Finocchiaro S, Mauro MS, Sclofani D
… +3 more, Spagnolo M, Greco A, Capodanno D
Cardiovasc Revasc Med
· 2025 Dec · PMID 41484035
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BACKGROUND: Quantitative flow ratio (QFR) is a recent, non-invasive method for functional coronary assessment, providing estimates of lesion-specific ischemia without the need for pressure wires or hyperemic agents. Whil...BACKGROUND: Quantitative flow ratio (QFR) is a recent, non-invasive method for functional coronary assessment, providing estimates of lesion-specific ischemia without the need for pressure wires or hyperemic agents. While its diagnostic concordance with fractional flow reserve (FFR) has been previously explored, data comparing QFR to non-hyperemic pressure ratios (NHPRs), such as instantaneous wave-free ratio (iwFR) and resting full-cycle ratio (RFR), remain limited. OBJECTIVES: This study aimed to evaluate the diagnostic agreement between QFR and NHPRs in real-world patients undergoing physiological assessment for intermediate coronary stenoses. METHODS: Lesions from the CAST registry with available iwFR or RFR and analyzable angiograms for QFR computation were included. Ischemia was defined as NHPRs ≤0.89 or QFR ≤0.80. Diagnostic performance was assessed using sensitivity, specificity, predictive values, and ROC analysis (AUC via DeLong's method). Agreement was evaluated with Cohen's kappa and Bland-Altman analysis. McNemar's test assessed asymmetry in discordant pairs. Spearman's correlation and logistic univariate and multivariable regressions identified predictors of QFR-NHPRs discordance. RESULTS: A total of 174 lesions from 142 patients were included in the final analysis. QFR demonstrated a diagnostic accuracy of 79 %, with a sensitivity of 90 % and a negative predictive value of 82 %, in respect of NHPRs. Specificity and positive predictive value were 63 % and 78 %, respectively. The area under the ROC curve was 0.80 (95 % CI, 0.733-0.867). QFR underestimated ischemia in 14.9 % of lesions (false negatives), and overall diagnostic discordance with NHPRs occurred in 20.7 % of cases. Longer lesion length was independently associated with higher concordance (OR 0.95, 95 % CI 0.91-0.99, p = 0.012), while bifurcation lesions were predictors of discordance (OR 4.81, 95 % CI 1.30-21.12, p = 0.024). CONCLUSIONS: QFR shows moderate concordance with NHPRs and may serve as a useful, wire-free alternative for excluding functionally significant stenoses. While it demonstrated high sensitivity, the risk of false negatives in certain anatomical subsets highlights the value of a cautious, individualized approach, possibly integrating QFR with invasive indices or imaging modalities in selected cases.
Zuin M, Marchese G, Prevedello F
… +4 more, Hiso E, Bertolini A, Foroni M, Rigatelli G
Cardiovasc Revasc Med
· 2026 May · PMID 41455669
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BACKGROUND: Provisional single stenting is the recommended default strategy for complex left main (LM) bifurcation lesions. However, double stenting may improve side branch patency in such cases, though its effect on myo...BACKGROUND: Provisional single stenting is the recommended default strategy for complex left main (LM) bifurcation lesions. However, double stenting may improve side branch patency in such cases, though its effect on myocardial performance remains uncertain. We compare 30-day changes in non-invasive myocardial work (MW) indices following double versus provisional single stenting in patients with complex LM bifurcations. METHOD: In this prospective, single-center analysis, 282 patients with complex LM bifurcation lesions undergoing PCI between October 2023 and June 2025 were included. Patients were treated with either double stenting (culotte, nano-inverted-T, or TAP; n = 141) or provisional single stenting (n = 141) and matched 1:1 by propensity score. Echocardiography was performed at baseline and 30 days post-PCI. MW indices, including global work index (GWI), global constructive work (GCW), global wasted work (GWW), and global work efficiency (GWE), were derived from non-invasive pressure-strain analysis. RESULTS: Baseline characteristics and echocardiographic indices were comparable between groups. Both strategies improved GWI and GCW and reduced GWW (all p < 0.0001). However, double stenting was associated with greater improvements in all MW indices [ΔGWI 218.3 ± 93.3 vs. 117.2 ± 83.4 mmHg% and ΔGCW177.7 ± 75.4 vs. 99.7 ± 83.6 mmHg% (both p < 0.001); ΔGWW -44.9 ± 31.0 vs. -23.8 ± 32.1 mmHg% (p < 0.001), and ΔGWE +3.1 ± 1.9 vs. +1.4 ± 1.9 % (p < 0.001)]. CONCLUSIONS: In complex LM bifurcation lesions, double stenting leads to superior 30-day recovery of MW compared with provisional single stenting, suggesting enhanced left ventricular efficiency.
