Treatment Of Coronary Bifurcation Lesions Research Articles

Acute and long-term results of percutaneous coronary intervention of bifurcation lesions with the dedicated Bioss Lim C stent: the Italian BIfurcation Observational Spontaneous Study (IBIOSS).

Percutaneous coronary intervention (PCI) for bifurcation lesions still represents a clinical challenge. The Bioss Lim C is a dedicated device for bifurcation lesions, features a tapered shape and large cells, and thus appears as a promising adjunct to the current interventional cardiologists' armamentarium. We aimed at conducting a prospective multicenter study focusing on early and long-term results after Bioss Lim C implantation for true coronary bifurcation lesions. Patients with true bifurcation lesions in whom Bioss Lim C implantation was attempted were enrolled in four Italian centers. An explicit bifurcation management approach was recommended, leaving however the choice between one- vs. two-stent strategies at operator's discretion. Acute and long-term results were systematically appraised, focusing on an acute composite of complex side branch (SB) rewiring, SB pinching, or SB occlusion (primary efficacy endpoint), as well as major adverse events (MACE, i.e. death, myocardial infarction [MI], or target vessel revascularization [TVR]), individual components of MACE, and stent thrombosis. A total of 207 patients were included, with age of 67.3±10.8 years, and 40 (19.3%) women. The target lesion was located in the left main in 48 (23.2%) patients, whereas proximal reference vessel diameter was 3.69±0.48 mm, and lesion length 20.3±3.4 mm. According to the Medina classification, most patients (60 [30.9%]) had 1-1-1 lesions. Drug-eluting stent implantation in the SB was carried out in 19 (9.3%) subjects, and kissing balloon inflation was used in 67 (32.5%). The primary efficacy endpoint occurred in 27 (13.0%), with side branch (SB) occlusion in two (1.0%), SB pinching in 23 (11.1%), and complex SB rewiring in six (2.9%), and was most frequent in patients with lower body mass index or dyslipidemia. After 24.1±19.5 months, MACE were adjudicated in 23 (11.1%) subjects, with death in 10 (4.8%), MI in six (2.9%), and TVR in seven (3.4%), as well as stent thrombosis in one (0.5%). This study supports a wider adoption of the Bioss Lim C dedicated bifurcation device, thanks to the favorable acute results as well as long-term clinical outcomes, as well as its versatility for the stenting strategy provisionally or eventually adopted by operators.

Rationale and design of a prospective, open-label, randomized, multicentric clinical trial on the role of drug-coated balloons for bifurcation coronary lesions: the PRO-DAVID study

Background. Coronary bifurcation lesions (CBL) are associated with impaired outcome. The role of drug-coated balloons (DCB) in this setting has been only investigated in small studies so far. Aim. We here describe the design of PRO-DAVID study, aiming at investigating the clinical outcomes of a “provisional DCB” versus a "standard" approach (provisional or upfront two stent techniques) for the treatment of complex CBL. Methods and results. The PRO-DAVID trial is a prospective, open-label, randomized, multicentric clinical trial of the interventions with true CBL (Medina 1,0,1; 1,1,1; 0,1,1) of unprotected left main (LM), and non-left main (non-LM) CBL with affected significant side branche (SB). The study hypothesis is that a “provisional DCB approach” with PCI using first DCB in SB after optimal predilatation and then DES implantation in the main vessel will be non-inferior to standard bifurcation-PCI as per EBC recommendations. The calculated sample size is 602 patients in total, and allocation is 1:1. The primary study endpoint is a composite of cardiac death, target vessel MI, or clinically-driven target lesion revascularization (TLR) at 12 months, and patients will be followed up for up to 3 years. Implications. CBL management with stents only is associated with impaired outcome, and some preliminary data on the performance of DCB show their safety and efficacy in this setting. PRO DAVID study is an adequately powered randomized trial with clinical endpoints aimed to test DCB use in true CBL.

