Imperial College London

Dr Ricardo Petraco

Faculty of MedicineNational Heart & Lung Institute

Senior Clinical Research Fellow
 
 
 
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Contact

 

+44 (0)20 7594 3386r.petraco

 
 
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Location

 

Block B Hammersmith HospitalHammersmith Campus

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Summary

 

Publications

Publication Type
Year
to

173 results found

Cook CM, Howard JP, Ahmad Y, Shun-Shin MJ, Sethi A, Clesham GJ, Tang KH, Nijjer SS, Kelly PA, Davies JR, Malik IS, Kaprielian R, Mikhail G, Petraco R, Warisawa T, Al-Janabi F, Karamasis GV, Mohdnazri S, Gamma R, de Waard GA, Al-Lamee R, Keeble TR, Mayet J, Sen S, Francis DP, Davies JEet al., 2020, How Do Fractional Flow Reserve, Whole-Cycle PdPa, and Instantaneous Wave-Free Ratio Correlate With Exercise Coronary Flow Velocity During Exercise-Induced Angina?, CIRCULATION-CARDIOVASCULAR INTERVENTIONS, Vol: 13, ISSN: 1941-7640

Journal article

Wijntjens GWM, van Uffelen EL, Echavarria-Pinto M, Casadonte L, Stegehuis VE, Murai T, Marques KMJ, Yoon M-H, Tahk S-J, Casella G, Leone AM, Lopez Palop R, Schlundt C, Rivero F, Petraco R, Fearon WF, Johnson NP, Jeremias A, Koo B-K, Piek JJ, van de Hoef TPet al., 2020, Individual Lesion-Level Meta-Analysis Comparing Various Doses of Intracoronary Bolus Injection of Adenosine With Intravenous Administration of Adenosine for Fractional Flow Reserve Assessment, CIRCULATION-CARDIOVASCULAR INTERVENTIONS, Vol: 13, ISSN: 1941-7640

Journal article

Ahmad Y, Vendrik J, Eftekhari A, Howard J, Cook C, Rajkumar C, Malik I, Mikhail G, Ruparelia N, Hadjiloizou N, Nijjer S, Al-Lamee R, Petraco R, Warisawa T, Wijntjens GWM, Koch KT, van de Hoef T, de Waard G, Echavarria-Pinto M, Frame A, Sutaria N, Kanaganayagam G, Ariff B, Anderson J, Chukwuemeka A, Fertleman M, Koul S, Iglesias JF, Francis D, Mayet J, Serruys P, Davies J, Escaned J, van Royen N, Götberg M, Terkelsen CJ, Christiansen CH, Piek JJ, Baan Jr J, Sen Set al., 2019, Determining the Predominant Lesion in Patients With Severe Aortic Stenosis and Coronary Stenoses: A Multicenter Study Using Intracoronary Pressure and Flow, Circulation: Cardiovascular Interventions, Vol: 12, ISSN: 1941-7640

Background:Patients with severe aortic stenosis (AS) often have coronary artery disease. Both the aortic valve and the coronary disease influence the blood flow to the myocardium and its ability to respond to stress; leading to exertional symptoms. In this study, we aim to quantify the effect of severe AS on the coronary microcirculation and determine if this is influenced by any concomitant coronary disease. We then compare this to the effect of coronary stenoses on the coronary microcirculation.Methods:Group 1: 55 patients with severe AS and intermediate coronary stenoses treated with transcatheter aortic valve implantation (TAVI) were included. Group 2: 85 patients with intermediate coronary stenoses and no AS treated with percutaneous coronary intervention were included. Coronary pressure and flow were measured at rest and during hyperemia in both groups, before and after TAVI (group 1) and before and after percutaneous coronary intervention (group 2).Results:Microvascular resistance over the wave-free period of diastole increased significantly post-TAVI (pre-TAVI, 2.71±1.4 mm Hg·cm·s−1 versus post-TAVI 3.04±1.6 mm Hg·cm·s−1 [P=0.03]). Microvascular reserve over the wave-free period of diastole significantly improved post-TAVI (pre-TAVI 1.88±1.0 versus post-TAVI 2.09±0.8 [P=0.003]); this was independent of the severity of the underlying coronary stenosis. The change in microvascular resistance post-TAVI was equivalent to that produced by stenting a coronary lesion with an instantaneous wave-free ratio of ≤0.74.Conclusions:TAVI improves microcirculatory function regardless of the severity of underlying coronary disease. TAVI for severe AS produces a coronary hemodynamic improvement equivalent to the hemodynamic benefit of stenting coronary stenoses with instantaneous wave-free ratio values <0.74. Future trials of physiology-guided revascularization in severe AS may consider us

Journal article

Al-Lamee R, Shun-Shin M, Howard J, Nowbar A, Rajkumar C, Thompson D, Sen S, Nijjer S, Petraco R, Davies J, Keeble T, Tang K, Malik I, Bual N, Cook C, Ahmad Y, Seligman H, Sharp A, Gerber R, Talwar S, Assomull R, Cole G, Keenan N, Kanaganayagam G, Sehmi J, Wensel R, Harrell Jr F, Mayet J, Thom S, Davies J, Francis Det al., 2019, Dobutamine stress echocardiography ischemia as a predictor of the placebo-controlled efficacy of percutaneous coronary intervention in stable coronary artery disease: the stress echo-stratified analysis of ORBITA, Circulation, Vol: 140, Pages: 1971-1980, ISSN: 0009-7322

BackgroundDobutamine stress echocardiography (DSE) is widely used to test for ischemia in patients with stable coronary artery disease (CAD). In this analysis we studied the ability of pre-randomization stress echo score to predict the placebo-controlled efficacy of percutaneous coronary intervention (PCI) within the ORBITA trial. MethodsOne hundred and eighty-three patients underwent DSE before randomization. The stress echo score is broadly the number of segments abnormal at peak stress, with akinetic segments counting double and dyskinetic segments counting triple. The ability of pre-randomization stress echo to predict the placebo-controlled effect of PCI on response variables was tested using regression modelling.ResultsAt pre-randomization, the stress echo score was 1.561.77 in the PCI arm (n=98) and 1.611.73 in the placebo arm (n=85). There was a detectable interaction between pre-randomization stress echo score and the effect of PCI on angina frequency score with a larger placebo-controlled effect in patients with the highest stress echo score (pinteraction=0.031). With our sample size we were unable to detect an interaction between stress echo score and any other patient-reported response variables: freedom from angina (pinteraction=0.116), physical limitation (pinteraction=0.461), quality of life (pinteraction=0.689), EQ-5D-5L quality of life score (pinteraction=0.789) or between stress echo score and physician-assessed Canadian Cardiovascular Society angina class (pinteraction=0.693), and treadmill exercise time (pinteraction=0.426). ConclusionsThe degree of ischemia assessed by DSE predicts the placebo-controlled efficacy of PCI on patient-reported angina frequency. The greater the downstream stress echo abnormality caused by a stenosis, the greater the reduction in symptoms from PCI.

