Sirolimus-eluting iron bioresorbable scaffold versus cobalt-chromium everolimus-eluting stents in patients with coronary artery disease: Rationale and design of the IRONMAN-II trial.

BACKGROUND: The previous first-in-human study established the preliminary safety and effectiveness of the novel thin-strut iron bioresorbable scaffold (IBS). The current study aims to directly compare the imaging and physiological efficacy, and clinical outcomes of IBS with contemporary metallic drug-eluting stents (DES). METHODS: A total of 518 patients were randomly allocated to treatment with IBS (257 patients) or metallic DES (261 patients) from 36 centers in China. The study is powered to test noninferiority of the IBS compared with the metallic everolimus-eluting stent in terms of the primary endpoint of in-segment late lumen loss at 2 years, and major secondary endpoints including 2-year quantitative flow ratio and cross-sectional mean flow area measured by optical coherence tomography (OCT) (limited to the OCT subgroup, 25 patients in each group). CONCLUSION: This will be the first powered randomized trial investigating the safety and efficacy of the novel thin-strut IBS compared to a contemporary metallic DES. The findings will provide valuable evidence for future research of this kind and the application of metallic bioresorbable scaffolds.

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.

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.

Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial.

BACKGROUND: Compared with visual angiographic assessment, pressure wire-based physiological measurement more accurately identifies flow-limiting lesions in patients with coronary artery disease. Nonetheless, angiography remains the most widely used method to guide percutaneous coronary intervention (PCI). In FAVOR III China, we aimed to establish whether clinical outcomes might be improved by lesion selection for PCI using the quantitative flow ratio (QFR), a novel angiography-based approach to estimate the fractional flow reserve. METHODS: FAVOR III China is a multicentre, blinded, randomised, sham-controlled trial done at 26 hospitals in China. Patients aged 18 years or older, with stable or unstable angina pectoris or patients who had a myocardial infarction at least 72 h before screening, who had at least one lesion with a diameter stenosis of 50-90% in a coronary artery with a reference vessel of at least 2·5 mm diameter by visual assessment were eligible. Patients were randomly assigned to a QFR-guided strategy (PCI performed only if QFR ≤0·80) or an angiography-guided strategy (PCI based on standard visual angiographic assessment). Participants and clinical assessors were masked to treatment allocation. The primary endpoint was the 1-year rate of major adverse cardiac events, a composite of death from any cause, myocardial infarction, or ischaemia-driven revascularisation. The primary analysis was done in the intention-to-treat population. The trial was registered with ClinicalTrials.gov (NCT03656848). FINDINGS: Between Dec 25, 2018, and Jan 19, 2020, 3847 patients were enrolled. After exclusion of 22 patients who elected not to undergo PCI or who were withdrawn by their physicians, 3825 participants were included in the intention-to-treat population (1913 in the QFR-guided group and 1912 in the angiography-guided group). The mean age was 62·7 years (SD 10·1), 2699 (70·6%) were men and 1126 (29·4%) were women, 1295 (33·9%) had diabetes, and 2428 (63·5%) presented with an acute coronary syndrome. The 1-year primary endpoint occurred in 110 (Kaplan-Meier estimated rate 5·8%) participants in the QFR-guided group and in 167 (8·8%) participants in the angiography-guided group (difference, -3·0% [95% CI -4·7 to -1·4]; hazard ratio 0·65 [95% CI 0·51 to 0·83]; p=0·0004), driven by fewer myocardial infarctions and ischaemia-driven revascularisations in the QFR-guided group than in the angiography-guided group. INTERPRETATION: In FAVOR III China, among patients undergoing PCI, a QFR-guided strategy of lesion selection improved 1-year clinical outcomes compared with standard angiography guidance. FUNDING: Beijing Municipal Science and Technology Commission, Chinese Academy of Medical Sciences, and the National Clinical Research Centre for Cardiovascular Diseases, Fuwai Hospital.

Long-term prognostic value of dynamic function assessment of intermediate coronary lesion with computational physiology.

