Rationale and protocol of the LAQUA-HF trial: a factorial randomised controlled trial evaluating the effects of neurohormonal and diuretic agents on health-status reported outcomes in heart failure patients.

INTRODUCTION: The current guidelines strongly recommend early initiation of multiple classes of cardioprotective drugs for patients with heart failure with reduced ejection fraction to improve prognosis and health status. However, evidence on the optimal sequencing of approved drugs is scarce, highlighting the importance of individualised treatment plans. Registry data indicate that only a portion of these patients can tolerate all four recommended classes, underscoring the need to establish the favoured sequence when using these drugs. Additionally, the choice between long-acting and short-acting loop diuretics in the present era remains uncertain. This is particularly relevant given the frequent use of angiotensin receptor-neprilysin inhibitor and sodium-glucose cotransporter 2 inhibitor, both of which potentiate natriuretic effects. METHODS AND ANALYSIS: In a prospective, randomised, open-label, blinded endpoint method, LAQUA-HF (Long-acting vs short-acting diuretics and neurohormonal Agents on patients' QUAlity-of-life in Heart Failure patients) will be a 2×2 factorial design, with a total of 240 patients randomised to sacubitril/valsartan versus dapagliflozin and torsemide versus furosemide in a 1:1 ratio. Most enrolment sites have participated in an ongoing observational registry for consecutive patients hospitalised for heart failure involved dedicated study coordinators, and used the same framework to enrol patients. The primary endpoint is the change in patients' health status over 6 months, defined by the Kansas City Cardiomyopathy Questionnaire. Additionally, clinical benefit at 6 months defined as a hierarchical composite endpoint will be assessed by the win ratio as the secondary endpoint. ETHICS AND DISSEMINATION: The medical ethics committee Keio University in Japan has approved this trial. All participants provide written informed consent prior to study entry. The results of this trial will be disseminated in one main paper and additional papers on secondary endpoints and subgroup analyses. TRIAL REGISTRATION NUMBER: UMIN000045229.

Review of Bleeding and Thrombotic Risks Associated With Antithrombotic Therapy After Transcatheter Structural Heart Interventions.

Transcatheter structural heart interventions have drastically evolved over the past 2 decades. However, most catheterization procedures require the deployment of devices in the body; therefore, the adhesion of thrombi to those devices is a major problem, resulting in the requirement of a period of postprocedural antithrombotic regimen. However, in recent years, bleeding associated with these antithrombotic therapies has also become a major concern, attracting the attention of investigators. This is complicated by the fact that patients at high thrombotic risk are also at high bleeding risk, making the issue of administrating antithrombotic therapy challenging. The objective of this review was to identify the important issues and summarize the current status of postoperative antithrombotic therapy and assessment of the bleeding risk following transcatheter structural heart interventions such as transcatheter aortic valve replacement, transcatheter edge-to-edge repair, and transcatheter left atrial appendage occlusion.

Transradial intervention in dialysis patients undergoing percutaneous coronary intervention: a Japanese nationwide registry study.

Aims: Transradial intervention (TRI) for percutaneous coronary intervention (PCI) is used to reduce periprocedural complications. However, its effectiveness and safety for patients on dialysis are not well established. We aimed to investigate the association of TRI with in-hospital complications in dialysis patients undergoing PCI. Methods and results: We included 44 462 patients on dialysis who underwent PCI using Japanese nationwide PCI registry data (2019-21) regardless of acute or chronic coronary syndrome. Patients were categorized based on access site: TRI, transfemoral intervention (TFI). Periprocedural access site bleeding complication requiring transfusion was the primary outcome and in-hospital death, and other periprocedural complications were the secondary outcomes. Matched weighted analysis was performed for TRI and TFI. Here, 8267 (18.6%) underwent TRI, and 36 195 (81.4%) underwent TFI. Patients who received TRI were older and had lower rates of comorbidities than those who received TFI. Access site bleeding rate and in-hospital death were significantly lower in the TRI group (0.1% vs. 0.7%, P < 0.001; 1.8% vs. 3.2%, P < 0.001, respectively). After adjustment, TRI was associated with a lower risk of access site bleeding (odds ratio [OR] [95% confidence interval (CI)]: 0.19 [0.099-0.38]; P < 0.001) and in-hospital death (OR [95% CI]: 0.79 [0.65-0.96]; P = 0.02). Other periprocedural complications between TRI and TFI were not significantly different. Conclusion: In patients undergoing dialysis and PCI, TRI had a lower risk of access site bleeding and in-hospital death than TFI. This suggests that TRI may be safer for this patient population.

