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1.
Article in English | MEDLINE | ID: mdl-38714459

ABSTRACT

BACKGROUNDS: The impact of quantitative assessment to differentiate total occlusions (TOs) from severe stenoses on coronary computed tomography angiography (CCTA) remains unknown. OBJECTIVE: This study investigated whether quantitative characteristics assessed on CCTA could help differentiate a TO from a severe stenosis on invasive coronary angiography (ICA). METHODS: This study is a sub-analysis of the FASTTRACK CABG (NCT04142021) in which both CCTA and ICA were routinely performed. Quantitative analysis was performed with semi-automated CCTA plaque-analysis software. Blinded analysts compared TOs on CCTA, defined as a complete lack of contrast opacification within the coronary occlusion, with corresponding ICA. RESULTS: Eighty-four TOs were seen on CCTA in 59 of the 114 patients enrolled in the trial. The concordance in diagnosing a TO between ICA and CCTA was 56.0% (n â€‹= â€‹47). Compared to severe stenoses, TOs had a significantly longer lesion length (25.1 â€‹± â€‹23.0 â€‹mm vs 9.4 â€‹± â€‹11.2 â€‹mm, P â€‹< â€‹0.001). The best cut-off value to differentiate a TO from severe stenosis was a lesion length of 5.5 â€‹mm (area under the curve 0.77, 95% CI: 0.66-0.87), with a 91.1% sensitivity and 61.1% specificity. Dense calcium percentage atheroma volume (PAV) was significantly higher in TOs compared to severe stenoses (18.7 â€‹± â€‹19.6% vs. 6.6 â€‹± â€‹13.0%, P â€‹< â€‹0.001), whilst the opposite was seen for fibro-fatty PAV (31.3 â€‹± â€‹14.2% vs. 19.5 â€‹± â€‹10.5%, P â€‹< â€‹0.001). On a multivariable logistic regression analysis, lesion length (>5.5 â€‹mm) was the only parameter associated with differentiating a TO from a severe stenosis. CONCLUSION: In quantitative CCTA analysis, a lesion length >5.5 â€‹mm was the only independent predictor differentiating a TO from a severe stenosis. NCT REGISTRATION NUMBER: NCT04142021.

3.
Eur Heart J ; 2024 Apr 07.
Article in English | MEDLINE | ID: mdl-38583086

ABSTRACT

BACKGROUND AND AIMS: In patients with three-vessel disease and/or left main disease, selecting revascularization strategy based on coronary computed tomography angiography (CCTA) has a high level of virtual agreement with treatment decisions based on invasive coronary angiography (ICA). METHODS: In this study, coronary artery bypass grafting (CABG) procedures were planned based on CCTA without knowledge of ICA. The CABG strategy was recommended by a central core laboratory assessing the anatomy and functionality of the coronary circulation. The primary feasibility endpoint was the percentage of operations performed without access to the ICA. The primary safety endpoint was graft patency on 30-day follow-up CCTA. Secondary endpoints included topographical adequacy of grafting, major adverse cardiac and cerebrovascular (MACCE), and major bleeding events at 30 days. The study was considered positive if the lower boundary of confidence intervals (CI) for feasibility was ≥75% (NCT04142021). RESULTS: The study enrolled 114 patients with a mean (standard deviation) anatomical SYNTAX score and Society of Thoracic Surgery score of 43.6 (15.3) and 0.81 (0.63), respectively. Unblinding ICA was required in one case yielding a feasibility of 99.1% (95% CI 95.2%-100%). The concordance and agreement in revascularization planning between the ICA- and CCTA-Heart Teams was 82.9% with a moderate kappa of 0.58 (95% CI 0.50-0.66) and between the CCTA-Heart Team and actual treatment was 83.7% with a substantial kappa of 0.61 (95% CI 0.53-0.68). The 30-day follow-up CCTA in 102 patients (91.9%) showed an anastomosis patency rate of 92.6%, whilst MACCE was 7.2% and major bleeding 2.7%. CONCLUSIONS: CABG guided by CCTA is feasible and has an acceptable safety profile in a selected population of complex coronary artery disease.

