Journal: Circ Cardiovasc Interv

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Abstract

Differential Impact of Coronary Revascularization on Long-Term Clinical Outcome According to Coronary Flow Characteristics: Analysis of the International ILIAS Registry.

Hamaya R, van de Hoef TP, Lee JM, Hoshino M, ... Piek JJ, Kakuta T
Background
Coronary pressure indices such as fractional flow reserve are the standard for guiding elective revascularization. However, considering additional coronary flow parameters could further individualize and optimize the decision on revascularization. We aimed to investigate the potentially differential prognostic associations of elective percutaneous coronary intervention (PCI) according to coronary flow properties represented by coronary flow reserve (CFR), coronary flow capacity (CFC), and baseline CFC (bCFC).
Methods
From the ILIAS Registry (Inclusive Invasive Physiological Assessment in Angina Syndromes) composed of 16 hospitals globally from 7 countries, patients with obstructive coronary artery disease who underwent invasive coronary physiological assessment were included (N=2370 vessels). We assessed effect measure modifications of the association of PCI and 5-year target vessel failure according to CFR, CFC, and bCFC either assessed by Doppler-technique or thermodilution-method.
Results
The mean age of the population was 63.3 years, and there were 1322 (73.6%) males. Median fractional flow reserve was 0.85, and PCI was performed in 600 (25.3%) vessels. Reduced CFR, CFC, and abnormal bCFC were defined in 988 (41.7%), 542 (22.9%), and 600 (25.3%) vessels, respectively. Significant effect measure modifications were observed by CFC either in odds ratio (P=0.0018), additive (P=0.029), and hazard ratio scale (P=0.0002). The absolute risk of 5-year target-vessel failure was higher if treated by PCI in vessels with normal CFC by 1.8 (-1.7 to 5.3) percent, while that was lower by -5.9 (-12 to -0.1) percent in those with reduced CFC. CFR and bCFC were not significant effect modifiers in any scales. Similar associations were observed in per-patient analyses, whereas the findings were less robust.
Conclusions
We observed qualitative effect measure modification of PCI and 5-year clinical outcomes according to CFC status in additive scale. CFR and bCFC were not robust effect modifiers. Therefore, CFC could be potentially used to optimize the patient selection for elective PCI treatment combined with fractional flow reserve.



Circ Cardiovasc Interv: 23 May 2022:101161CIRCINTERVENTIONS121011948; epub ahead of print
Hamaya R, van de Hoef TP, Lee JM, Hoshino M, ... Piek JJ, Kakuta T
Circ Cardiovasc Interv: 23 May 2022:101161CIRCINTERVENTIONS121011948; epub ahead of print | PMID: 35603622
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Abstract

New Insights Into Long- Versus Short-Term Dual Antiplatelet Therapy Duration in Patients After Stenting for Left Main Coronary Artery Disease: Findings From a Prospective Observational Study.

Wang HY, Dou KF, Guan C, Xie L, ... Gao R, Xu B
Background
The appropriate duration of dual antiplatelet therapy (DAPT) and risk-benefit ratio for long-term DAPT in patients with left main (LM) disease undergoing percutaneous coronary intervention remains uncertain.
Methods
Four thousand five hundred sixty-one consecutive patients with stenting of LM disease at a single center from January 2004 to December 2016 were enrolled. Decision to discontinue or remain on DAPT after 12 months was left to an individualized decision-making based on treating physicians by weighing the patient\'s risks of ischemia versus bleeding and considering patient preference. The primary outcome was a composite of death, myocardial infarction, stent thrombosis, or stroke at 3 years. Key safety outcome was 3-year rate of Bleeding Academic Research Consortium 2, 3, or 5 bleeding.
Results
Of 3865 patients free of ischemic and bleeding events at 12 months, 1727 (44.7%) remained on DAPT (mostly clopidogrel based [97.7%]) beyond 12 months after LM percutaneous coronary intervention. DAPT>12-month versus ≤12-month DAPT was associated with a significant reduced risk of 3-year primary outcome (2.6% versus 4.6%; adjusted hazard ratio: 0.59 [95% CI, 0.41-0.84]). The same trend was found for other ischemic end points: death (0.9% versus 3.0%; Plog-rank<0.001), cardiovascular death (0.5% versus 1.7%; Plog-rank=0.001), myocardial infarction (0.8% versus 1.9%; Plog-rank=0.005), and stent thrombosis (0.4% versus 1.1%; Plog-rank=0.017). The key safety end point was not significantly different between 2 regimens (1.8% versus 1.6%; adjusted hazard ratio: 1.07 [95% CI, 0.65-1.74]). The effect of DAPT>12 month on primary and key safety outcomes was consistent across clinical presentations, high bleeding risk, P2Y12 inhibitor, and LM bifurcation percutaneous coronary intervention approach.
Conclusions
In a large cohort of patients free from clinical events during the first year after LM percutaneous coronary intervention and at low apparent future bleeding risk, an individualized patient-tailored approach to longer duration (>12 month) of DAPT with aspirin plus a P2Y12 inhibitor (mostly clopidogrel) improved both composite and individual efficacy outcomes by reducing ischemic risk, without a concomitant increase in clinically relevant bleeding.



Circ Cardiovasc Interv: 18 May 2022:101161CIRCINTERVENTIONS121011536; epub ahead of print
Wang HY, Dou KF, Guan C, Xie L, ... Gao R, Xu B
Circ Cardiovasc Interv: 18 May 2022:101161CIRCINTERVENTIONS121011536; epub ahead of print | PMID: 35582961
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Abstract

One-Year Health Status Outcomes Following Early Invasive and Noninvasive Treatment in Symptomatic Peripheral Artery Disease.

Angraal S, Hejjaji V, Tang Y, Gosch KL, ... Spertus JA, Smolderen KG
Background
Lifestyle changes and medications are recommended as the first line of treatment for claudication, with revascularization considered for treatment-resistant symptoms, based on patients\' preferences. Real-world evidence comparing health status outcomes of early invasive with noninvasive management strategies is lacking.
Methods
In the international multicenter prospective observational PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry, disease-specific health status was assessed by the Peripheral Artery Questionnaire in patients with new-onset or worsening claudication at presentation and 3, 6, and 12 months later. One-year health status trajectories were compared by early revascularization versus noninvasive management on a propensity-matched sample using hierarchical generalized linear models for repeated measures adjusted for baseline health status.
Results
In a propensity-matched sample of 1000 patients (67.4±9.3 years, 62.8% male, and 82.4% White), 297 (29.7%) underwent early revascularization and 703 (70.3%) were managed noninvasively. Over 1 year of follow-up, patients who underwent early invasive management reported significantly higher health status than patients managed noninvasively (interaction term for time and treatment strategy; P<0.001 for all Peripheral Artery Questionnaire domains). The average 1-year change in Peripheral Artery Questionnaire summary scores was 30.8±25.2 in those undergoing early invasive, compared with 16.7±23.4 in those treated noninvasively (P<0.001).
Conclusions
Patients with claudication undergoing early invasive treatment had greater health status improvements over the course of 1 year than those treated noninvasively. These data can be used to support shared decision-making with patients.
Registration
URL: https://www.
Clinicaltrials
gov; Unique identifier: NCT01419080.



