Review of Progress in Interventional Therapy for Coronary Bifurcation Lesions.

Despite a decade of extensive research and clinical insights, percutaneous coronary intervention strategies for coronary bifurcation lesions have remained a challenging and highly debated area. This article presents a review of the latest findings and advances in defining and classifying coronary bifurcation lesions, in vitro studies, intracoronary imaging, stenting strategies, and the deployment of drug-coated balloons. Based on current evidence, this review provides recommendations for interventional cardiologists to develop individualized interventional strategies and enhance the efficiency of stenting procedures.

Validation of the Cut-Plane Method for Accurate Measurement of Side-Branch Ostium Area in Coronary Bifurcation Lesions: A 3D-OCT Analysis.

Objective: This study aimed to validate the effectiveness, accuracy, and feasibility of the cut-plane method for measuring the side branch (SB) ostium area in three-dimensional optical coherence tomography (3D-OCT) pullbacks performed in the main branch (MB). Methods: A total of 109 sets of OCT pullbacks from the MB and SB of coronary artery bifurcation lesions were analyzed using Vivolight OCT software. Measurements of the SB ostium area from the MB and SB pullbacks were analyzed. Measurements of the SB ostium area from the actual SB pullback were used as a reference. 3D cut-plane analysis was used to estimate the correlations and mean errors with the reference measurements. Results: Thirty-four sets of OCT images from the C7XR system and 75 sets from the CornarisTM system were analyzed using Vivolight software. There was a strong correlation between the reference measurements of the SB ostium area and the measurements obtained through 3D cut-plane analysis in the overall dataset (r = 0.925). This correlation was observed consistently with both the C7XR system (r = 0.955) and CornarisTM system (r = 0.900). Similar results were found in subset analyses of true and nontrue bifurcations (r = 0.936; r = 0.898, respectively) and in left main (LM) or non-LM bifurcation subsets (r = 0.932; r = 0.873, respectively). Conclusions: There were strong correlations between measurements of the SB ostium area by 3D-OCT and the reference measurements, and thus may be a reliable and accurate alternative to direct OCT pullback examinations of the SB.

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 optimal treatment strategy for coronary bifurcation lesions by percutaneous coronary intervention (PCI) is complex and remains a subject of debate. Current guidelines advise a stepwise provisional approach with optional two-stent strategy. However, a two-stent strategy, both upfront and stepwise provisional, is technically demanding. Therefore, there is increasing interest in the use of drug-eluting balloons (DEB) in bifurcation lesions, mainly after a provisional approach with unsatisfactory result of the side branch. Some small pilot studies already showed that the use of DEB in bifurcation lesions is safe and feasible. However, a randomized comparison of this hybrid DEB strategy with a two-stent strategy is currently lacking. TRIAL DESIGN: 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. CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov no. NCT05731687.

High triglyceride-glucose index predicts cardiovascular events in patients with coronary bifurcation lesions: a large-scale cohort study.

BACKGROUND: Coronary bifurcation lesion, as a complex coronary lesion, is associated with higher risk of long-term poor prognosis than non-bifurcation lesions. The triglyceride-glucose (TyG) index has been shown to predict cardiovascular (CV) events in patients with coronary artery disease (CAD). However, the prognostic value of the TyG index in patients with bifurcation lesions who are at high risk of CV events remains undetermined. Therefore, this study aimed to investigate the association between the TyG index and CV events in patients with bifurcation lesions. METHODS: A total of 4530 consecutive patients with angiography-proven CAD and bifurcation lesions were included in this study from January 2017 to December 2018. The TyG index was calculated as Ln [fasting triglyceride (mg/dL) × fasting plasma glucose (mg/dL)/2]. Patients were assigned into 3 groups according to TyG tertiles (T) (T1: <8.633; T2: 8.633-9.096 and T3: ≥9.096). The primary endpoint was CV events, including CV death, nonfatal myocardial infarction and nonfatal stroke at 3-year follow-up. Restricted cubic spline (RCS) analysis, Kaplan-Meier curves and Cox proportional hazard models were used to investigate the associations between the TyG index and study endpoints. RESULTS: During a median follow-up of 3.1 years, 141 (3.1%) CV events occurred. RCS analysis demonstrated a linear relationship between the TyG index and events after adjusting for age and male sex (non-linear P = 0.262). After multivariable adjustments, elevated TyG index (both T2 and T3) was significantly associated with the risk of CV events (hazard ratio [HR], 1.68; 95% confidence interval [CI],1.06-2.65; HR, 2.10; 95%CI, 1.28-3.47, respectively). When study patients were further stratified according to glycemic status, higher TyG index was associated with significantly higher risk of CV events in diabetic patients after adjusting for confounding factors (T3 vs. T1; HR, 2.68; 95%CI, 1.17-6.11). In addition, subgroup analysis revealed consistent associations of the TyG index with 3-year CV events across various subgroups. Furthermore, adding the TyG index to the original model significantly improved the predictive performance. CONCLUSIONS: High TyG index was associated with CV events in patients with bifurcation lesions, suggesting the TyG index could help in risk stratification and prognosis in this population.