4.
J Cardiothorac Surg ; 19(1): 224, 2024 Apr 16.
Article in English | MEDLINE | ID: mdl-38627771

ABSTRACT

Coronary artery bypass grafting (CABG) is one of the foundations of treatment for coronary artery disease. While it has improved substantially since its inception more than 50 years ago, including a rising use of multiple arterial grafting, intraoperative quality assessment is yet to be disseminated as an integral part of the procedure. Herein we review the fundamentals of intraoperative quality assessment in CABG using transient time flow measurement (TTFM) with a focus on its use in arterial grafting.


Subject(s)
Coronary Artery Disease , Mammary Arteries , Humans , Coronary Angiography , Coronary Artery Bypass/methods , Coronary Artery Disease/surgery , Mammary Arteries/transplantation , Vascular Patency , Blood Flow Velocity
5.
J Am Coll Cardiol ; 83(11): 1073-1081, 2024 Mar 19.
Article in English | MEDLINE | ID: mdl-38479955

ABSTRACT

BACKGROUND: The frequency of and relationship between hospital readmissions and outcomes after revascularization for left main coronary artery disease (LMCAD) are unknown. OBJECTIVES: The purpose of this study was to study the incidence, predictors, and clinical impact of readmissions following percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for LMCAD. METHODS: In the EXCEL (XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with LMCAD were randomized to PCI vs CABG. The cumulative incidence of readmissions was analyzed with multivariable Anderson-Gill and joint frailty models to account for recurrent events and the competing risk of death. The impact of readmission on subsequent mortality within 5-year follow-up was determined in a time-adjusted Cox proportional hazards model. RESULTS: Within 5 years, 1,868 readmissions occurred in 851 of 1,882 (45.2%) hospital survivors (2.2 ± 1.9 per patient with readmission[s], range 1-16), approximately one-half for cardiovascular causes and one-half for noncardiovascular causes (927 [49.6%] and 941 [50.4%], respectively). One or more readmissions occurred in 463 of 942 (48.6%) PCI patients vs 388 of 940 (41.8%) CABG patients (P = 0.003). After multivariable adjustment, PCI remained an independent predictor of readmission (adjusted HR: 1.22; 95% CI: 1.10-1.35; P < 0.0001), along with female sex, comorbidities, and the extent of CAD. Readmission was independently associated with subsequent all-cause death, with interaction testing indicating a higher risk after PCI than CABG (adjusted HR: 5.72; 95% CI: 3.42-9.55 vs adjusted HR: 2.72; 95% CI: 1.64-4.88, respectively; Pint = 0.03). CONCLUSIONS: In the EXCEL trial, readmissions during 5-year follow-up after revascularization for LMCAD were common and more frequent after PCI than CABG. Readmissions were associated with an increased risk of all-cause death, more so after PCI than with CABG.


Subject(s)
Coronary Artery Disease , Percutaneous Coronary Intervention , Female , Humans , Coronary Artery Disease/epidemiology , Incidence , Patient Readmission , Percutaneous Coronary Intervention/adverse effects , Risk Factors , Treatment Outcome , Male
6.
Eur J Cardiothorac Surg ; 65(3)2024 Mar 01.
Article in English | MEDLINE | ID: mdl-38400814

