Stenting Strategy Research Articles

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.

TCT-328 Determining Beneficiaries of 2-Stent Strategy by BIFURCAT 2-Stent Score in a Large-Scale Coronary Bifurcation Registry

TCT-328 Determining Beneficiaries of 2-Stent Strategy by BIFURCAT 2-Stent Score in a Large-Scale Coronary Bifurcation Registry

TCT-514 Safety and Efficacy of 19 Stent Strategies in Percutaneous Coronary Intervention: A Trial-Sequential, Influential, Bivariate and Network Meta-Analysis

TCT-514 Safety and Efficacy of 19 Stent Strategies in Percutaneous Coronary Intervention: A Trial-Sequential, Influential, Bivariate and Network Meta-Analysis

Stenting the unprotected left main coronary artery- mid-term outcomes of the observational registry

Abstract Background New imaging modalities such as IVUS had improved results of Stenting of the unprotected left main coronary artery (UPLM). The results of stenting UPLM without these new modalities but with meticulous care need to be studied more. Methods This prospective and retrospective study was performed in multiple local centers. The local ethics committee approved the study, and the patients signed informed consent. In addition, the local heart team, including a cardiac surgeon, was consulted for a joint decision agreement. In the last five years, one hundred twenty patients with left main disease &amp;gt;50% were subjected to stenting with drug- eluted stents.All patients were subjected to detailed history taking with particular emphasis on acute coronary syndrome, angina duration, class, previous coronary interventions, and medications. In addition, 12 lead ECGs were revised with an evaluation of ST/T changes and any old infarction. An echocardiographic examination was done on all patients. Relevant laboratory tests were done.Risk assessment was calculated for every patient, including Euro SCORE and Syntax score. Patient selection: Consecutive patients arriving for primary Stenting or acute coronary episode were included. Medications: All patients received clopidogrel and aspirin before the planned procedure. Anticoagulation with unfractionated heparin in a dose of 10000 IU was given at the beginning of the PCI. Post PCI, all patients received B blockers, ACE inhibitors, statins, and dual antiplatelets in the guidelines recommended doses. Calcification was assessed by angiographic imaging only. We estimated the vessel diameter as 2/3 diameter of the branches. PCI technique: A steerable guidewire was advanced in LAD, followed by PCI with pre-dilatation or direct Stenting according to the operator’s discretion. One or two stent strategy was utilized according to the situation of the lesions. Results 92 patients (77.3%) presented with ACS, of which 65 patients (54.6%) had no Previous Intervention, and 27 patients (22.7%) had a previous PCI. Left ventricular ejection fraction significantly correlates with the complication at six months follow-up; all 16 patients with reported complications (100%) had baseline LVEF of &amp;lt;40% (P-value = 0.023). Syntax score 11 patients (55%) with a high score of more than 32 had adverse events, P = 0.004. Residual syntax shows a less significant correlation with a mean value of 7.3 in the complication group vs. 4.9 in the other group (P = 0.016). Final kissing balloon inflation shows no statistically significant difference. Conclusions PCI in UPLM is a safe, feasible option with a high technical success rate and acceptable outcome at follow-up, even without the utilization of IVUS

Deferred Stenting for Side Branch in STEMI Patients Presented by Bifurcation Culprit Lesion

Abstract Background True bifurcation lesions are challenging in some special populations like patients with heavily calcified vessels, unprotected left main, and thrombus-containing lesions. Multiple inflations are known to increase the incidence of no-reflow/slow-flow (NR/SL) during primary PCI. The ideal bifurcation stenting strategy during primary PCI is still obscure. Some studies have shown some benefits for deferred stenting in primary PCI but still this area needs more evidence. In our study, we compared deferred stenting for the side branch during primary PCI versus the complete bifurcation stenting strategy during primary PCI. Methods This is prospective observational study included patients who presented with STEMI due to true bifurcation culprit lesion amenable for two stents technique. Group one included patients with provisional stenting and deferred side branch stenting before hospital discharge. Group two included patients with complete two stents bifurcation technique during primary PCI. The technique used was according to operator discretion while patients with immediate indications for two stents strategy during the primary setting were excluded from our study. The primary outcome was MACE till hospital discharge. Secondary outcomes included angiographic outcomes by the end of the bifurcation technique. Results A total of 60 patients met our inclusion criteria, mean age (58.69±9.61), 31.2% women. Twenty-six patients received deferred stenting for side branch, and 34 received complete two stents bifurcation strategy at the primary PCI setting. MACE to hospital discharge was lower in the deferred stenting group without significant difference (21.62% vs 23.64%, P&amp;gt;0.01] compared with the two-stenting approach during primary PCI. Group I (deferred stenting) had significantly superior angiographic outcomes than group II. As regards TIMI II-III flow, 86.2% of patients achieved it in both main vessel and side branch versus 51.1% in group II, CTFC was 8.1 versus 9.6, and in group I, 78% of patients achieved TMPG II-III, compared to 56.7% in group II. Conclusion Deferred stenting for side branch in primary PCI achieved superior angiographic outcomes in the treatment of true bifurcation lesions. However, there was no significant difference in MACE between both strategies.