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.

Impact of diabetes on long-term outcomes of bifurcation percutaneous coronary intervention. An analysis from the BIFURCAT registry.

BACKGROUND: It is still unclear the impact of diabetes mellitus (DM) in complex coronary lesions treated with percutaneous coronary intervention (PCI) which themselves are at increased incidence of adverse events. METHODS: BIFURCAT registry encompassed patients treated with PCI for coronary bifurcation lesion from the COBIS III and the RAIN registry. The primary endpoint was the occurrence of major cardiovascular adverse event (MACE), a composite and mutual exclusive of all-cause death or myocardial infarction (MI) or target-lesion revascularization (TLR). A total of 5537 patients were included in the analysis and 1834 (33%) suffered from DM. RESULTS: After a median follow-up of 21 months, diabetic patients had a higher incidence of MACE (17% vs. 9%, p < 0.001), all-cause mortality (9% vs. 4%, p < 0.001), TLR (5% vs. 3%, p = 0.001), MI (4% vs. 2%, p < 0.001), and stent thrombosis (ST) (2% vs. 1%, p = 0.007). After multivariate analysis, diabetes remained significantly associated with MACE (hazard ratio [HR]: 1.37; confidence interval [CI]: 1.13-1.65; p = 0.001), all-cause death (HR: 1.65; 95% CI: 1.24-2.19, p = 0.001), TLR (HR: 1.45; CI: 1.03-2.04; p = 0.031) and ST (HR: 1.73, CI: 1.04-2.88; p = 0.036), but not with MI (HR: 1.34; CI: 0.93-1.92; p = 0.11). Among diabetics, chronic kidney disease (HR: 2.99; CI: 2.21-4.04), baseline left ventricular ejection fraction (HR: 0.98; CI: 0.97-0.99), femoral access (HR: 1.62; CI: 1.23-2.15), left main coronary artery (HR: 1.44; CI: 1.06-1.94), main branch diameter (HR: 0.79; CI: 0.66-0.94) and final kissing balloon (HR: 0.70; CI: 0.52-0.93) were independent predictors of MACE at follow-up. CONCLUSIONS: Patients with DM treated with PCI for coronary bifurcations have a worse prognosis due to higher incidence of MACE, all-cause mortality, TLR and ST compared to the non-diabetics.

Predictors of target lesion failure after treatment of left main, bifurcation, or chronic total occlusion lesions with ultrathin-strut drug-eluting coronary stents in the ULTRA registry.

