Prevalence and anatomical factors associated with stent under-expansion in non-severely calcified lesions.

BACKGROUND: Stent underexpansion, typically related to lesion calcification, is the strongest predictor of adverse events after percutaneous coronary intervention (PCI). Although uncommon, underexpansion may also occur in non-severely calcified lesions. AIM: We sought to identify the prevalence and anatomical characteristics of underexpansion in non-severely calcified lesions. METHODS: We included 993 patients who underwent optical coherence tomography-guided PCI of 1051 de novo lesions with maximum calcium arc <180°. Negative remodeling (NR) was the smallest lesion site external elastic lamina diameter that was also smaller than the distal reference. Stent expansion was evaluated using a linear regression model accounting for vessel tapering; underexpansion required both stent expansion <70% and stent area <4.5mm2. RESULTS: Underexpansion was observed in 3.6% of non-heavily calcified lesions (38/1051). Pre-stent maximum calcium arc and thickness were greater in lesions with versus without underexpansion (median 119° vs. 85°, p = 0.002; median 0.95 mm vs. 0.78 mm, p = 0.008). NR was also more common in lesions with underexpansion (44.7% vs. 24.5%, p = 0.007). In the multivariable logistic regression model, larger and thicker eccentric calcium, mid left anterior descending artery (LAD) location, and NR were associated with underexpansion in non-severely calcified lesions. The rate of underexpansion was especially high (30.7%) in lesions exhibiting all three morphologies. Two-year TLF tended to be higher in underexpanded versus non-underexpanded stents (9.7% vs. 3.7%, unadjusted hazard ratio [95% confidence interval] = 3.02 [0.92, 9.58], p = 0.06). CONCLUSION: Although underexpansion in the absence of severe calcium (<180°) is uncommon, mid-LAD lesions with NR and large and thick eccentric calcium were associated with underexpansion.

Prognostic Implications of Microvascular Resistance Reserve in Symptomatic Patients With Intermediate Coronary Stenosis.

BACKGROUND: Microvascular resistance reserve (MRR) is a novel index reflecting coronary microcirculatory function, irrespective of epicardial coronary artery stenosis. There is limited evidence regarding whether MRR can be an independent prognostic tool in patients with stable ischemic heart disease (IHD). OBJECTIVES: The aim of this study was to evaluate clinical outcomes according to MRR in patients with stable IHD accompanied with or without significant epicardial coronary artery stenosis. METHODS: The present study included 547 consecutive patients undergoing systematic echocardiographic and invasive physiological assessment for suspected stable IHD. Significant epicardial coronary artery stenosis was defined as fractional flow reserve (FFR) ≤0.80. Coronary microvascular dysfunction (CMD) was defined as MRR ≤3.0. The primary outcome was major adverse cardiovascular events (MACE), a composite of cardiovascular death, myocardial infarction, repeat revascularization, and admission for heart failure. RESULTS: Among the study group, 172 patients (31.4%) had FFR ≤0.80, and 200 patients (36.6%) had CMD defined by MRR ≤3.0. MRR showed no significant correlation with FFR (R = -0.031; P = 0.469), but it was significantly correlated with the index of microcirculatory resistance (R = -0.353; P < 0.001), N-terminal pro-B-type natriuretic peptide (R = -0.296; P < 0.001), left ventricular filling pressure (E/e' ratio) (R = -0.224; P < 0.001), and diastolic dysfunction grade (P < 0.001). During a median follow-up period of 3.3 years (Q1-Q3: 2.0-4.5 years), MRR was significantly associated with MACE risk (HR: 1.23 per 1-U decrease; 95% CI: 1.12-1.36; P < 0.001). CMD defined by MRR ≤3.0 was associated with an increased MACE risk for both FFR >0.80 (41.0% vs 26.0%; adjusted HR: 1.59; 95% CI: 1.07-2.35; P = 0.021) and FFR ≤0.80 (34.7% vs 14.8%; adjusted HR: 2.32; 95% CI: 1.12-4.82; P = 0.024). CONCLUSIONS: Decreased MRR was associated with the presence of cardiac diastolic dysfunction as well as increased left ventricular filling pressure. The presence of CMD defined by MRR was independently associated with the risk for a composite of cardiovascular death, myocardial infarction, repeat revascularization, and admission for heart failure in patients with stable IHD, irrespective of significant epicardial coronary artery stenosis. (Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function [DIAST-CMD]; NCT05058833).