Circ Cardiovasc Interv: 17 May 2022:101161CIRCINTERVENTIONS121011506; epub ahead of print
Angraal S, Hejjaji V, Tang Y, Gosch KL, ... Spertus JA, Smolderen KG
Circ Cardiovasc Interv: 17 May 2022:101161CIRCINTERVENTIONS121011506; epub ahead of print | PMID: 35579010
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Abstract

Percutaneous Coronary Intervention With and Without Intravascular Ultrasound for Patients With Complex Lesions: Utilization, Mortality, and Target Vessel Revascularization.

Hannan EL, Zhong Y, Reddy P, Jacobs AK, ... Walford G, Tamis-Holland J
Background
Intravascular ultrasound (IVUS) has several benefits during percutaneous coronary interventions (PCIs), including more accurate vessel sizing, improved stent expansion, and better strut apposition. Prior clinical trials have demonstrated a reduction in cardiac events when IVUS is used. However, there is limited information about the utilization of IVUS and the outcomes of IVUS-guided versus angiography-guided PCI in patients with complex lesions in a contemporary population-based setting.
Methods
New York\'s PCI registry was used to identify 44 305 patients with complex lesions (lesions that complicate stenting or that require multiple stents) undergoing PCI with and without IVUS guidance and discharged between December 1, 2013 and November 30, 2018. Trends and inter-hospital variation in IVUS use were examined. Risk-adjusted mortality and target vessel revascularization were compared.
Results
A total of 6174 (13.9%) PCI patients underwent IVUS-guided PCI. The median follow-up period was 2.5 years. The percent of patients with complex lesions who underwent IVUS-guided PCI rose from 13.4% in 2014 to 16.5% in 2018 (P<0.0001 for trend), with the main increases occurring in the last 2 years of the period. Only 31 of 66 hospitals in the study used IVUS for >5% of their study patients. IVUS-guided PCI patients experienced significantly lower mortality (adjusted hazard ratio=0.89 [0.79-0.98] after adjustment using a Cox proportional hazards model, and HR=0.88 [0.78-0.99] for propensity-matched patients). We also found that IVUS-guided PCI patients had a lower rate of target vessel revascularization (adjusted hazard ratio=0.88 [0.80-0.97]) after adjusting using Cox proportional hazards with competing risk of mortality and after propensity matching (0.88 [0.79-0.99]).
Conclusions
Utilization of IVUS for complex lesions has increased but contemporary rates remain low, and there are large inter-hospital variations. The use of IVUS for complex lesions was associated with lower risk of medium-term mortality and target vessel revascularization.



Circ Cardiovasc Interv: 11 May 2022:101161CIRCINTERVENTIONS121011687; epub ahead of print
Hannan EL, Zhong Y, Reddy P, Jacobs AK, ... Walford G, Tamis-Holland J
Circ Cardiovasc Interv: 11 May 2022:101161CIRCINTERVENTIONS121011687; epub ahead of print | PMID: 35543139
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Abstract

Role of Quantitative Flow Ratio in Predicting Future Cardiac Allograft Vasculopathy in Heart Transplant Recipients.

Spitaleri G, Brugaletta S, Potena L, Mirabet S, ... Campo G, Farrero M
Background
Coronary angiography is the gold standard for cardiac allograft vasculopathy (CAV) diagnosis, but it usually detects the disease at an advanced stage. We investigated the role of quantitative flow ratio (QFR), a noninvasive tool to identify potentially flow-limiting lesions, in predicting CAV development in heart transplant recipients.
Methods
Consecutive heart transplant recipients with no evidence of angiographic CAV at baseline coronary angiography were retrospectively included between January 2010 and December 2015, and QFR computation was performed. The relationship between vessel QFR and the occurrence of angiographic vessel-related CAV (50% stenosis) was assessed.
Results
One hundred forty-three patients were included and QFR computation was feasible in 241 vessels. The median value of QFR at baseline coronary angiography was 0.98 (interquartile range, 0.94-1.00). During a median follow-up of 6.0 years (interquartile range, 4.6-7.8 years), vessel-related CAV occurred in 25 (10.4%) vessels. Receiver-operating characteristic curve analysis identified a QFR best cutoff of 0.95 (area under the curve, 0.81 [95% CI, 0.71-0.90]; P<0.001). QFR0.95 was associated with an increased risk of vessel-related CAV (adjusted hazard ratio, 20.87 [95% CI, 5.35-81.43]; P<0.001). In an exploratory analysis, QFR0.95 in at least 2 vessels was associated with higher incidence of cardiovascular death or late graft dysfunction (71.4% in recipients with 2-3 vessels affected versus 5.1% in recipients with 0-1 vessels affected, P<0.001).
Conclusions
In a cohort of heart transplant recipients, QFR computation at baseline coronary angiography may be a safe and reliable tool to predict vessel-related CAV and clinical outcomes at long-term follow-up.



Circ Cardiovasc Interv: 01 May 2022; 15:e011656
Spitaleri G, Brugaletta S, Potena L, Mirabet S, ... Campo G, Farrero M
Circ Cardiovasc Interv: 01 May 2022; 15:e011656 | PMID: 35580200
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Abstract

Prophylactic Mechanical Circulatory Support Use in Elective Percutaneous Coronary Intervention for Patients With Stable Coronary Artery Disease.

Zeitouni M, Marquis-Gravel G, Smilowitz NR, Zakroysky P, ... Rao SV, Wang TY
Background
Mechanical circulatory support (MCS) devices can be used in high-risk percutaneous coronary intervention (PCI). Our objective was to describe trends and outcomes of prophylactic MCS use in elective PCI for patients with stable coronary artery disease in the American College of Cardiology National Cardiovascular Data Registry\'s CathPCI registry.
Methods
Among 2 108 715 consecutive patients with stable coronary artery disease undergoing elective PCI in the CathPCI registry between 2009 and 2018, we examined patterns of prophylactic use of MCS. Propensity score models with inverse probability of treatment weighting compared effectiveness (in-hospital death, cardiogenic shock, or new heart failure) and safety (stroke, tamponade, major bleeding, or vascular complication requiring treatment) between patients treated with intra-aortic balloon pump versus other MCS (Impella or extracorporeal membrane oxygenation).
Results
Overall, 6905 (0.3%) patients underwent elective PCI with prophylactic MCS. MCS use trended up from 0.2% of elective PCIs in 2009 to 0.6% in 2018 (P<0.0001), driven by other MCS (P<0.0001), whereas intra-aortic balloon pump use remained low and constant (P=0.12). In-hospital major adverse cardiac events and cardiovascular complications occurred in 7.1% and 18.8% of elective PCI patients with prophylactic MCS use and 0.5% and 2.3% of patients without prophylactic MCS use. Intra-aortic balloon pump use was associated with a higher risk of major adverse cardiac events (9.6% versus 6.0%, adjusted odds ratio, 1.59 [95% CI, 1.32-1.91]) but lower risk of complications (18.2% versus 19.1%, adjusted odds ratio, 0.88 [95% CI, 0.77-0.99]) than use of other MCS.
Conclusions
The use of prophylactic MCS has increased over time for elective PCI in patients with stable coronary artery disease. Intra-aortic balloon pump was associated with higher major adverse cardiac events but lower risk of procedural complications compared with other MCS.



