Bifurcation Lesions Research Articles

Stepwise Provisional Versus Systematic Dual-Stent Strategies for Treatment of True Left Main Coronary Bifurcation Lesions.

The optimal coronary stenting technique for true left main bifurcation lesions is uncertain. EBC MAIN (European Bifurcation Club Left Main Trial) aimed to evaluate clinical outcomes of a stepwise provisional strategy compared with a systematic dual-stent approach. EBC MAIN was a randomized, investigator-initiated, open-label, multicenter, parallel-group trial conducted across 35 hospitals in 11 European countries. A total of 467 participants undergoing percutaneous coronary intervention for unprotected true left main bifurcation lesions were randomly assigned to the stepwise provisional strategy (n=230) or an upfront dual-stent approach (n=237). The mean (SD) age was 71 (10) years and 23% of participants were women. The primary end point was a composite of major adverse cardiac events, defined as all-cause mortality, all myocardial infarction, or clinically driven target lesion revascularization. Events were adjudicated by an independent clinical events committee and all analyses were by the intention-to-treat principle. At 3 years, the primary end point occurred in 54 of 230 (23.5%) stepwise provisional and 70 of 237 (29.5%) dual-stent patients (hazard ratio, 0.75 [95% CI, 0.53-1.07]; P=0.11). There was no significant difference in all-cause mortality (10.0% versus 13.1%) or myocardial infarction (12.2% versus 11.0%). However, target lesion revascularization was significantly lower in the stepwise provisional group (8.3% versus 15.6%; hazard ratio, 0.50 [95% CI, 0.29-0.86]; P=0.013). In this population, the mean side vessel diameter by quantitative angiography was 2.9 mm, and median side vessel lesion length was 5 mm. Significant interactions were identified between the assigned bifurcation strategy and both side vessel diameter and lesion length with respect to the primary outcome (P=0.009 and P=0.005, respectively), with smaller vessels (<3.25 mm diameter) and shorter lesions (<10 mm length) favoring the provisional approach. In a European population with true left main stem bifurcation coronary disease requiring intervention, there was no difference in major adverse cardiovascular events between stepwise provisional and systematic dual-stent strategies at 3 years. Target lesion revascularization was significantly less frequent with the stepwise provisional approach, which should be the default strategy for noncomplex left main bifurcation coronary intervention. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02497014.

Differential Prognosis of True Bifurcation Lesions According to Left Main Versus Non-Left Main Location and Treatment Strategy.

Although true bifurcation lesions are associated with a high risk of procedural complications, the differential prognostic implications of percutaneous coronary intervention for true bifurcations according to lesion location are unclear. This study aimed to identify whether clinical outcomes of true bifurcation lesions differed between left main coronary artery (LM) and non-LM bifurcations and to determine the optimal treatment strategy for subtypes of bifurcation lesions in the current-generation drug-eluting stent era. The ULTRA-BIFURCAT (Combined Insights From the Unified COBIS III, RAIN, and ULTRA Registries) was created by merging 3 bifurcation-dedicated registries from Korea and Italy. For this, 6548 patients treated with bifurcation lesions were stratified by lesion location and subtype. The primary end point was major adverse cardiac events (MACEs; composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) at 800 days. In patients with an LM bifurcation, those with a true bifurcation had a significantly higher risk of a MACE than those with a nontrue bifurcation (20.2% versus 13.4%, adjusted hazard ratio [HR], 1.44 [95% CI, 1.11-1.86]; P=0.006). Conversely, there was no significant difference in the risk of a MACE according to true versus nontrue bifurcation in patients with non-LM bifurcation lesions (9.0% versus 8.8%; adjusted HR, 1.02 [95% CI, 0.82-1.27]; P=0.849). For LM true bifurcations, MACE rates were comparable between 1-stent and 2-stent strategies, whereas for LM nontrue bifurcations, the 2-stent strategy was associated with a significantly higher risk of MACEs than the 1-stent strategy. No significant differences in the risk of MACEs were observed in non-LM bifurcation lesions according to lesion subtype or treatment strategy. Clinical outcomes were worse for LM true bifurcation lesions than non-LM true bifurcation lesions. A provisional 1-stent strategy should be the preferred approach for treating LM nontrue bifurcation lesions. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03068494, NCT03544294, and NCT05205148.