BACKGROUND: Data about the long-term performance of new-generation ultrathin-strut drug-eluting stents (DES) in challenging coronary lesions, such as left main (LM), bifurcation, and chronic total occlusion (CTO) lesions are scant. METHODS: The international multicenter retrospective observational ULTRA study included consecutive patients treated from September 2016 to August 2021 with ultrathin-strut (<70 µm) DES in challenging de novo lesions. Primary endpoint was target lesion failure (TLF): composite of cardiac death, target-lesion revascularization (TLR), target-vessel myocardial infarction (TVMI), or definite stent thrombosis (ST). Secondary endpoints included all-cause death, acute myocardial infarction (AMI), target vessel revascularization, and TLF components. TLF predictors were assessed with Cox multivariable analysis. RESULTS: Of 1801 patients (age: 66.6 ± 11.2 years; male: 1410 [78.3%]), 170 (9.4%) experienced TLF during follow-up of 3.1 ± 1.4 years. In patients with LM, CTO, and bifurcation lesions, TLF rates were 13.5%, 9.9%, and 8.9%, respectively. Overall, 160 (8.9%) patients died (74 [4.1%] from cardiac causes). AMI and TVMI rates were 6.0% and 3.2%, respectively. ST occurred in 11 (1.1%) patients while 77 (4.3%) underwent TLR. Multivariable analysis identified the following predictors of TLF: age, STEMI with cardiogenic shock, impaired left ventricular ejection fraction, diabetes, and renal dysfunction. Among the procedural variables, total stent length increased TLF risk (HR: 1.01, 95% CI: 1-1.02 per mm increase), while intracoronary imaging reduced the risk substantially (HR: 0.35, 95% CI: 0.12-0.82). CONCLUSIONS: Ultrathin-strut DES showed high efficacy and satisfactory safety, even in patients with challenging coronary lesions. Yet, despite using contemporary gold-standard DES, the association persisted between established patient- and procedure-related features of risk and impaired 3-year clinical outcome.

A novel hybrid strategy of drug coated balloon and stent for coronary bifurcation lesions.

Background. Provisional side branch (SB) stenting strategy is the default approach for the majority of bifurcation lesions, but outcomes of SB is suboptimal. Though drug coated balloon (DCB) improving SB outcomes attracts an increasing attention, sequence of DCB hasn't yet been determined. We presented a novel hybrid strategy of DCB and stent for bifurcation lesions. Methods. With lesion preparation, DCB was persistently inflated in SB kissing with main branch (MB) stent deployment and balloon post-dilation of the bifurcation core. Proximal optimization technique was performed strictly not exceeding the bifurcation. Procedural and clinical adverse events were evaluated. Canadian Cardiovascular Society (CCS) angina classification was assessed at baseline and clinical follow-up. Results. Fourteen patients undergoing the hybrid technique from August 2020 to July 2021 were enrolled. The technique was successfully performed in all patients without rewiring or SB compromise. Minimal lumen diameter of SB increased from 0.60 ± 0.40 mm to 2.1 ± 0.2 mm while the percent stenosis decreased from 72.4 ± 17.9% to 19.6 ± 4.7%. In addition, intravascular ultrasound indicated comparable stent symmetry index and incomplete stent apposition between proximal and distal segments of stent. No further intervention was performed, and mean fractional flow reserve of SB (n = 12) was 0.88 ± 0.05. No major adverse cardiac events was noted in hospital and 12-month follow up. The mean CCS angina score was reduced by 84% (2.2 vs 0.4, p < .001). Conclusion. The hybrid strategy facilitates treatment of DCB and stent for bifurcation lesions, which appears to be feasible and acceptable in a short-term follow-up.

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

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

Protective ballooning technique for prevention of side branch occlusion in coronary nonleft main true bifurcation lesions: A single-center study.

OBJECTIVES: We aimed to evaluate the efficacy of a protective ballooning technique in preventing side branch (SB) occlusion and to assess the long-term clinical outcomes for coronary nonleft main true bifurcation lesions. BACKGROUND: SB occlusion is a major complication associated with percutaneous coronary intervention (PCI) for coronary bifurcation lesions. METHODS: Patients were consecutively enrolled and randomly assigned to protective ballooning technique or jailed wire technique group. Periprocedural and long-term clinical outcomes were compared. RESULTS: Patients in the protective ballooning technique (n = 173) and jailed wire technique (n = 167) groups were followed up for 12 months. SB occlusion occurred in one patient (0.6%) and nine patients (5.4%) in each group, respectively. The proportion of thrombolysis in myocardial infarction (TIMI) flow grade 3 of the SB was higher in the protective ballooning technique group (98.8% vs. 95.2%, p < 0.05). SB rewiring was necessary in one patient in the protective ballooning technique group (0.6%) with provisional stenting, significantly lower than that in the jailed wire technique group (seven patients, 4.2%; p = 0.03). Periprocedural myocardial infarction occurred in three (1.73%) and six (3.59%) patients in the protective ballooning technique and jailed wire technique groups without significant difference, respectively. Major adverse cardiovascular events at 12 months were similar in both groups. CONCLUSIONS: Protective ballooning technique is effective for the prevention of SB occlusion in nonleft main true bifurcation lesions and had favorable long-term outcomes at the 12-month follow-up.

