Takashi Muramatsu

The success of drug-coated balloon (DCB) therapy for de novo coronary lesions relies on optimal lesion preparation. However, evidence supporting the use of cutting balloons (CBs) for lesion preparation in DCB-only strategies remains limited. The NATURE trial assessed the effectiveness of CB compared with standard balloon (SB) predilatation in achieving optimal lesion preparation for a DCB-only strategy. The NATURE trial was a prospective, multicentre, randomised study conducted at 19 Japanese centres. Patients with de novo coronary lesions suitable for a DCB-only strategy were randomised (1:1) to lesion preparation with CB or SB. Post-predilatation assessment included coronary angiography, intravascular ultrasound (IVUS), and fractional flow reserve (FFR). The primary endpoint was optimal lesion preparation, defined as the simultaneous presence of: (1) no flow-limiting dissection, (2) residual diameter stenosis ≤ 30% by quantitative coronary angiography, and (3) FFR > 0.80. Among 201 patients included in the intention-to-treat population, optimal lesion preparation was achieved in 35.6% of the CB group and 30.0% of the SB group (adjusted risk ratio 1.19, 95% confidence interval 0.87-1.65; p = 0.28). Avoidance of flow-limiting dissection was high in both groups (98.0% vs 97.0%). CB predilatation resulted in lower residual diameter stenosis (30.8 ± 11.8% vs 34.5 ± 13.3%; p = 0.04) and less acute recoil (1.18 ± 0.36 vs 1.31 ± 0.50 mm; p = 0.03). Trends towards larger lumen dimensions on IVUS were also observed with CB. In patients undergoing DCB-only PCI for de novo coronary lesions, CB predilatation provided modest angiographic advantages compared with SB but did not significantly increase the rate of optimal lesion preparation. Optimal lesion preparation is essential for successful drug-coated balloon (DCB) therapy because DCBs do not provide mechanical scaffolding to maintain vessel patency. In this multicentre randomised trial, cutting balloon predilatation resulted in greater acute luminal expansion and less recoil than standard balloon predilatation, although it did not significantly increase the overall rate of optimal lesion preparation defined by angiographic and physiological criteria. These findings suggest that cutting balloons may offer modest mechanical advantages during lesion preparation in DCB-only PCI. However, the clinical significance of these acute angiographic advantages requires confirmation in larger trials and through longer-term follow-up.

AIMS: The global distribution of lipoprotein(a) [Lp(a)] levels varies due to racial and ethnic differences. However, the clinical relevance of Lp(a) levels in Japanese patients has not been fully explored. METHODS: We investigated the association of Lp(a) levels, the Suita score, and the presence of high-risk plaque (HRP) as well as that of ≥ 50% stenosis, quantitative plaque volume, and the value of coronary artery calcium score in coronary computed tomographic angiography (CCTA), among 272 Japanese patients (mean age: 65 years) in whom serum Lp(a) levels were measured due to suspected coronary artery disease. HRP was defined as positive remodeling and/or low attenuation. Plaque volume was quantified as the percent plaque volume. RESULTS: HRP was identified in 33 (12.1%) patients. The prevalence of HRP, ≥ 50% stenosis, and percent plaque volume progressively increased with higher Lp (a) levels and Suita scores. In multivariate analyses, Lp(a) and the Suita score independently predicted HRP when assessed as continuous (p = 0.02, p＜0.001, respectively) or categorical variables (p = 0.005, p = 0.007, respectively). Patients in the highest tertile of Lp(a) and classified as high- or intermediate-risk by the Suita score had the highest HRP risk, whereas those in the lower 2 tertiles and low-risk group had the lowest. Incorporating Lp(a) into the Suita score improved the prediction of HRP beyond the Suita score alone (p = 0.005). CONCLUSIONS: The combinatorial value of assessing Lp(a) levels and Suita score may provide useful insight regarding Japanese patients undergoing CCTA for the prediction of HRP.

AIMS: In percutaneous coronary intervention (PCI), a suboptimal choice of guiding catheter may compromise coaxial alignment and backup support, prolonging procedures and increasing radiation and contrast exposure. We assessed whether a computed tomography (CT)-driven, artificial intelligence (AI)-guided preprocedural simulation could improve procedural efficiency and safety. METHODS AND RESULTS: In a single-centre prospective registry with historical controls, 55 consecutive elective procedures performed with CT-based AI-assisted guiding-catheter selection were compared with 55 procedures performed without assistance. The primary endpoint was total procedure time from arterial access to completion. Secondary endpoints included time to coronary engagement, radiation dose, contrast volume, and guiding-catheter-related events. Computed tomography--based AI assistance was associated with shorter procedures (mean 68.5 vs. 91.8 min), shorter engagement time, lower radiation dose, and lower contrast use. Guiding-catheter exchanges were fewer, and catheter-related events were lower (3.6 vs. 16.4%; risk ratio 0.22; 95% confidence interval 0.05-0.98). Procedural success was 100% in both groups with no in-hospital major adverse cardiac or cerebrovascular events. CONCLUSION: A CT-driven, CT-based AI-guided simulation for guiding-catheter selection was associated with greater procedural efficiency and a favourable profile in elective PCI. This approach, which standardizes catheter choice and is associated with fewer empirical catheter exchanges, warrants confirmation in multicentre randomized studies and may help optimize resource utilization in routine PCI.

BACKGROUND: In the presence of a potent P2Y12inhibitor such as prasugrel, the additional clinical antithrombotic benefit of aspirin is unclear. The feasibility of prasugrel monotherapy without aspirin after percutaneous coronary intervention (PCI) has been demonstrated in chronic coronary syndrome, but is yet to be assessed in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) and low anatomical complexity. METHODS AND RESULTS: ASET-Japan is a single-arm study investigating the safety of prasugrel 12-month monotherapy with a locally approved dose (loading 20 mg; maintenance 3.75 mg), started immediately after successful PCI using platinum-chromium everolimus-eluting SYNERGY stents. The primary ischemic endpoint is a composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis; the primary bleeding endpoint is Bleeding Academic Research Consortium (BARC) Type 3 and 5 bleeding. ASET-Japan recruited 101 NSTE-ACS patients from 11 Japanese sites. The mean (±SD) age was 69.1±12.3 years and 36.6% had a PRECISE-DAPT score >25. The mean anatomical SYNTAX score was 7.9±4.7. At 1 year, the primary ischemic endpoint occurred in 1 patient (1.0%; cardiac death). Two BARC Type 3a bleeding events occurred (2.0%): 1 due to a gastric ulcer and 1 to a descending colon malignancy. CONCLUSIONS: Low-dose (3.75 mg/day) prasugrel monotherapy started immediately after SYNERGY stent deployment was feasible and safe in selected NSTE-ACS patients.

