118 The Journal of Invasive Cardiology®

Original Contribution

Predictors of Failure of Final Kissing-Balloon Inflation After Mini-Crush Stenting in Non-Left Main Bifurcation Lesions: Importance of the Main-Vessel Angle

Zafer Elbasan, MD, Rabia Eker Akıllı, MD, Gülhan Yüksel Kalkan, MD, Durmus Yıldıray Sahin, MD, Mustafa Gür, MD, Murat Çaylı, MD

ABStrACt: Background. The majority of bifurcation lesions are treated with crush stenting. However, the success of crush stent-ing depends on final kissing-balloon inflation (FKBI), which is po-tentially difficult. Although mini-crush stenting has a higher rate of successful FKBI, it still cannot be achieved in some patients. The aim of this study was to investigate the factors that contribute to failure of FKBI in mini-crush stenting. Methods and results. We included 173 consecutive patients who were treated with mini-crush stenting. The patients were divided into FKBI and non-FKBI groups. The bi-furcation angles were measured: (1) proximal bifurcation angle (angle A, between proximal main vessel and side branch); (2) distal bifur-cation angle (angle B, between distal main branch and side branch); and (3) the main-vessel angle (angle C, between proximal main vessel and distal main branch). FKBI could be performed in 153 patients. Angle C and calcification were significantly lower and angle A and mean stent diameter in the main vessel were significantly higher in the FKBI group. Multivariate logistic regression analysis showed that only Angle C was an independent predictor of FKBI failure. Conclusions. Main-vessel angle was the only independent predictor of FKBI failure in mini-crush stenting.

J INVASIVE CARDIOL 2013;25(3):118-122

Key words: mini-crush stenting, final kissing balloon inflation,main-vessel angle

Bifurcation lesions still represent a technical challenge for the in-terventional cardiologist. Although different techniques have been proposed, percutaneous coronary intervention (PCI) for bifurcation lesions is still associated with lower procedural success rate, higher major adverse cardiac event rate, and poor long-term outcomes compared with non-bifurcation lesions, even in the drug-eluting stent (DES) era.1-3

The majority of bifurcation lesions are treated with crush stent-ing in many clinics. However, the success of crush stenting depends on a final kissing-balloon inflation (FKBI), which is potentially dif-ficult, because wire and balloon have to cross double layers of stent at the side-branch (SB) orifice. Early and long-term results after PCI are not satisfactory in patients with FKBI failure.4 The rate of

FKBI success with this technique varies between 64%-92%.4-7 To overcome this problem, the mini-crush stent technique was devised. Although mini-crush stenting has a higher rate of FKBI success, it still cannot be achieved in all patients.7 The exact causes of FKBI failure during mini-crush stenting are not fully understood. The aim of this study was to investigate the factors that contribute to FKBI failure in mini-crush stenting.

Methods Patients. Of the 4375 PCI procedures performed between Janu-

ary 2010 and May 2012 at Adana Numune Education and Research Hospital in Adana, Turkey, we included 173 consecutive patients (101 males and 72 females; mean age, 58.0 ± 10.5 years) who were treated with the mini-crush stenting technique. Mini-crush stenting cases were identified through cineangiogram and procedural report review. Patients with acute myocardial infarction, left ventricular dysfunction, left main (LM) coronary bifurcation lesion, as well as those treated with crush stenting but had unsatisfactory cineangio-grams, were excluded from the study. Demographic, angiographic, and procedural variables were recorded. The Local Ethics Commit-tee approved the study protocol.

PCI procedure. All patients were previously treated with aspirin and clopidogrel. If patients were not pretreated with clopidogrel, a 600 mg loading dose of clopidogrel was administered just before the index procedure. The mini-crush stenting procedure was performed using the technique described by Galassi et al.8 In our laboratory, 2-step FKBI is routinely performed whenever possible for all pa-tients treated with crush or mini-crush stenting. Stepwise balloon inflation, beginning from 1.5 mm in diameter to the optimal SB stent dilatation was followed by FKBI. If the 1.5 mm balloon failed to cross through the stent struts, we then used a 1.25 or 1.5 mm Sprinter balloon to separate struts and allow a larger balloon to pass. If the Sprinter balloon also failed to cross the SB, we then used the proximal optimization technique (POT). In any case with difficulty crossing into the SB, the POT became routine in our clinic by 2010. Procedural time was defined from wiring of both vessels to FKBI. If predilatation was performed, procedure time was started after the predilatation. Based on the success of FKBI, the patients were divid-ed into an FKBI group (n = 153) and a non-FKBI group (n = 20).

