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(Circulation. 1998;97:1355-1361.)
© 1998 American Heart Association, Inc.

Clinical Investigation and Reports

Procedural Results and Late Clinical Outcomes After Placement of Three or More Stents in Single Coronary Lesions

Ran Kornowski, MD; Roxana Mehran, MD; Mun K. Hong, MD; Lowell F. Satler, MD; Augusto D. Pichard, MD; Kenneth M. Kent, MD; Gary S. Mintz, MD; Ron Waksman, MD; John R. Laird, MD; Alexandra J. Lansky, MD; Theresa A. Bucher, RN; Jeffrey J. Popma, MD; ; Martin B. Leon, MD

From the Cardiac Catheterization Laboratory, Division of Cardiology, Washington Hospital Center, Washington, DC.

	Abstract

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Background—Previous reports have suggested higher procedural and long-term complications among patients treated with multiple stents for diffuse lesions and/or long dissections.

Methods and Results—To evaluate procedural success, major complications, and clinical outcomes (1 year) in a consecutive series of patients treated with multiple (3) contiguous stents in single lesions, we evaluated in-hospital and long-term (1-year) clinical outcomes in 117 consecutive patients treated with 3 coronary stents compared with a concurrent series of patients treated with 1 or 2 stents (n=1673) between January 1, 1994, and December 31, 1995. Multiple stents were implanted more often in larger vessels, in the right coronary artery or saphenous vein grafts, and for unfavorable lesion characteristics, including long (>20 mm), calcified, ulcerated, thrombotic, and/or flow-obstructing lesions. Overall procedural success was obtained in 97.4% of patients and was similar whether 1 or 2 versus 3 stents were used. Non–Q-wave MI (CK-MB 5 times normal) was more frequent after 3 stents (22.8% versus 13.4%, P=.005). Target lesion revascularization (TLR) was 14.6% for 1 or 2 stents and 13.3% for 3 stents (P=.70). There was no difference in death (2.2% versus 0.9%, P=.34) or Q-wave MI (1.4% versus 0.9%, P=.64) between the two groups (1 or 2 stents versus 3 stents, respectively), and overall cardiac event–free survival was similar during follow-up (P=.70).

Conclusions—Patients treated with multiple (3) contiguous stents compared with 1 or 2 stents have (1) similar in-hospital procedural success and major complications despite having more unfavorable lesion characteristics, (2) a higher rate of procedural non–Q-wave MI, and (3) similar TLR and overall major cardiac event rates during 1 year of follow-up.

Key Words: stents • coronary disease • angioplasty • restenosis

	Introduction

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Conventional balloon angioplasty to treat diffuse lesions has frequently been associated with suboptimal angiographic results, increased procedural complications, and higher rates of restenosis.^{1 2 3 4 5 6 7 8 9} Stents have been found to improve the short-term and late outcomes when used for focal lesions in relatively large (3 mm) vessels.^{10 11 12 13 14 15 16} Until recently, most commonly used stents in clinical practice were 15 to 20 mm long, because of the unavailability of longer (>20 mm) stents in the United States. Therefore, multiple (3) coronary stents have been used to cover diffuse lesions or long dissections. Data regarding the clinical efficacy of stents in the treatment of diffuse disease are limited. Previous reports have suggested higher procedural complications, higher stent thrombosis, and more frequent late restenosis in patients treated with multiple stents.^{17 18 19 20 21 22} Thus, to determine the short- and long-term clinical outcomes associated with implantation of multiple coronary stents for diffuse lesions or long dissections, we evaluated procedural success, major in-hospital complications, and clinical outcomes (1 year) compared with a concurrent series of patients treated with one or two "short" stents in the same vessel.

