Initial experience with orbital atherectomy in a tertiary centre in the Netherlands.

BACKGROUND: In January 2021, the Diamondback 360 orbital atherectomy (OA) system received CE mark approval and became available in Europe. The first procedure in Europe was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. AIMS: To report the procedural safety and efficacy of the initial experience with OA in a tertiary care institution in the Netherlands. METHODS: Patients with de novo severely calcified coronary artery disease who were treated with intended invasive imaging-guided OA were included in a prospective single-centre registry. Device success, defined as less than 50% stenosis after OA, and procedural success, defined as successful stent implantation with less than 50% residual stenosis, were evaluated. Calcium debulking effects were assessed by invasive imaging. Safety was assessed up to 30 days after the index procedure. RESULTS: Between February 2021 and June 2021, 29 patients with a total of 39 coronary arteries underwent OA. Target lesions were heavily calcified with a mean length of 32 mm and a calcium arc of 320 degrees. Invasive imaging was applied in all but one patient and 36 vessels. Superficial sanding was observed in almost all vessels (90%) and fracturing of deeper medial calcium in more than half of the vessels (63%), with a device success of 66% and procedural success of 94%. The mean stent symmetry index was 0.84, indicating good circular stent expansion. No primary safety events occurred during 30 days of follow-up. CONCLUSION: Our initial experience with OA for heavily calcified coronary lesions demonstrated favourable debulking effects and plaque modification, with high procedural success and clinical safety.

Validation of novel 3-dimensional quantitative coronary angiography based software to calculate fractional flow reserve post stenting.

OBJECTIVES: To validate novel dedicated 3D-QCA based on the software to calculate post PCI vessel-FFR (vFFR) in a consecutive series of patients, to assess the diagnostic accuracy, and to assess inter-observer variability. BACKGROUND: Low post percutaneous coronary intervention (PCI) fractional flow reserve (FFR) predicts future adverse cardiac events. However, FFR assessment requires the insertion of a pressure wire in combination with the use of a hyperemic agent. METHODS: FAST POST study is an observational, retrospective, single-center cohort study. One hundred patients presenting with stable angina or non ST-elevation myocardial infarction, who underwent post PCI FFR assessment using a dedicated microcatheter were included. Two orthogonal angiographic projections were acquired to create a 3D reconstruction of the coronary artery using the CAAS workstation 8.0. vFFR was subsequently calculated using the aortic root pressure. RESULTS: Mean age was 65±12 years and 70% were male. Mean microcatheter based FFR and vFFR were 0.91±0.07 and 0.91±0.06, respectively. A good linear correlation was found between FFR and vFFR (r = 0.88; p <.001). vFFR had a higher accuracy in the identification of patients with FFR values <0.90, AUC 0.98 (95% CI: 0.96-1.00) as compared with 3D-QCA AUC 0.62 (95% CI: 0.94-0.74). Assessment of vFFR had a low inter-observer variability (r = 0.95; p <.001). CONCLUSION: 3D-QCA derived post PCI vFFR correlates well with invasively measured microcatheter based FFR and has a high diagnostic accuracy to detect FFR <0.90 with low inter-observer variability.

Correlation between 3D-QCA based FFR and quantitative lumen assessment by IVUS for left main coronary artery stenoses.

OBJECTIVES: We aimed to evaluate the feasibility of using three dimensional-quantitative coronary angiography (3D-QCA) based fractional flow reserve (FFR) (vessel fractional flow reserve [vFFR], CAAS8.1, Pie Medical Imaging) and to correlate vFFR values with intravascular ultrasound (IVUS) for the evaluation of intermediate left main coronary artery (LMCA) stenosis. BACKGROUND: 3D-QCA derived FFR indices have been recently developed for less invasive functional lesion assessment. However, LMCA lesions were vastly under-represented in first validation studies. METHODS: This observational single-center cohort study enrolled consecutive patients with stable angina, unstable angina, or non-ST-segment elevation myocardial infarction and nonostial, intermediate grade LMCA stenoses who underwent IVUS evaluation. vFFR was computed based on two angiograms with optimal LMCA stenosis projection and correlated with IVUS-derived minimal lumen area (MLA). RESULTS: A total of 256 patients with intermediate grade LMCA stenosis evaluated with IVUS were screened for eligibility; 147 patients met the clinical inclusion criteria and had a complete IVUS LMCA footage available, of them, 63 patients (63 lesions) underwent 3D-QCA and vFFR analyses. The main reason for screening failure was insufficient quality of the angiogram (51 patients,60.7%). Mean age was 65 ± 11 years, 75% were male. Overall, mean MLA within LMCA was 8.77 ± 3.17 mm2 , while mean vFFR was 0.87 ± 0.09. A correlation was observed between vFFR and LMCA MLA (r = .792, p = .001). The diagnostic accuracy of vFFR ≤0.8 in identifying lesions with MLA < 6.0 mm2 (sensitivity 98%, specificity 71.4%, area under the curve (AUC) 0.95, 95% confidence interval (CI) 0.89-1.00, p = .001) was good. CONCLUSIONS: In patients with good quality angiographic visualization of LMCA and available complete LMCA IVUS footage, 3D-QCA based vFFR assessment of LMCA disease correlates well to LMCA MLA as assessed by IVUS.