Drug-coated balloon: an effective alternative to stent strategy in small-vessel coronary artery disease-a meta-analysis.

Small-vessel coronary artery disease (CAD) is frequently observed in coronary angiography and linked to a higher risk of lesion failure and restenosis. Currently, treatment of small vessels is not standardized while having drug-eluting stents (DES) or drug-coated balloons (DCBs) as possible strategies. We aimed to conduct a meta-analytic approach to assess the effectiveness of treatment strategies and outcomes for small-vessel CAD. Comprehensive literature search was conducted using PubMed, Embase, MEDLINE, and Cochrane Library databases to identify studies reporting treatment strategies of small-vessel CAD with a reference diameter of ≤3.0 mm. Target lesion revascularization (TLR), target lesion thrombosis, all-cause death, myocardial infarction (MI), and major adverse cardiac events (MACE) were defined as clinical outcomes. Outcomes from single-arm and randomized studies based on measures by means of their corresponding 95% confidence intervals (CI) were compared using a meta-analytic approach. Statistical significance was assumed if CIs did not overlap. Thirty-seven eligible studies with a total of 31,835 patients with small-vessel CAD were included in the present analysis. Among those, 28,147 patients were treated with DES (24 studies) and 3,299 patients with DCB (18 studies). Common baseline characteristics were equally distributed in the different studies. TLR rate was 4% in both treatment strategies [0.04; 95% CI 0.03-0.05 (DES) vs. 0.03-0.07 (DCB)]. MI occurred in 3% of patients receiving DES and in 2% treated with DCB [0.03 (0.02-0.04) vs. 0.02 (0.01-0.03)]. All-cause mortality was 3% in the DES group [0.03 (0.02-0.05)] compared with 1% in the DCB group [0.01 (0.00-0.03)]. Approximately 9% of patients with DES developed MACE vs. 4% of patients with DCB [0.09 (0.07-0.10) vs. 0.04 (0.02-0.08)]. Meta-regression analysis did not show a significant impact of reference vessel diameter on outcomes. This large meta-analytic approach demonstrates similar clinical and angiographic results between treatment strategies with DES and DCB in small-vessel CAD. Therefore, DES may be waived in small coronary arteries when PCI is performed with DCB.

3D reconstruction of coronary artery bifurcations from intravascular ultrasound and angiography

Coronary bifurcation lesions represent a challenging anatomical subset, and the understanding of their 3D anatomy and plaque composition appears to play a key role in devising the optimal stenting strategy. This study proposes a new approach for the 3D reconstruction of coronary bifurcations and plaque materials by combining intravascular ultrasound (IVUS) and angiography. Three patient-specific silicone bifurcation models were 3D reconstructed and compared to micro-computed tomography (µCT) as the gold standard to test the accuracy and reproducibility of the proposed methodology. The clinical feasibility of the method was investigated in three diseased patient-specific bifurcations of varying anatomical complexity. The IVUS-based 3D reconstructed bifurcation models showed high agreement with the µCT reference models, with r2 values ranging from 0.88 to 0.99. The methodology successfully 3D reconstructed all the patient bifurcations, including plaque materials, in less than 60 min. Our proposed method is a simple, time-efficient, and user-friendly tool for accurate 3D reconstruction of coronary artery bifurcations. It can provide valuable information about bifurcation anatomy and plaque burden in the clinical setting, assisting in bifurcation stent planning and education.