Evaluating Drug-Eluting Balloons Versus Stenting for Provisional Bifurcation Lesions: Short-Term Outcomes and Future Directions

Evaluating Drug-Eluting Balloons Versus Stenting for Provisional Bifurcation Lesions: Short-Term Outcomes and Future Directions

Drug-Coated Balloon-Based Treatment of Left Main True Bifurcation Lesion.

There is a paucity of data regarding drug-coated balloon (DCB) treatment in the context of left main (LM) true bifurcation lesions. The aim of this study was to evaluate the safety and efficacy of DCB-based treatment for unprotected LM true bifurcation lesions. A total of 39 patients with LM true bifurcation lesion (Medina: 1,1,1/0,1,1/1,0,1) who were successfully treated with DCB alone or in combination with drug-eluting stent (DES) were retrospectively enrolled into the DCB-based group. They were compared with 39 propensity-matched patients who were treated with second-generation DES from the COBIS III registry (n = 2648). Major adverse cardiovascular events (MACE) were defined as cardiac death, myocardial infarction, stent or target lesion thrombosis, and target lesion revascularization at the 2-year follow-up. Baseline clinical characteristics were similar between the groups, except for the prevalence of in-stent restenosis (ISR) lesions (41.0% in DCB-based group vs. 17.9% in DES-only group, p = 0.047). In the DCB-based group, 59.0% of the patients (n = 23) underwent DCB-only treatment. There were no cases of abrupt vessel closure requiring treatment following DCB application. The MACE were comparable between both groups (12.8% in DCB-based group vs. 17.9% in DES-only group, p = 0.861) after 2 years. In patients with unprotected LM true bifurcation lesions, DCB-based treatment demonstrated comparable clinical outcomes at the 2-year follow-up when compared to DES-only treatment. DCB-based treatment could be considered a safe and effective alternative to DES for carefully selected patients who have achieved satisfactory predilation results (Impact of DCB Treatment in De Novo Coronary Lesion; NCT04619277).

The impact of bifurcation angle on clinical outcomes in patients who underwent nano-crush technique: the insight from the multicenter EVOLUTE-CRUSH V study.

This multicenter study aimed to retrospectively assess the relationship between bifurcation angle (BA) and major cardiovascular events (MACEs) in patients undergoing nano-crush technique (NCT) for complex bifurcation lesions (CBLs). A total of 122 consecutive patients [male: 85 (69.6%), mean age: 61.53 ± 9.03 years] who underwent NCT between January 2019 and January 2024 were included. The primary endpoint was a combined endpoint (MACE) including cardiac death, target vessel myocardial infarction (TVMI), or clinically driven target lesion revascularization (TLR). Patients were classified into two groups: MACE-positive and MACE-negative patients. Among the study population, 22 patients (18%) had at least one MACE. The BA (46.89 ± 14.65° vs. 65.23 ± 10.40°, P = 0.001) was notably lower in the MACE-positive group than the MACE-negative group. In multivariable regression analysis, decreased BA was identified as one of the independent predictors of MACE (odds ratio = 0.908; 95% confidence interval: 0.852-0.969; P < 0.001). We divided the study cohort into two subgroups based on historical narrow and wide BAs (<70 vs. ≥70°). The incidence of MACE (25.3 vs. 6.4%, P = 0.008), clinically driven TLR (22.7 vs. 4.3%, P = 0.009), and TVMI (18.7 vs. 0%, P = 0.001) were notably higher in the BA <70° group than in the BA ≥70° group. Kaplan-Meier analysis also revealed that MACE-free survival was significantly lower in the BA <70° group than in the BA ≥70° group under mid-term follow-up (log-rank P = 0.009). This observational multicenter study showed that the BA significantly affects mid-term outcomes in patients who underwent NCT. In addition, our findings suggest that NCT may not be a viable option in patients with narrow-angle (<70°) CBLs.