Serial invasive imaging follow-up of the first clinical experience with the Magmaris magnesium bioresorbable scaffold.

OBJECTIVES: To assess the performance of the commercially available Magmaris sirolimus-eluting bioresorbable scaffold (BRS) with invasive imaging at different time points. BACKGROUND: Coronary BRS with a magnesium backbone have been recently studied as an alternative to polymeric scaffolds, providing enhanced vessel support and a faster resorption rate. We aimed to assess the performance of the commercially available Magmaris sirolimus-eluting BRS at different time points. METHODS: A prospective, single-center, nonrandomized study was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. Six patients with stable de novo coronary artery lesions underwent single-vessel revascularization with the Magmaris sirolimus-eluting BRS. Invasive follow-up including intravascular imaging using optical coherence tomography (OCT) was performed at different time points. RESULTS: At a median of 8 months (range 4-12 months) target lesion failure occurred in one patient. Angiography revealed a late lumen loss of 0.59 ± 0.39 mm, a percentage diameter stenosis of 39.65 ± 15.81%, and a binary restenosis rate of 33.3%. OCT showed a significant reduction in both minimal lumen area (MLA) and scaffold area at the site of the MLA by 43.44 ± 28.62 and 38.20 ± 25.74%, respectively. A fast and heterogeneous scaffold degradation process was found with a significant reduction of patent struts at 4-5 months. CONCLUSIONS: Our findings show that the latest iteration of magnesium BRS suffers from premature dismantling, resulting in a higher than expected decrease in MLA.

Long-term outcome in patients treated with first- versus second-generation drug-eluting stents for the treatment of unprotected left main coronary artery stenosis.

OBJECTIVE AND BACKGROUND: The study aim is to provide long-term clinical outcome after percutaneous coronary intervention (PCI) for unprotected left main coronary arteries (ULMCA) stenosis with the first-generation (1st -gen) drug-eluting stents (DES) in comparison to 2nd -gen DES, since this is largely unknown. METHODS: Between May 2002, and December 2014, a consecutive series of 656 all-comer patients underwent a PCI for ULMCA stenosis at the Erasmus Medical Center. A total of 235 patients were treated with 1st -gen DES, while a total of 421 patients were treated with 2nd -gen DES. RESULTS: Overall, the population consisted of 73% males and 58% presented with an acute coronary syndrome. Median follow-up time was 1,361 days (range from 0 to 5,031). At 5 years, the cumulative incidence of major adverse clinical events (the primary composite endpoint of all-cause death, any myocardial infarction or target lesion revascularization; MACE) did not differ between 1st - and 2nd -gen DES (36.8 vs. 38.6%, respectively, Log Rank p = .79, adjusted hazard ratio [HR] = 1.28 [95% confidence interval (CI) 0.94-1.74]). No difference was found in the individual endpoints of all-cause mortality (29.5 vs. 29% respectively, p = .88, adjusted HR = 1.19 [95% CI, 0.84-1.68]), target vessel myocardial infarction (5.0 vs. 8.4%, p = 0.17, adjusted HR = 1.75 [95% CI, 0.78-3.96]) and target lesion revascularization (8.1 vs. 9.8%, p = .94, adjusted HR = 1.16 [95% CI, 0.59-2.29]) between the 1st - and 2nd -gen DES cohorts, respectively. CONCLUSIONS: In this large cohort of consecutive patients treated for ULMCA stenosis, no significant differences were found in the safety and efficacy of 1st versus 2nd -gen DES at 5 years follow-up.