A case of atrial septal defect with right-to-left shunting without pulmonary hypertension.

We report a case of a 54-year-old man with atrial septal defect who presented with oxygen desaturation on pulse oximetry. Cardiac magnetic resonance imaging and transesophageal echocardiography showed right-to-left shunting through an atrial septal defect, which was confirmed by superior vena cavography and suggested Eisenmenger syndrome. However, cardiac catheterization revealed a normal pulmonary arterial pressure. Simultaneous measurement of interatrial pressure identified two transient interatrial pressure gradient points, where the right atrial pressure was higher than the left atrial pressure. The patient was finally diagnosed with atrial septal defect without pulmonary hypertension. Right-to-left shunting was primarily caused by a transient interatrial pressure gradient due to a time delay in both initial atrial contraction and completion of passive ventricular filling between the right and left sides of the heart. Surgical closure of the atrial septal defect was performed, and hypoxemia improved. This is the first report of right-to-left shunting without pulmonary hypertension caused by a transient interatrial pressure gradient due to a time delay between the right and left cardiac cycles. Precise assessment of the simultaneous interatrial pressure in addition to diagnostic imaging played a pivotal role in clarifying the etiology of this rare condition. Learning objective: Atrial septal defect with right-to-left shunting without Eisenmenger syndrome is a rare condition. We identified transient interatrial pressure gradients associated with a time delay in both initial atrial contraction and completion of the passive ventricular filling phase, which we considered as the primary mechanism underpinning right-to-left shunting. Simultaneous measurement of interatrial pressure played a pivotal role in elucidating the hemodynamics and abnormal shunt flow mechanism.

One-year outcomes of patients undergoing percutaneous coronary intervention with the revived directional coronary atherectomy catheter: Insights from the J-PCI OUTCOME registry.

OBJECTIVES: We sought to investigate the 1-year outcomes, including all-cause and cardiovascular mortality, major adverse cardiovascular events (MACEs), and major bleeding, of patients undergoing percutaneous coronary intervention (PCI) with or without the revived directional coronary atherectomy (DCA) catheter in a Japanese nationwide registry. BACKGROUND: Clinical data regarding the midterm outcomes of patients undergoing PCI with DCA are scarce in contemporary real-world practice. METHODS: We analyzed the data of 74,764 patients who underwent PCI at 179 hospitals from January 2017 to December 2018. The baseline characteristics and 1-year outcomes of patients with stable coronary artery disease or unstable angina who underwent PCI with or without DCA were assessed. RESULTS: Overall, 431 patients (0.6%) underwent PCI with DCA. Patients in the DCA group were younger and predominantly male, with fewer comorbidities than patients in the non-DCA group. Stentless PCI with DCA following additional drug-coated balloon (DCB) angioplasty was the dominant strategy in the DCA group (43.6%). One-year outcomes, including all-cause mortality (1.2% in the DCA group vs. 2.5% in the non-DCA group, respectively, p = 0.075), cardiovascular death (0.9% vs. 1.0%, p = 0.69), MACEs (1.9% vs. 1.8%, p = 0.96), and nonfatal major bleeding requiring readmission (1.2% vs. 1.4%, p = 0.62), were comparable between the two groups. In the DCA group, 1-year outcomes were comparable, regardless of whether the stent or DCB was used. CONCLUSIONS: One-year clinical outcomes after PCI with DCA in patients with stable coronary artery disease or unstable angina are acceptable, regardless of stent use.

