of lesions were located in vessels of <3.0 mm, 19% of lesions were >15 mm, 7% of lesions were chronic total occlusions, and 9% of lesions were ostial. Type B2 and C lesions were present in 60% of cases. Despite this complex lesion subset, successful stent deployment was achieved in 97% of cases. In-hospital events included Q-wave MI in 2 patients (2%), emergency CABG in 2 patients (2%), elective CABG in 1 patient (1%), and death in 1 patient (1%). Procedural success and complications in this study are similar to results obtained with one-vessel stenting.¹⁶ However, these results represent an improvement from results obtained with multivessel PTCA, in particular with regard to the reduction in the need for in-hospital CABG, which ranged between 5% and 10%, as shown in Table 8.^7–11 In addition, the results of the present study are consistent with other reports on multivessel stenting. Laham et al³⁴ reported results of multivessel Palmaz-Schatz stenting in 103 patients (212 vessels). Angiographic success was achieved in 210 vessels. Non–Q-wave MI occurred in 11 patients, Q-wave MI occurred in 2 patients, and 1 patient died. There was no emergent CABG and no stent thrombosis.

With regard to the issue of completeness of revascularization, great variability exists in the literature in regard to its definition and impact on cardiac events and survival. Bourassa et al³⁵ reported on reasons for incomplete revascularization in the National Heart, Lung, and Blood Institute PTCA registry; those included chronic total occlusions, complex lesions, and operator decision not to dilate nonculprit lesions. With progress in angioplasty technique and equipment, operators became more aggressive, but complete revascularization remained less than what was expected with CABG. In our study, complete revascularization was achieved in all 69 patients (100%) with two-vessel disease and 21 of 31 patients with three-vessel disease (68%). However, the impact of completeness of revascularization on cardiac events and survival remains unclear. Bell et al³⁶ suggested that the main advantage of complete revascularization in patients undergoing CABG occurs in patients with impaired left ventricular function and severe angina.

Stent Thrombosis and Stent Restenosis in Multivessel Stenting
The incidence of stent thrombosis has declined with improvements in stent implantation technique^15,16 and pharmacological therapy^17,18 in patients with one-vessel stenting. Little data are available on the incidence of stent thrombosis with multivessel stenting. In this study, stent thrombosis occurred in 2 lesions (0.8%) in 2 patients (2%), which is similar to rates reported with one vessel stenting in the era of high-pressure stent deployment with antiplatelet therapy. This demonstrates that stenting several lesions in a patient does not increase the risk of stent thrombosis if the appropriate technique is used.^37,38

Angiographic follow-up was performed in 89% of eligible patients at 5.2±2.5 months. Angiographic restenosis on a per-lesion basis was 22%; however, 31 patients (37%) had one or more lesions with restenosis: 23 patients (74%) had only 1 lesion with restenosis, 4 patients (13%) had 2 lesions with restenosis, and 4 patients (13%) had 3 lesions with restenosis. The Figure shows te linear relationship between the number of stented lesions and the number of restenotic lesions (per patient). These results, if confirmed in larger studies, might help guide decision making with regard to the probability of restenosis according to the number of lesions that must be treated.

View larger version (17K): [in this window] [in a new window]   Figure 1. Simple linear regression analysis showing the correlation between the number of stented lesions (per patient) and the number of restenotic lesions (per patient).

Repeat Interventions and Clinical Events at Long-term Follow-up
In the present study, long-term clinical follow-up was performed in all patients at 21±10 months. A total of 30 patients (30%) needed target lesion revascularization for 1 lesion (28 patients needed PTCA and 2 patients needed CABG). The fact that only 2 patients needed CABG at follow-up is clearly a major advantage over multivessel PTCA, for which the need for CABG at long-term follow-up ranged from 16% to 31%, as shown in Table 8.^7–11 The reason for the lower need for CABG in the present study is because the majority of patients with restenosis had only 1 culprit lesion that was easily managed with repeat angioplasty. The long-term outcome for patients undergoing repeat angioplasty for instent restenosis remains a subject of debate, but data point to a favorable long-term outcome, particularly in patients with focal restenosis. Reimers et al³⁹ reported the long-term clinical outcome for 119 patients who underwent repeat balloon angioplasty for instent restenosis. In this series, only 10% of patients needed repeat target lesion revascularization for clinical restenosis.

To summarize, the present study demonstrates that patients who underwent multivessel coronary stenting have a favorable long-term outcome. The overall cumulative survival was 96% (2% noncardiac death), CABG-free survival was 89%, CABG-and-MI–free survival was 87%, and angina-free survival was 87%.

Cost Considerations
Cost effectiveness is an important factor in decision making in medicine. Cohen et al⁴⁰ reported a cost effectiveness comparison between one-vessel coronary stenting and one-vessel PTCA in the STRESS trial. At 1 year, stenting was found to cost 800$ more per patient compared with PTCA. This increase in cost was due to higher vascular complications and longer hospital stay. In our study, no cost calculations were made, but with the use of only antiplatelet therapy in 95% of patients, there was only a 1% incidence of vascular complication and all patients who had successful stenting were discharged home within 2 days. These developments in coronary stenting may result in cost savings, and future trials investigating this issue will provide the needed data.

Study Limitations
The results of this study should be interpreted in the context of several limitations. This is a retrospective analysis with an inherent selection bias for patients judged appropriate for coronary stenting. Even though the Palmaz-Schatz stent was the stent most commonly used, different stent designs were used for different indications, which might limit the ability to extrapolate data regarding outcome associated with different stent types. However, different stent types may be needed to provide a successful and complete revascularization in many patients with complex coronary anatomy. Despite these limitations, this study provides an insight into the angiographic and clinical outcomes for patients undergoing multivessel stenting.

Conclusions
This study describes the results of coronary artery stenting when used as an initial strategy to treat patients with multivessel coronary disease. This approach is safe; it is associated with a high success rate and a low need for emergency CABG. In addition, compared with historical results of multivessel PTCA, there is a modest decrease in the need for repeat interventions (combined angioplasty and CABG) and a significant decrease in the need for repeat CABG at long-term follow-up. These observations must be confirmed with randomized clinical trials to provide clinicians with guidance regarding the best strategy of treatment for this increasingly important patient population.

	Selected Abbreviations and Acronyms

 

CABG = coronary artery bypass graft surgery CI = confidence interval IVUS = intravascular ultrasound MI = myocardial infarction PTCA = percutaneous transluminal coronary angioplasty TIMI = Thrombolysis in Myocardial Infarction

Received May 8, 1997; revision received August 6, 1997; accepted August 21, 1997.

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