Side branch closure in patients undergoing coronary bifurcation stenting with or without side branch predilatation

Abstract Background Considerable progress in the treatment of coronary bifurcation lesions has been achieved. Side branch pre-dilatation (SPPD) is a technique that is generally not recommended by the latest guidelines and consensus statements. The main reason is the risk of side branch (SB) dissection or vessel closure. Aim The aim of the current study is to explore the rates of SB closure in patients undergoing bifurcation PCI with or without SB pre-dilatation. Methods All patients with coronary bifurcation lesions treated between 2012 and 2022 were included in the prospective registry. For the current analysis, only patients with stable or unstable angina were included, with follow-up of at least two years. Patients with STEMI and left main stenosis were excluded. Propensity Score Matching (PSM) was performed to equalize the effects of the following characteristics: age, sex, diabetes, smoking, hypertension, dyslipidemia, renal failure, cancer, COPD, atrial fibrillation, left ventricular ejection fraction, and SYNTAX score. SB closure was defined as SB ostial stenosis ≥99% with TIMI 0-1 flow. Results 832 patients from the registry covered the criteria for the current analysis. After PSM, 324 matched couples remained, and 648 patients were analyzed. The demographic characteristics of SBP(+) and SBP (-) were well balanced, with no differences between groups – age 68±10 years, 71% males, 40% smokers, 47% with diabetes, 26% with previous MI, 53% with previous PCI, 4% after CABG, 12% with peripheral arterial disease, 13% with COPD, 32% with renal failure, 23% AFib, LVEF 55±10%. Patient with SBP(+) wad more CTOs (17% vs. 9%, p=0.003), longer lesions (42±21mm vs. 36±20mm, p<0.001) and more severe SB stenoses (68%±25% vs. 41%±31%, p<0.001). Among true bifurcation stenoses (Medina xx1 – 63%, 410/648), 88% were predilated. SB closure was non-significantly different in groups with SBPD and SBnPD (3.6% vs. 2.2%, p=0.272). Acute SB closure after stenting occurred at similar rates in SBPD and SBnPD groups (3.6% vs. 2.7%, p=0.505), without difference in rates of MI if SB was closed or not (n=10/17, 59% vs. n=227/631, 36%, p=0.058). The rate of periprocedural MI was not significantly different between groups with and without SB closure – 52% vs. 34%, p=0.066. At the end of the procedure, only 7 SBs were closed, 2 in the SBPD group and 5 in the SBnPD group (p=0.461). Conclusions The rates of final SB closure were numerically lower (but not significantly different) when SBPD was performed. SB closure did not translate into worse clinical outcomes.

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.

“Main Vessel-Oriented” Treatment Strategy Versus “Open Side Branch” Treatment Strategy in Acute Coronary Syndrome Patients With Culprit Bifurcation Lesions

Percutaneous coronary intervention of bifurcation lesions is associated with an increased risk of complications in patients with acute coronary syndrome (ACS). The study aimed to evaluate the in-hospital outcomes of patients with ACS with culprit bifurcation lesions who were treated with either a "main vessel-oriented" (MVO) treatment strategy or an "open side branch" (OSB) treatment strategy. This retrospective study included 575 consecutive patients with ACS. "MVO" and "OSB" treatment strategies were defined as primary/urgent percutaneous coronary intervention procedures performed by either totally ignoring the side branch (SB) or trying to maintain both main vessel and SB open with thrombolysis in myocardial infarction 3 flow. Procedural success and major cardiac/cerebrovascular events during hospitalization were noted. MVO and OSB treatment strategies were performed on 384 and 191 patients, respectively. The procedural success rate was significantly higher in the OSB treatment strategy whereas major cardiac/cerebrovascular events rates were similar except for the contrast-induced nephropathy rate being slightly higher in OSB treatment strategy. Subgroup analysis revealed a significantly higher procedural success rate in OSB treatment strategy if the SB was located within the bifurcation core, especially in those where the diameter of SB was ≥2mm. In conclusion, our results suggest a better procedural result with SB protection attempts in patients with ACS with a culprit bifurcation lesion if the SB is originating within the bifurcation core and its diameter is ≥2mm. MVO treatment strategy may be preferred in most cases with minor SBs located distant to the bifurcation core because of the similar procedural success.

Drug-coated balloon combined with drug-eluting stent for the treatment of coronary bifurcation lesions: insights from the HYPER study.

True coronary bifurcation lesions (CBL) represent a challenging scenario for percutaneous coronary interventions (PCI), and are associated with a higher risk of target lesion failure (TLF), particularly when two stents are implanted. A hybrid strategy combining a drug-eluting stent (DES) in the main branch, and a drug-coated balloon in the side branch may improve outcomes by reducing the total stent length while maintaining an effective anti-prolipherative action. In this sub-study of the HYPER trial, 50 patients with true CBL were treated with a hybrid strategy: procedural success was 96%, one case of peri-procedural myocardial infarction and one case of TLF (in a DES-treated segment) at 1 year were reported. This study suggests that such a hybrid strategy may be a safe and effective option for true CBL PCI, and warrants additional investigations to compare outcomes with standard of care strategies.