Comparison of Outcomes Between 1- and 2-Stent Techniques for Medina Classification 0.0.1 Coronary Bifurcation Lesions

BackgroundAlthough Medina 0.0.1 bifurcation lesions are often treated by percutaneous coronary intervention (PCI) in real-world practice, the optimal revascularization strategy for this lesion is uncertain. ObjectivesThe current study aimed to compare the clinical outcomes between 1- and 2-stent strategies in patients treated with PCI for Medina 0.0.1 bifurcation lesions. MethodsThe extended BIFURCAT (Combined Insights From the Unified RAIN [Very Thin Stents for Patients with Left Main or Bifurcation in Real Life] and COBIS [Coronary Bifurcation Stenting] Bifurcation Registries) registry was obtained by patient-level merging the dedicated bifurcation COBIS II, III, and RAIN registries. Among 8,434 patients with bifurcation lesions undergoing PCI, 345 (4.1%) with Medina 0.0.1 lesions were selected for the current analysis. The primary endpoint was major adverse cardiac event (MACE, a composite of all-cause death, myocardial infarction, target vessel revascularization, and stent thrombosis) at 800 days. ResultsIn the total population, 209 patients (60.6%) received PCI with a 1-stent strategy and the remaining 136 patients (39.4%) with a 2-stent strategy. There was a tendency for higher use of a 1-stent strategy over time (36.0%, 47.4%, and 90.4% in 2003-2009, 2010-2014, and 2015-2017, respectively; P for trend < 0.001). For the treatment of Medina 0.0.1 lesions, there was no significant difference in the risk of MACE between 1- and 2-stent strategies (1 stent vs 2 stent, 14.3% vs 13.9%; HR: 1.034; 95% CI: 0.541-1.977; P = 0.92). The risk of MACE was also not significantly different when stratifying into 3 groups (1-stent crossover only, 1-stent with strut opening, and 2-stent strategy). ConclusionsIn patients with a Medina 0.0.1 type bifurcation lesion, PCI with a 1-stent strategy showed comparable outcomes to that of a 2-stent strategy. (Coronary Bifurcation Stenting II [COBIS II]; NCT01642992; Coronary Bifurcation Stenting III [COBIS III]; NCT03068494; Very Thin Stents for Patients with Left Main or Bifurcation in Real Life [RAIN]; NCT03544294)

An Approach to Non-left Main Bifurcation Lesions: A Contemporary Review.

Bifurcated anatomical locations in the arterial tree, such as coronary artery bifurcations, are prone to develop obstructive atherosclerotic lesions due to the pro-atherogenic low wall shear stress. The percutaneous treatment of bifurcation lesions is among the most challenging complex coronary interventions, including different multistep stenting strategies. Even though provisional side branch (SB) stenting is recommended as the primary approach in most cases, the debate continues between provisional SB and upfront two-stent strategies, particularly in complex bifurcations consisting of a significantly diseased SB that supplies a crucial myocardial territory. This review will highlight the importance of understanding the bifurcation philosophy and provide an individual algorithmic approach to find the optimal treatment strategy for each patient with a non-left main coronary bifurcation lesion. Considering the most recent scientific evidence, the advantages and disadvantages of each stenting technique and the role of intracoronary imaging to optimize bifurcation percutaneous coronary intervention outcomes will be discussed.

Post-procedural and long-term functional outcomes of jailed side branches in stented coronary bifurcation lesions assessed with side branch Murray law-based quantitative flow ratio.

In coronary bifurcation lesions treated with percutaneous coronary intervention (PCI) using a 1-stent strategy, the occurrence of side branch (SB) compromise may lead to long-term myocardial ischemia in the SB territory. Murray law-based quantitative flow ratio (μQFR) is a novel angiography-based approach estimating fractional flow reserve from a single angiographic view, and thus is more feasible to assess SB compromise in routine practice. However, its association with long-term SB coronary blood flow remains unknown. A total of 146 patients with 313 non-left main bifurcation lesions receiving 1-stent strategy with drug-eluting stents was included in this retrospective study. These lesions had post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 in SBs, and documented angiographic images of index procedure and 6- to 24-month angiographic follow-up. Post-procedural SB μQFR was calculated. Long-term SB coronary blood flow was quantified with the TIMI grading system using angiograms acquired at angiographic follow-up. At follow-up, 8 (2.6%), 16 (5.1%), 61 (19.5%), and 228 (72.8%) SBs had a TIMI flow grade of 0, 1, 2, and 3, respectively. The incidences of long-term SB TIMI flow grade ≤1 and ≤2 both tended to decrease across the tertiles of post-procedural SB μQFR. The receiver operating characteristic curve analyses indicated the post-procedural SB μQFR ≤0.77 was the optimal cut-off value to identify long-term SB TIMI flow grade ≤1 (specificity, 37.50%; sensitivity, 87.20%; area under the curve, 0.6673; P = 0.0064), and it was independently associated with 2.57-fold increased risk (adjusted OR, 2.57; 95% CI, 1.02-7.25; P = 0.045) in long-term SB TIMI flow grade ≤1 after adjustment. Post-procedural SB μQFR was independently associated with increased risk in impaired SB TIMI flow at long-term follow-up. Further investigations should focus on whether PCI optimization based on μQFR may contribute to improve SB flow in the long term.

