Provisional Stenting Technique Research Articles

Provisional stenting technique in the left main bifurcation setting: Computational fluid dynamics and optical coherence tomography pilot study in humans.

Provisional stenting technique in the left main bifurcation setting: Computational fluid dynamics and optical coherence tomography pilot study in humans.

A Bayesian meta-analysis of double kissing (DK) crush or provisional stenting for coronary artery bifurcation lesions

ObjectiveDespite the development of dedicated, two-stent strategies, including the double kissing (DK) crush technique, the ideal technique for coronary artery bifurcation stenting has not been identified. We aimed to compare and determine the absolute risk difference (ARD) of the DK crush technique alone versus provisional stenting approaches for coronary bifurcation lesions, using the Bayesian technique. MethodWe queried PubMed/MEDLINE to identify randomized controlled trials (RCTs) that compared DK crush technique with provisional stenting for bifurcation lesions, published till January 2023. We used Bayesian methods to calculate the ARD and 95% credible interval (CrI). ResultsWe included three RCTs, with 916 patients, in the final analysis. The ARD of cardiac death was centered at −0.01 (95% CrI: −0.04 to 0.02; Tau: 0.02, 85% probability of ARD of DK crush vs. provisional stenting <0). ARD for myocardial infarction was centered at −0.03 (95%CrI: −0.9 to 0.03; Tau: 0.05, 87% probability of ARD of DK crush vs. provisional stenting <0). ARD for stent thrombosis was centered at 0.00 (95% CrI: −0.04 to 0.03, Tau: 0.03, 51% probability of ARD for DK crush vs. provisional stenting <0). Finally, ARD for target lesion revascularization was centered at −0.05 (95% CrI: −0.08 to −0.03, Tau: 0.02, 99.97% probability of ARD for DK crush vs. provisional stenting <0). ConclusionsBayesian analysis demonstrated a lower probability of cardiac death, myocardial infarction and target lesion revascularization, with DK crush compared with provisional stenting techniques, and a minimal probability of difference in stent thrombosis.

Clinical outcomes following different stenting techniques for coronary bifurcation lesions: a systematic review and network meta-analysis of randomised controlled trials.

Controversy still exists regarding the optimal treatment of coronary bifurcation lesions. We aimed to analyse the evidence from randomised controlled trials (RCTs) to compare outcomes following different bifurcation stenting techniques. We systematically searched for RCTs comparing different techniques published up to July 2022. We then conducted a pairwise meta-analysis to compare outcomes between provisional stenting (PS) versus upfront 2-stent techniques. Moreover, we performed a network meta-analysis (NMA) to compare all strategies with each other. The primary endpoint was major adverse cardiac events (MACE). Twenty-four RCTs (6,890 patients) analysed PS, T-stenting, double-kissing (DK)-crush, crush, or culotte stenting. The pairwise meta-analysis did not reveal a significant difference between the PS and 2-stent techniques. However, the prespecified sensitivity analysis, which included RCTs exclusively enrolling patients with true bifurcation lesions, showed a lower rate of MACE following 2-stent techniques, and meta-regression indicated that a longer side branch lesion was associated with a greater benefit from the 2-stent strategy, which was the most apparent in RCTs with a mean lesion length >11 mm. NMA revealed that DK-crush was associated with the lowest MACE rate (odds ratio 0.47, 95% confidence interval: 0.36-0.62; p<0.01; PS as a reference). Overall, 2-stent techniques were not significantly better than PS in terms of clinical outcomes. However, the results of the sensitivity analysis suggested that there might be a benefit of a 2-stent approach in selected patients with true bifurcation lesions, especially in the case of long side branch lesions. An NMA revealed that DK-crush was associated with the lowest event rates when compared with other techniques.