Wong SF, Eskandari M, Cockburn J
… +7 more, Broyd C, Ferreira-Martins J, Abu-Own H, Hill A, Gomes A, Byrne J, Hildick-Smith D
Cardiovasc Revasc Med
· 2025 Dec · PMID 41455668
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BACKGROUND: Post-infarction ventricular septal defect (PiVSD) is a rare but fatal complication of myocardial infarction (MI). Percutaneous closure via conventional venous access and venoarterial rail increases procedural...BACKGROUND: Post-infarction ventricular septal defect (PiVSD) is a rare but fatal complication of myocardial infarction (MI). Percutaneous closure via conventional venous access and venoarterial rail increases procedural complexity and time, exerts strain on surrounding septal tissue, and results in device angulation. Whilst such drawbacks can be mitigated with the transaxillary arterial approach, the acute safety and long-term efficacy are unreported. METHODS: We included all patients undergoing percutaneous transaxillary transarterial PiVSD closure in two large tertiary centres in England from April 2020 to May 2025. Procedural data, periprocedural, in-hospital and 1-year mortality were determined through review of local and national electronic records. RESULTS: Nine patients with comorbid cardiogenic shock were included. The median duration from MI to PiVSD closure was 4 (interquartile range 3-11) days. Right axillary access was used in all cases. The device implanted was either a 24 mm Amplatzer P.I. Muscular VSD Occluder or a larger Amplatzer Septal Occluder (Abbott, USA) necessitating an 80 cm 12F introduction sheath. Closure of the PiVSD was technically successful in all patients with reduction of the interventricular shunt to mild or less in eight of them. One patient died periprocedurally due to device erosion and cardiac tamponade. In-hospital death occurred in seven patients (77.8 %), in five of whom (55.6 %) death was attributed to cardiovascular causes. The two surviving patients had no further adverse events during 36 months of follow-up. CONCLUSION: Transaxillary access is a technically reasonable approach for transarterial PiVSD closure. Periprocedural mortality is acceptable in a severely sick population. Survivors to discharge do well on longer-term follow-up.
Takahashi K, Kozuma K, Morino Y
… +13 more, Kashiwabara K, Otake H, Suwa S, Nanasato M, Muramatsu T, Anzai H, Shirakabe A, Yamamoto M, Asaumi Y, Sakuma M, Okayama H, Ikari Y, Nakazawa G
Cardiovasc Revasc Med
· 2025 Dec · PMID 41436299
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BACKGROUND: Previous randomized trials have demonstrated the safety of P2Y inhibitor monotherapy after 1-3 months of dual antiplatelet therapy (DAPT) compared with 12-month DAPT following percutaneous coronary interventi...BACKGROUND: Previous randomized trials have demonstrated the safety of P2Y 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.