	Methods

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Study Population
The patient cohort included a consecutive series of all 1790 patients (2493 lesions) in the Cardiology Research Foundation Angioplasty Database treated with stents between January 1, 1994, and December 31, 1995. Patients were divided into two groups according to the number of stents implanted to treat a single lesion (1 or 2 stents versus 3 stents). Multiple stents were implanted either for diffuse disease or extensive dissections in the setting of abrupt/threatened closure. All indications for stent use (elective use to improve acute procedural safety and reduce late clinical events, provisional use to treat suboptimal primary device results, or urgent use to treat abrupt or threatened closure) are included in this study. Baseline clinical demographics and in-hospital complications were confirmed by independent hospital chart review. All patients underwent preintervention and postintervention 12-lead ECG to detect procedure-related ischemic changes and/or MI and the appearance of a new pathological Q wave on the surface ECG. Blood samples were routinely acquired from all patients at 6 hours after the procedure for CK-MB enzyme (normal values, 0 to 4 ng/mL). The diagnosis of non–Q-wave MI was based on CK-MB elevation 5 times normal values in the absence of new pathological Q waves on postintervention ECGs. Clinical outcomes at 1 year were obtained by serial telephone interviews by research nurses, and late clinical events (death, Q-wave MI), TLR, or any cardiac events (death, Q-wave MI, any PTCA or CABG) were adjudicated and corroborated by accompanying source documentation. The diagnosis of Q-wave MI during follow-up was based on hospitalization records and documented discharge summaries with a clinical diagnosis of MI with CK-MB rise of >3 times normal and the appearance of new pathological Q waves on the ECG. Patients were excluded from analysis if they were treated with investigational stents (not approved by the FDA) or if the treatment site was in the left main coronary artery.

Stent Techniques
Details of the stent implantation procedure have been described previously.^{10 11} After the initial balloon angioplasty or ablative procedure, coronary or "biliary" Palmaz-Schatz (Johnson & Johnson Interventional Systems) or Gianturco-Roubin (Cook Inc) stents were implanted, usually over 0.014-in extra-support guidewires (Advanced Cardiovascular Systems, Inc). Coronary Palmaz-Schatz stents were used whenever possible; the larger biliary design was reserved for vessels 4 mm in diameter and was most commonly used in SVG lesions. The Gianturco-Roubin stent was most often used in (1) smaller (<3-mm diameter) vessels, to treat abrupt/threatened closure (mainly in the mid–distal vessel location) or (2) as a primary strategy in more tortuous vessels or to preserve side-branch access. Adjunct high-pressure PTCA was performed after initial stent deployment (routinely to 16 atm for Palmaz-Schatz stents and 14 atm for Gianturco-Roubin stents). IVUS assessment was obtained before treatment and after stent implantation in 91.2% of patients. Optimal stent implantation was carefully monitored by an iterative technique with prespecified IVUS end points and additional high-pressure balloon inflation as needed. IVUS was used to optimize stent apposition, expansion, and lesion coverage and to detect inflow-outflow obstruction and residual dissection at both stent margins. After Gianturco-Roubin stent implantation, IVUS was usually not performed, to minimize the risk of distorting the stent geometry. Careful attention was given to overlapping the stents whenever >1 stent was needed to cover a lesion.

The prestent and poststent anticoagulation regimens included aspirin and ticlopidine for 1 month and low-molecular-weight heparin (for 2 weeks) in high-risk subsets (eg, degenerated SVGs, thrombus-containing lesions, and patients with 3 stents).

Angiographic Analysis
All 120 lesions with 3 stents and 1553 of 2373 lesions (65%) with 1 or 2 stents had complete quantitative and qualitative angiographic analysis. Cineangiograms were reviewed by our Angiographic Core Laboratory at the Washington Hospital Center by an observer who was unaware of clinical outcomes. Standard morphological criteria were used for the identification of lesion location, length ("shoulder-to-shoulder"), eccentricity, irregularity, fluoroscopic calcification, and ulceration.³ Quantitative angiographic analysis was done with selected end-diastolic cine frames demonstrating the stenosis in its most severe and nonforeshortened projection. With the contrast-filled guiding catheter used as the calibration standard, reference and minimal lumen diameters were determined before and after stent implantation.