Circ Cardiovasc Interv: 01 May 2022; 15:e011534
Zeitouni M, Marquis-Gravel G, Smilowitz NR, Zakroysky P, ... Rao SV, Wang TY
Circ Cardiovasc Interv: 01 May 2022; 15:e011534 | PMID: 35580202
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Abstract

Prognostic Role of Residual Thrombus Burden Following Thrombectomy: Insights From the TOTAL Trial.

Alkhalil M, Kuzemczak M, Zhao R, Kavvouras C, ... Jolly SS, Džavík V
Background
It is unclear whether more effective forms of thrombus removal than current aspiration catheters would lead to improved outcomes. We sought to evaluate the prognostic role of residual thrombus burden (rTB), after manual thrombectomy, in patients undergoing primary percutaneous coronary intervention with routine manual thrombectomy in the TOTAL trial (Thrombectomy Versus PCI Alone).
Methods
This is a single-arm analysis of patients from the TOTAL trial who underwent routine manual aspiration thrombectomy. The rTB was quantified by an angiographic core laboratory using the Thrombolysis in Myocardial Infarction criteria and validated using existing optical coherent tomography data. Large rTB was defined as grade ≥3. The primary outcome was death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or new or worsening heart failure within 180 days.
Results
Of 5033 patients randomized to routine thrombectomy, 2869 patients had quantifiable rTB (1014 [35%] had large rTB). Patients with large rTB were more likely to have hypertension, previous percutaneous coronary intervention, myocardial infarction, or Killip class III on presentation but less likely to have Killip class I. The primary outcome occurred more frequently in patients with large rTB, even after adjustment for known risk predictors (8.6% versus 4.6%; adjusted hazard ratio, 1.83 [95% CI, 1.34-2.48]). These patients also had a higher risk of cardiovascular death (adjusted hazard ratio, 1.83 [95% CI, 1.13-2.95]), cardiogenic shock (adjusted hazard ratio, 2.02 [95% CI, 1.08-3.76]), and heart failure (adjusted hazard ratio, 1.74 [95% CI, 1.02-2.96]) but not myocardial infarction or stroke.
Conclusions
Large rTB is a common finding in primary percutaneous coronary intervention and is associated with increased risk of adverse cardiovascular outcomes, including cardiovascular death. Future technologies offering better thrombus removal than current devices may decrease or even eliminate the risk associated with rTB. This, potentially, can turn into a strategic option to be studied in clinical trials.
Registration
URL: https://www.
Clinicaltrials
gov; Unique identifier: NCT01149044.



Circ Cardiovasc Interv: 01 May 2022; 15:e011336
Alkhalil M, Kuzemczak M, Zhao R, Kavvouras C, ... Jolly SS, Džavík V
Circ Cardiovasc Interv: 01 May 2022; 15:e011336 | PMID: 35580203
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Abstract

Neonatal Myocardial Infarction: A Proposed Algorithm for Coronary Arterial Thrombus Management.

El-Sabrout H, Ganta S, Guyon P, Ratnayaka K, ... Nigro J, El-Said H
Background
Neonatal myocardial infarction is rare and is associated with a high mortality of 40% to 50%. We report our experience with neonatal myocardial infarction, including presentation, management, outcomes, and our current patient management algorithm.
Methods
We reviewed all infants admitted with a diagnosis of coronary artery thrombosis, coronary ischemia, or myocardial infarction between January 2015 and May 2021.
Results
We identified 21 patients (median age, 1 [interquartile range (IQR), 0.25-9.00] day; weight, 3.2 [IQR, 2.9-3.7] kg). Presentation included respiratory distress (16), shock (3), and murmur (2). Regional wall motion abnormalities by echocardiogram were a key criterion for diagnosis and were present in all 21 with varying degrees of depressed left ventricular function (severe [8], moderate [6], mild [2], and low normal [5]). Ejection fraction ranged from 20% to 54% (median, 43% [IQR, 34%-51%]). Mitral regurgitation was present in 19 (90%), left atrial dilation in 15 (71%), and pulmonary hypertension in 18 (86%). ECG was abnormal in 19 (90%). Median troponin I was 0.18 (IQR, 0.12-0.56) ng/mL. Median BNP (B-type natriuretic peptide) was 2100 (IQR, 924-2325) pg/mL. Seventeen had documented coronary thrombosis by cardiac catheterization. Seventeen (81%) were treated with intracoronary tPA (tissue-type plasminogen activator) followed by systemic heparin, AT (antithrombin), and intravenous nitroglycerin, and 4 (19%) were treated with systemic heparin, AT, and intravenous nitroglycerin alone. Nineteen of 21 recovered. One died (also had infradiaphragmatic total anomalous pulmonary venous return). One patient required a ventricular assist device and later underwent heart transplant; this patient was diagnosed late at 5 weeks of age and did not respond to tPA. Nineteen of 21 (90%) regained normal left ventricular function (ejection fraction, 60%-74%; mean, 65% [IQR, 61%-67%]) at latest follow-up (median, 6.8 [IQR, 3.58-14.72] months). Two of 21 (10%) had residual trivial mitral regurgitation. After analysis of these results, we present our current algorithm, which developed and matured over time, to manage neonatal myocardial infarction.
Conclusions
We experienced a lower mortality rate for infants with neonatal infarction than that reported in the literature. We propose a post hoc algorithm that may lead to improvement in patient outcomes following coronary artery thrombus.



Circ Cardiovasc Interv: 29 Apr 2022:101161CIRCINTERVENTIONS121011664; epub ahead of print
El-Sabrout H, Ganta S, Guyon P, Ratnayaka K, ... Nigro J, El-Said H
Circ Cardiovasc Interv: 29 Apr 2022:101161CIRCINTERVENTIONS121011664; epub ahead of print | PMID: 35485231
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Abstract

Thin-Cap Fibroatheroma Rather Than Any Lipid Plaques Increases the Risk of Cardiovascular Events in Diabetic Patients: Insights From the COMBINE OCT-FFR Trial.

