Provisional Side Branch Stenting Research Articles

An Approach to Non-left Main Bifurcation Lesions: A Contemporary Review

Bifurcated anatomical locations in the arterial tree, such as coronary artery bifurcations, are prone to develop obstructive atherosclerotic lesions due to the pro-atherogenic low wall shear stress. The percutaneous treatment of bifurcation lesions is among the most challenging complex coronary interventions, including different multistep stenting strategies. Even though provisional side branch (SB) stenting is recommended as the primary approach in most cases, the debate continues between provisional SB and upfront two-stent strategies, particularly in complex bifurcations consisting of a significantly diseased SB that supplies a crucial myocardial territory. This review will highlight the importance of understanding the bifurcation philosophy and provide an individual algorithmic approach to find the optimal treatment strategy for each patient with a non-left main coronary bifurcation lesion. Considering the most recent scientific evidence, the advantages and disadvantages of each stenting technique and the role of intracoronary imaging to optimize bifurcation percutaneous coronary intervention outcomes will be discussed.

Very long-term follow-up of patients with coronary bifurcation lesions treated with bioresorbable scaffolds.

The data concerning the use of bioresorbable vascular scaffolds (BVS) in coronary bifurcation lesions are limited. The objective of the study was to evaluate the early and very long-term clinical outcomes of bifurcation stenting with ABSORB BVS. One hundred consecutive patients with coronary bifurcation lesions treated with BVS were included. A total of 124 BVS were implanted. Provisional side branch stenting was performed in 66 patients, distal main stenting in 14 patients, systematic T stenting in 2, and T with minimal protrusion (TAP) in 5 patients. Side branch ostial stenting was performed in additional 12 patients. The procedural success was achieved in 98% of patients. In long-term follow-up, the rate of cardiac death was 4.0%, target vessel myocardial infarction was 5.0%, and target vessel revascularization (TVR) was 11%. The cumulative incidence of definite/probable scaffold thrombosis (ST) was 2% at long-term follow-up. Comparison with the historical drug-eluting stents (DES) group revealed higher mortality and major adverse cardiac events rate in the ABSORB group. Stenting of coronary bifurcation lesions of low-to-moderate complexity with BVS was feasible with good acute performance and acceptable results. However, the risk of death and major adverse cardiovascular events was higher as compared with DES.

Impact of directional coronary atherectomy followed by drug-coated balloon strategy to avoid the complex stenting for bifurcation lesions.

Although the simple single stenting rather than complex double stenting is recommended on percutaneous coronary intervention (PCI) for bifurcation lesions, double stenting cannot always be avoided. We investigated the impact of directional coronary atherectomy (DCA), followed by drug-coated balloon (DCB) treatment to reduce the number of stents and avoid complex stenting in PCI for bifurcation lesions and short-term patency. DCA treatment without stents was attempted for 27 bifurcation lesions in 25 patients, of those, 26 bifurcation lesions in 24 patients were successfully treated and 3-month follow-up angiography and optical coherence tomography (OCT) were performed. Sixteen lesions (59.3%) were related to left main trunk distal bifurcations, and 7 (25.9%) were true bifurcation lesions. Among the true bifurcation lesions, 4 lesions (57.1%) needed 1 stent, and the other 3 lesions (42.9%) needed no stents. Among the non-true bifurcation lesions, 1 lesion (5.0%) needed bailout stent and other lesions (95.0%) needed no stents. According to DCA followed by DCB treatment, the angiographic mean diameter stenosis improved from 65.5 ± 15.0% to 7.8 ± 9.8%, and the mean plaque area in intravascular ultrasound improved from 80.4 ± 10.5% to 39.0 ± 11.5%, respectively. Angiographic and OCT late lumen loss values were 0.2 ± 0.6mm and 1.4 ± 1.9mm, respectively. No patient had in-hospital major adverse cardiac events (MACE) and 3-month MACE. In conclusion, compared with standard provisional side branch stenting strategy, DCA followed by DCB treatment might reduce the number of stents, avoid complex stenting for major bifurcation lesions and provide good short-term outcomes.