This study sought to investigate the dynamic functional changes of coronary intermediate lesions using quantitative flow ratio (QFR) and its implication on long-term clinical outcomes. Physiology-guided percutaneous coronary intervention in patients with angiographic intermediate lesions has been associated with favorable outcomes. This study consecutively enrolled 1130 patients with deferred intermediate lesions at baseline angiography and subsequently received second-time angiography between 9 months and 2 years later from two centers in China. The functional changes of intermediate lesions at angiographic follow-up (ΔQFR) were defined as (baseline QFR-follow-up QFR)/years. The primary outcome was vessel-oriented composite endpoint (VOCE), defined as the composite of vessel-related cardiac death, vessel-related myocardial infarction (MI), and ischemia-driven target vessel revascularization (ID-TVR) at angiographic follow-up for up to 5 years. Retrospective QFR assessment was available in 820 patients (996 intermediate lesions). QFR ≤ 0.80 at second-time angiography was associated with significantly higher 5-year VOCE (41.9% vs. 13.4%, p < 0.0001). In 777 intermediate lesions with baseline QFR > 0.80, mean ΔQFR was 0.03 ± 0.07 (median: 0.006; Q1: 0; and Q3: 0.04). The optimal cutoff of ΔQFR for predicting the primary outcome was 0.03 (area under the curve [AUC]: 0.68). The cumulative event rate of VOCE in patients with ΔQFR ≥ 0.03 was significantly higher than in those with ΔQFR < 0.03 (33.8% vs. 12.2%, p < 0.0001), driven by higher vessel-related MI and ID-TVR. The ΔQFR was a useful tool for evaluating the dynamic functional change of deferred intermediate lesions, as it demonstrates good prognostic value for long-term target vessel-related adverse events.

Establishing the optimal duration of DAPT following PCI in high-risk TWILIGHT-like patients with acute coronary syndrome.

OBJECTIVES: To determine the association of extended-term (>12-month) versus short-term dual antiplatelet therapy (DAPT) with ischemic and hemorrhagic events in high-risk "TWILIGHT-like" patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) in clinical practice. BACKGROUND: Recent emphasis on shorter DAPT regimen after PCI irrespective of indication for PCI may fail to account for the substantial residual risk of recurrent atherothrombotic events in ACS patients. METHODS: All consecutive patients fulfilling the "TWILIGHT-like" criteria undergoing PCI were identified from the prospective Fuwai PCI Registry. High-risk patients (n = 8,358) were defined by at least one clinical and one angiographic feature based on TWILIGHT trial selection criteria. The primary ischemic endpoint was major adverse cardiac and cerebrovascular events at 30 months, composed of all-cause mortality, myocardial infarction, or stroke while BARC type 2, 3, or 5 bleeding was key secondary outcome. RESULTS: Of 4,875 high-risk ACS patients who remained event-free at 12 months after PCI, DAPT>12-month compared with shorter DAPT reduced the primary ischemic endpoint by 63% (1.5 vs. 3.8%; HRadj: 0.374, 95% CI: 0.256-0.548; HRmatched: 0.361, 95% CI: 0.221-0.590). The HR for cardiovascular death was 0.049 (0.007-0.362) and that for MI 0.45 (0.153-1.320) and definite/probable stent thrombosis 0.296 (0.080-1.095) in propensity-matched analyses. Rates of BARC type 2, 3, or 5 bleeding (0.9 vs. 1.3%; HRadj: 0.668 [0.379-1.178]; HRmatched: 0.721 [0.369-1.410]) did not differ significantly between two groups. CONCLUSIONS: Among high-risk ACS patients undergoing PCI, long-term DAPT, compared with shorter DAPT, reduced ischemic events without a concomitant increase in clinically meaning bleeding events, suggesting that prolonged DAPT can be considered in ACS patients who present with a particularly higher risk for thrombotic complications without excessive risk of bleeding.

Integrated coronary disease burden and patterns to discriminate vessels benefiting from percutaneous coronary intervention.

