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In the multicenter, randomized, sham-controlled FAVOR (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) III China trial, quantitative flow ratio (QFR)-based lesion selection improved 1-year clinical outcomes compared with conventional angiographic guidance for percutaneous coronary intervention (PCI).The purpose of this study was to determine whether the benefits of QFR guidance persist at 2 years, particularly for patients in whom QFR changed the revascularization strategy.Eligible patients were randomized to a QFR-guided strategy (PCI performed only if QFR ≤0.80) or a standard angiography-guided strategy. Major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization occurring within 2 years were analyzed in the intention-to-treat population.Among 3,825 randomized participants, 2-year MACE occurred in 161 of 1,913 (8.5%) patients in the QFR-guided group and in 237 of 1,912 (12.5%) patients in the angiography-guided group (HR: 0.66; 95% CI: 0.54-0.81; P 0.0001), driven by fewer MIs (4.0% vs 6.8%; HR: 0.58; 95% CI: 0.44-0.77; P = 0.0002) and ischemia-driven revascularizations (4.2% vs 5.8%; HR: 0.71; 95% CI: 0.53-0.95; P = 0.02) in the QFR-guided group. Landmark analysis showed consistent results within the first year and between 1-2 years (PQFR-guided lesion selection improved 2-year clinical outcomes compared with standard angiography guidance. The benefits were most pronounced among patients in whom QFR assessment altered the planned revascularization strategy. (FAVOR III China Study [The Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease] NCT03656848).

Aims The ESC/EACTS myocardial revascularization guidelines recently standardized the definition of patients at high ischemic risk (HIR). However, the ability of ESC/EACTS-HIR criteria to stratify ischemic and bleeding risk in a contemporary real-world East Asian cohort remains unexplored. Methods A total of 10,167 consecutive patients undergoing PCI from prospective Fuwai PCI Registry (January 2013 to December 2013) were reviewed. ESC/EACTS-HIR features was defined as having at least one of the eight clinical and angiographic characteristics. The primary ischemic endpoint was target vessel failure (cardiac death, target vessel myocardial infarction [MI], or target vessel revascularization [TVR]); bleeding outcome was assessed using the BARC type 2, 3, or 5 bleeding. Median follow-up was 29 months. Results Compared with non-HIR patients, HIR patients (n=5,149, 50.6%) were associated with increased risk for target vessel failure (adjusted hazard ratio [HRadjust]: 1.48 [1.25-1.74]) and patient-oriented composite outcome (HRadjust: 1.44 [1.28-1.63]), as well as cardiac death, MI, and TVR. By contrast, the risk of clinically relevant bleeding was not significantly different between the two groups. (HRadjust: 0.84 [0.66-1.06]). Greater than or equal to three implanted stents and diabetic patients with diffuse multivessel coronary disease emerged as independent predictors for long-term adverse outcomes. There was no significant interaction between high bleeding risk (HBR) status and clinical outcomes associated with ESC/EACTS-HIR criteria (all Pinteraction ＞0.05). Conclusion The ESC/EACTS-HIR features identified patients at increased risk of thrombotic events, including cardiac death, but not for clinically relevant bleeding. Importantly, HBR did not modify cardiovascular risk subsequent to patients with ESC/EACTS-HIR features, suggesting its potential clinical applicability in tailoring antithrombotic therapy.

BACKGROUND: Quantitative flow ratio (QFR) is a novel angiography-based physiological index for fast computation of fractional flow reserve without the use of a pressure wire or induction of hyperaemia. AIMS: We sought to investigate the prevalence and prognostic implications of achieving physiology-consistent percutaneous coronary intervention (PCI) according to the baseline angiographic QFR in an all-comers cohort. METHODS: QFR was retrospectively analysed from the angiograms of 1,391 patients enrolled in the randomised PANDA III trial. Patients in whom all functionally ischaemic vessels (baseline QFR ≤0.80) were treated and in whom all non-ischaemic vessels (baseline QFR>0.80) were deferred were termed as having had QFR-consistent treatment; otherwise, they were termed as having had QFR-inconsistent treatment. The major outcome was two-year major adverse cardiac events (MACE; a composite of all-cause death, all myocardial infarction (MI), or any ischaemia-driven revascularisation). RESULTS: Overall, 814 (58.5%) patients had QFR-consistent PCI, while 577 (41.5%) patients received QFR-inconsistent PCI. Patients with QFR-consistent versus those with QFR-inconsistent treatment had a lower risk of two-year MACE (8.4% vs 14.7%; hazard ratio [HR] 0.56, 95% confidence interval [CI]: 0.41-0.78). After adjusting for differences in baseline covariates, two-year rates of MACE remained significantly lower in the QFR-consistent group (8.8% vs 13.6%; adjusted HR 0.64, 95% CI: 0.44-0.93), due mainly to reduced ischaemia-driven revascularisation (2.9% vs 8.0%; adjusted HR 0.35, 95% CI: 0.20-0.60). CONCLUSIONS: In this post hoc analysis of an all-comers PCI trial, approximately 60% of patients were treated in accordance with what the QFR measurement would have recommended, the achievement of which was associated with improved two-year clinical outcomes. ClinicalTrials.gov identifier: NCT02017275

