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J Am Coll Cardiol, 2000; 35:612-618
© 2000 by the American College of Cardiology Foundation
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CLINICAL STUDIES

Procedural results and late clinical outcomes after percutaneous interventions using long (≥25 mm) versus short (<20 mm) stents

Ran Kornowski, MD, FACCa,b, Balram Bhargava, MDa,b, D. M. Shmuel Fuchs, MDa,b, Alexandra J. Lansky, MD, FACCa,b, Lowell F. Satler, MD, FACCa,b, Augusto D. Pichard, MD, FACCa,b, Mun K. Hong, MD, FACCa,b, Kenneth M. Kent, MD, PhD, FACCa,b, Roxana Mehran, MD, FACCa,b, Gregg W. Stone, MD, FACCa,b and Martin B. Leon, MD, FACCa,b

a Cardiac Catheterization Laboratory, The Washington Hospital Center, Washington, DC, USA
b The Cardiovascular Research Foundation, The Washington Hospital Center, Washington, DC, USA

Manuscript received April 21, 1999; revised manuscript received August 16, 1999, accepted November 3, 1999.

Reprint requests and correspondence: Dr. Ran Kornowski, Cardiovascular Research Foundation, Washington Hospital Center, 110 Irving Street, Northwest, Suite 4B-1, Washington, DC 20010
rxk3{at}mhg.edu


   Abstract
Top
 Abstract
Methods
 Results
 Discussion
 References
 
OBJECTIVES

To evaluate clinical outcomes after the use of long coronary stents.

BACKGROUND

The use of long slotted-tube stents has been recently approved in the U.S. to treat long lesions or dissections. Procedural success and long-term outcomes of long versus short stents have not been established.

METHODS

We evaluated procedural success, major in-hospital complications, target lesion revascularization and long-term (one year) clinical outcomes in 1,226 consecutive patients (1,259 native coronary lesions) who underwent a single vessel intervention using a single long (≥25 mm, 116 patients) or short (<20 mm, 1,110 patients) tubular-slotted stent.

RESULTS

Patients treated with long stents had more diffuse (>10 mm length) lesions (63% vs. 28%, p = 0.001). The mean stent length was 28 ± 5 mm versus 15 ± 2 mm for long versus short stent groups (p = 0.001). Overall procedural success was similar in the long versus short stent groups (96% vs. 98%, p = 0.08). However, major in-hospital complications tended to occur more frequently in patients treated with longer stents (3.4% vs. 1.0%, p = 0.04). The rate of periprocedural non-Q-wave myocardial infarction (MI) (creatine kinase-MB ≥5 times normal) was notably higher after long stent implantation (23% vs. 11%, p = 0.001). Target lesion revascularization at one year was 14.5% vs. 13.8% (p = 0.69), and target vessel revascularization rate was 19.6% vs. 17.3% (p = 0.41) in the long versus short stent group, respectively. There was no difference in one year mortality (2.5% vs. 3.5%, p = 0.49) or Q-wave MI (2.7% vs. 1.2%, p = 0.48), and the overall cardiac event-free survival was similar for the two groups (81%).

CONCLUSIONS

The use of single coronary long (≥25 mm) versus short (<20 mm) stents is associated with: 1) somewhat increased major procedural complications, 2) significantly higher frequency of periprocedural non-Q-wave MIs, and 3) equivalent repeat revascularization risk and cardiac event-free survival out-of-hospital up to one year.

Abbreviations and Acronyms
  CK = creatinine kinase
  IVUS = intravascular ultrasound
  MB = myocardial band
  MI = myocardial infarction
  OR = odds ratio
  QCA = quantitative coronary angiography
  TIMI = thrombolysis in myocardial infarction
  TLR = target lesion revascularization
  TVR = target vessel revascularization

The treatment of atherosclerotic coronary plaques with metallic slotted-tube stents has been shown to improve the acute and long-term outcomes obtained by catheter-based coronary interventions (1–4). Improved implantation techniques using high-pressure balloon inflation and the addition of new antiplatelet pharmacotherapy enable stent implantation without long-term anticoagulation, with very low rates of periprocedural complications (5–7). Initiatory trials have shown favorable stent results compared with balloon angioplasty in short lesions and relatively large sized vessels (1,2). It is still unclear whether these results can be generalized to longer lesions in diffuse coronary disease (8). Data on the effectiveness of stent treatment in diffuse disease scenarios are limited. Prior studies have reported higher procedural complications and stent thrombosis rates and more frequent late restenosis in patients treated with multiple stents placed in diffuse lesions (9–13). Recently, we showed that patients with relatively large sized vessels treated with multiple contiguous stents have favorable procedural results and major cardiac event rates during follow-up (14). Accurate positioning of multiple stents may become difficult, however, with long overlapping stent segments or uncovered gaps leading to inadequate results compared with single stent implantation in most otherwise reported series.