Comparison of Different Stenting Techniques of Coronary Bifurcation Lesions: A Network Meta-Analysis of 7601 Patients

IntroductionIntervention on coronary bifurcations lesions (CBL) is challenging. While provisional side branch (PS) stenting is the recommended method in most cases, there is no consensus on the preferred 2-stent technique.Material and methodsWe performed a network meta-analysis including randomized controlled trials (RCT) and observational studies comparing stenting techniques in CBL with reported clinical outcomes. A mixed treatment comparison model generation was performed to compare culotte, T and protrusion (TAP), crush and provisional techniques.ResultsWe included 14 RCT and 14 observational studies comprising 7,601 patients among whom 2,516 were treated with PS, 792 with TAP, 1,493 with culotte and 2,808 with crush. A Bayesian network meta-analysis showed a significant rate reduction of major adverse cardiovascular events (OR=0.73; 95%CI 0.52-0.99) and a trend for reduction in lesion revascularization (OR=0.72; 95%CI 0.48-1.11) and myocardial infarction (OR=0.62; 95%CI 0.3-1.08) with the crush technique, mainly driven by the double kissing (DK) crush, compared with all other stenting techniques. Other clinical outcomes, including mortality and stent thrombosis (ST) did not differ significantly between methods.ConclusionsThe crush technique, and especially DKcrush, is associated with improved outcomes compared to culotte, T and protrusion (TAP) and provisional techniques for CBL treatment. Further research is required to determine the optimal stenting technique for CBL.

Comparison of fractional flow reserve and instantaneous wave-free ratio for the hemodynamic assessment of jailed side branches in bifurcation stenting

Abstract Background Provisional side-branch stenting strategy is one of the preferred strategies for treatment of bifurcation lesions. Whereas using fraction flow reserve (FFR) for the physiologic assessment of jailed side branches is well studied, the reliability of resting indices such as instantaneous wave free ratio (iFR) is unknown. Methods Consecutive patients with provisional stenting of a bifurcation and a jailed side branch were enrolled in this study. FFR and iFR were measured and, after assuring absence of baseline shift and drift, both measurements were repeated after 3 minutes. Hyperemia was induced by intra-coronary adenosine with a dose of 48μg for the right coronary artery and 96μg for the left coronary artery. Cut-off for the assumed functional significance of a stenosis was 0.80 for FFR and 0.89 for iFR. The decision to treat the side branch was left to the interventionalist's discretion. Results 37 jailed side branches in 36 patients (age 68.4±8.2; male 81% (n=29)) were consecutively enrolled in the study. The main vessel was the left main in 3% (n=1), the left anterior descending (LAD) in 65% (n=24), the diagonal branch (D1) in 3% (n=1), the left circumflex artery (LCX) in 24% (n=9) and the right coronary artery (RCA) in 5% (n=2). The Medina classification revealed true bifurcation stenosis defined as Medina 1–1-1 prior to treatment in 35% (n=13). FFR showed 35% (n=13) of the stenosis to be functionally significant with a high reproducibility of the results (r=0.986). FFR showed a low correlation with angiographic assessment (r=−0.477). iFR indicated hemodynamic relevance in 38% of lesions (n=14) with a high reproducibility (r=0.967) and also correlated poorly with angiographic assessment (r=−0.271). iFR was found to closely correlate with FFR in jailed side branches (r=0.720, Figure 1A). Bland-Altman analysis showed iFR and FFR agreed with a mean difference between FFR and iFR of −0.054±0.146. In 81% (n=30) FFR and iFR showed the same results regarding functional significance. In 8% (n=3) FFR was ≤0.80 and iFR >0.89, in 11% (n=4) FFR was >0.80 and iFR was ≤0.89 (Figure 1B). Side branch treatment was performed in 32% (n=12). All of these lesions showed functional significance in FFR or iFR. Stent implantation was performed in 8% (n=3), balloon angioplasty in 19% (n=7) and balloon angioplasty with a drug-eluting balloon in 5% (n=2). Conclusions The results of this study confirm the poor correlation of angiographic and functional assessment of coronary artery stenoses. Our data show close agreement of iFR and FFR in stent-jailed side branches. Therefore, iFR can be considered as a reliable technique for guidance of provisional side branch stenting. Figure 1 Funding Acknowledgement Type of funding source: None

Optical coherence tomography predictors of target vessel myocardial infarction after provisional stenting in patients with coronary bifurcation disease.