Impact of Incomplete Revascularization After PCI in Left Main Disease: The EXCEL Trial.

BACKGROUND: The importance of complete revascularization after percutaneous coronary intervention (PCI) in patients with left main coronary artery disease is uncertain. We investigated the clinical impact of complete revascularization in patients with left main coronary artery disease undergoing PCI in the EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization). METHODS: Composite rates of death or myocardial infarction (MI) following PCI during 5-year follow-up were examined in 903 patients based on core laboratory definitions of anatomic and functional complete revascularization, residual SYNTAX score (The Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), and residual Jeopardy Score (rJS). RESULTS: The risk of death or MI did not vary based on anatomic, functional, or residual SYNTAX score complete revascularization but did differ according to the rJS (5-year rates 17.6%, 19.5%, and 38.9% with rJS 0, 2, and ≥4, respectively; P=0.006). The higher rate of death or MI with rJS≥4 versus rJS≤2 was driven conjointly by increased mortality (adjusted hazard ratio, 2.29 [95% CI, 1.11-4.71]; P=0.02) and spontaneous MI (adjusted hazard ratio, 2.89 [95% CI, 1.17-7.17]; P=0.02). The most common location for untreated severe stenoses in the rJS≥4 group was the left circumflex artery (LCX), and the post-PCI absence, compared with the presence, of any untreated lesion with diameter stenosis ≥70% in the LCX was associated with reduced 5-year rates of death or MI (18.9% versus 35.2%; hazard ratio, 0.48 [95% CI, 0.32-0.74]; P<0.001). The risk was the highest for residual ostial/proximal LCX lesions. CONCLUSIONS: Among patients undergoing PCI in EXCEL trial, incomplete revascularization according to the rJS was associated with increased rates of death and spontaneous MI. Post-PCI untreated high-grade lesions in the LCX (especially the ostial/proximal LCX) drove these outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01205776.

Cost-Effectiveness of Intravascular Imaging-Guided Complex PCI: Prespecified Analysis of RENOVATE-COMPLEX-PCI Trial.

BACKGROUND: Although clinical benefits of intravascular imaging-guided percutaneous coronary intervention (PCI) in patients with complex coronary artery lesions have been observed in previous trials, the cost-effectiveness of this strategy is uncertain. METHODS: RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance vs Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) was conducted in Korea between May 2018 and May 2021. This prespecified cost-effectiveness substudy was conducted using Markov model that simulated 3 states: (1) post-PCI, (2) spontaneous myocardial infarction, and (3) death. A simulated cohort was derived from the intention-to-treat population, and input parameters were extracted from either the trial data or previous publications. Cost-effectiveness was evaluated using time horizon of 3 years (within trial) and lifetime. The primary outcome was incremental cost-effectiveness ratio (ICER), an indicator of incremental cost on additional quality-adjusted life years (QALYs) gained, in intravascular imaging-guided PCI compared with angiography-guided PCI. The current analysis was performed using the Korean health care sector perspective with reporting the results in US dollar (1200 Korean Won, ₩=1 dollar, $). Willingness to pay threshold was $35 000 per QALY gained. RESULTS: A total of 1639 patients were included in the trial. During 3-year follow-up, medical costs ($8661 versus $7236; incremental cost, $1426) and QALY (2.34 versus 2.31; incremental QALY, 0.025) were both higher in intravascular imaging-guided PCI than angiography-guided PCI, resulting incremental cost-effectiveness ratio of $57 040 per QALY gained within trial data. Conversely, lifetime simulation showed total cumulative medical cost was reversed between the 2 groups ($40 455 versus $49 519; incremental cost, -$9063) with consistently higher QALY (8.24 versus 7.89; incremental QALY, 0.910) in intravascular imaging-guided PCI than angiography-guided PCI, resulting in a dominant incremental cost-effectiveness ratio. Consistently, 70% of probabilistic iterations showed cost-effectiveness of intravascular imaging-guided PCI in probabilistic sensitivity analysis. CONCLUSIONS: The current cost-effectiveness analysis suggests that imaging-guided PCI is more cost-effective than angiography-guided PCI by reducing medical cost and increasing quality-of-life in complex coronary artery lesions in long-term follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03381872.