Recently, with the availability of long stents in the U.S., we have compared the acute procedural and long-term (one year) outcomes of patients with a single long (≥25 mm) versus short (<20 mm) slotted-tube stent implantation in native coronary arteries.


   Methods
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 Abstract
 Methods
Results
 Discussion
 References
 
Patients and follow-up.   The patient cohort includes a consecutive series of 1,226 patients (1,259 native coronary lesions) in the Cardiology Research Foundation Angioplasty Database treated with a single stent implanted in a single native coronary artery between July 1, 1997, and July 1, 1998. Patients were divided into two groups: long stents (≥25 mm) (n = 116 patients) and a short (<20 mm) stent group (n = 1,110 patients). All indications for stent use (elective use to optimize angiographic results and reduce late restenosis, provisional use to treat suboptimal primary device result or urgent use to treat abrupt or threatened vessel closure) are included in this study. Baseline clinical demographics and in-hospital complications were confirmed by independent hospital chart review.

All patients underwent pre- and post-intervention, 12-lead electrocardiogram to detect procedural related ischemic changes or the appearance of a new pathologic Q-wave on the surface ECG. Blood samples were routinely acquired from all patients after the procedure for creatine kinase (CK)-MB enzyme at 8, 16 and 24 h (normal values 0 to 4 ng/ml). The diagnosis of non-Q-wave myocardial infarction (MI) was based on CK-MB elevation ≥5 times normal values in the absence of new pathologic Q-waves on post-intervention electrocardiograms. Periprocedural CK-MB elevation is also reported as three times normal cut-off. Out-of-hospital clinical outcomes up to eight months were obtained by serial telephone interviews by research nurses and late clinical events (death, Q-wave MI), target lesion revascularization (TLR), target vessel revascularization (TVR) or any cardiac event (death, Q-wave MI, TLR) was adjudicated and corroborated by accompanying source documentation.

Stent techniques.   After the initial balloon angioplasty or ablative procedure, coronary stents were implanted over 0.014 in. extra-support guidewire. All stents used during the study period were included in the current analysis. Adjunct balloon inflation (usually ~16 atmospheres) was added after initial stent deployment in all cases. Optimal stent implantation was carefully monitored using an iterative technique with intravascular ultrasound (IVUS) monitoring in the majority of cases. The pre- and post-stent anticoagulation regimens included aspirin (325 mg daily) and ticlopidine (250 mg twice daily) for one month. Patients with intervention in more than one vessel or more than a single stent were excluded from analysis.

Quantitative angiographic analysis.   Five hundred ninety-six lesions were available for complete quantitative and qualitative angiographic analysis. Standard morphologic criteria were used for the identification of lesion location, length, eccentricity, calcification and ulceration. Quantitative angiographic analysis was performed using selected end-diastolic frames demonstrating the stenosis in its most severe projection. Using the contrast-filled guiding catheter as the calibration standard, proximal and distal references (within 5 mm of lesion margins) were measured and lesion minimal lumen diameters and percent diameter stenosis were determined before and after intervention.

Statistics.   Continuous variables are presented as mean ± 1 standard deviation. Categorical data are presented as percent frequency and compared between groups using chi-square statistics. Survival curves were calculated and displayed using the SAS LIFETEST (SAS Institute, Cary, North Carolina) procedure and Log-Rank statistics were used for testing of survival homogeneity between the two groups. Wilcoxon statistics were used for survival comparison between groups (long versus short stents). Mean values were compared using the unpaired Student t test. A p value <0.05 was accepted as statistically significant.


   Results
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 Abstract
 Methods
 Results
Discussion
 References
 
Baseline demographics.   Table 1 lists the baseline characteristics of all treated patients, distinguished according to long versus short stents. Patients treated with long stents on the average were younger and suffered more often from hypertension and previous MI but had sustained fewer prior coronary angioplasty procedures. Otherwise, the demographics were similar between these two groups.