BACKGROUND: Previous randomized trials have demonstrated the safety of P2Y12 inhibitor monotherapy after 1-3 months of dual antiplatelet therapy (DAPT) compared with 12-month DAPT following percutaneous coronary intervention (PCI) in patients with acute coronary syndromes. However, the safety of initiating prasugrel monotherapy at the time of primary PCI in patients presenting with ST-segment elevation myocardial infarction (STEMI) remains unknown. METHODS/DESIGN: The PREMIUM (Prasugrel monotherapy following primary percutaneous coronary intervention for ST-elevation myocardial infarction) trial is an investigator-initiated, open-label, multicenter randomized controlled trial. A total of 2268 STEMI patients indicated for primary PCI with current generation platinum‑chromium everolimus-eluting stents were randomized 1:1 to either prasugrel monotherapy (20 mg loading, 3.75 mg daily) initiated before PCI or standard 12-month DAPT with aspirin plus prasugrel. The primary endpoint is a composite of all-cause death, myocardial infarction, or stroke at 12 months tested for noninferiority. The major secondary endpoint is Bleeding Academic Research Consortium type 3 or 5 bleeding at 12 months tested for superiority. SUMMARY: The PREMIUM trial is the first large-scale randomized study to evaluate an upfront aspirin-free strategy with prasugrel monotherapy compared with standard 12-month DAPT in STEMI undergoing contemporary imaging-guided PCI. The trial is designed to determine noninferiority for ischemic outcomes and to assess superiority in reducing major bleeding at 12 months in East Asian patients. TRIAL REGISTRATION: NCT05709626; jRCTs052220145.

The Drug Coated Balloon Academic Research Consortium project originated from the lack of standardization and comparability between studies using drug-coated balloons in the treatment of obstructive coronary artery disease. This document is a collaborative effort between academic research organizations and percutaneous coronary intervention societies in Europe, the USA, and Asia. This consensus sought to standardize study designs and endpoints for clinical trials involving drug-coated balloons, including defining angiographic, intravascular, and non-invasive imaging methods for lesion assessment, alongside considerations for post-revascularization pharmaco-therapy. The concept of 'blended therapy', which advocates for combining device strategies, is also discussed. This paper delineates study types, endpoint definitions, follow-up protocols, and analytical approaches, aiming to provide consistency and guidance for interventional cardiologists and trialists.

We present a novel, simple, and low-cost "side-hole" technique for a patient with ST-segment elevation myocardial infarction (STEMI) caused by an occlusion of an anomalous origin of the culprit coronary artery (AOCCA). In a case where standard guiding catheters failed to engage the anomalous left coronary artery (LCA), we created an approximately 3 mm side-hole near the tip of a 5 Fr diagnostic catheter and then introduced a guidewire and microcatheter directly into the anomalous left main trunk (LMT). Subsequently, we withdrew this diagnostic catheter and exchanged it for a guiding catheter over the guide wire, enabling rapid primary PCI. This approach facilitated rapid wire passage, minimized additional device use, and helped reduce overall reperfusion time. It may be especially useful in urgent STEMI cases where a suitable guiding catheter for AOCCA lesions cannot be readily identified.

Evaluation of calcified lesions by intravascular imaging has revealed that atherectomy devices have only limited impact. However, subsequent use of coronary intravascular lithotripsy (IVL) may increase treatment effectiveness without increasing risk of complications. This study was designed to evaluate the safety and effectiveness of IVL use after atherectomy in severely calcified coronary lesions as pre-treatment for drug-eluting stents (DES). The Dual-Prep registry is a multicenter, prospective registry of consecutive image-guided percutaneous coronary interventions (PCI). The primary effectiveness and safety endpoints were procedural success (residual stenosis < 50% by quantitative coronary angiography) without an in-hospital major adverse cardiac event (MACE) and 30-day freedom from MACE, respectively. Baseline vessel calcification score and final DES expansion were evaluated by optical coherence tomography (OCT). A total of 118 patients with 120 lesions were enrolled at 20 sites. The calcification score of lesions after atherectomy by core-lab assessment was 4.0 in all cases. Rotational atherectomy was applied prior to IVL in 83.9% cases with mean burr size of 1.57 ± 0.20 mm; IVL was subsequently successfully delivered in all cases (mean balloon diameter 3.02 ± 0.45 mm), followed by DES deployment (mean diameter 3.19 ± 0.51 mm, length of 36.3 ± 16.0 mm). The primary efficacy and safety endpoints were met in 98.3% and 98.3% of cases, respectively. A DES expansion index < 0.8 was seen in 42.2%, and an eccentricity index < 0.7 was not observed in any patient. In severely calcified lesions, image-guided atherectomy followed by IVL lesion preparation demonstrated high procedural success rates and satisfactory non-eccentric stent expansion. This approach may be considered for lesions where an 'IVL-first' strategy may not be feasible. jRCT1032230384 (Oct 7, 2023).

OBJECTIVE: This study highlights a case in which we performed a complex percutaneous coronary intervention on a 60-mm chronic total occlusion lesion with a remarkably low radiation dose by using the SPOT region of interest (SPOT ROI) function available on the Alphenix Evolve Edition X-ray system (Canon Medical Systems). KEY STEPS: Fluoroscopy was conducted exclusively using SPOT ROI from the start of guiding catheter engagement. The wire successfully traversed the chronic total occlusion lesion with SPOT ROI. Despite a fluoroscopy time of 71 min, the total radiation dose was kept at 990 mGy, remaining <1 Gy. POTENTIAL PITFALLS: The SPOT ROI function is only available on the Alphenix Evolve Edition X-ray system and cannot be used with other X-ray equipment. TAKE-HOME MESSAGE: This case suggests that SPOT ROI can be leveraged to safely reduce radiation during complex percutaneous coronary intervention.