B-16 | The RESOLUTE ONYX Bifurcation Study: 3-Year Outcomes in Patients With Coronary Bifurcation Lesions

Coronary bifurcation lesions are challenging to treat, with higher risk of procedural complications and adverse events than non-bifurcation lesions. In this study, we evaluated the 3-year clinical outcomes in patients with bifurcation lesions treated with the Resolute Onyx zotarolimus-eluting stent (ZES). Patients with a single bifurcation target lesion undergoing planned treatment using the provisional stenting technique were enrolled at 25 centers in the United States and Europe. Inclusion criteria included main branch reference vessel diameter (RVD) 2.25-5.0 mm, lesion length ≤35 mm, stenosis ≥50%, side branch ≥2.0 mm, and TIMI flow ≥2. The primary endpoint was target vessel failure (TVF) at 1-year. Follow-up was for 3 years. Between Apr 2017 to Dec 2019, 205 patients with 209 bifurcation lesions (of 267 total) were enrolled. Patients were 66.6 ± 10.7yrs, 21.5% female, 26.3% type II diabetic, 35.1% had previous PCI. Core lab analysis showed that 32.5% of lesions were true bifurcation lesions per Medina classification (1.1.1, 1.0.1, 0.1.1). Target vessel RVD was 2.65 ± 0.47 mm and lesion length was 17.03 ± 9.64 mm. 12.1% of patients had TVF through 3 years. There were no instances of stent thrombosis (Figure). Patients with coronary bifurcation lesions treated with the Resolute Onyx ZES had favorable long-term clinical outcomes at 3 years, with only 6% of target lesion revascularization and no cases of stent thrombosis. These results support the use of Resolute Onyx ZES to treat complex coronary bifurcation lesions using a planned provisional stenting technique, safely and effectively.

TCTAP A-033 Optimal Left Main Bifurcation Provisional Stenting Technique Assessed by Computational Fluid Dynamics Based on Low and Oscillatory Wall Shear Stress

TCTAP A-033 Optimal Left Main Bifurcation Provisional Stenting Technique Assessed by Computational Fluid Dynamics Based on Low and Oscillatory Wall Shear Stress

Provisional Stenting Techniques Using A Novel Modified Jailed Balloon

Coronary bifurcation lesions are frequently found; account for one-fifth of all Percutaneous Coronary Interventions (PCI), and are considered as complex cases to treat. The provisional stenting strategy is thought of as the stenting of choice for most coronary bifurcation lesions. Still, it has a risk of side branch (SB) occlusion after the main vessel (MV) stenting. Several strategies have been proposed to overcome this challenge. Jailed balloon technique (JBT), first proposed by Burzotta et al. in 2010 was a more recent modification of jailed wire technique (JWT) to further decrease the risk for SB occlusion during crossover stenting in bifurcation lesion. Since then, certain modifications had been tested to the conventional jailed balloon technique to maximize SB protection during the provisional stenting strategy. We tried to make a mini case series of 6 patients with application of jailed ballon technique with some modifications in bifurcation lesion with provisional stenting strategy and evaluate its efficacy and safety, with quite satisfying results. Our novel JBT technique had some different characteristics from previous JBT techniques and aimed at simplifying the procedure while preserving side branch during crossover stenting.

Provisional Vs Dual Stenting of Left Main Coronary Artery Bifurcation Lesions

Background: The primary LMCA stenting methods used nowadays consist of single stent (provisional), and two stent (T and protrusion, and double kissing crush {DK crush}, culotte, or classic crush). The optimal technique for bifurcation lesion treatment for the patients present with distal ULMCA disease is still unclear and not much is known about the best course of action and the clinical outcomes following various PCI techniques for ULMCA bifurcations in Pakistan. Objective: To investigate the midterm (3-year) outcomes related to the provisional stenting compared to two-stenting technique for the bifurcations of ULMCA undergoing the percutaneous coronary intervention. Methodology: A single-center retrospective, non-randomized cohort study was conducted during the period from March 2021 to August 2022 including all the consecutive LM bifurcation lesions. The patients attending Punjab Institute of Cardiology, Lahore were divided into two groups, depending upon the treatment received. One group underwent PCI with provisional stenting technique while the other underwent 2-stent PCI. The groups were compared for procedural success and 3-year clinical outcomes. Data was analyzed using SPSS. Results: The success rate of left main bifurcation angiography was comparable between both the techniques (2-stent 93.6 % vs. Provisional 92.1 %, P = 0.62). MACE rates were comparable between groups at 1, 2, and 3 years (PS 3.0 % vs. Dual stent 2.4 %, p = 0.75 at 1-year, PS 4.8 % vs. Dual stent 8 %, p = 0.26 at 2-years, and PS 10.2 % vs. Dual stent 12 % at 3-years, p = 0.62). Conclusion: Two stenting strategy was linked to same rates of MACEs at the 3-year duration in comparison to the single stenting technique (PS 10.2 % vs. 2-Stent 12 %, p=0.62) and both the dual and single provisional stent techniques have comparable angiographic success rate for LM bifurcation lesions.