Clinical Outcomes of Various Two Stent Bifurcation Techniques in Treating Coronary Bifurcation Lesions at Pakistan Institute of Medical Sciences (PIMS), Islamabad

Objective: To determine the clinical outcomes of different two stent bifurcation techniques in the treatment of coronary bifurcation lesions, taking this as a challenge presented at the Pakistan Institute of Medical Sciences (PIMS), Islamabad. Methods: This descriptive cross-sectional was done at the Cardiology Department, PIMS, Islamabad, from September 2017 to February 2018. Individuals aged 20–60 years with true bifurcation lesions (&gt; 50% stenosis diameter) in both parent/main vessel side branch ostia from lesions and with a diameter of &gt;2.5 mm via visual approximation, silent ischemia, un-stable or stable angina, and denovo coronary bifurcation lesions of either gender were included. For PCI of these lesions, a variety of methods have been developed, frequently involving the use of numerous balloons and the implantation of two or more stents, including the crush stent technique, the Cullotte stent technique, and the kissing stent technique to allow maximum apposition to the vascular wall with efficient drug delivery in situation of drug-eluting stents. Patients were observed for clinical outcomes like cardiac death, stent thrombosis, nonprocedural MI, and during operation complications like edge dissection and side branch closure, recurrent myocardial infarction (MI), unstable angina, and MACE. All the information was collected via a study proforma, and the analysis was done using SPSS version 20. Results: The study included 100 cases, with an average age of 40 years and a range of 20 to 60 years. Out of all 58 (58%) males and 42 (42%) females. The T-Stent Technique was used in 30% of the study population, the Crush Stenting approach was used in 18% of the cases, the Culotte stenting approach was done in 22% of the cases, and kissing stenting approach was done in 30% of the study subjects. Amongst all the procedures, the Kissing Stent Technique was most successful in treating coronary bifurcating lesions 93.3%. As per procedures, complications were found to be statistically significant (p = 0.011). Conclusions: As per the study conclusion, kissing stent technique has been observed to be the most successful and least complicated technique in treating coronary bifurcating lesions.

Intracoronary Electrocardiography-guided Strategy for the Treatment of Coronary Bifurcation Lesions

Introduction: Revascularization of bifurcation lesions remains an interventional challenge. Intracoronary electrocardiograms can predict the functional significance of side branch stenosis after bifurcation stenting. Aim: This study was aimed at evaluating the effects of an intracoronary ECG electrocardiography (icECG)-guided revascularization strategy, compared with the currently accepted standard of care, on the clinical outcomes of patients after coronary bifurcation stenting. Methods: Patients with coronary bifurcation lesions who underwent percutaneous revascularization were enrolled in a prospective all-comers’ registry. Clinical outcomes were compared between patients who underwent icECG-guided revascularization versus the current standard of care (SOC), provisional stenting. Results: A total of 768 patients were included in the analysis: 349 were treated with an icECG-guided strategy, and 419 received SOC. The overall all-cause death rate was 23.2%, and the cardiovascular death rate was 15.9%. Patients with icECG guidance had significantly lower all-cause mortality (20.3% vs. 25.5% for icECG vs. SOC, log-rank P = 0.006) and cardiovascular mortality (12.6% vs. 18.6% for icECG vs. SOC, log-rank P = 0.004). The decrease in mortality was most pronounced in patients with no increase or a moderate increase in troponin post-PCI, or with higher-than-normal baseline troponin concentrations. Conclusion: An icECG-guided strategy for coronary bifurcation PCI led to lower patient mortality than the provisional stenting strategy.

Percutaneous Coronary Intervention of bifurcation lesions: The proof is in the pudding!

Key Points Provisional stenting strategy is the most common technique for treatment of bifurcation lesion in the ‘real world' patients undergoing percutaneous coronary intervention. The technical success appears to be lower in provisional stent strategy compared to upfront two stent strategy due to worsening of the ostial side branch lesions after main branch stenting; following wire recrossing and side branch dilation/stent implantation stenting leads to equivalent procedural success and in hospital outcomes. Side branch access after main branch stenting is technically challenging and an algorithmic approach helps to achieve procedural success.

Impact of Clinical and Lesion Features on Outcomes After Percutaneous Coronary Intervention in Bifurcation Lesions.