Differential Impact of Fractional Flow Reserve Measured After Coronary Stent Implantation by Left Ventricular Dysfunction.

Background: Both left ventricular systolic function and fractional flow reserve (FFR) are prognostic factors after percutaneous coronary intervention (PCI). However, how these prognostic factors are inter-related in risk stratification of patients after PCI remains unclarified. Objectives: This study evaluated differential prognostic implication of post-PCI FFR according to left ventricular ejection fraction (LVEF). Methods: A total of 2,965 patients with available LVEF were selected from the POST-PCI FLOW (Prognostic Implications of Physiologic Investigation After Revascularization with Stent) international registry of patients with post-PCI FFR measurement. The primary outcome was a composite of cardiac death or target-vessel myocardial infarction (TVMI) at 2 years. The secondary outcome was target-vessel revascularization (TVR) and target vessel failure, which was a composite of cardiac death, TVMI, or TVR. Results: Post-PCI FFR was independently associated with the risk of target vessel failure (per 0.01 decrease: HRadj: 1.029; 95% CI: 1.009-1.049; P = 0.005). Post-PCI FFR was associated with increased risk of cardiac death or TVMI (HRadj: 1.145; 95% CI: 1.025-1.280; P = 0.017) among patients with LVEF ≤40%, and with that of TVR in patients with LVEF >40% (HRadj: 1.028; 95% CI: 1.005-1.052; P = 0.020). Post-PCI FFR ≤0.80 was associated with increased risk of cardiac death or TVMI in the LVEF ≤40% group and with that of TVR in LVEF >40% group. Prognostic impact of post-PCI FFR for the primary outcome was significantly different according to LVEF (Pinteraction = 0.019). Conclusions: Post-PCI FFR had differential prognostic impact according to LVEF. Residual ischemia by post-PCI FFR ≤0.80 was a prognostic indicator for cardiac death or TVMI among patients with patients with LVEF ≤40%, and it was associated with TVR among patients with patients with LVEF>40%. (Prognostic Implications of Physiologic Investigation After Revascularization with Stent [POST-PCI FLOW]; NCT04684043).

Intravascular Imaging-Guided Percutaneous Coronary Intervention Before and After Standardized Optimization Protocols.

BACKGROUND: Although benefits of intravascular imaging (IVI) in percutaneous coronary intervention (PCI) have been observed in previous studies, it is not known whether changes in contemporary practice, especially with application of standardized optimization protocols, have improved clinical outcomes. OBJECTIVES: The authors sought to investigate whether clinical outcomes of IVI-guided PCI are different before and after the application of standardized optimization protocols in using IVI. METHODS: 2,972 patients from an institutional registry (2008-2015, before application of standardized optimization protocols, the past group) and 1,639 patients from a recently published trial (2018-2021 after application of standardized optimization protocols, the present group) were divided into 2 groups according to use of IVI. The primary outcome was 3-year target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. RESULTS: Significant reduction of TVF was observed in the IVI-guided PCI group compared with the angiography-guided PCI group (10.0% vs 6.7%; HR: 0.77; 95% CI: 0.61-0.97; P = 0.027), mainly driven by reduced cardiac death or myocardial infarction in both past and present IVI-guided PCI groups. When comparing past IVI and present IVI groups, TVF was significantly lower in the present IVI group (8.5% vs 5.1%; HR: 0.63; 95% CI: 0.42-0.94; P = 0.025), with the difference being driven by reduced target vessel revascularization in the present IVI group. Consistent results were observed in inverse-probability-weighting adjusted analysis. CONCLUSIONS: IVI-guided PCI improved clinical outcomes more than angiography-guided PCI. In addition, application of standardized optimization protocols when using IVI further improved clinical outcomes after PCI. (Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention For Complex Coronary Artery Disease [RENOVATE-COMPLEX-PCI]; NCT03381872; and the institutional cardiovascular catheterization database of Samsung Medical Center: Long-Term Outcomes and Prognostic Factors in Patient Undergoing CABG or PCI; NCT03870815).

