True Coronary Bifurcation Lesions Research Articles

Clinical Outcomes of Double-Kissing Crush or Double-Kissing Culotte in Nonleft Main Bifurcation Lesions: The ROUTE Trial.

Double-kissing (DK) crush and DK culotte are the recommended 2-stent strategies in true coronary bifurcation lesions. However, it is a matter of curiosity about which of the DK crush and DK culotte stenting techniques will have superior results. We aimed to compare the clinical outcomes of DK crush and DK culotte stenting in nonleft main coronary artery bifurcation. Consecutive patients who received DK crush or DK culotte technique for de novo true nonleft main coronary artery bifurcation lesion were categorized according to which treatment they received. The primary end point of the study was target lesion failure as a composite end point of target lesion revascularization, target vessel myocardial infarction, and cardiac death. Secondary end points were all-cause death and definite stent thrombosis. A total of 202 patients were categorized as DK crush (101 patients) or DK culotte (101 patients) techniques. The target lesion failure had occurred frequently in the DK crush (10.9%) compared with the DK culotte (3.0%; P=0.028) that was mainly driven by increased target lesion revascularization (9.9% in the DK crush versus 3.0% in the DK culotte; P=0.045). The number of patients with target vessel myocardial infarction (3.0% in the DK crush versus 2.0% in the DK culotte; P=0.651) and cardiac death (1.0% in the DK crush versus 0.0% in the DK culotte; P=0.315) was higher in the DK crush. There were no differences in terms of definite stent thrombosis and all-cause death between groups. In the present analysis, DK culotte was associated with lower 1-year target lesion failure rates compared with DK crush in true nonleft main coronary artery bifurcations. URL: https://www.clinicaltrials.gov; Unique identifier: NCT04789161.

Drug-Coated Balloon Angioplasty of the Side Branch During Provisional Stenting: TheMulticenter Randomized DCB-BIF Trial.

Side branch stenting is often required during provisional stenting, leading to suboptimal results. Drug-coated balloons (DCB) for the compromised side branch have emerged as an attractive strategy. However, the benefit of DCB for coronary bifurcations remains unclear. This study aimed to investigate whether DCB, compared with a noncompliant balloon (NCB), for the pinched side branch improves the outcomes of provisional stenting in patients with simple, true coronary bifurcations. In this multicenter, randomized controlled trial, patients with true coronary bifurcations who had side branch diameter stenosis of≥70% after main vessel stenting at 22 centers in China, Indonesia, Italy, and Korea were randomly assigned to either DCB or NCB intervention. The primary endpoint was major adverse cardiac events, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target-lesion revascularization at the 1-year follow-up. Between September 8, 2020, and June 2, 2023, 784 patients with true coronary bifurcation lesions undergoing main vessel stenting and having a severely compromised side branch were randomly assigned to the DCB (n=391) or NCB (n=393) group. One-year follow-up was completed in all patients. The primary endpoint occurred in 28 patients in the DCB group and 49 patients in the NCB group (Kaplan-Meier rate: 7.2% vs 12.5%; HR: 0.56; 95%CI: 0.35-0.88; P=0.013), driven by a reduction in myocardial infarction. There were no significant differences between groups in procedural success, crossover to a 2-stent approach, all-cause death, revascularization, or stent thrombosis. In patients with simple and true coronary bifurcation lesions undergoing provisional stenting, main vessel stenting with a DCB for the compromised side branch resulted in a lower 1-year rate of the composite outcome compared with an NCB intervention for the side branch. The high rates of periprocedural myocardial infarction, which occurred early and did not lead to revascularization, are of unclear clinical significance.

TCT-568 Drug-Coated Balloon vs Noncompliant Balloon Angioplasties for Side Branch After Main Vessel Stenting for True Coronary Bifurcation Lesions: The Prospective, Multicenter, Randomized, Blinded DCB-BIF Trial

TCT-568 Drug-Coated Balloon vs Noncompliant Balloon Angioplasties for Side Branch After Main Vessel Stenting for True Coronary Bifurcation Lesions: The Prospective, Multicenter, Randomized, Blinded DCB-BIF Trial

Five-year outcomes of double kissing mini-culotte stenting vs. mini-culotte stenting using drug-eluting stents for the treatment of true coronary bifurcation lesions.