Validation of the V-RESOLVE (Visual Estimation for Risk prEdiction of Side Branch OccLusion in Coronary Bifurcation interVEntion) score system in unprotected left main bifurcation.

OBJECTIVES: This study aimed to assess the risk of side branch (SB) occlusion using the V-RESOLVE (The Visual Estimation for Risk prEdiction of Side Branch OccLusion in Coronary Bifurcation interVEntion) score in unprotected left main (LM) bifurcation percutaneous coronary intervention (PCI). BACKGROUND: The V-RESOLVE score is a validated score system, based on visual estimation of angiographic data, for prediction of the risk of SB occlusion after main vessel (MV) stenting in non-LM bifurcation lesions. However, its predictive value for unprotected LM bifurcation lesions remains to be validated. METHODS: From January 2014 to December 2016, 855 patients undergoing unprotected LM bifurcation PCI using a provisional strategy were included. Baseline and prestenting angiographic data were analyzed, and the V-RESOLVE score was calculated. SB occlusion was defined as any decrease in thrombolysis in myocardial infarction (TIMI) flow grade or the absence of flow in the SB after MV stenting. The predictive performance of the V-RESOLVE score was judged by discrimination, calibration, and clinical application. RESULTS: vSB occlusion occurred in 19 (2.2%) of 855 unprotected LM bifurcation PCI procedures using a provisional strategy. The V-RESOLVE score for SB occlusion had brilliant discrimination (the area under the receiver operating characteristic curve = 0.80, 95% confidence interval [CI]: 0.77-0.84) and good calibration (Hosmer-Lemeshow: p = 0.154). Stratified by the V-RESOLVE score, significantly higher rates of SB occlusion were observed in the high-risk group (score: 12-43) compared with the nonhigh-risk group (score: 0-11) (4.4% vs. 0.6%, p < 0.001). CONCLUSIONS: The V-RESOLVE score is a promising tool to predict the risk of SB occlusion and facilitate decision-making for unprotected LM bifurcation PCI.

6-year results of BiOSS stents in coronary bifurcation treatment.

BACKGROUND: The wide variation in bifurcation anatomy has generated an ongoing search for stents explicitly designed for coronary bifurcations, and to date, results have been underachieved. METHODS: The POLBOS I and POLBOS II were international, multicentre, randomized, open-label, controlled trials. Patients were randomly assigned to BiOSS Expert (in POLBOS I, biodegradable polymer eluting paclitaxel)/BiOSS LIM (in POLBOS II, biodegradable polymer eluting sirolimus) stent implantation or regular drug-eluting stent (rDES) deployment. A provisional T-stenting strategy was the default treatment option. The primary endpoint of this pooled data study was the cumulative rate of major adverse cardiovascular events (MACE) consisting of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). Telephone follow-up was performed annually up to 72 months. (ClinicalTrials.gov Identifier: POLBOS I-NCT02192840, POLBOS II-NCT02198300). RESULTS: The total study population consisted of 445 patients, 222 patients in the BiOSS group and 223 patients in the rDES group. The follow-up rate was 93.7% in the BiOSS group and 91.9% in the rDES group. At 72 months, there was no significant difference between BiOSS and rDES groups regarding MACE (25.7% vs 25.1%, HR 1.06, 95% CI 0.73-1.52), cardiac death (3.1% vs 4.0%, HR 0.94, 95% CI 0.43-2.34), MI (3.6% vs 4.9%, HR 0.76, 95% CI 0.32-2.89), TLR (18.9% vs 16.1%, HR 1.17, 95% CI 0.75-1.83) and stent thrombosis rates (0.9% vs 0.5%, HR 1.21, 95CI 0.75-2.09). CONCLUSIONS: At the 6-year follow-up, clinically significant clinical events did not differ between BiOSS stents and rDES.

Back to the future: the role of DCB for the treatment of coronary bifurcation.

Coronary bifurcation lesion (CBL) is a common but challenging scenario in percutaneous coronary interventions. Drug-coated balloons (DCBs) are modern devices with attractive perspective in CBL treatment. In-stent restenosis, small vessel and diffuse de-novo coronary artery disease have been, so far, considered the ideal scenario for DCBs application. Studies assessing DCBs in de-novo CBL demonstrated the safety and efficacy of this strategy. However, the heterogeneity of the study populations and the presence of methodological limitations prevent from drawing definite recommendations. Considering that the best treatment of bifurcations has not yet been defined, the "leaving nothing behind" philosophy will be the topic of future studies.