Provisional side branch (SB) stenting is correlated with target vessel myocardial infarction (TVMI) in patients with coronary bifurcation lesions. However, the mechanisms underlying this association remain unknown. To determine the correlation between SB lesion length with vulnerable plaques and TVMI using optical coherence tomography (OCT). The correlation between SB lesion length with vulnerable plaques and TVMI is unknown. A total of 405 patients with 405 bifurcation lesions who underwent preprocedure OCT imaging of both the main vessel (MV) and the SB were enrolled. Patients were divided into long SB lesion (SB lesion length ≥10 mm) and short SB lesion (SB lesion length <10 mm) groups according to quantitative coronary analysis; they were also stratified by the presence of vulnerable plaques identified by OCT. The primary endpoint was the occurrence of TVMI after provisional stenting at 1-year follow-up. In total, 178 (43.9%) patients had long SB lesions. Vulnerable plaques were predominantly localized in the MV and were more frequently in the long SB lesion group (42.7%) than in the short SB lesion group (24.2%, p < .001). At 1-year follow-up after provisional stenting, there were 31 (7.7%) TVMIs, with 21 (11.8%) in the long SB lesion group and 10 (4.4%) in the short SB lesion group (p=.009). Multivariate regression analysis showed that long SB lesion length (p=.011), absence of vulnerable plaques in the polygon of confluence (p=.001), and true coronary bifurcation lesions (p=.004) were the three independent factors of TVMI. The presence of long SB lesion with MV vulnerable plaques predicts the increased risk of TVMI after provisional stenting in patients with true coronary bifurcation lesions. Further studies are warranted to identify the best stenting techniques for coronary bifurcation lesions with long SB lesions.

Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV

BackgroundIt is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple)...

P968Comparison of re-proximal optimizing technique with kissing balloon technique in provisional stenting during primary percutaneous coronary intervention

Abstract Background Re-proximal optimizing technique (rePOT) (POT, side branch inflation and final POT) is a new provisional coronary bifurcation stenting technique which has better results in bench tests in comparison with kissing balloon inflation (KBI) techique. A clinical study showed that rePOT had beneficial effects in terms of strut malapposition, side branch obstruction and stent geometry. But it has not been compared with KBI technique especially in patients with ST segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (p-PCI). Purpose The aim of our study is to compare the new rePOT technique with a known and widely used provisional stenting technique in a real-world special patient population in terms of clinical and technical aspects Methods 51 patients with STEMI who underwent p-PCI and needed provisional side branch stenting were enrolled in a tertiary center. Patients who needed “two stent strategy” at the beginning of procedure were deferred. Results Results were shown in Table 1. In-hospital death, contrast induced acute kidney injury, side branch dissection, need for side branch stenting and acute stent thrombosis were lower in rePOT group but there was no statistically significance. Table 1 rePOT group (n=23) KBI group (n=28) p value Age 51.6±11.7 51.2±9.4 0.87 Male gender 18 (78.3%) 24 (85.7%) 0.16 Diabetes Mellitus 3 (13%) 6 (21.4%) 0.43 Hypertension 5 (21.7%) 5 (17.9%) 0.73 Ejection fraction 46.8±10.6 44.8±8.4 0.43 Killip class&gt;2 1 (4.3%) 4 (14.3%) 0.47 Stent type (DES) 21 (91.3%) 23 (82.1%) 0.34 Side branch dissection 3 (13%) 8 (28.6) 0.18 Side branch stenting 3 (13%) 6 (21.4%) 0.43 In-hospital death 2 (8.7%) 3 (10.7%) 0.81 CI-AKI 3 (13%) 6 (21.4%) 0.43 Acute stent thrombosis 0 2 (7.1%) 0.19 DES: Drug eluting stent; CI-AKI: contrast induced acute kidney injury. Conclusion To the best of our knowledge this is the first study which compares the new rePOT technique with KBI in patients with STEMI who underwent p-PCI and needed provisional coronary bifurcation stenting. Although results are similiar in terms of clinical and technical aspects, rePOT may be a useful and user-friendly technique in such a complex and emergent procedure. Acknowledgement/Funding None

TCT-267 A Multicenter Registry to Evaluate Drug-Coated Balloon Angioplasty After Directional Coronary Atherectomy for Coronary Bifurcation Lesions

The standard therapy of coronary bifurcation lesions is drug-eluting stent (DES) to the main branch with provisional side branch stenting; however, the optimal strategy for the treatment of bifurcations has not been established yet even in the DES era. Directional coronary atherectomy (DCA) was used

MODIFIED JAILED BALLOON TECHNIQUE FOR CORONARY BIFURCATION LESIONS

Adverse cardiac events are higher for percutaneous coronary intervention (PCI) of bifurcation lesions. Recent studies support the use of provisional side branch (SB) stenting, but a risk of SB closure and peri-procedural myocardial infarction (MI) remain important limitations. To demonstrate the

Rational and design of the European randomized Optical Coherence Tomography Optimized Bifurcation Event Reduction Trial (OCTOBER)