This study aimed to compare the clinical outcomes of double kissing mini-culotte (DKMC) stenting with those of mini-culotte (MC) stenting in treating patients with true coronary bifurcation lesions (CBLs) in the clinical real world. This retrospective observational cohort study included 180 consecutive patients with true CBLs (Medina type 1,1,1; 1,0,1; 0,1,1). All eligible patients underwent coronary angiography and percutaneous coronary intervention with two-stent techniques in our hospital; among them, 97 received DKMC treatment and 83 MC treatment. The primary clinical endpoints were the major adverse cardiovascular events (MACE), which included cardiac death, myocardial infarction, and target vessel/lesion revascularization (TVR/TLR). The secondary endpoints were stent thrombosis, in-stent restenosis, and individual components of MACE. Quantitative coronary angiography analysis (at 5 years) revealed that late lumen loss (0.25 ± 0.41 mm vs. 0.14 ± 0.32 mm, P = 0.032) and segmental diameter restenosis of the side branch (27.84 ± 12.34% vs. 19.23 ± 9.76%, P = 0.016) were lower in the DKMC treatment group than that in the MC treatment group. Notably, compared to that in the MC treatment group, the cumulative event rate of MACE at 5 years (22.8% vs. 8.3%, P = 0.007) and TVR/TLR (17.7% vs. 6.3%, P = 0.018) was higher in the DKMC treatment group, driven mainly by TVR/TLR. Especially, the DKMC group was related to a significant reduction in the primary and secondary endpoints in high-risk patients. DKMC treatment was associated with less late lumen loss and restenosis in the side branch and a lower rate of cumulative MACE and TVR/TLR. DKMC treatment is more effective for treating true CBLs than MC treatment; however, these findings warrant further confirmation through a randomized clinical trial.

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.

Bifurcation PCI with a hybrid strategy with drug- eluting balloons versus a stepwise provisional two- stent strategy: Rationale and design of the hybrid DEB study

The Hybrid DEB study is a prospective, multicenter, randomized controlled trial investigating noninferiority of a hybrid DEB approach, using a combination of a drug-eluting stent (DES) in the main vessel and DEB in the side branch, compared to stepwise provisional two-stent strategy in patients with true bifurcation lesions. A total of 500 patients with de novo true coronary bifurcation lesions, treated with a stepwise provisional approach and an unsatisfactory result of the side branch after main vessel stenting (≥ 70% stenosis and/or < thrombolysis in myocardial infarction III flow), will be randomized in a 1:1 ratio to receive either treatment with a DEB or with a DES in the side branch. The primary endpoint is a composite endpoint of the occurrence of all-cause death, periprocedural or spontaneous myocardial infarction and/or target vessel revascularization at the anticipated median 2-year follow-up. The Hybrid DEB study will compare in a multicenter, randomized fashion a hybrid DEB approach with a stepwise provisional two-stent strategy in patients with true bifurcation lesions. ClinicalTrials.gov no. NCT05731687.

The COBRA II (COmplex Bifurcation lesions: RAndomized comparison of a fully bioresorbable modified-T stenting strategy versus bifurcation reconstruction with a dedicated self-expanding stent in combination with bioresorbable scaffolds) study: Final 5-year follow-up