OBJECTIVE: To evaluate the prognostic implications of atherosclerosis functional pattern on ischemia-causing vessels received percutaneous coronary intervention (PCI) or conservative treatment. BACKGROUND: Quantitative flow ratio (QFR)-derived pullback pressure gradient (PPG) index is recently proposed to characterize atherosclerosis functional pattern, but its prognostic value remains unclear. METHODS: QFR-derived PPG index was retrospectively calculated in patients from the PANDA III trial. Vessels with low or high PPG treated by PCI or not were compared for the risk of 2-year vessel-oriented composite outcome (VOCO), which was a composite of vessel-related ischemia-driven revascularization, vessel-related myocardial infarction, or cardiac death. RESULTS: A total of 1444 vessels were included while 94 (6.5%) VOCOs occurred within 2 years. Among physiologically ischemic vessels (QFR ≤ 0.80) treated by PCI, those with low PPG acquired higher VOCO risk than those with high PPG (8.4% vs. 3.8%; adjusted hazard ratio [HR] 2.13, 95% confidence interval [CI] 1.18 to 3.86), and a similar VOCO risk (8.4% vs. 7.8%; adjusted HR 1.11, 95%CI 0.70-1.78) compared to those treated by conservatively. After multiple adjustment, PPG index was an independent predictor for VOCO (HR 1.30, 95% CI 1.05-1.62). The addition of PPG to the model of clinical risk factors substantially improved the predictions of VOCO (C-index 0.67 vs. 0.62, net reclassification index 0.42). CONCLUSIONS: PCI treatment was associated with improved outcomes in vessels with high PPG, but not for those with low PPG, which acquired similar risk of VOCO compared to vessels treated conservatively. QFR-derived PPG might assist the treatment strategy selection in ischemia-causing vessels.

Automatic construction of coronary artery tree structure based on vessel blood flow tracking.

We sought to propose an innovative vessel blood flow tracking (VBFT) method to extract coronary artery tree (CAT) and to assess the effectiveness of this VBFT versus the single-frame method. Construction of a CAT from a segmented artery is the basis of artificial intelligence-aided angiographic diagnosis. However, construction of a CAT using a single frame remains challenging, due to bifurcations and overlaps in two-dimensional angiograms. Overall, 13,222 angiograms, including 28,539 vessels, were retrospectively collected from 3275 patients and were then annotated. Coronary arteries were automatically segmented by a previously established deep neural networks (DNNs), and the skeleton lines were then extracted from segmentation images to construct CAT using the single-frame method and the VBFT method. Additionally, 1322 angiograms with 2201 vessels were used to test these two methods. Compared to the single-frame method, the VBFT method can significantly improve the accuracy of CAT as (84.3% vs. 72.3%; p < 0.001). Overlap (OV) was higher in the VBFT group than that in the Single-Frame group (91.1% vs. 87.5%; p < 0.001). The VBFT method significantly reduced the incidence of the lack of branching (7.30% vs. 13.9%, p < 0.001), insufficient length (6.70% vs. 11.0%, p < 0.001), and redundant branches (1.60% vs. 3.10%, p < 0.001). The VBFT method improved the extraction of a CAT structure, which will facilitate the development of artificial intelligence-aided angiographic diagnosis. Cardiologists can efficiently diagnose CAD using this method.

Thrombotic vs. Bleeding Events of Interruption of Dual Antiplatelet Therapy within 12 Months among Patients with Stent-Driven High Ischemic Risk Definition following PCI.