ABSTRACT

OBJECTIVES: Since 2000, we anastomosed the saphenous vein graft to the right coronary artery system using the stump of the right internal thoracic artery as inflow. The long-term results of patients where the right coronary artery was grafted with the right internal thoracic artery or the ascending aorta as saphenous vein inflow has not been reported. METHODS: From 2000 to 2018, 699 consecutive patients had right internal thoracic artery elongated with saphenous vein (I-graft group, n = 358, 51.2%) or saphenous vein from the aorta (Ao-graft group, n = 341, 48.8%) on right coronary artery system. Inclusion criteria were age ≤75 years, bilateral internal thoracic arteries as a Y graft on the left system (three-vessel disease, n = 603, 86.3%) or as a left internal thoracic artery on left anterior descending and right internal thoracic artery elongated with saphenous vein on the right coronary artery system (two-vessel disease, n = 96, 13.7%), only 1 saphenous vein per patient. Propensity-matching identified 272 patients per group. One-hundred and twenty-two patients underwent coronary computed tomographic angiography to asses grafts patency after a median follow-up of 88 (65-93) months. RESULTS: In the paired samples, there was no difference in the early outcome. Ten-year survival and freedom from death, non-fatal acute myocardial infarction and repeat revascularization were higher in I-graft group: 90.6 [standard error (SE): 2.0] vs 78.2 (SE: 5.3), P = 0.0266, and 85.2 (SE: 2.4) vs 69.9 (SE: 5.3), P = 0.0179. Saphenous vein graft, at a long-time follow-up, showed a higher patency rate (81.6% (SE: 7.0) vs 50.7% (SE: 7.9), P < 0.0001) and a smaller internal lumen diameter (2.7, standard deviation: 0.4 vs 3.4, standard deviation: 0.6 mm, P < 0.0001) when right internal thoracic artery was the inflow. CONCLUSIONS: Grafting the right coronary artery with saphenous vein may entail higher patency rate and better outcome when the inflow is the right internal thoracic artery than when is the ascending aorta. Prospective randomized data are needed to test this hypothesis.


Subject(s)
Coronary Artery Bypass , Mammary Arteries , Humans , Aged , Coronary Artery Bypass/methods , Coronary Angiography , Saphenous Vein/transplantation , Prospective Studies , Vascular Patency , Treatment Outcome , Aorta/diagnostic imaging , Aorta/surgery , Mammary Arteries/transplantation
7.
Heart Lung Circ ; 33(4): 510-517, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38403570

ABSTRACT

BACKGROUND: The management of adult patients with anomalous aortic origin of the right coronary artery (ARCA) from the left aortic sinus poses important challenges. The presence of symptoms or documented ischaemia, the anatomical characteristics of the ostium, and the course of the coronary determine decision-making. METHODS: A retrospective review was performed of all cases of surgical management of ARCA at a single centre. The primary endpoints were mortality and myocardial infarction at 30 days. Secondary endpoints included recurrence of symptoms, freedom from re-intervention, and mortality during long-term follow-up. RESULTS: From October 2019 to August 2023, 15 adult patients underwent surgery for ARCA; 13 patients were included in this study (mean age 53.9±11.1 years; 10 female). A slit-like orifice, a long intramural segment, and an interarterial course were found in all patients. Twelve (12) patients (92.3%) were symptomatic: nine with angina, combined with dyspnoea on exertion in seven. One (1) patient had history of pre-syncope. One (1) patient presented with out-of-hospital cardiac arrest. All patients underwent formal unroofing of the orifice and intramural portion of the ARCA; five patients had a concomitant procedure. No 30-day mortality nor myocardial infarction was recorded. At a mean follow-up of 20.1±12.8 months, all patients were alive. One (1) patient (7.6%) developed recurrent dyspnoea; investigations showed no ischaemia. No repeated interventions were required. CONCLUSIONS: Surgical unroofing of anomalous coronary artery in the adult is safe and effective; correction of both the slit-like orifice and intramural portion of the anomaly provides a durable result in patients with ARCA.


Subject(s)
Coronary Vessel Anomalies , Coronary Vessels , Humans , Female , Male , Retrospective Studies , Middle Aged , Coronary Vessel Anomalies/surgery , Coronary Vessel Anomalies/diagnosis , Coronary Vessels/surgery , Coronary Vessels/diagnostic imaging , Follow-Up Studies , Adult , Coronary Angiography , Cardiac Surgical Procedures/methods , Treatment Outcome
8.
J Cardiothorac Vasc Anesth ; 38(1): 183-188, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37940456