Fractional flow reserve guided percutaneous coronary intervention optimization directed by high-definition intravascular ultrasound versus standard of care: Rationale and study design of the prospective randomized FFR-REACT trial.

BACKGROUND: Post percutaneous coronary intervention (PCI) fractional flow reserve (FFR) is a significant predictor of major adverse cardiac events (MACE). The rationale for low post procedural FFR values often remains elusive based on angiographic findings alone, warranting further assessment using an FFR pullback or additional intravascular imaging. It is currently unknown if additional interventions intended to improve the PCI, decrease MACE rates. STUDY DESIGN: The FFR REACT trial is a prospective, single-center randomized controlled trial in which 290 patients with a post PCI FFR <0.90 will be randomized (1:1) to either standard of care (no additional intervention) or intravascular ultrasound (IVUS)-directed optimization of the FFR (treatment arm). Eligible patients are those treated with angiographically successful PCI for (un)stable angina or non-ST elevation myocardial infarction (MI). Assuming 45% of patients will have a post PCI FFR <0.90, approximately 640 patients undergoing PCI will need to be enrolled. Patients with a post PCI FFR ≥ 0.90 will be enrolled in a prospective registry. The primary end point is defined as a composite of cardiac death, target vessel MI and clinically driven target vessel revascularisation (target vessel failure) at 1 year. Secondary end points will consist of individual components of the primary end point, procedural success, stent thrombosis and correlations on clinical outcome, changes in post PCI Pd/Pa and FFR and IVUS derived dimensions. All patients will be followed for 3 years. CONCLUSION: The FFR-REACT trial is designed to explore the potential benefit of HD-IVUS-guided PCI optimization in patients with a post PCI FFR <0.90 (Dutch trial register: NTR6711).

References for left main stem dimensions: A cross sectional intravascular ultrasound analysis.

BACKGROUND: Angiographic assessment of left main coronary artery (LMCA) lesions remains challenging and limited data is available on reference diameters and length of nonobstructive LMCA dimensions. Our aim was to provide insights in the dimensions of nonobstructive LMCA and to find a possible correlation with gender and patient habitus. METHODS: This retrospective single center study was performed in a consecutive cohort of patients who underwent Intravascular Ultrasound (IVUS) guided percutaneous coronary interventions of the left coronary system including complete pullbacks of a non-obstructive LMCA (n = 254). RESULTS: Mean LMCA length as measured with IVUS was 7.37 ± 4.2 mm and mean lumen area (LA) was 15.63 ± 4.76 mm2 corresponding to a mean lumen diameter (LD) of 4.41 ± 0.67 mm. An IVUS derived mean LD of >4 mm was present in 71.7%, >4.5 mm in 43% and > 5 mm in 19% of patients. LMCA mean LA was significantly smaller in women as compared to men (14.1 ± 4.1 mm2 and 16.2 ± 4.8 mm2 , P < 0.01). Multivariable analysis identified weight of the patient as the sole significant predictor for LMCA length while height of the patient and LMCA length were predictors of LMCA mean LA. Correlation coefficients of determination for all independent predictors were low (R2 < 0.1 for all). CONCLUSION: This study demonstrated that the mean LD of a non-obstructive LMCA is 4 mm or greater in the majority of patients, with a mean LMCA length of 7.4 mm. Women have smaller luminal dimension than men. No clinically relevant predictors were found for both LMCA length and mean LA.

Association Between 3D-Angiography Based Fractional Flow Reserve and Non-Invasive Myocardial Ischemia Testing: The FAST ISCHEMIA Study.