BACKGROUND: There is a paucity of real-world data regarding the clinical impact of dual antiplatelet therapy (DAPT) interruption (temporary or permanent) among patients at high ischemic risk. The aim of this study was to assess the risk of cardiovascular events after interruption of DAPT in high-risk PCI population. METHODS: This study used data from the Fuwai PCI registry, a large, prospective cohort of consecutive patients who underwent PCI. We assessed 3,931 patients with at least 1 high ischemic risk criteria of stent-related recurrent ischemic events proposed in the 2017 ESC guidelines for focused update on DAPT who were free of major cardiac events in the first 12 months. The primary ischemic endpoint was 30-month major adverse cardiac and cerebrovascular events, and the key safety endpoints were BARC class 2, 3, or 5 bleeding and net adverse clinical events. RESULTS: DAPT interruption within 12 months occurred in 1,122 patients (28.5%), most of which were due to bleeding events or patients' noncompliance to treatment. A multivariate Cox regression model, propensity score (PS) matching, and inverse probability of treatment weighting (IPTW) based on the propensity score demonstrated that DAPT interruption significantly increased the risk of primary ischemic endpoint compared with prolonged DAPT (3.9% vs. 2.2%; Cox-adjusted hazard ratio (HR): 1.840; 95% confidence interval (CI): 1.247 to 2.716; PS matching-HR: 2.049 [1.236-3.399]; IPTW-adjusted HR: 1.843 [1.250-2.717]). This difference was driven mainly by all-cause death (1.8% vs. 0.7%) and MI (1.3% vs. 0.5%). Furthermore, the rate of net adverse clinical events (4.9% vs. 3.2%; Cox-adjusted HR: 1.581 [1.128-2.216]; PS matching-HR: 1.639 [1.075-2.499]; IPTW-adjusted HR: 1.554 [1.110-2.177]) was also higher in patients with DAPT interruption (≤12 months), whereas no significant differences between groups were observed in terms of BARC 2, 3, or 5 bleeding. These findings were consistent across various stent-driven high-ischemic risk subsets with respect to the primary ischemic endpoints, with a greater magnitude of harm among patients with diffuse multivessel diabetic coronary artery disease. CONCLUSIONS: In patients undergoing high-risk PCI, interruption of DAPT in the first 12 months occurred infrequently and was associated with a significantly higher adjusted risk of major adverse cardiovascular events and net adverse clinical events. 2017 ESC stent-driven high ischemic risk criteria may help clinicians to discriminate patient selection in the use of long-term DAPT when the ischemic risk certainly overcomes the bleeding one.

Predictors for adverse outcomes of patients with recanalized chronic total occlusion lesion.

BACKGROUND: It is ill-defined which factors affect the prognosis of patients with recanalized chronic total occlusion (CTO). This study sought to investigate predictors for adverse outcome in such a cohort with long-time follow-up. METHODS: From 2010 to 2013, patients with successfully recanalized CTO were included. The primary endpoint was a composite of all-cause death, myocardial infarction or target vessel revascularization (TVR). The secondary endpoints were TVR and target lesion revascularization (TLR). RESULTS: A total of 1987 patients were enrolled and 1806 (90.6%) subjects completed 5-year follow-up. Multivariate Cox analysis revealed that age ≥ 75 years (HR,1.70; 95% CI, 1.09-2.64; P = .02), left ventricular ejection fraction <40% (HR, 1.94; 95% CI, 1.02-3.69; P = .04) and residual SYNTAX score (HR, 1.02; 95% CI, 1.01-1.04; P = .01) were predictors for the primary endpoint. Non-LAD CTO (HR, 1.82; 95% CI, 1.23-2.70; P < .01), J-CTO score (HR, 1.31; 95% CI, 1.11-1.54; P < .01) and residual SYNTAX score (HR, 1.02; 95% CI, 1.00-1.04; P = .04) were independently related to TVR. Non-LAD CTO, high J-CTO score and residual SYNTAX score was also correlated with TLR. CONCLUSIONS: Advanced age, left ventricular dysfunction and residual SYNTAX score were predictors for composite cardiovascular events in patients with CTO after revascularization. Those with non-LAD CTO, high J-CTO and residual SYNTAX score had higher risk for revascularization.

Angiographic characteristics and long-term outcomes of single-vessel chronic total occlusion percutaneous coronary intervention in patients with and without previous myocardial infarction.