The Drug Coated Balloon Academic Research Consortium project originated from the lack of standardization and comparability between studies using drug-coated balloons in the treatment of obstructive coronary artery disease. This document is a collaborative effort between academic research organizations and percutaneous coronary intervention societies in Europe, the USA, and Asia. This consensus sought to standardize study designs and endpoints for clinical trials involving drug-coated balloons, including defining angiographic, intravascular, and non-invasive imaging methods for lesion assessment, alongside considerations for post-revascularization pharmaco-therapy. The concept of 'blended therapy', which advocates for combining device strategies, is also discussed. This paper delineates study types, endpoint definitions, follow-up protocols, and analytical approaches, aiming to provide consistency and guidance for interventional cardiologists and trialists.

BACKGROUND: Drug-coated balloons (DCBs) have emerged as an alternative to drug-eluting stents (DESs) for percutaneous coronary intervention (PCI) in de novo coronary artery diseases (CADs). However, the optimal predilatation strategy prior to DCB dilatation has yet to be validated. METHODS/DESIGN: The NATURE (Non-stent PCI with an appropriate dilatation by means of cutting balloon and drug-coated balloon in de novo lesion) study is a prospective, multi-center, randomized controlled trial designed to evaluate the safety and efficacy of a cutting balloon compared to standard balloons (semi-compliant or non-compliant balloons) for lesion preparation prior to DCB treatment in normal-sized vessels. The DCB treatment is performed with the guidance of intravascular ultrasound (IVUS) and fractional flow reserve (FFR). The study will enroll 200 patients with a single de novo coronary lesion (reference vessel diameter: 2.5-4.0 mm) at 18 sites. Patients are randomized 1:1 to undergo predilatation with either a cutting or standard balloons, followed by DCB dilatation. The primary endpoint is the success rate of optimal predilatation, as defined by the International DCB Consensus Group: no flow-limiting dissections, residual stenosis ≤30 %, and FFR >0.80. Secondary endpoints include in-segment late lumen loss (LLL) at 9 months, the incidence of bailout stenting, and clinical outcomes at 6 and 12 months. SUMMARY: The NATURE study aims to address the critical gap in evidence regarding optimal predilatation for DCBs in de novo CADs. By utilizing state-of-the-art DCB treatment strategies, including cutting balloons, intravascular imaging, and physiological tools, this study is expected to provide meaningful insights for refining DCB-based PCI strategies. CLINICAL TRIAL REGISTRATION URL: https://jrct.niph.go.jp/. Unique Identifier: jRCTs032230543.

BACKGROUND: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) improves outcomes compared with angiography-guided PCI, however cardiac events still occur during long-term follow-up of FFR-negative patients. In the PREVENT study preventive PCI reduced cardiac-events in lesions which were FFR-negative (FFR > 0.80) and had intracoronary imaging defined vulnerable plaque. Coronary computed tomography angiography (CTA)-defined high risk plaque (HRP) is known to predict future cardiac events. We hypothesized that CTA defined HRP would identify which FFR-negative patients were at greatest risk of future cardiac events. METHODS AND RESULTS: We examined 373 consecutive CCS patients undergoing CTA followed not more than 90 days later by invasive FFR. Cardiac events were defined as cardiac death, non-fatal acute coronary syndromes, and ischemia-driven revascularization. Clinical follow-up was performed in all patients at a median of 32 months. Revascularization was performed in 131 of the 373 patients due to an FFR ≤ 0.80 (Treat group), with the remaining 242 having revascularization deferred (Defer group) due to an FFR > 0.80. In the Treat group the cardiac event rates between patients with and without HRP on CTA were similar (9.4 % versus 10.1 %, p = 0.90), whilst in the Defer group they were higher in patients with HRP (21.1 % versus 4.7 %, Log-rank-p < 0.0001). In multivariate Cox hazard analysis the presence of HRP (Hazard-ratio 12.79, 95 %confidence-intervals: 3.57-45.83, p < 0.0001) was an independent predictor for cardiac events in the Defer group. CONCLUSIONS: HRP on CTA was associated with future cardiac events in patients in whom revascularization was deferred due to a negative invasive-FFR (UMIN000054067; CAPTURE).

BACKGROUND: The effect of worsening renal function and baseline chronic kidney disease (CKD) on outcomes in patients with chronic coronary syndrome in the setting of optimal medical therapy remains unknown. METHODS AND RESULTS: The REAL-CAD (Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease) study is a prospective, multicenter, randomized trial of high-dose (pitavastatin 4 mg/day) or low-dose (pitavastatin 1 mg/day) statin therapy in 12 118 patients with chronic coronary syndrome. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, stroke, or unstable angina requiring hospitalization (major adverse cardiac and cerebral events [MACCE]). CKD was defined as an estimated glomerular filtration rate [eGFR] <60 mL/min per 1.73 m2. WRF was defined as a decrease in eGFR ≥20% in the initial year; borderline renal function was an annual decrease of 0%<eGFR<20%, and stable renal function was no decrease. Of 12 118 patients, 4340 had baseline CKD and 7778 did not. The rate of MACCE at 5 years was significantly lower in those without (5.5%) versus with CKD (9.5%) (P<0.0001). After excluding 1247 patients who had MACCE, were censored, or missing eGFR within 1 year, 10 871 patients were included. Of these, 3885 were baseline CKD and the remaining 6986 did not have baseline CKD. Of the 10 871 patients, 577 patients had WRF, 6014 patients showed borderline renal function, and the remaining 4280 patients maintained stable renal function. In patients with CKD, WRF was an independent predictor for MACCE at 4 years as compared with stable renal function (hazard ratio [HR]: 1.67; [95% CI, 1.03-2.73; P=0.039]). In patients without CKD, borderline renal function was a significant predictor for MACCE at 4 years compared with stable renal function (HR: 1.40 [95% CI, 1.03-1.91; P=0.032]). CONCLUSIONS: Baseline CKD was an independent predictor for MACCE in patients with CCS. WRF was a significant predictor for MACCE in patients with CKD. Because borderline renal function was an independent predictor for MACCE even in patients without CKD, mild-to-moderate annual declines of eGFR should be carefully monitored (NCT01042730). REGISTRATION: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT01042730.

