The prognostic value of collateral circulation in coronary chronic total occlusion underwent percutaneous coronary intervention.

BACKGROUND: The prognostic value of coronary collateral circulation (CC) in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is underdetermined. The purpose of the study was to assess the prognostic value of current two CC grading systems and their association with long-term outcomes in patients with CTO underwent PCI. METHODS: We consecutively enrolled patients with single-vessel CTO underwent PCI between January 2010 and December 2013. All patients were categorized into well-developed or poor-developed collaterals group according to angiographic Werner's CC (grade 2 vs. grade 0-1) or Rentrop (grade 3 vs. grade 0-2) grading system. The primary endpoint was 5-year cardiac death. RESULTS: Of 2452 enrolled patients, the overall technical success rate was 74.1%. Well-developed collaterals were present in 686 patients (28.0%) defined by Werner's CC grade 2, and in 1145 patients (46.7%) by Rentrop grade 3. According to Werner's CC grading system, patients with well-developed collaterals had a lower rate of 5-year cardiac death compared with those with poor-developed collaterals (1.6% vs. 3.3%, P = 0.02), those with suboptimal recanalization was associated with higher rate of 5-year cardiac death compared with optimal recanalization (4.7% vs. 0.8%, P = 0.01) and failure patients (4.7% vs. 1.6%, P = 0.12). However, the similar effect was not shown in Rentrop grading system. CONCLUSIONS: In patients with the single-vessel CTO underwent PCI, well-developed collaterals by Werner's CC definition were associated with lower rate of 5-year cardiac death. Werner's CC grading system had a greater prognostic value than Rentrop grading system in patients with CTO underwent PCI.

Development and validation of a model integrating clinical and coronary lesion-based functional assessment for long-term risk prediction in PCI patients.

OBJECTIVES: To establish a scoring system combining the ACEF score and the quantitative blood flow ratio (QFR) to improve the long-term risk prediction of patients undergoing percutaneous coronary intervention (PCI). METHODS: In this population-based cohort study, a total of 46 features, including patient clinical and coronary lesion characteristics, were assessed for analysis through machine learning models. The ACEF-QFR scoring system was developed using 1263 consecutive cases of CAD patients after PCI in PANDA III trial database. The newly developed score was then validated on the other remaining 542 patients in the cohort. RESULTS: In both the Random Forest Model and the DeepSurv Model, age, renal function (creatinine), cardiac function (LVEF) and post-PCI coronary physiological index (QFR) were identified and confirmed to be significant predictive factors for 2-year adverse cardiac events. The ACEF-QFR score was constructed based on the developmental dataset and computed as age (years)/EF (%) + 1 (if creatinine ≥ 2.0 mg/dL) + 1 (if post-PCI QFR ≤ 0.92). The performance of the ACEF-QFR scoring system was preliminarily evaluated in the developmental dataset, and then further explored in the validation dataset. The ACEF-QFR score showed superior discrimination (C-statistic = 0.651; 95% CI: 0.611-0.691, P < 0.05 versus post-PCI physiological index and other commonly used risk scores) and excellent calibration (Hosmer-Lemeshow χ2 = 7.070; P = 0.529) for predicting 2-year patient-oriented composite endpoint (POCE). The good prognostic value of the ACEF-QFR score was further validated by multivariable Cox regression and Kaplan-Meier analysis (adjusted HR = 1.89; 95% CI: 1.18-3.04; log-rank P < 0.01) after stratified the patients into high-risk group and low-risk group. CONCLUSIONS: An improved scoring system combining clinical and coronary lesion-based functional variables (ACEF-QFR) was developed, and its ability for prognostic prediction in patients with PCI was further validated to be significantly better than the post-PCI physiological index and other commonly used risk scores.

Diagnostic performance of intravascular ultrasound-based fractional flow reserve in evaluating of intermediate left main stenosis.

BACKGROUND: The recently introduced ultrasonic flow ratio (UFR), is a novel fast computational method to derive fractional flow reserve (FFR) from intravascular ultrasound (IVUS) images. In the present study, we evaluate the diagnostic performance of UFR in patients with intermediate left main (LM) stenosis. METHODS: This is a prospective, single center study enrolling consecutive patients with presence of intermediated LM lesions (diameter stenosis of 30%-80% by visual estimation) underwent IVUS and FFR measurement. An independent core laboratory assessed offline UFR and IVUS-derived minimal lumen area (MLA) in a blinded fashion. RESULTS: Both UFR and FFR were successfully achieved in 41 LM patients (mean age, 62.0 ± 9.9 years, 46.3% diabetes). An acceptable correlation between UFR and FFR was identified (r = 0.688, P < 0.0001), with an absolute numerical difference of 0.03 (standard difference: 0.01). The area under the curve (AUC) in diagnosis of physiologically significant coronary stenosis for UFR was 0.94 (95% CI: 0.87-1.01), which was significantly higher than angiographic identified stenosis > 50% (AUC = 0.66, P < 0.001) and numerically higher than IVUS-derived MLA (AUC = 0.82; P = 0.09). Patient level diagnostic accuracy, sensitivity and specificity for UFR to identify FFR ≤ 0.80 was 82.9% (95% CI: 70.2-95.7), 93.1% (95% CI: 82.2-100.0), 58.3% (95% CI: 26.3-90.4), respectively. CONCLUSION: In patients with intermediate LM diseases, UFR was proved to be associated with acceptable correlation and high accuracy with pressure wire-based FFR as standard reference. The present study supports the use of UFR for functional evaluation of intermediate LM stenosis.