Percutaneous coronary intervention in complex bifurcation lesions is prone to suboptimal implantation results and is associated with increased risk of subsequent clinical events. Angiographic ambiguity is high during bifurcation stenting, but it is unknown if procedural guidance by intravascular optical coherence tomography (OCT) improves clinical outcome. OCTOBER is a randomized, investigator-initiated, multicenter trial aimed to show superiority of OCT-guided stent implantation compared to standard angiographic-guided implantation in bifurcation lesions. The primary outcome measure is a 2-year composite end point of cardiac death, target lesion myocardial infarction, and ischemia-driven target lesion revascularization. The calculated sample size is 1,200 patients in total, and allocation is 1:1. Eligible patients have stable or unstable angina pectoris or stabilized non–ST elevation myocardial infarction, and a coronary bifurcation lesion with significant main vessel stenosis and more than 50 % stenosis in a side branch with a reference diameter ≥2.5mm. Treatment is performed by the provisional side branch stenting technique or 2-stent techniques, and the systematic OCT guiding protocol is aimed to evaluate (1) plaque preparation, (2) lesion length, (3) segmental reference sizes, (4) lesion coverage, (5) stent expansion, (6) malapposition, (7) wire positions, and (8) ostial results. A positive outcome of the OCTOBER trial may establish OCT as a routine tool for optimization of complex percutaneous coronary intervention, whereas a negative result would indicate that OCT remains a tool for ad hoc evaluation in selected cases.

GW28-e0177 A preliminary experience with angiographic fractional flow reserve in the provisional side branch stenting of coronary bifurcation lesions

GW28-e0177 A preliminary experience with angiographic fractional flow reserve in the provisional side branch stenting of coronary bifurcation lesions

GW28-e0177 A preliminary experience with angiographic fractional flow reserve in the provisional side branch stenting of coronary bifurcation lesions

GW28-e0177 A preliminary experience with angiographic fractional flow reserve in the provisional side branch stenting of coronary bifurcation lesions

TCT-318 Ten-year All-cause Mortality after Simple versus Complex Stenting of Coronary Artery Bifurcation Lesions in the Randomized Nordic Bifurcation Study

Long-term follow-up in treatment of coronary bifurcation lesions have indicated worse outcome after planned two-stent techniques compared to treatment by the provisional side branch stenting technique. Here we report 10-year all-cause mortality in the randomized Nordic Bifurcation study. Patients

Design and rationale for the treatment effects of provisional side branch stenting and DK crush stenting techniques in patients with unprotected distal left main coronary artery bifurcation lesions (DKCRUSH V) Trial

BackgroundProvisional stenting (PS) is effective for great majority of patients with coronary bifurcation lesions. Double kissing (DK) crush approach demonstrated significant reduction of target lesion revascularization (TLR) for patients with more complex bifurcation lesion when compared with PS. Furthermore, DK crush technique was associated with lower rate of composite major adverse cardiac event (MACE), revascularization and stent thrombosis (ST) for patients with unprotected distal left main coronary artery bifurcation lesions (ULMb), compared to culotte stenting approach. The DKCRUSH V trial is designed to elucidate the benefits of DK crush over PS in patients with ULMb. Study designDKCRUSH V is a randomized, prospective, multinational clinical trial designed to evaluate the efficacy and safety of DK crush over PS for patients with ULMb. Subjects with Medina 1,1,1 or 0,1,1 ULMb will be randomized in a 1:1 fashion to PS or DK crush. The primary endpoint is target lesion failure (TLF) including target vessel myocardial infarction, cardiac death and TLR. Other endpoints address individual event of primary endpoint, and target vessel revascularization. The safety objective is the ST. Recruitment began in January 2012 and was completed in December 2015; 484 patients were randomized. The trial will continue until at least 56 adjudicated primary endpoints occur. ConclusionsThe DKCRUSH V study is investigating if DK crush approach versus PS will reduce the incidence of TLF in patients with symptomatic ULMb.

Contemporary Approach to Coronary Bifurcation Lesion Treatment

Coronary bifurcations are frequent and account for approximately 20% of all percutaneous coronary interventions. Nonetheless, they remain one of the most challenging lesion subsets in interventional cardiology in terms of a lower procedural success rate and increased rates of long-term adverse cardiac events. Provisional side branch stenting should be the default approach in the majority of cases and we propose easily applicable and reproducible stepwise techniques associated with low risk of failure and complications.

Culotte stenting vs. TAP stenting for treatment of de-novo coronary bifurcation lesions with the need for side-branch stenting: the Bifurcations Bad Krozingen (BBK) II angiographic trial.