Long-term outcomes of periprocedural coronary dissection and perforation for patients undergoing percutaneous coronary intervention in a Japanese multicenter registry.

Long-term outcomes of iatrogenic coronary dissection and perforation in patients undergoing percutaneous coronary intervention (PCI) remains under-investigated. We analyzed 8,721 consecutive patients discharged after PCI between 2008 and 2019 from Keio Cardiovascular (KiCS) PCI multicenter prospective registry in the Tokyo metropolitan area. Significant coronary dissection was defined as persistent contrast medium extravasation or spiral or persistent filling defects with complete distal and impaired flow. The primary outcome was a composite of all-cause death, acute coronary syndrome, heart failure, bleeding, stroke requiring admission, and coronary artery bypass grafting two years after discharge. We used a multivariable Cox hazard regression model to assess the effects of these complications. Among the patients, 68 (0.78%) had significant coronary dissections, and 61 (0.70%) had coronary perforations at the index PCI. Patients with significant coronary dissection had higher rates of the primary endpoint and heart failure than those without (25.0% versus 14.3%, P = 0.02; 10.3% versus 4.2%, P = 0.03); there were no significant differences in the primary outcomes between the patients with and without coronary perforation (i.e., primary outcome: 8.2% versus 14.5%, P = 0.23) at the two-year follow-up. After adjustments, patients with coronary dissection had a significantly higher rate of the primary endpoint than those without (HR 1.70, 95% CI 1.02-2.84; P = 0.04), but there was no significant difference in the primary endpoint between the patients with and without coronary perforation (HR 0.51, 95% CI 0.21-1.23; P = 0.13). For patients undergoing PCI, significant coronary dissection was associated with poor long-term outcomes, including heart failure readmission.

Impact of coronary bifurcation angle on stent malapposition in a randomized comparison between proximal optimization technique followed by side branch dilatation and kissing balloon inflation.

Background: The impact of coronary bifurcation angle (BA) on incomplete stent apposition (ISA) after crossover stenting followed by side branch (SB) intervention has not been established. Methods: A total of 100 crossover stentings randomly treated with proximal optimization technique followed by short balloon dilation in the SB (POT-SBD group, 48 patients) and final kissing balloon technique (KBT group, 52 patients) were analyzed in the PROPOT trial. Major ISA with maximum distance > 400 µm and its location was determined using optical coherence tomography before SB intervention and at the final procedure. The BA was defined as the angle between the distal main vessel and SB. Optimal POT was determined when the difference in stent volume index between the proximal and distal bifurcation was greater than the median value (0.86 mm3/mm) before SB intervention. Result: Major ISA was more frequently observed in the POT-SBD than in the KBT group (35% versus 17%, p < 0.05). In the POT-SBD group, worsening ISA after SBD was prominent at the distal bifurcation. The BA was an independent predictor of major ISA (odds ratio 1.04, 95% confidence interval 1.00-1.07, p < 0.05) with a cut-off value of 59.5° (p < 0.05). However, the cases treated with optimal POT in the short BA (<60°) indicated the lowest incidence of major ISA. In the KBT group, BA had no significant impact. Conclusion: A wide BA has a potential risk for the occurrence of major ISA after POT followed by SBD in coronary bifurcation stenting.

Gender Differences in Long-Term Outcomes of Young Patients Who Underwent Percutaneous Coronary Intervention: Long-Term Outcome Analysis from a Multicenter Registry in Japan.