Sex Differences in Clinical Outcomes Associated With Quantitative Flow Ratio-Guided Percutaneous Coronary Intervention.

Background: FAVOR III China (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) reported improved clinical outcomes in quantitative flow ratio (QFR) relative to angiography-guided percutaneous coronary intervention (PCI), but the clinical impact of QFR-guided PCI according to sex remains unknown. Objectives: The authors sought to compare sex differences in the 2-year clinical benefits of a QFR-guided PCI strategy and to evaluate the differences in outcomes between men and women undergoing contemporary PCI. Methods: This study involved a prespecified subgroup analysis of the FAVOR III China trial, in which women and men were randomized to a QFR-guided strategy or a standard angiography-guided strategy. Sex differences in clinical benefit of the QFR guidance were analyzed for major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction, or ischemia-driven revascularization within 2 years. Results: A total of 1,126 women and 2,699 men were eligible and the occurrence of 2-year MACE was similar between women and men (10.3% vs 10.5%; P = 0.96). Compared with an angiography-guided strategy, a QFR-guided strategy resulted in a 7.9% and 9.7% reduction in PCI rates in men and women, respectively. A QFR-guided strategy resulted in similar relative risk reductions for 2-year MACE in women (8.0% vs 12.7%; HR: 0.62; 95% CI: 0.42-0.90) and men (8.7% vs 12.4%; HR: 0.69; 95% CI: 0.54-0.87) (Pinteraction = 0.61). Furthermore, QFR values were not significantly different between men and women with various angiographic stenosis categories. Conclusions: A QFR-guided PCI strategy resulted in improved MACE in both men and women at 2 years compared with an angiography-guided PCI strategy. The FAVOR III China Study [FAVOR III China]; (NCT03656848).

Diagnostic performance of ultrasonic flow ratio versus quantitative flow ratio for assessment of coronary stenosis.

BACKGROUND: Ultrasonic flow ratio (UFR) is a novel intravascular ultrasound (IVUS)-derived modality for fast computation of fractional flow reserve (FFR) without pressure wires and adenosine. AIMS: This study was sought to compare the diagnostic performance of UFR and quantitative flow ratio (QFR), using FFR as the reference standard. METHODS: This is a retrospective study enrolling consecutive patients with intermediate coronary artery lesions (diameter stenosis of 30%-90% by visual estimation) for IVUS and FFR measurement. UFR and QFR were performed offline in a core-lab by independent analysts blinded to FFR. RESULTS: From December 2022 to May 2023, a total of 78 eligible patients were enrolled. IVUS and FFR measurements were successfully conducted in 104 vessels, finally 98 vessels with both FFR, UFR and QFR evaluation were analyzed. Mean FFR was 0.79 ± 0.12. UFR showed a strong correlation with FFR similar to QFR (r = 0.83 vs. 0.82, p = 0.795). Diagnostic accuracy of UFR was non-inferior to QFR (94% [89%-97%] versus 90% [84%-94%], p = 0.113). Sensitivity and specificity in identifying hemodynamically significant stenosis were comparable between UFR and QFR (sensitivity: 89% [79%-96%] versus 85% [74%-92%], p = 0.453; specificity: 97% [91%-99%] versus 95% [88%-99%], p = 0.625). The area under curve for UFR was 0.95 [0.90-0.98], non-inferior to QFR (difference = 0.021, p = 0.293), and significantly higher than minimum lumen area (MLA; difference = 0.13, p < 0.001). Diagnostic accuracy of UFR and QFR was not statically different in bifurcation nor non-bifurcation lesions. CONCLUSIONS: UFR showed excellent concordance with FFR, non-inferior to QFR, superior to MLA. UFR provides a potentiality for the integration of physiological assessment and intravascular imaging in clinical practice.

Impact of Relative Improvement in Quantitative Flow Ratio on Clinical Outcomes After Percutaneous Coronary Intervention　- A Subanalysis of the PANDA III Trial.

