Risk Assessment of Side Branch Compromise After Coronary Bifurcation Stenting　- A Substudy of the 3D-OCT Bifurcation Registry.

BACKGROUND: Side branch (SB) occlusion during bifurcation stenting is a serious complication. This study aimed to predict SB compromise (SBC) using optical coherence tomography (OCT).Methods and Results: Among the 168 patients who enrolled in the 3D-OCT Bifurcation Registry, 111 bifurcation lesions were analyzed to develop an OCT risk score for predicting SBC. SBC was defined as worsening of angiographic SB ostial stenosis (≥90%) immediately after stenting. On the basis of OCT before stenting, geometric parameters (SB diameter [SBd], length from proximal branching point to carina tip [BP-CT length], and distance of the polygon of confluence [dPOC]) and 3-dimensional bifurcation types (parallel or perpendicular) were evaluated. SBC occurred in 36 (32%) lesions. The parallel-type bifurcation was significantly more frequent in lesions with SBC. The receiver operating characteristic curve indicated SBd ≤1.77 mm (area under the curve [AUC]=0.73, sensitivity 64%, specificity 75%), BP-CT length ≤1.8 mm (AUC=0.83, sensitivity 86%, specificity 68%), and dPOC ≤3.96 mm (AUC=0.68, sensitivity 63%, specificity 69%) as the best cut-off values for predicting SBC. To create the OCT risk score, we assigned 1 point to each of these factors. As the score increased, the frequency of SBC increased significantly (Score 0, 0%; Score 1, 8.7%; Score 2, 28%; Score 3, 58%; Score 4, 85%; P<0.0001). CONCLUSIONS: Prediction of SBC using OCT is feasible with high probability.

Clinical Characteristics and Outcomes of Patients Presenting With Acute Myocardial Infarction Without Cardiogenic Shock.

BACKGROUND: Most patients with acute myocardial infarction (AMI) present in the emergency department in a hemodynamically stable condition (i.e., non-cardiogenic shock) (AMI-NCS). However, few studies specifically focused on the clinical characteristics and outcomes of AMI-NCS patients. Temporal trends in clinical characteristics, in-hospital occurrence of in-hospital adverse outcomes, and the effect of primary percutaneous coronary intervention (PPCI) were examined.Methods and Results: Between April 2012 and March 2018, 176,275 AMI-NCS patients (67.7% of the total AMI population; 25.4% female; mean age 68.6±13.1 years) were identified in a nationwide Japanese administrative database. During the 6-year study period, AMI-NCS patients have been getting older and had an increasing burden of comorbidities. The rates of 30-day all-cause mortality and in-hospital complications were 2.6% and 30.5%, respectively. Thirty-day all-cause mortality did not change significantly over time, whereas in-hospital complications, especially major non-cardiac events, increased progressively. On multivariable analyses, higher age, higher Killip class, atrial fibrillation, chronic renal failure, and malignancy were independently associated with both increased 30-day mortality and in-hospital complications. PPCI was independently associated with lower mortality and in-hospital complications. CONCLUSIONS: The clinical background of AMI-NCS patients has been becoming more complex with increasing age and the burden of comorbidities, with increased in-hospital complications. More active and appropriate application of PPCI may further decrease adverse events and improve survival of AMI-NCS patients.

European Bifurcation Club white paper on stenting techniques for patients with bifurcated coronary artery lesions.

