Treatment Of Bifurcation Lesions Research Articles

Carina: A major determinant in the pathophysiology and treatment of coronary bifurcation lesions.

Over the last decade, several in vivo and computational investigations have significantly advanced our understanding of the pathophysiology of coronary bifurcations, contributing to the enhancement of their percutaneous revascularization. The carina of the coronary bifurcations plays a substantial role in generating their main hemodynamic features, including distinctive flow patterns with secondary flows and specific shear stress patterns. These factors play a pivotal role in determining the susceptibility, development, and progression of atherosclerosis. The underlying pathophysiological mechanisms of atherosclerosis in coronary bifurcations are complex and multifactorial. Understanding these mechanisms is fundamental to comprehending lesions at the bifurcation level and informing future treatment strategies. This review aims to present the currently available data regarding the pathophysiological and prognostic role of the carina in coronary bifurcations, offering an interpretation of these findings from the perspective of interventional cardiologists, providing valuable insights for their clinical practice.

Coronary bifurcation lesion treatment with the BioMime™ Branch sirolimus-eluting coronary side-branch stent system: A single-center experience

BackgroundCoronary bifurcation lesions (CBL) comprise 15 %–20 % of percutaneous coronary procedures and remain a challenge despite advances in stent and interventional techniques. The BioMime™ Branch sirolimus-eluting coronary side-branch stent (BBSES) is specifically designed for CBL treatment in conjunction with a standard drug-eluting stent (DES). We report the first single-center experience of treating complex CBL with the novel BBSES. MethodsThis is a retrospective, single-center study involving consecutive prospectively identified patients who underwent treatment of true CBL with the BBSES. The protocol included BBSES+DES implantation in the CBL and simultaneous final kissing balloon inflation. ResultsFifty-eight CBL were treated in 58 consecutive patients (89.6 % men, mean age 69.0 ± 9.5 years) presenting primarily with stable angina (84.4 %) and true (Medina 1,1,1,) CBL. Procedural success was 100 % without major adverse cardiac events (MACE). At a median follow-up of 18 months, one sudden death was reported that was accounted as possible late stent thrombosis. One patient had spontaneous myocardial infarction due to subacute thrombosis of a DES implanted in the main vessel proximally to the BBSES before the index procedure. Another patient was hospitalized for atrial fibrillation. ConclusionsThis is the first clinical experience to date of true CBL treatment with the BBSES demonstrating high procedural success, no in-hospital MACE and sustained clinical results at a median follow-up of 18 months.

Jailed high-pressure balloon technique is superior to jailed wire technique in protecting side branch of coronary bifurcation lesions

Objectives. This study investigated the influence of higher pressure protection with a small diameter balloon of side branch (SB) on bifurcation lesions. Background. Of the different coronary stent implantation techniques, the modified jailed balloon technique has become a viable option for bifurcation lesions. However, there was no detailed study on the relationship between the balloon inflation pressure of the main vessel (MV) and SB. Methods. In this study, we collected information of patients who underwent percutaneous coronary intervention (PCI) for bifurcated lesions between March 2019 and December 2022. They were divided into two groups according to the operation way: active jailed balloon technique (A-JBT) group and jailed wire technique (JWT) group. Results. A total of 216 patients were enrolled. The A-JBT group had a larger SB stenosis diameter (1.53 ± 0.69 vs. 0.95 ± 0.52, p < .001), the lower degree of stenosis (44.34 ± 18.30 vs. 63.69 ± 17.34, p < .001) compared to the JWT group. However, the JWT group had a higher incidence of SB occlusion (18.0% vs. 1.9%, p < .001) compared to the A-JBT group. Nevertheless, the success rate for both groups was 100%. Conclusions. This novel high inflation pressure and small diameter balloon approach we propose has significant advantages. There is a lower rate of SB occlusion and SB dissection, which is more cost-effective and provides better clinical outcomes for the patient. This method should be considered in the future for treating bifurcation lesions.

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.

The role of drug-coated balloons for coronary bifurcation management: results from the prospective EASTBOURNE-BIF study.