BACKGROUND: The clinical impact of relative improvements in coronary physiology in patients receiving percutaneous coronary intervention (PCI) for coronary artery disease (CAD) remains undetermined.Methods and Results: The quantitative flow ratio (QFR) recovery ratio (QRR) was calculated in 1,424 vessels in the PANDA III trial as (post-PCI QFR-pre-PCI QFR)/(1-pre-PCI QFR). The primary endpoint was the 2-year vessel-oriented composite endpoint (VOCE; a composite of vessel-related cardiac death, vessel-related non-procedural myocardial infarction, and ischemia-driven target vessel revascularization). Study vessels were dichotomously stratified according to the optimal QRR cut-off value. During the 2-year follow-up, 41 (2.9%) VOCEs occurred. Low (<0.86) QRR was associated with significantly higher rates of 2-year VOCEs than high (≥0.86) QRR (6.6% vs. 1.4%; adjusted hazard ratio [aHR] 5.05; 95% confidence interval [CI] 2.53-10.08; P<0.001). Notably, among vessels with satisfactory post-procedural physiological results (post-PCI QFR >0.89), low QRR also conferred an increased risk of 2-year VOCEs (3.7% vs. 1.4%; aHR 3.01; 95% CI 1.30-6.94; P=0.010). Significantly better discriminant and reclassification performance was observed after integrating risk stratification by QRR and post-PCI QFR to clinical risk factors (area under the curve 0.80 vs. 0.71 [P=0.010]; integrated discrimination improvement 0.05 [P<0.001]; net reclassification index 0.64 [P<0.001]). CONCLUSIONS: Relative improvement of coronary physiology assessed by QRR showed applicability in prognostication. Categorical classification of coronary physiology could provide information for risk stratification of CAD patients.

One-year clinical outcomes of bivalirudin versus unfractionated heparin in patients with type 2 diabetes undergoing elective percutaneous coronary intervention.

BACKGROUND: Patients with diabetes and coronary artery disease have a higher risk of bleeding and thrombotic events. However, data on the safety and efficacy of bivalirudin in these patients undergoing elective percutaneous coronary intervention (PCI) are lacking. METHODS: 1152 patients undergoing elective PCI anticoagulated with bivalirudin and 10,250 patients anticoagulated with unfractionated heparin (UFH) (with or without glycoprotein IIb/IIIa inhibitors [GPI]) were performed propensity-score matching method. The thrombotic endpoint was major adverse cardiovascular and cerebrovascular events (MACCE). The bleeding endpoint was according to the Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding. RESULTS: Finally, 376 (bivalirudin group) and 878 (UFH group) patients with type 2 diabetes (T2D) were enrolled. After one-year follow-up, there were 130 (10.4%) MACCE and 27 (2.2%) bleeding events occurred. Multivariate COX regression analysis showed no significant difference for MACCE between bivalirudin group and UFH group (P > 0.05). Further analysis showed that there was a reduction in the risk of myocardial infarction (MI) between two groups (Hazard ratio [HR] = 0.199, 95% confidence interval [CI]: 0.047-0.845, P = 0.029), but not in the risk of death, revascularization, stent thrombosis or stroke (all P > 0.05). As for BARC 2, 3 or 5 bleeding, no significant difference was found between two groups (P > 0.05). CONCLUSIONS: Although diabetes is considered a high-risk factor for poor prognosis, compared with UFH (with or without GPI), bivalirudin did not increase the risk of MACCE and even decreased the risk of MI in patients with T2D undergoing elective PCI, while the risk of bleeding was similar between two groups.

Comparison of Recurrent With First-Time In-Stent Restenosis.

Recurrent in-stent restenosis (Re-ISR) remains a therapeutic challenge. We aimed to investigate the clinical characteristics, treatment, and long-term outcomes in patients with Re-ISR compared with those with first-time ISR (First-ISR). This retrospective study consecutively enrolled patients who underwent percutaneous coronary intervention (PCI) for ISR in Fuwai Hospital between January 2017 and December 2018. Re-ISR was defined as a second event of ISR after a previous successful treatment of the ISR lesion. The primary outcome was defined as a composite of all-cause death, spontaneous myocardial infarction, and repeat revascularization. A total of 2,006 patients (2,154 lesions) with ISR underwent successful PCI were enrolled and categorized into 2 groups: the Re-ISR group (246 patients/259 lesions) and the First-ISR group (1,760 patients/1,895 lesions). During a mean follow-up of 36 months, the primary outcomes occurred in 80 patients (32.5%) in the Re-ISR group and 349 patients (19.3%) in the First-ISR group (p <0.001 by log-rank test), major driven by spontaneous myocardial infarction (4.9% vs 2.7%, p = 0.049) and repeat revascularization (30.1% vs 16.5%, p <0.001). The multivariable Cox regression analysis revealed that Re-ISR was independently associated with a higher rate of major adverse cardiovascular events (adjusted hazard ratio 1.88, 95% confidence interval 1.39 to 2.53, p <0.001) and repeated revascularization (adjusted hazard ratio 2.09, 95% confidence interval 1.53 to 2.84, p <0.001). The relation remained consistent after the propensity score analysis. In conclusion, in the present cohort of patients who underwent PCI for ISR, Re-ISR was significantly associated with a higher risk of long-term outcomes than First-ISR.