Combined Main Branch Stenting and Side Branch Drug-Coated Balloon versus Two-Stent Strategy in Patients with Left Main Bifurcation Lesions

Combined Main Branch Stenting and Side Branch Drug-Coated Balloon versus Two-Stent Strategy in Patients with Left Main Bifurcation Lesions

Comparison of PROVISIONal 1-stent strategy with Drug-Eluting Balloon versus Planned 2-stent strategy in patients with Non-LM Coronary True-Bifurcation Lesions (PROVISION-DEB).

Percutaneous coronary intervention (PCI) for bifurcation lesions presents several difficulties and often results in suboptimal procedural, post-procedural clinical outcomes. While the provisional 1-stent strategy is generally favored for its simplicity and favorable outcomes, a few studies suggest no significant difference between 1-stent and 2-stent techniques for true bifurcation lesions. Drug-eluting balloons (DEBs) have demonstrated potential in small vessel disease, including bifurcation side branches. However, no studies have compared the 2-stent strategy with the provisional 1-stent plus DEB strategy in non-LM true bifurcation lesions. Our study aims to address this gap by comparing these strategies, with a focus on real-world practice and detailed endpoint analysis. The PROVISION-DEB study is an open-label, randomized, multi-center clinical trial designed to investigate noninferiority and compare a 1-stent strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation lesions. A total of 750 patients with de novo non-LM coronary bifurcation lesions undergoing coronary interventions will be randomized 1:1 to either a provisional 1-stent plus DEB strategy or a 2-stent strategy with stratified Diabetes. The primary endpoint is a target lesion failure, composite outcome of cardiac death, target vessel myocardial infarction, or target lesion revascularization at the anticipated 3 years follow-up (6, 12, and 36 months). In conclusion, PROVISION-DEB study is a randomized, multi-center, non-inferior clinical trial and will compare a 1-setnt strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation.

Mini-crush or Nano-crush Stenting Technique for Complex Coronary Bifurcation Lesions: The Multicenter MINANO Registry.

This multicenter study aimed to retrospectively evaluate the mid-term clinical outcomes of mini-crush (MCT) and nano-crush (NCT) techniques in patients with complex bifurcation lesions (CBLs). The study comprised 431 patients [male: 318 (73.8%), mean age: 60.96 ± 10.34 years] who underwent bifurcation PCI between January 2018 and December 2023 were included in the study from six tertiary centers. The primary endpoint was defined as the major cardiovascular events (MACE), which include cardiac death, target vessel myocardial infarction (TVMI), or clinically driven target lesion revascularization (TLR). This is the first study to compare the clinical outcomes of MCT and NCT in patients with CBL. The initial revascularization strategy was MCT in 302 (70%) cases and NCT in 129 (30%) patients. SYNTAX scores [24.33±6.54 vs 24.43±5.45, p=0.707] were comparable in both groups. The incidence of MACE (18.6 vs. 10.9%, p=0.031), TVMI (11.6 vs 5.6%, p=0.030), and clinically driven TLR (14 vs. 6%, p=0.006) were significantly higher in the NCT group compared to the MCT group. Being in the MCT group (HR: 0.549, p=0.035), high SYNTAX score (HR: 1.105, p<0.001), non-fatal intra-procedural complications (HR: 3.269, p<0.001), proximal side-branch optimization (HR: 0.451, p=0.013), diabetes mellitus (HR: 2.263, p=0.009), and chronic kidney disease (HR: 1.948, p=0.024) were found to be independent predictors of MACE. This non-randomized study suggests that MCT was associated with better mid-term MACE, TVMI, and clinically driven TLR rates compared with NCT in patients with CBLs.

Double kissing crush versus culotte for bifurcation percutaneous coronary interventions: insights from the PROGRESS-BIFURCATION registry.