Bifurcation percutaneous coronary intervention (PCI) is associated with higher risk of clinical events. This study aimed to determine clinical and lesion features that predict adverse outcomes, and to evaluate the differential prognostic impact of these features in patients undergoing PCI for bifurcation lesions. We analyzed 5,537 patients from the BIFURCAT (comBined Insights From the Unified RAIN and COBIS bifurcAtion regisTries) registry. The primary outcome was major adverse cardiac events (MACE) at 2-year follow-up; secondary outcomes included hard endpoints (all-cause death, myocardial infarction) and lesion-oriented clinical outcomes (LOCO) (target-vessel myocardial infarction, target lesion revascularization). The least absolute shrinkage andselection operator (LASSO) model was used for feature selection. During the 2-year follow-up period, MACE occurred in 492 patients (8.9%). The LASSO model identified 5clinical features (old age, chronic renal disease, diabetes mellitus, current smoking, and left ventricular dysfunction) and 4 lesion features (left main disease, proximal main branch disease, side branch disease, and a small main branch diameter) as significant features that predict MACE. A combination of all 9 features improved the predictive value for MACE compared with clinical and lesion features (area under the receiver-operating characteristics curve: 0.657 vs 0.636 vs 0.581; P< 0.001). For secondary endpoints, the clinical features had a higher impact than lesion features on hard endpoints, whereas lesion features had a higher impact than clinical features on LOCO. In bifurcation PCI, 9 features were associated with MACE. Clinical features were predominant predictors for hard endpoints, and lesion features were predominant for predicting LOCO. Clinical and lesion features have distinct values, and both should be considered in bifurcation PCI.

Provisional Technique for Bifurcation Left Main In-Stent Restenosis Lesion: A Case Report

Background: Percutaneous coronary intervention for bifurcation lesions remains challenging because of its complexity and the lack of trials to guide decision-making. It also comes with several debatable issues, including the requirement for kissing balloon inflation as the post-dilation produces. Case Illustration: A 64-year-old male with some coronary risk factors of hypertension, passive smoker, and family history of CAD presented with recurring exertional chest pain for the last 4 months. He was hospitalized to undergo DCA-Adhoc after the ECG stress test revealed a positive result. The coronary angiography revealed a 95% ISR in the osteal LAD and 20% ISR of the proximal LCx. Since the patient refused to undergo coronary bypass surgery, the team decided to perform catheter intervention to the LM bifurcation of LAD-LCx. The procedure begins with the insertion of IABP through the access of the left femoral artery. We performed a provisional approach with the main vessel stenting of LM-LAD. At the end of the procedure, we performed simultaneous kissing balloon inflation of LAD-LCx followed by POT in LM stent as the post-dilation produces. Discussion: When considering intervention on a bifurcation lesion, there are two general strategies i.e the more conservative or provisional technique that intent to only use one stent and the two-stent approach. The provisional technique is considered to offer advantages in terms of reducing procedure complexity, reducing fluoroscopic time, requiring less contrast volume, and reducing resource (stent) use compared by 2 stent strategy. Conclusion: Coronary bifurcation lesions are fairly frequent, and their management is associated with an increased risk of MACE, increased complexity, and prolonged treatment times.

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

Treatment Strategies for Coronary Bifurcation Lesions: Complexity and Risk

Treatment Strategies for Coronary Bifurcation Lesions: Complexity and Risk

New Insights into Intravascular Imaging of Coronary Bifurcation Lesions and Left Main Stenosis: What Have We Accomplished?

Coronary bifurcation lesions (CBL) are one of the most challenging lesions to treat in interventional cardiology. Intravascular imaging including intravascular ultrasound (IVUS) and optical coherence tomography (OCT) is paramount for the assessment of lesion characteristics and suboptimal stent results and to improve the outcome of percutaneous coronary intervention (PCI). After upgrading the use of IVUS and OCT by the American College of Cardiology/American Heart Association guidelines, their use has increased. Likewise, there has been significant improvement in image quality and the profile of system (ie, IVUS catheter size). The main indication for the use of IVUS includes: assessment of lesion characteristics, optimization of stent deployment, optimal stent expansion, exclusion of plaque burden &gt;50%, and edge dissection. Intravascular imaging plays a significant role in the assessment and treatment of left main (LM) coronary artery stenosis and CBL. In particular, the use of intravascular imaging for alleviating mechanical issues during stenting and managing stent thrombosis has significantly increased. Overall, a compelling body of evidence has shown that the use of IVUS or OCT during PCI leads to optimal stenting results and mitigates the risk of adverse cardiac events. However, to date, the American College of Cardiology/American Heart Association Guidelines have assigned a Class IIb recommendation for IVUS or OCT, while the European Society of Cardiology Guidelines upgraded it to the Class IIa recommendation. This review summarized the role of IVUS and OCT for the assessment of stenosis and stent optimization in patients with CBL and LM stenosis. In addition, we discuss new insights into the role of IVUS- and OCT-guided stenting in patients with CBL and LM stenosis provided by the ongoing randomized trials.