Quantitative flow ratio as a continuous predictor of myocardial infarction.

BACKGROUND: The quantitative flow ratio (QFR) identifies functionally ischaemic lesions that may benefit more from percutaneous coronary intervention (PCI) than from medical therapy. AIMS: This study investigated the association between QFR and myocardial infarction (MI) as affected by PCI versus medical therapy. METHODS: All vessels requiring measurement (reference diameter ≥2.5 mm and existence of at least one stenotic lesion with diameter stenosis of 50-90%) in the FAVOR III China (5,564 vessels) and PANDA-III trials (4,471 vessels) were screened and analysed for offline QFR. The present study reported clinical outcomes on a per-vessel level. Interaction between vessel treatment and QFR as a continuous variable was evaluated for the threshold of 2-year MI estimated by Cox proportional hazards model. RESULTS: Compared with medical therapy at 2 years, PCI reduced the MI risk in vessels with a QFR ≤0.80 (3.0% vs 4.6%) but increased the MI risk in vessels with a QFR>0.80 (3.6% vs 1.2%). Additionally, continuous QFR showed an inverse association with spontaneous MI (hazard ratio [HR] 0.89, 95% confidence interval [CI]: 0.79-0.99; p=0.04) that was reduced by PCI compared to medical therapy (HR 0.26, 95% CI: 0.17-0.40; p<0.0001). The interaction indicated a net benefit for PCI over medical therapy to reduce total MI beginning at QFR ≤0.64. CONCLUSIONS: The present study demonstrated a continuous, inverse relationship between the QFR value of a vessel and its subsequent risk for MI, and PCI, compared to medical therapy, reduced this risk beginning at a QFR value of 0.64. These novel findings provide physicians with an angiographic tool for optimising vessel selection for PCI.

Outcomes of quantitative flow ratio-based functional incomplete revascularization after coronary artery bypass grafting surgery.

OBJECTIVE: Quantitative flow ratio is a novel functional assessment tool of coronary diseases. Whether quantitative flow ratio could improve the outcomes of coronary artery bypass grafting is undetermined. This study aimed to investigate the association between the quantitative flow ratio based functional incomplete revascularization and the outcomes after coronary artery bypass grafting surgery. METHODS: The quantitative flow ratio assessment was retrospectively performed in patients undergoing coronary artery bypass grafting surgery in the PATENCY trial. The anatomic complete revascularization denoted revascularizing each territory with stenosis greater than 50% evaluated by angiography. The functional complete revascularization was defined as grafting all vessels with a quantitative flow ratio 0.80 or less. The primary end point was the 12-month composite major adverse cardiac or cerebral vascular events. RESULTS: A total of 2024 patients with available quantitative flow ratio values were included. Functional complete revascularization was achieved in 1846 patients (91.2%), and 1600 received anatomic complete revascularization (79.1%). Both the functional incomplete revascularization and anatomic incomplete revascularization groups were associated with significantly increased risks of 12-month major adverse cardiac or cerebral vascular events (functional: hazard ratio, 2.91; 95% confidence interval, 1.56 to 5.43; P = .001; anatomic: hazard ratio, 2.82; 95% confidence interval, 1.54 to 5.16; P = .001). Additionally, for the subgroup of patients (n = 246) receiving anatomic incomplete revascularization but judged as functional complete revascularization by quantitative flow ratio, the risk of the 12-month major adverse cardiac or cerebral vascular events was not significantly increased (adjusted hazard ratio, 1.36; 95% confidence interval, 0.71-2.60; P = .35). CONCLUSIONS: Both the functional incomplete revascularization and anatomic incomplete revascularization were associated with increased risks of 12-month major adverse cardiac or cerebral vascular events after coronary artery bypass grafting surgery. The quantitative flow ratio can serve as a supplementary tool for the decision-making of surgical revascularization.

Impact of Preoperative Quantitative Flow Ratio of the Left Anterior Descending Artery on Internal Mammary Artery Graft Patency and Midterm Patient Outcomes After Coronary Artery Bypass Grafting.