Efficacy and safety of drug-coated balloon combined with cutting balloon for side branch of true coronary bifurcation lesions: Study protocol for a multicenter, prospective, randomized controlled trial.

Coronary bifurcation lesions are common of percutaneous coronary intervention (PCI), and the optimal interventional therapy strategy is still a matter of debate and remains a challenge for interventional cardiologists. The provisional stenting technique is still a preferred method for most bifurcation lesions, but restenosis of the side branch (SB) occurs in approximately 17-19% of cases. Therefore, the dilemma of reducing SB restenosis still exists, and further research on strategies to reduce restenosis for SB is necessary. Drug-coated balloon (DCB) can reduce clinical events in small vessel disease and in-stent restenosis. The efficacy and safety of DCB for SB of true coronary bifurcation lesions have not been fully investigated. A randomized comparison of DCB combined with cutting balloon angioplasty vs. cutting balloon angioplasty for SB has never been published. The purpose of this study is to explore the superiority of DCB combined with cutting balloon vs. cutting balloon angioplasty for SB after main vessel (MV) drug-eluting stent implantation of true coronary bifurcation lesions. This study is a multicenter, prospective, randomized controlled trial including 140 patients with true coronary bifurcation lesions. Patients will be randomized in a 1:1 manner to receive either DCB combined with cutting balloon or cutting balloon angioplasty for SB after MV drug-eluting stent implantation. The primary endpoint is the evaluation of late lumen loss (LLL) of SB at the 9-month follow-up. The secondary endpoints include procedural success during initial hospitalization, LLL of MV at the 9-month follow-up, binary angiographic restenosis in MV and SB at the 9-month follow-up, the proportion of patients with a final post-PCI quantitative flow ratio result ≤ 0.80 for SB at the 9-month follow-up, and major adverse cardiac events during the 24-month follow-up. This clinical trial will provide evidence as to whether DCB combined with cutting balloon for SB of true coronary bifurcation lesions is a superior treatment approach. ChiCTR2000040475. The results of this clinical trial will be published in a peer-reviewed journal.

Outcomes and challenges of the provisional stenting technique: Insights from the PROGRESS-BIFURCATION registry.

Provisional stenting is the most commonly used coronary bifurcation stenting strategy. We examined the clinical and angiographic characteristics, challenges encountered, and procedural outcomes with the provisional bifurcation stenting strategy in the Prospective Global Registry of Percutaneous Coronary Intervention (PCI) in Bifurcation Lesions (PROGRESS-BIFURCATION,NCT05100992). Provisional stenting was used in 334 of 430 bifurcation interventions (78%). Technical success was lower (95% vs. 100%, p = 0.017) in provisional, but procedural success (90% vs. 95%, p = 0.095) and incidence of in-hospital major adverse cardiovascular events were similar (5% vs. 5%, p = 0.945) compared with two-stent strategies. Provisional was less often preferred in left main/left anterior descending involvement (47% vs. 73%, p &lt; 0.001). Provisional stenting cases had smaller side branch (SB) diameter (2.4 ± 0.5 vs. 2.7 ± 0.6 mm, p &lt; 0.001), shorter SB lesion length (5 [3-8] vs. 10 [5-10] mm, p &lt; 0.001), less SB diameter stenosis (46 ± 35 vs. 81 ± 20%, p &lt; 0.001), and were less likely to be Medina 1,1,1 (34% vs. 73%, p &lt; 0.001). PCI challenges were less common (30% vs. 58%, p &lt; 0.001) with provisional stenting: (1) rewiring difficulty (43%) that was overcome with use of a different wire (74%) or microcatheter (46%); (2) inability to deliver a stent (22%) or balloon (9%) that was overcome with use of a smaller balloon (88%), rewiring (25%), or increased support/microcatheter (25%). Provisional bifurcation stenting was more often performed in distal lesions with less SB involvement and had lower technical success, but similar procedural success and complications compared with two-stent strategies.