Configuration of two-stent coronary bifurcation techniques in explanted beating hearts: the MOBBEM study.

In patients with complex coronary bifurcation lesions undergoing percutaneous coronary intervention (PCI), various 2-stent techniques might be utilised. The Visible Heart Laboratories (VHL) offer an experimental environment where PCI results can be assessed by multimodality imaging. We aimed to assess the post-PCI stent configuration achieved by 2-stent techniques in the VHL and to evaluate the procedural factors associated with suboptimal results. Bifurcation PCI with 2-stent techniques, performed by expert operators in the VHL on explanted beating swine hearts, was studied. The adopted bifurcation PCI strategy and the specific procedural steps applied in each procedure were classified according to Main, Across, Distal, Side (MADS)-2 and to their adherence to the European Bifurcation Club (EBC) recommendations. Microcomputed tomography (micro-CT) was used to assess the post-PCI stent configuration. The primary endpoint was "suboptimal stent implantation", defined as acomposite of stent underexpansion (<90%), side branch ostial area stenosis >50% and the gap between stents. Atotal of 82 PCI with bifurcation stenting were assessed, comprised of 29 crush, 25 culotte, 28 T/T and small protrusion (TAP) techniques. Suboptimal stent implantation was observed in as many as 53.7% of the cases, regardless of baseline anatomy or the stenting strategy. However, less frequent use of the proximal optimisation technique (POT; p=0.015) and kissing balloon inflations (KBI; p=0.027) and no adherence to EBC recommendations (p=0.004, p multivariate=0.006) were significantly associated with the primary endpoint. Commonly practised bifurcation 2-stent techniques may result in imperfect stent configurations. More frequent use of POT/KBI and adherence to expert recommendations might reduce the occurrence of post-PCI suboptimal stent configurations.

Stepwise Provisional versus Planned Double Stenting Strategies in Treating Unprotected Left Main Distal Bifurcation Lesions: A Systematic Review and Meta-Analysis Comprising 11,672 Patients.

Provisional stenting is the preferred strategy for non-left main bifurcation lesions. However, its superiority over planned double stenting for unprotected left main distal bifurcation (UPLMB) lesions remains unclear. Previous studies have reported conflicting results. Randomised controlled trials (RCTs) and observational studies comparing the outcomes of provisional stenting to planned double stenting for UPLMB lesions were identified. The primary endpoint was major adverse cardiac events (MACE). The secondary endpoints were myocardial infarction (MI), target vessel revascularisation (TVR), target lesion revascularisation (TLR), all-cause death, cardiac death and stent thrombosis (ST). Aggregated odds ratios (OR) and 95% confidence intervals were calculated. A sensitivity analysis was conducted if was 50% or p 0.01. Publication bias analysis was considered if more than 10 studies were enrolled. Two RCTs and 19 observational studies comprising 11,672 patients were enrolled. Provisional stenting had a significantly lower incidence of MACE, mainly driven by TLR and TVR. Double stenting had a significantly lower incidence of cardiac death. In addition, patients undergoing provisional stenting had a lower tendency towards the occurrence of MI, while patients undergoing double stenting had a lower tendency towards all-cause death and ST. A provisional stenting strategy was associated with lower MACE, TVR and TLR but higher cardiac death. Further investigation is needed through RCTs to assess which strategy performs better.

Comparing the clinical outcomes of single vs. systematic dual stenting strategies for unprotected left main bifurcation lesion: a systematic review and meta-analysis.