ABSTRACT

OBJECTIVES: Determine the effect of low-dose pregabalin in the perioperative enhanced recovery after cardiac surgery protocol. DESIGN: Pre-post observational study. SETTING: Tertiary care hospital. PARTICIPANTS: Patients undergoing off-pump coronary artery bypass graft procedures. INTERVENTIONS: Pregabalin 75 mg BID for 48 hours postoperatively versus no pregabalin in a perioperative setting. MEASUREMENTS AND MAIN RESULTS: Perioperative opioid use, pain scores, length of stay, time to extubation, and mortality were all measured. Descriptive data were presented as mean (SD), median (IQR), or N (%). Ordinal and continuous data used the t-test or Kruskal-Wallis test. Categorical data were compared between groups using the chi-square test or Fisher's exact test, as appropriate. Low-dose pregabalin administration (75 mg twice daily for 48 hours after surgery) was associated with a clinically significant reduction in opioid consumption on postoperative day 0 by 30.6%, with a median requirement of 318 (233, 397) morphine milligram equivalents (MME) in the pregabalin group compared with 458 (375, 526) MME in the control group (p < 0.001). There was no significant difference in pain scores between the groups with the exception at 0-to-12 hours, during which the pregabalin group had greater pain scores (median 3.32 [1.65, 4.36] v 2.0 [0, 3.25], p = 0.013) (Table 3). Moreover, there was no significant difference in pain scores on postoperative day 1 (p = 0.492), day 2 (p = 0.442), day 3 (p = 0.237), and day 4 (p = 0.649). The difference in average Richmond Agitation Sedation Score scores was also not statistically significant between groups at 12 hours (p = 0.954) and at 24 hours (p = 0.301). The pregabalin group had no increased incidence of adverse events or any significant differences in intensive care unit length of stay, time to extubation, or mortality. CONCLUSIONS: In this evaluation of perioperative pregabalin administration for patients requiring cardiac surgery, pregabalin reduced postoperative opioid use, with significant reductions on postoperative day 0, and without any significant increase in adverse reactions. However, no differences in intensive care unit length of stay, time to extubation, or mortality were noted. The implementation of low-dose perioperative pregabalin within an Enhanced Recovery After Cardiac Surgery protocol may be effective at reducing postoperative opioid use in the immediate postoperative period, and may be safe with regard to adverse events. Ideal dosing strategies have not been determined; thus, further randomized control trials with an emphasis on limiting confounding factors need to be conducted.


Subject(s)
Analgesics, Opioid , Coronary Artery Bypass, Off-Pump , Humans , Coronary Artery Bypass, Off-Pump/adverse effects , Pain, Postoperative/diagnosis , Pain, Postoperative/drug therapy , Pain, Postoperative/prevention & control , Pregabalin
9.
J Cardiovasc Comput Tomogr ; 18(2): 120-136, 2024.
Article in English | MEDLINE | ID: mdl-37923578

ABSTRACT

BACKGROUND: Since the initial attempt to adapt the anatomical SYNTAX score (aSS) to coronary computed tomography angiography (CCTA), CCTA imaging technology has evolved, and is currently used as a "decision-maker" for revascularization strategy in complex coronary artery disease (CAD) and has rendered necessary some updating of the aSS to the CCTA modality. OBJECTIVES: The aim is to provide updated definitions of the aSS derived from CCTA in patients with complex CAD undergoing CABG. METHODS: The modifications of CCTA-aSS are the following; (i) updated definition and detection criteria of total occlusion (TO) in CCTA based on length assessment, (ii) inclusion of scoring points for serial bifurcations located in one single coronary segment. (iii) inclusion of weighing score points for lesions located distal to a TO, not visualized on conventional coronary angiography, but visible in CCTA, (iv) removal of thrombus and bridging collateral items from the weighing score, considering the limited diagnostic capability of CCTA in detecting these specific lesion characteristics. RESULTS: the updated CCTA-aSS was tested in a first-in-man study using the sole guidance of CCTA for the planning and performance of bypass surgery in complex CAD (n â€‹= â€‹114). An interobserver analysis showed excellent reproducibility (ICC â€‹= â€‹0.96, 95 â€‹% confidence interval 0.94-0.97). CONCLUSION: The updated CCTA-aSS was implemented in a cohort of patients with complex CAD undergoing CABG with the sole guidance of CCTA and FFRCT and the Inter-reproducibility of the analysis of the updated score was found excellent. The prognostic value of the modified CCTA-aSS will be examined in future studies.


