Complex Bifurcation Lesions Research Articles

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.

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.

A retrospective study on real world, 2-stent left main bifurcation PCI using DK crush technique with IVUS guidance - a single center experience

Abstract Objectives The aim of this study is to investigate clinical outcome of the IVUS guided 2-stent bifurcation strategy using DK crush technique performed in a complex Left Main (LM) bifurcation lesions defined according to DEFINITION study in our local setting. We seek to assess the composite endpoint of target vessel failure (TVF) at 9-12 months. Methods All patients underwent IVUS guided 2-stent Bifurcation PCI with DK crush technique for complex LM bifurcation lesions defined by the DEFINITION criteria performed in a heart institute from 1.1.2019 to 31.7.2023 were included..Patient baseline characteristics, post-procedural and 12-months follow-up outcomes including cardiac death,myocardial infarction (MI),rate of target vessel failure (TVF),rate of stent thrombosis (ST) and major adverse coronary event (MACE) were analysed.Exclusion criteria are patients age &amp;lt;18 years and previous stenting in the target vessel Results A total of 50 patients were included in this analysis. Mean age was 64.3±9.1 years with predominant males (n= 38, 76%).Majority were hypertensive (n=37, 74%) and diabetes mellitus accounted for 32 (64%) cases.Patients with pre-existing coronary artery disease were 39 (78%) cases. 40% presented with history of recent myocardial infarction (MI), 12% had new onset angina and 6% had heart failure. Pre-existing chronic renal failure (18%) and history of CVA (2%). Among chronic renal failure cases, 50% had eGFR &amp;lt;50 during index procedure.Additionally, previous PCI was performed in 22 cases (44%) and 2 previous CABG cases included (4%).Majority of the cases were performed as staged elective procedure ( n=45, 90%) and others were indicated for ACS ( n=5, 10%). Radial approach was predominantly preferred with 25 cases (50%), where additional 5 cases (10%) were converted to femoral approach due to severe radial spasm. Among these 50 cases, 1 case required additional PCI to CTO LAD and mid LCX, while 7 cases (14%) had calcified lesions requiring scoring / cutting balloons and atherectomy device utilization for adequate lesion preparation prior to bifurcation stenting.All 50 patients received combination of both aspirin and a P2Y12 inhibitors for 12 months. Follow up done at at 30-day, 60-days and 1 year after the index procedure.Clinical follow-up were available in 46 (92%) patients only.4 cases were lost to follow up due to logistic reasons. At 1 year follow-up, cardiac death occurred in 5 (10.9%) patients, out of which 3 (6.5%) cases were cardiac related and 2 (4.4%) are non-cardiac. Major adverse cardiac events (MACE) and target vessel failure (TVF) occurred in total 4 (8.7%) cases, where 3 (6.5%) cases resulted in cardiac death and 1 (2.2%) case had MI and clinically driven target lesion revascularization. Conclusion Our experience demonstrates that IVUS guided, upfront 2-stent Bifurcation PCI using DK crush technique for complex bifurcation lesions is effective and safe with a low MACE and TLR rate at 1 year follow-up.

Long-term cardiovascular outcomes after mini-crush or T and minimal protrusion techniques in complex bifurcation lesions: the EVOLUTE-CRUSH III study.