BACKGROUND: Defining the optimal conduction of percutaneous-coronary-intervention (PCI) to treat bifurcation lesions has been the subject of many clinical studies showing that the applied stenting technique may influence clinical outcome. Accordingly, bifurcation stenting classifications and technical sequences should be standardized to allow proper reporting and comparison. METHODS: The European Bifurcation Club (EBC) is a multidisciplinary group dedicated to optimize the treatment of bifurcations and previously created a classification of bifurcation stenting techniques that is based on the first stent implantation site. Since some techniques have been abandoned, others have been refined and dedicated devices became available, EBC promoted an international task force aimed at updating the classification of bifurcation stenting techniques as well as at highlighting the best practices for most popular techniques. Original descriptive images obtained by drawings, bench tests and micro-computed-tomographic reconstructions have been created in order to serve as tutorials in both procedure reporting and clinical practice. RESULTS: An updated Main-Across-Distal-Side (MADS)-2, classification of bifurcation stenting techniques has been realized and is reported in the present article allowing standardized procedure reporting in both clinical practice and scientific studies. The EBC-promoted task force deeply discussed, agreed on and described (using original drawings and bench tests) the optimal steps for the following major bifurcation stenting techniques: (a) 1-stent techniques ("provisional" and "inverted provisional") and (b) 2-stent techniques ("T/TAP," "culotte," and "DK-crush"). CONCLUSIONS: The present EBC-promoted paper is intended to facilitate technique selection, reporting and performance for PCI on bifurcated lesions during daily clinical practice.

Randomized comparison between 2-link cell design biolimus A9-eluting stent and 3-link cell design everolimus-eluting stent in patients with de novo true coronary bifurcation lesions: the BEGIN trial.

The appropriate stent platform for treating coronary bifurcation lesions (CBLs) remains controversial. Previous bench tests have demonstrated the superiority of a 2-link cell design to 3-link cell design for creating inter-strut dilation at the side branch ostium. This randomized multicenter prospective BEGIN trial compared the biodegradable polymer-based biolimus A9-eluting stent (2-link BES) with the durable polymer-based cobalt chromium everolimus-eluting stent (3-link EES) in 226 patients with de novo CBLs. Patients with true bifurcations, defined as > 50% stenosis in the main vessel and side branch (SB) and an SB diameter > 2.25 mm, were enrolled. Guide wire re-crossing to the distal cell (near the carina) in the jailed SB and final kissing inflation were recommended. The SB angiographic endpoint was < 50% stenosis diameter. Left-main CBLs (13.5% vs. 13.0%) and 2-stent technique (30.6% vs. 22.6%) rates were similar. The primary endpoints (minimum lumen diameter at the SB ostium measured at an independent core laboratory at the 8-month follow-up) were comparable (1.64 ± 0.50 mm vs. 1.63 ± 0.51 mm, p = 0.976). There was no significant difference in composite outcomes of cardiac death, myocardial infarction, or target vascular revascularization at 12 months (7.4% vs. 8.0%, p = 0.894). Two-link BES and 3-link EES showed similar 8-month angiographic and 1-year clinical outcomes for true CBLs.

Effect of pioglitazone on cardiometabolic profiles and safety in patients with type 2 diabetes undergoing percutaneous coronary artery intervention: a prospective, multicenter, randomized trial.

Pioglitazone has superior antiatherosclerotic effects compared with other classes of antidiabetic agents, and there is substantial evidence that pioglitazone improves cardiovascular (CV) outcomes. However, there is also a potential risk of worsening heart failure (HF). Therefore, it is clinically important to determine whether pioglitazone is safe in patients with type 2 diabetes mellitus (T2DM) who require treatment for secondary prevention of CV disease, since they have an intrinsically higher risk of HF. This prospective, multicenter, open-label, randomized study investigated the effects of pioglitazone on cardiometabolic profiles and CV safety in T2DM patients undergoing elective percutaneous coronary intervention (PCI) using bare-metal stents or first-generation drug-eluting stents. A total of 94 eligible patients were randomly assigned to either a pioglitazone or conventional (control) group, and pioglitazone was started the day before PCI. Cardiometabolic profiles were evaluated before PCI and at primary follow-up coronary angiography (5-8 months). Pioglitazone treatment reduced HbA1c levels to a similar degree as conventional treatment (pioglitazone group 6.5 to 6.0%, P < 0.01; control group 6.5 to 5.9%, P < 0.001), without body weight gain. Levels of high-molecular weight adiponectin increased more in the pioglitazone group than the control group (P < 0.001), and the changes were irrespective of baseline glycemic control. Furthermore, pioglitazone significantly reduced plasma levels of natriuretic peptides and preserved cardiac systolic and diastolic function (assessed by echocardiography) without incident hospitalization for worsening HF. The incidence of clinical adverse events was also comparable between the groups. These results indicate that pioglitazone treatment before and after elective PCI may be tolerable and clinically safe and may improve cardiometabolic profiles in T2DM patients.