Cost-Effectiveness of Fractional Flow Reserve-Guided Treatment for Acute Myocardial Infarction and Multivessel Disease: A Prespecified Analysis of the FRAME-AMI Randomized Clinical Trial.

Importance: Complete revascularization by non-infarct-related artery (IRA) percutaneous coronary intervention (PCI) in patients with acute myocardial infarction is standard practice to improve patient prognosis. However, it is unclear whether a fractional flow reserve (FFR)-guided or angiography-guided treatment strategy for non-IRA PCI would be more cost-effective. Objective: To evaluate the cost-effectiveness of FFR-guided compared with angiography-guided PCI in patients with acute myocardial infarction and multivessel disease. Design, Setting, and Participants: In this prespecified cost-effectiveness analysis of the FRAME-AMI randomized clinical trial, patients were randomly allocated to either FFR-guided or angiography-guided PCI for non-IRA lesions between August 19, 2016, and December 24, 2020. Patients were aged 19 years or older, had ST-segment elevation myocardial infarction (STEMI) or non-STEMI and underwent successful primary or urgent PCI, and had at least 1 non-IRA lesion (diameter stenosis >50% in a major epicardial coronary artery or major side branch with a vessel diameter of ≥2.0 mm). Data analysis was performed on August 27, 2023. Intervention: Fractional flow reserve-guided vs angiography-guided PCI for non-IRA lesions. Main Outcomes and Measures: The model simulated death, myocardial infarction, and repeat revascularization. Future medical costs and benefits were discounted by 4.5% per year. The main outcomes were quality-adjusted life-years (QALYs), direct medical costs, incremental cost-effectiveness ratio (ICER), and incremental net monetary benefit (INB) of FFR-guided PCI compared with angiography-guided PCI. State-transition Markov models were applied to the Korean, US, and European health care systems using medical cost (presented in US dollars), utilities data, and transition probabilities from meta-analysis of previous trials. Results: The FRAME-AMI trial randomized 562 patients, with a mean (SD) age of 63.3 (11.4) years. Most patients were men (474 [84.3%]). Fractional flow reserve-guided PCI increased QALYs by 0.06 compared with angiography-guided PCI. The total cumulative cost per patient was estimated as $1208 less for FFR-guided compared with angiography-guided PCI. The ICER was -$19 484 and the INB was $3378, indicating that FFR-guided PCI was more cost-effective for patients with acute myocardial infarction and multivessel disease. Probabilistic sensitivity analysis showed consistent results and the likelihood iteration of cost-effectiveness in FFR-guided PCI was 97%. When transition probabilities from the pairwise meta-analysis of the FLOWER-MI and FRAME-AMI trials were used, FFR-guided PCI was more cost-effective than angiography-guided PCI in the Korean, US, and European health care systems, with an INB of $3910, $8557, and $2210, respectively. In probabilistic sensitivity analysis, the likelihood iteration of cost-effectiveness with FFR-guided PCI was 85%, 82%, and 31% for the Korean, US, and European health care systems, respectively. Conclusions and Relevance: This cost-effectiveness analysis suggests that FFR-guided PCI for non-IRA lesions saved medical costs and increased quality of life better than angiography-guided PCI for patients with acute myocardial infarction and multivessel disease. Fractional flow reserve-guided PCI should be considered in determining the treatment strategy for non-IRA stenoses in these patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02715518.

Impact of Calcium Eccentricity on the Safety and Effectiveness of Coronary Intravascular Lithotripsy: Pooled Analysis From the Disrupt CAD Studies.