Mini-crush (MC) and T-stenting and small protrusion (TAP) techniques are frequently used, but the long-term comparison of both techniques in patients with complex bifurcation lesions (CBLs) is still a debatable issue. This study sought to retrospectively evaluate the long-term outcomes of MC and TAP techniques in patients with CBLs. A total of 271 patients [male: 202 (78.9%), mean age: 58.90 ± 10.11 years] patients in whom complex bifurcation intervention was performed between 2014 and 2023 were involved. The primary endpoint was major cardiovascular events (MACE) as the combination of cardiac death, target vessel myocardial infarction, or clinically driven-target lesion revascularization. The Cox proportional hazard models were adjusted by the inverse probability weighting approach to reduce treatment selection bias. The initial management strategy was MC in 146 patients and TAP in 125 cases. MACE occurred in 52 patients (19.2%) during a mean follow-up period of 32.43 ± 16 months. The incidence of MACE (13 vs. 26.4%, P = 0.005) and major cardiovascular and cerebral events (15.1 vs. 28.8%, P = 0.006) were significantly lower in the MC group than in the TAP group. Additionally, the incidence of definite or probable stent thrombosis was numerically lower in the MC group compared with the TAP group but did not differ significantly (2.7 vs. 8%, P = 0.059). The long-term MACE was notably higher in the TAP group than the MC group [adjusted hazard ratio (inverse probability weighted): 1.936 (95% confidence interval: 1.053-3.561), P = 0.033]. In this study involving patients with CBLs, percutaneous coronary intervention with the MC technique had better long-term outcomes than the TAP technique.

Long-term outcomes following double kissing crush or mini-culotte stenting for complex coronary bifurcation lesions: the EVOLUTE-CRUSHIV study.

This study aimed to evaluate the long-term outcomes of double kissing crush stenting (DKC) and mini-culotte technique (MCT) in patients with complex bifurcation lesions. This retrospective study enrolled 236 patients who underwent percutaneous coronary intervention (PCI) for complex coronary bifurcation disease between January 2014 and November 2022. The primary endpoint was target lesion failure (TLF), defined as the combination of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (TLR). The secondary endpoint was major cardiovascular and cerebral events (MACCE) including all-cause death, MI, TLR, stroke, or stent thrombosis. The regression models were adjusted by applying the inverse probability weighted (IPW) approach to reduce treatment selection bias. The initial management strategy was DKC in 154 (65.3%) patients and MCT in 82(34.7%) patients (male: 194 [82.2%], mean age: 60.85 ± 10.86years). The SYNTAX scores were similar in both groups. The rates of long-term TLF and MACCE rates were 17.4% and 20%, respectively. The rate of TLF (26.8% vs. 12.3%, p = 0.005) was higher in patients treated with MCT than those treated with the DKC technique, mainly driven by more frequent TLR (15.9% vs. 7.1%, p = 0.035). The long-term TLF and MACCE rates were notably lower in the DKC group compared to the others: adjusted hazard ratio (HR; IPW): 0.407, p = 0.009 for TLF, and adjusted HR(IPW): 0.391 [95% CI: 0.209-0.730], p = 0.003 for MACCE. At long-term follow-up, the rates of TLF and MACCE were 17.4% and 20%, respectively. However, long-term TLF was significantly higher in patients treated with MCT than those treated with the DKC technique, primarily due to amore frequent occurrence of clinically driven TLR.

Comparison of long-term outcomes of double kissing crush versus T and minimal protrusion techniques in complex bifurcation lesions: The EVOLUTE-CRUSH II registry.

Double kissing (DK)-crush and T-stenting and small protrusion (TAP) techniques are gaining popularity, but the comparison for both techniques is still lacking. This study sought to retrospectively evaluate the long-term outcomes of DK-crush and TAP techniques in patients with complex bifurcation lesions. A total of 255 (male: 205 [80.3%], mean age: 59.56 ± 10.13 years) patients who underwent coronary bifurcation intervention at a single-center between January 2014 and May 2021 were included. Angiographic features, procedure details, and in-hospital or long-term outcomes were assessed. The primary endpoint was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven-target lesion revascularization (TLR). The regression models were adjusted applying by the inverse probability weighted (IPW) approach to reduce treatment selection bias. The initial management strategy was DK-crush in 152 (59.6%) patients and TAP in 103 (40.4%) cases. The SYNTAX scores (24.58 ± 7.4 vs. 24.26 ± 6.39, p = 0.846) were similar in both groups. The number of balloon (6.32 ± 1.82 vs. 3.92 ± 1.19, p < 0.001) usage was significantly higher in the DK-crush group than in the TAP group. The rates of TLF (11.8 vs. 22.3%, p = 0.025) and clinically driven TLR (6.6 vs. 15.5%, p = 0.020) were significantly lower in the DK-crush group compared to the TAP group. The long-term TLF was significantly higher in the TAP group compared to the DK-crush group (unadjusted HR: 1.974, [95% CI: 1.044-3.732], p = 0.035 and adjusted HR [IPW]: 2.498 [95% CI: 1.232-5.061], p = 0.011). The present study showed that the DK-crush technique of bifurcation treatment was associated with lower long-term TLF and TLR rates compared to the TAP technique.