Background In coronary artery bypass grafting, grafting a target vessel with nonsignificant stenosis increases the risk of graft failure. The present study aims to investigate the impact of preoperative quantitative flow ratio (QFR), a novel functional assessment of the coronary artery, on internal mammary artery graft failure rate and midterm patient outcomes. Methods and Results Between January 2016 and January 2020, we retrospectively included 419 patients who underwent coronary artery bypass grafting who had received preoperative angiography and postoperative coronary computed tomographic angiography in our center. QFR of the left anterior descending (LAD) artery was computed based on preoperative angiograms. The primary end point was the failure of the graft on the LAD artery assessed by coronary computed tomographic angiography at 1 year, and the secondary end point was major adverse cardiac and cerebrovascular events including death from any cause, myocardial infarction, stroke, or repeat revascularization. Grafts on functionally nonsignificant LAD arteries (QFR >0.80) had a significantly higher failure rate than those on functionally significant LAD arteries (31.4% versus 7.2%, P<0.001). QFR outperforms degree of stenosis in discriminating graft failure (C statistic, 0.76 versus 0.58). Clinical follow-up (3.6 years, interquartile range [3.3-4.1]) was accomplished in 405 patients, and the rate of major adverse cardiac and cerebrovascular events was significantly higher among patients with functionally nonsignificant LAD arteries (10.1% versus 4.2%; adjusted hazard ratio, 3.08 [95% CI, 1.18-8.06]; P=0.022). Conclusions In patients receiving internal mammary artery to LAD artery coronary artery bypass grafting, preoperative QFR of the LAD artery of >0.80 was associated with a higher graft failure rate at 1 year and worse patient outcomes at the 3.6-year follow-up.

Left main bifurcation stenting: impact of residual ischaemia on cardiovascular mortality.

AIMS: The present study sought to determine the rate and prognostic implications of post-procedural physiologically significant residual ischemia according to Murray law-based quantitative flow ratio (µQFR) after left main (LM) bifurcation percutaneous coronary intervention (PCI). METHODS AND RESULTS: Consecutive patients undergoing LM bifurcation stenting at a large tertiary care center between January 2014 and December 2016 with available post-PCI µQFR were included. Physiologically significant residual ischemia was defined by post-PCI µQFR values ≤0.80 in the left anterior descending (LAD) or left circumflex artery (LCX). The primary outcome was 3-year cardiovascular death. The major secondary outcome was 3-year bifurcation-oriented composite endpoint (BOCE). Among 1170 included patients with analyzable post-PCI µQFR, 155 (13.2%) had residual ischemia in either LAD or LCX. Patients with vs. those without residual ischemia had a higher risk of 3-year cardiovascular mortality [5.4% vs. 1.3%; adjusted hazard ratio (HR) 3.20, 95% confidence interval (CI): 1.16-8.80]. The 3-year risk of BOCE was significantly higher in the residual ischemia group (17.8% vs. 5.8%; adjusted HR 2.79, 95% CI: 1.68-4.64), driven by higher incidence of the composite of cardiovascular death and target bifurcation-related myocardial infarction (14.0% vs. 3.3%; adjusted HR 4.06, 95% CI: 2.22-7.42). A significant, inverse association was observed between continuous post-PCI µQFR and the risk of clinical outcomes (per 0.1 µQFR decrease, HR of cardiovascular death 1.27, 95% CI: 1.00-1.62; HR of BOCE 1.29, 95% CI: 1.14-1.47). CONCLUSION: After angiographically successful LM bifurcation PCI, residual ischemia assessed by µQFR was identified in 13.2% of patients and was associated with higher risk of 3-year cardiovascular death, indicating the superior prognostic value of post-PCI physiological assessment.

Association between lipoprotein(a) and long-term outcomes after percutaneous coronary intervention for lesions with in-stent restenosis.