Subject(s)
Coronary Artery Disease , Coronary Stenosis , Humans , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/surgery , Computed Tomography Angiography , Reproducibility of Results , Predictive Value of Tests , Coronary Angiography/methods , Tomography, X-Ray Computed/methods
10.
Ann Thorac Surg ; 2023 Dec 21.
Article in English | MEDLINE | ID: mdl-38135262

ABSTRACT

BACKGROUND: This study investigated the safety and effectiveness of surgical aortic valve replacement with RESILIA tissue (Edwards Lifesciences) through 5 years in patients with native bicuspid aortic valves. Outcomes were compared with those for patients with tricuspid aortic valves. METHODS: Of 689 patients from the COMMENCE (ProspeCtive, nOn-randoMized, MulticENter) trial who received the study valve, 645 had documented native valve morphology and core laboratory-evaluable echocardiograms from any postoperative visit, which were used to model hemodynamic outcomes over 5 years. Linear mixed-effects models were used to estimate longitudinal changes in mean gradient and effective orifice area. RESULTS: Patients with native bicuspid aortic valves (n = 214) were more than a decade younger than those with tricuspid aortic valves (n = 458; 59.8 ± 12.4 years vs 70.2 ± 9.5 years; P < .001). The bicuspid aortic valve cohort exhibited no structural valve deterioration over 5 years, and rates of paravalvular leak and transvalvular regurgitation were low (0.7% and 2.9%, respectively [all mild] at 5 years). These outcomes mirrored those in patients with native tricuspid aortic valves. The model-estimated postoperative mean gradient and effective orifice area, as well as the rate of change of these outcomes, adjusted for age, body surface area, and bioprosthesis size, did not differ between the 2 cohorts. CONCLUSIONS: Among patients with bicuspid aortic valves, RESILIA tissue valves demonstrated excellent outcomes to 5 years, including no structural valve deterioration and very low rates of paravalvular and transvalvular regurgitation. These results are encouraging for RESILIA tissue durability in young patients.

11.
Article in English | MEDLINE | ID: mdl-37778503

ABSTRACT

OBJECTIVE: As bioprosthetic aortic valve replacement (AVR) extends to younger cohorts, tissue durability is of paramount importance. We report 7-year outcomes from an AVR bioprosthesis utilizing novel tissue. METHODS: This was an international investigational device exemption trial for novel AVR with annual follow-up and a subset re-consented at 5 years for extended 10-year follow-up. Safety end points and echocardiographic measurements were adjudicated by an independent clinical events committee and by a dedicated core laboratory, respectively. RESULTS: Between January 2013 and March 2016, 689 patients underwent AVR with the study valve. Mean age was 66.9 ± 11.6 years, Society of Thoracic Surgeons risk score was 2.0% ± 1.8%, and 74.3% of patients were New York Heart Association functional class II and III. Five-year follow-up was completed by 512 patients, and 225 re-consented for extended follow-up. Follow-up duration was 5.3 ± 2.2 years (3665.6 patient-years), and 194 and 195 patients completed 6- and 7-year follow-ups, respectively. One-, 5-, and 7-year freedom from all-cause mortality was 97.7%, 89.4%, and 85.4%, respectively. Freedom from structural valve deterioration at 7 years was 99.3%. At 7 years, effective orifice area and mean gradients were 1.82 ± 0.57 cm2 (n = 153), and 9.4 ± 4.5 mm Hg (n = 157), respectively. At 7 years, predominantly none (96.8% [152 out of 157]) or trivial/trace (2.5% [4 out of 157]) paravalvular regurgitation and none (84.7% [133 out of 157]) or trivial/trace (11.5% [18 out of 157]) transvalvular regurgitation were observed. CONCLUSIONS: We report the longest surgical AVR follow-up with novel tissue in an investigational device exemption trial utilizing an independent clinical events committee and an echocardiography core laboratory. This tissue demonstrates excellent outcomes through 7 years and is the benchmark for future surgical and transcatheter prostheses.