BACKGROUND: There are different definitions of periprocedural myocardial infarction (PPMI) both in terms of thresholds for cardiac biomarkers and the ancillary criteria for myocardial ischemia. Cardiac Troponin I (cTnI) and cardiac Troponin T (cTnT) are used interchangeably to diagnose PPMI. OBJECTIVES: This study evaluated the frequency of periprocedural myocardial injury and infarction as defined by the Society of Cardiovascular Angiography & Interventions (SCAI), the Academic Research Consortium-2 (ARC-2), and the 4th Universal definition of MI (4UDMI) stratified using cTnT versus cTnI, among patients with chronic coronary syndrome (CCS) and unstable angina. RESULTS: Among 830 patients, PPMI rates according to the SCAI, ARC2 and 4UDMI criteria were 4.34 %, 2.05 %, and 4.94 % respectively, with higher rates seen for all definitions when using cTnI versus cTnT (SCAI: 9.84 % vs. 1.91 %, p < 0.001; ARC 2: 3.15 % vs. 1.56 %, p = 0.136; and 4UDMI 5.91 % vs. 4.51 %, p = 0.391). Minor and major periprocedural myocardial injury was respectively observed in 58.31 % and 27.10 % of patients, with rates of both significantly higher when using cTnI versus cTnT (Minor: 69.29 % vs. 53.47 %, p < 0.001, Major: 49.21 % vs. 17.36 %, p < 0.001). CONCLUSIONS: Among patients with CCS and unstable angina, PPMIs defined by SCAI occurred more frequently when using cTnI as opposed to cTnT, whereas the type of troponin had no impact on the incidence of PPMIs according to the ARC-2 and 4UDMI.

We report two cases of successful percutaneous coronary intervention (PCI) of a chronic total occlusion (CTO) lesion with an anomalous origin of the right coronary artery (AORCA) and challenging guiding catheter engagement using a new 3D virtual reality (VR) guiding catheter simulation system. Appropriate guiding catheter selection is critical for a successful complex PCI. A more suitable guiding catheter size, shape, and position with a robust backup force often leads to the successful completion of more accessible and safer procedures. The present case report highlights that VR simulation provides a greater possibility than usual of pre-procedural planning when selecting appropriate guiding catheters and vascular access. The present VR simulation system is based on three-dimensional volume rendering reconstructions of the computed tomography (CT) imaging data; thus, another strength of this technology is that it does not require radiation or radiocontrast exposure to patients. Therefore, transcatheter interventionalists who usually perform complex PCI should be familiar with this innovative system.

AIMS: Segmental pressure gradients post-percutaneous coronary intervention (PCI) can detect residual disease and optimization targets. Ultrasonic flow ratio (UFR) or optical flow ratio (OFR) offer simultaneous physiological and morphological assessment using a single imaging catheter. This study evaluated the utility of UFR and OFR in identifying residual disease post-PCI. METHODS AND RESULTS: The study include patients from the Acetyl Salicylic Elimination Trial JAPAN Pilot study with complete intravascular imaging pullback data, where UFR or OFR was obtained post-PCI. Anatomical focal lesions distal and proximal to the stent were analysed in segments ≥5 mm long. UFR or OFR virtual pullback curves assessed intra-stent pressure gradients, defining physiological focal or diffuse by segmental pressure drops ≥0.05 over lengths <10 or ≥10 mm, respectively. The median post-PCI UFR/OFR was 0.93 (0.88-0.96) with 35.4% (69/195) vessels having a UFR/OFR < 0.91. There were significantly more focal lesions, both anatomical and physiological, proximal and distal to the stent in vessels with UFR/OFR < 0.91 compared with those ≥0.91. Agreement between anatomical and physiological focal lesions was moderate proximally (kappa = 0.553, P < 0.001) and fair distally (kappa = 0.219, P = 0.002). The in-stent gradient poorly predicted significant stent under-expansion. However, the virtual fractional flow reserve gradient performed well in detecting proximal or distal focal disease (area under the curve = 0.835 and 0.877, respectively). CONCLUSION: UFR/OFR effectively identifies sub-optimal vessel physiology post-PCI and locates precise anatomical issues, validated by intravascular imaging. TRIAL REGISTRATION: The ASET JAPAN ClinicalTrials.gov reference: NCT05117866.

BACKGROUND: Growing evidence shows an association between higher post-PCI quantitative flow ratios (QFR) and improved clinical prognosis, however, no models are available to predict suboptimal QFRs (< 0.91) after angiographically successful PCI. This study aims to establish a prediction nomogram for this domain. METHODS: This study included 450 vessels derived from 421 consecutive patients enrolled in the PIONEER IV trial, which were randomly assigned in a 1:1 ratio to a training (N = 225) and internal validation (N = 225) set, with external validation performed in 97 vessels from 95 consecutive patients enrolled in the ASET Japan trial. LASSO regression was used for optimal feature selection, and multivariate logistic regression was subsequently utilized to construct the nomogram. The performance of the nomograms was assessed and validated by area under the receiver operating characteristics curve (AUC), calibration curves, decision curve analysis, and clinical impact curves. RESULTS: The nomogram was constructed incorporating a novel metric, quantitative flow ratio derived pullback pressure gradient (QFR-PPG), alongside four conventional parameters: left anterior descending artery disease, pre-procedural QFR, reference vessel diameter, and percent diameter stenosis. AUCs of the nomogram were 0.866 (95%CI:0.818-0.914), 0.784 (95% CI:0.722-0.847), and 0.781 (95% CI:0.682-0.879) in the training, internal validation and external validation sets, respectively. Bias-corrected curves revealed a strong consistency between actual observations and prediction. CONCLUSION: The risk of a suboptimal post-PCI QFR in patients after angiographically successful PCI can be effectively predicted using a nomogram incorporating five variables available pre-PCI, with its performance and clinical predictive value confirming its utility in helping clinicians with decision-making and planning revascularization. TRIAL REGISTRATION: Registered on clinicaltrial.gov (NCT04923191 and NCT05117866).

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 Intervention and Therapeutics (CVIT) proposed an expert consensus document for the management of acute myocardial infarction (AMI) focusing on procedural aspects of primary PCI in 2018 and updated in 2022. Recently, the European Society of Cardiology (ESC) published the guidelines for the management of acute coronary syndrome in 2023. Major new updates in the 2023 ESC guideline include: (1) intravascular imaging should be considered to guide PCI (Class IIa); (2) timing of complete revascularization; (3) antiplatelet therapy in patient with high-bleeding risk. Reflecting rapid advances in the field, the Task Force on Primary PCI of the CVIT group has now proposed an updated expert consensus document for the management of ACS focusing on procedural aspects of primary PCI in 2024 version.