BACKGROUND: Coronary intravascular lithotripsy (IVL) safely facilitates successful stent implantation in severely calcified lesions. This analysis sought to determine the relative impact of lesion calcium eccentricity on the safety and effectiveness of IVL using high-resolution optical coherence tomography imaging. METHODS: Individual patient-level data (n=262) were pooled from 4 distinct international prospective studies (Disrupt CAD I, II, III, and IV) and analyzed by an independent optical coherence tomography core laboratory. IVL performance in eccentric versus concentric calcification was analyzed by dividing calcified lesions into quartiles (≤180° [most eccentric], 181°-270°, 271°-359°, and 360° [concentric]) by maximum continuous calcium arc. RESULTS: In the 230 patients with clear imaging field on optical coherence tomography, there were no differences in preprocedure minimum lumen area, diameter stenosis, or maximum calcium thickness. The calcium length and volume index increased progressively with increasing mean and maximum continuous calcium arc (ie, concentricity). Conversely, the minimum calcium thickness decreased progressively with increasing concentricity. Post-procedure, the number of calcium fractures, fracture depth, and fracture width increased with increasing concentricity, with a 4-fold increase in the number of fractures in lesions with 360° of calcium arc compared with ≤180°. This increase in IVL-induced calcium fracture with increasing calcium burden and concentricity facilitated stent expansion and luminal gain such that there were no significant differences across quartiles. CONCLUSIONS: IVL induced calcium fractures proportional to the magnitude of coronary artery calcium, including in eccentric calcium, leading to consistent improvements in stent expansion and luminal gain in both eccentric and concentric calcified coronary lesions.

QFR Assessment and Prognosis After Nonculprit PCI in Patients With Acute Myocardial Infarction.

BACKGROUND: Complete revascularization using either angiography-guided or fractional flow reserve (FFR)-guided strategy can improve clinical outcomes in patients with acute myocardial infarction (AMI) and multivessel disease. However, there is concern that angiography-guided percutaneous coronary intervention (PCI) may result in un-necessary PCI of the non-infarct-related artery (non-IRA), and its long-term prognosis is still unclear. OBJECTIVES: This study sought to evaluate clinical outcomes after non-IRA PCI according to the quantitative flow ratio (QFR). METHODS: We performed post hoc QFR analysis of non-IRA lesions of AMI patients enrolled in the FRAME-AMI (FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease) trial, which randomly allocated 562 patients into either FFR-guided PCI (FFR ≤0.80) or angiography-guided PCI (diameter stenosis >50%) for non-IRA lesions. Patients were classified by non-IRA QFR values into the QFR ≤0.80 and QFR >0.80 groups. The primary outcome was a major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, and repeat revascularization. RESULTS: A total of 443 patients (552 lesions) were eligible for QFR analysis. Of 209 patients in the angiography-guided PCI group, 30.0% (n = 60) underwent non-IRA PCI despite having QFR >0.80 in the non-IRA. Conversely, only 2.7% (n = 4) among 209 patients in the FFR-guided PCI group had QFR >0.80 in the non-IRA. At a median follow-up of 3.5 years, the rate of MACEs was significantly higher among patients with non-IRA PCI despite QFR >0.80 than in patients with deferred PCI for non-IRA lesions (12.9% vs 3.1%; HR: 4.13; 95% CI: 1.10-15.57; P = 0.036). Non-IRA PCI despite QFR >0.80 was associated with a higher risk of non-IRA MACEs than patients with deferred PCI for non-IRA lesions (12.9% vs 2.1%; HR: 5.44; 95% CI: 1.13-26.19; P = 0.035). CONCLUSIONS: In AMI patients with multivessel disease, 30.0% of angiography-guided PCI resulted in un-necessary PCI for the non-IRA with QFR >0.80, which was significantly associated with an increased risk of MACEs than in those with deferred PCI for non-IRA lesions. (FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease [FRAME-AMI] ClinicalTrials.gov number; NCT02715518).

Differential predictability for high-risk plaque characteristics between fractional flow reserve and instantaneous wave-free ratio.