OBJECTIVES: This study aimed to evaluate the association between increased lipoprotein (a) [Lp(a)] and long-term outcomes in patients undergoing percutaneous coronary intervention (PCI) for in-stent restenosis (ISR). BACKGROUND: Elevated Lp(a) is demonstrated to be associated with recurrent ischemic events after PCI. However, the impact of Lp(a) in patients with ISR remains undetermined. METHODS: Between January 2017 and December 2018, a total of 2086 patients who underwent PCI for ISR were consecutively enrolled. Patients were categorized as elevated group (> 30 mg/dL, n=834) and non-elevated group (≤ 30 mg/dL, n=1252) according to baseline Lp(a) levels. The primary outcome was the rate of major adverse cardiac events (MACE), defined as a composite endpoint of all-cause death, spontaneous myocardial infarction (MI), or repeat revascularization. RESULTS: During a median follow-up of 36 months, the primary outcome occurred in 202 of 1252 patients (26.7%) in the elevated Lp(a) group and 237 of 834 patients (21.8%) in the non-elevated Lp(a) group (adjusted hazard ratio: 1.31; 95% confidence interval: 1.08-1.58; P = 0.007), driven by higher rate of all-cause death (4.1% vs. 2.5%, P = 0.002 by Log-rank test; aHR: 1.77; 95% CI: 1.07-2.94; P = 0.03) and repeat revascularization (22.3% vs. 19.5%, P = 0.04 by Log-rank test; aHR: 1.18; 95% CI: 0.94-1.49; P = 0.16). Adding continuous or categorical Lp(a) to the Cox model led to a significant improvement in C-statistic, net reclassification, and integrated discrimination. The results were consistent across subgroups. CONCLUSIONS: In the current cohort of patients who underwent PCI for ISR, elevated Lp(a) at baseline is associated with higher risk of long-term MACE.

First-in-human evaluation of a novel ultrathin sirolimus-eluting iron bioresorbable scaffold: 3-year outcomes of the IBS-FIM trial.

BACKGROUND: The first-generation polymeric bioresorbable scaffolds resulted in higher than acceptable 3-year rates of device-related adverse outcomes. AIMS: We aimed to assess the intermediate-term safety and performance of a novel ultrathin-strut sirolimus-eluting iron bioresorbable scaffold (IBS) in non-complex coronary lesions. METHODS: The prospective, single-arm, open-label IBS first-in-human study enrolled 45 patients, each with a single de novo lesion. Enrolled patients were randomly assigned to 2 follow-up cohorts. Angiographic and imaging follow-up with intravascular ultrasound and optical coherence tomography (OCT) were conducted at 6 and 24 months in cohort 1 (n=30) and at 12 and 36 months in cohort 2 (n=15). Clinical follow-up was conducted at 1, 6 and 12 months, and annually thereafter up to 5 years. The coprimary outcomes were target lesion failure (TLF) and angiographic late lumen loss (LLL) at 6 months. RESULTS: A total of 45 patients were enrolled between April 2018 and January 2019. The mean age was 53.2 years, 77.8% were male, and 26.7% had diabetes. The TLF rates were 2.2% at 6 months and 6.7% at 3 years, which in all cases were due to clinically indicated target lesion revascularisation. No deaths, myocardial infarctions or stent thromboses occurred during 3-year follow-up. In-scaffold LLL was 0.33±0.27 mm at 6 months and 0.37±0.57 mm at 3 years. By OCT, the proportion of covered struts was 99.8% at 6 months and 100% after 1 year. The 3-year strut absorption rate was 95.4%. CONCLUSIONS: In this first-in-human experience, an ultrathin IBS was safe and effective for the treatment of de novo non-complex coronary lesions up to 3-year follow-up.

Quantitative flow ratio and graft outcomes of coronary artery bypass grafting surgery: A retrospective study.

OBJECTIVE: Quantitative flow ratio (QFR) is a novel noninvasive tool for the functional assessment of coronary stenosis. Whether or not QFR could predict graft outcomes after coronary artery bypass grafting procedure is unknown. This study aimed to investigate the association of QFR value with graft outcomes after coronary artery bypass grafting surgery. METHODS: The QFR values were retrospectively obtained from patients receiving coronary artery bypass grafting surgery from 2017 to 2019 in the Graft Patency Between No-Touch Vein Harvesting Technique and Conventional Approach in Coronary Artery Bypass Graft Surgery (PATENCY) trial. QFR calculation was conducted in eligible coronary arteries, defined as those with ≥50% stenosis and a diameter ≥1.5 mm. A threshold of QFR ≤0.80 was considered functionally significant stenosis. The primary outcome was graft occlusion at 12 months evaluated by computed tomography angiography. RESULTS: Two thousand twenty-four patients with 7432 grafts (2307 arterial grafts and 5125 vein grafts) were included. For the arterial grafts, the risk of 12-month occlusion was significantly increased in the QFR >0.80 group than in the QFR ≤0.80 group (7.1% vs 2.6%; P = .001; unadjusted model: odds ratio, 3.08; 95% CI, 1.65-5.75; fully adjusted model: odds ratio, 2.67; 95% CI, 1.44-4.97). No significant association was observed in the vein grafts (4.6% vs 4.3%; P = .67; unadjusted model: odds ratio, 1.10; 95% CI, 0.82-1.47; fully adjusted model: odds ratio, 1.12; 95% CI, 0.83-1.51). Results were stable across sensitivity analyses with a QFR threshold of 0.78 and 0.75. CONCLUSIONS: Target vessel QFR >0.80 was associated with a significantly higher risk of arterial graft occlusion at 12 months after coronary artery bypass grafting surgery. No significant association was found between target lesion QFR and vein graft occlusion.