Fabris E, Berta B, Roleder-Dylewska T, Hermanides RS, ... Wojakowski W, Kedhi E
Background
Autopsy studies have established that thin-cap fibroatheromas (TCFAs) are the most frequent cause of fatal coronary events. In living patients, optical coherence tomography (OCT) has sufficient resolution to accurately differentiate TCFA from thick-cap fibroatheroma (ThCFA) and not lipid rich plaque (non-LRP). However, the impact of OCT-detected plaque phenotype of nonischemic lesions on future adverse events remains unknown. Therefore, we studied the natural history of OCT-detected TCFA, ThCFA, and non-LRP in patients enrolled in the prospective multicenter COMBINE FFR-OCT trial (Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients).
Methods
In the COMBINE FFR-OCT trial, patients with diabetes and ≥1 lesion with a fractional flow reserve >0.80 underwent OCT evaluation and were clinically followed for 18 months. A composite primary end point of cardiac death, target vessel-related myocardial infarction, target-lesion revascularization, and hospitalization for unstable angina was evaluated in relation to OCT-based plaque morphology.
Results
A total of 390 patients (age 67.5±9 years; 63% male) with ≥1 nonischemic lesions underwent OCT evaluation: 284 (73%) had ≥1 LRP and 106 (27%) non-LRP lesions. Among LRP patients, 98 (34.5%) had ≥1 TCFA. The primary end point occurred in 7% of LRP patients compared with 1.9% of non-LRP patients (7.0% versus 1.9%; hazard ratio [HR], 3.9 [95% CI, 0.9-16.5]; P=0.068; log rank-P=0.049). However, within LRP patients, TCFA patients had a much higher risk for primary end point compared with ThCFA (13.3% versus 3.8%; HR, 3.8 [95% CI, 1.5-9.5]; P<0.01), and to non-LRP patients (13.3% versus 1.9%; HR, 7.7 [95% CI, 1.7-33.9]; P<0.01), whereas ThCFA patients had risk similar to non-LRP patients (3.8% versus 1.9%; HR, 2.0 [95% CI, 0.42-9.7]; P=0.38). Multivariable analyses identified TCFA as the strongest independent predictor of primary end point (HR, 6.79 [95% CI, 1.50-30.72]; P=0.013).
Conclusions
Among diabetes patients with fractional flow reserve-negative lesions, patients carrying TCFA lesions represent only one-third of LRP patients and are associated with a high risk of future events while patients carrying LRP-ThCFA and non-LRP lesions portend benign outcomes.
Registration
URL: https://www.
Clinicaltrials
gov; Unique identifier: NCT02989740.



Circ Cardiovasc Interv: 29 Apr 2022:101161CIRCINTERVENTIONS121011728; epub ahead of print
Fabris E, Berta B, Roleder-Dylewska T, Hermanides RS, ... Wojakowski W, Kedhi E
Circ Cardiovasc Interv: 29 Apr 2022:101161CIRCINTERVENTIONS121011728; epub ahead of print | PMID: 35485232
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Abstract

Transcatheter Myotomy to Relieve Left Ventricular Outflow Tract Obstruction: The Septal Scoring Along the Midline Endocardium Procedure in Animals.

Khan JM, Bruce CG, Greenbaum AB, Babaliaros VC, ... Guyton RA, Lederman RJ
Background
Left ventricular outflow tract obstruction complicates hypertrophic cardiomyopathy and transcatheter mitral valve replacement. Septal reduction therapies including surgical myectomy and alcohol septal ablation are limited by surgical morbidity or coronary anatomy and high pacemaker rates, respectively. We developed a novel transcatheter procedure, mimicking surgical myotomy, called Septal Scoring Along the Midline Endocardium (SESAME).
Methods
SESAME was performed in 5 naive pigs and 5 pigs with percutaneous aortic banding-induced left ventricular hypertrophy. Fluoroscopy and intracardiac echocardiography guided the procedures. Coronary guiding catheters and guidewires were used to mechanically enter the basal interventricular septum. Imparting a tip bend to the guidewire enabled intramyocardial navigation with multiple df. The guidewire trajectory determined the geometry of SESAME myotomy. The myocardium was lacerated using transcatheter electrosurgery. Cardiac function and tissue characteristics were assessed by cardiac magnetic resonance at baseline, postprocedure, and at 7- or 30-day follow-up.
Results
SESAME myotomy along the intended trajectory was achieved in all animals. The myocardium splayed after laceration, increasing left ventricular outflow tract area (753 to 854 mm2, P=0.008). Two naive pigs developed ventricular septal defects due to excessively deep lacerations in thin baseline septa. No hypertrophy model pig, with increased septal thickness and left ventricular mass compared with naive pigs, developed ventricular septal defects. One animal developed left axis deviation on ECG but no higher conduction block was seen in any animal. Coronary artery branches were intact on angiography with no infarction on cardiac magnetic resonance late gadolinium imaging. Cardiac magnetic resonance chamber volumes, function, flow, and global strain were preserved. No myocardial edema was evident on cardiac magnetic resonance T1 mapping.
Conclusions
This preclinical study demonstrated feasibility of SESAME, a novel transcatheter myotomy to relieve left ventricular outflow tract obstruction. This percutaneous procedure using available devices, with a safe surgical precedent, is readily translatable into patients.



Circ Cardiovasc Interv: 05 Apr 2022:101161CIRCINTERVENTIONS121011686; epub ahead of print
Khan JM, Bruce CG, Greenbaum AB, Babaliaros VC, ... Guyton RA, Lederman RJ
Circ Cardiovasc Interv: 05 Apr 2022:101161CIRCINTERVENTIONS121011686; epub ahead of print | PMID: 35378990
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Abstract

Periprocedural Pericardial Effusion Complicating Transcatheter Left Atrial Appendage Occlusion: A Report From the NCDR LAAO Registry.

Price MJ, Valderrábano M, Zimmerman S, Friedman DJ, ... Masoudi FA, Freeman JV
Background: Pericardial effusion (PE) is a potential complication of transcatheter left atrial appendage occlusion (LAAO). The objective of this study was to investigate the incidence, associated characteristics, and outcomes of PE following LAAO. Methods: Patients in the NCDR LAAO Registry who underwent a Watchman procedure between January 1, 2016 and December 31, 2019 were included. The primary outcome was in-hospital PE requiring intervention (percutaneous drainage or surgery). Odds ratios [ORs] were calculated for adverse event rates associated with PE. Results: The study population consisted of 65,355 patients. The mean patient age was 76.2±8.1 years and the mean CHA2DS2-VASc score was 4.6±1.5. PE occurred in 881 patients (1.35%). Clinical variables independently associated with PE included older age, female sex, left ventricular function, paroxysmal atrial fibrillation, prior bleeding, lower serum albumin, and pre-procedural dual antiplatelet therapy; procedural variables included number of delivery sheaths used, sinus rhythm during the procedure, and moderate sedation rather than general anesthesia. PE was associated with increased risk of in-hospital stroke (OR, 6.58 [95% CI, 3.32 to 13.06], P<0.0001), death (OR, 56.88 [95% CI, 39.79 to 81.32], P<0.0001), and the composite of death, stroke, or systemic embolism (SE) (OR, 28.64 [95% CI, 21.24 to 38.61], P<0.0001). PE during the index hospitalization was associated with increased risk of death (OR 3.52 [95% CI, 2.23 to 5.54], P<0.0001) and the composite of death, stroke, or SE (OR 3.42 [95% CI, 2.31 to 5.07], P<0.0001) between discharge and 45-day follow-up. Conclusions: In-hospital PE during transcatheter LAAO is infrequent but associated with a substantially higher risk of adverse events, including in-hospital and early post-discharge mortality. Strategies to minimize PE are critical to improve the risk-benefit ratio for this therapy.



Circ Cardiovasc Interv: 02 Apr 2022; epub ahead of print
Price MJ, Valderrábano M, Zimmerman S, Friedman DJ, ... Masoudi FA, Freeman JV
Circ Cardiovasc Interv: 02 Apr 2022; epub ahead of print | PMID: 35369701
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Abstract

Change in Left Ventricular Ejection Fraction With Coronary Artery Revascularization and Subsequent Risk for Adverse Cardiovascular Outcomes.