Provisional or 2-Stent Technique for Bifurcation Lesions in the Second-Generation Drug-Eluting Stent Era.

For bifurcating coronary lesions, a provisional stent technique is recommended compared with a routine 2-stent strategy. However, much of these data are from trials involving first-generation drug-eluting stents (DES) or bare-metal stents where the risk of restenosis with the 2-stent technique is higher. We investigated the efficacy of various 2-stent techniques versus a provisional stent technique for bifurcation lesions with newer-generation DES. PubMed and Embase were searched through May 2022 for randomized control trials investigating bifurcation percutaneous coronary intervention techniques using newer-generation DES, and a meta-analysis was conducted. The primary end point was major adverse cardiovascular events (MACE) at the longest reported follow-up time. Our study identified 13 randomized control trials including 4041 patients. Compared with the provisional technique, 2-stent techniques significantly decreased MACE (hazard ratio [HR], 0.76; 95% CI, 0.59-0.97; P = .03), target vessel myocardial infarction (HR, 0.38; 95% CI, 0.20-0.71; P = .002), and target vessel revascularization (HR, 0.66; 95% CI, 0.47-0.93; P = .02). There were no significant differences in all-cause mortality (HR, 0.94; 95% CI, 0.62-1.45; P = .79), cardiovascular mortality (HR, 0.82; 95% CI, 0.49-1.38; P = .45), myocardial infarction (HR, 1.00; 95% CI, 0.73-1.37; P = .99), and stent thrombosis (HR, 0.86; 95% CI, 0.52-1.44; P = .58). Of the 2-stent techniques, the double kissing crush technique significantly decreased MACE and target lesion revascularization than other 2-stent techniques. In this era of newer-generation DES, a 2-stent approach, especially the double kissing crush technique, is superior to a provisional stenting technique for a bifurcation lesion, with a significant reduction in MACE, target vessel myocardial infarction, and revascularization.

Impact of Side Branch Lesion Length on Clinical Outcome after Coronary Stenting Techniques in Patients with Coronary Artery Bifurcation Disease: A Meta-Analysis

Objective: The optimal percutaneous coronary intervention (PCI) technique for bifurcation lesions remains controversial, especially considering the variability of the side branch (SB). A provisional stenting technique is currently recommended in most cases. This meta-analysis aimed to compare outcomes of different bifurcation PCI strategies, clarifying their scope of application. Methods: Randomized controlled trials comparing PCI strategies for coronary bifurcation lesions were systematically retrieved from PubMed, Cochrane, Web of Science, and EBSCO literature databases without limitations on published date or language. Major adverse cardiovascular events (MACEs) were stipulated as main outcomes. Secondary outcomes of interest were all-cause mortality, cardiovascular mortality, target lesion revascularization (TLR), target vessel revascularization, myocardial infarction (MI), and stent thrombosis. Both pooled analysis and sub-group analysis were performed. Results: Twenty-three randomized controlled trials with 6380 participants were included. Eighteen studies compared the provisional strategy with 2-stent approaches. No significant difference in MACEs (relative risk (RR), 1.16; 95% confidence interval (CI), 0.90–1.48; I2 = 62%) was found between 1-stent and 2-stent techniques. However, when SB lesion length was used as the separation condition, the 2-stent strategy was associated with fewer MACEs (RR, 1.87; 95% CI, 1.46–2.41; I2 = 70%), TLRs (RR, 2.13; 95% CI, 1.50–3.02; I2 = 59%), and MIs (RR, 2.17; 95% CI, 1.19–3.95; I2 = 52%) than the provisional strategy in those where SB lesions measured &gt;10 mm long. Conclusions: In the current work, there was no significant difference between 1-stent and 2-stent techniques in terms of MACEs or secondary outcomes. However, 2-stent approaches have clinical advantages over the provisional strategy in bifurcation when the SB lesion length is &gt;10 mm due to fewer cases of TLR and MI.