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  		Table 1 Baseline Characteristics of the Study Population

 
Procedural data.   Before stent deployment, atheroablation was performed in 17% and 16% of the patients in the two groups (Table 2). Overall, the types of stents used were different between groups with the majority (80%) of patients in the short stent group treated with the Palmaz-Schatz stent (Cordis Corp., Warren, New Jersey) and the long stent group treated with either the multilink (33%), Micro-II/GFX (Applied Vascular Engineering Inc., Santa Rosa, California) (32%) or the NIR stent (13%). The mean stent length (long vs. short) was 28 ± 5 mm versus 15 ± 2 mm (p = 0.001). The number of provisional/planned versus urgent stenting was similar in the two groups (97% vs. 96% and 3% vs. 4%; p = NS). Importantly, the periprocedural use of abciximab was significantly more frequent in patients treated with long versus short stents (14 vs. 3.9%, p = 0.001).


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  		Table 2 Interventional Procedures

 
Lesion characteristics.   Table 3 lists the lesion location data for all 1,259 native coronary lesions and full qualitative and quantitative measurements obtained in 535 lesions. The lesions were similarly distributed among the coronary arteries between groups but short stents were more frequently implanted in the ostial location. Longer stents were more often implanted in longer (>10 mm) lesions or in those with preprocedural Thrombolysis in Myocardial Infarction (TIMI) 0/1 flow but less often in restenotic or calcified lesions. Angiographic complications (dissections, abrupt closure or no reflow) were similarly observed in both groups. By quantitative angiography, the average proximal reference diameter was similar between groups, but the distal reference was smaller for the long stent group (2.7 ± 0.8 vs. 2.9 ± 0.6 mm, p = 0.01) as the vessel tapered to a longer distance in this group. Postprocedural lesion measurements were different; the final poststent minimal lumen diameter was smaller (2.5 ± 0.7 mm vs. 2.8 ± 0.6 mm, p = 0.001), and accordingly, the final stent diameter stenosis was higher (19 ± 13% vs. 9 ± 16%, p = 0.001), signifying more residual stenosis immediately after longer stenting (Table 3).


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  		Table 3 Qualitative and Quantitative Characteristics of Stented Lesions

 
Procedural results.   Overall procedural success was similar in the long versus short stent groups (96% vs. 98%, p = 0.08) (Table 4). However, major in-hospital complications tended to occur more frequently in patients treated with longer stents (3.4% vs. 1.0%, p = 0.04). The rate of periprocedural non-Q-wave MI (CK-MB ≥ 5 times normal) was notably higher after longer stent implantation (23% vs. 11%, p = 0.001). The length of hospitalization, however, was similar for both groups (3.2 ± 2.7 vs. 3.8 ± 4.5 days for long vs. short stents, respectively, p = 0.08). The rates of in-hospital repeat target vessel angioplasty and stent thrombosis were similar for the two groups.


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  		Table 4 In-Hospital Procedural Results and Clinical Outcomes at 12 Months Follow-up

 
Long-term outcomes.   Clinical follow-up at one year was available in 102 of 116 patients (88%) treated with long stents and in 1,024 of 1,110 patients (92%) treated with shorter stents. During follow-up, there was no difference in mortality between groups (2.5% for long versus 3.5% for short stents, p = 0.49) (Table 4). The rate of Q-wave MI was also similar for long stent group versus short stenting (2.7% vs. 1.2%, p = 0.18). Overall TLR at one year was 14.5% for long stents versus 13.8% in short stent group (p = 0.69, Fig. 1A). Similarly, TVR was higher but similar for both groups (p = 0.41). Likewise, actuarial event-free survival curves for any event during one-year follow-up (death, Q-wave MI, TLR) was similar for both group (81.3% for long stents versus 81.5% for short stents, p = 0.44, Fig. 1B).



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  		Figure 1 (A) Actuarial event-free survival curves for target lesion revascularization (TLR), (B) or any adverse event (death, Q-wave MI or TLR) for one year following long (≥25 mm) versus short (<20 mm) slotted-tube single vessel stenting.