12.
J Am Coll Cardiol ; 82(21): 2034-2053, 2023 Nov 21.
Article in English | MEDLINE | ID: mdl-37855757

ABSTRACT

As a result of increasing adoption of imaging screening, the number of adult patients with a diagnosis of anomalous aortic origin of the coronary arteries (AAOCA) has grown in recent years. Existing guidelines provide a framework for management and treatment, but patients with AAOCA present with a wide range of anomalies and symptoms that make general recommendations of limited applicability. In particular, a large spectrum of interventions can be used for treatment, and there is no consensus on the optimal approach to be used. In this paper, a multidisciplinary group of clinical and interventional cardiologists and cardiac surgeons performed a systematic review and critical evaluation of the available evidence on the interventional treatment of AAOCA in adult patients. Using a structured Delphi process, the group agreed on expert recommendations that are intended to complement existing clinical practice guidelines.


Subject(s)
Coronary Vessel Anomalies , Coronary Vessels , Adult , Humans , Coronary Vessels/surgery , Coronary Vessel Anomalies/diagnostic imaging , Coronary Vessel Anomalies/therapy , Retrospective Studies , Aorta
13.
Ann Thorac Surg ; 116(6): 1124-1141, 2023 12.
Article in English | MEDLINE | ID: mdl-37855783

ABSTRACT

As a result of increasing adoption of imaging screening, the number of adult patients with a diagnosis of anomalous aortic origin of the coronary arteries (AAOCA) has grown in recent years. Existing guidelines provide a framework for management and treatment, but patients with AAOCA present with a wide range of anomalies and symptoms that make general recommendations of limited applicability. In particular, a large spectrum of interventions can be used for treatment, and there is no consensus on the optimal approach to be used. In this paper, a multidisciplinary group of clinical and interventional cardiologists and cardiac surgeons performed a systematic review and critical evaluation of the available evidence on the interventional treatment of AAOCA in adult patients. Using a structured Delphi process, the group agreed on expert recommendations that are intended to complement existing clinical practice guidelines.


Subject(s)
Coronary Vessel Anomalies , Coronary Vessels , Humans , Adult , Coronary Vessels/surgery , Coronary Vessel Anomalies/complications , Coronary Vessel Anomalies/diagnosis , Coronary Vessel Anomalies/surgery , Aorta
14.
JTCVS Open ; 15: 151-163, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37808026

ABSTRACT

Objective: Novel tissue leaflets (RESILIA tissue) may improve durability of bioprosthetic heart valves. The COMMENCE trial is an ongoing prospective study to evaluate valve replacement using RESILIA tissue. This report describes mid-term outcomes in the mitral cohort of COMMENCE. Methods: Adult patients requiring mitral valve replacement were enrolled in a prospective, single-arm trial at 17 sites in the United States and Canada. An independent clinical events committee adjudicated safety events using definitions from established guidelines, and hemodynamic performance was evaluated by an independent echocardiographic core laboratory. Results: Eighty-two patients (median age 70 years) successfully underwent mitral valve replacement with the study valve. Five-year event-free probabilities for all-cause mortality, structural valve deterioration, and reoperation were 79.9%, 98.7%, and 97.1%, respectively. Hemodynamic valve function measurements were stable through the 5-year follow-up period; valvular leaks were infrequently observed and primarily clinically insignificant/mild. Conclusions: Mitral valve replacement patients implanted with a RESILIA tissue bioprosthesis had a good safety profile and clinically stable hemodynamic performance.

15.
18.
Eur J Cardiothorac Surg ; 64(2)2023 08 01.
Article in English | MEDLINE | ID: mdl-37535847

ABSTRACT

PREAMBLE: The finalized document was endorsed by the EACTS Council and STS Executive Committee before being simultaneously published in the European Journal of Cardio-thoracic Surgery (EJCTS) and The Annals of Thoracic Surgery (The Annals) and the Journal of Thoracic and Cardiovascular Surgery (JTCVS).


