scholarly journals Safety and feasibility evaluation of planning and execution of surgical revascularisation solely based on coronary CTA and FFRCT in patients with complex coronary artery disease: study protocol of the FASTTRACK CABG study

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e038152
Author(s):  
Hideyuki Kawashima ◽  
Giulio Pompilio ◽  
Daniele Andreini ◽  
Antonio L Bartorelli ◽  
Saima Mushtaq ◽  
...  

IntroductionThe previously published SYNTAX III REVOLUTION trial demonstrated that clinical decision-making between coronary artery bypass graft (CABG) and percutaneous coronary intervention based on coronary CT angiography (CCTA) had a very high agreement with the treatment decision derived from invasive coronary angiography (ICA). The study objective of the FASTTRACK CABG is to assess the feasibility of CCTA and fractional flow reserve derived from CTA (FFRCT) to replace ICA as a surgical guidance method for planning and execution of CABG in patients with three-vessel disease with or without left main disease.Methods and analysisThe FASTTRACK CABG is an investigator-initiated single-arm, multicentre, prospective, proof-of-concept and first-in-man study with feasibility and safety analysis. Surgical revascularisation strategy and treatment planning will be solely based on CCTA and FFRCT without knowledge of the anatomy defined by ICA. Clinical follow-up visit including CCTA will be performed 30 days after CABG in order to assess graft patency and adequacy of the revascularisation with respect to the surgical planning based on non-invasive imaging (CCTA) with functional assessment (FFRCT) and compared with ICA. Primary feasibility endpoint is CABG planning and execution solely based on CCTA and FFRCT in 114 patients. Primary safety endpoint based on 30 day CCTA is graft assessment and topographical adequacy of the revascularisation procedure. Automatic non-invasive assessment of functional coronary anatomy complexity is also evaluated with FFRCT for functional Synergy Between percutaneous coronary intervention With Taxus and Cardiac Surgery Score assessment on CCTA. CCTA with FFRCT might provide better anatomical and functional analysis of the coronary circulation leading to appropriate anatomical and functional revascularisation, and thereby contributing to a better outcome.Ethics and disseminationEach patient has to provide written informed consent as approved by the ethical committee of the respective clinical site. Results will be submitted for publication in peer-reviewed journals and will be disseminated at scientific conferences.Trial registration numberNCT04142021.

2019 ◽  
Vol 34 (1) ◽  
pp. 37-43
Author(s):  
AHM Waliul Islam ◽  
Shams Munwar ◽  
Azfar Hossain ◽  
AQM Reza ◽  
Sahabuddin Talukder ◽  
...  

Background: Importance of Physiological study by Fractional Flow Reserve (FFR) in the management of patient with coronary artery disease (CAD is well established. Objective: Angiographic-guided percutaneous coronary intervention (PCI) is a common practice in Bangladeshi interventional era. Data on Pre-PCI physiological study by Fractional Flow Reserve (FFR) in our patient is not available. Therefore, our primary aim was to perform pre-PCI FFR to assess the angiographically significant coronary stenosis and thus to avoid inappropriate stenting. Methods: Total 22 patients (Male 20, Female 2) were enrolled in this observational non-randomized prospective cohort. Patient who had angiographically significant lesion, planned for physiological study by pre-PCI FFR. Cut off value for FFR were clinically significant only if Pd/Pa ratio <0.75 and differed stenting if > 0.76-0.80 or above. Results: In the studied patient population, FFR done in total 27 vessels of 22 patients. Among the vessel wise FFR distribution were in LAD 67%(18), LCX 14.8%(4), RCA 14.8%(4) and Ramus Intermedius 3.7% (1). FFR was nonsignificant (<0.75) in 59% (13) patients and significant (>0.75) were in 41%(9) patients. Conclusion: In this single center, very preliminary observational prospective cohort of non-randomized study, we found, that FFR is an important aid to perform PCI in patient with angiographically significant coronary lesion, and to avoid inappropriate stenting of insignificant stenosis by physiological study. Thus, to reduce cost and untoward effects of inappropriate stenting. Bangladesh Heart Journal 2019; 34(1) : 37-43


2016 ◽  
Vol 39 (1) ◽  
pp. 25 ◽  
Author(s):  
Jiancheng Xiu ◽  
Gangbin Chen ◽  
Hua Zheng ◽  
Yuegang Wang ◽  
Haibin Chen ◽  
...  