Mughal MS, Verma DR, Lotun K
… +6 more, Suppah M, Kumar S, Waggoner T, Fang HK, Atmakuri S, Naik H
Cardiovasc Revasc Med
· 2025 Dec · PMID 41412894
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BACKGROUND: Acute mitral regurgitation (MR) associated with cardiogenic shock (CS) is a medical emergency with excessive in-hospital mortality. The vast majority of these patients are turned down for corrective surgery....BACKGROUND: Acute mitral regurgitation (MR) associated with cardiogenic shock (CS) is a medical emergency with excessive in-hospital mortality. The vast majority of these patients are turned down for corrective surgery. The combined strategy of transcatheter edge-to-edge repair of mitral valves and percutaneous mechanical circulatory support devices to treat high-risk patients with severe mitral regurgitation and cardiogenic shock has not been evaluated in randomized controlled trials. AIMS: In this multicenter registry we aimed to assess the outcomes (all-cause mortality, other important secondary outcomes included freedom from 30-day cardiac death or cardiac readmission, 30-day all-cause mortality, 30-day cardiovascular mortality, and 30-day MACE events) of the combined strategy of Transcatheter Edge-to-Edge Repair of Mitral Valve and Percutaneous Mechanical Circulatory Support Device to Treat High-Risk Patients with Severe Mitral Regurgitation and Cardiogenic Shock. METHODS: This multicenter registry retrospectively evaluated all consecutive patients who presented with severe MR, had persistent cardiogenic shock (CS) despite appropriate therapy (including mechanical circulatory support [MCS]), were turned down for surgery due to operative risk from acuity at presentation, and were considered for TEER by a heart team. RESULTS: Twenty-one consecutive patients with severe acute or acute-on-chronic MR (anatomy suitable for M-TEER) and CS who were undergoing TEER after surgical turndown were included. Mean age was 63 years (SD ± 12.4), 71 % males, mean Society of Thoracic Surgeons Score predicted risk of mortality (STS-PROM) was 20.1 ± 19.2 % (range: 3.1 to 82), 71 % required mechanical ventilation, 52 % had pulmonary edema, 48 % had index acute myocardial infarction (AMI), 19 % required dialysis, 100 % had Impella™ in place. Immediate procedural outcomes included 100 % technical success, MR grade 1.2+ (mild, p < 0.001), and no events for device-device interaction were observed. The primary outcome of in-hospital all-cause mortality was 4.7 % (1 death from multiorgan failure). All-cause mortality at 30 days was 14 %, and three patients died. The procedural success rate was 81 %, with one readmission for DVT that was treated with oral anticoagulation, and none of the patients required mitral valve reintervention at 30-day follow up. Echocardiography at 30 days revealed an MR grade of ≤2+ (mild or moderate) in 94 %, and mean LVEF improved from baseline to 30 days (24.3 ± 11.3 % vs 30.5 ± 14 % respectively) (p = 0.001). CONCLUSIONS: Patients with severe mitral regurgitation and cardiogenic shock, who are at high risk for surgery, were treated with a combined approach of percutaneous mechanical circulatory support and transcatheter edge-to-edge repair of MV. We found this approach safe and it effectively improved mortality and symptoms. Larger studies and clinical trials are required to evaluate the effectiveness of this combined approach prospectively.
Ishizu K, Shirai S, Hayashi M
… +22 more, Morofuji T, Isotani A, Ohno N, Kakumoto S, Ando K, Yamamoto M, Hioki H, Shimura T, Yashima F, Naganuma T, Asami M, Ohno Y, Watanabe Y, Yamanaka F, Nakazawa G, Noguchi M, Izumo M, Nishina H, Fuku Y, Otsuka T, Hayashida K, OCEAN-TAVI Investigators
Cardiovasc Revasc Med
· 2025 Dec · PMID 41391990
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BACKGROUND: Limited evidence has been available on the long-term prognosis and valve durability of balloon-expandable transcatheter heart valve (BE-THV) and self-expandable transcatheter heart valve (SE-THV) in patients...BACKGROUND: Limited evidence has been available on the long-term prognosis and valve durability of balloon-expandable transcatheter heart valve (BE-THV) and self-expandable transcatheter heart valve (SE-THV) in patients with large aortic annulus (LAA). OBJECTIVES: To compare the long-term outcomes between the BE-THV and SE-THV. METHODS: We retrospectively analyzed 1054 patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) for tricuspid aortic valve stenosis with LAA, defined as an annulus area > 430 mm, using either a BE-THV (SAPIEN 3, Edwards Life Sciences) or SE-THV (Evolut R/PRO, Medtronic). The 7-year cumulative incidences of all-cause mortality and bioprosthetic valve failure (BVF) were evaluated in the overall cohort and the propensity score (PS)-matched cohort. RESULTS: Among the 1054 patients with LAA, 829 (78.7 %) received a BE-THV. The PS-matched population resulted in 218 pairs. The cumulative incidence of all-cause mortality 7 years after TAVI was comparable between the BE-THV and SE-THV groups in the overall cohort (58.6 % vs. 67.6 %, log-rank P = 0.848) and the PS-matched cohort (53.2 % vs. 69.9 %, log-rank P = 0.173). In the overall cohort, the BE-THV group demonstrated a lower exposure-adjusted BVF rate as compared with the SE-THV, although the difference was not significant (6.1 vs. 9.6 events per 1000 patient-years, P = 0.258). This trend became pronounced after PS matching (3.3 vs. 9.9 events per 1000 patient-years, P = 0.017), which was also confirmed by Gray's test (P = 0.032). CONCLUSIONS: In the current analysis focusing on patients with LAA, the BE-THV and SE-THV groups had a comparable long-term prognosis, but the BE-THV group had a lower BVF rate than did the SE-THV group. CLINICAL TRIAL REGISTRATION: UMIN000020423.