Clinical Outcomes of Percutaneous Coronary Intervention for Bifurcation Lesions According to Medina Classification.

BackgroundCoronary bifurcation lesions (CBLs) are frequently encountered in clinical practice and are associated with worse outcomes after percutaneous coronary intervention. However, there are limited data around the prognostic impact of different CBL distributions.Methods and ResultsAll CBL percutaneous coronary intervention procedures from the prospective e‐Ultimaster (Prospective, Single‐Arm, Multi Centre Observations Ultimaster Des Registry) multicenter international registry were analyzed according to CBL distribution as defined by the Medina classification. Cox proportional hazards models were used to compare the hazard ratio (HR) of the primary outcome, 1‐year target lesion failure (composite of cardiac death, target vessel–related myocardial infarction, and clinically driven target lesion revascularization), and its individual components between Medina subtypes using Medina 1.0.0 as the reference category. A total of 4003 CBL procedures were included. The most prevalent Medina subtypes were 1.1.1 (35.5%) and 1.1.0 (26.8%), whereas the least prevalent was 0.0.1 (3.5%). Overall, there were no significant differences in patient and procedural characteristics among Medina subtypes. Only Medina 1.1.1 and 0.0.1 subtypes were associated with increased target lesion failure (HR, 2.6 [95% CI, 1.3–5.5] and HR, 4.0 [95% CI, 1.6–9.0], respectively) at 1 year, compared with Medina 1.0.0, prompted by clinically driven target lesion revascularization (HR, 3.1 [95% CI, 1.1–8.6] and HR, 4.6 [95% CI, 1.3–16.0], respectively) as well as cardiac death in Medina 0.0.1 (HR, 4.7 [95% CI, 1.0–21.6]). No differences in secondary outcomes were observed between Medina subtypes.ConclusionsIn a large multicenter registry analysis of coronary bifurcation percutaneous coronary intervention procedures, we demonstrate prognostic differences in 1‐year outcomes between different CBL distributions, with Medina 1.1.1 and 0.0.1 subtypes associated with an increased risk of target lesion failure.

Treatment of coronary bifurcation lesions, part I: implanting the first stent in the provisional pathway. The 16th expert consensus document of the European Bifurcation Club.

Stepwise layered provisional stenting (PS) is the most commonly used strategy to treat coronary bifurcation lesions (CBL). The term 'stepwise layered' emphasises the versatility of this approach that allows the adjustment of the procedure plan according to the CBL complexity, starting with stent implantation in one branch and implantation of a second stent in the other branch only when required. A series of refinements have been implemented over the years to facilitate the achievement of predictable procedural results using this approach. However, despite its simplicity and versatility, operators using this technique require full knowledge of the pitfalls of each procedural step. Part I of this 16th European Bifurcation Club consensus paper provides a detailed step-by-step overview of the pitfalls and technical troubleshooting during the implantation of the first stent using the PS strategy for the treatment of CBL.

Treatment of coronary bifurcation lesions, part II: implanting two stents. The 16th expert consensus document of the European Bifurcation Club.

The European Bifurcation Club (EBC) supports a continuous review of the field of coronary artery bifurcation interventions and aims to facilitate a scientific discussion and an exchange of ideas on the management of bifurcation disease. The recent focus of meetings and consensus statements has been on the technical issues in bifurcation stenting, recognising that the final result of a bifurcation procedure and the long-term outcome for our patients are strongly influenced by factors, including preprocedural strategy, stenting technique selection, performance of optimal procedural steps, the ability to identify and correct complications and finally, and most important, the overall performance of the operator. Continuous refinement of bifurcation stenting techniques and the promotion of education and training in bifurcation stenting techniques represent a major clinical need. Accordingly, the consensus from the latest EBC meeting in Brussels, October 2021, was to promote education and training in bifurcation stenting based on the EBC principle. Part II of this 16th EBC consensus document aims to provide a step-by-step overview of the pitfalls and technical troubleshooting during the implantation of the second stent either in the provisional stenting (PS) strategy or in upfront 2-stent techniques (e.g., 2-stent PS pathway and double kissing crush stenting). Finally, a detailed overview and discussion of the numerous modalities available to provide continuous education and technical training in bifurcation stenting techniques are discussed, with consideration of their future application in enhancing training and practice in coronary bifurcation lesion treatment.