Journal article

Howard JP, Cook CM, van de Hoef TP, Meuwissen M, de Waard GA, van Lavieren MA, Echavarria-Pinto M, Danad I, Piek JJ, Gotberg M, Al-Lamee RK, Sen S, Nijjer SS, Seligman H, van Royen N, Knaapen P, Escaned J, Francis DP, Petraco R, Davies JEet al., 2019, Artificial Intelligence for Aortic Pressure Waveform Analysis During Coronary Angiography Machine Learning for Patient Safety, JACC-CARDIOVASCULAR INTERVENTIONS, Vol: 12, Pages: 2093-2101, ISSN: 1936-8798

Journal article

Kim CH, Koo B-K, Dehbi H-M, Lee JM, Doh J-H, Nam C-W, Shin E-S, Cook CM, Al-Lamee R, Petraco R, Sen S, Malik IS, Nijjer SS, Mejia-Renteria H, Alegria-Barrero E, Alghamdi A, Altman J, Baptista SB, Bhindi R, Bojara W, Brugaletta S, Silva PC, Di Mario C, Erglis A, Gerber RT, Going O, Haerle T, Hellig F, Indolfi C, Janssens L, Jeremias A, Kharbanda RK, Khashaba A, Kikuta Y, Krackhardt F, Laine M, Lehman SJ, Matsuo H, Meuwissen M, Niccoli G, Piek JJ, Ribichini F, Samady H, Sapontis J, Seto AH, Sezer M, Sharp ASP, Singh J, Takashima H, Talwar S, Tanaka N, Tang K, Van Belle E, van Royen N, Vinhas H, Vrints CJ, Walters D, Yokoi H, Samuels B, Buller C, Patel MR, Serruys PW, Escaned J, Davies JEet al., 2019, Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve-Guided Revascularization Strategy, JACC-CARDIOVASCULAR INTERVENTIONS, Vol: 12, Pages: 2035-2046, ISSN: 1936-8798

Journal article

Lee JM, Choi KH, Koo B-K, Dehbi H-M, Doh J-H, Nam C-W, Shin E-S, Cook CM, Al-Lamee R, Petraco R, Sen S, Malik IS, Nijjer SS, Mejia-Renteria H, Alegria-Barrero E, Alghamdi A, Altman J, Baptista SB, Bhindi R, Bojara W, Brugaletta S, Silva PC, Di Mario C, Erglis A, Gerber RT, Going O, Haerle T, Hellig F, Indolfi C, Janssens L, Jeremias A, Kharbanda RK, Khashaba A, Kikuta Y, Krackhardt F, Laine M, Lehman SJ, Matsuo H, Meuwissen M, Niccoli G, Piek JJ, Ribichini F, Samady H, Sapontis J, Seto AH, Sezer M, Sharp ASP, Singh J, Takashima H, Talwar S, Tanaka N, Tang K, Van Belle E, van Royen N, Vinhas H, Vrints CJ, Walters D, Yokoi H, Samuels B, Buller C, Patel MR, Serruys P, Escaned J, Davies JEet al., 2019, Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial, JAMA CARDIOLOGY, Vol: 4, Pages: 857-864, ISSN: 2380-6583

Journal article

van der Hoeven NW, Janssens GN, de Waard GA, Everaars H, Broyd CJ, Beijnink CWH, van de Ven PM, Nijveldt R, Cook CM, Petraco R, Ten Cate T, von Birgelen C, Escaned J, Davies JE, van Leeuwen MAH, van Royen Net al., Temporal Changes in Coronary Hyperemic and Resting Hemodynamic Indices in Nonculprit Vessels of Patients With ST-Segment Elevation Myocardial Infarction., JAMA Cardiol

Importance: Percutaneous coronary intervention (PCI) of nonculprit vessels among patients with ST-segment elevation myocardial infarction (STEMI) is associated with improved clinical outcome compared with culprit vessel-only PCI. Fractional flow reserve (FFR) and coronary flow reserve are hyperemic indices used to guide revascularization. Recently, instantaneous wave-free ratio was introduced as a nonhyperemic alternative to FFR. Whether these indices can be used in the acute setting of STEMI continues to be investigated. Objective: To assess the value of hemodynamic indices in nonculprit vessels of patients with STEMI from the index event to 1-month follow-up. Design, Setting, and Participants: This substudy of the Reducing Micro Vascular Dysfunction in Revascularized STEMI Patients by Off-target Properties of Ticagrelor (REDUCE-MVI) randomized clinical trial enrolled 98 patients with STEMI who had an angiographic intermediate stenosis in at least 1 nonculprit vessel. Patient enrollment was between May 1, 2015, and September 19, 2017. After successful primary PCI, nonculprit intracoronary hemodynamic measurements were performed and repeated at 1-month follow-up. Cardiac magnetic resonance imaging was performed from 2 to 7 days and 1 month after primary PCI. Main Outcomes and Measures: The value of nonculprit instantaneous wave-free ratio, FFR, coronary flow reserve, hyperemic index of microcirculatory resistance, and resting microcirculatory resistance from the index event to 1-month follow-up. Results: Of 73 patients with STEMI included in the final analysis, 59 (80.8%) were male, with a mean (SD) age of 60.8 (9.9) years. Instantaneous wave-free ratio (SD) did not change significantly (0.93 [0.07] vs 0.94 [0.06]; P = .12) and there was no change in resting distal pressure/aortic pressure (mean [SD], 0.94 [0.06] vs 0.95 [0.06]; P = .25) from the acute moment to 1-month follow-up. The FFR decreased (mean [SD], 0.88 [0.07] vs 0.86 [0.09];

Journal article

Cook CM, Ahmad Y, Howard JP, Shun-Shin MJ, Sethi A, Clesham GJ, Tang KH, Nijjer SS, Kelly PA, Davies JR, Malik IS, Kaprielian R, Mikhail G, Petraco R, Warisawa T, Al-Janabi F, Karamasis GV, Mohdnazri S, Gamma R, deWaard GA, Al-Lamee R, Keeble TR, Mayet J, Sen S, Francis DP, Davies JEet al., 2019, Association Between Physiological Stenosis Severity and Angina-Limited Exercise Time in Patients With Stable Coronary Artery Disease, JAMA CARDIOLOGY, Vol: 4, Pages: 569-574, ISSN: 2380-6583