Velagaleti RS, Vetter J, Parker R, Kurgansky KE, ... Gagnon D, Joseph J
Background
Coronary revascularization is recommended to treat ischemic cardiomyopathy. However, the relations of revascularization-associated ejection fraction (EF) change to subsequent outcomes have not been elucidated.
Methods
In 10 071 veterans (mean age 67 years; 1% women; 15% non-White) who underwent a first percutaneous coronary intervention (PCI) or coronary artery bypass grafting between January 1, 1995, and December 31, 2010, and had prerevascularization and postrevascularization EF measured, we calculated delta-EF (postprocedure EF-preprocedure EF). We related delta-EF as a continuous measure and as categories (≤-5, -5<delta-EF<0, delta-EF=0, 0<delta-EF<5, and delta-EF≥5) to death (using Cox regression) and heart failure hospitalization days (using negative binomial regression) in multivariable-adjusted models, for total sample, and PCI and coronary artery bypass grafting strata.
Results
Over follow-up (mean/maximum 5/14 years) 56% died. Each 5% improvement in delta-EF was associated with statistically significant reductions in death and heart failure hospitalization days of 5% (95% CI, 3%-7%) and 10% (95% CI, 5%-15%), respectively, in the total sample and 6% (95% CI, 4%-8%) and 10% (95% CI, 5%-16%), respectively, in the PCI subgroup. Patients in the highest delta-EF category had 27% (95% CI, 19%-34%) lower mortality (30% [95% CI, 21%-37%] lower in PCI stratum) and ≈40% lower heart failure hospitalization days in total sample and PCI stratum, compared with those in the lowest category. Relations of delta-EF and outcomes in coronary artery bypass grafting subgroup did not reach statistical significance.
Conclusions
Revascularization-associated EF improvement was associated with significant reductions in mortality and heart failure hospitalization burden, particularly in the PCI subgroup.



Circ Cardiovasc Interv: 31 Mar 2022; 15:e011284
Velagaleti RS, Vetter J, Parker R, Kurgansky KE, ... Gagnon D, Joseph J
Circ Cardiovasc Interv: 31 Mar 2022; 15:e011284 | PMID: 35411780
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Abstract

Outcomes With Intermediate Left Main Disease: Analysis From the ISCHEMIA Trial.

Bangalore S, Spertus JA, Stevens SR, Jones PG, ... Maron DJ, ISCHEMIA Research Group
Background
Patients with significant (≥50%) left main disease (LMD) have a high risk of cardiovascular events, and guidelines recommend revascularization to improve survival. However, the impact of intermediate LMD (stenosis, 25%-49%) on outcomes is unclear.
Methods
Randomized ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) participants who underwent coronary computed tomography angiography at baseline were categorized into those with (25%-49%) and without (<25%) intermediate LMD. The primary outcome was a composite of cardiovascular mortality, myocardial infarction (MI), or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. The primary quality of life outcome was the Seattle Angina Questionnaire summary score.
Results
Among the 3699 participants who satisfied the inclusion criteria, 962 (26%) had intermediate LMD. Among invasive strategy participants with intermediate LMD on coronary computed tomography angiography, 49 (7.0%) had significant (≥50% stenosis) left main stenosis on invasive angiography. Patients with intermediate LMD had a higher risk of cardiovascular events in the unadjusted but not in the fully adjusted model compared with those without intermediate LMD. An invasive strategy increased procedural MI and decreased nonprocedural MI with no significant difference for other outcomes including the primary end point. There was no meaningful heterogeneity of treatment effect based on intermediate LMD status except for nonprocedural MI for which there was a greater absolute reduction with invasive management in the intermediate LMD group (-6.4% versus -2.0%; Pinteraction=0.049). The invasive strategy improved angina-related quality of life and the benefit was durable throughout follow-up without significant heterogeneity based on intermediate LMD status.
Conclusions
In the ISCHEMIA trial, there was no meaningful heterogeneity of treatment benefit from an invasive strategy regardless of intermediate LMD status except for a greater absolute risk reduction in nonprocedural MI with invasive management in those with intermediate LMD. An invasive strategy increased procedural MI, reduced nonprocedural MI, and improved angina-related quality of life.
Registration
URL: https://www.
Clinicaltrials
gov; Unique identifier: NCT01471522.



Circ Cardiovasc Interv: 31 Mar 2022; 15:e010925
Bangalore S, Spertus JA, Stevens SR, Jones PG, ... Maron DJ, ISCHEMIA Research Group
Circ Cardiovasc Interv: 31 Mar 2022; 15:e010925 | PMID: 35411785
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Impact:
Abstract

Drug-Coated Balloon for Small Coronary Artery Disease in Patients With and Without High-Bleeding Risk in the BASKET-SMALL 2 Trial.

Scheller B, Rissanen TT, Farah A, Ohlow MA, ... Jeger RV, BASKET-SMALL 2 Investigators
Background
Patients at high-bleeding risk (HBR) undergoing percutaneous coronary intervention represent a challenging patient population. The use of drug-coated balloon (DCB) allows shorter duration of dual antiplatelet therapy compared with drug-eluting stents (DES) and reduces thrombotic risk due to the absence of a permanent implant. The present analysis aimed to investigate if the effect of DCB versus DES differed between patients with and without HBR treated with percutaneous coronary intervention in small coronary arteries.
Methods
This prespecified subgroup analysis of a multicenter, randomized, noninferiority trial included 758 patients with de novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention, randomized to DCB (n=382) or second-generation DES (n=376). Patients were followed over 3 years for major adverse cardiac events.
Results
Of the 758 patients randomized, 155 (20%) had HBR; these patients had higher mortality at 3 years (hazard ratio [95% CI], 3.09 [1.78-5.36]; P<0.001). Rates of major bleeding events were overall low but tended to be lower after DCB versus DES (1.6% versus 3.7%; P=0.064), were similar in patients with HBR (4.5% versus 3.4%) but less frequent in DCB-versus DES-treated patients without HBR (0.9% versus 3.8%). There was no difference in major adverse cardiac events between DCB and DES regardless of bleeding risk (HBR, hazard ratio: 1.16 [0.51-2.62]; P=0.719 versus non-HBR, 0.96 [0.62-1.49]; P=0.863).
Conclusions
DCBs were similarly safe and effective as current-generation DES in the treatment of coronary arteries <3 mm, regardless of bleeding risk. In patients treated with DCB, there was a trend towards a reduction of severe bleeding events at 3 years.
Registration
URL: https://www.
Clinicaltrials
gov; Unique identifier: NCT01574534.



Circ Cardiovasc Interv: 31 Mar 2022; 15:e011569
Scheller B, Rissanen TT, Farah A, Ohlow MA, ... Jeger RV, BASKET-SMALL 2 Investigators
Circ Cardiovasc Interv: 31 Mar 2022; 15:e011569 | PMID: 35411792
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Impact:
Abstract

Short-Term Postoperative Use of Rivaroxaban to Prevent Radial Artery Occlusion After Transradial Coronary Procedure: The RESTORE Randomized Trial.