Young patients who underwent percutaneous coronary intervention (PCI) have shown worse long-term outcomes but remain inadequately investigated. We analyzed 1,186 consecutive young patients (aged ≤55 years) from the Keio Cardiovascular PCI registry who were successfully discharged after PCI (2008 to 2019) and compared them to 5,048 older patients (aged 55 to 75 years). The primary outcome was a composite of all-cause death, acute coronary syndrome, heart failure, bleeding, stroke requiring admission, and coronary artery bypass grafting within 2 years after discharge. In the young patients, the mean age was 48.4 ± 5.4 years, acute coronary syndrome cases accounted for 69.6%, and 92 (7.8%) were female. Body mass index; hemoglobin levels; and proportions of smoking, hyperlipidemia, and ST-elevation myocardial infarction were lower and dialysis or active cancer proportions were higher in young female patients than male patients. A higher number of young female than male patients reached the primary end point and all-cause death (15.2% vs 7.1%, p = 0.01; 4.3% vs 1.0%, p = 0.023), mainly because of noncardiac death (4.3% versus 0.5%, p = 0.001). After covariate adjustment, the primary end point rates were higher among young women than men (hazard ratio 2.00, 95% confidence interval 1.03 to 3.89, p = 0.042). Gender did not predict the primary end point among older patients (vs men; hazard ratio 0.84, 95% confidence interval 0.67 to 1.06, p = 0.14). In conclusion, young women showed worse outcomes during the 2-year post-PCI follow-up, but this gender difference was absent in patients aged 55 to 75 years.

Ischemic and Bleeding Outcomes in Patients Who Underwent Percutaneous Coronary Intervention With Chronic Kidney Disease or Dialysis (from a Japanese Nationwide Registry).

The relation between chronic kidney disease (CKD) and outcomes in patients receiving percutaneous coronary intervention (PCI) is thought to be bidirectional; these patients are at a higher risk of ischemic and bleeding events. From a Japanese nationwide PCI registry, ischemic (cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke) and bleeding events (fatal or nonfatal major bleeding) 1 year after discharge among patients who had second- or newer-generation drug-eluting stent implantation were analyzed. Patients on oral anticoagulants were excluded. Patients were stratified according to their preprocedural renal function: CKD stages 1 to 2 (estimated glomerular filtration rate [eGFR] ≥60 ml/min/1.73 m2), 3 (eGFR 30 to 59), or 4 to 5 (eGFR <30), or those receiving dialysis. Overall, 23,349 patients, including 2,798 patients with CKD 3 to 5 (12.0%) and 1,464 patients on dialysis (6.3%), were investigated. One-year ischemic events were observed in 1.5%, 5.2%, 9.7%, and 5.3% in the CKD stages 1-to-2, 3, 4-to-5, and dialysis groups, respectively; patients with CKD stages 3 or 4 to 5 and those receiving dialysis were associated with higher risks of ischemic events after adjustment of covariates than were patients without CKD. Compared with ischemic events, 1-year bleeding events were low, with incidence rates of 1.5%, 2.0%, 3.4%, and 2.3%, respectively. Furthermore, the presence of CKD or dialysis was not associated with a higher risk of bleeding events after adjustment of covariates. In conclusion, in the contemporary nationwide PCI registry, the presence of CKD and dialysis was independently associated with a higher risk of ischemic events but not with bleeding events, and this suggests a need to alter the models of care delivery in these patients.

Standard modifiable cardiovascular risk factors in patients with acute coronary syndrome: A report from multicenter percutaneous coronary intervention registry.