OBJECTIVE: This study evaluated the angiographic characteristics and clinical outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) among patients with and without a history of myocardial infarction (MI). BACKGROUND: The pathogenesis of CTO and myocardial viability are different in cases with or without previous MI. However, the lesion characteristics and clinical outcomes are unclear for these two groups. METHODS: We reviewed consecutive patients who underwent single-vessel CTO PCI from 2010 to 2013. Patients were classified according to their history of MI. Acute procedural results were classified as optimal recanalization, suboptimal recanalization, or technical failure. The primary endpoint was the 5 year rate of cardiac death. RESULTS: We identified 2,191 eligible patients, including 859 patients (39.2%) with previous MI. The overall technical success rate was 74.4%. Relative to the non-MI group, the MI group had a larger reference vessel diameter (3.0 ± 0.5 vs. 2.9 ± 0.4 mm, p = .002), a lower proportion of Werner grade ≥ 1 collateral circulation (65.4 vs. 79.2%, p < .001), a higher proportion of optimal recanalization (63.1 vs. 58.6%, p = .006), and a higher 5-year rate of cardiac death (3.9 vs. 2.1%, p = .02). In the MI group, suboptimal recanalization was associated with a significantly higher 5-year rate of spontaneous MI, relative to optimal recanalization and technical failure (11.7 vs. 4.6 vs. 4.1%, p = .006). CONCLUSIONS: Patients with CTO and previous MI had a larger reference vessel diameter, lower level of collateral circulation, and higher proportion of optimal recanalization. However, suboptimal recanalization in these patients was associated with an increased risk of spontaneous MI.

Thirty-day and 5-year results of percutaneous coronary intervention for in-stent restenotic chronic total occlusion lesions: Data from 2,659 consecutive patients.

OBJECTIVES: To investigate the procedure success rate and clinical outcomes of in-stent restenotic chronic total occlusion (ISR-CTO) percutaneous coronary intervention (PCI). BACKGROUND: Few studies have reported the short- and long-term clinical outcomes of ISR-CTO PCI. METHOD: Patients who underwent ISR-CTO (n = 212) or de-novo CTO (n = 2,447) PCI at Fuwai Hospital from 2010 to 2013 were enrolled. Thirty-day and 5-year clinical outcomes were analyzed. The primary outcome was the incidence of all-cause death, myocardial infarction (MI), and heart failure at follow-up. The secondary outcome was the recanalization result (reasonable, suboptimal, or failed recanalization). RESULTS: ISR-CTO PCI had a higher rate of suboptimal recanalization than de-novo CTO PCI (p < .01). The syntax score before PCI (odds ratio (OR): 1.06; 95% confidence interval (CI): 1.02-1.10; p = .002) and occlusion length ≥ 20 mm (OR: 2.70:95% CI: 1.46-4.98; p = .001) were predictors of suboptimal recanalization in ISR-CTO PCI. Cardiac death (p = .03) and 30-day all-cause mortality (p = .05) were higher among patients who underwent ISR-CTO PCI. The ISR-CTO group had a higher rate of MI (p = .07) at 5 years. Suboptimal recanalization (hazard ratio: 2.56; 95% CI: 1.13-5.83; p = .025) was an independent predictor of long-term major adverse events in ISR-CTO. CONCLUSIONS: Suboptimal recanalization, 30-day cardiac death, and long-term MI rates are higher for ISR-CTO PCI than de-novo CTO PCI. Suboptimal recanalization is an independent predictor of long-term major adverse events after ISR-CTO PCI.

Long-term clinical outcomes in transradial versus transfemoral access for left main percutaneous coronary intervention.

OBJECTIVE: The present study compared 10-year clinical outcomes between transradial access (TRA) and transfemoral access (TFA) for left main (LM) percutaneous coronary intervention (PCI). BACKGROUND: There are limited data regarding the long-term safety and efficacy of TRA for LM PCI. METHODS: This retrospective study evaluated consecutive patients who underwent unprotected LM PCI between January 2004 and December 2008 at Fu Wai Hospital. The exclusion criteria were age of less than 18 years and presentation with acute myocardial infarction. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), which was defined as a composite of all-cause death, myocardial infarction, stroke, and any revascularization at the 10-year follow-up. RESULTS: Among 913 eligible patients, TRA was used for 417 patients (45.7%) and TFA was used for 496 patients (54.3%). The 30-day clinical outcomes were similar between the two groups. Results from the 10-year follow-up revealed that MACCE occurred in 180 patients (46.7%) from the TRA group and in 239 patients (51.2%) from the TFA group (log-rank p = .3). The TRA and TFA groups also had low and comparable cumulative rates of all-cause death (14.6% vs. 17.3%, log-rank p = .56) and cardiac death (7.9% vs. 9.1%, log-rank p = .7). CONCLUSION: The present study revealed no significant differences in long-term clinical outcomes when TRA or TFA were used for LM PCI.