In this study, the Liberté bare-metal stent (Boston Scientific) was used in 37 patients for treatment of the main vessel and in 46 patients for the treatment of a side branch. In other patients, PCI was performed with the following DESs: Endeavor stents (Medtronic Inc), Coraxel paclitaxel-eluting stents (Alvi Medica),

From the Department of Cardiology, Adana Numune Education and Research Hospital, Adana, Turkey.

Disclosure: The authors have completed and returned the ICMJE Form for Dis-closure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.

Manuscript submitted August 29, 2012, provisional acceptance given November 13, 2012, final version accepted December 7, 2012.

Address for correspondence: Dr Durmus Y. Sahin, MD, Adana Numune Education and Research Hospital, Department of Cardiology, Seyhan Application Center, Çuku-rova, Adana, 01170, Turkey. Email: dysahin79@hotmail.com

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Main Vessel Angle in Mini-Crush Stenting

Coracto sirolimus-eluting stents (Alvi Medica), Xience V stents (Ab-bott Vascular), and Promus stents (Boston Scientific).

All procedural cineangiograms were acquired digitally and stored in Digital Imaging and Communication in Medicine standard for-mat. Lesion morphology, stent type, and stent size were recorded in all patients. Three-dimensional reconstruction was performed off-line by the same experienced operator (MG), blinded to individual patient data and clinical outcome, using 3-dimensional software (CardiOp-B system, version 2.1.0.151, Paieon Medical, Ltd).9,10 The software algorithm rendered an image as well as quantitative information, including bifurcation angle measurement. All bifurca-tion angle evaluations were performed before PCI in the absence of the guidewires in place (as these could modify the angle). All three non-left main bifurcation angles were presented in accordance with the European Bifurcation Club consensus definition (Figures 1 and 2).11 Angle A (proximal bifurcation angle) is defined as the angle be-tween the proximal main vessel and the SB; angle B (distal bifurca-tion angle) is defined as between the distal main branch and the SB; and angle C (main-vessel angle) is defined as the angle between the

proximal main vessel and the distal main branch.

Statistical analysis. All calculations were per-formed with the SPSS version 13.0 (SPSS Inc). Continuous variables were tested for normality with the Kolmogorov–Smirnov test. Continuous variables were expressed as mean ± standard deviation and compared using indepen-dent sample t-tests or anal-ysis of variance (ANOVA) where appropriate. Cate-gorical variables were com-pared with the chi-square test. Multiple logistic re-gression analysis with back-

ward elimination process was used to identify predictors of FKBI failure. All significant parameters on univariate analysis, such as lesion calcification, angle A, angle C, and mean stent diameter in the main vessel were selected in the multivariate model. A receiv-er operator characteristic (ROC) curve analysis was performed to identify the optimal cut-off point of MVA and PBA to predict the failure of FKBI. The area under the curve (AUC) value was calculated. A P-value of <.05 was considered significant.

resultsThe index lesion location was the left anterior descending artery/

diagonal branch in 159 patients (91.9%), the circumflex artery/ob-tuse marginal branch in 12 patients (6.9%), and the right coronary artery/posterior descending artery/posterolateral branch in 2 patients (1.2%). Patients underwent PCI due to stable angina pectoris and unstable angina pectoris in 145 (83.8%) and 28 (16.2%), respec-tively. FKBI could be performed in 153 patients (88.4%). Baseline demographic characteristics of patients with FKBI and non-FKBI were similar (Table 1).

Main vessel angle(Angle C)

A B C

Proximal bifurcation angle

(Angle A)

Distal bifurcation angle(Angle B)

Figure 1. Wideness of stent strut cell at the side-branch ostium according to the main vessel angle. (A) Vessel with steep angle: the stent strut cell at the side-branch ostium is wider and advancement of balloon into the side branch is easy. (B) Straight vessel: normal stent strut cell at the side-branch ostium. (C) Vessel with wider angle: the stent strut cell at the side-branch ostium is narrowed and advancement of balloon into the side branch is extremely difficult.

Figure 2. (A) Left anterior descending artery-diagonal bifurcation lesion in RAO projection. (B) Circumflex artery-obtuse marginal bifurcation lesion in AP caudal projection. (C) Left anterior descending artery-diagonal bifurcation lesion in LAO projection.