BackgroundIn order to advocate further research in bioresorbable scaffold (BVS) technology we report the final 5-year outcomes of the COBRA II study, the only randomized controlled trial (RCT) performed to investigate the safety, feasibility, and performance of Absorb BVS (Abbott Vascular) in true coronary bifurcations. MethodsCOBRA II was a prospective single-center RCT. Fifteen patients with true coronary bifurcation lesions were randomized to bifurcation treatment with self-expanding biolimus-eluting Axxess bifurcation device (Biosensors International) combined with additional bioresorbable everolimus-eluting Absorb BVS in the bifurcation branches on (Axxess group) or to 2-stent mod-T stenting technique with Absorb BVS (mod-T group). Optical coherence tomography was performed post-procedure and at 30-months. The primary endpoint was change in minimal luminal area (MLA) on OCT from baseline to 30-months. ResultsFifteen patients with coronary bifurcation lesions were randomized to the Axxess group (n = 8) or Modified-T group (n = 7). At 30 months, MLAs were significantly smaller than post-procedure in the majority of bifurcation segments treated with BVS due to neointima formation, while MLAs in the proximal Axxess segment remained stable (primary endpoint).Five-year clinical follow-up was available for all patients. Only 1 major adverse cardiac event occurred; a patient underwent target lesion revascularization at 30 months in the Axxess group. There were no cases of cardiac death, spontaneous MI, or stent/scaffold thrombosis. ConclusionsIn this small RCT bifurcation study, BVS luminal dimensions were significantly smaller at 30 months, with acute strut discontinuities and late Intraluminal dismantling frequently observed, although acceptable clinical outcomes were noted at 5 years.

Clinical prognostic value of a novel quantitative flow ratio from a single projection in patients with coronary bifurcation lesions treated with the provisional approach.

A novel quantitative flow ratio (μQFR) for bifurcated coronary vessels, derived from a single projection, has been recently reported. Provisional stenting is effective for most bifurcation lesions. However, the clinical value of the side branch (SB) μQFR in patients with coronary bifurcation lesions undergoing provisional stenting remains unclear. This study aims to determine the clinical predictive value of the SB μQFR after provisional stenting in patients with coronary bifurcation lesions. Between June 2015 and May 2018, 288 patients with true coronary bifurcation lesions who underwent a provisional approach without SB treatment (including predilation, kissing balloon inflation or stenting) were classified by an SB μQFR <0.8 (n=65) and ≥0.8 (n=223) groups. The primary endpoint was the three-year composite of target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (TVMI), and revascularisation (TVR). Three years after the procedures, there were 43 (14.9%) TVFs, with 19 (29.2%) in the SB μQFR <0.8 and 24 (10.8%) in the SB μQFR ≥0.8 groups (adjusted hazard ratio [HR] 2.45, 95% confidence interval [CI] 1.39-5.54; p=0.003), mainly driven by increased TVMI (16.9% vs 5.4%, adjusted HR 3.29, 95% CI: 1.15-6.09; p=0.030) and TVR (15.4% vs 2.2%, adjusted HR 6.39, 95% CI: 2.04-13.48; p=0.007). Baseline diameter stenosis at the ostial SB and SB lesion length were the two predictors of an SB μQFR <0.8 immediately after stenting the main vessel, whereas previous percutaneous coronary intervention and an SB μQFR <0.8 were the two independent factors of 3-year TVF. An SB μQFR <0.8 immediately after the provisional approach is strongly associated with clinical events. Further randomised studies with large patient populations are warranted.

Stepwise provisional versus systematic culotte for stenting of true coronary bifurcation lesions: five-year follow-up of the multicentre randomised EBC TWO Trial.

The multicentre European Bifurcation Club Trial (EBC TWO) showed no significant differences in 12-month clinical outcomes between patients randomised to a provisional stenting strategy or systematic culotte stenting in non-left maintrue bifurcations. This study aimed to investigate the 5-year clinical results of the EBC TWO Trial. A total of 200 patients undergoing stent implantation for non-left main bifurcation lesions were recruited into EBC TWO. Inclusion criteria required a side branch diameter ≥2.5 mm and side branch lesion length >5 mm. Five-year follow-up was completed for 197 patients. The primary endpoint was the composite of all-cause mortality, myocardial infarction, or target vessel revascularisation. The mean side branch stent diameter was 2.7±0.3 mm and mean side branch lesion length was 10.3±7.2 mm. At 5-year follow-up, the primary endpoint occurred in 18.4% of provisional and 23.7% of systematic culotte patients (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.41-1.38). No significant differences were identified individually for all-cause mortality (7.8% vs 7.2%, HR 1.11, 95% CI: 0.40-3.05), myocardial infarction (8.7% vs 13.4%, HR 0.64, 95% CI: 0.27-1.50) or target vessel revascularisation (6.8% vs 9.3%, HR 1.12, 95% CI: 0.37-3.34). Stent thrombosis rates were also similar (1.9% vs 3.1%, HR 0.63, 95% CI: 0.11-3.75). There was no significant interaction between the extent of side branch disease and the primary outcome (p=0.34). In large non-left main true bifurcation lesions, the use of a systematic culotte strategy showed no benefit over provisional stenting for the composite outcome of all-cause mortality, myocardial infarction, or target vessel revascularisation at 5 years. The stepwise provisional approach may be considered preferable for the majority of true coronary bifurcation lesions. gov: NCT01560455.