Journal article

Warisawa T, Cook CM, Howard JP, Ahmad Y, Doi S, Nakayama M, Goto S, Yakuta Y, Karube K, Shun-Shin MJ, Petraco R, Sen S, Nijjer S, Al Lamee R, Ishibashi Y, Matsuda H, Escaned J, di Mario C, Francis DP, Akashi YJ, Davies JEet al., 2019, Physiological pattern of disease assessed by pressure-wire pullback has an influence on fractional flow reserve/instantaneous wave-free ratio discordance, Circulation: Cardiovascular Interventions, Vol: 12, ISSN: 1941-7640

BACKGROUND: Fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) disagree on the hemodynamic significance of a coronary lesion in ≈20% of cases. It is unknown whether the physiological pattern of disease is an influencing factor for this. This study assessed whether the physiological pattern of coronary artery disease influences discordance between FFR and iFR measurement. METHODS AND RESULTS: Three-hundred and sixty intermediate coronary lesions (345 patients; mean age, 64.4±10.3 years; 76% men) with combined FFR, iFR, and iFR pressure-wire pullback were included for analysis from an international multicenter registry. Cut points for hemodynamic significance were FFR ≤0.80 and iFR ≤0.89, respectively. Lesions were classified into FFR+/iFR+ (n=154; 42.7%), FFR-/iFR+ (n=38; 10.6%), FFR+/iFR- (n=41; 11.4%), and FFR-/iFR- (n=127; 35.3%) groups. The physiological pattern of disease was classified according to the iFR pullback recordings as predominantly physiologically focal (n=171; 47.5%) or predominantly physiologically diffuse (n=189; 52.5%). Median FFR and iFR were 0.80 (interquartile range, 0.75-0.85) and 0.89 (interquartile range, 0.86-0.92), respectively. FFR disagreed with iFR in 22% (79 of 360). The physiological pattern of disease was the only influencing factor relating to FFR/iFR discordance: predominantly physiologically focal was significantly associated with FFR+/iFR- (58.5% [24 of 41]), and predominantly physiologically diffuse was significantly associated with FFR-/iFR+ (81.6% [31 of 38]; P<0.001 for pattern of disease between FFR+/iFR- and FFR-/iFR+ groups). CONCLUSIONS: The physiological pattern of coronary artery disease was an important influencing factor for FFR/iFR discordance.

Journal article

Seligman H, Shun-Shin M, Vasireddy A, Cook C, Ahmad Y, Howard J, Sen S, Al-Lamee R, Nijjer S, Chamie D, Davies J, Mayet J, Francis D, Petraco Ret al., 2019, Fractional flow reserve derived from microcatheters versus standard pressure wires: a stenosis-level meta-analysis, Open Heart, Vol: 6, ISSN: 2053-3624

Aims: To determine the agreement between sensor-tipped microcatheter (MC) and pressure wire (PW) derived Fractional Flow Reserve (FFR). Methods and results: Studies comparing FFR obtained from MC (FFRMC, Navvus Microcatheter System, ACIST Medical Systems, Minnesota, USA) versus standard PW (FFRPW) were identified and a meta-analysis of numerical and categorical agreement was performed. The relative levels of drift and device failure of MC and PW systems from each study were assessed. Six studies with 440 lesions (413 patients) were included. The mean overall bias between FFRMC and FFRPW was -0.029 (FFRMC lower). Bias and variance were greater for lesions with lower FFRPW (p <0.001). Using a cut-off of 0.80, 18% of lesions were re-classified by FFRMC versus FFRPW (with 15% being false-positives). The difference in reported drift between FFRPW and FFRMC was small. Device failure was more common with MC than PW (7.1% versus 2%). Conclusion: FFRMC systematically overestimates lesion severity, with increased bias in more severe lesions. Using FFRMC changes revascularisation guidance in approximately 1 out of every 5 cases. Pressure wire drift was similar between systems. Device failure was higher with MC.

Journal article

Sen S, Ahmad Y, Dehbi H-M, Howard JP, Iglesias JF, Al-Lamee R, Petraco R, Nijjer S, Bhindi R, Lehman S, Walters D, Sapontis J, Janssens L, Vrints CJ, Khashaba A, Laine M, Van Belle E, Krackhardt F, Bojara W, Going O, Härle T, Indolfi C, Niccoli G, Ribichini F, Tanaka N, Yokoi H, Takashima H, Kikuta Y, Erglis A, Vinhas H, Silva PC, Baptista SB, Alghamdi A, Hellig F, Koo B-K, Nam C-W, Shin E-S, Doh J-H, Brugaletta S, Alegria-Barrero E, Meuwissen M, Piek JJ, van Royen N, Sezer M, Di Mario C, Gerber RT, Malik IS, Sharp ASP, Talwar S, Tang K, Samady H, Altman J, Seto AH, Singh J, Jeremias A, Matsuo H, Kharbanda RK, Patel MR, Serruys P, Escaned J, Davies JEet al., 2019, Clinical events after deferral of LAD revascularization following physiological coronary assessment, Journal of the American College of Cardiology, Vol: 73, Pages: 444-453, ISSN: 0735-1097

BACKGROUND: Physicians are not always comfortable deferring treatment of a stenosis in the left anterior descending (LAD) artery because of the perception that there is a high risk of major adverse cardiac events (MACE). The authors describe, using the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) trial, MACE rates when LAD lesions are deferred, guided by physiological assessment using fractional flow reserve (FFR) or the instantaneous wave-free ratio (iFR). OBJECTIVES: The purpose of this study was to establish the safety of deferring treatment in the LAD using FFR or iFR within the DEFINE-FLAIR trial. METHODS: MACE rates at 1 year were compared between groups (iFR and FFR) in patients whose physiological assessment led to LAD lesions being deferred. MACE was defined as a composite of cardiovascular death, myocardial infarction (MI), and unplanned revascularization at 1 year. Patients, and staff performing follow-up, were blinded to whether the decision was made with FFR or iFR. Outcomes were adjusted for age and sex. RESULTS: A total of 872 patients had lesions deferred in the LAD (421 guided by FFR, 451 guided by iFR). The event rate with iFR was significantly lower than with FFR (2.44% vs. 5.26%; adjusted HR: 0.46; 95% confidence interval [CI]: 0.22 to 0.95; p = 0.04). This was driven by significantly lower unplanned revascularization with iFR and numerically lower MI (unplanned revascularization: 2.22% iFR vs. 4.99% FFR; adjusted HR: 0.44; 95% CI: 0.21 to 0.93; p = 0.03; MI: 0.44% iFR vs. 2.14% FFR; adjusted HR: 0.23; 95% CI: 0.05 to 1.07; p = 0.06). CONCLUSIONS: iFR-guided deferral appears to be safe for patients with LAD lesions. Patients in whom iFR-guided deferral was performed had statistically significantly lower event rates than those with FFR-guided deferral.