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Angiographic and procedural variables of the FKBI and non-FK-BI groups were compared in Table 2. Lesion calcification (14.5% vs 35.0%; P=.04) and angle C (148.4 ± 14.7 vs 175.0 ± 10.3; P<.001) were significantly lower in the FKBI group than in the non-FKBI group. Angle A (154.3 ± 14.2 vs 130.7 ± 16.4; P<.001) and the mean stent diameter in the main vessel were significantly higher in the FKBI group than in the non-FKBI group (3.37 ± 0.42 vs 3.16 ± 0.41; P=.04) . As expected, the procedure time and contrast volume were significantly higher in the non-FKBI group. However, there were no significant differences in angle B, the need for predilatation, stent type, or the stent length between the two groups. Multivari-ate logistic regression analysis showed that only angle C was an

independent predictor of FKBI failure (odds ratio [OR], 0.80; 95% confidence interval [CI], 0.73-0.88; P<.001). ROC curve analysis was performed to evaluate the usefulness of angle C for predicting FKBI failure. The AUC was 0.931 (95% CI, 0.874-0.987; P<.001) and the cut-off value of angle C was 167° for predicting FKBI fail-ure, with a sensitivity of 86.7% and a specificity of 89.2% (Figure 3).

The median angle C was 152°. The patients were divided into three groups according to tertiles of angle C, which were defined as angle Clow <141° (n = 57), angle Cmid = 141°-160° (n = 59), and angle Chigh >160° (n = 57). Failure of FKBI, procedure time, and contrast volume increased significantly from the angle Clow group to the Angle Chigh group. Angiographic and procedural characteristics of the patients according to the angle C tertiles are summarized in Table 3.

DiscussionTo the best of our knowledge, this is the first article investigat-

ing the reasons for FKBI failure during mini-crush stenting. We found that only angle C was an independent predictor of FKBI failure. We also showed that increased angle C is associated with a higher incidence of FKBI failure, longer procedure time, and more contrast volume.

The Achilles’ heel of true bifurcation lesion PCI is restenosis in the SB ostium. One of the most important reasons of SB ostial reste-nosis is incomplete coverage.12 Colombo et al13 described the crush stenting technique, which offers complete coverage of SB ostium, in 2003. Using this technique, SB restenosis was reduced to about 13%-26%.7,14-16 However, three stent layers in the proximal part of the bifurcation lesion in crush stenting predisposes to incomplete stent apposition and potentially leads to thrombotic complications. Furthermore, the success of crush stenting depends on achievement of FKBI, which is potentially difficult because the wire and balloon have to cross double layers of stent at the SB orifice.4 The rate of FKBI success with this technique varies between 64%-92%.4-7 The mini-crush stent technique was devised to improve the success rate of FKBI. Although the success rate of FKBI while using the mini-crush stent technique is significantly improved, it still cannot be achieved in approximately 12% of patients.7 The exact reasons for FKBI failure remain unknown. In our study, the failure rate of FKBI was 11.6%, which was consistent with the literature.

Previous studies have researched the effect of bifurcation angles on clinical outcome and the success of FKBI.2,17 Dzavik et al16 inves-tigated the effects of bifurcation angle on the performance of FKBI in 133 patients with crush stenting. They divided the patients into four groups according to quartiles of the bifurcation angle and re-ported that the success rate of FKBI was similar in all groups. In addition, Chen et al2 recently showed that there is no influence of angle B on the success of FKBI. In our study, there was also no rela-tion between angle B and FKBI failure, and only angle C was an independent predictor of FKBI failure. We also showed that when angle C was increased, FKBI failure and procedural difficulty were increased. A possible explanation of these findings is that the stent strut cell at the SB ostium is relatively narrowed in patients with wid-er angle C and advancement of the balloon into the SB is extremely difficult. However, patients with lower angle C have relatively larger strut cells at the SB ostium with easier advancement of balloons into the SB to facilitate FKBI (Figure 1).

AUC: 0.931The cut-off value of MVA: 167Sensitivity: 86.7%Specificity: 89.2%

1 - Specificity

0.0 .3 .5 .8 1.0

1.0

.8

.5

.3

0.0

Sen

siti

vity

Figure 3. The receiver operating characteristic curve analysis of main vessel angle for predicting the failure of final kissing-balloon inflation in mini-crush stenting.

Table 1. Baseline clinical characteristics of groups.

FKBI Group (n = 153)

Non-FKBI Group (n = 20)

P

Age (years) 57.8 ± 10.7 59.6 ± 8.7 .4

Sex (male/female) 89/64 12/8 .9

Hypertension 99 (64.7%) 12 (60.0%) .7

Diabetes mellitus 30 (19.6%) 7 (35.0%) .1

Smoking 73 (47.7%) 11 (55.0%) .5

Hyperlipidemia 95 (62.1%) 13 (65.0%) .8

Previous PCI 12 (11.8%) 3 (15.0%) .6

Previous CABG 11 (7.2%) 1 (5.0%) .7

PCI indication

.6 ACS 24 (15.7%) 4 (20.0%)

SAP 129 (84.3%) 16 (80.0%)

FKBI = final kissing balloon inflation; PCI = percutaneous coronary intervention; CABG = coronary artery bypass graft operation; ACS = acute coronary syndrome; SAP = stable angina pectoris.