One-Year Outcome of Fractional Flow Reserve-Based Coronary Intervention in Japanese Daily Practice　- CVIT-DEFER Registry.

BACKGROUND: Clinical use of fractional flow reserve (FFR) has been rapidly increasing, but outcomes after FFR-based coronary intervention in Japanese daily clinical practice have not been well investigated.Methods and Results:The prospective multicenter cardiovascular intervention therapeutics registry (CVIT)-DEFER enrolled consecutive patients for whom FFR measurement was clinically indicated. This study comprised 3,857 vessels in 3,272 patients. Lesions were categorized into 4 groups according to FFR result and revascularization strategy: group 1: FFR >0.8, and deferral of PCI (n=1992); group 2: FFR >0.8, then PCI (n=230); group 3: FFR ≤0.8, and deferral of PCI (n=506); and group 4: FFR ≤0.8, then PCI (n=1,129). The event rate for deferred lesions was significantly low compared with that for PCI lesions (3.5% vs. 6.6%; P<0.05). Vessel-related events occurred in 62 (3.1%), 11 (4.8%), 25 (4.9%), and 79 (7.0%) patients in groups 1, 2, 3, and 4, respectively. PCI for lesions in which FFR was >0.8 (group 2) showed no improvement in the event rate compared with a defer-strategy. On the other hand, deferred lesions with lower FFR values had a higher risk of vessel-related events. CONCLUSIONS: A FFR-based revascularization strategy in daily clinical practice was safe with regard to vessel-related events.

Acute effects of statin on reduction of angiopoietin-like 2 and glyceraldehyde-derived advanced glycation end-products levels in patients with acute myocardial infarction: a message from SAMIT (Statin for Acute Myocardial Infarction Trial).

Experimental ischemia-reperfusion models have shown that 3-hydroxy-3methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, statins, have cardioprotective effects. SAMIT (Statin Acute Myocardial Infarction Trial) is a multicenter prospective open randomized trial, designed to evaluate the effects of statin treatment from the earliest stage on cardioprotection in patients with acute myocardial infarction (AMI). Patients were randomly assigned to receive atorvastatin (initial dose of 40 mg at admission followed by the maintenance dose of 10 mg/day for 30 days) or not (control), and then immediately underwent percutaneous coronary intervention (PCI) for the culprit lesion. The primary endpoints were infarct size and left ventricular function. The secondary endpoints were major adverse cardiac and cerebrovascular events (MACCE) and various biomarkers. There were no significant differences in baseline characteristics between 2 groups of the statin treatment group and the control group. The left ventricular ejection fraction increased at 6 months after the onset of AMI, compared with the baseline level in the atorvastatin group (P < 0.05), while it did not change in the control group. Although there were no significant differences in the MACCE, the changes in the levels of angiopoietin-like protein 2 (ANGPTL2) (P < 0.05), and glyceraldehyde-derived advanced glycation end-products, (TAGE) (P < 0.01) were suppressed at 2 weeks in the atorvastatin group, compared with the control group. Statin therapy started early after the onset reduced the levels of ANGPTL2 and TAGE, and thus, might have cardioprotective effects in patients with AMI.

Percutaneous coronary intervention for bifurcation coronary lesions using optimised angiographic guidance: the 18th consensus document from the European Bifurcation Club.