Statistics
Continuous variables are presented as mean±SD. Categorical data are presented as percent frequency and compared between groups by ² statistics. Multivariate analysis was performed with SAS Logistic Regression Statistics software. Survival curves were calculated and displayed with the SAS LIFETEST procedure. Wilcoxon statistics were used for survival comparison between groups (1 or 2 versus 3 stents). The means of nominal values were compared by the unpaired Student's t test. Values of P<.05 were accepted as significant.

	Results

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Baseline Demographics
Table 1 lists the baseline characteristics of all treated patients according to the number of stents (1 or 2 versus 3 stents). Overall, patient demographics were similar among these two groups. The patient population had a relatively high frequency of unstable angina, prior MI, previous PTCA, and/or CABG surgery. Patients treated with 3 stents proportionally underwent similar procedures before stent implantation, although they tended to be treated more frequently by rotational atherectomy or excimer laser angioplasty techniques (Table 2). The coronary Palmaz-Schatz stent was used in the majority of cases, and more often in patients treated with 3 stents (79.2% versus 68%, P=.01).

View this table: [in this window] [in a new window]   Table 1. Baseline Characteristics of the Study Population

View this table: [in this window] [in a new window]   Table 2. Interventional Procedures

Lesion Location and Characteristics
Multiple (3) stents were implanted more often in the right coronary artery and for unfavorable lesion morphologies, including long (>20 mm), calcified, ulcerated, thrombotic, and/or flow-obstructing (TIMI grade 0/1) lesions (Table 3). Multiple stents were more often implanted in the setting of an extensive dissection (13.5% versus 4.9%, P=.004) or abrupt/threatened closure (8.3% versus 5.0%, P=.05). The proximal reference vessel diameter was larger in vessels treated with 3 stents than with 1 or 2 stents (3.46±0.5 versus 3.17±0.6 mm, P=.0005). Angiographic results indicated that final lumen diameters were similar between the two groups, but there was a trend toward a lower final diameter stenosis in the 1- or 2-stent group (6±16% versus 11±16%, P=.07).

View this table: [in this window] [in a new window]   Table 3. Location Data and Qualitative and Quantitative Angiographic Results of the Treated Lesions

Procedural Results
Overall procedural success was obtained in 97.4% of patients and was similar whether 1 or 2 versus 3 stents were used (Table 4). Similarly, overall, major in-hospital complications (death, Q-wave MI, and emergent CABG) did not differ significantly between the groups (2.6% for each group). The rate of stent thrombosis, although somewhat higher for 3 stents (0.9%), did not differ significantly compared with that for 1 or 2 stents (0.4%, P=.46). Similarly, the need for repeat PTCA of the treated vessel during hospitalization was indistinguishable between the 3 and 1 or 2 stent groups (2.6% versus 1.3%, P=.23). Importantly, the incidence of non–Q-wave MI (defined as CK-MB 5 times normal) was significantly higher in patients treated with 3 stents compared with 1 or 2 stents (22.8% versus 13.4%, P<.0001). A representative procedural result before and after implantation of multiple (3) contiguous stents to treat a diffuse lesion is shown in Fig 1.

View this table: [in this window] [in a new window]   Table 4. In-Hospital Events and 1-Year Follow-Up Clinical Outcomes in All Study Patients

View larger version (119K): [in this window] [in a new window]   Figure 1. Representative angiogram of patient with unstable angina reveals diffuse lesion extending from ostium to middle segment of right coronary artery (A, arrows). After implantation of 4 overlapping Palmaz-Schatz stents in diseased segments (B, arrows), excellent angiographic result was achieved.

Long-term Outcomes
Clinical follow-up at 1 year was available in 1655 of 1673 patients (98.9%) with 1 or 2 stents and in 116 of 117 patients (99.1%) treated with 3 stents. There was no difference in death or Q-wave MI between the two groups during late follow-up (Table 4). Overall TLR at 1 year was 14.6% and 13.3% in patients treated with 1 or 2 versus 3 stents, respectively (P=.70). The rate for any cardiac event was similar between groups (27.2% for 1 or 2 stents versus 24.5% for 3 stents, P=.54). Actuarial event-free survival curves for any cardiac event up to 18 months (death, Q-wave MI, PTCA, and CABG) and for TLR alone are shown in Fig 2. Event-free survival was similar in both groups for both end points (P=.70 for any event and P=.56 for TLR).