BACKGROUND: High mortality in patients with acute coronary syndrome (ACS) without standard modifiable cardiovascular risk factors [SMuRFs (e.g. diabetes, hypertension, smoking, and dyslipidemia)] has been reported. However, details regarding their acute presentation and reasons for the excess risk remain unclear. METHOD: Patient-level data were extracted from a multicenter procedure-based registry (KiCS-PCI). We analyzed consecutive patients with ACS who underwent de novo percutaneous coronary intervention (PCI) between 2009 and 2020. The primary outcome of interest was the in-hospital mortality. RESULTS: Among the 10,523 patients with ACS, 7775 met the inclusion criteria. Patients without SMuRFs who underwent PCI [n = 529 (6.8 %)] were older [median 71 (IQR: 63-79) vs. 68 (59-76) years, p < 0.001] and more often presented with cardiogenic shock or cardiopulmonary arrest (14.6 % vs. 8.6 %, p < 0.001; 12.7 % vs. 5.3 %, p < 0.001, respectively). In patients with ST-elevation myocardial infarction (STEMI), median door-to-balloon time was significantly longer in SMuRF-less patients (90 min vs 82 min). In-hospital death was significantly higher in SMuRF-less patients [10.2 % vs. 4.1 %, p < 0.001, adjusted odds ratio, 1.81 (95%CI, 1.26-2.59); p = 0.001], whereas the rate of procedural complications showed no significant difference. When stratified by the ACS presentation pattern, the findings were consistent, although the association between SMuRF-less and the increased risk of in-hospital mortality was not statistically significant in patients with non-ST-elevation- (NSTE)-ACS. CONCLUSIONS: SMuRF-less ACS patients frequently presented with cardiopulmonary arrest and/or cardiogenic shock, leading to high in-hospital mortality. When stratified by the ACS presentation pattern, the association of SMuRF-less and the increased risk of mortality was more prominent in STEMI patients and it was not statistically significant in NSTE-ACS patients. Almost half of these patients had amendable left main trunk or left anterior descending artery disease and treating clinicians should be aware of this paradox to avoid the delay in treatment.

Time Trend in Incidence of Sudden Cardiac Death After Percutaneous Coronary Intervention from 2009 to 2017 (from the Japanese Multicenter Registry).

The advances in the integrated management of patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) have reduced subsequent cardiovascular events. Nonetheless, sudden cardiac death (SCD) remains a major concern. Therefore, we aimed to investigate the time trend in SCD incidence after PCI and to identify the clinical factors contributing to SCD. From a prospective, multicenter cohort registry in Japan, 8,723 consecutive patients with coronary artery disease undergoing PCI between 2009 and 2017 were included. We evaluated the SCD incidence 2 years after PCI; all death events were adjudicated, and SCD was defined as unexpected death without a noncardiovascular cause in a previously stable patient within 24 hours from the onset. The Fine and Gray method was used to identify the factors associated with SCD. Overall, the mean age of the patients was 68.3 ± 11.3 years, and 1,173 patients (13.4%) had heart failure (HF). During the study period, the use of second-generation drug-eluting stents increased. The 2-year cumulative incidence of all-cause mortality and SCD was 4.29% and 0.45%, respectively. All-cause mortality remained stable during the study period (p for trend = 0.98), whereas the crude incidence of SCD tended to decrease over the study period (p for trend = 0.052). HF was the strongest predictor associated with the risk of SCD (crude incidence [vs non-HF] 2.13% vs 0.19%; p <0.001). In conclusion, the incidence of SCD after PCI decreased over the last decade, albeit the high incidence of SCD among patients with HF remains concerning.

Contrast volume and in-hospital outcomes of dialysis patients undergoing percutaneous coronary intervention.

Toxicity resulting from retained contrast media may cause adverse cardiovascular outcomes (e.g., heart failure and cardiogenic shock) for dialysis patients. However, the association between the administered contrast volume and outcomes of dialysis patients after percutaneous coronary intervention (PCI) has not been sufficiently investigated. We evaluated 953 consecutive dialysis patients (age, 67.9 ± 9.9 years; 30.1% with acute coronary syndrome) who underwent PCI between September 2008 and March 2019. Patients were divided into two groups: those with a contrast volume ≥ 200 ml and those with a contrast volume < 200 ml. The cutoff was 200 ml because 100 ml increment of contrast volume is known to raise the risk of acute kidney injury, and 200 ml is more than the average volume used at most PCI centers. The primary endpoint was a composite of in-hospital death, post-PCI cardiogenic shock and post-PCI heart failure. A multivariable logistic regression model and smooth spline curve were constructed to assess the association between contrast volume and the primary endpoint. The median contrast volume was 157 ml (interquartile range, 115-210 ml). The overall primary endpoint incidence was 6.8% (N = 65). A contrast volume ≥ 200 ml was associated with a higher risk of the primary endpoint (odds ratio 2.91; 95% confidence interval 1.42-6.05; P = 0.004). The smooth spline curve demonstrated a linear relationship between the contrast volume and primary endpoint. In conclusions, the contrast volume was associated with adverse in-hospital outcomes of dialysis patients undergoing PCI. Attention should be focused on the contrast volume used for dialysis patients undergoing PCI.