Impact of stent designs of second-generation drug-eluting stents on long-term outcomes in coronary bifurcation lesions.

OBJECTIVES: We compared the long-term clinical outcomes of four different types of second-generation drug-eluting stents (DESs) in coronary bifurcation lesions. BACKGROUND: Clinical outcomes of different designs of second-generation DESs are not well known in bifurcation lesions. METHODS: Patients who underwent percutaneous coronary intervention with second-generation DESs for coronary bifurcation lesion were enrolled from 21 centers in South Korea. A total of 2,526 patients was evaluated and divided into four treatment groups according to DES type: bioabsorbable polymer biolimus-eluting stent (BP-BES group, n = 514), platinum chromium everolimus-eluting stent (PtCr-EES group, n = 473), cobalt nickel zotarolimus-eluting stent (CoNi-ZES group, n = 736), or cobalt chromium everolimus-eluting stent (CoCr-EES group, n = 803). Primary outcome was target lesion failure (TLF, defined as a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization). Inverse probability of treatment weighting (IPTW) was performed to reduce selection bias and potential confounding factors. RESULTS: For 5 years of follow-up, the rates of TLF among the four DES groups were not significantly different (6.2% for BP-BES group, 8.2% for PtCr-EES group, 6.5% for CoNi-ZES group, and 8.6% for CoCr-EES group, p = .434). The results were consistent after IPTW adjustment (6.8, 8.4, 6.0, and 7.5%, respectively, p = .554). In subgroup analysis, the similarity of long-term outcomes among the four different types of second-generation DES was consistent across subgroups regardless of side branch treatment (p for interaction = .691). CONCLUSION: There seems to be no significant difference in long-term clinical outcomes among patients who received different types of second-generation DES for coronary bifurcation lesion.

Double kissing inflation outside the stent secures the patency of small side branch without rewiring.

BACKGROUND: The jailed balloon technique is widely used for coronary bifurcation lesions, but a residual risk of SB occlusion remains, necessitating SB rewiring and further interventions, including balloon inflation or stenting, which may result in failure and SB loss. This study introduced a novel modified technique of small side branch (SB) protection, namely, double kissing inflation outside the stent (DKo) technique, for coronary bifurcations without the need for SB rewiring. METHODS: We performed the DKo technique in consecutive patients in our center from 1/2019 to 12/2019. The procedure was as follows. We inserted a guide wire into both branches followed by proper preparation. The SB balloon was simultaneously inflated with main vessel (MV) stenting. The SB balloon remained in situ until it was kissing inflated with postdilation of the bifurcation core, which is different from traditional strategies. The proximal optimization technique was performed with a short noncompliant balloon strictly not exceeding the bifurcation. Rates of SB loss and in-hospital outcomes were evaluated. RESULTS: The technique was successfully performed in all 117 enrolled patients without any rewiring or SB loss. The mean lesion lengths of the MV and SB were 38.3 ± 19.9 mm and 11.7 ± 7.1 mm, respectively. On average, 1.5 ± 0.6 stents were used per patient, while the mean pressure of the SB balloon was 7.4 ± 3.1 atm. DKo achieved excellent procedural success in the proximal and distal MVs: increased minimal lumen diameter (0.64 ± 0.58 mm to 3.05 ± 0.38 mm, p < 0.001; 0.57 ± 0.63 mm to 2.67 ± 0.35 mm, p < 0.001) and low residual stenosis (11.4 ± 3.4%; 7.2 ± 4.6%). DKo secured the patency of the SB without any rewiring and improved the SB stenosis with minimal lumen diameter (0.59 ± 0.48 mm to 1.20 ± 0.42 mm, p < 0.001) and stenosis (71.9 ± 19.4% to 42.2 ± 14.0%, p < 0.001). No MACE was noted in the hospital. CONCLUSIONS: DKo for bifurcation lesions was shown to be acceptable with high procedural success and excellent SB protection.

Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial.