BACKGROUND: In order to facilitate fractional flow reserve (FFR)-guided lesion assessment, several 3-dimensional (3D)-angiography-based physiological indices have been recently validated. Thus far, limited data are available on the association of these indices with conventional forms of ischemia testing. AIM: The aim of the study was to determine the association between 3D-angiography-based vessel-FFR (vFFR) and myocardial ischemia as assessed by exercise electrocardiography (ECG) testing, dobutamine stress echocardiography, single photon emission computed tomography myocardial perfusion imaging (SPECTMPI), and stress cardiovascular magnetic resonance imaging (stress CMR). METHODS: FAST ISCHEMIA is a retrospective, single-center cohort study including patients who underwent non-invasive myocardial ischemia testing and subsequent coronary angiography (≤3 months). A total of 145 patients (340 vessels) were analyzed. The overall patient-based sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) of vFFR ≤0.80 in any vessel for ischemia was 64% (95% confidence interval [CI], 53-74), 71% (95% CI, 54-84), 83% (95% CI, 72-91), 46% (95% CI, 33-60), 2.16 (95% CI, 1.25-3.74), and 0.52 (95% CI, 0.36-0.74), respectively. Multivariable logistic regression showed that vFFR ≤0.80 was significantly associated with ischemia on a patient level (odds ratio, 8.13; 95% CI, 2.51-30.06; P<.001) and on a vascular territory level (odds ratio, 2.75; 95% CI, 1.17-6.44; P<.01). CONCLUSION: Our study suggests that vFFR ≤0.80 has a modest association with non-invasive myocardial ischemia testing using either exercise ECG or stress imaging modalities. After correcting for independent confounders, vFFR was independently associated with ischemia on a non-invasive myocardial ischemia detection test.

Correlation of 3D Quantitative Coronary-Angiography Based Vessel FFR With Diastolic Pressure Ratio: A Single-Center Pooled Analysis of the FAST EXTEND and FAST II Studies.

BACKGROUND: Vessel fractional flow reserve (vFFR) has a high diagnostic accuracy in assessing functional lesion significance compared with FFR. Nonhyperemic pressure ratios (NHPRs) were noninferior to FFR to guide revascularization of intermediate lesions. Therefore, the diagnostic performance of vFFR compared with NHPR warrants interest. AIM: To evaluate the diagnostic performance of vFFR with a generic diastolic pressure ratio (dPR) as a reference. METHODS: The study population was derived from the FAST EXTEND and FAST II studies. Between January 2016 and September 2020, a total of 475 patients were enrolled. RESULTS: Median dPR was 0.92 (interquartile range [IQR], 0.87-0.95), median vFFR was 0.86 (IQR, 0.80-0.90). The sensitivity, specificity, positive and negative predictive values, and diagnostic accuracy of vFFR ≤0.80 for dPR ≤0.89 were 66%, 92%, 79%, 85%, and 84%, respectively. Vessel FFR showed a good agreement with dPR (r=0.68), consistent among specific clinical lesion subsets and a high diagnostic accuracy for dPR ≤0.89 (area under the curve=0.89). Discordance between vFFR and dPR was observed in 78/492 cases (15.6%) and logistic regression analysis did not reveal any clinical, angiographic, or hemodynamic variables associated with vFFR and dPR discordance. CONCLUSION: Vessel FFR shows a good agreement with dPR and a high diagnostic accuracy for dPR ≤0.89.

Diagnostic Accuracy of Coronary Angiography-Based Vessel Fractional Flow Reserve (vFFR) Virtual Stenting.

3D coronary angiography-based vessel fractional flow reserve (vFFR) proved to be an accurate diagnostic alternative to invasively measured pressure wire based fractional flow reserve (FFR). The ability to compute post-PCI vFFR using pre-PCI vFFR virtual stent analysis is unknown. We aimed to assess the feasibility and diagnostic accuracy of pre-PCI vFFR virtual stenting analysis (residual vFFR) with post-PCI FFR as a reference. This is an observational, single-center retrospective cohort study including consecutive patients from the FFR-SEARCH registry. We blindly calculated residual vFFR from pre-PCI angiograms and compared them to invasive pressure-wire based post-PCI FFR. Inclusion criteria involved presentation with either stable or unstable angina or non-ST elevation myocardial infarction (NSTEMI), ≥1 significant stenosis in one of the epicardial coronary arteries (percentage diameter stenosis of >70% by QCA or hemodynamically relevant stenosis with FFR ≤0.80) and pre procedural angiograms eligible for vFFR analysis. Exclusion criteria comprised patients with ST elevation myocardial infarction (STEMI), coronary bypass grafts, cardiogenic shock or severe hemodynamic instability. Eighty-one pre-PCI residual vFFR measurements were compared to post-PCI FFR and post-PCI vFFR measurements. Mean residual vFFR was 0.91 ± 0.06, mean post-PCI FFR 0.91 ± 0.06 and mean post-PCI vFFR was 0.92 ± 0.05. Residual vFFR showed a high linear correlation (r = 0.84) and good agreement (mean difference (95% confidence interval): 0.005 (−0.002−0.012)) with post-PCI FFR, as well as with post-PCI-vFFR (r = 0.77, mean difference −0.007 (−0.015−0.0003)). Residual vFFR showed good accuracy in the identification of lesions with post-PCI FFR < 0.90 (sensitivity 94%, specificity 71%, area under the curve (AUC) 0.93 (95% CI: 0.86−0.99), p < 0.001). Virtual stenting using vFFR provided an accurate estimation of post-PCI FFR and post-PCI vFFR. Further studies are needed to prospectively validate a vFFR-guided PCI strategy.