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Main Vessel Angle in Mini-Crush Stenting

It has been reported that another possible reason for FKBI failure in crush stenting is a long main-vessel stent, which can have a higher probability for malapposition, resulting in the in-correct advancement of the guidewire.18 In this study, we could

not see any relationship between main-vessel stent length and FKBI failure. We think that usage of POT in patients with FKBI failure has decreased malapposition in the bifurcation region. In addition, we found a weak correlation between FKBI failure and both stent diameter in the main vessel and lesion calcification on univariate analysis. However, multi-variate logistic regression analysis showed that only angle C was an independent predictor of FKBI failure.

It is well known that bifurcation treatment with two stenting techniques modifies bifurcation angle19-21 and that modification may influence FKBI performance.22 Important-ly, Godino et al19 reported that change in bifurcation angle is most pronounced after the crush stenting technique. Inter-estingly, they found no significant difference comparing an-gle C at baseline and after stenting.19 This angle appears to be the least affected by the different types of stenting technique. In this study, we measured bifurcation angle only before PCI without the guidewires in place and found that only angle C was an independent predictor of FKBI failure.

Stent design is another factor that may potentially affect FKBI performance. Open-cell stent designs with a large cell size should be used in the treatment of coronary bifurcation lesions. When the cell size is large, the access to the SB is facili-tated. Maximal achievable cell diameters of the studied stent designs differ considerably, with values varying between 3.0 and 6.3 mm.23 These stent cell sizes play an important role during coronary bifurcation treatment.24,25 All of the stents used in this study were open-cell design with large cell size. In addition, stent types were similar in the FKBI and non-FKBI groups. Furthermore, the patients who were divided into three groups according to angle C tertile also had similar stent types.

Impact of bifurcation angles on outcomes. It has been known that angle A has an influence on the accessibility of the SB, which is frequently the main reason for selecting a double-stent technique, and that angle B has an impact on the risk of SB occlusion during main-vessel stenting. This angle appears to be the most influenced by the choice of bi-furcation stenting technique.19 Our study suggests that angle C is related to the success rate of FKBI when using the mini-crush stent technique.

Study limitations. We studied the effect of angle C on procedure success only in patients who underwent mini-crush stenting. It can be further investigated in other bifur-cation techniques, such as culotte stenting or provisional stenting. In this study, we showed the effect of angle C on the success rate of FKBI during mini-crush stenting. The re-lationship between angle C and long-term clinical outcomes must be investigated by further research.

ConclusionsIn this study, we found that angle C was the only inde-

pendent predictor of FKBI failure in patients who underwent mini-crush stenting. Patients with lower angle C have rela-tively larger strut cells at the SB ostium with easier advance-

ment of balloons into the SB to facilitate FKBI. Increased angle C is associated with difficulty of procedure, FKBI failure, more procedure time, and more contrast used.

Table 2. Angiographic and procedural characteristics of groups.

FKBI Group (n = 153)

Non-FKBI Group (n = 20)

P

Lesion location .4

LAD-D 141 (92.2%) 18 (90.0%)

CX-OM 10 (6.5%) 2 (10.0%)

Right coronary artery 2 (1.3%) 0 (0.0%)

Lesion characteristics

Restenosis 2 (1.3%) 1 (5.0%) .8

Calcification 22 (14.5%) 7 (35.0%) .04

Bifurcation angles

Angle A 154.3 ± 14.2 130.7 ± 16.4 <.001

Angle B 57.3 ± 10.0 54.4 ± 11.3 .2

Angle C 148.4 ± 14.7 175.0 ± 10.3 <.001

Predilatation

Main vessel 35 (22.9%) 6 (30.0%) .5

Side branch 28 (18.3%) 4 (20.0%) .9

Main-vessel stent type .8

Liberte 32 (20.9%) 5 (25.0%)

Endeavor 24 (15.7%) 3 (15.0%)

Coraxel 21 (13.7%) 4 (20.0%)

Coracto 39 (25.5%) 3 (15.0%)

Xience V 22 (14.4%) 2 (10.0%)

Promus 15 (9.8%) 3 (15.0%)

Side-branch stent type .6

Liberté 40 (26.1%) 6 (30.0%)

Endeavor 26 (17.0%) 2 (10.0%)

Coraxel 27 (17.6%) 4 (20.0%)