Slow-flow or no-reflow phenomenon is a common procedural complication during percutaneous coronary intervention (PCI). Given the presence of fragile plaque or thrombotic materials, we hypothesized that long-time predilatation using a perfusion balloon in conjunction with intracoronary nicorandil administration reduces the risk of slow-flow or no-reflow in patients presenting with acute coronary syndrome (ACS). Subjects were patients presenting with ACS who underwent PCI between April 2020 and April 2022. We retrospectively investigated the incidence of slow-flow or no-reflow during the procedure as well as in-hospital outcomes in comparison between the cases undergoing 3-min predilatation using a perfusion balloon in conjunction with intracoronary nicorandil administration followed by DES implantation (PB group) and those with direct stenting (DS group). Among 439 ACS patients, 36 patients in the PB group and 51 patients in the DS group were examined. Mean age was 70 years and 78.2% was male. Distal protection devices were more frequently used in the DS group than in the PB group (31.3% vs. 11.1%, p = 0.02). The incidence rate of slow-flow or no-reflow was significantly lower in the PB group than in the DS group (2.8% vs. 23.5%; p < 0.01). Six cases (11.7%) in the DS group required intra-aortic balloon pumping (IABP), while none in the PB group required (p < 0.01). In-hospital clinical outcomes did not differ between the two groups. Prolonged perfusion balloon predilatation in conjunction with intracoronary nicorandil administration was safe and feasible. This novel strategy could be an attractive alternative to conventional direct stenting for ACS patients.

The CHA2DS2 -VASc score is a vital clinical tool for evaluating thromboembolic risk in patients with atrial fibrillation (AF). This study investigated the efficacy of the CHA2DS2 -VASc score in a cohort of 737 heterogeneous patients (mean age: 63 years) receiving care in cardiac intensive care units (CICUs), with a creatinine-based estimated glomerular filtration rate (eGFR) of ≥60 mL/min/1.73 m2 upon admission and discharge. Incident chronic kidney disease (CKD) was defined as the emergence of a new-onset eGFR<60 mL/min/1.73 m2, accompanied by a decline of >5 mL/min/1.73 m2 compared to that at discharge. The primary endpoint was the incidence of CKD, and the secondary endpoints included all-cause mortality, cardiovascular events, and progression to end-stage kidney disease. In this cohort, 210 (28 %) patients developed CKD. Multivariate analyses revealed that CHA2DS2 -VASc score was a significant independent predictor of incident CKD, regardless of the presence of AF. Integration of CHA2DS2 -VASc scores with eGFR enhanced the predictive accuracy of incident CKD, as evidenced by the improved C-index, net reclassification improvement, and integrated discrimination improvement values (all p < 0.05). Over the 12-month follow-up period, a composite endpoint was observed in 61 patients (8.3 %), with elevated CHA2DS2 -VASc scores being independently associated with this endpoint. In conclusion, CHA2DS2-VASc scores have emerged as robust predictors of both CKD incidence and adverse outcomes. Their inclusion substantially refined the 12-month risk stratification of patients with preserved renal function hospitalized in the CICUs.

We report two case series in which we encountered the difficulties to retrieve disrupted devices during percutaneous coronary intervention and endovascular treatment. The broken devices were successfully and safely retrieved by the "flower technique" that creates multiple cut and slit in the tip of the guiding catheter. This technique can be easily and safely applied in situations where a balloon catheter or stent has been disrupted and device entrapment has occurred, as the technique simply involves manually placing multiple cuts or slits in the tip of the guiding catheter. Transcatheter interventionists should be familiar with this technique because it can be bailout from device entrapment without additional cost or clinical experience.

OBJECTIVES: Evaluation of in-stent restenosis (ISR), especially for small stents, remains challenging during computed tomography (CT) angiography. We used deep learning reconstruction to quantify stent strut thickness and lumen vessel diameter at the stent and compared it with values obtained using conventional reconstruction strategies. METHODS: We examined 166 stents in 85 consecutive patients who underwent CT and invasive coronary angiography (ICA) within 3 months of each other from 2019-2021 after percutaneous coronary intervention with coronary stent placement. The presence of ISR was defined as percent diameter stenosis ≥ 50% on ICA. We compared a super-resolution deep learning reconstruction, Precise IQ Engine (PIQE), and a model-based iterative reconstruction, Forward projected model-based Iterative Reconstruction SoluTion (FIRST). All images were reconstructed using PIQE and FIRST and assessed by two blinded cardiovascular radiographers. RESULTS: PIQE had a larger full width at half maximum of the lumen and smaller strut than FIRST. The image quality score in PIQE was higher than that in FIRST (4.2 ± 1.1 versus 2.7 ± 1.2, p < 0.05). In addition, the specificity and accuracy of ISR detection were better in PIQE than in FIRST (p < 0.05 for both), with particularly pronounced differences for stent diameters < 3.0 mm. CONCLUSION: PIQE provides superior image quality and diagnostic accuracy for ISR, even with stents measuring < 3.0 mm in diameter. CLINICAL RELEVANCE STATEMENT: With improvements in the diagnostic accuracy of in-stent stenosis, CT angiography could become a gatekeeper for ICA in post-stenting cases, obviating ICA in many patients after recent stenting with infrequent ISR and allowing non-invasive ISR detection in the late phase. KEY POINTS: • Despite CT technology advancements, evaluating in-stent stenosis severity, especially in small-diameter stents, remains challenging. • Compared with conventional methods, the Precise IQ Engine uses deep learning to improve spatial resolution. • Improved diagnostic accuracy of CT angiography helps avoid invasive coronary angiography after coronary artery stenting.