Techniques and Evidence for Percutaneous Coronary Intervention for Coronary Bifurcation Lesions: An Ongoing Journey

Techniques and Evidence for Percutaneous Coronary Intervention for Coronary Bifurcation Lesions: An Ongoing Journey

A Review of Double Kissing Crush Stenting in Coronary Bifurcation Lesions

Double kissing (DK) crush stenting for coronary bifurcation lesions has gain popularity worldwide because of its superior randomized studies data and excellent clinical outcomes. This review evaluates all DK crush clinical trials and studies. It also reveals the contemporary technique steps by steps as well as the trouble shooting with illustrated clinical scenarios. Among all the available evidence, the DK crush technique is superior when compared to the provisional stenting technique for complex bifurcation lesion. DK crush stenting provides the best evidence-based approach to complex bifurcation lesions especially the left main coronary artery bifurcation lesions. Future direction of how to make this DK crush technique better is also proposed.

3-Year Outcomes After 2-Stent With Provisional Stenting for Complex Bifurcation Lesions Defined by DEFINITION Criteria.

The multicenter and randomized DEFINITION II (Two-Stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions) trial showed less 1-year target lesion failure (TLF) after a 2-stent approach for complex coronary bifurcation lesions compared with provisional stenting (PS). The authors report the 3-year clinical outcome of the DEFINITION II trial. The aim of the present study was to investigate the difference in TLF at 3 years after a planned 2-stent approach vs PS for complex coronary bifurcation lesions stratified by DEFINITION (Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents) criteria. A total of 653 patients with complex coronary bifurcation lesions were randomly assigned to either the 2-stent group or the PS group in the DEFINITION II trial and were followed for 3 years. The primary endpoint was the occurrence of TLF at 3 years. Stent thrombosis was the safety endpoint. At 3 years, TLF had occurred in 52 patients (16.0%) in the PS group and in 34 (10.4%) patients in the 2-stent group (HR: 0.63; 95%CI: 0.41-0.97; P=0.035), driven mainly by increased target vessel myocardial infarction (8.0% vs 3.7%; HR: 0.45; 95%CI: 0.23-0.89; P=0.022) and target lesion revascularization (8.3% vs 4.3%; HR: 0.50; 95%CI: 0.26-0.96; P=0.038). There was no difference in TLF between the 2 groups between year 1 and year3. For patients with complex coronary bifurcations who reach 1-year postprocedure without experiencing endpoint events, there is still a risk for future events. The type of procedure performed initially is no longer a future event risk determinant. (Two-Stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions; NCT02284750).

Polymer Coating Integrity, Thrombogenicity and Computational Fluid Dynamics Analysis of Provisional Stenting Technique in the Left Main Bifurcation Setting: Insights from an In-Vitro Model.

Currently, the provisional stenting technique is the gold standard in revascularization of lesions located in the left main (LM) bifurcation. The benefit of the routine kissing balloon technique (KBI) in bifurcation lesions is still debated, particularly following the single stent treatment. We compared the latest-generation drug-eluting stent (DES) with no side branch (SB) dilatation “keep it open” technique (KIO) vs. KBI technique vs. bifurcation dedicated drug-eluting stent (BD-DES) implantation. In vitro testing was performed under a static condition in bifurcation silicone vessel models. All the devices were implanted in accordance with the manufacturers’ recommendations. As a result, computational fluid dynamics (CFD) analysis demonstrated a statistically higher area of high shear rate in the KIO group when compared to KBI. Likewise, the maximal shear rate was higher in number in the KIO group. Floating strut count based on the OCT imaging was significantly higher in KIO than in KBI and BD-DES. Furthermore, according to OTC analysis, the thrombus area was numerically higher in both KIO and KBI than in the BD-DES. Scanning electron microscopy (SEM) analysis shows the highest degree of strut coating damage in the KBI group. This model demonstrated significant differences in CFD analysis at SB ostia with and without KBI optimization in the LM setting. The adoption of KBI was related to a meaningful reduction of flow disturbances in conventional DES and achieved results similar to BD-DES.