Long-term clinical outcomes of percutaneous coronary intervention for ostial left main coronary artery disease.

BACKGROUND: There are limited data regarding the long-term prognosis of percutaneous coronary intervention treatment for left main (LM) ostial stenosis. AIMS: The present study sought to investigate the long-term clinical outcomes and risk factors for adverse events in LM ostial lesions following drug-eluting stent implantation (DES) in a large cohort of an LM registry database. METHODS: Patients presenting with LM coronary disease from January 2004 to December 2016 at Fuwai Hospital were included. The primary endpoint was target vessel failure (TVF), a composite endpoint of cardiac death, target vessel myocardial infarction and target vessel revascularisation. Cox proportional hazards models were constructed to identify independent predictors. RESULTS: Among 4,625 LM patients, 627 (13.6%) patients were identified with LM ostial lesions. There were more female patients in the ostial group (31.3%), compared with the shaft (18.1%) and bifurcation groups (19.9%) (p<0.0001). Among patients with DES implantation, 3-year TVF occurred in 44 patients (7.5%) in the ostial group, which is comparable with the other two groups. Myocardial infarction (MI) was significantly lower in the ostial group (2.0%) compared with the bifurcation group (4.2%) (p=0.02), especially for MI events originating in the LM vessel (p=0.02). For patients with ostial LM disease who received percutaneous coronary intervention (PCI) treatment, procedural complications were an independent risk factor for long-term cardiac death or MI, while a more recent PCI proved to be a protective factor. CONCLUSIONS: PCI treatment for ostial LM lesions achieved favourable long-term outcomes, with a similar MI risk compared with the mid-shaft group but a significantly lower risk of MI compared with the distal group.

Short-Term Risk Stratification of Non-Flow-Limiting Coronary Stenosis by Angiographically Derived Radial Wall Strain.

BACKGROUND: Deferred revascularization of mildly stenotic coronary vessels based exclusively on physiological evaluation is associated with up to 5% residual incidence of future adverse events at 1 year. OBJECTIVES: We aimed to evaluate the incremental value of angiography-derived radial wall strain (RWS) in risk stratification of non-flow-limiting mild coronary narrowings. METHODS: This is a post hoc analysis of 824 non-flow-limiting vessels in 751 patients from the FAVOR III China (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients With Coronary Artery Disease) trial. Each individual vessel had ≥1 mildly stenotic lesion. The primary outcome was vessel-oriented composite endpoint (VOCE), defined as the composite of vessel-related cardiac death, vessel-related myocardial infarction (nonprocedural), and ischemia-driven target vessel revascularization at 1-year follow-up. RESULTS: During 1-year follow-up, VOCE occurred in 46 of 824 vessels, with a cumulative incidence of 5.6%. Maximum RWS (RWSmax) was predictive of 1-year VOCE with an area under the curve of 0.68 (95% CI: 0.58-0.77; P < 0.001). The incidence of VOCE was 14.3% in vessels with RWSmax >12% vs 2.9% in those with RWSmax ≤12%. In the multivariable Cox regression model, RWSmax >12% was a strong independent predictor of 1-year VOCE in deferred non-flow-limiting vessels (adjusted HR: 4.44; 95% CI: 2.43-8.14; P < 0.001). The risk of deferred revascularization based on combined normal RWSmax and Murray-law-based quantitative flow ratio (µQFR) was significantly reduced compared with µQFR alone (adjusted HR: 0.52; 95% CI: 0.30-0.90; P = 0.019). CONCLUSIONS: Among vessels with preserved coronary flow, angiography-derived RWS analysis has the potential to further discriminate vessels at risk of 1-year VOCE. (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients With Coronary Artery Disease [FAVOR III China Study]; NCT03656848).

Data simulation to forecast the outcomes of the FAVOR III China trial.

BACKGROUND: FAVOR III China (F3C) is a large-scale randomized trial comparing QFR-guided and angiography-guided percutaneous coronary intervention (PCI) strategies. The aim of current study was to assess the feasibility of predicting the 1-year outcomes of the F3C trial using simulation of retrospectively assessed quantitative flow ratio (QFR) data obtained from the all-comers PANDA III trial. METHODS: Among 2348 subjects from the PANDA III trial, angiography from 1391 patients was able to be analyzed with QFR. Each subject from the F3C was matched to a PANDA III patient according to the five baseline characteristics (age, sex, diabetes, multivessel disease, and existence of any vessel with diameter stenosis % >90% and thrombolysis in myocardial infarction flow <3) through a bootstrapping sampling process. Outcome predictions were based on these blinded baseline data. The primary endpoint was a composite of death, myocardial infarction, or revascularization at 1 year. RESULTS: Among the patients with analyzable QFR, 814 patients were able to be matched to F3C patients undergoing a QFR-guided treatment strategy. After 10,000 simulations, the patients in the QFR-guided group were simulated to have a 1.9% (95% predictive intervals: -3.5% to -0.3%) absolute reduction of the occurrence of the primary study endpoint compared with the angiography-guided group. In total, 72.7% (7266/10,000) simulated point estimates fell within the actual 95% CI of F3C (-4.7% to -1.4%). CONCLUSIONS: Using a simulation process based on a comparison to an existing trial cohort, the primary results of a prospectively conducted randomized controlled trial could be predicted with reasonable precision.