Luna-López R, Flores-Umanzor E, Cepas-Guillén P
… +18 more, Ruberti A, Montserrat S, Abrahamyan L, Carretero Bellón JM, Rodriguez LÁ, Schrutka L, Morr-Verenzuela I, Prat-González S, Pereda D, Freixa X, Sanz-Ruiz R, Rodés-Cabau J, Gillespie MJ, Aboulhosn JA, Benson L, Osten M, Alonso-Gonzalez R, Horlick E
Cardiovasc Revasc Med
· 2026 May · PMID 41390301
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Transposition of the great arteries (TGA) is a complex congenital heart defect with two primary anatomical subtypes: dextro-TGA and levo-TGA. Advances in neonatal surgical techniques, particularly the arterial switch ope...Transposition of the great arteries (TGA) is a complex congenital heart defect with two primary anatomical subtypes: dextro-TGA and levo-TGA. Advances in neonatal surgical techniques, particularly the arterial switch operation, have significantly improved survival rates. However, as this population ages, late complications such as heart failure and valve dysfunction present new clinical challenges. Transcatheter interventions have emerged as valid alternatives to surgical reintervention for these patients, providing effective symptom relief and improved quality of life, reducing the need for repeated sternotomies. As more adults with repaired TGA reach advanced ages, long-term studies are needed to assess the durability and safety of transcatheter therapies. Expanding the indications, refining procedural techniques, and developing specialized devices will be essential in optimizing outcomes for this growing patient population.
Zuin M, Marchese G, Hiso E
… +3 more, Bertolini A, Zamboni A, Rigatelli G
Cardiovasc Revasc Med
· 2025 Dec · PMID 41390300
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BACKGROUND: Calcific coronary nodules (CNs) are a challenging form of coronary artery disease, often linked to acute coronary syndromes (ACS) and resistant to standard lesion preparation. While intravascular lithotripsy...BACKGROUND: Calcific coronary nodules (CNs) are a challenging form of coronary artery disease, often linked to acute coronary syndromes (ACS) and resistant to standard lesion preparation. While intravascular lithotripsy (IVL) and rotational atherectomy (RA) are used for plaque modification, the optimal strategy remains unclear. This study compares procedural characteristics and mid-term outcomes of IVL alone versus IVL combined with RA (IVL + RA) in patients with CNs. METHODS: In this prospective, single-center study, 120 patients with angiographically confirmed CNs undergoing PCI were analyzed after 1:1 propensity score matching (PSM) to compare IVL (n = 60) versus IVL + RA (n = 60). Clinical, angiographic, and procedural data were collected. The primary endpoint was major adverse cardiovascular events (MACE) at 6 months, including cardiovascular death, ACS, or target vessel revascularization. Secondary endpoints included intraprocedural complications and 30-day outcomes. RESULTS: Baseline characteristics and lesion complexity were well matched between groups. Procedural success and stent deployment metrics were similar. Rates of intraprocedural complications were low and not significantly different (6.7 % IVL vs. 8.3 % IVL + RA; p = 0.68). At 6 months, MACE rates were comparable (8.3 % vs. 10.3 %; p = 0.68), with no differences in cardiovascular death (5.0 % vs. 6.9 %) or ACS (6.7 % vs. 8.6 %). CONCLUSIONS: In patients with calcific nodules, both IVL alone and the IVL + RA combination showed similar safety and efficacy, with low complication rates and comparable mid-term outcomes. Further randomized studies are needed to determine the optimal treatment approach for this high-risk group.