The 2023 European Bifurcation Club (EBC) meeting took place in Warsaw in October, and the latest evidence for the use of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to optimise percutaneous coronary interventions (PCI) on coronary bifurcation lesions (CBLs) was a major focus. The topic generated deep discussions and general appraisal on the potential benefits of IVUS and OCT in PCI procedures. Nevertheless, despite an increasing recognition of IVUS and OCT capabilities and their recognised central role for guidance in complex CBL and left main PCI, it is expected that angiography will continue to be the primary guidance modality for CBL PCI, principally due to educational and economic barriers. Mindful of the restricted access/adoption of intracoronary imaging for CBL PCI, the EBC board decided to review and describe a series of tips and tricks which can help to optimise angiography-guided PCI for CBLs. The identified key points for achieving an optimal angiography-guided PCI include a thorough analysis of pre-PCI images (computed tomography angiography, multiple angiographic views, quantitative coronary angiography vessel estimation), a systematic application of the technical steps suggested for a given selected technique, an intraprocedural or post-PCI use of stent enhancement and a low threshold for bailout use of intravascular imaging.

Serial changes of the side-branch ostial area after single crossover stenting with kissing-balloon inflation.

PURPOSE: We aimed to investigate the serial change of the side-branch ostial area (SBOA) depended on the wire-position before Kissing-balloon inflation (KBI) in the single-stent strategy for bifurcation lesions separately in the left main coronary artery (LMCA) and in non-LMCA. METHODS: Patients who underwent a single-stent KBI for a bifurcation lesion and had OCT images at the timing of the rewiring, at the post-procedure, and at the 9-month follow-up were extracted from the 3D-OCT Bifurcation Registry, which is a multicenter-prospective registry of patients with a percutaneous coronary intervention for a bifurcation lesion under OCT guidance. The SBOA was measured by dedicated software, and the rewiring position at the side-branch ostium after crossover stenting was assessed by three-dimensional-optical coherence tomography (3D-OCT). The optimal rewiring was defined as link-free-type and distal rewiring. The relationship between the optimal rewiring and the serial change of the SBOA was investigated separately in LMCA and non-LMCA cases. RESULTS: We examined 75 bifurcation lesions (LMCA, n = 35; non-LMCA, n = 40). The serial changes of the SBOA with the optimal rewiring were not significantly different regardless of LMCA and non-LMCA (LMCA:3.96 to 3.73 mm2, p = 0.38; non-LMCA:2.16 to 2.21 mm2, p = 0.98), whereas the serial changes of the SBOA with the sub-optimal rewiring were significantly reduced (LMCA:6.75 to 5.54 mm2, p = 0.013; non-LMCA:2.28 mm2 to 2.09 mm2, p = 0.024). There was no significant difference in clinical events between the optimal and sub-optimal rewiring group regardless of the LMCA and non-LMCA. CONCLUSION: The side-branch ostial area dilated with the optimal rewiring position in a bifurcation lesion treated with single crossover stenting and kissing-balloon inflation was preserved regardless of whether the bifurcation was in the LMCA or a non-LMCA.

Difference in basic concept of coronary bifurcation intervention between Korea and Japan. Insight from questionnaire in experts of Korean and Japanese bifurcation clubs.

The coronary bifurcation intervention varies among countries due to the differences in assessment of lesion severity and treatment devices. We sought to clarify the difference in basic strategy between South Korea and Japan. A total of 19 and 32 experts from Korean (KBC) and Japanese Bifurcation Clubs (JBC), respectively, answered a survey questionnaire concerning their usual procedure of coronary bifurcation intervention. JBC experts performed less two-stent deployment in the left main (LM) bifurcation compared to KBC experts (JBC vs. KBC: median, 1-10% vs. 21-30%, p < 0.0001) instead of higher performance of side branch dilation after cross-over stenting in both LM (60% vs. 21%, p = 0.001) and non-LM bifurcations (30% vs. 5%, p = 0.037). KBC experts more frequently performed proximal optimization technique (POT) in non-LM bifurcation (41-60% vs. 81-99%, p = 0.028) and re-POT in both LM (1-20% vs. 81-99%, p = 0.017) and non-LM bifurcations (1-20% vs. 81-99%, p = 0.0003). JBC experts more frequently performed imaging-guided percutaneous coronary intervention, whereas KBC experts more often used a pressure wire to assess side branch ischemia. JBC experts used a rotablator more aggressively under the guidance of optical coherence tomography. We clarified the difference in the basic strategy of coronary bifurcation intervention between South Korea and Japan for better understanding the trend in each country.