In percutaneous coronary intervention for de-novo coronary bifurcation lesions, the optimal technique for provisional side-branch stenting is still a matter of debate. We tested whether in this setting culotte stenting reduces the incidence of restenosis as compared with T-and-protrusion (TAP) stenting. This trial included 300 patients with a coronary bifurcation lesion requiring a side-branch stent. Patients were randomly assigned to culotte stenting or TAP stenting using drug-eluting stents in a 1:1 fashion. Primary endpoint was maximal per cent diameter stenosis of the bifurcation lesion at 9-month angiographic follow-up. As clinical endpoints we assessed target lesion re-intervention (TLR) and target lesion failure (composite of cardiac death, target vessel myocardial infarction, and TLR).Angiographic follow-up was available in 91% of the patients. After culotte stenting, the maximum per cent diameter stenosis in the treated bifurcation lesion was 21 ± 20% as compared with 27 ± 25% after TAP stenting (P = 0.038). The respective corresponding binary restenosis rates were 6.5 and 17% (P = 0.006). The 1-year incidence of TLR was 6.0% after culotte stenting vs. 12.0% after T-stenting (P = 0.069). Target lesion failure occurred in 6.7% of the culotte group and in 12.0% of the TAP group (P = 0.11). Only one patient of the culotte group incurred a definite stent thrombosis during 1-year follow-up. Compared with the TAP stenting, culotte stenting was associated with a significantly lower incidence of angiographic restenosis.

Predictors for Side Branch Failure During Provisional Strategy of Coronary Intervention for Bifurcation Lesions (from the Korean Bifurcation Registry)

The most favored strategy for bifurcation lesion is stenting main vessel with provisional side branch (SB) stenting. This study was performed to elucidate predictors for SB failure during this provisional strategy. The study population was patients from 16 centers in Korea who underwent drug-eluting stent implantation for bifurcation lesions with provisional strategy (1,219 patients and 1,236 lesions). On multivariate analysis, the independent predictors for SB jailing after main vessel stenting were SB calcification, large SB reference diameter, severe stenosis of SB, and not taking clopidogrel. Regarding SB compromise, however, the independent predictors were true bifurcation lesion and small SB reference diameter, whereas possible predictors were parent vessel thrombus and parent vessel total occlusion. In addition, SB predilation helps us to get favorable SB outcome. The diameter of SB ostium after main vessel stenting became similar between severe SB lesions treated with predilation and mild SB lesions not treated with predilation. In conclusion, SB calcification, less clopidogrel use, large SB reference diameter, and high SB diameter stenosis are independent predictors for SB jailing, and true bifurcation and small SB reference diameter are independent predictors for SB compromise after main vessel stenting.

Update on Provisional Technique for Bifurcation Interventions.

A series of scientific evidence supports the concept that provisional side-branch stenting should be the preferred strategy for percutaneous coronary intervention of bifurcation coronary lesions. However, to date, many interventional cardiologists still consider this technique unsuitable for complex bifurcation lesions. This is mainly due to the fact that provisional stenting may be performed in different ways and several technical refinements may influence the procedural outcome. We here systematically overviewed the arguments which should be considered during the following steps of the provisional strategy: branch wiring, side-branch predilation, "crossover" stenting, proximal optimization, kissing balloon and the side-branch rescue techniques. We suggest that provisional stenting should be regarded as a highly flexible technique which, with specific technical tricks, may allow us to safely treat patients with wide spectrum of bifurcated lesion complexity.

Drug eluting balloons as stand alone procedure for coronary bifurcational lesions: results of the randomized multicenter PEPCAD-BIF trial.

We set out to investigate the benefit of distal main or side branch treatment with a DCB compared to POBA in coronary bifurcation lesions. The standard treatment of bifurcation lesions is application of a DES to the main branch with provisional side branch stenting. While this resulted in considerable improvement in overall MACE rate suboptimal side branch results remained a problem. The study was performed from 2011 to 2013 in six German centers. Native bifurcation lesions were included if side branch vessel diameter was ≥2 and ≤3.5mm and no proximal main branch lesions was found. After successful predilatation randomization was performed to either DCB application or no further treatment. Follow-up angiograms for QCA analysis were done after 9months. Primary endpoint was late lumen loss (LLL). 64 patients were successfully randomized. Minimal lumen diameter and grade of stenosis were equal in both groups. Only five stents were used as bail out. Angiographic follow-up was achieved in 75% of patients. No patient died. There was one NSTEMI in the POBA group. Restenosis rate was 6% in the DCB group vs 26% in the POBA group (p=0.045). TLR was necessary in one patient of the DCB group vs three patients of the POBA. The primary endpoint LLL was 0.13mm in the DCB vs 0.51mm in the POBA group (p=0.013). In bifurcation lesions that show only class A or B dissection and recoil not beyond 30% the use of DCBs is a sound strategy.