The optimal percutaneous coronary intervention (PCI) strategy for coronary left main (LM) bifurcation lesions remains controversial. This meta-analysis compared the medium and long-term follow-up clinical outcomes of single vs. systematic dual stenting strategies of LM bifurcation lesions. We systematically identified studies published within 5 years comparing single vs. systematic double stenting strategies for LM bifurcation lesions. The primary endpoint was medium-term (1 year) and long-term (at least 3 years) all-cause death. Secondary outcomes included major adverse cardiovascular events (MACEs), target lesion revascularization (TLR), overall occurrence of stent thrombosis (ST), cardiovascular (CV) mortality, and myocardial infarction (MI). Two randomized controlled trials and nine observational studies with 7,318 patients were included in this meta-analysis. In terms of the medium-term follow-up clinical outcomes, our pooled analysis showed that use of the systematic dual stenting strategy was associated with a lower ST risk (odds ratio [OR] = 0.43, 95% confidence interval [CI]: 0.20-0.89, P = 0.02) and cardiac death risk (OR = 0.43, 95% CI: 0.21-0.89, P = 0.02) compared to the single stenting strategy; there was no significant difference between the two strategies regarding rates of all-cause death, MACE, TLR, and MI. Patients with long-term follow-up showed comparable observed clinical outcomes between the two strategies. Most importantly, for patients with true LM bifurcation, the risk of all-cause death, ST, and CV mortality following the systematic dual stenting strategy was significantly lower than the single stenting strategy. For patients with LM bifurcation lesions, both the systematic dual stenting strategy and single stenting strategy demonstrated comparable results in terms of all-cause mortality during medium-term and long-term follow-up. However, the systematic dual stenting strategy showed a tendency towards lower incidence of ST and CV mortality compared to the single stenting strategy during medium-term follow-up. Consequently, the systematic dual stenting strategy yielded superior clinical outcomes for patients with LM bifurcation lesions.

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

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.

Management of Bifurcation Culprit Lesion in the Setting of Anterior ST Elevation Myocardial Infarction

Introduction: Coronary bifurcation lesions are considered one of the challenging entities in the field of coronary intervention due to the risk of side branch loss and higher risk of stent thrombosis. However, there is limited data about the proper management of such lesions in the setting of myocardial infarction as most bifurcation lesion studies excluded patients with acute coronary syndromes (ACS). The aim of this study was to compare in-hospital and mid-term outcomes of single-stent and two-stents strategy in the management of bifurcation culprit lesions in patients presenting with anterior STEMI.&#x0D; Methods: This retrospective multi-center study included all patients presented with anterior STEMI who underwent primary PCI between January 2017 and December 2019, coronary angiography showed true bifurcation lesion with sizable side branch that can be managed by stenting. Patients with left main bifurcation, those indicated for urgent CABG, and patients in cardiogenic shock were excluded. Included patients were divided into two groups according to the stenting strategy either single or two stents. Six months follow up data were collected by telephone calls and by examination of medical records.&#x0D; Results: Out of 1355 anterior STEMI patients presented between January 2017 and December 2019, 158 patients (11.6%) were identified to have bifurcation culprit lesions with a sizable diagonal branch. 93 patients (59%) were treated by single stent while 65 patients (41%) were managed by two-stents strategy. The baseline characteristics and angiographic findings were similar in both groups except for higher side branch involvement in the two stents group (83.31%±11.20 vs 71.88%±15.05, t= -5.39, p &lt;0.001). Mean fluoroscopy time (23.96±8.90 vs 17.81±5.72 mins) and contrast volume (259.23± 59.45 vs 232.58± 96.18 ml) were significantly higher in two stents group than single stent group (p=0.049). However, the angiographic success rates (residual stenosis ≤30% and restoration of TIMI flow grade II or III) were comparable (96.8% vs 99%, MCp=0.151). There is no significant difference in the overall incidence rate of MACE in both groups 6 months following the index procedure (13.9 % vs 16.9%, FEp=0.698), with no difference between different bifurcation stenting techniques in patients managed with two stents.&#x0D; Conclusion: Although two stents strategy in the setting of STEMI is much complex with more fluoroscopy time and contrast volume, the procedural success rate and the incidence of MACE were comparable to one stent strategy, on medium-term follow up.

Intravascular imaging of angioplasty balloon under-expansion during pre-dilation predicts hyperelastic behavior of coronary artery lesions.