Dziewierz A, Zdzierak B, Rzeszutko Ł
… +3 more, Niewiara Ł, Legutko J, Kleczyński P
Cardiovasc Revasc Med
· 2025 Dec · PMID 41387152
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BACKGROUND: Assessing coronary artery disease in severe aortic stenosis (AS) is challenging due to altered hemodynamics, causing discordance between fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR)....BACKGROUND: Assessing coronary artery disease in severe aortic stenosis (AS) is challenging due to altered hemodynamics, causing discordance between fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR). The role of angiographic lesion characteristics in predicting this discordance remains unclear. OBJECTIVES: To identify angiographic predictors of FFR/iFR discordance and define distinct angiographic phenotypes using unsupervised machine learning. METHODS: This prospective, single-center registry evaluated 401 intermediate coronary lesions from 221 patients with severe AS (aortic valve area < 1.0 cm, mean gradient >40 mmHg) using FFR and iFR. Quantitative coronary angiography measured percent diameter stenosis (%DS), lesion length (LL), and other parameters. The primary outcome was FFR/iFR discordance. Receiver operating characteristic and decision curve analyses evaluated %DS predictive utility. K-means clustering was applied to %DS and LL to identify lesion phenotypes. RESULTS: FFR/iFR discordance occurred in 30 lesions (7.5 %), exclusively as FFR-negative/iFR-positive pattern. Higher %DS was the only independent angiographic predictor of discordance (adjusted OR 1.35 per 10 % increase; 95 % CI 1.12-1.64; p = 0.002), with modest discriminative ability (AUC = 0.69). Cluster analysis identified three phenotypes: Cluster 0 (High %DS [median 75.0 %]/Intermediate LL [median 15.0 mm], n = 103); Cluster 1 (Low %DS [median 49.0 %]/Short-Intermediate LL [median 13.6 mm], n = 220); and Cluster 2 (Intermediate %DS [median 63.5 %]/Long LL [median 32.4 mm], n = 78). Discordance incidence was highest in Cluster 0 (16.5 %) versus Clusters 1 (2.7 %) and 2 (9.0 %) (p < 0.001). CONCLUSIONS: In severe AS, FFR/iFR discordance manifests solely as FFR-negative/iFR-positive pattern. While %DS modestly predicts this mismatch, unsupervised clustering reveals that "High %DS / Intermediate Length" lesions primarily drive physiological discordance, identifying cases where iFR may overestimate severity due to AS-related hemodynamics.
Prasad M, Naidu SS, Basir MB
… +2 more, Batchelor WB, Hashim H
Cardiovasc Revasc Med
· 2026 Mar · PMID 41372026
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Technological advancements have improved safety and efficacy outcomes in patients undergoing complex and high-risk percutaneous coronary intervention (PCI). Increasingly, patients present to the cardiac catheterization l...Technological advancements have improved safety and efficacy outcomes in patients undergoing complex and high-risk percutaneous coronary intervention (PCI). Increasingly, patients present to the cardiac catheterization laboratory both acutely and electively with advanced age, multiple comorbidities, and complex anatomy, representing a higher-risk group of patients who also may have the most to gain from percutaneous revascularization, as their response to medical therapy is usually limited and surgical risks may be prohibitive. These patients typically face thrombosis, slow flow, and other adverse events during and after PCI, which carry significant risk, especially given patients' poor surgical candidacy. Accordingly, optimal antiplatelet and anticoagulant therapies are pivotal to limiting periprocedural thrombotic risk. Oral P2Y inhibitors have proven effective in reducing short-term and long-term cardiovascular events, although reduced bioavailability and delayed onset of action limit their efficacy during the procedural and immediate aftermath phases of PCI. Although intravenous glycoprotein IIb/IIIa receptor inhibitors are effective in reducing thrombotic events, bleeding risks have attenuated their use, and recent guidelines relegate their use to bailout. Best practices concerning intraprocedural antiplatelet therapies in patients undergoing complex PCI therefore remain unclear. The inherently high risks of thrombosis and bleeding among these patients must be balanced and considered when determining an antiplatelet strategy. Given the potential advantages of achieving potent but rapidly reversible P2Y inhibition in high-risk PCI, we review the data surrounding intravenous P2Y inhibition in this setting and provide best practice recommendations for clinical use.