Association of symptom status, myocardial viability, and clinical/anatomic risk on long-term outcomes after chronic total occlusion percutaneous coronary intervention.

OBJECTIVES: This study aimed to examine the association of less-certain indication of chronic total occlusion percutaneous coronary intervention (CTO-PCI) with subsequent clinical outcomes. BACKGROUND: The impact of patient symptoms, myocardial viability, and clinical and anatomic risk on long-term outcomes is underdetermined. METHODS: Consecutive patients undergoing CTO-PCI at a large-volume single center between 2010 and 2013 were included. Central adjudication was used to assess the appropriateness of three prespecified indications. The primary outcome was the 5-year composite endpoint of death or myocardial infarction (MI). RESULTS: Of 2,659 patients with 2,735 CTO lesions, the 348 (13.1%) asymptomatic patients, 164 (6.2%) patients without viable myocardium in the CTO territory, and 306 (11.5%) patients in whom the Synergy between PCI with Taxus and Cardiac Surgery Score II favored coronary artery bypass grafting (CABG) had higher 5-year death or MI compared with the rest patients in each category (12.0% vs. 8.6%, p = .04; 16.3% vs. 8.5%, p < .0001; 12.2% vs. 8.6%, p = .03), respectively. Multivariable regression analysis demonstrated that without symptom (hazard ratio: 1.51; 95% confidence interval: 1.06-2.15; p = .02), non-viable myocardium in CTO territory (hazard ratio: 1.77; 95% confidence interval: 1.16-2.72; p = .009), and deemed more favorable for CABG (hazard ratio:1.54; 95% confidence interval: 1.04-2.28; p = .03), but not the technical success (hazard ratio:0.85; 95% confidence interval: 0.62-1.18; p = .34), were independent predictors for the primary endpoint. CONCLUSIONS: In this large cohort of CTO-PCI, those who were asymptomatic, non-viable myocardium in the CTO territory, or deemed more favorable for CABG were associated with higher risk of long-term mortality or MI.

Predicting 2-year all-cause mortality after contemporary PCI: Updating the logistic clinical SYNTAX score.

AIMS: We aimed to update the logistic clinical SYNTAX score to predict 2 year all-cause mortality after contemporary percutaneous coronary intervention (PCI). METHODS AND RESULTS: We analyzed 15,883 patients in the GLOBAL LEADERS study who underwent PCI. The logistic clinical SYNTAX model was updated after imputing missing values by refitting the original model (refitted original model) and fitting an extended new model (new model, with, selection based on the Akaike Information Criterion). External validation was performed in 10,100 patients having PCI at Fu Wai hospital. Chronic obstructive pulmonary disease, prior stroke, current smoker, hemoglobin level, and white blood cell count were identified as additional independent predictors of 2 year all-cause mortality and included into the new model. The c-indexes of the original, refitted original and the new model in the derivation cohort were 0.74 (95% CI 0.72-0.76), 0.75 (95% CI 0.73-0.77), and 0.78 (95% CI 0.76-0.80), respectively. The c-index of the new model was lower in the validation cohort than in the derivation cohort, but still showed improved discriminative ability of the newly developed model (0.72; 95% CI 0.67-0.77) compared to the refitted original model (0.69; 95% CI 0.64-0.74). The models overestimated the observed 2 year all-cause mortality of 1.11% in the Chinese external validation cohort by 0.54 percentage points, indicating the need for calibration of the model to the Chinese patient population. CONCLUSIONS: The new model of the logistic clinical SYNTAX score better predicts 2 year all-cause mortality after PCI than the original model. The new model could guide clinical decision making by risk stratifying patients undergoing PCI.

The Predictive Value of Baseline Target Lesion SYNTAX Score for No-Reflow during Urgent Percutaneous Coronary Intervention in Acute Myocardial Infarction.