Single-stent and double-stent strategy for complex, true and false bifurcation lesions of the left main coronary artery in patients with acute coronary syndrome: a single-center retrospective analysis

Single-stent and double-stent strategy for complex, true and false bifurcation lesions of the left main coronary artery in patients with acute coronary syndrome: a single-center retrospective analysis

One year results of coronary bifurcation revascularization with the re-POT provisional sequential technique. The CABRIOLET registry

BackgroundRe-POT (proximal optimization technique (POT)) is a simple provisional sequential technique for percutaneous coronary bifurcation revascularization with better arterial geometry respect compared to classical techniques. Re-POT has demonstrated excellent mechanical and short-term clinical results. The multicenter CABRIOLET registry (NCT03550196) evaluate the long-term clinical benefit of the re-POT sequence in non-selected patients. MethodsAll consecutive patients presenting a coronary bifurcation lesion for which provisional stenting was indicated were included in 5 european centers. Re-POT strategy was systematically attempted. The primary endpoint was target lesion failure (TLF), comprising cardiac death, myocardial infarction, stent thrombosis and target lesion revascularization (TLR) at 12 months' follow-up. The secondary endpoints were the individual components of the primary endpoint, all-cause death, target vessel failure (TVF) and target vessel revascularization (TVR). Complex bifurcation was defined as Medina 0.1.1 or 1.1.1. ResultsA total of 500 patients aged 67.7 ± 11.7 years, 78.4% male, were included from 2015 to 2019, 174 of whom (34.8%) were considered having complex bifurcation lesions. Bifurcations involved the left main in 35.2% of cases. The full re-POT sequence was systematically performed in all cases. At 1 year, TLF was 2.0% (1.7% in complex vs. 2.1% in non-complex bifurcation; p = NS), and TLR was 1.6%, (1.1% vs. 1.8% respectively; p = NS). TVF and TVR rates were 3.2% and 2.8%. On multivariate analysis, only multivessel disease was predictive of TLF at 1 year (OR = 1.66 (1.09–2.53), p = 0.02). ConclusionsIn this large prospective all-comer registry, provisional stenting with re-POT technique appeared safe and effective at 1 year, without anatomical bifurcation restriction.

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.

Cardiovascular Outcomes After Mini-Crush or Double Kissing Crush Stenting Techniques for Complex Bifurcation Lesions: The EVOLUTE-CRUSH Registry

Comparison of clinical outcomes of double kissing crush (DKC) and mini-crush (MC) techniques in patients with complex coronary bifurcation lesions is lacking. This study sought to determine the clinical results of DKC and MC stenting techniques in mid-term follow-up. This retrospective study included a total of 269 consecutive patients with complex bifurcation lesions who underwent percutaneous coronary intervention; 132 (49%) of them were treated with MC technique, whereas 137 (51%) treated with DKC technique. The primary end point was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. This is the first study to compare the cardiovascular outcomes of DKC and MC stenting techniques in patients with complex bifurcation lesions. The SYNTAX scores were similar in both groups (23 [20 to 30] vs 23 [19 to 28], p=0.631)]. The number of balloons (6.31 ± 1.80 vs 4.42 ± 0.87, p <0.001) and guidewires (3.55 ± 0.83 vs 2.86 ± 0.74, p <0.001) used, fluoroscopy time (21.55 ± 7.05 vs 16.66 ± 4.19minutes, p <0.001), and procedure time (80.42 ± 27.95 vs 69.61 ± 18.97minutes, p <0.001) were significantly higher in the DKC group. The rate of composite TLF was similar in complex bifurcation patients treated with MC than those treated with the DKC technique (14% vs 12%, p=0.453). Moreover, both groups had similar rates in terms of cardiac death or all-cause death, target vessel-related myocardial infarction, clinically driven target lesion revascularization, and stent thrombosis. In conclusion, the present study showed that both techniques of bifurcation treatment met high angiographic success with low complication and similar TLF rates.

OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions

BackgroundImaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain.MethodsWe conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years.ResultsWe assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P=0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group.ConclusionsAmong patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.)

Three-Year Outcomes of the DEFINITION II Trial Comparing Two-Stent With Provisional Stenting for Complex Bifurcation Lesions Defined by DEFINITION Criteria

Three-Year Outcomes of the DEFINITION II Trial Comparing Two-Stent With Provisional Stenting for Complex Bifurcation Lesions Defined by DEFINITION Criteria

Comparison of single-stent and double-stent strategies for stenting a complex bifurcation lesion of the left main coronary artery in hemodynamically stable patients with acute coronary syndrome. Randomized study protocol (non-inferiority)

To date, a single­stent strategy for stenting bifurcation lesions is considered the most optimal and is recommended for routine use. However, there are complex lesions that are unique in terms of morphological and anatomical features. Such lesions are not clearly defined in literature and may require an alternative approach to stenting. In this study, a complex bifurcation lesion of the left main coronary artery is presented, as well as a prospective randomized analysis of immediate and long­term outcomes of two approaches to stenting such lesions (single­stent and double­stent) in hemodynamically stable patients with acute coronary syndrome. Objective. To perform a comparative analysis of intraoperative, immediate and long­term outcomes of single­stent and double­stent strategies for stenting a complex bifurcation lesion of the left main coronary artery (LMCA) in hemodynamically stable patients with acute coronary syndrome (ACS). Materials and methods. To the open prospective randomized single­center (non­inferiority) study it is planned to enroll 114 hemodynamically stable patients with ACS (n=114) and complex (according to study criteria) bifurcation lesions of the LMCA; patients will undergo a single­stent or double­stent strategy of percutaneous coronary intervention (PCI) with implantation of drug­eluting stents. Randomization into two groups will be performed after coronary angiography, confirmation of eligibility (checking for inclusion criteria and exclusion criteria), and signing of informed consent; group 1 ­ single­stent stenting strategy; group 2 ­ double­stent stenting strategy. The total duration of the study will be 52 weeks, with mandatory telephone calls on 30th (±3 days) and 364th (±3 days) day after PCI and the final in­person visit after the entire follow­up period. Over the course of the study, patients will receive optimal drug therapy according to clinical recommendations. During the follow­up period, information will be collected on the clinical status of patients, events in the combined control points, compliance/adjustment of drug therapy. During in­person visit, patients will undergo multispiral computed tomography of coronary arteries. Combined primary endpoint: cardiac death, non­fatal myocardial infarction, acute cerebrovascular accident and repeated revascularization of target vessel. Combined secondary endpoint: thrombosis and restenosis of the stent. Conclusion. In our study, a bifurcation lesion of the LMCA, unique in terms of morphological and anatomical criteria, will be identified in hemodynamically stable patients with ACS. This is a complex lesion that may initially require double­stent approach to stenting, which differs from the recommended single­stent strategy. Keywords: percutaneous coronary intervention, bifurcation stenting, single­stent technique, double­stent technique, culotte­stenting, crush­stenting, TAP­stenting, complex lesion, acute coronary heart disease

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

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

Six-months clinical and intracoronary imaging follow-up after reverse T and protrusion or double-kissing and crush stenting for the treatment of complex left main bifurcation lesions.