Antiplatelet therapy after percutaneous coronary intervention: current status and future perspectives.

Antiplatelet therapy after percutaneous coronary intervention (PCI) has been changing in parallel with the development of drug-eluting stents (DES) and antiplatelet agents. The recommendation of dual antiplatelet therapy duration is getting shorter due to the decreased risk of stent thrombosis in new-generation DES, the use of a P2Y12 inhibitor as a monotherapy, and the increasing prevalence of high bleeding risk patients. Antithrombotic therapy after PCI has also changed due to the introduction of direct oral anticoagulants. Aspirin-free P2Y12 inhibitor monotherapy is now being evaluated in several prospective studies as a novel strategy of antiplatelet therapy after PCI. This review shows a current status and provides future perspectives for the antiplatelet therapy after PCI.

Ultrathin, Biodegradable-Polymer Sirolimus-Eluting Stent vs Thin, Durable-Polymer Everolimus-Eluting Stent.

BACKGROUND: Previous trials suggested the superiority of ultrathin- over thin-strut drug-eluting stents (DES) concerning target lesion failure (TLF) at 1 year after index percutaneous coronary intervention. OBJECTIVES: The aim of this randomized comparison study of ultrathin-strut and thin-strut DES (CASTLE [Randomized Comparison All-Comer Study of Ultrathin Strut and Thin Strut Drug-Eluting Stent]; jRCTs032180084) was to examine the impact of differences in strut thickness of DES on clinical outcomes when implanted with angiography and intravascular ultrasound or optical coherence tomographic guidance. METHODS: CASTLE was a multicenter, prospective, noninferiority study conducted at 65 institutions in Japan. Percutaneous coronary intervention patients were assigned (1:1) to an ultrathin, biodegradable-polymer sirolimus-eluting stent (BP-SES) or a thin, durable-polymer everolimus-eluting stent (DP-EES). The primary endpoint was TLF, defined as a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target lesion revascularization at 1-year follow-up. RESULTS: Between May 2019 and March 2020, 1,440 patients were randomly assigned to BP-SES (n = 722) or DP-EES (n = 718). TLF occurred in 6.0% and 5.7% of patients, respectively. Noninferiority (P = 0.040) was met because the upper limit (2.67%) of the 1-sided 95% CI between the groups was lower than the prespecified noninferiority margin (3.3%). No significant interactions were observed in the relative rates of TLF between prespecified subgroups. CONCLUSIONS: The BP-SES was noninferior to the DP-EES regarding 1-year TLF. This demonstrates that strut thickness differences among DES have little impact on clinical outcomes when implanted with intravascular imaging guidance.

Vascular healing after kissing balloon inflation: Nine-month 3D optical coherence tomography analysis in corelab.

Background: The jailing strut configuration with link-free and distal guidewire recrossing (LFD) at the side branch orifice (SBO) reduces incomplete stent apposition (ISA) after kissing balloon technique (KBT) in crossover stenting of coronary bifurcation lesions (CBLs). However, data regarding vascular healing after KBT are lacking. We investigated vascular healing 9 months after crossover stenting followed by KBT with optical coherence tomography (OCT) guidance in a prospective multicenter registry. Methods: Fifty-nine patients with CBLs (LFD, 35 patients; non-LFD, 24 patients) were studied. The jailing configuration of the SB and the wire-recrossing position, incidence of ISA and uncovered struts, and neointima unevenness score (NUS) in the main vessel (MV) after 9 months were determined by off-line 3D-OCT in the core laboratory. Results: The ISA rate was significantly higher at the SB ostium and distal MV after KBT in the non-LFD group, compared to the LFD group. After 9 months, incidence of ISA (18.3 ± 18.2 vs. 6.0 ± 8.7%, p < 0.01) and uncovered struts (8.7 ± 9.9 vs. 4.7 ± 7.3 %, p = 0.08) were higher at the SB ostium with higher SB restenosis in the non-LFD group. In distal MV, NUS was significantly higher (3.1 ± 1.1 vs. 2.5 ± 0.6, p < 0.05). In true-CBLs, an increase in uncovered struts and ISA rate was prominent in the proximal MV and opposite SB. No differences were observed in the 9-month clinical outcomes. Conclusion: Visualization of the wire recrossing point and the SB-jailing strut pattern by OCT plays an important role to optimize the KBT in CBL stenting, resulting in favorable mid-term vascular healing.