View larger version (20K): [in this window] [in a new window]   Figure 2. Actuarial event-free survival curves for any adverse event (death, Q-wave MI, PTCA, and CABG, top) or TLR (bottom) for 550 days after 3 vs 1 or 2 stents.

Multivariate Analysis
Logistic regression analysis was used to identify independent predictors of any cardiac event (death, Q-wave MI, PTCA, and CABG) or TLR at follow-up (Table 5). Candidate variables in the model were expected to correlate with outcomes and included the number of stents (3 versus 1 or 2), unstable angina, age, sex, history of PTCA, history of CABG, diabetes mellitus, left ventricular ejection fraction, SVG lesion, lesion length, and reference vessel diameter. History of CABG, history of PTCA, and reference vessel diameter were each found to be associated with any adverse cardiac event at follow-up. History of PTCA and reference vessel size were found to predict TLR at 1 year (Table 5). In none of these analyses did the number of stents implanted (3 versus 1 or 2) predict late clinical outcome or TLR, and diabetes mellitus had a marginal effect only on TLR. On the basis of this regression model and the incidence of the predictive variables in our studied population, the probability of TLR after stenting of a single lesion is given in Fig 3, according to proximal reference vessel size and the presence or absence of prior PTCA.

View this table: [in this window] [in a new window]   Table 5. Independent Predictors of Any Cardiac Event (Death, Q-Wave MI, PTCA, and CABG) or TLR at 1 Year of Follow-Up

View larger version (55K): [in this window] [in a new window]   Figure 3. TLR rates after stent implantation in single lesions according to proximal reference vessel size as measured by quantitative angiography in presence or absence of prior PTCA.

Native Coronary Arteries Versus SVGs
Patients with native coronary artery lesions treated with 1 or 2 stents (n=1253 patients) compared with 3 stents (n=87) had similar procedural success (97.2% versus 97.7%, P=.80). At follow-up (1 year), there was no significant difference in death (1.6% versus 0%, P=.23), Q-wave MI (0.9% versus 1.1%, P=.82), or TLR (15.7% versus 13.1%, P=.52) between these groups (1 or 2 stents versus 3 stents in native coronary arteries, respectively). Also, overall cardiac event–free survival at 18 months (death, Q-wave MI, PTCA, or CABG) was similar between the two groups (22.9% for 1 or 2 stents versus 20.7% for 3 stents, P=.63).

Patients with SVG lesions treated with 1 or 2 stents (n=423 patients) compared with 3 stents (n=27) had similar procedural success (98.1% versus 96.1%, P=.48). At follow-up (1 year), there was no difference in death (3.6% versus 3.7%, P=.98), Q-wave MI (2.7% versus 0%, P=.39), or TLR (11.2% versus 14.3%, P=.61) between these groups (1 or 2 stents versus 3 stents in SVGs, respectively). Also, overall cardiac event–free survival was similar (33.7% for 1 or 2 stents versus 33.3% for 3 stents, P=.96). A representative case of multiple (3) stents used to treat an SVG is shown in Fig 4.

View larger version (100K): [in this window] [in a new window]   Figure 4. Representative angiogram of patient with previous CABG and unstable angina reveals diffuse lesion in proximal to middle portions of SVG to right coronary artery (A, arrows). After implantation of 3 overlapping biliary Palmaz-Schatz stents in proximal to mid portions of graft (B, arrows), excellent angiographic result was achieved.