OBJECTIVES: To evaluate the predictive value of target lesion SYNTAX score (TL-SS) for no-reflow in the patients with acute myocardial infarction undergoing urgent percutaneous coronary intervention (PCI). BACKGROUND: Risk assessment, prevention, and prompt management of no-reflow in urgent PCI are crucial but remain challenging. SYNTAX score emerged as a tool for prediction, but may contain redundant information. METHODS: After screening of consecutive patients who underwent urgent PCI in Fuwai Hospital from January 2013 to December 2013, 487 patients with 528 lesions were involved. The endpoint was no-reflow during the PCI procedure. RESULTS: No-reflow occurred in 52 patients (10.7%) and 53 lesions (10.0%). High TL-SS levels were strongly associated with increased risks of no-reflow in the urgent PCI procedure (all adjusted P < 0.05). TL-SS displayed good discrimination ability for no-reflow (C-statistics = 0.76, 95% CI 0.72-0.80), which was better than that of SYNTAX score (P=0.016). Following categorizing the lesions into two groups according to the Youden Index, the high-risk group (TL-SS ≥8) showed significantly higher no-reflow rate compared with the low-risk group (TL-SS <8) (20.6% vs. 3.6%, odds ratio 6.86, 95% confidence interval 3.50-13.41, P < 0.001). In the target lesions that underwent balloon predilation, maximum predilation pressure >10 atm was associated with higher rate of no-reflow in the high-risk group (odds ratio 3.81, 95% confidence interval 1.10-13.17). CONCLUSIONS: TL-SS is a potential predictor for risk stratification of no-reflow in urgent PCI. In the high TL-SS lesions that underwent balloon predilation, maximum predilation pressure >10 atm was associated with higher risk of no-reflow.

Long-Term Clinical Outcomes of Unprotected Left Main Percutaneous Coronary Intervention: A Large Single-Centre Experience.

AIMS: This study sought to report the 10-year clinical outcomes of patients who underwent unprotected left main (LM) percutaneous coronary intervention (PCI) in a large centre. METHODS AND RESULTS: A total of 913 consecutive patients who underwent unprotected LM PCI from January 2004 to December 2008 at Fu Wai Hospital were retrospectively analysed; the mean age was 60.0 ± 10.9 years, females accounted for 22% of patients, diabetes was present in 27.7% of patients, and an LM bifurcation lesion occurred in 82.9% of patients. During the median follow-up of 9.7 years, major adverse cardiac or cerebrovascular events (MACCEs) occurred in 25.6% (234) of patients, and the rates of all-cause death, myocardial infarction, and stroke were 14.9%, 11.0%, and 7.1%, respectively. Cardiac death occurred in only 7.9% of patients. The estimated event rate was 41.9% for death/myocardial infarction/any revascularization and 45.9% for death/MI/stroke/any revascularization. Definite/probable stent thrombosis occurred in 4.3% (39) of patients. According to the subgroup analysis, IVUS-guided PCI was associated with less long-term MACCEs. Further multivariate analysis identified that age and LVEF<40% were the only independent predictors for 10-year death. Age, LVEF<40%, creatinine clearance, and incomplete revascularization were independent predictors for death/MI, while a two-stent strategy, diabetes, a transradial approach, and the use of bare metal stents (BMSs) or first-generation drug-eluting stents (DESs) were not. CONCLUSIONS: Unprotected LM PCI in a large cohort of consecutive patients in a single large centre demonstrated favourable long-term outcomes up to 10 years even with the use of BMSs and first-generation of DESs.

Quantitative flow ratio-guided strategy versus angiography-guided strategy for percutaneous coronary intervention: Rationale and design of the FAVOR III China trial.

BACKGROUND: Quantitative flow ratio (QFR) is a novel angiography-based approach enabling fast computation of fractional flow reserve without use of pressure wire or adenosine. The objective of this investigator-initiated, multicenter, patient- and clinical assessor-blinded randomized trial is to evaluate the efficacy and cost-effectiveness of a QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only guided (angiography-guided) strategy for percutaneous coronary intervention (PCI) in patients with coronary artery disease. METHODS: Approximately 3,830 patients will be randomized in a 1:1 ratio to a QFR-guided or an angiography-guided strategy. Included subjects scheduled for coronary angiography have at least 1 lesion eligible for PCI with 50%-90% stenosis in an artery with ≥2.5 mm reference diameter. Subjects assigned to the QFR-guided strategy will have QFR measured in each interrogated vessel and undergo PCI when QFR ≤0.80, with deferral for lesions with QFR >0.80. Those assigned to the angiography-guided strategy will undergo PCI based on angiography. Optimal medical therapy will be administered to all treated and deferred patients. The primary end point is the 1-year rate of major adverse cardiac events (MACE), a composite of all-cause mortality, any myocardial infarction, or any ischemia-driven revascularization. The major secondary end point is 1-year MACE excluding periprocedural myocardial infarction. Other secondary end points include the individual components of MACE and cost-effectiveness end points. The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance. CONCLUSIONS: The FAVOR III China study will be the first randomized trial to examine the effectiveness and cost-effectiveness of a QFR-guided versus an angiography-guided PCI strategy in coronary artery disease patients.