Purpose: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is used to assess the need for angioplasty in vessels with intermediate blockages. The treatment outcomes of FFR-guided vs. conventional angiography-guided PCI were evaluated in patients with multi-vessel coronary artery disease (CAD). Methods: Prospective and retrospective studies comparing FFR-guided vs. angiography-guided PCI in patients with multi-vessel CAD were identified from medical databases by two independent reviewers using the terms “percutaneous coronary intervention, fractional flow reserve, angiography, coronary heart disease, major adverse cardiac events (MACE) and myocardial infarction”. The primary outcome was the number of stents placed, and the secondary outcomes were procedure time, mortality, myocardial infarction (MI) and MACE rates. Results: Seven studies (three retrospective and four prospective), which included 49,517 patients, were included in this review. A total of 4,755 patients underwent FFR, while 44,697 received angiography-guided PCI. The mean patient age ranged from 58 to 71.7 years. The average number of stents used in FFR patients ranged from 0.3-1.9, and in angiography-guided PCI patients ranged from 0.7-2.7. Analysis indicated there was a greater number of stents placed in the angiography-guided group compared with the FFR group (pooled difference in means: -0.64, 95% confidence interval [CI]: -0.81 to -0.47, P < 0.001). There were no differences in the secondary outcomes between the two groups. Conclusions: Both procedures produce similar clinical outcomes, but the fewer number of stents used with FFR may have clinical as was as cost implications.


Author(s):  
Christopher A. Rajkumar ◽  
Matthew Shun-Shin ◽  
Henry Seligman ◽  
Yousif Ahmad ◽  
Takayuki Warisawa ◽  
...  

Background: Physiological assessment with pressure wire pullback can characterize coronary artery disease (CAD) with a focal or diffuse pattern. However, the clinical relevance of this distinction is unknown. We use data from the ORBITA trial (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina) to test if the pattern of CAD predicts the placebo-controlled efficacy of percutaneous coronary intervention (PCI) on stress echocardiography ischemia and symptom end points. Methods: One hundred sixty-four patients in ORBITA underwent blinded instantaneous wave-free ratio (iFR) pullback assessment before randomization. Focal disease was defined as a ≥0.03 iFR unit drop within 15 mm, rather than over a longer distance. Analyses were performed using regression modeling. Results: In the PCI arm (n=85), 48 were focal and 37 were diffuse. In the placebo arm (n=79), 35 were focal and 44 were diffuse. Focal stenoses were associated with significantly lower fractional flow reserve (FFR) and iFR values than diffusely diseased vessels (mean FFR and iFR, focal 0.60±0.15 and 0.65±0.24, diffuse 0.78±0.10 and 0.88±0.08, respectively, P <0.0001). With adjustment for this difference, PCI for focal stenoses resulted in significantly greater reduction in stress echo ischemia than PCI for diffuse disease ( P <0.05). The effect of PCI on between-arm pre-randomization adjusted exercise time was 9.32 seconds (95% CI, −17.1 to 35.7 seconds; P =0.487). When stratified for pattern of disease, there was no detectable difference between focal and diffuse CAD ( P interaction=0.700). PCI improved Seattle Angina Questionnaire angina frequency score and freedom from angina more than placebo ( P =0.034; P =0.0035). However, there was no evidence of interaction between the physiological pattern of CAD and these effects ( P interaction=0.436; P interaction=0.908). Conclusions: PCI achieved significantly greater reduction of stress echocardiography ischemia in focal compared with diffuse CAD. However, for symptom end points, no such difference was observed. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT02062593.


2014 ◽  
Vol 155 (49) ◽  
pp. 1952-1959
Author(s):  
Zsolt Piróth

Percutaneous coronary intervention is a well-established symptomatic therapy of stable coronary artery disease. Using a literature search with special emphasis on the newly-published FAME 2 trial data, the author wanted to explore why percutaneous coronary intervention fails to reduce mortality and myocardial infarction in stable coronary artery disease, as opposed to surgical revascularisation. In the FAME 2 trial, fractional flow reserve-guided percutaneous coronary intervention with second generation drug eluting stents showed a significant reduction in the primary composite endpoint of 2-year mortality, myocardial infarction and unplanned hospitalization with urgent revascularisation as compared to medical therapy alone. In addition, landmark analysis showed that after 8 days, mortality and myocardial infarction were significantly reduced. The author concludes that percutaneous coronary intervention involving fractional flow reserve guidance and modern stents offers symptomatic, as well as prognostic benefit. Orv. Hetil., 2014, 155(49), 1952–1959.


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