Journal article

van der Hoeven NW, de Waard GA, Quiros A, De Hoyos A, Broyd CJ, Nijjer SS, van de Hoef TP, Petraco R, Driessen RS, Mejia-Renteria H, Kikuta Y, Pinto ME, van de Ven PM, Meuwissen M, Knaapen P, Piek JJ, Davies JE, van Royen N, Escaned Jet al., 2019, Comprehensive physiological evaluation of epicardial and microvascular coronary domains using vascular conductance and zero flow pressure, EUROINTERVENTION, Vol: 14, Pages: E1593-E1600, ISSN: 1774-024X

Journal article

De Waard GA, Broyd CJ, Cook CM, Van Der Hoeven NW, Petraco R, Nijjer SS, Van De Hoef TP, Echavarria-Pinto M, Meuwissen M, Sen S, Knaapen P, Escaned J, Piek JJ, Van Royen N, Davies JEet al., 2019, Diastolic-systolic velocity ratio to detect coronary stenoses under physiological resting conditions: A mechanistic study, Open Heart, Vol: 6

© © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Objective Diastolic-systolic velocity ratio (DSVR) is a resting index to assess stenoses in the left anterior descending artery (LAD). DSVR can be measured by echocardiographic or intracoronary Doppler flow velocity. The objective of this cohort study was to elucidate the fundamental rationale underlying the decreased DSVR in coronary stenoses. Methods In cohort 1, simultaneous measurements of intracoronary Doppler flow velocity and pressure were acquired in the LAD of 228 stable patients. Phasic stenosis resistance, microvascular resistance and total vascular resistance (defined as stenosis and microvascular resistance combined) were studied during physiological resting conditions. Stenoses were classified according to severity by strata of 0.10 fractional flow reserve (FFR) units. Results DSVR was decreased in stenoses with lower FFR. Stenosis resistance was equal in systole and diastole for every FFR stratum. Microvascular resistance was consistently higher during systole than diastole. In lower FFR strata, stenosis resistance as a percentage of the total vascular resistance increases both during systole and diastole. The difference between the stenosis resistance as a percentage of total vascular resistance during systole and diastole increases for lower FFR strata, with an accompanying rise in diastolic-systolic resistance ratio. A significant inverse correlation was observed between DSVR and the diastolic-systolic resistance ratio (r=0.91, p<0.001). In cohort 2 (n=23), DSVR was measured both invasively and non-invasively by transthoracic echocardiography, yielding a good correlation (r=0.82, p<0.001). Conclusions The rationale by which DSVR is decreased distal to coronary stenoses is dependent on a comparatively higher influence of the increased stenosis resistance on total vascular resistance during di

Journal article

de Waard GA, Danad I, Petraco R, Driessen RS, Raijmakers PG, Teunissen PF, van de Ven PM, van Leeuwen MAH, Nap A, Harms HJ, Lammertsma AA, Davies JE, Knaapen P, van Royen Net al., 2018, Fractional flow reserve, instantaneous wave-free ratio, and resting P-d/P-a compared with [O-15]H2O positron emission tomography myocardial perfusion imaging: a PACIFIC trial sub-study, EUROPEAN HEART JOURNAL, Vol: 39, Pages: 4072-+, ISSN: 0195-668X

Journal article

Ahmad Y, Götberg M, Cook C, Howard J, Malik I, Mikhail G, Frame A, Petraco R, Rajkumar C, Demir O, Iglesias JF, Bhindi R, Koul S, Hadjiloizou N, Gerber R, Ramrakha P, Ruparelia N, Sutaria N, Kanaganayagam G, Ariff B, Fertleman M, Anderson J, Chukwuemeka A, Francis D, Mayet J, Serruys P, Davies J, Sen Set al., 2018, Coronary hemodynamics in patients with severe aortic stenosis and coronary Artery disease undergoing transcatheter aortic valve replacement: implications for clinical indices of coronary stenosis severity, JACC: Cardiovascular Interventions, Vol: 11, Pages: 2019-2031, ISSN: 1936-8798

OBJECTIVES: In this study, a systematic analysis was conducted of phasic intracoronary pressure and flow velocity in patients with severe aortic stenosis (AS) and coronary artery disease, undergoing transcatheter aortic valve replacement (TAVR), to determine how AS affects 1) phasic coronary flow; 2) hyperemic coronary flow; and 3) the most common clinically used indices of coronary stenosis severity, instantaneous wave-free ratio and fractional flow reserve. BACKGROUND: A significant proportion of patients with severe aortic stenosis (AS) have concomitant coronary artery disease. The effect of the valve on coronary pressure, flow, and the established invasive clinical indices of stenosis severity have not been studied. METHODS: Twenty-eight patients (30 lesions, 50.0% men, mean age 82.1 ± 6.5 years) with severe AS and coronary artery disease were included. Intracoronary pressure and flow assessments were performed at rest and during hyperemia immediately before and after TAVR. RESULTS: Flow during the wave-free period of diastole did not change post-TAVR (29.78 ± 14.9 cm/s vs. 30.81 ± 19.6 cm/s, p = 0.64). Whole-cycle hyperemic flow increased significantly post-TAVR (33.44 ± 13.4 cm/s pre-TAVR vs. 40.33 ± 17.4 cm/s post-TAVR, p = 0.006); this was secondary to significant increases in systolic hyperemic flow post-TAVR (27.67 ± 12.1 cm/s pre-TAVR vs. 34.15 ± 17.5 cm/s post-TAVR, p = 0.02). Instantaneous wave-free ratio values did not change post-TAVR (0.88 ± 0.09 pre-TAVR vs. 0.88 ± 0.09 post-TAVR, p = 0.73), whereas fractional flow reserve decreased significantly post-TAVR (0.87 ± 0.08 pre-TAVR vs. 0.85 ± 0.09 post-TAVR, p = 0.001). CONCLUSIONS: Systolic and hyperemic coronary flow increased significantly post-TAVR; consequently, hyperemic indices that include systole underestimated coronary stenosis severity in patients with severe AS. Flow during the wave-free per