A modified predilation, sizing, and postdilation scoring system for patients undergoing metallic drug-eluting stent implantations.

OBJECTIVE: This study sought to assess whether the predilation, scaffold/stent sizing, and postdilation (PSP) score for bioresorbable scaffold (BRS) implantation was associated with outcomes following metallic drug-eluting stent (DES) implantation. BACKGROUND: The PSP score is associated with patients' prognoses after BRS implantation. METHODS: This study involved 2,348 patients who underwent biodegradable polymer DES implantations during the PANDA III trial. The optimal PSP technique was defined according to previous studies of BRS implantations. The main outcome was target lesion failure (TLF) that comprised cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization. RESULTS: Twenty-five (1.1%) patients fulfilled all the PSP criteria. The BRS-derived PSP score was of limited prognostic value for 2-year TLF after metallic DES implantation; optimal sizing was a protective factor, but optimal predilation was a risk factor. We built a new PSP model for DESs by identifying the following risk factors: predilation performed with a residual stenosis ≥70% or a balloon-to-quantitative coronary angiography (QCA)-determined reference vessel diameter (RVD) ratio >1:1, sizing performed with an RVD <2.25 mm or a stent diameter >0.25 mm wider than the QCA-RVD, a postprocedural stenosis diameter ≥30%, age, and the baseline SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) score. The new PSP scoring system predicted 2-year TLF (area under the curve, 0.69; 95% confidence interval, 0.65-0.73); a cutoff value of 19.2 points identified high-risk patients. CONCLUSIONS: The new PSP scoring system, based on redefined PSP criteria, age, and the SYNTAX score, could help optimize metallic DES implantations.

Integrating the residual SYNTAX score to improve the predictive ability of the age, creatinine, and ejection fraction (ACEF) score for cardiac mortality in percutaneous coronary intervention patients.

OBJECTIVES: To improve the prognostic value of the age, creatinine, and ejection fraction (ACEF) score following percutaneous coronary intervention (PCI) by integrating the residual SYNTAX score (rSS). BACKGROUND: ACEF score was proposed for predicting the operative mortality risk in elective cardiac operations and has been validated in numerous studies. However, it does not incorporate coronary lesion-based variables for risk assessment of patients who undergo PCI. METHODS: Overall, 10,072 patients who underwent PCI at our hospital in 2013 were enrolled. The endpoint was 2-year cardiac death after PCI, defined as death that was not attributed to a non-cardiac cause. ACEF-rSS was constructed with incremental weights attributed to the ACEF score and rSS according to their estimated coefficients. RESULTS: 2-year cardiac death occurred in 63 patients (0.63%). In multivariable analyses, the ACEF score and rSS > 8 were independently associated with the risk of cardiac death. ACEF-rSS was computed as age (years)/ejection fraction (%) + 1 (if creatinine ≥2.0 mg/dl) + 1 (if rSS >8). The discrimination of ACEF-rSS was significantly better than that of the ACEF score based on receiver operating characteristic (ROC) curve analysis and integrated discrimination improvement (IDI) (C-statistics = 0.835 vs. 0.776 for ACEF-rSS and ACEF score, respectively, p = .029; IDI = 0.014, p < .001). Compared with all other SYNTAX-derived risk scores, ACEF-rSS had significantly better discrimination ability based on ROC curve analysis, net reclassification improvement, and IDI. CONCLUSIONS: Combining the ACEF score with rSS to produce the ACEF-rSS enhanced the predictive ability for long-term cardiac mortality.