 
Multivariate analysis.   Logistic regression analysis was used to identify independent predictors of any cardiac event (death, Q-wave MI, TLR) or TLR alone following a single vessel/lesion stenting among the treated patients (Table 5). Variables included in the model were unstable angina, age, gender, history of angioplasty, diabetes mellitus, use of abciximab, proximal reference vessel diameter, distal reference vessel diameter, final percent diameter stenosis, stent length, stent type, ostial location, and lesion length. Diabetes (odds ratio [OR] = 1.9), history of angioplasty (1.9), proximal reference diameter (0.68) and unstable angina (OR = 1.6) were independent predictors of any adverse cardiac event during follow-up. History of angioplasty (OR = 2.1) and proximal reference vessel diameter (OR = 0.57) were the only predictors for TLR. Neither stent length nor lesion length predicted subsequent adverse cardiac events from the time of hospital discharge to one-year follow-up.


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  		Table 5 Independent Predictors of Any Cardiac Event and TLR During One-Year Follow-up Period

 
Stent to artery ratio.   Stent to lesion length ratio (as determined by the known stent length and the measured lesion length by QCA) was plotted against TLR and TVR at follow-up. According to this analysis, there were no significant differences in rates of TLR or TVR between groups distinguished on the basis of stent to lesion length ratio, (Fig. 2).



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  		Figure 2 Stent-to-lesion length ratio plotted against target lesion (TLR) and target vessel (TVR) revascularization rates.

 

   Discussion
Top
 Abstract
 Methods
 Results
 Discussion
References
 
The treatment of diffuse coronary artery disease has been traditionally associated with disappointing acute and long-term results in most reported "conventional" balloon angioplasty and new-devices series, with increased risk for acute complications and restenosis (15–18). In the stent era, two main approaches to stenting of diffuse lesions have been advocated: "spot" stenting of only severe stenosis or full lesion coverage with the goal of anchoring stents into "normal" reference segments (19). Until long stents became available, full coverage of diffuse lesions or long dissection could have been achieved only by the use of multiple overlapping stents (9–13) or long self-expandable stents (20,21). Recent experiences suggested that such strategy advocated to treat long lesions is feasible, with relatively low procedural complications but with relatively high restenosis rate, unless used to scaffold diffuse lesions in large (≥3.25 mm) sized vessels (14). The various problems that were observed in other studies with multiple stenting in the same vessel included increased risk of subacute thrombosis (11), restenosis (12,13) and technical difficulty in deploying multiple stents with increased catheterization time, dye volume and radiation exposure (22). Moreover, the greater metal density and repeated stent on stent trauma with overlapping stents was proposed to impair vessel wall integrity causing a higher degree of vascular injury and promoting more neointimal proliferation (23,24).

The availability of long stents in the U.S. with improved flexibility, trackablity and scaffolding properties has provided us with the opportunity to compare the acute procedural and long-term results following treatment of coronary narrowing using longer slotted-tube stents in native coronary arteries. Several studies have implicated stent length or the number of stents implanted as contributing factors to restenosis in addition to intrinsic lesion characteristics that predispose neointimal formation (23–25). Our study’s main finding is that, unlike previous reports, the use of a single coronary long (≥25 mm) versus short (<20 mm) stent is associated with: 1) somewhat increased major procedural complications, 2) significantly higher frequency of periprocedural non-Q-wave MIs or any CK-MB elevation, and 3) equivalent repeat revascularization risk and event-free survival out-of-hospital up to one year. According to our experience, the periprocedural use of abciximab was significantly more prevalent in patients treated with long versus short stents. This may partially account for improved procedural and long-term results obtained by longer stents in our patient cohort. However, the overall use of abciximab has been relatively low in both groups at the time of this study. Importantly, the stent to lesion length ratio has not been shown to be a major determinant of subsequent TLR or TVR in our experience. It is also notable that the proximal reference vessel diameter (but not the distal one) was among the strongest predictors of TLR according to a multivariate model, implying that the vessel size in its proximal lesion inlet plays an important role in achieving favorable results in diffuse disease scenarios requiring long stents. Interestingly, stent length was not predictive of TLR in our model. This finding is in accordance with our previous observation in single and multivessel stenting (14,26).