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.

Safety and Efficacy of a Hybrid Approach Combining a Paclitaxel-Coated Balloon With a New Generation Drug-Eluting Stent in Patients With De Novo True Coronary Bifurcation Lesions

BackgroundThe use of drug-coated balloon in the management of true bifurcation lesions appears to be an attractive option to reduce the rate of stent thrombosis and restenosis particularly at the level of the side branch ostium. We aim to assess the safety and the efficacy of a hybrid approach combining a drug-eluting stent in the main branch and a drug-coated balloon to treat the side branch ostium in patients with de novo true bifurcation. MethodsFrom September 2020 to March 2022, 45 patients with a de novo true bifurcation lesion Medina (1.1.1) or Medina (0.1.1) were enrolled. All patients underwent a percutaneous coronary intervention with the hybrid approach. Clinical assessment with functional stress imaging test was scheduled at 6 months. In case of documented ischemia, coronary angiography was performed. The primary endpoint was the composite of target lesion failure at 6 months including cardiac death, target vessel MI or ischemia-driven target lesion revascularization. The secondary endpoints were technical success, defined by performing the percutaneous coronary intervention without an additional drug-eluting stent at the level of the side branch ostium, and clinical success, defined by a technical success associated with the absence of severe complications during in-hospital phase. ResultsThe immediate results show a technical success of the procedure in the majority of cases (88.9 %) with a low rate of bailout side branch stenting (11.1 %). The clinical success was obtained in 86.7 % and only one patient experienced a severe in-hospital complication. A side branch ostial lesion length > 10 mm was the only independent predictor of clinical failure of the procedure (OR 12.49, 95 % CI 1.17–133.6; p = 0.037). At 6 months, the TLF was low and occurred in 1 patient (2.2 %). No cardiac death was observed. No TVMI was observed. Importantly, at 6 months, no side branch thrombosis was observed. ConclusionThe use of a hybrid approach combining a drug-eluting stent in the main branch and a drug-coated balloon in the side branch to treat true bifurcation lesions appears to be safe and efficient with few immediate complications and with satisfactory results at mid-term follow up.

Long-term outcomes of drug-eluting balloons for treatment of side branches in patients with true coronary bifurcation lesions

Background: Bifurcation treatments make up ca. 15–20% of coronary interventions. Despite the use of drug-eluting stents, the management of bifurcation lesions, especially with side branches involved, remains a challenge.Objective: To evaluate long-term clinical and angiographic outcomes after using a paclitaxel-coated balloon for the treatment of side branches in patients with true bifurcation lesions.Methods: Eighty patients with coronary artery disease were enrolled after true bifurcation lesion stenting. All patients were randomized at the 1:1 ratio to the group of main branches stenting followed by the dilatation of side branches with drug-eluting balloons and provisional stenting group.Results: Long-term results were analyzed after 12 months. The most common bifurcation lesion involved the left anterior descending artery and diagonal branch (57.5%). Late lumen loss in the side branch (0.51 ± 0.22 vs 0.33 ± 0.24 mm) and in both the bifurcation branches (main branch + side branch) (1.06 ± 0.29 vs 0.79 ± 0.27 mm) was significantly higher in the patients after provisional stenting.Overall postoperative incidence of major adverse cardiovascular events was 17.5% and 7.5% (p = 0.31) in the provisional stenting and drug coated balloon groups, respectively. Patients with drug-eluting balloons for the treatment of side branches had a more pronounced decrease in angina symptoms after 12 months. Multivariate analysis showed that diabetes mellitus (OR: 10.9) and glomerular filtration rate (OR: 0.95) were independent predictors of major adverse cardiovascular events in bifurcation interventions.Conclusion: Drug-eluting balloons for the dilatation of side branches after the stenting of main branches are superior to provisional stenting in terms of the late lumen loss. Received 31 August 2022. Revised 17 November 2022. Accepted 18 November 2022. Funding: The study did not have sponsorship. Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsConception and study design: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. KrestyaninovData collection and analysis: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. GorgulkoStatistical analysis: T.K. Eraliev, D.A. Khelimskii, A.G. BadoianDrafting the article: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. GorgulkoCritical revision of the article: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. KrestyaninovFinal approval of the version to be published: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. Gorgulko