Subject(s)
Thoracic Surgery , Humans , Coronary Artery Bypass , Heart , Prostheses and Implants , Societies, Medical
19.
Int J Cardiovasc Imaging ; 39(9): 1795-1804, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37368152

ABSTRACT

The diagnostic performance of the SYNTAX score 2020 (SS-2020) when calculated using CCTA remains unknown. This study aimed to compare treatment recommendations based on the SS-2020 derived from coronary computed tomography angiography (CCTA) versus invasive coronary angiography (ICA). This interim analysis included 57 of the planned 114 patients with de-novo three-vessel disease, with or without left main coronary artery disease, enrolled in the ongoing FASTTRACK CABG trial. The anatomical SYNTAX scores derived from ICA or CCTA were evaluated by two separate teams of blinded core-lab analysts. Treatment recommendations were based on a maximal individual absolute risk difference in all-cause mortality between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) of 4.5% ([predicted PCI mortality] - [predicted CABG mortality]). The level of agreement was evaluated with Bland-Altman plots and Cohen's Kappa. The mean age was 66.2 ± 9.2 years and 89.5% of patients were male. Mean anatomical SYNTAX scores derived from ICA and CCTA were 35.1 ± 11.5 and 35.6 ± 11.4 (p = 0.751), respectively. The Bland-Altman analysis showed mean differences of - 0.26 and - 0.93, with standard deviation of 3.69 and 5.23, for 5- and 10-year all-cause mortality, respectively. The concordance in recommended treatment for 5- and 10-year mortalities were 84.2% (48/57 patients) and 80.7% (46/57 patients), with Cohen's κ coefficients of 0.672 and 0.551. There was moderate to substantial agreement between treatment recommendations based on the SS-2020 derived using CCTA and ICA, suggesting that CCTA could be used as an alternative to ICA when making decisions regarding the modality of revascularization.


Subject(s)
Coronary Artery Disease , Percutaneous Coronary Intervention , Humans , Male , Middle Aged , Aged , Female , Computed Tomography Angiography/methods , Coronary Angiography/methods , Percutaneous Coronary Intervention/adverse effects , Predictive Value of Tests , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy
20.
Cardiovasc Revasc Med ; 50: 34-40, 2023 05.
Article in English | MEDLINE | ID: mdl-36639338

ABSTRACT

BACKGROUND: Personalized long term vital prognosis plays a key role in deciding between percutaneous coronary intervention (PCI) and CABG in patients with complex coronary artery disease. The FASTTRACK CABG trial enrolls patients with the sole guidance of coronary computed tomographic angiography (CCTA) and fractional flow reserve CCTA (FFRCT). The feasibility/non-feasibility of this approach is determined by the surgeon request to have access to the invasive coronary angiography. METHODS: This interim analysis, which was requested by the Data and Safety Monitoring Board (DSMB), compared the treatment decision of the "on site" Heart team to the recommended treatment as per the SYNTAX Score II 2020 (SS-2020), which was prospectively assessed by the central core laboratory in the first 57 consecutive patients (half of the planned population) enrolled in this First in Man study. RESULTS: The average anatomical SYTAX Score is 35.6 ± 11.5. The SS-2020 predicted 5-year MACE and 10-year all-cause mortality are 14.7 % and 21.6 % following CABG, and 23.0 % and 30.4 % following PCI. Among the enrolled patients the SS-2020 predicts long-term PCI outcomes similar to CABG (absolute risk difference ≤0 % in favor of PCI) in only two patients whilst the remaining 55 patients had a predicted survival benefit with CABG. CONCLUSIONS: According to the SS-2020, the first 57 patients recruited into the FASTTRACK CABG trial received the appropriate modality of revascularization and the DSMB allowed the investigators to complete the study.


Subject(s)
Coronary Artery Disease , Fractional Flow Reserve, Myocardial , Percutaneous Coronary Intervention , Humans , Coronary Artery Bypass , Patient Selection , Treatment Outcome , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/surgery
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