To evaluate the differential associations of high-risk plaque characteristics (HRPC) with resting or hyperemic physiologic indexes (instantaneous wave-free ratio [iFR] or fractional flow reserve [FFR]), a total of 214 vessels from 127 patients with stable angina or acute coronary syndrome who underwent coronary computed tomography angiography (CCTA) and invasive physiologic assessment were investigated. HPRC were classified into quantitative (minimal luminal area < 4 mm2 or plaque burden ≥ 70%) and qualitative features (low attenuation plaque, positive remodeling, napkin ring sign, or spotty calcification). Vessels with FFR ≤ 0.80 or iFR ≤ 0.89 had significantly higher proportions of HRPC than those with FFR > 0.80 or iFR > 0.89, respectively. FFR was independently associated with both quantitative and qualitative HRPC, but iFR was only associated with quantitative HRPC. Both FFR and iFR were significantly associated with the presence of ≥ 3 HRPC, and FFR demonstrated higher discrimination ability than iFR (AUC 0.703 vs. 0.648, P = 0.045), which was predominantly driven by greater discriminating ability of FFR for quantitative HRPC (AUC 0.832 vs. 0.744, P = 0.005). In conclusion, both FFR and iFR were significantly associated with CCTA-derived HRPC. Compared with iFR, however, FFR was independently associated with the presence of qualitative HRPC and showed a higher predictive ability for the presence of ≥ 3 HRPC.

Prognosis after discontinuing renin angiotensin aldosterone system inhibitor for heart failure with restored ejection fraction after acute myocardial infarction.

Prognostic effect of discontinuing renin-angiotensin-aldosterone-system-inhibitor (RAASi) for patients with heart failure (HF) after acute myocardial infarction (AMI) whose left ventricular (LV) systolic function was restored during follow-up is unknown. To investigate the outcome after discontinuing RAASi in post-AMI HF patients with restored LV ejection fraction (EF). Of 13,104 consecutive patients from the nationwide, multicenter, and prospective Korea Acute Myocardial Infarction-National Institutes of Health (KAMIR-NIH) registry, HF patients with baseline LVEF < 50% that was restored to ≥ 50% at 12-month follow-up were selected. Primary outcome was a composite of all-cause death, spontaneous MI, or rehospitalization for HF at 36-month after index procedure. Of 726 post-AMI HF patients with restored LVEF, 544 maintained RAASi (Maintain-RAASi) beyond 12-month, 108 stopped RAASi (Stop-RAASi), and 74 did not use RAASi (RAASi-Not-Used) at baseline and follow-up. Systemic hemodynamics and cardiac workloads were similar among groups at baseline and during follow-up. Stop-RAASi group showed elevated NT-proBNP than Maintain-RAASi group at 36-month. Stop-RAASi group showed significantly higher risk of primary outcome than Maintain-RAASi group (11.4% vs. 5.4%; adjusted hazard ratio [HRadjust] 2.20, 95% confidence interval [CI] 1.09-4.46, P = 0.028), mainly driven by increased risk of all-cause death. The rate of primary outcome was similar between Stop-RAASi and RAASi-Not-Used group (11.4% vs. 12.1%; HRadjust 1.18 [0.47-2.99], P = 0.725). In post-AMI HF patients with restored LV systolic function, RAASi discontinuation was associated with significantly increased risk of all-cause death, MI, or rehospitalization for HF. Maintaining RAASi will be necessary for post-AMI HF patients, even after LVEF is restored.

Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice.

BACKGROUND: The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. METHODS: The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patient-oriented composite outcome (POCO) at 2 years. RESULTS: Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group. Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel. Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487-3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663-3.012, P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. CONCLUSION: With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02601404, NCT04265443.

Prognostic Impact of Coronary Microvascular Dysfunction According to Different Patterns by Invasive Physiologic Indexes in Symptomatic Patients With Intermediate Coronary Stenosis.