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.

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

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). 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). 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 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). 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.

Percutaneous coronary intervention for true bifurcation lesions: a single-center experience including the setting of acute coronary syndromes

Abstract Funding Acknowledgements Type of funding sources: None. Background Percutaneous coronary intervention (PCI) for true coronary bifurcation lesions is challenging. Purpose To describe procedural and clinical outcomes of true bifurcation PCI. Methods Single-center retrospective study of consecutive patients (pts) submitted to PCI for true bifurcation lesions (06/2018-06/2020). MACE comprised death, myocardial infarction (MI), stroke, restenosis and reintervention. Results During the study period, 1678 PCI were performed, of which 7% were for true bifurcation lesions (Medina x,x,1). 118 pts (mean age 66.4 ± 11.0 years; 74.6% male; 32.2% diabetic; mean left ventricular ejection fraction 49.8 ± 8.4%) were included. Most pts (64.7%) were treated in the setting of an acute coronary syndrome (ACS): 26.7% ST-elevation MI, 31.9% non-ST-elevation MI, 6.0% unstable angina. 35.3% were treated for a chronic coronary syndrome. 24.8% of pts presented with 3-vessel disease and 11.1% had a left main (LM) lesion. The most frequently diseased main branch was the left anterior descending artery: 21.2% (68), followed by the left circumflex: 17.8% (21), right coronary artery: 12.7% (15) and LM: 11.9% (14). In terms of bifurcation classification, lesions were mainly Medina 1,1,1 (71.2%), followed by 0,1,1 (13.6%); 1,0,1 (9.2%) and 0,0,1 (5.9%). PCI was mainly performed via radial artery (73.7%). Mean number of stents: 1.4 ± 0.6. Lesions were predominantly treated with single stenting technique (80.3%). Double-stenting was used in 23 (19.7%) pts: TAP was the most used technique (10), followed by culotte (3), crush (2), double kissing crush (2) and T-stent (1). Proximal optimization technique and kissing balloon inflation were performed in 38.1% and 44.9% of cases, respectively. Rotational atherectomy was used in 10.4%. Ventricular support devices were used in 3 pts (1 Impella, 2 intra-aortic balloon pump). Intracoronary imaging was used in 13 pts: intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in 8 and 5 pts, respectively; its use was more frequent in cases of LM PCI (p=.002). OCT was associated with higher contrast doses (350 vs 224 ml, p&amp;lt;.001), with no increase in acute kidney injury incidence (p=.413). Fluoroscopic time (p=.684) and radiation dose (p=.916) did not differ. Side branch occlusion occurred in 5 pts and iatrogenic coronary dissection in 7 pts. At a mean follow-up time of 17.3 ± 8.1 months, MACE and mortality rates were 13.3% and 6.9%. MACE occurred more frequently in pts with LM lesion (p&amp;lt;.001) and less often in cases where complete revascularization was achieved (p=.006). Conclusions True bifurcations represented a relatively small percentage of PCI lesions and were mainly performed in ACS setting. In line with literature, single stenting was the most used technique. MACE rate was globally low and was decreased by complete revascularization. Still, LM bifurcation PCI was associated with increased MACE.