Essential thrombocythemia complicated with simultaneous two-vessel acute myocardial infarction in the subacute phase of takotsubo cardiomyopathy: A case report.

We report the case of a 79-year-old woman with essential thrombocythemia who presented with simultaneous two-vessel acute myocardial infarction (AMI) in the subacute phase of takotsubo cardiomyopathy. Despite sufficient anticoagulation therapy with warfarin to prevent thrombus formation in the left ventricle, the patient developed simultaneous two-vessel AMI in the right and left circumflex coronary arteries 16 days after the onset of takotsubo cardiomyopathy. Thromboembolism from the left ventricle associated with takotsubo cardiomyopathy was considered a potential cause of this event. However, macroscopic and pathological findings of the aspirated thrombi revealed that the primary cause of AMI was non-organized white platelet thrombi associated with essential thrombocythemia. In addition to oral anticoagulation therapy with warfarin, low-dose aspirin was started. The patient was discharged without any symptoms, and the clinical course has been uneventful for >5 years. This case highlights the potential risk of fatal complications associated with essential thrombocythemia, including simultaneous multivessel AMI. Additionally, pathological findings of the thrombi may play a crucial role in clarifying the etiology in such complicated cases. Appropriate antithrombotic therapy should be selected according to the pathogenesis of the condition. Learning objective: We describe a 79-year-old woman with essential thrombocythemia complicated with simultaneous two-vessel acute myocardial infarction (AMI) in the subacute phase of takotsubo cardiomyopathy. Although patients with essential thrombocythemia are highly predisposed to thrombotic events including AMI, the appropriate antithrombotic regimen remains controversial. The macroscopic and pathological findings of the thrombi play a pivotal role in clarifying the etiology, which may lead to the appropriate antithrombotic therapy.

Overview of in-hospital outcomes in patients undergoing percutaneous coronary intervention with the revived directional coronary atherectomy.

OBJECTIVES: We sought to provide clinical insights on the usage rate, indications, and in-hospital outcomes of the revived directional coronary atherectomy (DCA) catheter (Atherocut™) in a Japanese nationwide percutaneous coronary intervention (PCI) registry. BACKGROUND: Debulking devices such as the revived DCA catheter have become increasingly important in the era of complex PCI. However, little is known about PCI outcomes using a novel DCA catheter in contemporary real-world practice. METHODS: We analyzed 188,324 patients who underwent PCI in 1112 hospitals from January to December 2018. Baseline characteristics and in-hospital outcomes of patients with stable coronary artery disease or unstable angina who underwent PCI with or without the DCA were analyzed. RESULTS: Overall, 1696 patients (0.9%) underwent PCI with the DCA during the study period, predominantly for left main trunk or proximal left anterior descending artery lesions under a transfemoral approach. Patients in the DCA group were younger and had fewer comorbidities such as hypertension, diabetes mellitus, and chronic kidney disease than patients in the non-DCA group. Stentless PCI using the DCA with drug-coated balloon angioplasty was a preferred treatment strategy in the DCA group (50.0%). Predefined in-hospital adverse outcomes, including mortality (0.2% vs. 0.3%, p = 0.446) and periprocedural complications (1.8% vs. 1.7%, p = 0.697), were comparable between the two groups, whereas the fluoroscopy time was longer and the total contrast volume was higher in the DCA group. CONCLUSIONS: In Japan, PCI using the revived DCA catheter is safely performed with low complication rates in patients with stable coronary artery disease or unstable angina.