Coracto 29 (19.0%) 2 (10.0%)

Xience V 17 (11.1%) 2 (10.0%)

Promus 14 (9.2%) 4 (20.0%)

Stent diameter (mm)

Main vessel 3.37 ± 0.42 3.16 ± 0.41 .04

Side branch 2.78 ± 0.36 2.75 ± 0.23 .5

Stent length (mm)

Main vessel 19.6 ± 5.4 21.9 ± 5.4 .08

Side branch 15.3 ± 5.3 17.2 ± 5.4 .1

Procedural time (min) 27.9 ± 11.1 65.0 ± 9.5 <.001

Contrast volume (mL) 120.7 ± 34.4 204.0 ± 38.2 <.001

FKBI = final kissing-balloon inflation; LAD-D = left anterior descending artery and diagonal branch; CX-OM = circumflex coronary artery and obtuse marginal branch.

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8. Galassi AR, Colombo A, Buchbinder M, et al. Long-term outcomes of bifurcation lesions after implantation of drug-eluting stents with the “mini-crush technique.” Catheter Cardiovasc Interv. 2007;69(7):976-983.

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11. Louvard Y, Thomas M, Dzavik V, et al. Classifica-tion of coronary artery bifurcation lesions and treat-ments: time for a consensus! Catheter Cardiovasc Interv. 2008;71(2):175-183.

12. Ge L, Iakovou I, Cosgrave J, et al. Treatment of bifur-cation lesions with two stents: one year angiographic and clinical follow up of crush versus T stenting. Heart. 2006;92(3):371-376.

13. Colombo A, Stankovic G, Orlic D, et al. Modified T-stenting technique with crushing for bifurcation le-sions: immediate results and 30-day outcome. Catheter Cardiovasc Interv. 2003;60(2):145-151.

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Table 3. Angiographic and procedural characteristics of the patient groups.

Angle Clow (n = 57)

Angle Cmid (n = 59)

Angle Chigh (n = 57)

P

Lesion location .2

LAD-D 54 (94.7%) 55 (93.2%) 50 (87.7%)

CX-OM 3 (5.3%) 4 (6.8%) 5 (8.8%)

Right coronary artery 0 (0.0%) 0 (0.0%) 2 (3.5%)

Bifurcation angles

Angle A 165.6 ± 6.2 153.5 ± 10.2 135.6 ± 14.3 <.001

Angle B 61.5 ± 6.8 55.3 ± 10.1 54.1 ± 11.4 .01

Angle C 132.8 ± 6.1 151.2 ± 5.1 170.3 ± 8.3 <.001

Main-vessel stent type .6

Liberté 13 (22.8%) 11 (18.6%) 13 (22.8%)

Endeavor 10 (17.5%) 8 (13.6%) 9 (15.8%)

Coraxel 9 (15.8%) 7 (11.9%) 9 (15.8%)

Coracto 17 (29.8%) 12 (20.3%) 13 (22.8%)

Xience V 4 (7.0%) 11 (18.6%) 9 (15.8%)

Promus 4 (7.0%) 10 (16.9%) 4 (7.0%)

Side-branch stent type .4

Liberté 12 (21.1%) 16 (27.1%) 18 (31.6%)

Endeavor 7 (12.3%) 13 (22.0%) 8 (14.0%)

Coraxel 13 (22.8%) 8 (13.6%) 10 (17.5%)

Coracto 14 (24.6%) 8 (13.6%) 9 (15.8%)

Xience V 5 (8.8%) 8 (13.6%) 6 (10.5%)

Promus 6 (10.5%) 6 (10.2%) 6 (10.5%)

Main-vessel stent diameter (mm) 3.37 ± 0.42 3.36 ± 0.46 3.31 ± 0.36 .7

Side-branch stent diameter (mm) 2.78 ± 0.40 2.78 ± 0.36 2.78 ± 0.29 .9

Main-vessel stent length (mm) 18.9 ± 5.7 19.8 ± 4.8 20.7 ± 5.7 .2

Side-branch stent length (mm) 15.0 ± 5.9 15.3 ± 4.7 16.1 ± 5.4 .5

FKBI 57 (100.0%) 57 (96.6%) 39 (68.4%) <.001

Procedural time (min) 19.8 ± 4.7 29.3 ± 9.9 47.4 ±16.9 <.001

Contrast volume (mL) 96.2 ± 10.7 137.9 ± 45.1 156.5 ± 41.6 <.001

LAD-D = left anterior descending artery and diagonal branch; CX-OM = circumflex coronary artery and obtuse marginal branch; FKBI = final kissing-balloon inflation.

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