AIM: The present study aimed to assess the benefits of two-stent techniques for patients with DEFINITION criteria-defined complex coronary bifurcation lesions. METHODS AND RESULTS: In total, 653 patients with complex bifurcation lesions at 49 international centres were randomly assigned to undergo the systematic two-stent technique (two-stent group) or provisional stenting (provisional group). The primary endpoint was the composite of target lesion failure (TLF) at the 1-year follow-up, including cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR). The safety endpoint was definite or probable stent thrombosis. At the 1-year follow-up, TLF occurred in 37 (11.4%) and 20 (6.1%) patients in the provisional and two-stent groups, respectively [77.8%: double-kissing crush; hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.30-0.90; P = 0.019], largely driven by increased TVMI (7.1%, HR 0.43, 95% CI 0.20-0.90; P = 0.025) and clinically driven TLR (5.5%, HR 0.43, 95% CI 0.19-1.00; P = 0.049) in the provisional group. At the 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31-2.37; P = 0.772). CONCLUSION: For DEFINITION criteria-defined complex coronary bifurcation lesions, the systematic two-stent approach was associated with a significant improvement in clinical outcomes compared with the provisional stenting approach. Further study is urgently warranted to identify the mechanisms contributing to the increased rate of TVMI after provisional stenting. STUDY REGISTRATION: http://www.clinicaltrials.com; Identifier: NCT02284750.

The impact of the extent of side branch disease on outcomes following bifurcation stenting.

OBJECTIVES: To define the impact of side branch (SB) lesion length on clinical outcomes after percutaneous coronary intervention (PCI) on bifurcation lesions. BACKGROUND: The role of the SB lesion length remains questionable in PCI planning and its implication on clinical outcome is controversial. METHODS: Data from the retrospective multicenter EBC-P2BiTO registry were analyzed. The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction excluding periprocedural, or stent thrombosis at 13 months median follow-up (IQR 11-28). By using propensity scores for inverse probability of treatment weighting (IPTW), the comparison of treatment groups was adjusted to correct for potential confounding. RESULTS: Among 1,252 patients, SB was normal in 489 (39%), diseased in 763 (61%) cases. MACE occurred in 68 patients (5.4%). The optimal discriminant SB lesion length for MACE was ≥10 mm, with an area under the curve of 0.71 (p < .01). The incidence of MACE was higher among patients with SB lesions ≥10 mm (8%) than with normal SB (4.1%) (hazard ratio [HR], 2.8; 95% confidence interval [CI], 1.5-5.3; p = .001, IPTW-adjusted) or SB lesions <10 mm (5.1%) (HR, 1.5; 95% CI, 1.1-3.3; p = .048, IPTW-adjusted), being similar between these last two groups. CONCLUSIONS: In bifurcation PCI, SB lesion length ≥ 10 mm identifies patients at higher risk of MACE than those with <10 mm SB lesions and those without SB disease, considering that no differences were observed among these last two groups. Careful planning is mandatory when approaching bifurcations with long SB lesions.

Comparison of bioresorbable vs durable polymer drug-eluting stents in unprotected left main (from the RAIN-CARDIOGROUP VII Study).

BACKGROUND: There are limited data regarding the impact of bioresorbable polymer drug eluting stent (BP-DES) compared to durable polymer drug eluting stent (DP-DES) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. METHODS: In the RAIN registry (ClinicalTrials NCT03544294, june 2018 retrospectively registered) patients with a ULM or bifurcation stenosis treated with PCI using ultrathin stents (struts thinner than 81 µm) were enrolled. The primary endpoint was the rate of target lesion revascularization (TLR); major adverse cardiovascular events (MACE, a composite of all-cause death, myocardial infarction, TLR and stent thrombosis) and its components, along with target vessel revascularization (TVR) were the secondary ones. A propensity score with matching analysis to compare patients treated with BP-DES versus DP-DES was also assessed. RESULTS: From 3001 enrolled patients, after propensity score analysis 1400 patients (700 for each group) were selected. Among them, 352 had ULM disease and 1048 had non-LM bifurcations. At 16 months (12-22), rates of TLR (3.7% vs 2.9%, p = 0.22) and MACE were similar (12.3% vs. 11.6%, p = 0.74) as well as for the other endpoints. Sensitivity analysis of outcomes after a two-stents strategy, showed better outcome in term of MACE (20.4% vs 10%, p = 0.03) and TVR (12% vs 4.6%, p = 0.05) and a trend towards lower TLR in patients treated with BP-DES. CONCLUSION: In patients with bifurcations or ULM treated with ultrathin stents BP-DES seems to perform similarly to DP-DES: the trends toward improved clinical outcomes in patients treated with the BP-DES might potentially be of value for speculating the stent choice in selected high-risk subgroups of patients at increased risk of ischemic events. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03544294. Retrospectively registered June 1, 2018.