Journal article

Ahmad Y, Gotberg M, Cook C, Howard J, Malik I, Mikhail G, Frame A, Petraco R, Rajkumar C, Demir O, Iglesias JF, Bhindi R, Koul S, Hadjiloizou N, Gerber R, Ramrakha P, Ruparelia N, Sutaria N, Kanaganayagam G, Ariff B, Fertleman M, Anderson J, Chukwuemeka A, Francis D, Mayet J, Serruys P, Davies J, Sen Set al., 2018, Coronary haemodynamics in patients with severe aortic stenosis and coronary artery disease undergoing Transcatheter Aortic Valve Replacement: implications for clinical indices of coronary stenosis severity, JACC: Cardiovascular Interventions, Vol: 11, Pages: 2019-2031, ISSN: 1936-8798

Objectives In this study, a systematic analysis was conducted of phasic intracoronary pressure and flow velocity in patients with severe aortic stenosis (AS) and coronary artery disease, undergoing transcatheter aortic valve replacement (TAVR), to determine how AS affects 1) phasic coronary flow; 2) hyperemic coronary flow; and 3) the most common clinically used indices of coronary stenosis severity, instantaneous wave-free ratio and fractional flow reserve.Background A significant proportion of patients with severe aortic stenosis (AS) have concomitant coronary artery disease. The effect of the valve on coronary pressure, flow, and the established invasive clinical indices of stenosis severity have not been studied.Methods Twenty-eight patients (30 lesions, 50.0% men, mean age 82.1 ± 6.5 years) with severe AS and coronary artery disease were included. Intracoronary pressure and flow assessments were performed at rest and during hyperemia immediately before and after TAVR.Results Flow during the wave-free period of diastole did not change post-TAVR (29.78 ± 14.9 cm/s vs. 30.81 ± 19.6 cm/s, p = 0.64). Whole-cycle hyperemic flow increased significantly post-TAVR (33.44 ± 13.4 cm/s pre-TAVR vs. 40.33 ± 17.4 cm/s post-TAVR, p = 0.006); this was secondary to significant increases in systolic hyperemic flow post-TAVR (27.67 ± 12.1 cm/s pre-TAVR vs. 34.15 ± 17.5 cm/s post-TAVR, p = 0.02). Instantaneous wave-free ratio values did not change post-TAVR (0.88 ± 0.09 pre-TAVR vs. 0.88 ± 0.09 post-TAVR, p = 0.73), whereas fractional flow reserve decreased significantly post-TAVR (0.87 ± 0.08 pre-TAVR vs. 0.85 ± 0.09 post-TAVR, p = 0.001).Conclusions Systolic and hyperemic coronary flow increased significantly post-TAVR; consequently, hyperemic indices that include systole underestimated coronary stenosis severity in patients with severe AS. Flow during the wave-free period of diastole did not change pos

Journal article

Cook CM, Ahmad Y, Howard JP, Shun-Shin MJ, Sethi A, Clesham GJ, Tang KH, Nijjer SS, Kelly PA, Davies JR, Malik IS, Kaprielian R, Mikhail G, Petraco R, Al-Janabi F, Karamasis GV, Mohdnazri S, Gamma R, Al-Lamee R, Keeble TR, Mayet J, Sen S, Francis DP, Davies JEet al., 2018, Impact of percutaneous revascularization on exercise hemodynamics in patients with stable coronary disease, Journal of the American College of Cardiology, Vol: 72, Pages: 970-983, ISSN: 0735-1097

BACKGROUND: Recently, the therapeutic benefits of percutaneous coronary intervention (PCI) have been challenged in patients with stable coronary artery disease (SCD). OBJECTIVES: The authors examined the impact of PCI on exercise responses in the coronary circulation, the microcirculation, and systemic hemodynamics in patients with SCD. METHODS: A total of 21 patients (mean age 60.3 ± 8.4 years) with SCD and single-vessel coronary stenosis underwent cardiac catheterization. Pre-PCI, patients exercised on a supine ergometer until rate-limiting angina or exhaustion. Simultaneous trans-stenotic coronary pressure-flow measurements were made throughout exercise. Post-PCI, this process was repeated. Physiological parameters, rate-limiting symptoms, and exercise performance were compared between pre-PCI and post-PCI exercise cycles. RESULTS: PCI reduced ischemia as documented by fractional flow reserve value (pre-PCI 0.59 ± 0.18 to post-PCI 0.91 ± 0.07), instantaneous wave-free ratio value (pre-PCI 0.61 ± 0.27 to post-PCI 0.96 ± 0.05) and coronary flow reserve value (pre-PCI 1.7 ± 0.7 to post-PCI 3.1 ± 1.0; p < 0.001 for all). PCI increased peak-exercise average peak coronary flow velocity (p < 0.0001), coronary perfusion pressure (distal coronary pressure; p < 0.0001), systolic blood pressure (p = 0.01), accelerating wave energy (p < 0.001), and myocardial workload (rate-pressure product; p < 0.01). These changes observed immediately following PCI resulted from the abolition of stenosis resistance (p < 0.0001). PCI was also associated with an immediate improvement in exercise time (+67 s; 95% confidence interval: 31 to 102 s; p < 0.0001) and a reduction in rate-limiting angina symptoms (81% reduction in rate-limiting angina symptoms post-PCI; p < 0.001). CONCLUSIONS: In patients with SCD and severe single-vessel stenosis, objective physiological

Journal article

Escaned J, Ryan N, Mejia-Renteria H, Cook CM, Dehbi H-M, Alegria-Barrero E, Alghamdi A, Al-Lamee R, Altman J, Ambrosia A, Baptista SB, Bertilsson M, Bhindi R, Birgander M, Bojara W, Brugaletta S, Buller C, Calais F, Silva PC, Carlsson J, Christiansen EH, Danielewicz M, Di Mario C, Doh J-H, Erglis A, Erlinge D, Gerber RT, Going O, Gudmundsdottir I, Haerle T, Hauer D, Hellig F, Indolfi C, Jakobsen L, Janssens L, Jensen J, Jeremias A, Karegren A, Karlsson A-C, Kharbanda RK, Khashaba A, Kikuta Y, Krackhardt F, Koo B-K, Koul S, Laine M, Lehman SJ, Lindroos P, Malik IS, Maeng M, Matsuo H, Meuwissen M, Nam C-W, Niccoli G, Nijjer SS, Olsson H, Olsson S-E, Omerovic E, Panayi G, Petraco R, Piek JJ, Ribichini F, Samady H, Samuels B, Sandhall L, Sapontis J, Sen S, Seto AH, Sezer M, Sharp ASP, Shin E-S, Singh J, Takashima H, Talwar S, Tanaka N, Tang K, Van Belle E, van Royen N, Varenhorst C, Vinhas H, Vrints CJ, Walters D, Yokoi H, Frobert O, Patel MR, Serruys P, Davies JE, Gotberg Met al., 2018, Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes, JACC-CARDIOVASCULAR INTERVENTIONS, Vol: 11, Pages: 1437-1449, ISSN: 1936-8798