BACKGROUND: The geographical disparity in the pathophysiological pattern of coronary artery disease (CAD) among patients undergoing percutaneous coronary intervention (PCI) is unknown. OBJECTIVES: To elucidate the geographical variance in the pathophysiological characteristics of CAD. METHODS: Physiological indices derived from angiography-based fractional flow reserve pullbacks from patients with chronic coronary syndrome enrolled in the ASET Japan (n = 206) and ASET Brazil (n = 201) studies, which shared the same eligibility criteria, were analysed. The pathophysiological patterns of CAD were characterised using Murray law-based quantitative flow ratio (μQFR)-derived indices acquired from pre-PCI angiograms. The diffuseness of CAD was defined by the μQFR pullback pressure gradient index. RESULTS: Significant functional stenoses pre-PCI (μQFR ≤0.80) were more frequent in ASET Japan compared to ASET Brazil (89.9% vs. 67.5%, p < 0.001), as were rates of a post-PCI μQFR <0.91 (22.1% vs. 12.9%, p = 0.013). In the multivariable analysis, pre-procedural μQFR and diffuse disease were independent factors for predicting a post-PCI μQFR <0.91, which contributed to the different rates of post-PCI μQFR ≥0.91 between the studies. Among vessels with a post-PCI μQFR <0.91, a consistent diffuse pattern of CAD pre- and post-PCI occurred in 78.3% and 76.7% of patients in ASET Japan and Brazil, respectively; only 6.3% (Japan) and 10.0% (Brazil) of vessels had a major residual gradient. Independent risk factors for diffuse disease were diabetes mellitus in ASET Japan, and age and male gender in Brazil. CONCLUSIONS: There was geographic disparity in pre-procedural angiography-based pathophysiological characteristics. The combined pre-procedural physiological assessment of vessel μQFR and diffuseness of CAD may potentially identify patients who will benefit most from PCI.

BACKGROUND: The ASET (Acetyl-Salicylic Elimination Trial) pilot studies recently investigated P2Y12 inhibitor monotherapy without aspirin immediately after percutaneous coronary intervention (PCI) in Brazil and Japan. OBJECTIVES: This comparative analysis of the 2 ASET pilot studies aimed to summarize clinical outcomes and assess geographic and ethnic differences in baseline demographics and procedures. METHODS: Patients undergoing successful platinum-chromium everolimus-eluting stent implantation for chronic coronary syndrome were included. Following the index PCI, patients received prasugrel monotherapy with a maintenance dose of 10 mg/day in Brazil and 3.75 mg/day in Japan. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding at up to 3 months. RESULTS: Of 409 enrollments, 3-month follow-up was completed in 406 patients. Mean age was 64.3 ± 8.4 years, and 73% were men. Overall, post-TIMI flow grade 3 was achieved in 99.8%. Intravascular imaging for poststent optimization was used in 16.8% and 99.6% of treated lesions in Brazil and Japan, respectively. The primary ischemic and bleeding endpoints occurred in the same patient (0.2%). No stent thrombosis events occurred. CONCLUSIONS: Prasugrel monotherapy following PCI was safe and feasible in selected low-risk chronic coronary syndrome patients after optimal platinum-chromium everolimus-eluting stent implantation regardless of the ethnic and geographic differences in baseline demographics, procedures, and prasugrel dosage. Randomized controlled trials will be needed to compare P2Y12 inhibitor monotherapy without aspirin with the current standard of care.

OBJECTIVE: To examine the clinical outcomes of optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI). METHODS: We retrospectively investigated 533 consecutive patients who underwent primary PCI for STEMI between June 2016 and December 2020. The primary endpoint was a target lesion failure (TLF; defined as a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization). Propensity score (PS) matching was performed to allow direct comparison of OCT-guided and intravascular ultrasound (IVUS)-guided PCI. RESULTS: Patients in the OCT group (n=166) were younger than those in the IVUS group (n=367) and had a significantly higher left ventricular ejection fraction and estimated glomerular filtration rate. Killip class IV and left main stem disease were more common in the IVUS group. The median peak creatine kinase level was comparable between the two groups (1953 U/L vs 1603 U/L). A significantly larger amount of contrast was used in the OCT group (200 mL vs 165 mL; p<0.001). The cumulative incidence of TLF during a median follow-up of 2.2 years did not differ significantly between OCT and IVUS groups (9.6% vs 13.6%; p=0.221) but cardiac mortality was significantly higher in the IVUS group (8.7% vs 3.6%; p=0.047). After PS matching (n=161 in each group), there was no significant between-group difference in TLF or any other clinical outcome measures. CONCLUSIONS: OCT-guided PCI demonstrated clinical outcomes in patients with STEMI that were comparable to those of IVUS-guided PCI despite considerable differences in background characteristics.

The renal angina index (RAI) is a validated scoring tool for predicting acute kidney injury (AKI). We investigated the efficacy of the RAI in 2436 heterogeneous patients (mean age, 70 years) treated in cardiac intensive care units (CICUs). The RAI was calculated from creatinine and patient condition scores. AKI was diagnosed by the Kidney Disease: Improving Global Outcome criteria. The primary and secondary endpoints were the development of severe AKI and all-cause mortality, respectively. Four hundred thirty-three patients developed AKI, 87 of them severe. In multivariate analyses, the RAI was a significant independent predictor of severe AKI. During the 12-month follow-up period, 210 patients suffered all-cause death. Elevated RAI was independently associated with all-cause mortality, as was NT-proBNP (p < 0.001). The RAI is a potent predictor not only of severe AKI but also of adverse outcomes and substantially improved the 12-month risk stratification of patients hospitalized in CICUs.

BACKGROUND: Even with intracoronary imaging-guided stent optimisation, suboptimal haemodynamic outcomes post-percutaneous coronary intervention (PCI) can be related to residual lesions in non-stented segments. Preprocedural assessment of pathophysiological coronary artery disease (CAD) patterns could help predict the physiological response to PCI. AIMS: The aim of this study was to assess the relationship between preprocedural pathophysiological haemodynamic patterns and intracoronary imaging findings, as well as their association with physiological outcomes immediately post-PCI. METHODS: Data from 206 patients with chronic coronary syndrome enrolled in the ASET-JAPAN study were analysed. Pathophysiological CAD patterns were characterised using Murray law-based quantitative flow ratio (μQFR)-derived indices acquired from pre-PCI angiograms. The diffuseness of CAD was defined by the pullback pressure gradient (PPG) index. Intracoronary imaging in stented segments after stent optimisation was also analysed. RESULTS: In the multivariable analysis, diffuse disease - defined by the pre-PCI μQFR-PPG index - was an independent factor for predicting a post-PCI μQFR <0.91 (per 0.1 decrease of PPG index, odds ratio 1.57, 95% confidence interval: 1.07-2.34; p=0.022), whereas the stent expansion index (EI) was not associated with a suboptimal post-PCI μQFR. Among vessels with an EI ≥80% and post-PCI μQFR <0.91, 84.0% of those vessels had a diffuse pattern preprocedure. There was no significant difference in EI between vessels with diffuse disease and those with focal disease. The average plaque burden in the stented segment was significantly larger in vessels with a preprocedural diffuse CAD pattern. CONCLUSIONS: A physiological diffuse pattern preprocedure was an independent factor in predicting unfavourable immediate haemodynamic outcomes post-PCI, even after stent optimisation using intracoronary imaging. Preprocedural assessment of CAD patterns could identify patients who are likely to exhibit superior immediate haemodynamic outcomes following PCI.