Culprit Lesion Detection in Patients Presenting With Non-ST Elevation Acute Coronary Syndrome and Multivessel Disease.

BACKGROUND/PURPOSE: Identification of the culprit lesion in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) allows appropriate coronary revascularization but may be unclear in patients with multivessel coronary disease (MVD). Therefore, we investigated the rate of culprit lesion identification during coronary angiography in NSTE-ACS and multivessel disease. METHODS/MATERIALS: Consecutive patients presenting with NSTE-ACS and MVD, between January 2012 and December 2016 were evaluated. Coronary angiograms, intravascular imaging, and ECGs were analyzed for culprit lesion identification. Long-term clinical outcomes in terms of major adverse cardiac events (MACE) and mortality were reported in patients with or without culprit identification. RESULTS: A total of 1107 patients with NSTE-ACS and MVD were included in the analysis, 310 (28.0%) with unstable angina and 797 (72.0%) with non-ST elevation myocardial infarction. The culprit lesion was angiographically identified in 952 (86.0%) patients, while no clear culprit lesion was found in 155 (14.0%) patients. ECG analysis allowed to predict the location of the culprit vessel with low sensitivity (range 28.4%-36.7%) and high specificity (range 90.6%-96.5%). Higher lesion complexity was associated with inability to identify the culprit. Intravascular imaging was applied in 55 patients and helped to identify the culprit lesion in 53 patients (96.4%). There was no difference in all-cause mortality (21.4% vs. 25.8%, p = 0.24) and MACE (39.2% vs. 47.6%, p = 0.07) between the cohorts with or without culprit lesion identification by angiography. CONCLUSIONS: The culprit lesion appeared unclear by coronary angiography in >10% of patients with NSTE-ACS and MVD. Complementary invasive imaging substantially enhanced the diagnostic accuracy of culprit lesion detection.

The prognostic value of angiography-based vessel fractional flow reserve after percutaneous coronary intervention: The FAST Outcome study.

BACKGROUND: Vessel Fractional Flow Reserve (vFFR) as assessed by three-dimensional quantitative coronary angiography has high correlation with pressure wire-based fractional flow reserve in both a pre- and post-PCI setting. The present study aims to assess the prognostic value of post-PCI vFFR on the incidence of target vessel failure (TVF), a composite endpoint of cardiac death, target vessel myocardial infarction and target vessel revascularization (TVR) at 5-year follow up. METHODS: Post-PCI vFFR was calculated after routine PCI in a total of 748 patients (832 vessels) with available orthogonal angiographic projections of the stented segment. RESULTS: Median age was 65 (IQR 55-74) years, 18.2% were diabetic, and 29.1% presented with stable angina. Median post-PCI vFFR was 0.91 (IQR 0.86-0.95). Vessels were categorized into tertiles based on post-PCI vFFR: low (vFFR <0.88), middle (vFFR 0.88-0.93), and upper (vFFR ≥0.94). Vessels in the lower and middle tertile were more often LADs and had smaller stent diameters (p<0.001). Vessels in the lower and middle tertile had a higher risk of TVF as compared to vessels in the upper tertile (24.6% and 21.5% vs. 17.1%; adjusted HR 1.84 (95%CI 1.15-2.95), p = 0.011, and 1.58 (95%CI 1.02-2.45), p = 0.040) at 5-years follow-up. Additionally, vessels in the lower tertile had higher rates of TVR as compared to vessels in the higher tertile (12.6% vs. 6.5%, adjusted HR 1.93 (95%CI 1.06-3.53), p = 0.033). CONCLUSION: Lower post-PCI vFFR values are associated with a significantly increased risk of TVF and TVR at 5-years follow-up.