BACKGROUND: Coronary microvascular dysfunction is a clinically significant component of ischemic heart disease. There can be heterogenous patterns of coronary microvascular dysfunction defined by invasive physiologic indexes such as coronary flow reserve (CFR) and index of microcirculatory resistance (IMR). We sought to compare the prognosis of coronary microvascular dysfunction according to different patterns of CFR and IMR. METHODS: The current study included 375 consecutive patients undergoing invasive physiologic assessment for suspected stable ischemic heart disease and intermediate but functionally nonsignificant epicardial stenosis (fractional flow reserve, >0.80). According to cutoff values of invasive physiologic indexes reflecting microcirculatory function (CFR, <2.5; IMR, ≥25), patients were classified into 4 groups: (1) preserved CFR and low IMR (group 1), (2) preserved CFR and elevated IMR (group 2), (3) depressed CFR and low IMR (group 3), and (4) depressed CFR and elevated IMR (group 4). Primary outcome was a composite of cardiovascular death or admission for heart failure during the follow-up time. RESULTS: Cumulative incidence of the primary outcome was significantly different among the 4 groups (group 1, 20.1%; group 2, 18.8%; group 3, 33.9%; and group 4, 45.0%; overall P<0.001). Depressed CFR had significantly higher risk of primary outcome than preserved CFR in both low (hazard ratio [HR], 1.894 [95% CI, 1.112-3.225]; P=0.019) and elevated IMR subgroups (HR, 3.307 [95% CI, 1.519-7.202]; P=0.003). Conversely, the risk of primary outcome was not significantly different between elevated and low IMR in preserved CFR subgroups (HR, 0.926 [95% CI, 0.428-2.005]; P=0.846). Furthermore, as continuous variables, IMR-adjusted CFR (adjusted HR, 0.644 [95% CI, 0.537-0.772]; P<0.001) was significantly associated with the risk of primary outcome but CFR-adjusted IMR (adjusted HR, 1.004 [95% CI, 0.992-1.016]; P=0.515) was not. CONCLUSIONS: Among patients with suspected stable ischemic heart disease who were found to have an intermediate but functionally nonsignificant epicardial stenosis, depressed CFR was associated with an increased risk of cardiovascular death and admission for heart failure. However, elevated IMR alone with preserved CFR showed limited prognostic value in this population. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT05058833.

Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function on Cardiovascular Death.

Background Coronary microvascular dysfunction (CMD) has been considered as a possible cause of cardiac diastolic dysfunction. The current study evaluated the association between cardiac diastolic dysfunction and CMD, and their prognostic implications in patients without significant left ventricular systolic dysfunction and epicardial coronary stenosis. Methods and Results A total of 330 patients without left ventricular systolic dysfunction (ejection fraction ≥50%) and significant epicardial coronary stenosis (fractional flow reserve >0.80) were analyzed. Cardiac diastolic dysfunction was defined by echocardiographic parameters (early diastolic transmitral flow velocity/early diastolic mitral annular velocity, e' velocity, tricuspid regurgitation velocity, and left atrial volume index). Overt CMD was defined as coronary flow reserve <2.0 and index of microcirculatory resistance ≥25 U. The primary end point was cardiovascular death or admission for heart failure during 5 years of follow-up. In patients without left ventricular systolic dysfunction and significant epicardial coronary stenosis, prevalence of cardiac diastolic dysfunction and overt CMD was 25.5% and 11.2%, respectively. Overt CMD was independently associated with cardiac diastolic dysfunction (adjusted odds ratio, 3.440 [95% CI, 1.599-7.401]; P=0.002). Patients with cardiac diastolic dysfunction showed significantly higher risk of the primary outcome than those without (adjusted hazard ratio [HR], 2.996 [95% CI, 1.888-4.755]; P<0.001). Patients with overt CMD also showed significantly higher risk of the primary outcome than those without (adjusted HR, 2.939 [95% CI, 1.642-5.261]; P<0.001). Presence of overt CMD was associated with significantly increased risk of cardiovascular death among the patients with cardiac diastolic dysfunction (43.8% versus 14.5%; P=0.006) but not in patients without cardiac diastolic dysfunction (interaction P<0.001). Inclusion of overt CMD into the model with cardiac diastolic dysfunction significantly improved predictive ability for cardiovascular death or heart failure admission (conconrdance index, 0.719 versus 0.737; P for comparison=0.034). Conclusions There was significant association between the presence of cardiac diastolic dysfunction and overt CMD. Both cardiac diastolic dysfunction and overt CMD were associated with increased risk of cardiovascular death or admission for heart failure. Integration of overt CMD into cardiac diastolic dysfunction showed improvement of the risk stratification in patients without significant left ventricular systolic dysfunction and epicardial coronary stenosis. Registration DIAST-CMD (Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function) registry; Unique identifier: NCT05058833.

Prognostic Impact of Coronary Flow Reserve in Patients With CKD.