Upfront 2-stent techniques are often used in bifurcation percutaneous coronary interventions (PCI), but there is controversy about optimal strategy selection. The authors examined the clinical and angiographic characteristics and long-term outcomes of 232 bifurcation PCIs that were performed using the double kissing (DK) crush or culotte technique in 216 patients between 2014 and 2023 using data from the Prospective Global Registry for the Study of Bifurcation Lesion Interventions (NCT05100992). The inverse probability of treatment weighted (IPTW) Cox proportional hazards model was used to assess long-term outcomes. DK crush was more commonly used (69.0%). Patients in the DK-crush group had similar baseline characteristics to those in the culotte group. Lesions treated with DK crush were more likely to be in the left main coronary artery (42.9% vs 15.5%, P less than .001), had larger proximal (3.50 [3.50-4.00] vs 3.50 [3.21-3.79] mm, P = .027) and distal (3.00 [3.00-3.50] vs 3.00 [2.75-3.25] mm, P = .047) main vessel diameter, and were more likely to have severe calcification (29.8% vs 5.6%, P less than .001). Technical (98.8% vs 97.2%, P = .588), procedural success (96.5% vs 95.1%, P = .698), and in-hospital major adverse cardiovascular events (MACE) (6.1% vs 3.0%, P = .509) were similar in both groups. During a median follow-up of 43 months, 60 (33.9%) patients experienced MACE. On IPTW adjusted Cox analysis, DK crush was associated with lower follow-up MACE (hazard ratio 0.28; 95% CI, 0.13-0.60; P = .001) compared with culotte driven by lower target vessel revascularization (TVR) (14.3% vs 29.3%, P = .029). Compared with culotte, DK crush is associated with similar periprocedural outcomes but lower TVR and MACE during follow-up.

Coronary bifurcation lesion: Comparison between provisional stenting and two-stent techniques

Coronary bifurcation lesion: Comparison between provisional stenting and two-stent techniques

Sex Differences in Procedural Characteristics and Clinical Outcomes Among Patients Undergoing Bifurcation PCI.

The risk profiles, procedural characteristics, and clinical outcomes for women undergoing bifurcation percutaneous coronary intervention (PCI) are not well defined compared to those in men. COronary BIfurcation Stenting III (COBIS III) is a multicenter, real-world registry of 2,648 patients with bifurcation lesions treated with second-generation drug-eluting stents. We compared the angiographic and procedural characteristics and clinical outcomes based on sex. The primary outcome was 5-year target lesion failure (TLF), a composite of cardiac death, myocardial infarction, and target lesion revascularization. Women (n=635, 24%) were older, had hypertension and diabetes more often, and had smaller main vessel and side branch reference diameters than men. The pre- and post-PCI angiographic percentage diameter stenoses of the main vessel and side branch were comparable between women and men. There were no differences in procedural characteristics between the sexes. Women and men had a similar risk of TLF (6.3% vs. 7.1%, p=0.63) as well as its individual components and sex was not an independent predictor of TLF. This finding was consistent in the left main and 2 stenting subgroups. In patients undergoing bifurcation PCI, sex was not an independent predictor of adverse outcome.

Impact of Bifurcation Lesions on Outcomes After FFR-Guided PCI or CABG.