Journal article

Al-Lamee R, Howard JP, Shun-Shin MJ, Thompson D, Dehbi H-M, Sen S, Nijjer S, Petraco R, Davies J, Keeble T, Tang K, Malik IS, Cook C, Ahmad Y, Sharp ASP, Gerber R, Baker C, Kaprielian R, Talwar S, Assomull R, Cole G, Keenan NG, Kanaganayagam G, Sehmi J, Wensel R, Harrell FE, Mayet J, Thom SA, Davies JE, Francis DPet al., 2018, Fractional flow reserve and instantaneous wave-free ratio as predictors of the placebo-controlled response to percutaneous coronary intervention in stable single-vessel coronary artery disease: physiology-stratified analysis of ORBITA, Circulation, Vol: 138, ISSN: 0009-7322

BACKGROUND : There are no data on how fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are associated with the placebo-controlled efficacy of percutaneous coronary intervention (PCI) in stable single-vessel coronary artery disease. METHODS : We report the association between prerandomization invasive physiology within ORBITA (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina), a placebo-controlled trial of patients who have stable angina with angiographically severe single-vessel coronary disease clinically eligible for PCI. Patients underwent prerandomization research FFR and iFR assessment. The operator was blinded to these values. Assessment of response variables, treadmill exercise time, stress echocardiography score, symptom frequency, and angina severity were performed at prerandomization and blinded follow-up. Effects were calculated by analysis of covariance. The ability of FFR and iFR to predict placebo-controlled changes in response variables was tested by using regression modeling. RESULTS : Invasive physiology data were available in 196 patients (103 PCI and 93 placebo). At prerandomization, the majority had Canadian Cardiovascular Society class II or III symptoms (150/196, 76.5%). Mean FFR and iFR were 0.69±0.16 and 0.76±0.22, respectively; 97% had ≥1 positive ischemia tests. The estimated effect of PCI on between-arm prerandomization-adjusted total exercise time was 20.7 s (95% confidence interval [CI], -4.0 to 45.5; P=0.100) with no interaction of FFR (Pinteraction=0.318) or iFR (Pinteraction=0.523). PCI improved stress echocardiography score more than placebo (1.07 segment units; 95% CI, 0.70-1.44; P<0.00001). The placebo-controlled effect of PCI on stress echocardiography score increased progressively with decreasing FFR (Pinteraction<0.00001) and

Journal article

Broyd CJ, Rigo F, Nijjer S, Sen S, Petraco R, Al-Lamee R, Foin N, Chukwuemeka A, Anderson J, Parker J, Malik IS, Mikhail GW, Francis DP, Parker K, Hughes AD, Mayet J, Davies JEet al., 2018, Regression of left ventricular hypertrophy provides an additive physiological benefit following treatment of aortic stenosis: Insights from serial coronary wave intensity analysis., Acta Physiologica, Vol: 2018, Pages: e13109-e13109, ISSN: 1748-1708

AIM: Severe aortic stenosis frequently involves the development of left ventricular hypertrophy (LVH) creating a dichotomous haemodynamic state within the coronary circulation. Whilst the increased force of ventricular contraction enhances its resultant relaxation and thus increases the distal diastolic coronary "suction" force, the presence of LVH has a potentially opposing effect on ventricular-coronary interplay. The aim of this study was to use non-invasive coronary wave intensity analysis (WIA) to separate and measure the sequential effects of outflow tract obstruction relief and then LVH regression following intervention for aortic stenosis. METHODS: Fifteen patients with unobstructed coronary arteries undergoing aortic valve intervention (11 surgical aortic valve replacement [SAVR], 4 TAVI) were successfully assessed before and after intervention, and at 6 and 12 months post-procedure. Coronary WIA was constructed from simultaneously acquired coronary flow from transthoracic echo and pressure from an oscillometric brachial cuff system. RESULTS: Immediately following intervention, a decline in the backward decompression wave (BDW) was noted (9.7 ± 5.7 vs 5.1 ± 3.6 × 103  W/m2 /s, P < 0.01). Over 12 months, LV mass index fell from 114 ± 19 to 82 ± 17 kg/m2 . Accompanying this, the BDW fraction increased to 32.8 ± 7.2% at 6 months (P = 0.01 vs post-procedure) and 34.7 ± 6.7% at 12 months (P < 0.001 vs post-procedure). CONCLUSION: In aortic stenosis, both the outflow tract gradient and the presence of LVH impact significantly on coronary haemodynamics that cannot be appreciated by examining resting coronary flow rates alone. An immediate change in coronary wave intensity occurs following intervention with further effects appreciable with hypertrophy regression. The improvement

Journal article

Ahmad Y, Howard J, Arnold A, Shun-Shin M, Cook C, Malik I, Mayet J, Francis D, Sen Set al., 2018, PFO CLOSURE IS SUPERIOR TO MEDICAL THERAPY FOR CRYPTOGENIC STROKE: A META-ANALYSIS OF RANDOMISED CONTROLLED TRIALS, Annual Conference of the British-Cardiovascular-Society on High Performing Teams, Publisher: BMJ PUBLISHING GROUP, Pages: A2-A2, ISSN: 1355-6037

Conference paper

Ahmad Y, Howard J, Arnold A, Shun-Shin MJ, Cook C, Petraco R, Demir O, Williams L, Igelsias J, Sutaria N, Malik I, Davies J, Mayet J, Francis D, Sen Set al., 2018, Patent foramen ovale closure versus medical therapy for cryptogenic stroke: a meta-analysis of randomised controlled trials, European Heart Journal, Vol: 39, Pages: 1638-1649, ISSN: 1522-9645