In this study, there was a notably higher frequency (23%) of procedural related non-Q-wave MI in patients treated with long stents. Such higher prevalence of periprocedural CK-MB elevation may reflect a more complex clinical and anatomic milieu in patients treated with longer lesions such as diffuse disease, thrombus containing lesions, more extensive dissections, chronic total occlusions and side branch vessel occlusion. In this respect, it was recently found that pre-intervention lesion characteristics and especially the measured amount of plaque at the lesion site are the major determinants of CK-MB elevation after coronary stenting (27). Despite other reports indicating a strong association between periprocedural CK-MB elevations and late adverse cardiac events (28–30), thus far, our preliminary out-of-hospital experience with long stents did not indicate higher mortality or Q-wave MI rates compared with shorter stents. However, it should be noted that if "major" CK-MB elevation had to be accounted for by major adverse cardiac events, the overall event rates would have been much higher in the long stent group in our study.

Our results corroborate with previous reports by showing that stenting of long lesions using the "new generation" long stents can be accomplished with high procedural success and relatively low complications rates. Rozenman et al. (31) have treated 57 patients with 67 long (>30 mm) various types of stents. Procedural success has been obtained in all but one patient. Beyar et al. (32) have reported the results obtained by using the long version of the BeStent (Medtronic Inc., Minneapolis, Minnesota) to treat diffuse lesions. Procedural success was high and achieved in 97% of patients, but overall restenosis rate was higher in patients with longer lesions who were treated with longer (mostly 25 mm) stents. Kobayashi et al., (33) using a 32 mm NIR stent have reported angiographic restenosis rates of 51% compared with 13.3% in patients treated with 16 mm NIR stents. Nevertheless, those patients also differed in reference vessel size, with bigger reference diameter found in the shorter stent group, probably accounting for the difference in restenosis rate. More recently, LeBreton et al. (34) have reported their experience with the use of long (32 mm) NIR stents in 187 patients enrolled in a large multicenter French registry. Angiographic success has been obtained in 99% of treated lesions. At follow-up (mean seven months), stent thrombosis occurred in 0.5%, death and MI occurred in 3% and 0.6%, respectively, and TLR rate was only 6%. Overall, cardiac event-free survival has been 86% and very similar to our own experience. Finally, a nonrandomized registry comparing the long (39 mm) AVE Micro II stent with the Palmaz-Schatz (15 mm) stent found similar procedural results and a similar TLR rate (9.2% vs. 8.1%, p = NS) despite longer lesions on average (23 vs. 12 mm) and more "high risk" baseline demographics among patients treated with the longer stent (35).

Two IVUS studies from our laboratory may explain the observed findings in which clinical restenosis rates have not been excessive with longer stent implantation or higher stent-to-lesion length coverage ratio. Hong et al. (36) have measured in vivo stent length by IVUS and found that when stent length has been adjusted to IVUS measured postintervention lumen area, the increase in length did not impact TLR. Moreover, it was found that increasing the stent to lesion length ratio while optimizing full lesion coverage actually decreased the TLR rate (37). Those observations help explain our study findings in which relatively low TLR rates were observed among patients treated with single long stents, and they may indicate the full lesion coverage approach for diffuse lesions.

Study limitations.   Since this study was a retrospective analysis, it is unknown whether the use of a different therapeutic strategy for diffuse disease (e.g., "spots" stenting, more use of atheroablation devices before stenting) would result in comparable procedural or late outcomes obtained by long stenting. Moreover, the significantly increased use of abciximab with longer stents is another important factor that may have had a beneficial impact on the results obtained by the use of longer stents. However, the overall use of abciximab in this study was relatively low. Importantly, the comparison of long versus short stents is necessarily confounded by significant differences in lesion characteristics between the two groups, with the short stent group having more ostial, restenotic and calified lesions but less total occlusions and prior MI. It is also possible that, if long stents were to be implanted in smaller vessels, the acute and especially long-term clinical outcomes would be less favorable compared with short stents. Also, it is possible that the higher incidence of total occlusions with TIMI 0/1 flow in the long stent group might have diminished the capacity for revascularization in the event that restenosis or reocclusion occurred, masking additional restenosis in the longer stent group. The lack of angiographic follow-up with an accurate assessment of restenosis is another potential limitation of our study. This is also the reason we could not assess retenosis patterns (focal vs. diffuse) in each group. In addition, the power of the multivariate analysis was limited by the relatively small number of lesions with quantitative angiographic assessment compared with the clinical data. Finally, our study did not compare different stent designs to determine which may have properties better suited for the treatment of long lesions.


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


   References
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 Abstract
 Methods
 Results
 Discussion
 References
 

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