Urgent Coronary Stenting
Stents were used to treat acute or threatened closure and/or dissections in 217 of 1673 patients (13.0%) with 1 or 2 stents and in 22 of 117 patients (18.8%) with 3 stents. Patients undergoing such "bailout" stent procedures with 1 or 2 stents compared with 3 stents had similar procedural success (90.2% versus 90.9%, P=.91). Also, in-hospital mortality (4.0% versus 0%, P=.34), Q-wave MI (3.1% versus 0%, P=.40), and emergent CABG (4.9% versus 9.0%, P=.40) did not differ significantly between those groups (1 or 2 stents versus 3 stents for bailout stenting, respectively). At follow-up (1 year), there was no significant difference in death (1.3% versus 0%, P=.58), Q-wave MI (0.9% versus 0%, P=.66), or TLR (16.6% versus 19.0%, P=.77) between those groups (1 or 2 versus 3 stents, respectively). Also, overall cardiac event–free survival at 18 months (death, Q-wave MI, PTCA, or CABG) was similar between the two groups (22.8% for 1 or 2 stents versus 18.2% for 3 stents, P=.62).

One Stent Compared With 3 Stents in Single Vessels
Additional analysis has been performed to explore potential differences in late outcome for a single-vessel intervention, comparing between patients treated with 1 stent in one vessel (n=1226) versus 3 stents in one vessel (n=102). There was no difference in death (2.1% versus 1.0%, P=.43) or Q-wave MI (1.4% versus 0%, P=.23) between the two groups (1 stent versus 3 stents, respectively) during late follow-up. Overall TLR at 1 year was 14.5% and 17.4% in patients treated with 1 stent versus 3 stents, respectively (P=.46). Also, overall cardiac event–free survival at 18 months of follow-up (death, Q-wave MI, PTCA, or CABG) was similar between the two groups (26.9% for 1 stent versus 24.7% for 3 stents, P=.65).

	Discussion

Top Abstract Introduction Methods Results Discussion References

 
This study shows that patients treated with multiple (3) contiguous stents compared with 1 or 2 stents have (1) similar procedural success and major complications despite having more unfavorable lesion characteristics; (2) significantly higher procedural non–Q-wave MI or CK-MB elevations, which reflect procedure-related events, such as extensive dissections and/or abrupt/threatened closure; and (3) similar TLR and rates of any cardiac event during 1-year follow-up. In the present study, we also found that history of CABG or PTCA and reference vessel diameter are the strongest predictors for composite cardiac events, whereas prior PTCA and reference vessel size are predictive for clinical restenosis (Table 5). In none of these analyses did the number of stents used (3 versus 1 or 2) predict late clinical outcome or TLR.

Significance of the Present Study Results
The treatment of diffuse coronary artery disease has been associated with disappointing acute and long-term results in most reported conventional balloon angioplasty reports and new-devices series, with increased risk for acute complications and restenosis.^{1 2 3 4 5 6 7 8 9 23 24 25 26 27} Initial literature reports on use of multiple overlapping stents for diffuse disease were disappointing.^{17 21 22} Those early experiences did not include modern operator techniques, which may play a crucial role in achieving optimal results when multiple contiguous stents are used. More recent experiences suggested that multiple-stent therapy is feasible, with relatively low procedural complications but with relatively high rates of restenosis.^{19 20 28}

Unlike previous reports, the present study suggests that treatment of diffuse lesions and/or long dissections with multiple contiguous stents is associated with high procedural success, low procedural complications, and relatively infrequent TLR at 1 year. It is important to note that the results in the present study were obtained in relatively large vessels (average diameter, 3.46 mm) and more often in right coronary artery or SVG lesions. This suggests that vessel size and anatomic location play an important role in achieving favorable results in diffuse-disease scenarios requiring 3 stents. Indeed, reference vessel size, but not the number of stents used, was an independent determinant of TLR or any cardiac event in the multivariate analysis. Moreover, these single-center findings were achieved with meticulous stent technique, including the frequent use of prestenting ablative devices to remove excessive plaque burden, thrombotic material, and/or fibrocalcific elements before stenting.²⁹ It has also been our bias to use IVUS: first to assess true vessel size, lesion composition, and lesion length, and after stenting to help optimize stent expansion, detect edge dissections, and ensure full lesion (inlet and outlet) coverage.^{30 31} It is not clear whether less meticulous placement of multiple stents without IVUS assistance would have equally favorable outcome. Finally, unlike earlier reports, high-pressure dilatation after stenting and routine aspirin and ticlopidine therapy were routinely used.