Rationale and design for comparison of non-compliant balloon with drug-coating balloon angioplasty for side branch after provisional stenting for patients with true coronary bifurcation lesions: a prospective, multicentre and randomised DCB-BIF trial

IntroductionProvisional stenting using drug-eluting stent is effective for simple coronary bifurcation lesions. Kissing balloon inflation using conventional non-compliant balloon is the primary treatment of side branch (SB) after main vessel...

Double kissing – crush technique to treat coronary bifurcation lesions: analysis of success rate, procedural times and device usage

Abstract Background The Double Kissing Crush (“DK Crush”) technique is one of the recommended planned 2-stent techniques to treat true coronary bifurcation lesions (Medina 1–1-1, Medina 0–1-1). While some trials demonstrated superiority to other techniques, DK Crush requires a sequence of specific and potentially technically challenging steps. No data exists on the procedural difficulty of the various steps required for DK Crush. We therefore analyzed procedural times and device usage in a systematic fashion. Methods and results 54 patients (42 male, mean age 67±12 years) intended for treatment with DK Crush were enrolled. Detailed procedural characteristics including exact times and device usage for each step of DK Crush were prospectively measured and analyzed. DK Crush was successful in 48/54 patients (89%). In two patients stenting technique was changed to T- or TAP-stenting due to anatomical reasons at the moment of positioning of the SB stent. In one patient no balloon could cross the lesion and in another the procedure had to be modified due to coronary perforation directly after pre-dilatation. True failure of DK Crush was observed in two cases: In one case, the first rewiring of the SB, in the other, placement of a balloon for first kissing balloon (KB) maneuver in the SB was not possible. These 6 patients were excluded from further analysis. Median times for each step were: 1:21min (IQR 0:52min-1:50min) for wiring SB, 1:18min (IQR 0:47min-1:42min) for wiring MV, 1:30min (IQR 0:54min-2:15min) for stent placement in the SB, 0:40min (IQR 0:29min-1:21min) for balloon placement in the MV. First rewiring of the SB after SB stent crush required 1:30min (IQR 0:37min-2:05min), 1st KB placement in the SB took 1:42min (IQR 1:00min-3:13min) and 1st KB placement in the MV required 0:45min (IQR 0:27min-1:19min). Stent placement in the MV required 1:34min (IQR 1:09min-2:40min) and 2nd rewiring of the SB 1:21min (IQR 0:55min-2:04min), 2nd KB placement of the SB 2:08min (IQR 1:01min-3:36min) and 2nd KB placement of the MV 0:50min (IQR 0:34min-1:01min). Final POT was performed in all cases. Median total procedure time was 52:35 min (IQR 00:42:54h-1:01:37h). Additional devices were needed in 10% (3x1, 2x2 balloons) for stent placement in the SB; in 46% (20x1, 1x4 wires) for the first rewiring of the SB and in 49% (20x1, 3x2 balloons) for 1st KB placement in the SB. The 2nd rewiring of the SB required additional wires in 32% (13x1, 2x2 wires) and 54% of the patients required additional balloons for the 2nd KB placement in the SB (20x1, 2x2, 1x3, 2x5 balloons). Final TIMI flow was III in 97.9%. Complications occurred in 6% (n=3), each showing coronary dissection with TIMI III flow in 2 patients and TIMI I flow in 1 patient after placement of additional stents. Conclusion DKMC has a high success rate but is a time-consuming and material-intensive technique. The placement of the 2nd KB in the SB requires most of the procedural time and resources. Funding Acknowledgement Type of funding sources: None.

Single stenting versus double stenting technique in true bifurcation coronary lesions