There is a debate regarding the best stent strategy for unprotected distal left main (LM) bifurcation disease. Among two-stent techniques, double-kissing and crush (DKC) is favored in current guidelines but is complex and requires expertise. Reverse T and Protrusion (rTAP) was shown to be a comparable strategy regarding short-term efficacy and safety, but with reduced procedural complexity. To compare rTAP vs. DKC by optical coherence tomography (OCT) on the intermediate term. 52 consecutive patients with complex unprotected LM stenoses (Medina 0,1,1 or 1,1,1) were randomized to either DKC or rTAP and followed-up for a median of 189[180-263] days for clinical and OCT outcomes. At follow-up OCT showed similar change in the side branch (SB) ostial area (primary endpoint). The confluence polygon showed a higher percentage of malapposed stent struts in the rTAP group that did not reach statistical significance (rTAP: 9.7[4.4-18.3] % vs. DKC: 3[0.07-10.9] %; p = 0.064). It also showed a trend towards larger neointimal area relative to the stent area (DKC: 8.8 [6.9 to 13.4] % vs. rTAP: 6.5 [3.9 to 8.9] %; p = 0.07), and smaller luminal area (DKC: 9.54[8.09-11.07] mm2 vs. rTAP: 11.21[9.53-12.42] mm²; p = 0.09) in the DKC group. The minimum luminal area in the parent vessel distal to the bifurcation was significantly smaller in the DKC group (DKC: 4.64 [3.64 to 5.34] mm² vs. rTAP: 6.76 [5.20 to 7.29] mm²; p = 0.03). This segment also showed a trend for smaller stent areas (p = 0.05 to 0.09), and a bigger neointimal area relative to the stent area (DKC: 8.94 [5.43 to 10.5]% vs. rTAP: 4.75 [0.08 to 8.5]%; p = 0.06) in the DKC patients. The incidence of clinical events was comparably low in both groups. At 6-months, OCT showed a similar change in the SB ostial area (primary endpoint) in rTAP compared to DKC. There was also a trend for smaller luminal areas in the confluence polygon and the distal parent vessel, and a larger neointimal area relative to the stent area, in DKC, along with a tendency for more malapposed stent struts in rTAP. https://clinicaltrials.gov/ct2/show/NCT03714750, identifier: NCT03714750.

Randomized Pilot Study to Compare DCB-Based versus DST-Based Strategies for the Treatment of True or Complex Coronary Bifurcation Lesions.

Dual stenting technique (DST) is still mandatory for some true bifurcation lesions (BLs), but drug-coated balloon (DCB) alone may offer a new optional treatment with the potential benefits of fewer implants. However, procedural safety presents a concern when using DCB-only to treat true BLs. This study sought to explore the safety and efficacy of the DCB-only strategy for the treatment of true BLs. Sixty patients with TBLs were randomly assigned to be treated by a DCB-based strategy or DST-based strategy. All patients received angiographic follow-up scheduled after one-year and staged clinical follow-up. The primary endpoint was the one-year late lumen loss (LLL) and cumulative major cardiac adverse events (MACEs) composed of cardiac death (CD), target vessel myocardial infarction (TVMI), target lesion thrombosis (TVT), or target vessel/lesion revascularization (TLR/TVR). The secondary endpoint was the one-year minimal lumen diameter (MLD), diameter stenosis percentage (DSP) or binary restenosis (BRS), and each MACE component. The baseline clinical and lesioncharacteristics were comparable with similar proportions (20.0% vs. 23.3%, p = 1.000) of the complex BLs between the two groups. At the one-year follow-up, LLL was significantly lower in the DCB-based group (main-vessel: 0.05 0.24 mm vs. 0.25 0.35 mm, p = 0.013; side-branch: -0.02 0.19 mm vs. 0.11 0.15 mm, p = 0.005). MLD, DSP and TLR/TVR were comparable between the groups. The one-year cumulative MACE, all driven by TLR/TVR (6.7% vs. 13.3%, p = 0.667), was low and similar without CD, TVMI or TVT in both groups. Compared to the DST strategy, the DCB- based strategy may be safe and effective in treatment of the selected true BLs. Clinical registration number is ChiCTR1900024914.

Coronary stent failure: role of a blended approach with drug-coated balloons for complex lesions.