BackgroundThe efficacy of patent foramen ovale (PFO) closure for cryptogenic stroke has been controversial. We undertook a meta-analysis of randomised controlled trials (RCTs) comparing device closure with medical therapy to prevent recurrent stroke for patients with PFO.Methods and ResultsWe systematically identified all RCTs comparing device closure to medical therapy for cryptogenic stroke in patients with PFO. The primary efficacy endpoint was recurrent stroke, analysed on an intention-to-treat basis. The primary safety endpoint was new onset atrial fibrillation (AF). 5 studies (3440 patients) were included. 1829 patients were randomised to device closure and 1611 to medical therapy. Across all patients, PFO closure was superior to medical therapy for prevention of stroke (HR 0.32, 95% CI 0.13 to 0.82, p=0.018, I2 = 73.4%). The risk of AF was significantly increased with device closure (RR 4.54, 95% CI 2.17 to 9.48, p<0.001, heterogeneity I2 = 22.9%). In patients with large shunts, PFO closure was associated with a significant reduction in stroke (HR 0.33, 95% CI 0.16 to 0.72, p=0.005), whilst there was no significant reduction in stroke in patients with a small shunt (HR 0.90, 95% CI 0.50 to 1.60, p=0.712). There was no effect from the presence or absence of an atrial septal aneurysm on outcomes (p=0.994).ConclusionIn selected patients with cryptogenic stroke, PFO closure is superior to medical therapy for the prevention of further stroke: this is particularly true for patients with moderate-to-large shunts. Guidelines should be updated to reflect this.

Journal article

Kikuta Y, Cook CM, Sharp ASP, Salinas P, Kawase Y, Shiono Y, Giavarini A, Nakayama M, De Rosa S, Sen S, Nijjer SS, Al-Lamee R, Petraco R, Malik IS, Mikhail GW, Kaprielian RR, Wijntjens GWM, Mori S, Hagikura A, Mates M, Mizuno A, Hellig F, Lee K, Janssens L, Horie K, Mohdnazri S, Herrera R, Krackhardt F, Yamawaki M, Davies J, Takebayashi H, Keeble T, Haruta S, Ribichini F, Indolfi C, Mayet J, Francis DP, Piek JJ, Di Mario C, Escaned J, Matsuo H, Davies JEet al., 2018, Pre-Angioplasty Instantaneous Wave-Free Ratio Pullback Predicts Hemodynamic Outcome In Humans With Coronary Artery Disease Primary Results of the International Multicenter iFR GRADIENT Registry, JACC-CARDIOVASCULAR INTERVENTIONS, Vol: 11, Pages: 757-767, ISSN: 1936-8798

ObjectivesThe authors sought to evaluate the accuracy of instantaneous wave-Free Ratio (iFR) pullback measurements to predict post-percutaneous coronary intervention (PCI) physiological outcomes, and to quantify how often iFR pullback alters PCI strategy in real-world clinical settings.BackgroundIn tandem and diffuse disease, offline analysis of continuous iFR pullback measurement has previously been demonstrated to accurately predict the physiological outcome of revascularization. However, the accuracy of the online analysis approach (iFR pullback) remains untested.MethodsAngiographically intermediate tandem and/or diffuse lesions were entered into the international, multicenter iFR GRADIENT (Single instantaneous wave-Free Ratio Pullback Pre-Angioplasty Predicts Hemodynamic Outcome Without Wedge Pressure in Human Coronary Artery Disease) registry. Operators were asked to submit their procedural strategy after angiography alone and then after iFR-pullback measurement incorporating virtual PCI and post-PCI iFR prediction. PCI was performed according to standard clinical practice. Following PCI, repeat iFR assessment was performed and the actual versus predicted post-PCI iFR values compared.ResultsMean age was 67 ± 12 years (81% male). Paired pre- and post-PCI iFR were measured in 128 patients (134 vessels). The predicted post-PCI iFR calculated online was 0.93 ± 0.05; observed actual iFR was 0.92 ± 0.06. iFR pullback predicted the post-PCI iFR outcome with 1.4 ± 0.5% error. In comparison to angiography-based decision making, after iFR pullback, decision making was changed in 52 (31%) of vessels; with a reduction in lesion number (−0.18 ± 0.05 lesion/vessel; p = 0.0001) and length (−4.4 ± 1.0 mm/vessel; p < 0.0001).ConclusionsIn tandem and diffuse coronary disease, iFR pullback predicted the physiological outcome of PCI with a high degree of accuracy. Compared with angiography alone, availability of iFR pullback

Journal article

Ahmad Y, Demir O, Rajkumar CA, Howard J, Shun-Shin M, Cook C, Petraco R, Jabbour R, Arnold A, Frame A, Sutaria N, Ariff B, Kanaganayagam G, Francis D, Mayet J, Mikhail G, Malik I, Sen Set al., 2018, Optimal antiplatelet strategy after transcatheter aortic valve implantation: a meta-analysis, Open Heart, Vol: 5, ISSN: 2053-3624

Objective International guidelines recommend the use of dual antiplatelet therapy (DAPT) after transcatheter aortic valve implantation (TAVI). The recommended duration of DAPT varies between guidelines. In this two-part study, we (1) performed a structured survey of 45 TAVI centres from around the world to determine if there is consensus among clinicians regarding antiplatelet therapy after TAVI; and then (2) performed a systematic review of all suitable studies (randomised controlled trials (RCTs) and registries) to determine if aspirin monotherapy can be used instead of DAPT.Methods A structured electronic survey regarding antiplatelet use after TAVI was completed by 45 TAVI centres across Europe, Australasia and the USA. A systematic review of TAVI RCTs and registries was then performed comparing DAPT duration and incidence of stroke, bleeding and death. A variance weighted least squared metaregression was then performed to determine the relationship of antiplatelet therapy and adverse events.Results 82.2% of centres routinely used DAPT after TAVI. Median duration was 3 months. 13.3% based their practice on guidelines. 11 781 patients (26 studies) were eligible for the metaregression. There was no benefit of DAPT over aspirin monotherapy for stroke (P=0.49), death (P=0.72) or bleeding (P=0.91).Discussion Aspirin monotherapy appears to be as safe and effective as DAPT after TAVI.

Journal article

Petraco Da Cunha R, Dehbi H-M, Howard J, Shun-Shin MJ, Sen S, Nijjer S, Mayet J, Davies JE, Francis DFet al., 2018, Effects of disease severity distribution on the performance of quantitative diagnostic methods and proposal of a novel ‘V-plot’ methodology to display accuracy values, Open Heart, Vol: 5, ISSN: 2053-3624

Background Diagnostic accuracy is widely accepted by researchers and clinicians as an optimal expression of a test’s performance. The aim of this study was to evaluate the effects of disease severity distribution on values of diagnostic accuracy as well as propose a sample-independent methodology to calculate and display accuracy of diagnostic tests.Methods and findings We evaluated the diagnostic relationship between two hypothetical methods to measure serum cholesterol (Cholrapid and Cholgold) by generating samples with statistical software and (1) keeping the numerical relationship between methods unchanged and (2) changing the distribution of cholesterol values. Metrics of categorical agreement were calculated (accuracy, sensitivity and specificity). Finally, a novel methodology to display and calculate accuracy values was presented (the V-plot of accuracies).Conclusion No single value of diagnostic accuracy can be used to describe the relationship between tests, as accuracy is a metric heavily affected by the underlying sample distribution. Our novel proposed methodology, the V-plot of accuracies, can be used as a sample-independent measure of a test performance against a reference gold standard.