In this study, there was a higher than expected frequency (22.8%) of procedure-related non–Q-wave MI in patients treated with 3 stents. This high prevalence of periprocedural CK-MB elevation probably reflects a more complex clinical and anatomic milieu (including diffuse disease, extensive dissection, abrupt/threatened closure, and side-branch vessel occlusion) and more extensive adjunct prestent atheroablative devices. Although other reports have indicated an association between periprocedural CK-MB elevations and late adverse cardiac events,^{32 33 34} thus far our preliminary long-term experience did not indicate higher mortality, Q-wave MI, or repeat revascularization among patients with 3 stents despite a higher prevalence of procedural CK-MB rises. Nevertheless, our data do not refute the potential significance of CK-MB rise on late clinical outcomes, especially after SVG interventions.³⁵ One should note, however, that if in-hospital non–Q-wave MI events had to be included in the 1-year postintervention analysis, then the overall MI rate would appear to be higher in the 3 stent group during follow-up.

Limitations of the Present Study
The primary limitation of our study is that despite a very large interventional volume that was included in our analysis, the study might have been underpowered to detect differences between the two cohorts studied. Also, the very large number of statistical analyses performed might have subjected our study to overinterpretation of differences with borderline P values. Because this study was a retrospective analysis, it is unknown whether the use of a different therapeutic strategy for diffuse disease (eg, fewer stents in the most narrowed spots, other transcatheter devices without stenting, or adjunctive abciximab therapy) would have resulted in comparable procedural or late results. Importantly, the comparison of 1 or 2 stents versus 3 stents is necessarily confounded by significant differences in lesion characteristics among the groups, including reference vessel size, lesion location, and complex lesion morphologies. It is quite possible that if 3 stents were implanted in smaller vessels and more frequently in the left anterior descending location (rather than the right coronary artery or SVG), the acute and especially long-term clinical outcomes would be less favorable. Also, it is possible that the higher incidence of total occlusions in the 3 stent group might have diminished the sense for revascularization in the event that restenosis or reocclusion occurred, masking additional differences in restenosis between the two studied groups. Another limitation of the present study was its inability to compare different stent designs or to evaluate newer coronary stents (not approved by the FDA at the time of the study) (eg, Wallstent, AVE stent, Multilink stent, NIR stent), which may have properties better suited to the treatment of long lesions. Finally, because no long stents (>20 mm) were available for this study, it would be interesting to compare multiple (3) short stents with newly available long stents in comparable patient cohorts.

Conclusions
This study suggests that the "full metal jacket" approach, ie, the use of multiple short (20 mm) contiguous stents in the same vessel, may be a viable therapeutic alternative in appropriate patients, especially in the treatment of patients with diffuse lesions or extensive dissection in relatively large vessels. In the near future, the use of longer stents and other adjunctive therapies (device-based and pharmacological) will be directed toward optimizing the treatment of patients with the challenging scenario of diffuse lesions and/or long procedural dissections.

	Selected Abbreviations and Acronyms

 

CABG = coronary artery bypass graft CK = creatine kinase IVUS = intravascular ultrasound MI = myocardial infarction PTCA = percutaneous transluminal coronary angioplasty SVG = saphenous vein graft TLR = target lesion revascularization

	Acknowledgments

 
This study was supported by a grant from the Cardiology Research Foundation, The Washington Cardiology Center, Washington, DC.

	Footnotes

 
Reprint requests to Martin B. Leon, MD, Director, Cardiovascular Research, Washington Cardiology Center, Suite 4B-1, 110 Irving St NW, Washington, DC 20010.

Received September 11, 1997; revision received November 20, 1997; accepted December 12, 1997.

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