Coronary bifurcation lesions are associated with less favourable outcome as compared to other lesion subsets. The role of drug-coated balloons (DCB) for bifurcation lesions has been only investigated in small studies so far, which reported encouraging results. We here describe the results of EASTBOURNE-BIF prospective registry, in which a sirolimus-DCB was used for the treatment of bifurcation lesions. Overall, 194 patients with bifurcations lesions identified in the EASTBOURNE study (Medina 1.1.1/1.1.0/1.0.1/0.1.1/0.1.0) were compared with 1049 patients with de-novo lesions from the same registry. Both a blended-strategy using a drug-eluting stent in the main branch and a DCB in the side branch as well as a full-DCB approach were used in the treatment of bifurcation lesions. At one year of follow-up the study primary endpoint, target-lesion revascularization occurred at a similar rate in the bifurcation group versus the de-novo group (4.2 vs. 2%, P=0.28). Similar outcomes were observed in terms of all-cause death (3.3 vs. 1.4%, P=0.138), major adverse cardiovascular events (8.8 vs. 5.2%, P=0.081) and the rate of spontaneous myocardial infarction (2.8 vs. 1.0%, P=0.117). The results of EASTBOURNE-BIF study show how the use of this DCB alone or in combination with drug eluting stents could represent a safe and effective alternative to stents for the treatment of bifurcations.

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.

Clinically E Clinically Effective Regener e Regenerative Therapy for Primar y for Primary Endodontic y Endodontic Lesions with Secondary Periodontal Lesions: A Case Report

The diagnosis and prognosis of teeth with endo-perio lesions present a major challenge for dentists. Proper diagnosis is critical in determining treatment and the long-term prognosis. However, treating complex endodontic and periodontal lesions is one of the most common challenges in current clinical practice. The coexistence of pulpal and periodontal tissue damage may complicate diagnosis and further influence dental prognosis. This article consists of a case report evaluating the efficacy of xenografts and resorbable membrane pericardium in treating bifurcation lesions associated with periodontal lesions of the left mandibular first molar. A 22-year-old female patient was referred by conservative dentistry with complaints of gingival swelling on tooth 36 with furcation involvement associated with periodontal lesions. A gingivectomy was performed after the first stage of periodontal therapy because gingival swelling precluded endodontic treatment. After 3 months of endodontic treatment, the grade II bifurcated lesion had not yet healed, so regenerative surgery using xenografts and a resorbable pericardial membrane was performed. Periodontal treatment showed no gingival inflammation, and radiographic evidence showed bone improvement. Endo-perio lesions are complex in etiology and require a high degree of expertise to identify and treat them. Therefore, effective treatment of lesions requires collaboration between various multidisciplinary disciplines.

Shedding the optical coherence tomography light on the treatment of complex coronary bifurcation lesions.

Shedding the optical coherence tomography light on the treatment of complex coronary bifurcation lesions.

Review of Techniques for Protecting Side Branch from Occlusion during Provisional Stenting in Coronary Bifurcation Lesions.

Coronary bifurcation lesions remain one of the most challenging lesions for cardiology interventionists. The provisional stenting strategy has been regarded as the first option for most of these lesions. However, the main complication of this technique is side branch (SB) occlusion, which could lead to a peri-procedural myocardial infarction or even death. Various studies have focused on addressing this issue, but there are no definitive guidelines in the literature to treat these lesions. There isn't enough clinical evidence from randomized controlled trial or two-arm cohort studies to illustrate which techniques provide the best outcomes. In this review, we summarize the mechanisms, independent predictors and predictive models of SB occlusion, and review seventeen techniques involving SB protection and occlusion rescue. Every technique was evaluated according to related bench tests, clinical studies and our own clinical experiences. The aim of this review is to provide interventionists with new insights for the treatment of coronary bifurcation lesions.

Intracoronary imaging guided percutaneous coronary intervention of stent restenosis: does it make a difference?