In the era of first-generation drug-eluting stents and angiography-guided percutaneous coronary intervention (PCI), the presence of a bifurcation lesion was associated with adverse outcomes after PCI. In contrast, the presence of a bifurcation lesion had no impact on outcomes following coronary artery bypass grafting (CABG). Therefore, the presence of a coronary bifurcation lesion requires special attention when choosing between CABG and PCI. The aim of this study is to assess whether the presence of a bifurcation lesion still influences clinical outcomes after contemporary PCI using second-generation drug-eluting stent and fractional flow reserve (FFR) guidance versus CABG. The randomized FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) compared FFR-guided PCI using current drug-eluting stents with CABG in patients with 3-vessel coronary artery disease. The prespecified key end point at 3-year follow-up was the composite of death, myocardial infarction, or stroke. In this substudy, the impact of bifurcation lesions on outcomes after FFR-guided PCI and CABG was investigated. The FAME 3 trial enrolled 1500 patients and 653 (45.2%) patients had at least 1 true bifurcation lesion. There was no difference in the composite of death, myocardial infarction, or stroke at the 3-year follow-up between patients with or without at least 1 true bifurcation lesion (11.6% versus 10.0%; hazard ratio, 1.17 [95% CI, 0.86-1.61]; P=0.32), regardless of revascularization strategy. The composite end point was not statistically different between FFR-guided PCI and CABG in patients with at least 1 true bifurcation lesion (hazard ratio, 1.27 [95% CI, 0.80-2.00]) or without a true bifurcation lesion (hazard ratio, 1.36 [95% CI, 0.87-2.12]), with no significant interaction (Pinteraction=0.81). In patients with 3-vessel coronary artery disease, the presence of a true bifurcation lesion was not associated with a different treatment effect after FFR-guided PCI with contemporary drug-eluting stent versus CABG.

STENTING AS A METHOD OF CHOICE FOR TREATING LEFT MAIN CORONARY ARTERY LESIONS

The aim of this study is to justify the use of stenting as the method of choice for revascularization of left main coronary artery lesions. Materials and methods. A comprehensive analysis of scientific publications and randomized trials was conducted to evaluate the advantages and disadvantages of various stenting techniques for left main coronary artery lesions, to optimize treatment strategies for individual patients, to improve clinical outcomes, to reduce complications, and to enhance the quality of life for patients with left main coronary artery disease. Results. The proper selection of stenting techniques for left main coronary artery lesions is a critical factor for procedural success. The choice of intervention should consider the lesion characteristics of both the main trunk and its side branches. To achieve optimal immediate and long-term outcomes, strict adherence to intervention protocols is essential, particularly in patients requiring the initial use of double-stent techniques. It is worth noting that single-stent techniques may sometimes necessitate a switch to double-stent strategies, with the TAP (T and small protrusion) and Culotte techniques being the most accessible transitions. The single-stent technique remains highly effective for patients with simple anatomical lesions. For simple bifurcation lesions, the “T-stenting” and “TAP” techniques are selectively utilized. Comparative analysis reveals a higher rate of thrombosis with the Culotte technique compared to the DK Crush technique. A critical prerequisite for successful stenting of the left main coronary artery is the use of intravascular imaging, as it ensures precise selection of equipment and reduces the risk of long-term restenosis in the stented segment. Conclusions. The right choice of stenting technique for the left main coronary artery is a key factor in the success of the procedure. Modern technologies and two-stent strategies enable effective treatment of complex lesions, minimizing the risks to the patient.

A Novel Modified Mini-Crush Technique for Complex Coronary Bifurcation Lesions: Controlled Balloon-Crush

A Novel Modified Mini-Crush Technique for Complex Coronary Bifurcation Lesions: Controlled Balloon-Crush

Percutaneous Coronary Interventional Treatment of Left Main Trifurcation Lesion: A Case Report

ABSTRACTCoronary artery disease (CAD) remains a leading cause of morbidity and mortality worldwide, particularly among complex high‐risk and indicated patients (CHIP). Revascularization is often beneficial for these patients; however, it requires thorough risk stratification and close multidisciplinary collaboration between cardiologists and cardiac surgeons to optimize outcomes. Personalized treatment plans, including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), are crucial in this context. In this report, we present a case of a 70‐year‐old man with left main trunk bifurcation lesions, referred to as a “Four Forks Lesion,” who was successfully revascularized using a PCI strategy, resulting in a favorable prognosis.

The shortcomings of the Medina compared to the Movahed coronary bifurcation classification.