Liang D, Lin Q, Zhu Q, Zhou X, ... Huang W, Shan P
Background
Adequate procedural anticoagulation is crucial for radial artery occlusion (RAO) prevention in patients undergoing transradial access coronary catheterization, although the effect of postprocedural anticoagulation lack thorough investigation. The aim of this study was to evaluate the clinical value of short-term postoperative anticoagulation with rivaroxaban for 24 hours and 1-month RAO prevention in patients who received transradial coronary procedures.
Methods
A total of 382 patients were randomized to receive either placebo (control group) or rivaroxaban 10 mg once daily for a period of 7 days (rivaroxaban group) to evaluate the effect of the rivaroxaban in the prevention of 24 hours and 1-month RAO assessed by Doppler ultrasound.
Results
There was no significant difference in the incidence of 24-hour RAO (8.9% versus 11.5%; P=0.398) between the rivaroxaban group and control group (odds ratio, 0.75 [95% CI, 0.39-1.46]; P=0.399). In contrast, the 1-month RAO (3.8% versus 11.5%; P=0.011) was significantly reduced in patients who received rivaroxaban as compared with those who did placebo (odds ratio, 0.22 [95% CI, 0.08-0.65]; P=0.006). For patients with 24-hour RAO, the rivaroxaban group was associated with higher recanalization rate of the radial artery (69.2% versus 30.0%; P=0.027) compared with the control group. No significant differences can be observed between the 2 groups for access-site complications or bleeding events.
Conclusions
Short-term postoperative anticoagulation with rivaroxaban did not reduce the rate of 24-hour RAO but improved 1-month RAO, because of higher recanalization of the radial artery. However, larger clinical trials are needed to prove our results.
Registration
URL: https://www.chictr.org.cn; Unique identifier: ChiCTR1900026974.



Circ Cardiovasc Interv: 31 Mar 2022; 15:e011555
Liang D, Lin Q, Zhu Q, Zhou X, ... Huang W, Shan P
Circ Cardiovasc Interv: 31 Mar 2022; 15:e011555 | PMID: 35317614
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Impact:
Abstract

Ticagrelor With or Without Aspirin in Chinese Patients Undergoing Percutaneous Coronary Intervention: A TWILIGHT China Substudy.

Han Y, Claessen BE, Chen SL, Chunguang Q, ... Baber U, Mehran R
Background
The risk/benefit tradeoff of dual antiplatelet therapy after percutaneous coronary intervention may vary in East Asian patients as compared with their non-East Asian counterparts.
Methods
The double-blind, placebo-controlled, randomized TWILIGHT trial (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) enrolled patients undergoing high-risk percutaneous coronary intervention. After 3 months of treatment with ticagrelor plus aspirin, event-free and adherent patients remained on ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding; the key secondary end point was the first occurrence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke.
Results
Of 9006 enrolled and 7119 randomized patients in TWILIGHT, 1169 patients (13.0%) were enrolled at 27 Chinese sites in this prespecified substudy, of whom 1028 (14.4%) patients were randomized after 3 months. The incidence of the primary end point was 6.2% in the ticagrelor+aspirin group versus 3.5% in the ticagrelor+placebo group between randomization and 1 year (hazard ratio, 0.56 [95% CI, 0.31-0.99]; P=0.048). The key secondary end point occurred in 3.4% of patients in the ticagrelor+aspirin group versus 2.4% in the ticagrelor+placebo group (hazard ratio, 0.70 [95% CI, 0.33-1.46]; P=0.34). There was no interaction between the region of randomization (China versus the rest of the world) and randomized treatment assignment in terms of the primary or key secondary end points.
Conclusions
Ticagrelor monotherapy significantly reduced clinically relevant bleeding without increasing ischemic events as compared with ticagrelor plus aspirin in Chinese patients undergoing high-risk percutaneous coronary intervention.
Registration
URL: https://www.
Clinicaltrials
gov; Unique identifier: NCT02270242.



Circ Cardiovasc Interv: 31 Mar 2022; 15:e009495
Han Y, Claessen BE, Chen SL, Chunguang Q, ... Baber U, Mehran R
Circ Cardiovasc Interv: 31 Mar 2022; 15:e009495 | PMID: 35317615
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Impact:
Abstract

Impact of Ticagrelor Versus Clopidogrel on Coronary Microvascular Function After Non-ST-Segment-Elevation Acute Coronary Syndrome.

Xu J, Lo S, Mussap CJ, French JK, ... Juergens CP, Leung DY
Background
Coronary microvascular dysfunction after acute coronary syndrome is an important predictor of long-term prognosis. Data is lacking on the effects of oral P2Y12-inhibitors on coronary microvascular function in non-ST-segment-elevation acute coronary syndrome. The aim of this study was to compare the acute effects of ticagrelor versus clopidogrel pretreatment on coronary microvascular function in non-ST-segment-elevation acute coronary syndrome patients.
Methods
Hospitalized non-ST-segment-elevation acute coronary syndrome patients were randomized (1:1) to ticagrelor or clopidogrel. The index of microcirculatory resistance, coronary flow reserve, and resistive reserve ratio were obtained using an intracoronary pressure-temperature sensor-tipped wire.
Results
In total, 128 patients were randomized between March 2018 and July 2020. Mean age 59.2±11.8 years, 84% were male, mean Global Registry of Acute Coronary Events score was 93.7±24.5. Intracoronary physiological measurements were obtained in 118 patients (60 ticagrelor, 58 clopidogrel). In the infarct-related artery, the ticagrelor group had lower baseline index of microcirculatory resistance (22.0 [13.0-34.9] versus 27.7 [19.3-29.8]; P=0.02) and higher baseline resistive reserve ratio (3.0 [2.3-4.4] versus 2.4 [1.7-3.4]; P=0.01) compared with the clopidogrel group. A total of 88 patients underwent percutaneous coronary intervention (PCI; 45 ticagrelor, 43 clopidogrel). The ticagrelor group had lower post-PCI index of microcirculatory resistance (22.0 [15.0-29.0] versus 27.0 [18.5-47.5]; P=0.02) and higher post-PCI resistive reserve ratio (3.0 [1.8-3.8] versus 1.8 [1.5-3.4]; P=0.006) compared with the clopidogrel group. The coronary flow reserve was not significantly different between the 2 groups at baseline or post-PCI. No between-group differences were seen in any of the indices in the non-infarct-related artery.
Conclusions
In non-ST-segment-elevation acute coronary syndrome patients, ticagrelor significantly improved coronary microvascular function before and after PCI compared with clopidogrel.
Registration
URL: https://www.anzctr.org.au; Unique identifier: ACTRN12618001610224.



Circ Cardiovasc Interv: 31 Mar 2022; 15:e011419
Xu J, Lo S, Mussap CJ, French JK, ... Juergens CP, Leung DY
Circ Cardiovasc Interv: 31 Mar 2022; 15:e011419 | PMID: 35369712
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Abstract

Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry.