Abstract Background In-stent restenosis (ISR) remains the most common cause of stent failure after percutaneous coronary intervention (PCI). Compared to coronary angiography (CA), intracoronary imaging (ICI) provides a more accurate and detailed characterization of the degree of ISR and may help identify the underlying pathophysiological mechanism. Although recommended in the European guidelines, the impact of ICI in clinical outcomes in ISR is still under discussion. Purpose Our study aimed to analyze and compare clinical outcomes between CA PCI (group 1 - G1) and ICI-guided PCI (Intravascular ultrasound (IVUS) or optical coherence tomography (OCT)) (group 2 - G2). Methods We performed a retrospective single-center review of all consecutive patients with ISR treated in our center from September 2014 to January 2022. Patients with acute stent thrombosis were excluded. Primary endpoint was defined as death by all causes and secondary endpoint as a composite of cardiovascular (CV) mortality, culprit ISR PCI and ischemic stroke. Results 130 patients were included (mean age 66.23 ± 11.832 years, 77.7% male and mean follow-up period (FUP) 48.70 ± 27.356 months). Mean left ventricular ejection fraction was 50.19 ± 10.509%, 66.2% had dyslipidemia, 45.3% hypertension, 38.5% diabetes, 36.2% heart failure and 29.2% previous multivessel PCI. A total of 142 ISR lesions from 136 arteries were treated and ICI was used in 37 (28.5%) patients (IVUS in 16 (12.3%) and OCT in 21 (16.2%)). The ISR coronary segment and pattern is described in Table 1. The mechanism for ISR was identified in 23 lesions. The most common indication for coronary angiography was stable angina in 34.6% and NSTEMI in 31.5% and ISR was the culprit in 128 (98.5%) of the cases. The groups were well matched regarding baseline characteristics and comorbidities. PCI strategy was more often drug-eluting stenting (DES) vs drug-coated balloon (DCB) in group 2 (DES 18.3% vs 51.4% and DCB 81.7% vs 43.2% in G1 and G2 respectively). And, as expected, treatment of bifurcation lesions was more frequent in group 2 (9.7% G1 vs 30.6% G2). During the FUP there were 10 (7.7%) CV deaths and 19 (14.6%) non-CV deaths (19 in G1 and 0 in G2). The composite outcome of CV mortality, ischemic stroke and culprit ISR PCI occurred in 19 (20.2%) patients in G1 and 1 (2.7%) patient in G2. The use of ICI was associated with reduced all-cause mortality (HR=0.667 [95% CI 0.584-0.760], p=0.011) and reduced composite outcome (B (95%CI): -0.251 (-0.455 - -0.046), p=0.017). No difference between IVUS or OCT was found. The PCI strategy (DES vs DCB), stent type, length or diameter were not predictors of outcomes. Conclusion In IRS PCI, the use of ICI compared to standard of care CA was associated with a reduction in all-cause mortality and composite outcome of CV mortality, culprit ISR PCI and ischemic stroke. The strategy of PCI differed with DES being used more frequently than DCB. No difference between IVUS or OCT was found.

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

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

Clinical outcomes following different stenting techniques for coronary bifurcation lesions: a systematic review and network meta-analysis of randomised controlled trials.

Controversy still exists regarding the optimal treatment of coronary bifurcation lesions. We aimed to analyse the evidence from randomised controlled trials (RCTs) to compare outcomes following different bifurcation stenting techniques. We systematically searched for RCTs comparing different techniques published up to July 2022. We then conducted a pairwise meta-analysis to compare outcomes between provisional stenting (PS) versus upfront 2-stent techniques. Moreover, we performed a network meta-analysis (NMA) to compare all strategies with each other. The primary endpoint was major adverse cardiac events (MACE). Twenty-four RCTs (6,890 patients) analysed PS, T-stenting, double-kissing (DK)-crush, crush, or culotte stenting. The pairwise meta-analysis did not reveal a significant difference between the PS and 2-stent techniques. However, the prespecified sensitivity analysis, which included RCTs exclusively enrolling patients with true bifurcation lesions, showed a lower rate of MACE following 2-stent techniques, and meta-regression indicated that a longer side branch lesion was associated with a greater benefit from the 2-stent strategy, which was the most apparent in RCTs with a mean lesion length >11 mm. NMA revealed that DK-crush was associated with the lowest MACE rate (odds ratio 0.47, 95% confidence interval: 0.36-0.62; p<0.01; PS as a reference). Overall, 2-stent techniques were not significantly better than PS in terms of clinical outcomes. However, the results of the sensitivity analysis suggested that there might be a benefit of a 2-stent approach in selected patients with true bifurcation lesions, especially in the case of long side branch lesions. An NMA revealed that DK-crush was associated with the lowest event rates when compared with other techniques.

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.

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

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

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.

The 17th expert consensus document of the European Bifurcation Club - techniquesto preserve access to the side branch during stepwise provisional stenting.

Provisional stenting has become the default technique for the treatment of most coronary bifurcation lesions. However, the side branch (SB) can become compromised after main vessel (MV) stenting and restoring SB patency can be difficult in challenging anatomies. Angiographic and intracoronary imaging criteria can predict the risk of side branch closure and may encourage use of side branch protection strategies. These protective approaches provide strategies to avoid SB closure or overcome compromise following MV stenting, minimising periprocedural injury. In this article, we analyse the strategies of SB preservation discussed and developed during the most recent European Bifurcation Club (EBC) meetings.

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.

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.

TCTAP A-034 Bifurcation Lesion Treatment With Contemporary Implantation of Two Bifurcation Dedicated Stents: First Side Branch Scaffolding and Second Main Branch Stenting

TCTAP A-034 Bifurcation Lesion Treatment With Contemporary Implantation of Two Bifurcation Dedicated Stents: First Side Branch Scaffolding and Second Main Branch Stenting

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.