Outcomes of Venoarterial Extracorporeal Membrane Oxygenation Plus Intra-Aortic Balloon Pumping for Treatment of Acute Myocardial Infarction Complicated by Cardiogenic Shock.

Background Clinical outcomes of acute myocardial infarction complicated by cardiogenic shock remain poor with high in-hospital mortality. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has been widely used for patients with acute myocardial infarction complicated by cardiogenic shock refractory to conservative therapy, which is likely fatal without mechanical circulatory support. However, whether additional intra-aortic balloon pumping (IABP) use during VA-ECMO support improves clinical outcomes remains controversial. This study sought to investigate prognostic impact of the combined VA-ECMO plus IABP treatment compared with VA-ECMO alone. Methods and Results From the nationwide Japanese administrative case-mix Diagnostic Procedure Combination (DPC), the JROAD (Japanese Registry of All Cardiac and Vascular Diseases)-DPC, we identified 3815 patients with acute myocardial infarction complicated by cardiogenic shock who underwent primary percutaneous coronary intervention and managed with VA-ECMO. Of these, 2964 patients (77.7%) were managed with IABP (VA-ECMO plus IABP), whereas 851 (22.3%) were managed without IABP (VA-ECMO alone). We compared in-hospital, 7-day, and 30-day mortality between the VA-ECMO plus IABP versus the VA-ECMO alone support. Patients managed with VA-ECMO plus IABP demonstrated significantly lower in-hospital, 7-day, and 30-day mortality than those managed with VA-ECMO alone (adjusted odds ratios [95% CI] of 0.47 [95% CI, 0.38-0.59], 0.41 [95% CI, 0.33-0.51], and 0.30 [95% CI, 0.25-0.37], respectively). The findings were consistent in the propensity matching and inverse probability of treatment-weighting models. Conclusions This large-scale, nationwide study demonstrated that the combination of VA-ECMO plus IABP support was associated with significantly lower mortality compared with VA-ECMO support alone in patients presenting with acute myocardial infarction complicated by cardiogenic shock who underwent primary percutaneous coronary intervention.

Resources for cardiovascular healthcare associated with 30-day mortality in acute myocardial infarction with cardiogenic shock.

Aims: Although primary percutaneous coronary intervention (PCI) and mechanical circulatory support (MCS), such as extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pumping (IABP), have been widely used for acute myocardial infarction (AMI) patients with cardiogenic shock (AMICS), their in-hospital mortality remains high. This study aimed to investigate the association of cardiovascular healthcare resources with 30-day mortality in AMICS. Methods and results: This was an observational study using a Japanese nationwide administrative data (JROAD-DPC) of 260 543 AMI patients between April 2012 and March 2018. Of these, 45 836 AMICS patients were divided into three categories based on MCS use: with MCS (ECMO with/without IABP), IABP only, or without MCS. Certified hospital density and number of board-certified cardiologists were used as a metric of cardiovascular healthcare resources. We estimated the association of MCS use, cardiovascular healthcare resources, and 30-day mortality. The 30-day mortality was 71.2% for the MCS, 23.9% for IABP only, and 37.8% for the group without MCS. The propensity score-matched and inverse probability-weighted Cox frailty models showed that primary PCI was associated with a low risk for mortality. Higher hospital density and larger number of cardiologists in the responsible hospitals were associated with a lower risk for mortality. Conclusion: Although the 30-day mortality remained extremely high in AMICS, indication of primary PCI and improvement in providing cardiovascular healthcare resources associated with the short-term prognosis of AMICS.

Physiological Approach for Coronary Artery Bifurcation Disease: Position Statement by Korean, Japanese, and European Bifurcation Clubs.