Three-dimensional QCA-based vessel fractional flow reserve (vFFR) in Heart Team decision-making: a multicentre, retrospective, cohort study.

OBJECTIVES: To evaluate the feasibility of three-vessel three-dimensional (3D) quantitative coronary angiography (QCA)-based fractional flow reserve (FFR) computation in patients discussed within the Heart Team in whom the treatment decision was based on angiography alone, and to evaluate the concordance between 3D QCA-based vessel FFR (vFFR)-confirmed functional lesion significance and revascularisation strategy as proposed by the Heart Team. DESIGN: Retrospective, cohort. SETTING: 3D QCA-based FFR indices have not yet been evaluated in the context of Heart Team decision-making; consecutive patients from six institutions were screened for eligibility and three-vessel vFFR was computed by blinded analysts. PARTICIPANTS: Consecutive patients with chronic coronary syndrome or unstable angina referred for Heart Team consultation. Exclusion criteria involved: presentation with acute myocardial infarction (MI), significant valve disease, left ventricle ejection fraction <30%, inadequate quality of angiogram precluding vFFR computation in all three epicardial coronary arteries (ie, absence of a minimum of two angiographic projections with views of at least 30° apart, substantial foreshortening/overlap of the vessel, poor contrast medium injection, ostial lesions, chronic total occlusions). PRIMARY AND SECONDARY OUTCOME MEASURES: Discordance between vFFR-confirmed lesion significance and revascularisation was assessed as the primary outcome measure. Rates of major adverse cardiac events (MACE) defined as cardiac death, MI and clinically driven revascularisation were reported. RESULTS: Of a total of 1003 patients were screened for eligibility, 416 patients (age 65.6±10.6, 71.2% male, 53% stable angina) were included. The most important reason for screening failure was insufficient quality of the angiogram (43%). Discordance between vFFR confirmed lesion significance and revascularisation was found in 124/416 patients (29.8%) corresponding to 149 vessels (46/149 vessels (30.9%) were reclassified as significant and 103/149 vessels (69.1%) as non-significant by vFFR). Over a median of 962 days, the cumulative incidence of MACE was 29.7% versus 18.5% in discordant versus concordant patients (p=0.031). CONCLUSIONS: vFFR computation is feasible in around 40% of the patients referred for Heart Team discussion, a limitation that is mostly based on insufficient quality of the angiogram. Three vessel vFFR screening indicated discordance between vFFR confirmed lesion significance and revascularisation in 29.8% of the patients.

Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study.

BACKGROUND: Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is superior to angiography-guided PCI. The clinical uptake of FFR has been limited, however, by the need to advance a wire in the coronary artery, the additional time required and the need for hyperaemic agents which can cause patient discomfort. FFR derived from routine coronary angiography eliminates these issues. AIMS: The aim of this study was to assess the diagnostic performance and accuracy of three-dimensional quantitative coronary angiography (3D-QCA)-based vessel FFR (vFFR) compared to pressure wire-based FFR (≤0.80). METHODS: The FAST II (Fast Assessment of STenosis severity) study was a prospective observational multicentre study designed to evaluate the diagnostic accuracy of vFFR compared to the reference standard (pressure wire-based FFR ≤0.80). A total of 334 patients from six centres were enrolled. Both site-determined and blinded independent core lab vFFR measurements were compared to FFR. RESULTS: The core lab vFFR was 0.83±0.09 and pressure wire-based FFR 0.83±0.08. A good correlation was found between core lab vFFR and pressure wire-based FFR (R=0.74; p<0.001; mean bias 0.0029±0.0642). vFFR had an excellent diagnostic accuracy in identifying lesions with an invasive wire-based FFR ≤0.80 (area under the curve [AUC] 0.93; 95% confidence interval [CI]: 0.90-0.96; p<0.001). Positive predictive value, negative predictive value, diagnostic accuracy, sensitivity and specificity of vFFR were 90%, 90%, 90%, 81% and 95%, respectively. CONCLUSIONS: 3D-QCA-based vFFR has excellent diagnostic performance to detect FFR ≤0.80. The study was registered on clinicaltrials.gov under identifier NCT03791320.

FFR-Guided PCI Optimization Directed by High-Definition IVUS Versus Standard of Care: The FFR REACT Trial.