Szabo 2-stent technique for coronary bifurcation lesions: procedural and short-term outcomes.

BACKGROUND: Provisional 1-stent technique is currently regarded as the default approach for the majority of bifurcation lesions. Nonetheless, 2-stent techniques may be required for complex bifurcations with high compromise risk or fatal consequences of side branch (SB) occlusion. Limitations exist in current approaches, as stents gap, multiple metal layers and stent malapposition caused by imprecise placement with fluoroscopic guide and intrinsic technical defects. This study was designed to investigate the effectiveness of the novel Szabo 2-stent technique for coronary bifurcation lesions. METHODS: In the Szabo 2-stent technique, one stent is precisely implanted at the SB ostium with Szabo technique resulting in a single strut protruding into the main vessel (MV). After MV rewiring and SB guidewire withdrawal, another stent is implanted in MV followed by proximal optimization technique, SB rewiring, and final kissing inflation (FKI). RESULTS: The technique tested successfully in silicone tubes (n = 9) with: procedure duration, 31.2 ± 6.8 min; MV and SB rewiring time, 26.8 ± 11.2 s and 33.3 ± 15 s; easy FKI; and 2.3 ± 0.5 balloons/procedure. Bifurcation lesions (n = 22) were treated with angiographic success in MV and SB, respectively: increased minimal lumen diameter (0.63 ± 0.32 mm to 3.20 ± 0.35 mm; 0.49 ± 0.37 mm to 2.67 ± 0.25 mm); low residual stenosis (12.4 ± 2.4%; 12.4 ± 2.3%); and intravascular ultrasound confirmed (n = 19) full coverage; minimal overlap and malapposition; minimal lumen area (2.4 ± 1.2 mm2; 2.1 ± 1.0 mm2); plaque burden (78.1 ± 11.3%; 71.6 ± 15.5%); and minimal stent area (9.1 ± 1.6 mm2; 6.1 ± 1.3 mm2). Periprocedural cardiac troponin increased in 1 asymptomatic patient without electrocardiographic change. There was no target lesion failure (cardiac death, myocardial infarction, target lesion revascularization) at 6-month follow-up. CONCLUSIONS: The Szabo 2-stent technique for bifurcation lesions provided acceptable safety and efficacy at short-term follow-up.

Concept and practice of transradial 5 French percutaneous treatment of coronary bifurcation lesions.

OBJECTIVES: To assess the efficacy and safety of transradial 5 French percutaneous treatment of coronary bifurcations using conventional devices. BACKGROUND: Radial artery is smaller than femoral artery, and its size may potentially limit transradial intervention, especially when coronary anatomy is not known. METHODS: Patients with bifurcations lesions undergoing transradial 5 French ad hoc revascularization were treated according to provisional side branch (SB) stenting followed by the POT-SB dilation-final POT sequence. Only conventional devices were used. RESULTS: Overall, 80 patients (58 men, 65 ± 10 years) were enrolled. True bifurcations accounted for 64% of cases, with the left anterior descending artery/diagonal branch being the most frequent bifurcation site (n = 37, 46%) and left main coronary artery bifurcation being treated in 6 (8%) patients. Angiographic success was achieved in 78 (97.5%) patients through a 5 French guiding catheter whereas in two cases, a 5-6 French guiding catheter upgrade was required to optimize SB treatment after the main bifurcation vessel have been secured. Overall, procedural success was achieved in all but one patient who had periprocedural necrosis following multivessel PCI. Another patient underwent target bifurcation revascularization because of a critical restenosis in a significant SB yielding an acute coronary syndrome five months after the index procedure. CONCLUSIONS: This study demonstrates the feasibility of transradial 5 French bifurcation intervention with nondedicated devices and preliminary supports its efficacy and safety over a wide range of bifurcation anatomy and complexity.