Journal article

De Rosa S, Polimeni A, Petraco R, Davies JE, Indolfi Cet al., 2018, Diagnostic Performance of the Instantaneous Wave-Free Ratio: Comparison With Fractional Flow Reserve, CIRCULATION-CARDIOVASCULAR INTERVENTIONS, Vol: 11, ISSN: 1941-7640

Journal article

Cook CM, Petraco R, Davies JE, 2018, Coronary Computed Tomography-Based Fractional FlowReserve: A Rapidly Developing Field Reply, JAMA CARDIOLOGY, Vol: 3, Pages: 87-88, ISSN: 2380-6583

Journal article

Cook CM, Jeremias A, Petraco R, Sen S, Nijjer S, Shun-Shin MJ, Ahmad Y, de Waard G, van de Hoef T, Echavarria-Pinto M, van Lavieren M, Al Lamee R, Kikuta Y, Shiono Y, Buch A, Meuwissen M, Danad I, Knaapen P, Maehara A, Koo B-K, Mintz GS, Escaned J, Stone GW, Francis DP, Mayet J, Piek JJ, van Royen N, Davies JEet al., 2017, Fractional Flow Reserve/Instantaneous Wave-Free Ratio Discordance in Angiographically Intermediate Coronary Stenoses: An Analysis Using Doppler-Derived Coronary Flow Measurements, JACC: Cardiovascular Interventions, Vol: 10, Pages: 2514-2524, ISSN: 1936-8798

ObjectivesThe study sought to determine the coronary flow characteristics of angiographically intermediate stenoses classified as discordant by fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR).BackgroundDiscordance between FFR and iFR occurs in up to 20% of cases. No comparisons have been reported between the coronary flow characteristics of FFR/iFR discordant and angiographically unobstructed vessels.MethodsBaseline and hyperemic coronary flow velocity and coronary flow reserve (CFR) were compared across 5 vessel groups: FFR+/iFR+ (108 vessels, n = 91), FFR–/iFR+ (28 vessels, n = 24), FFR+/iFR– (22 vessels, n = 22), FFR–/iFR– (208 vessels, n = 154), and an unobstructed vessel group (201 vessels, n = 153), in a post hoc analysis of the largest combined pressure and Doppler flow velocity registry (IDEAL [Iberian-Dutch-English] collaborators study).ResultsFFR disagreed with iFR in 14% (50 of 366). Baseline flow velocity was similar across all 5 vessel groups, including the unobstructed vessel group (p = 0.34 for variance). In FFR+/iFR– discordants, hyperemic flow velocity and CFR were similar to both FFR–/iFR– and unobstructed groups; 37.6 (interquartile range [IQR]: 26.1 to 50.4) cm/s vs. 40.0 [IQR: 29.7 to 52.3] cm/s and 42.2 [IQR: 33.8 to 53.2] cm/s and CFR 2.36 [IQR: 1.93 to 2.81] vs. 2.41 [IQR: 1.84 to 2.94] and 2.50 [IQR: 2.11 to 3.17], respectively (p > 0.05 for all). In FFR–/iFR+ discordants, hyperemic flow velocity, and CFR were similar to the FFR+/iFR+ group; 28.2 (IQR: 20.5 to 39.7) cm/s versus 23.5 (IQR: 16.4 to 34.9) cm/s and CFR 1.44 (IQR: 1.29 to 1.85) versus 1.39 (IQR: 1.06 to 1.88), respectively (p > 0.05 for all).ConclusionsFFR/iFR disagreement was explained by differences in hyperemic coronary flow velocity. Furthermore, coronary stenoses classified as FFR+/iFR– demonstrated similar coronary flow characteristics to angiographically unobstructed vessels.

Journal article

Al-Lamee R, Thompson D, Dehbi H-M, Sen S, Tang K, Davies J, Keeble T, Mielewczik M, Kaprielian R, Malik IS, Nijjer SS, Petraco R, Cook C, Ahmad Y, Howard J, Baker C, Sharp A, Gerber R, Talwar S, Assomull R, Mayet J, Wensel R, Collier D, Shun-Shin M, Thom SA, Davies JE, Francis DP, ORBITA investigatorset al., 2017, Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial., Lancet, Vol: 391, Pages: 31-40, ISSN: 0140-6736

BACKGROUND: Symptomatic relief is the primary goal of percutaneous coronary intervention (PCI) in stable angina and is commonly observed clinically. However, there is no evidence from blinded, placebo-controlled randomised trials to show its efficacy. METHODS: ORBITA is a blinded, multicentre randomised trial of PCI versus a placebo procedure for angina relief that was done at five study sites in the UK. We enrolled patients with severe (≥70%) single-vessel stenoses. After enrolment, patients received 6 weeks of medication optimisation. Patients then had pre-randomisation assessments with cardiopulmonary exercise testing, symptom questionnaires, and dobutamine stress echocardiography. Patients were randomised 1:1 to undergo PCI or a placebo procedure by use of an automated online randomisation tool. After 6 weeks of follow-up, the assessments done before randomisation were repeated at the final assessment. The primary endpoint was difference in exercise time increment between groups. All analyses were based on the intention-to-treat principle and the study population contained all participants who underwent randomisation. This study is registered with ClinicalTrials.gov, number NCT02062593. FINDINGS: ORBITA enrolled 230 patients with ischaemic symptoms. After the medication optimisation phase and between Jan 6, 2014, and Aug 11, 2017, 200 patients underwent randomisation, with 105 patients assigned PCI and 95 assigned the placebo procedure. Lesions had mean area stenosis of 84·4% (SD 10·2), fractional flow reserve of 0·69 (0·16), and instantaneous wave-free ratio of 0·76 (0·22). There was no significant difference in the primary endpoint of exercise time increment between groups (PCI minus placebo 16·6 s, 95% CI -8·9 to 42·0, p=0·200). There were no deaths. Serious adverse events included four pressure-wire related complications in the placebo group, which required PCI, and five major bleeding

Journal article

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