Introduction: Stent-induced mechanical stimuli cause pathophysiological responses in the coronary artery post-treatment. These stimuli can be minimized through choice of stent, size, and deployment strategy. However, the lack of target lesion material characterization is a barrier to further personalizing treatment. A novel ex-vivo angioplasty-based intravascular imaging technique using optical coherence tomography (OCT) was developed to characterize local stiffness of the target lesion. Methods: After proper institutional oversight, atherosclerotic coronary arteries (n = 9) were dissected from human donor hearts for ex vivo material characterization <48h post-mortem. Morphology was imaged at the diastolic blood pressure using common intravascular OCT protocols and at subsequent pressures using a specially fabricated perfusion balloon that accommodates the OCT imaging wire. Balloon under-expansion was quantified relative to the nominal balloon size at 8 ATM. Correlation to a constitutive hyperelastic model was empirically investigated (n = 13 plaques) using biaxial extension results fit to a mixed Neo-Hookean and Exponential constitutive model. Results and discussion: The average circumferential Cauchy stress was 66.5, 130.2, and 300.4kPa for regions with <15, 15-30, and >30% balloon under-expansion at a 1.15 stretch ratio. Similarly, the average longitudinal Cauchy stress was 68.1, 172.6, and 412.7kPa, respectively. Consequently, strong correlation coefficients >0.89 were observed between balloon under-expansion and stress-like constitutive parameters. These parameters allowed for visualization of stiffness and material heterogeneity for a range of atherosclerotic plaques. Balloon under-expansion is a strong predictor of target lesion stiffness. These findings are promising as stent deployment could now be further personalized via target lesion material characterization obtained pre-operatively.

P38 SINGLE VERSUS DOUBLE STENTING IN NSTEMI PATIENTS WITH COMPLEX LEFT MAIN BIFURCATION DISEASE

Abstract Background Among patients with non–ST–segment elevation myocardial infarction (NSTEMI) the presence of a bifurcation left main (LM) disease represents a particular subset graved by both clinical and technical challenges. We sought to assess the long–term outcomes of patients with NSTEMI treated either by single or double stent strategy, having an LM bifurcation culprit lesion. Methods We retrospectively analyzed the procedural and medical data of consecutive patients referred to our center for NSTEMI due to complex LM bifurcation disease as the culprit lesion, treated using either single or dual stenting (provisional stenting, T or T–and–Protrusion (TAP), Culotte, and Nano–inverted–T (NIT)) techniques between January 2008 and May 2018. Target lesion failure (TLF) was defined as the composite of cardiovascular death, target–vessel myocardial infarction (MI), and clinically driven target lesion revascularization (TLR). Results Four hundred and forty–five patients (54.1% males, mean age 70.3 ± 12.8 years, mean Syntax score 31.6 ± 6.3) were evaluated. Of these, 155 patients (34.8%) were treated using a single stent while the remaining were treated with a double stent strategy. After a mean follow–up of 37.1 months (IQR 22.1–39.3), TLF rate was 8.7% (n = 39): 5/155 (3.2%) in the crossover group; 10/53 (18.8%) in T/TAP group, 14/89 (15.7%) in the culotte group, and 10/148 (6.7%) in the NIT group of patients. Cardiovascular mortality rate was 2.9% (n = 13) while stent thrombosis was 0.89% (n = 4). On multivariate analysis dyslipidemia, Syntax score &amp;gt; 25, triple vessel disease, additional LM ostial, or LM body lesions and the use of Rotablator, were independent predictors of TLF. Conclusions Either a single or double stent strategy resulted in low rates of TLF, cardiovascular death, and stent thrombosis in the long–term period in NSTEMI LM patients with contraindications or refusal of surgery. A single stent strategy appeared to have a slightly better outcome compared to a 2–stent strategy.

Predictors of 1-and 12-month mortality in bifurcation coronary intervention: a contemporary perspective.

Aim: Bifurcation-PCI is performed frequently, although without extensive evidence to back up a definitive solution for its complexity. We set out to identify factors associated with 1- and 12-month mortality after bifurcation-PCI between 2017 and 2021 in our tertiary centre in Wales, UK. Results: Of 732 bifurcation PCI cases (mean age 69; 25% female), 67% were in ACS, 42% were left main PCI and 25.3% involved two-stent strategy. 30-day and 12-month mortality were 1.9% and 8.2%, respectively. Age, diabetes, smoking and renal failure are associated with mortality after bifurcation-PCI, while the choice between provisional and 2-stent strategies did not impact mortality/TLR. Conclusion: Awareness of 'real-world' outcomes of bifurcation-PCI should be used for appropriate patient selection, technique planning and procedural consent.

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.