Wild MG, Lubos E, Cruz-Gonzalez I, Amat-Santos I, ... Windecker S, Praz F
Background
Patients with severe tricuspid regurgitation present late and are often ineligible for surgery or transcatheter repair systems. Transfemoral venous implantation of a bicaval valved stent has been proposed as therapeutic option in selected patients. The aim of this study was to summarize the early procedural and clinical outcomes of the novel TRICENTO system for the treatment of patients with symptomatic severe tricuspid regurgitation.
Methods
All consecutive patients treated with the custom-made TRICENTO implant at the participating centers were included in this retrospective multicentre registry.
Results
A total of 21 high-risk patients (mean age 76±7 years; 67% female) with severe or higher grade tricuspid regurgitation were analyzed. The majority of the patients were in New York Heart Association class III/IV (95%), had peripheral edema (95%), and previous hospitalization for right heart failure (67%). Technical success was 100%, and there was no case of in-hospital mortality. During follow-up (median 61 days), symptomatic improvement was observed (65% in New York Heart Association class I/II; P<0.001). Computed tomography revealed asymptomatic fractures of the TRICENTO prosthesis in 3 patients. Cardiac magnetic resonance imaging obtained in 7 patients showed a significant decrease (252±65 mm3 at baseline versus 216±58 mm3 at follow-up, P=0.006) of right ventricular end-diastolic volume. The overall-survival rate was 76% at 1 year.
Conclusions
The present data indicate the feasibility of transfemoral bicaval valved stent implantation for the treatment of severe tricuspid regurgitation. Functional improvement and signs of right ventricular reverse remodeling were observed. Stent fractures did not impair valve function, but require refinement of prosthesis design and careful assessment of eligibility criteria.



Circ Cardiovasc Interv: 02 Mar 2022:CIRCINTERVENTIONS121011302; epub ahead of print
Wild MG, Lubos E, Cruz-Gonzalez I, Amat-Santos I, ... Windecker S, Praz F
Circ Cardiovasc Interv: 02 Mar 2022:CIRCINTERVENTIONS121011302; epub ahead of print | PMID: 35236096
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Impact:
Abstract

Clinical Impact of Hypoattenuating Leaflet Thickening After Transcatheter Aortic Valve Replacement.

Garcia S, Fukui M, Dworak MW, Okeson BK, ... Bradley SM, Sorajja P
Background
Hypoattenuated leaflet thickening (HALT), identified on functional cardiac computed tomography (CTA), can affect valve function and clinical outcomes. The objective of this study was to assess the impact of HALT on clinical outcomes in patients treated with transcatheter aortic valve replacement (TAVR).
Methods
In July 2015, Minneapolis Heart Institute implemented prospective screening of HALT at 30-day post-TAVR with CTA. Patients with evidence of HALT were recommended to initiate anticoagulation for 3 to 6 months with warfarin. Echocardiographic, ischemic, and bleeding outcomes were compared between HALT+ and HALT- patients. Survival rates were compared between HALT+ and HALT- patients using log-rank test, with Cox regression analysis used to identify variables independently associated with long-term death landmarked at time of CTA. This analysis included patients treated from July 1, 2015 to October 31, 2019.
Results
Of 856 patients undergoing TAVR during the study period, 638 (75%) underwent CTA post-TAVR (median time 31 [30-37] days). HALT+ was evident in 79 (12.3%). HALT+ patients were more likely prescribed warfarin at 1, 3, and 12 months (all P<0.001) and had similar gradients compared with HALT- patients. After a median follow-up of 2.2 years (1.5-3.2), HALT+ patients had increased mortality (30% versus 20%; P=0.001). In Cox regression analysis, presence of HALT (hazard ratio, 1.83 [95% CI, 1.13-2.97]; P=0.014) remained independently associated with long-term mortality.
Conclusions
In a large, real-world cohort of patients receiving TAVR followed by systematic screening with CTA 30-days post-procedure, HALT was found in 12% of patients and independently associated with long-term mortality. Findings of this nonrandomized, observational cohort study require independent validation.



Circ Cardiovasc Interv: 02 Mar 2022:CIRCINTERVENTIONS121011480; epub ahead of print
Garcia S, Fukui M, Dworak MW, Okeson BK, ... Bradley SM, Sorajja P
Circ Cardiovasc Interv: 02 Mar 2022:CIRCINTERVENTIONS121011480; epub ahead of print | PMID: 35236097
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Impact:
Abstract

Effect of Evolocumab in Patients With Prior Percutaneous Coronary Intervention.

Furtado RHM, Fagundes AA, Oyama K, Zelniker TA, ... Sabatine MS, Bergmark BA
Background
Patients with prior percutaneous coronary intervention (PCI) are at high residual risk for multiple types of coronary events within and beyond the stented lesion. This risk might be mitigated by more intensive LDL-C (low-density lipoprotein cholesterol)-lowering beyond just with statin therapy.
Methods
FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) randomized 27 564 patients with stable atherosclerotic disease on statin to the PCSK9 (proprotein convertase subtilisin-kexin type 9) inhibitor evolocumab or placebo with a median follow-up of 2.2 years. The end points of interest were major adverse cardiovascular events (MACE; a composite of cardiovascular death, myocardial infarction, stroke, unstable angina or coronary revascularization), and major coronary events (a composite of coronary heart death, myocardial infarction, or coronary revascularization). We compared the risk of MACE and the magnitude of relative and absolute risk reductions with evolocumab in patients with and without prior PCI.
Results
Seventeen thousand seventy-three patients had prior PCI. In the placebo arm, those with prior PCI had higher rates of MACE (13.2% versus 8.3%; hazard ratio [HR]adj 1.61 [95% CI, 1.42-1.84]; P<0.0001) and major coronary events (11.5% versus 6.0%; HRadj, 1.72 [95% CI, 1.49-1.99]; P<0.0001). Relative risk reductions with evolocumab were similar in patients with and without prior PCI (MACE: HR, 0.84 [0.77-0.91] versus HR, 0.88 [0.77-1.01]; Pinteraction 0.51; major coronary events: HR, 0.82 [0.75-0.90] versus HR, 0.88 [0.75-1.04]; Pinteraction 0.42). Absolute risk reductions for MACE were 2.0% versus 0.9% (Pinteraction 0.14) and for major coronary events 2.0% versus 0.7% (Pinteraction 0.045). In those with prior PCI, the effect of evolocumab on coronary revascularization (HR, 0.76 [0.69-0.85]) was directionally consistent across types of revascularization procedures: coronary artery bypass grafting (HR, 0.71 [0.54-0.94]); any PCI (HR, 0.77 [0.69-0.86]); PCI for de novo lesions (HR, 0.76 [0.66-0.88]); and PCI for stent failure or graft lesions (HR, 0.76 [0.63-0.91]).
Conclusions
Evolocumab reduces the risk of MACE in patients with prior PCI including the risk of coronary revascularization, with directionally consistent effects across several types of revascularization procedures, including coronary artery bypass grafting and PCI for stent or graft failure.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01764633.



Circ Cardiovasc Interv: 24 Feb 2022:CIRCINTERVENTIONS121011382; epub ahead of print
Furtado RHM, Fagundes AA, Oyama K, Zelniker TA, ... Sabatine MS, Bergmark BA
Circ Cardiovasc Interv: 24 Feb 2022:CIRCINTERVENTIONS121011382; epub ahead of print | PMID: 35209731
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Impact:
Abstract

Effect of Platelet Inhibition by Cangrelor Among Obese Patients Undergoing Coronary Stenting: Insights From CHAMPION.