TCTAP A-031 The Importance of Performing Final Kissing Balloon Dilation Before Final Proximal Optimization When Using Provisional Stenting Technique in Bifurcation Lesions: A Computational Fluid Dynamics Study

TCTAP A-031 The Importance of Performing Final Kissing Balloon Dilation Before Final Proximal Optimization When Using Provisional Stenting Technique in Bifurcation Lesions: A Computational Fluid Dynamics Study

Fundamentals of percutaneous coronary bifurcation interventions.

Coronary bifurcation lesions (CBLs) account for 15%-20% of all percutaneous coronary interventions. The complex nature of these lesions is responsible for poorer procedural, early and late outcomes. This complex lesion subset has received great attention in the interventional cardiac community, and multiple stenting techniques have been developed. Of these, the provisional stenting technique is most often the default strategy; however, the elective double stenting (EDS) technique is preferred in certain subsets of complex CBLs. The double kissing crush technique may be the preferred EDS technique because of its efficacy and safety in comparative trials; however, this technique consists of many steps and requires training. Many new methods have recently been added to the EDS techniques to provide better stent scaffolding and to reduce early and late adverse outcomes. Intravascular imaging is necessary to determine the interventional strategy and postinterventional results. This review discusses the basic concepts, contemporary percutaneous interventional technical approaches, new methods, and controversial treatment issues of CBLs.

Under-deployment of extra-large drug-eluting stent: an adapted provisional technique for selected patients with distal lesions in large left main.

In provisional technique, main vessel (MV) drug-eluting stent (DES) diameter is usually selected according to distal MV to reduce carina shift. Proximal optimization technique (POT) is used to expand the DES in the proximal MV. Occasionally, the size discrepancy between left main (LM) and left anterior descending artery (LAD) may be huge and this may cause stent malapposition and poor vessel wall coverage in large-sized LM. Recently, some manufactures designed extra-large DES to treat large vessels. We developed an "adapted" provisional strategy based on under-deployment of extra-large DES in case of major size mismatch between LM and proximal LAD. Bench tests were realized in appropriately designed LM bifurcation model using an extra-large DES (Onyx XL, Medtronic, Santa Rosa, CA, USA). This technique was adopted when such "rare" anatomy was found in our clinical practice. At bench test, Onyx XL 4.5 mm stent reaches 3.8 mm at 5-6 atmospheres, with favorable stent deformation achieved after POT, kissing balloon and re-POT. This technique was performed in 10 patients undergoing unprotected LM stenting with large LM and major mismatch toward LAD. Angiographic success was achieved in all cases and optical coherence tomography assessment was performed in 5 patients revealing optimal stent result. After a follow-up of 557 days (range: 90-1369 days), clinical course was uneventful in all treated patients. Under-deployment of extra-large DES is a technical option that can be considered to optimize the provisional stenting technique in selected patients with major diameter mismatch between large-sized LM and LAD.

Provisional Stenting for Left Main Bifurcation Disease under IVUS guidance: A Case Series

Around 15-20% of coronary lesions include bifurcation, and among which left main (LM) bifurcation lesions are critical and complex to manage. Though the two-stent strategy is the preferred option for complex LM bifurcation lesions, the provisional strategy should be considered if the side branch is disease-free to avoid peri- and post-procedural complications. Thus, precise anatomical and physiological assessment of LM lesion should be made using intravascular imaging techniques for appropriate decision making. Here, we report three cases of successfully managed LM bifurcation lesions using the provisional stenting technique with the guidance of intravascular ultrasound, fractional flow reserve, and heart team. All three patients were doing well and were ischemia-free on stress echocardiography at three months follow-up.

Factors associated with side branch occlusion treated with provisional stenting technique in bifurcation lesions

Factors associated with side branch occlusion treated with provisional stenting technique in bifurcation lesions