Percutaneous coronary intervention during the COVID-19 pandemic in Japan: Insights from the nationwide registration data.

Background: Coronavirus disease 2019 (COVID-19) has negatively affected access to healthcare systems and treatment timelines. This study was designed to explore the impact of the COVID-19 pandemic on patients who underwent percutaneous coronary intervention (PCI). Methods: From January 2019 to December 2020, 489,001 patients from 1068 institutions were registered in the Japanese nationwide PCI (J-PCI) registry. We constructed generalized linear models to assess the difference in the daily number of patients and in-hospital outcomes between 2019 and 2020. Findings: In total, 207 institutions (19·3%) had closed or restricted access during the first COVID-19 outbreak in May 2020; the number of closed or restricted institutions had plateaued at a median of 121 institutions (11·3%). The daily case volume of PCI significantly decreased in 2020 (by 6·7% compared with that in 2019; 95% confidence interval [CI], 6·2-7·2%; p < 0·001). Marked differences in the presentation of PCI patients were observed; more patients presented with ST-segment elevation myocardial infarction (18·3% vs. 17·5%; p < 0·001), acute heart failure (4·49% vs. 4·30%; p = 0·001), cardiogenic shock (3·79% vs. 3·45%; p < 0·001), and cardiopulmonary arrest (2·12% vs. 2·00%; p = 0·002) in 2020. The excess adjusted in-hospital mortality rate in patients treated in 2020 relative to those treated in 2019 was significant (adjusted odds ratio, 1·054; 95% CI, 1·004-1·107; p = 0·03). Interpretation: While the number of patients who underwent PCI substantially decreased during the COVID-19 pandemic, more patients presented with high-risk characteristics and were associated with significantly higher adjusted in-hospital mortality. Funding: The J-PCI registry is a registry led and supported by the Japanese Association of Cardiovascular Intervention and Therapeutics. The present study was supported by the Grant-in-Aid from the Ministry of Health and Labour (No. 20IA2002 and 21FA1015), the Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (KAKENHI; No. 21K08064), and the Japan Agency for Medical Research and Development (No. 17ek0210097h000).

Effect of proximal optimization technique on coronary bifurcation stent failure: Insights from the multicenter randomized PROPOT trial.

OBJECTIVE: We investigated the effect of proximal optimization technique (POT) on coronary bifurcation stent failure (BSF) in cross-over stenting by comparing with the kissing balloon technique (KBT) in a multicenter randomized PROPOT trial. BACKGROUND: POT is recommended due to increased certainty for optimal stent expansion and side branch (SB) wiring. METHODS: We randomized 120 patients treated with crossover stenting into the POT group, which was followed by SB dilation (SBD), and the KBT group. Finally, 52 and 57 patients were analyzed by optical coherence tomography before SBD and at the final procedure, respectively. Composite BSF was defined as a maximal malapposition distance of >400 µm, or malapposed and SB-jailed strut rates of >5.95% and >21.4%, respectively. RESULTS: Composite BSF before SBD in the POT and KBT groups was observed in 29% and 26% of patients, respectively. In the POT group, differences in stent volumetric index between the proximal and distal bifurcation (odds ratio [OR] 60.35, 95% confidential interval [CI] 0.13-0.93, p = 0.036) and between the proximal bifurcation and bifurcation core (OR: 3.68, 95% CI: 1.01-13.40, p = 0.048) were identified as independent risk factors. Composite BSF at final in 27% and 32%, and unplanned additional procedures in 38% and 25% were observed, respectively. Composite BSF before SBD was a risk factor for the former (OR: 6.33, 95% CI: 1.10-36.50, p = 0.039) and the latter (OR: 6.43, 95% CI: 1.25-33.10, p = 0.026) in the POT group. CONCLUSION: POT did not result in a favorable trend in BSF. Insufficient expansion of the bifurcation core after POT was associated with BSF.