Simultaneous Hybrid Coronary Revascularization vs Conventional Strategies for Multivessel Coronary Artery Disease: A 10-Year Follow-Up.

BACKGROUND: Although evidence is sufficient to confirm that hybrid coronary revascularization (HCR) is safe and effective in the short term, its value in the long run is debatable. OBJECTIVES: This study sought to compare the long-term outcomes of HCR with coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for multivessel disease. METHODS: Three groups of patients, 540 each, receiving HCR, CABG, or PCI between June 2007 to September 2018, were matched using propensity score matching. Patients were stratified by EuroSCORE (European System for Cardiac Operative Risk Evaluation) II (low ≤0.9; 0.9 < medium <1.5; high ≥1.5) and SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (low ≤22; 22 < medium <33; high ≥33). Major adverse cardiac and cerebrovascular events (MACCE) and Seattle Angina Questionnaire (SAQ) scores were compared among the 3 groups. RESULTS: In terms of MACCE and SAQ, HCR performed similarly to off-pump CABG but significantly outperformed PCI (P < 0.001). In the low-to-medium EuroSCORE II and medium-to-high SYNTAX score tertiles, MACCE rates in the HCR group were significantly lower than those in the PCI (EuroSCORE II: low, 30.7% vs 41.2%; P = 0.006; medium, 31.3% vs 41.7%; P = 0.013; SYNTAX score: medium, 27.6% vs 41.2%; P = 0.018; high, 32.4% vs 52.7%; P = 0.011) but were similar to those in the CABG group. In the high EuroSCORE II stratum, HCR had a lower MACCE rate than CABG (31.9% vs 47.0%; P = 0.041) and PCI (31.9% vs 53.7%; P = 0.015). CONCLUSIONS: Compared with conventional strategies, HCR provided satisfactory long-term outcomes in MACCE and functional status for multivessel disease.

Outcomes of Functionally Complete vs Incomplete Revascularization: Insights From the FAVOR III China Trial.

BACKGROUND: Functional complete revascularization (FCR) after percutaneous coronary intervention (PCI) as determined by the residual functional SYNTAX score (rFSS) based on pressure wire fractional flow reserve assessment has been associated with an improved prognosis. OBJECTIVES: This study sought to determine the rates and clinical implications of FCR as assessed by the quantitative flow ratio (QFR), and to determine the outcomes of pre-PCI QFR guidance compared with standard angiography guidance in patients achieving and not achieving FCR after PCI. METHODS: In the randomized, sham-controlled, blinded, multicenter FAVOR (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) III China trial, QFR-guided PCI reduced the 1-year rate of major adverse cardiac events (MACE) compared with angiography-guided PCI. In the present prespecified substudy, the incidence of MACE was compared according to the presence of post-PCI FCR (rFSS = 0 based on core laboratory-assessed QFR) in the QFR-guided and angiography-guided groups. RESULTS: Among 3,781 patients with available rFSS assessments, 3,221 (85.2%) achieved FCR, including 88.1% after QFR guidance and 82.2% after angiography guidance (P < 0.001). Patients with FCR had a markedly lower rate of 1-year MACE compared with those with functional incomplete revascularization (FIR) (rFSS ≥1) (5.1% vs 19.7%; P < 0.001). Prognostic models including the rFSS had higher discrimination and reclassification ability than those with the anatomic residual SYNTAX score. The relative risks for 1-year MACE with QFR-guided compared with the angiography-guided lesion selection were consistent in patients achieving FCR (4.1% vs 6.3%; HR: 0.65; 95% CI: 0.47-0.88) and in those with FIR (18.7% vs 20.4%; HR: 0.90; 95% CI: 0.61-1.32) (Pinteraction = 0.19). CONCLUSIONS: In this large-scale trial, achieving FCR after PCI was associated with markedly lower 1-year rates of MACE. Compared with standard angiography guidance, QFR-guided PCI lesion selection improved the likelihood of achieving FCR and improved 1-year clinical outcomes in patients with both FCR and FIR.