The Medina classification separates true bifurcation lesions into three unnecessary groups: 1.1.1, 1.0.1, and 0.1.1. Non-true bifurcation lesions are divided into three unnecessary subgroups called 0.0.1, 0.1.0, and 1.0.0. Furthermore, the Medina classification does not describe any other important features of a given bifurcation lesion, making it useless when comparing complex bifurcation lesions. This has led to confusion in clinical settings and stagnation of bifurcation research. The Movahed bifurcation classification has overcome those problems by summarizing all true bifurcation lesions into one simple relevant category called B2 (B for bifurcation, 2 meaning both main and side branches at bifurcation site have significant lesions) and non-true bifurcation lesions into two simple categories called B1m (B for bifurcation, 1 m meaning only the main branch has significant lesion) and B1S lesions (B for bifurcation and 1 s meaning only the side branch has significant lesion). Moreover, at the same time, additional unlimited suffixes can be added if needed to describe a given bifurcation lesion, making this bifurcation also very comprehensive. In this perspective, the shortcomings of the Medina classification compared to the Movahed classification are discussed in detail.

Caveats in application of protected rotational atherectomy with double-guiding catheter technique for nonleft main bifurcation lesion.

Caveats in application of protected rotational atherectomy with double-guiding catheter technique for nonleft main bifurcation lesion.

Management of woven coronary bifurcation lesion with mini-crush technique.

Management of woven coronary bifurcation lesion with mini-crush technique.

Application of Drug-Coated Balloons in Complex High Risk and Indicated Percutaneous Coronary Interventions.

There is a growing trend of patients with significant comorbidities among those referred for percutaneous coronary intervention (PCI). Consequently, the number of patients undergoing complex high risk indicated PCI (CHIP) is rising. CHIP patients frequently present with factors predisposing to extensive drug-eluting stent (DES) implantation, such as bifurcation and/or heavily calcified coronary lesions, which exposes them to the risks associated with an increased stent burden. The drug-coated balloon (DCB) may overcome some of the limitations of DES, either through a hybrid strategy (DCB and DES combined) or as a leave-nothing-behind strategy (DCB-only). As such, there is a growing interest in extending the application of DCB to the CHIP population. The present review provides an outline of the available evidence on DCB use in CHIP patients, which comprise the elderly, comorbid, and patients with complex coronary anatomy. Although the majority of available data are observational, most studies support a lower threshold for the use of DCBs, particularly when multiple CHIP factors coexist within a single patient. In patients with comorbidities which predispose to bleeding events (such as increasing age, diabetes mellitus, and hemodialysis) DCBs may encourage shorter dual antiplatelet therapy duration-although randomized trials are currently lacking. Further, DCBs may simplify PCI in bifurcation lesions and chronic total coronary occlusions by reducing total stent length, and allow for late lumen enlargement when used in a hybrid fashion. In conclusion, DCBs pose a viable therapeutic option in CHIP patients, either as a complement to DES or as stand-alone therapy in selected cases.

Challenges in the Management of Dislodged Coronary Stent Embolization: A Case Report

AbstractAlthough device embolization is a rare complication in percutaneous coronary interventions (PCI), its mortality and morbidity are serious complications. With the increasing prevalence of complicated procedures, invasive cardiologists encounter device embolization daily. Different devices and techniques are utilized to retrieve these devices. Most devices used during PCIs are infection stents. More infrequently, the tip of diverting wires, angioplasty balloons, or balloon holders may break and embolize distally into the arteries. A 51-year-old man with non-ST elevation myocardial infarction was presented for restoration of the ring of the stent, which was stripped in the first diagonal ostium, with snare communication. The patient had an anterior myocardial infarction and underwent stent implantation in the left anterior descending artery (LAD) 1 month ago. While the stripped stent was being retracted, the LAD stent had been inserted, causing the stent implanted a month ago to be retracted. Additionally, the dissection was observed in the proximal LAD, and the procedure was terminated by stenting the LAD-Diagonal bifurcation lesion using the mini-crush technique. This case report highlights the importance of constant vigilance that invasive cardiologists must show when removing the embolized device. The maturity of the technique depends on the operator's experience with the methods of use and the material possibilities in the laboratory.