BACKGROUND: Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) <0.90 is common and has been related to impaired patient outcome. OBJECTIVES: The authors sought to evaluate if PCI optimization directed by intravascular ultrasound (IVUS) in patients with post-PCI FFR <0.90 could improve 1-year target vessel failure (TVF) rates. METHODS: In this single-center, randomized, double-blind trial, patients with a post-PCI FFR <0.90 at the time of angiographically successful PCI were randomized to IVUS-guided optimization or the standard of care (control arm). The primary endpoint was TVF (a composite of cardiac death, spontaneous target vessel myocardial infarction, and clinically driven target vessel revascularization) at 1 year. RESULTS: A total of 291 patients with post-PCI FFR <0.90 were randomized (IVUS-guided optimization arm: n = 145/152 vessels, control arm: n = 146/157 vessels). The mean post-PCI FFR was 0.84 ± 0.05. A total of 104 (68.4%) vessels in the IVUS-guided optimization arm underwent additional optimization including additional stenting (34.9%) or postdilatation only (33.6%), resulting in a mean increase in post-PCI FFR in these vessels from 0.82 ± 0.06 to 0.85 ± 0.05 (P < 0.001) and a post-PCI FFR ≥0.90 in 20% of the vessels. The 1-year TVF rate was comparable between the 2 study arms (IVUS-guided optimization arm: 4.2%, control arm: 4.8%; P = 0.79). There was a trend toward a lower incidence of clinically driven target vessel revascularization in the IVUS-guided optimization arm (0.7% vs. 4.2%, P = 0.06). CONCLUSIONS: IVUS-guided post-PCI FFR optimization significantly improved post-PCI FFR. Because of lower-than-expected event rates, post-PCI FFR optimization did not significantly lower TVF at the 1-year follow-up.

Impact of Poststenting Fractional Flow Reserve on Long-Term Clinical Outcomes: The FFR-SEARCH Study.

[Figure: see text].

Patient perspectives on left main stem revascularization strategies, the OPINION-2 study.

BACKGROUND: Treatment preferences in patients with left main (LM) stem disease and no prior revascularization are unknown. The objectives of this study were to determine (i) patient-reported importance ratings of particular features related to percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery, (ii) how these features determine treatment preference, and (iii) how educational and psychosocial background influence this preference. METHODS: In this prospective, multicenter study a total of 500 patients without previous revascularization who underwent diagnostic angiography for suspected coronary disease were asked to complete a case-vignette on a (hypothetical) LM stenosis qualifying for both PCI and CABG, in addition to 6 validated questionnaires to assess the influence of psychosocial factors on treatment preference. RESULTS: Overall, 90% favored PCI over CABG because of the lower bleeding and stroke risk despite a higher likelihood for repeat revascularization. By multivariable regression, the only independent determinant of treatment preference for CABG was lower educational level (14% in low vs. 8% in higher educated patients, OR: 3.22, CI: 1.16-8.95, p=0.025) while psychosocial variables were not associated. Compared to higher educated patients, those with lower educational level suffered more from depression, anxiety, loneliness, and uncertainty. CONCLUSIONS: Overall, patients who are informed about risk and benefits of each treatment modality clearly favor PCI over CABG and particularly value lower short-term morbidity while being aware of higher risk of repeat revascularization. Lower educational level was associated with a higher prevalence of psychosomatic phenotypes and a 14% preference for CABG. Educational and psychosocial background matter in the revascularization strategy decision-making process.

Impact of intravascular ultrasound findings in patients with a post PCI fractional flow reserve ≤0.85 on 2 year clinical outcome.

BACKGROUND: Patients with a low post PCI fractional flow reserve (FFR) are at increased risk for future adverse cardiac events. The aim of the present study was to assess the impact of specific intravascular ultrasound (IVUS) findings in patients with a low post percutaneous coronary intervention (PCI) FFR on long-term clinical outcome. METHODS: In a subgroup analysis, 100 vessels with an FFR value ≤0.85 underwent post PCI IVUS to further assess the potential determinants for low post PCI FFR. No further action was taken to improve post PCI FFR. The primary endpoint of this study was the event free survival of target vessel failure (TVF) at two years in patients with a post PCI FFR ≤0.85, which was defined as a composite of cardiac death, target vessel myocardial infarction or target vessel revascularization. RESULTS: In patients with a post PCI FFR ≤0.85, TVF free survival rates were 88.5% vs. 95.5% for patients with versus without residual proximal lesions and 88.2% vs. 95.5% for patients with versus without residual distal lesions respectively (HR = 2.53, 95% confidence interval (CI) 0.52-12.25, p = .25 and HR = 2.60, 95% CI 0.54-12.59, p = .24 respectively). TVF free survival was 92.8% vs. 93.5% in patients with versus without stent underexpansion >20% (HR = 1.01, 95% CI 0.21-4.88, p = .99) and 89.3% vs. 97.8% in patients with versus without any residual focal lesion including lumen compromising hematoma (HR = 4.64, 95% CI 0.55-39.22, p = .18). CONCLUSION: Numerically higher TVF rates were observed in patients with a post PCI FFR ≤0.85 and clear focal residual disease as assessed with IVUS.