The purposes of the present study were: (1) to investigate the relationship between hospital-associated functional decline (HAFD) and non-lying time and (2) to clarify the optimal cut-off value for non-lying time associated with HAFD in older patients undergoing transcatheter aortic valve implantation (TAVI). From January 2021 to December 2022, patients admitted to a university hospital who underwent trans-femoral TAVI were consecutively recruited. We measured short physical performance battery (SPPB) pre and post-TAVI, and non-lying time from post-operative days 3-5. HAFD was defined as at least 1 point decrease in SPPB during pre and post-TAVI. Among 75 patients (47 female, mean age of 84.5 years) enrolled, 14 patients were classified as having HAFD. Non-lying time was significantly shorter in the HAFD group than in the non-HAFD group (371 min vs. 539 min, P < 0.001). Receiver-operating characteristic analysis determined an optimal cut-off value of 477 min for differentiating the patients more likely to experience HAFD (sensitivity, 75%; specificity, 92%; area under the curve, 0.798). The non-lying time could be one of the associated factors of HAFD in older patients with TAVI. Non-lying time of about 480 min (8 h) during hospitalization may be an initial target for preventing HAFD.

BACKGROUND: Coronary computed tomography angiography (CTA) followed by computed tomography angiography-derived fractional flow reserve (FFRCT) is now commonly used for the management of chronic coronary syndrome (CCS). CTA-verified high-risk plaque (HRP) characteristics have also been reported to be associated with a greater likelihood of adverse cardiac events but have not been used for management decisions. OBJECTIVES: The aim of this study was to evaluate clinical outcomes based on a combination of point-of-care computed tomography angiography-derived fractional flow reserve (POC-FFRCT) and the presence of HRP in CCS patients initially treated medically or with revascularization based on invasive coronary angiography findings. METHODS: CTA was performed as the initial test in 5,483 patients presenting with CCS between September 2015 and December 2020 followed by invasive coronary angiography and revascularization as necessary. POC-FFRCT assessment and HRP characterization were obtained subsequently in 745 consecutive patients. We investigated how HRP and POC-FFRCT, which were not available during the original clinical decision making, correlated with the endpoint defined as a composite of cardiac death, acute coronary syndrome, and a need for unplanned revascularization. RESULTS: Cardiac events occurred in 20 patients (2.7%) during a median follow-up of 744 days. The event rate was significantly higher in patients with POC-FFRCT <0.80 compared with POC-FFRCT ≥0.8 (5.4 vs 0.5 per 100 vessel years; log-rank P < 0.0001) and in patients with HRP compared to those without HRP (3.6 vs 0.8 per 100 vessel years; log-rank P = 0.0001). POC-FFRCT <0.80 and the presence of HRP were the independent predictors of cardiac events (HR: 16.67; 95% CI: 2.63-105.39; P = 0.002) compared with POC-FFRCT ≥0.8 and absent HRP. For the vessels with POC-FFRCT <0.80 and HRP, a significantly higher rate of adverse events was observed in patients who did not undergo revascularization compared with those revascularized (16.4 vs 1.4 per 100 vessel years; log-rank P = 0.006). CONCLUSIONS: POC-FFRCT <0.80 and the presence of HRP were the independent predictors of cardiac events, and revascularization of HRP lesions with abnormal POC-FFRCT was associated with a lower event rate.

BACKGROUND: Left ventricular (LV) global longitudinal strain (GLS) has emerged as a more sensitive index than LV ejection fraction (LVEF) for detecting subclinical LV dysfunction. We examined whether changes in GLS values are associated with the long-term prognosis of patients with a preserved LVEF and acute decompensated heart failure (HF). METHODS: We studied 100 consecutive patients (mean age: 71 years) who were hospitalized for HF with preserved ejection fraction (HFpEF) and had a preserved LVEF (≥ 50%) in both the acute and stable phases. We performed two-dimensional speckle-tracking echocardiography in the acute (GLS-acute) and stable (GLS-stable) phases at a median of 2 and 347 days after admission, respectively, and calculated the rate of change of the absolute value of GLS-stable with respect to that of GLS-acute. An improved GLS was defined as a rate of change in GLS ≥ 16%, and a non-improved GLS was a rate of change < 16%. The primary endpoint was the occurrence of major cardiovascular events (MACE). RESULTS: During a mean follow-up period of 1218 days, MACE occurred in 26 patients, including 8 all-cause deaths and 18 readmissions for HF. The rate of change in GLS for patients with MACE was lower than compared to those without MACE (10.6% vs 26.0%, p < 0.001). Multivariate Cox regression analyses indicated the rate of change in GLS was an independent predictor of MACE (p < 0.001). A non-improved GLS was correlated with a high risk of MACE. CONCLUSION: Changes in GLS values could be useful for the long-term risk stratification of patients hospitalized for HFpEF and persistently preserved LVEF.

Drug-coated balloon (DCB) technology was developed to deliver the antiproliferative drugs to the vessel wall without leaving any permanent prosthesis or durable polymers. The absence of foreign material can reduce the risk of very late stent failure, improve the ability to perform bypass-graft surgery, and reduce the need for long-term dual antiplatelet therapy, potentially reducing associated bleeding complications. The DCB technology, like the bioresorbable scaffolds, is expected to be a therapeutic approach that facilitates the "leave nothing behind" strategy. Although newer generation drug-eluting stents are the most common therapeutic strategy in modern percutaneous coronary interventions, the use of DCB is steadily increasing in Japan. Currently, the DCB is only indicated for treatment of in-stent restenosis or small vessel lesions (< 3.0 mm), but potential expansion for larger vessels (≥ 3.0 mm) may hasten its use in a wider range of lesions or patients with obstructive coronary artery disease. The task force of the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) was convened to describe the expert consensus on DCBs. This document aims to summarize its concept, current clinical evidence, possible indications, technical considerations, and future perspectives.