Percutaneous coronary intervention of bifurcation lesions.

Bifurcation coronary artery disease is common as the development of atherosclerosis is facilitated by altered endothelial shear stress. Multiple anatomical and physiological factors need to be considered when treating bifurcation lesions. To achieve optimal results, various stenting techniques have been developed, each with benefits and limitations. In this state-of-the-art review we describe technically important characteristics of bifurcation lesions and summarise the evidence supporting contemporary bifurcation techniques.

Prediction of All-Cause Mortality Following Percutaneous Coronary Intervention in Bifurcation Lesions Using Machine Learning Algorithms.

Stratifying prognosis following coronary bifurcation percutaneous coronary intervention (PCI) is an unmet clinical need that may be fulfilled through the adoption of machine learning (ML) algorithms to refine outcome predictions. We sought to develop an ML-based risk stratification model built on clinical, anatomical, and procedural features to predict all-cause mortality following contemporary bifurcation PCI. Multiple ML models to predict all-cause mortality were tested on a cohort of 2393 patients (training, n = 1795; internal validation, n = 598) undergoing bifurcation PCI with contemporary stents from the real-world RAIN registry. Twenty-five commonly available patient-/lesion-related features were selected to train ML models. The best model was validated in an external cohort of 1701 patients undergoing bifurcation PCI from the DUTCH PEERS and BIO-RESORT trial cohorts. At ROC curves, the AUC for the prediction of 2-year mortality was 0.79 (0.74–0.83) in the overall population, 0.74 (0.62–0.85) at internal validation and 0.71 (0.62–0.79) at external validation. Performance at risk ranking analysis, k-center cross-validation, and continual learning confirmed the generalizability of the models, also available as an online interface. The RAIN-ML prediction model represents the first tool combining clinical, anatomical, and procedural features to predict all-cause mortality among patients undergoing contemporary bifurcation PCI with reliable performance.

Simple Stenting Strategy with or without Branch Ostial Optimization Technique for Treatment of Coronary Bifurcation Lesions

Background: A simple stenting strategy with provisional side-branch (SB) stenting or crossover stenting has been recommended as the default approach for most coronary bifurcation lesions (CBLs). The proximal optimization technique (POT) and POT-associated techniques (POTAs) were introduced to optimize the ostium of SB. However, these techniques are unable to remove the jailed struts or completely diminish vessel damage. In this study we developed a novel branch ostial optimization technique (BOOT) and assessed its efficacy and safety by a propensity score matching comparison (PSM) with POT-associated techniques (POTA). Methods: From June 2016 to March 2018, a total of 203 consecutive patients with true CBLs were treated with BOOT (50 patients) or POTA stenting (153 patients). We performed PSM to correct for confounders from clinical and lesion characteristics. The primary endpoint was cumulative major adverse cardiac events (MACE) at 12 months including cardiac death, non-fatal myocardial infarction, and target vessel/lesion revascularization (TVR/TLR) or target vessel/lesion thrombosis (ST). Results: After PSM, there were 43 patients in each group. Follow-up coronary angiography was performed in 77 (89.5%) patients. At 12 months, the angiographic restenosis rate was significantly different between the BOOT group and the POTA group after PSM (proximal main branch: 20.01 ± 11.33% vs. 26.81 ± 14.02%, p = 0.003; distal main branch: 18.07 ± 3.71% vs. 23.44 ± 10.78%, p = 0.006; side branch: 23.53 ± 10.12% vs. 39.01 ± 10.29%, p &lt; 0.001, respectively). The incidence of MACE at 12 months was not different between the BOOT group before PSM (8.0% vs. 11.8%, p = 0.604), but less frequent after PSM (4.7% vs. 23.3%, p = 0.026) when compared with the POTA group, mainly due to TVR/TLR (2.3% vs. 20.9%, p = 0.015). Conclusions: In patients with CBLs, BOOT is feasible for optimization of the SB ostium and may be superior to POTAs in terms of the angiographic measurements and long-term clinical outcomes at 12 months follow-up.