Coronary artery bifurcation lesions are frequently encountered in cardiac catheterization laboratories and are associated with more complex procedures and worse clinical outcomes than nonbifurcation lesions. Therefore, anatomical and physiological assessment of bifurcation lesions before, during, and after percutaneous coronary intervention is of paramount clinical importance. Physiological assessment can help interventionalists appreciate the hemodynamic significance of coronary artery disease and guide ischemia-directed revascularization. However, it is important to understand that the physiological approach for bifurcation disease is more important than simply using physiological indexes for its assessment. This joint consensus document by the Korean, Japanese, and European bifurcation clubs presents the concept of a physiological approach for coronary bifurcation lesions, as well as current knowledge, practical tips, pitfalls, and future directions of applying physiological indexes in bifurcation percutaneous coronary intervention. This document aims to guide interventionalists in performing appropriate physiology-based assessments and treatment decisions for coronary bifurcation lesions.

Simple risk-score model for in-hospital major bleeding based on multiple blood variables in patients with acute myocardial infarction.

BACKGROUND: In-hospital bleeding is associated with poor prognosis in patients with acute myocardial infarction (AMI). We sought to investigate whether a combination of pre-procedural blood tests could predict the incidence of in-hospital major bleeding in patients with AMI. METHODS AND RESULTS: A total of 1684 consecutive AMI patients who underwent primary percutaneous coronary intervention (PCI) were recruited and randomly divided into derivation (n = 1010) and validation (n = 674) cohorts. A risk-score model was created based on a combination of parameters assessed on routine blood tests on admission. In the derivation cohort, multivariate analysis revealed that the following 5 variables were significantly associated with in-hospital major bleeding: hemoglobin level < 12 g/dL (odds ratio [OR], 3.32), white blood cell count >10,000/µL (OR, 2.58), platelet count <150,000/µL (OR, 2.51), albumin level < 3.8 mg/dL (OR, 2.51), and estimated glomerular filtration rate < 60 mL/min/1.73 m2 (OR, 2.31). Zero to five points were given according to the number of these factors each patient had. Incremental risk scores were significantly associated with a higher incidence of in-hospital major bleeding in both cohorts (P < 0.001). Receiver operating characteristic curve analysis of risk models showed adequate discrimination between patients with and without in-hospital major bleeding (derivation cohort: area under the curve [AUC], 0.807; 95% confidence interval [CI], 0.759-0.848; validation cohort: AUC, 0.793; 95% CI, 0.725-0.847). CONCLUSIONS: Our novel laboratory-based bleeding risk model could be useful for simple and objective prediction of in-hospital major bleeding events in patients with AMI.

Serum Albumin and Bleeding Events After Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction (from the HAGAKURE-ACS Registry).

Low serum albumin (SA) on admission in patients with acute myocardial infarction (AMI) has been reported to be associated with adverse cardiovascular events. The relation between low SA and post-AMI bleeding events is presently unknown. We analyzed 1,724 patients with AMI enrolled in the HAGAKURE-ACS registry who underwent primary percutaneous coronary intervention from January 2014 to December 2018. To assess the influence of low SA at admission, patients were divided into 3 groups according to the albumin tertiles: the low SA group (<3.8 g/100 ml), the middle SA (MSA) group (3.8 to 4.1 g/100 ml), and the normal SA (NSA) group (≥4.2 g/100 ml). The primary end point was the incidence of Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries moderate/severe bleeding. The cumulative 3-year incidence of the primary end point was significantly higher in the low SA group than in the MSA and NSA groups (30.8% and 11.9% vs 7.7%; p <0.001). In the landmark analysis at 30 days, the cumulative incidences of the primary end point were also significantly higher in the low SA group than in the MSA and NSA groups, both within and beyond 30 days (20.1% and 6.1% vs 3.5%; p <0.001, and 12.4% and 6.2% vs 4.5%; p <0.001, respectively). After adjusting for confounders, the low SA group showed excess risk of bleeding events relative to NSA (hazard ratio 1.56; 95% confidence interval 1.06 to 2.30; p = 0.026), whereas risk of bleeding was neutral in MSA relative to NSA (hazard ratio 0.94; 95% confidence interval 0.63 to 1.34; p = 0.752). In conclusion, low SA at admission was independently associated with higher risk for bleeding events in patients with AMI undergoing percutaneous coronary intervention.