Giangiacomi F, Popelier B, Lochy S
… +7 more, Nieboer K, Von Kemp M, Belsack D, Tanaka K, Cosyns B, Argacha JF, De Mey J
Cardiovasc Revasc Med
· 2026 Jan · PMID 41314866
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BACKGROUND: ECG-less coronary computed tomography angiography (CCTA) is a novel and promising tool for the diagnosis of coronary artery disease (CAD). Compared to conventional ECG-gated CCTA, it is less dependent on hear...BACKGROUND: ECG-less coronary computed tomography angiography (CCTA) is a novel and promising tool for the diagnosis of coronary artery disease (CAD). Compared to conventional ECG-gated CCTA, it is less dependent on heart rate control and gives the possibility of ruling out both pulmonary embolism and CAD using a single contrast injection. Recently, it has shown good sensitivity in detecting obstructive CAD. Given the limitations of current emergency room algorithms-primarily based on clinical presentation, ECG, and biomarkers-the triage of patients with acute chest pain or cardiac arrest may benefit from this emerging imaging modality. METHODS: We designed two prospective, single-center, double-blinded clinical studies to investigate the role of ECG-less CCTA in acute scenarios. The ECLECTIC study (ECG-LEss coronary Computed Tomography angiography in the management of patients presenting with hIgh-troponin and Chest pain, NCT07192965) will evaluate diagnostic accuracy and prognostic value in patients presenting with acute chest pain, mildly elevated troponin levels, and a high clinical suspicion of CAD. The OPEN-CCT Arrest (Optimizing Post-arrest Evaluation with Non-gated Cardiac CT) will assess the feasibility and diagnostic utility of this technique in cardiac arrest survivors. In both studies, patients will undergo ECG-less CCTA followed by ICA, considered the gold standard. CLINICAL IMPLICATIONS: ECG-less CCTA pushes the boundaries of using CCTA in acute clinical scenarios. This technique may reduce preparation time and improve workflow, especially in highly instrumented patients. If its diagnostic accuracy and prognostic value are proven, ECG-less CCTA could significantly decrease the need for unnecessary invasive procedures, the length of hospital stay, and the overall healthcare costs.
Molony DS, Hung O, Corban M
… +34 more, Gogas B, Lefieux A, Shah I, Komilian K, Adams A, Sykalo C, Dodoo S, Kumar A, Kumar S, Azarnoosh J, Piccinelli M, McDaniel MC, King SB, Maynard C, Chatzizisis YS, Chen SL, Shin ES, Stankovic G, Milasinovic D, Erglis A, Otake H, Akasaka T, Escaned J, Kwon-Koo B, Wook-Nam C, Won KB, Murasato Y, Lee WY, Lee SH, Hahn JY, Lee JM, Giddens DP, Veneziani A, Samady H
Cardiovasc Revasc Med
· 2025 Nov · PMID 41285658
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BACKGROUND: While disturbed wall shear stress (WSS) is associated with coronary plaque progression and vulnerability, its influence on stent neointimal healing is not well characterized. We designed a prospective, random...BACKGROUND: While disturbed wall shear stress (WSS) is associated with coronary plaque progression and vulnerability, its influence on stent neointimal healing is not well characterized. We designed a prospective, randomized trial to investigate the influence of WSS on neointimal healing in angulated arteries undergoing percutaneous coronary intervention (PCI). METHODS: Eighty-six patients were randomized to Xience Xpedition® (X-EES) or Resolute® Integrity/Onyx (R-ZES) drug-eluting stents. Patients underwent serial OCT imaging post PCI and at 12-months. Angiography was combined with OCT to generate post-stent vessel reconstructions. WSS was calculated using computational fluid dynamics. Post-stent WSS was related to strut, frame and patient level neointimal thickness (NIT) at 12-months. RESULTS: Sixty patients met inclusion criteria and had adequate OCT image quality for analysis. Mean age was 62.7 years, 78 % were men, and 37 % had diabetes. NIT at 12-months was 0.09 mm (0.05-0.15). There was no difference in frame level NIT (p = 0.08) or post-stent WSS (p = 0.75) between X-EES or R-ZES. Patient level analysis demonstrated correlation coefficients between WSS and NIT ranging from -0.78 to 0.67. Of these, 33 % were significantly positive, indicating an association between high WSS and increased NIT, while 31.6 % were significantly negative signifying an association between low WSS and increased NIT. Age, gender, hyperlipidemia, diabetes, renal insufficiency or prior MI was not associated with the distribution of correlation coefficients. CONCLUSIONS: The SHEAR-STENT study demonstrated no significant differences in WSS or NIT at 12 months between R-ZES and X-EES. A wide range of patient level correlation coefficients between WSS and NIT were observed, with some patients showing increased NIT was associated with low WSS and others associated with high WSS. REGISTRATION:URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02098876.