Abstract Introduction The ideal treatment technique for coronary bifurcation lesions remains unknown. Although single-stenting strategy has been recommended by default, little evidence exists regarding clinical outcomes between single versus double-stenting in current practice. Purpose To compare procedural details and clinical outcomes between single vs double-stenting techniques in true bifurcation coronary lesions. Methods Retrospective study of all patients (pts) referred for percutaneous coronary intervention (PCI) of true bifurcation lesions between June 2018 and June 2020. Only Medina X,X,1 lesions were included. Pts were split in 2 groups: group 1 (single-stenting) and group 2 (double-stenting). Procedural details and clinical outcomes were assessed. Acute and long-term adverse events included procedural complications (a composite outcome of side branch occlusion, coronary iatrogenic dissection and type 4 acute myocardial infarction (AMI)) and a composite of cardiovascular death, AMI, stroke, re-restenosis and reintervention, respectively. Results A total of 118 pts were included, 74,6% male, mean age of 66,4±11 years. Ninety-five pts (80,5%) were treated with single-stenting (G1) and 23 pts (19,5%) with double-stenting technique (G2). Both groups were well matched regarding baseline characteristics and clinical presentation. T and protrusion (TAP) and minicrush were the most frequent double-stenting techniques (43,5% and 21,7%). G2 lesions mainly involved the left main (LM) and proximal left anterior descendent artery (LAD) (52,2%) and in G1 mid LAD (34,7%). LM lesions were more common in G2 (26,1% vs 8,4%; p=0,030). G1 had more lesions Medina 1,1,1 (75,8% vs 52,2%; p=0,025) and less Medina 0,1,1 (9,5% vs 30,4%; p=0,015). Proximal optimization technique and kissing balloon occurred more in G2 (p&amp;lt;0,05). G2 had more intravascular ultrasound guided PCI (p=0,046). Femoral access, heparin, contrast and radiation dose, and fluoroscopy time were higher in G2 (p&amp;lt;0,05). Acute adverse composite outcome was similar in both groups (G1 13% vs G2 14,3%; p=0,855). Median follow-up was similar (G1 16,8±7,9 and G2 19,7±8,8 months; p=0,127). G1 had less occurrence of long-term adverse composite outcome (7,4% vs 26,3%; p=0,032). Excluding interventions in LM, G2 had more significant incidence of acute events (20% vs 2,6%; p=0,028), and higher rate of long-term adverse events (20% vs 4,2%; p=0,056). In interventions of the LM only, no differences were noticed in acute and long-term composite events between groups. Conclusions Double-stenting techniques in true coronary bifurcation lesions included more often LM lesions and were complex procedures requiring frequently intracoronary imaging. Although acute adverse events were similar to those of single-stenting, long-term adverse outcomes were more frequent in double-stent group, except for LM lesions. Funding Acknowledgement Type of funding sources: None.

Association of peri-procedural myocardial infarction with mortality after stenting true coronary bifurcation lesions: A pooled individual participant data analysis from four randomized controlled trials.

Five definitions of peri-procedural myocardial infarction (PMI) following percutaneous coronary intervention (PCI) are used in clinical trials; their clinical relevance in coronary bifurcation stenting remains unclear. To understand the correlation between PMI and mortality in bifurcation lesions from the DKCRUSH studies. PMI was defined using serum creatine kinase-myocardial band (CK-MB) values within 48 h of PCI according to the SYNTAX, Fourth Universal Definition of MI (4th UDMI), ISCHEMIA, SCAI, and EXCEL definitions. Overall, 1300 patients with both CK and CK-MB measurements pre- and post-stenting were evaluated. The association of each PMI type and all-cause death or cardiac death at a median of 5.58 years of follow-up was analyzed using Cox regression. In total, 56 (4.3%) patients had PMI. According to SYNTAX, 4th UDMI or ISCHEMIA, SCAI, and EXCEL definitions, PMI occurred in 21 (1.6%), 56 (4.3%), 29 (2.2%), and 32 (2.5%) patients, respectively. All definitions were significantly correlated with unadjusted mortality at the end of follow-up but not at 30 days or 1-year after stenting. PMI using SYNTAX, SCAI, and EXCEL definitions rather than 4th UDMI definition was strongly associated with adjusted all-cause death. By adjusted analysis, PMI according to 4th UDMI, SCAI, and EXCEL definitions but not SYNTAX definition was positively correlated with cardiac death at a median of 5.58 years of follow-up. CK-MB ≥ 5 x UNL strongly enhanced the correlation of CK-MB values with mortality. PMI rate varies with the definition following stenting for bifurcation lesions. PMI defined by SCAI and EXCEL definitions is strongly correlates with adjusted all-cause and cardiac death.