Peterson BE, Harrington RA, Stone GW, Steg PG, ... White HD, Bhatt DL
Background
In randomized trials, cangrelor reduced periprocedural ischemic events related to percutaneous coronary intervention without increasing GUSTO severe bleeding. However, some antiplatelet agents have shown a differential treatment effect by body mass index (BMI).
Methods
Patients from the 3 CHAMPION trials (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition) who were randomized to cangrelor versus clopidogrel during percutaneous coronary intervention were stratified by BMI. The primary efficacy end point was a composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis within 48 hours. The principal safety outcome was GUSTO moderate or severe bleeding at 48 hours, although more sensitive bleeding measures such as Thrombolysis in Myocardial Infarction major bleeding were also assessed. We examined obese patients (defined as BMI≥30) versus nonobese patients.
Results
There were 24 893 patients, with 8979 (36.1%) having BMI of ≥30. There was no significant difference in the primary efficacy end point among obese versus nonobese patients (4.3% versus 4.2%; rate ratio, 1.01 [95% CI, 0.89-1.15]; P=0.82). There was a consistent benefit in the primary efficacy end point in patients who received cangrelor versus placebo who were obese (3.9% versus 4.7%, rate ratio, 0.83 [95% CI, 0.68-1.02]; P=0.07) and not obese (3.8% versus 4.7%; rate ratio, 0.81 [95% CI, 0.69-0.94]; P=0.0053); interaction P=0.77. There was no difference in GUSTO moderate or severe bleeding among patients who received cangrelor versus placebo who were obese (0.6% versus 0.6%; rate ratio, 0.99 [95% CI, 0.58-1.67]; P=0.96).
Conclusions
Cangrelor at the time of percutaneous coronary intervention is effective and safe in obese and nonobese patients. There was no difference in short-term efficacy between obese and nonobese patients. Periprocedural cangrelor is an effective and safe antiplatelet agent, irrespective of BMI.
Registration
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01156571, NCT00385138, NCT00305162.



Circ Cardiovasc Interv: 23 Feb 2022:CIRCINTERVENTIONS121011069; epub ahead of print
Peterson BE, Harrington RA, Stone GW, Steg PG, ... White HD, Bhatt DL
Circ Cardiovasc Interv: 23 Feb 2022:CIRCINTERVENTIONS121011069; epub ahead of print | PMID: 35196863
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Impact:
Abstract

Recurrent Mitral Regurgitation After MitraClip: Predictive Factors, Morphology, and Clinical Implication.

Sugiura A, Kavsur R, Spieker M, Iliadis C, ... Pfister R, Becher MU
Background
Recurrent mitral regurgitation (MR) following MitraClip has not been thoroughly investigated. We aimed to examine the predictive factors, morphology, and long-term outcome of recurrent MR after MitraClip.
Methods
We assessed data from the Heart Failure Network Rhineland registry from August 2010 to October 2018. Competing risk analyses were performed using the Fine and Gray model to assess the risk of recurrent MR.
Results
Among 685 MitraClip patients with a reduction in MR to ≤2+, 61 patients developed recurrent MR within the first 12 months. Flail leaflet (hazard ratio, 3.68; P=0.002) and residual MR (MR grade 2+ versus ≤1+: hazard ratio, 2.56; P=0.03) were the predictors of recurrent MR in primary MR patients, while left atrial volume (per 10 mL increase: hazard ratio, 1.11; P<0.001) and residual MR (hazard ratio, 2.45; P=0.01) were independently associated with recurrent MR in secondary MR patients. In primary MR patients, loss of leaflet insertion or leaflet tear were the predominant morphologies with recurrent MR. In secondary MR patients, more than half of the patients with recurrent MR did not show any disorder of the clip or leaflets. Patients with recurrent MR were more likely to experience unplanned heart failure hospitalization or heart failure symptom with New York Heart Association scale III/IV (54.1% versus 37.8%; P=0.018) and undergo a repeat mitral valve intervention (9.8% versus 2.2%; P=0.005) during the follow-up. In the landmark survival analysis, patients with recurrent MR tended to have lower long-term survival (58.7% versus 83.9%; P=0.08) than patients without recurrent MR.
Conclusions
Flail leaflet and residual MR were the predictors of recurrent MR in primary MR patients, while a larger left atrial volume and residual MR were associated with recurrent MR in secondary MR patients, which may be associated with long-term clinical outcomes of patients after MitraClip.



Circ Cardiovasc Interv: 22 Feb 2022:CIRCINTERVENTIONS121010895; epub ahead of print
Sugiura A, Kavsur R, Spieker M, Iliadis C, ... Pfister R, Becher MU
Circ Cardiovasc Interv: 22 Feb 2022:CIRCINTERVENTIONS121010895; epub ahead of print | PMID: 35193380
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Impact:
Abstract

Contemporary Costs Associated With Transcatheter Versus Surgical Aortic Valve Replacement in Medicare Beneficiaries.

Baron SJ, Ryan MP, Moore KA, Clancy SJ, Gunnarsson CL
Background
In patients with severe aortic stenosis, treatment with transcatheter aortic valve replacement (TAVR) has been shown to be cost-effective in the high-risk surgical population and cost-saving in the intermediate-risk population when compared with surgical aortic valve replacement (SAVR) in early pivotal clinical trials. Whether TAVR is associated with comparable or lower costs when compared with SAVR in contemporary clinical practice is unknown.
Methods
Using data from the Medicare Dataset Standard Analytic Files 5% Fee for Service database, patients receiving either TAVR or SAVR between 2016 and 2018 were identified. Patients were categorized as low, intermediate, or high mortality risk based on 2 validated indices-the Hospital Frailty Risk Score and the logEuroScore. Health care costs out to 1 year were compared between TAVR and SAVR among the low, intermediate, and high-risk groups, after adjustment for patient demographics.
Results
Nine thousand seven hundred forty-six patients were identified (4834 TAVR; 3760 SAVR) and included in the analysis. Patients receiving TAVR were older and more likely to be female. Index hospitalization costs were significantly lower with TAVR compared with SAVR across all risk strata (logEuroScore: low: $61 845 versus $68 986; intermediate: $64 658 versus $76 965; high: $65 594 versus $91 005; P<0.001 for all). Follow-up costs through 1 year were generally lower with TAVR and this difference was more pronounced in the low risk groups (logEuroScore: $9763 versus $14 073; Hospital Frailty Risk Score: $10 116 versus $12 880). Accordingly, cumulative 1-year costs were substantially lower with TAVR compared with SAVR.
Conclusions
At 1 year, TAVR is associated with lower health care costs across all risk strata when compared with SAVR in contemporary practice. If long-term data continue to demonstrate similar clinical outcomes and valve durability with TAVR and SAVR, these findings suggest that TAVR may be the preferred treatment strategy for patients with aortic stenosis from an economic standpoint.



Circ Cardiovasc Interv: 22 Feb 2022:CIRCINTERVENTIONS121011295; epub ahead of print
Baron SJ, Ryan MP, Moore KA, Clancy SJ, Gunnarsson CL
Circ Cardiovasc Interv: 22 Feb 2022:CIRCINTERVENTIONS121011295; epub ahead of print | PMID: 35193382
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Impact:

This program is still in alpha version.