Introduction: Both coronary flow reserve (CFR) and chronic kidney disease (CKD) are known to be associated with adverse cardiac events. However, it is unclear how these prognostic factors are interrelated. This study evaluated the association between intracoronary physiologic indexes and CKD and their prognostic implications. Methods: A total of 351 patients without left ventricular systolic dysfunction (ejection fraction ≥ 40%) and not on dialysis whose revascularization was deferred based on fractional flow reserve (FFR) > 0.80 were analyzed. Depressed CFR was defined as CFR ≤ 2.0. The primary outcome was a composite of cardiac death or hospitalization for heart failure at 3 years. Results: Patients with CKD showed lower CFR than the non-CKD population (3.28 ± 1.77 vs. 2.60 ± 1.09, P < 0.001), mainly driven by increased resting coronary flow. There was no significant difference in hyperemic coronary flow, FFR, and index of microvascular resistance between the 2 groups. CFR was significantly associated with estimated glomerular filtration rate (eGFR) (P = 0.045), and the proportion of depressed CFR was significantly increased with higher CKD stages (P = 0.011). The risk of cardiac death or hospitalization for heart failure was the lowest in the non-CKD and preserved CFR group (11.9%) and the highest in the CKD and depressed CFR group (60.0%, overall log rank P < 0.001). Both CKD (adjusted hazard ratio [HRadj] 2.614, 95% confidence interval [CI] 1.505-4.539, P < 0.001) and depressed CFR (HRadj 3.237, 95% CI 2.015-5.199, P < 0.001) were independently associated with the risk of the primary outcome. Conclusion: There was a significant association between severity of CKD and CFR. Both CKD and depressed CFR showed independent association with higher risk of cardiac death or hospitalization for heart failure.

Prognostic Impact of Indeterminate Diastolic Function in Patients With Functionally Insignificant Coronary Stenosis.

BACKGROUND: Cardiac diastolic dysfunction is an independent predictor of mortality, regardless of left ventricular (LV) systolic function. However, the current guidelines that define cardiac diastolic dysfunction may underrate the clinical implications of those with indeterminate diastolic function. OBJECTIVES: We sought to evaluate the prognostic implications of indeterminate diastolic function on echocardiography and its association with coronary microvascular dysfunction (CMD). METHODS: A total of 330 patients without LV systolic dysfunction and significant epicardial coronary stenosis (fractional flow reserve > 0.80) were analyzed from a prospective registry. Cardiac diastolic dysfunction was defined according to 2 algorithms depending on the presence of myocardial disease. First, the presence of myocardial disease and evidence of elevated LV filling pressure indicated diastolic dysfunction. Second, diastolic function in those without myocardial disease was defined using echocardiographic parameters (E/e', e' velocity, tricuspid regurgitation velocity, and left atrial volume index). Patients who did not meet half of the available criteria were classified as having indeterminate diastolic function. Coronary microvascular dysfunction was defined as coronary flow reserve < 2.0 and index of microcirculatory resistance ≥ 25 U. The primary outcome was cardiovascular death or admission for heart failure at 5 years. RESULTS: Coronary flow reserve was lower in patients with indeterminate diastolic function compared with those with no diastolic dysfunction (3.5 ± 1.6 vs 3.2 ± 1.6, P = .002). The prevalence of CMD was also higher in patients with indeterminate diastolic function than in those with no diastolic dysfunction (10.6% vs 4.9%, P < .034). Patients with indeterminate diastolic function showed significantly higher risk of cardiovascular death or admission for heart failure than those without indeterminate diastolic function but not greater than those with definite diastolic dysfunction (cumulative incidence: 12.6%, 27.2%, and 32.7%, respectively, log-rank P < .001). Presence of CMD and elevated LV filling pressure (E/e' > 14) were independent predictors for cardiovascular death or admission for heart failure in patients with indeterminate diastolic function. CONCLUSIONS: Patients with indeterminate diastolic function on echocardiogram showed higher risk of cardiovascular death or admission for heart failure than those with no diastolic dysfunction. Presence of CMD and elevated LV filling pressure were independent predictors for cardiovascular death or admission for heart failure among patients with indeterminate diastolic function.