CVIT expert consensus document on primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) update 2022.

Primary Percutaneous Coronary Intervention (PCI) has significantly contributed to reducing the mortality of patients with ST-segment elevation myocardial infarction (STEMI) even in cardiogenic shock and is now the standard of care in most of Japanese institutions. The Task Force on Primary PCI of the Japanese Association of Cardiovascular Interventional and Therapeutics (CVIT) society proposed an expert consensus document for the management of acute myocardial infarction (AMI) focusing on procedural aspects of primary PCI in 2018. Updated guidelines for the management of AMI were published by the European Society of Cardiology (ESC) in 2017 and 2020. Major changes in the guidelines for STEMI patients included: (1) radial access and drug-eluting stents (DES) over bare-metal stents (BMS) were recommended as a Class I indication, (2) complete revascularization before hospital discharge (either immediate or staged) is now considered as Class IIa recommendation. In 2020, updated guidelines for Non-ST-Elevation Myocardial Infarction (NSTEMI) patients, the followings were changed: (1) an early invasive strategy within 24 h is recommended in patients with NSTEMI as a Class I indication, (2) complete revascularization in NSTEMI patients without cardiogenic shock is considered as Class IIa recommendation, and (3) in patients with atrial fibrillation following a short period of triple antithrombotic therapy, dual antithrombotic therapy (e.g., DOAC and single oral antiplatelet agent preferably clopidogrel) is recommended, with discontinuation of the antiplatelet agent after 6 to 12 months. Furthermore, an aspirin-free strategy after PCI has been investigated in several trials those have started to show the safety and efficacy. The Task Force on Primary PCI of the CVIT group has now proposed the updated expert consensus document for the management of AMI focusing on procedural aspects of primary PCI in 2022 version.

Percutaneous coronary intervention in side branch coronary arteries: Insights from the Japanese nationwide registry.

BACKGROUND: Performance of percutaneous coronary intervention (PCI) in side-branch vessels (SB-PCI) has not been fully investigated despite the technical advancement of PCI. METHODS: We investigated 257,492 patients registered in the Japanese nationwide PCI registry from January to December 2018; 199,767 (78%) underwent PCI for major vessel PCI (MV-PCI), 21,555 (8.4%) underwent SB-PCI, and 24,862 (9.6%) underwent PCI for both vessels (SB + MV-PCI). The frequencies of primary composite adverse events, defined as in-hospital mortality and procedural complications (i.e., peri-procedural myocardial infarction, tamponade, new-onset cardiogenic shock, stent thrombosis, emergent surgery, and bleeding), and PCI for restenotic lesions were investigated. Their association with institutional frequency of each PCI was also investigated. RESULTS: Fewer drug-eluting stents (66% vs. 86%) and more drug-coated balloons (23% vs. 9%) were used in SB-PCI than in MV-PCI (p < 0.001). Pre-procedure non-invasive testing was similarly performed in SB-PCI and MV-PCI (57% vs. 61%). The composite endpoint was observed in 0.7%, 1.9%, and 2.2% of the SB-PCI, SB + MV-PCI, and MV-PCI groups, respectively (p < 0.001). Institutional frequency of SB-PCI was inversely associated with the composite-endpoint risk for all PCI procedures (odds ratio 1.37, 95% confidence interval 1.04-1.81 in the lowest tertile, with reference to the middle tertile, p = 0.02). Frequency of PCI for restenotic lesions was also inversely associated with the institutional frequency of MV-PCI (p < 0.001). CONCLUSION: SB-PCI was performed safely with a low frequency of acute complications, and higher SB-PCI frequency presented a lower risk of in-hospital adverse events, albeit with a cost of an increase in PCI for restenotic lesions.