The management of coronary artery disease by means of percutaneous approach have been focused initially to overcome the recoil and acute occlusion after vessel ballooning; therefore, to develop and improve metallic stent platforms, and later drug-eluting technologies. Contemporarily, the necessity emerged to optimize interventional procedures using functional physiologic tests and intravascular imaging guidance, but still stent failures, especially in the complex lesion setting, continue to be not negligible. This comprehensive review is focused on the technology of drug-coated balloons as a tool to treat coronary artery disease without the need for metal implantation but still eluting antirestenotic drugs such as paclitaxel or sirolimus. We delve into these technologies, the drugs, the technical aspects of the deployment and the most updated evidence also proposing a dedicated interventional algorithm. There is solid data to support the use of drug-coated balloons in patients with in-stent restenosis and de-novo small coronary artery disease but also new evidence with promising results from recent studies indicate the feasibility of this approach in complex coronary interventions, bifurcation lesions and larger coronary vessels. In this state-of-the-art review, we also propose a blended approach based on the combination of drug-eluting stents and drug-coated balloons, keeping in mind the necessity to reduce the total stent length in order to reduce the long-term risk of complications.

Bifurcation lesions : Are new strategies and devices needed?

Interventional treatment of bifurcation lesions, especially true complex bifurcation lesions, continue to be a challenge for interventional cardiologists. Aprimary one stent strategy is always preferred for simple bifurcation lesions, whereas studies in recent years have shown that a two stent strategy may be advantageous for true bifurcations, i.e. those involving at least the distal main branch as well as the side branch. This seems to be even more pronounced when the lesion presents as complex, i.e., the side branch shows high-grade stenosis over longer stretches and the complete lesion fulfils certain criteria, e.g., severe calcification and a bifurcation angle < 45° or > 70°. According to the latest randomized trials and meta-analyses, the double kissing (DK) crush and double kissing mini-crush (DKMC) techniques in particular seem to be advantageous for these lesions; however, in recent years the established techniques have been continuously refined and further developed. The DK culotte technique and the nano-crush technique deserve special attention. Both techniques seem to further improve and simplify the existing underlying strategies; however, further studies to prove the superiority of these techniques over the established ones are still pending. Overall, the implementation of the available randomized study results, the further development of the techniques and also of the materials can continuously improve the outcome of the patients after interventional treatment of bifurcation lesions. This is also confirmed by the latest registry data, which for the first time could show equal event rates in patients after treatment of complex lesions compared to simple lesions in the clinical practice.

A Review of Double Kissing Crush Stenting in Coronary Bifurcation Lesions

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

Long-Term Clinical Outcomes and Its Predictors Between the 1- and 2-Stent Strategy in Coronary Bifurcation Lesions - A Baseline Clinical and Lesion Characteristic-Matched Analysis.

Differences in the impact of the 1- or 2-stent strategy in similar coronary bifurcation lesion conditions are not well understood. This study investigated the clinical outcomes and its predictors between 1 or 2 stents in propensity score-matched (PSM) complex bifurcation lesions.Methods and Results: We analyzed the data of patients with bifurcation lesions, obtained from a multicenter registry of 2,648 patients (median follow up, 53 months). The patients were treated by second generation drug-eluting stents (DESs). The primary outcome was target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction (TVMI), and ischemia-driven target lesion revascularization (TLR). PSM was performed to balance baseline clinical and angiographic discrepancies between 1 and 2 stents. After PSM (N=333 from each group), the 2-stent group had more TLRs (hazard ratio [HR] 3.14, 95% confidence interval [CI] 1.42-6.97, P=0.005) and fewer hard endpoints (composite of cardiac death and TVMI; HR 0.44, 95% CI 0.19-1.01, P=0.054), which resulted in a similar TLF rate (HR 1.40, 95% CI 0.83-2.37, P=0.209) compared to the 1-stent group. Compared with 1-stent, the 2-stent technique was more frequently associated with less TLF in the presence of main vessel (pinteraction=0.008) and side branch calcification (pinteraction=0.010). The 2-stent strategy should be considered to reduce hard clinical endpoints in complex bifurcation lesions, particularly those with calcifications.