Incidence and predictors of outcomes after a first definite coronary stent thrombosis.

AIMS: Stent thrombosis (ST) is a rare but potentially fatal complication of coronary artery stenting. Little is known about the optimal treatment strategy at the time of an ST event. We aimed to identify the incidence and predictors of adverse cardiac events after treatment of a definite ST. METHODS AND RESULTS: A total of 695 patients with definite ST were included between 1996 and 2017 in two academic medical centres. The primary endpoint was MACE, the composite of cardiac death, myocardial infarction (MI) and target vessel revascularisation (TVR). Mean age was 62.8±12.1 years and 76.3% were male. ST occurred at a median of 22 days (IQR 3-551 days); 50.8% were early and 49.2% were late/very late ST. At 60-month follow-up, the MACE rate was 43.7%, cardiac death 19.5%, MI 17.9%, TVR 24.8%, and repeat definite ST was 12.1% (10.5% in target vessel). Independent predictors of MACE were cardiogenic shock (HR 2.54, 95% CI: 1.75-3.70; p<0.001), ST in the LAD (HR 1.76, 95% CI: 1.32-2.35; p<0.001), prior CVA/TIA (HR 1.68, 95% CI: 1.08-2.62; p=0.020), peripheral vascular disease (HR 1.55, 95% CI: 1.00-2.39; p=0.046), multivessel disease (HR 1.53, 95% CI: 1.12-2.08; p=0.007), and final TIMI flow 2-3 (HR 0.54, 95% CI: 0.34-0.85; p=0.009). No specific treatment of ST influenced MACE; however, new-generation P2Y12 inhibitors reduced the risk of MI (HR 0.56, 95% CI: 0.32-0.99; p=0.049). CONCLUSIONS: The incidence of adverse events remains high after a first episode of ST. New-generation P2Y12 inhibitors reduce the risk of MI. Additional stenting, GP IIb/IIIa inhibitors and thrombectomy did not improve outcomes following ST.

Revascularization Strategies in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Coronary Disease.

The optimal revascularization strategy for residual coronary stenosis following primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) remains controversial. This is a retrospective single-centre study including patients with STEMI and MVD. Based on the revascularization strategy, 3 groups were identified: (1) culprit only (CO), (2) ad hoc multivessel revascularization (MVR), and (3) staged MVR. Clinical outcomes were compared in terms of major adverse cardiac events (MACE), a composite of cardiac death, any myocardial infarction, and any unplanned revascularization at a long-term follow-up. A total of 958 patients were evaluated, 489 in the CO, 254 in the ad hoc, and 215 in the staged group. In the staged group, 65.6% of the patients received planned percutaneous coronary intervention, 9.7% coronary artery bypass grafting, 8.4% no further intervention after lesion reassessment, and in 16.3% an event occurred before the planned procedure. At 1,095 days, MACE was 36.1%, 16.7%, and 31% for CO, ad hoc, and staged groups, respectively. A MVR strategy was associated with lower rate of all-cause death compared with CO (HR 0.50; 95%CI [0.31 to 0.80]; p = 0.004). Complete revascularization reduced the rate of MACE (HR 0.30 [0.21 to 0.43] p < 0.001) compared with incomplete revascularization. Ad hoc MVR had lower rate of MACE compared with staged MVR (HR 0.61 [0.39 to 0.96] p = 0.032) mainly driven by less unplanned revascularizations. In conclusion, in patients with STEMI and MVD, complete revascularization reduced the risk of MACE. Ad hoc MVR appeared a reasonable strategy with lower contrast and stent usage and costs.