BACKGROUND: P2Y12 inhibitor monotherapy without aspirin immediately after percutaneous coronary intervention (PCI) has not been tested in East Asian patients, so in this study we aimed to assess the safety and feasibility of reduced dose (3.75 mg/day) prasugrel monotherapy in Japanese patients presenting with chronic coronary syndrome (CCS).Methods and Results: ASET-JAPAN is a prospective, multicenter, single-arm pilot study that completed enrolment of 206 patients from 12 Japanese centers in September 2022. Patients with native de-novo coronary lesions and a SYNTAX score <23 were treated exclusively with biodegradable-polymer platinum-chromium everolimus-eluting stent(s). Patients were loaded with standard dual antiplatelet therapy (DAPT) and following successful PCI and optimal stent deployment, they received low-dose prasugrel (3.75 mg/day) monotherapy for 3 months. The primary ischemic endpoint was a composite of cardiac death, spontaneous target-vessel myocardial infarction, or definite stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5. At 3-month follow-up, there were no primary bleeding or ischemic events, or any stent thrombosis. CONCLUSIONS: This pilot study showed the safety and feasibility of prasugrel monotherapy in selected low-risk Japanese patients with CCS. This "aspirin-free" strategy may be a safe alternative to traditional DAPT following PCI.

The Acetyl Salicylic Elimination Trial (ASET) Japan pilot study is a multicentre, single-arm, open-label, proof-of-concept study with a stopping rule based on the occurrence of definite stent thrombosis. This study aims to demonstrate the feasibility and safety of low-dose prasugrel monotherapy following percutaneous coronary intervention (PCI) in Japanese patients presenting with chronic coronary syndromes (CCS) or non-ST-elevation acute coronary syndromes (NSTE-ACS). Four hundred patients with a SYNTAX score <23 requiring PCI due to CCS or NSTE-ACS will be screened and considered eligible for the study. The enrolment is planned in two phases: 1) 200 patients presenting with CCS, followed by 2) 200 patients presenting with NSTE-ACS. After optimal PCI with implantation of a SYNERGY (Boston Scientific) stent, patients will be enrolled and loaded with prasugrel 20 mg, followed by a maintenance dose of prasugrel 3.75 mg once daily without aspirin continued for 3 months in Phase 1 (CCS patients), and for 12 months in Phase 2 (NSTE-ACS patients). After these follow-up periods, prasugrel will be replaced by standard antiplatelet therapy according to local practice. The primary endpoint is a composite of cardiac death, target vessel myocardial infarction, or definite stent thrombosis after the index procedure. The primary bleeding endpoint is any Bleeding Academic Research Consortium type 3 or 5 bleeding occurring within 3 months of the index PCI for CCS patients, or 12 months for NSTE-ACS patients. The ASET Japan study is designed to demonstrate the feasibility and safety of reduced-dose prasugrel monotherapy after PCI in East Asian patients with acute and chronic coronary syndromes.

BACKGROUND: This study compares the efficacy of coronary computed tomography angiography (CCTA) and near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS) in patients with significant coronary stenosis for predicting periprocedural myocardial injury during percutaneous coronary intervention (PCI). METHODS: We prospectively enrolled 107 patients who underwent CCTA before PCI and performed NIRS-IVUS during PCI. Based on the maximal lipid core burden index for any 4-mm longitudinal segments (maxLCBI4mm) in the culprit lesion, we divided the patients into two groups: lipid-rich plaque (LRP) group (maxLCBI4mm ≥ 400; n = 48) and no-LRP group (maxLCBI4mm < 400; n = 59). Periprocedural myocardial injury was a postprocedural cardiac troponin T (cTnT) elevation of ≥5 times the upper limit of normal. RESULTS: The LRP group had a significantly higher cTnT (p = 0.026), lower CT density (p < 0.001), larger percentage atheroma volume (PAV) by NIRS-IVUS (p = 0.036), and larger remodeling index measured by both CCTA (p = 0.020) and NIRS-IVUS (p < 0.001). A significant negative linear correlation was found between maxLCBI4mm and CT density (rho = -0.552, p < 0.001). Multivariable logistic regression analysis identified maxLCBI4mm [odds ratio (OR): 1.006, p = 0.003] and PAV (OR: 1.125, p = 0.014) as independent predictors of periprocedural myocardial injury, while CT density was not an independent predictor (OR: 0.991, p = 0.22). CONCLUSION: CCTA and NIRS-IVUS correlated well to identify LRP in culprit lesions. However, NIRS-IVUS was more competent in predicting the risk of periprocedural myocardial injury.

UNLABELLED: There have been few case reports on fatal outcomes in patients with acute myocarditis after mRNA coronavirus disease 2019 (COVID-19) vaccination. In most cases of myocarditis after mRNA COVID-19 vaccination, the myocarditis is mild, and the prognosis is good. Here we report an autopsy case of fulminant myocarditis following mRNA COVID-19 vaccination. LEARNING OBJECTIVE: The global distribution of the mRNA coronavirus disease 2019 vaccine requires consideration of appropriate treatment for postvaccination myocarditis. Eosinophil-mediated immunological injury to cardiomyocytes can be involved in the cause of fulminant inflammation from the pathological findings of postvaccination myocarditis.

It remains unclear whether the acute-phase ambulation program (AAP) improves the prognosis of heart failure (HF) patients. We examined the association between the initiation of AAP and the prognosis of patients with worsening HF. We enrolled 560 consecutive patients admitted due to worsening HF from March 2019 to April 2021. Our hospital introduced AAP in May 2020, but we did not perform AAP until April 2020. We retrospectively compared cardiac events within 180 days after discharge between patients admitted before April 2020 (conventional group) and after May 2020 (AAP group). Primary endpoints were all-cause mortality and readmission for worsening HF. The Kaplan-Meier survival curves showed a significantly lower event rate in the AAP group in HF readmission or the primary endpoint (p = 0.020 and p = 0.014). The occurrence of the primary endpoint was associated with age, history of HF, systolic blood pressure, medications including renin-angiotensin system inhibitors or angiotensin receptor blocker, hemoglobin, NT-proBNP, and AAP participation. After adjusting for these parameters and sex, participation in AAP was an independent factor associated with a reduced risk of primary endpoint occurrence (hazard ratio of 0.62 (0.41-0.95), p = 0.028). The AAP for patients with acute HF might lead to improved short-term prognosis and should be considered for implementation.