This study aimed to assess the risk of side branch (SB) occlusion using the V-RESOLVE (The Visual Estimation for Risk prEdiction of Side Branch OccLusion in Coronary Bifurcation interVEntion) score in unprotected left main (LM) bifurcation percutaneous coronary intervention (PCI).The V-RESOLVE score is a validated score system, based on visual estimation of angiographic data, for prediction of the risk of SB occlusion after main vessel (MV) stenting in non-LM bifurcation lesions. However, its predictive value for unprotected LM bifurcation lesions remains to be validated.From January 2014 to December 2016, 855 patients undergoing unprotected LM bifurcation PCI using a provisional strategy were included. Baseline and prestenting angiographic data were analyzed, and the V-RESOLVE score was calculated. SB occlusion was defined as any decrease in thrombolysis in myocardial infarction (TIMI) flow grade or the absence of flow in the SB after MV stenting. The predictive performance of the V-RESOLVE score was judged by discrimination, calibration, and clinical application.vSB occlusion occurred in 19 (2.2%) of 855 unprotected LM bifurcation PCI procedures using a provisional strategy. The V-RESOLVE score for SB occlusion had brilliant discrimination (the area under the receiver operating characteristic curve = 0.80, 95% confidence interval [CI]: 0.77-0.84) and good calibration (Hosmer-Lemeshow: p = 0.154). Stratified by the V-RESOLVE score, significantly higher rates of SB occlusion were observed in the high-risk group (score: 12-43) compared with the nonhigh-risk group (score: 0-11) (4.4% vs. 0.6%, p 0.001).The V-RESOLVE score is a promising tool to predict the risk of SB occlusion and facilitate decision-making for unprotected LM bifurcation PCI.

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.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.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.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) (PIn 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.

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.

OBJECTIVES We aimed to explore the impact of 7-Fr sheaths on the incidence of early radial artery occlusion (RAO) after transradial coronary intervention (TRI) in Chinese patients. BACKGROUND RAO precludes future use of the vessel for vascular access. Transradial catheterization is usually performed via 5-Fr or 6-Fr catheters; 7-Fr sheath insertion enables complex coronary interventions but may increase the RAO risk. METHODS We prospectively enrolled 130 consecutive patients undergoing complex TRI using 7-Fr sheaths. Radial artery ultrasound assessment was performed before and after TRI. Early RAO was defined as the absence of flow on ultrasound within 6-24 hr after TRI. Multivariate logistic regression was used to determine the factors related to early RAO after TRI. RESULTS 7-Fr sheaths were mainly used for chronic total occlusion (44.6%), bifurcation (30.0%), and tortuous calcification (25.4%) lesions. All patients were successfully sheathed. Percutaneous coronary intervention (PCI) procedural success was 96.2%; 119 patients (91.5%) had preserved radial artery patency after TRI. All 11 RAO cases (8.5%) were asymptomatic. The radial artery diameter was significantly larger postoperatively (3.1 ± 0.4 mm) than preoperatively (2.6 ± 0.5 mm) (p

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

Post-percutaneous coronary intervention (PCI) residual disease is associated with clinical outcomes. Nevertheless, the prognostic value of residual disease patterns remains unknown.This study aimed to evaluate clinical implications of 2-dimensional residual disease patterns after PCI.One thousand six hundred seven vessels that underwent successful PCI were included. Two-dimensional residual disease patterns were determined by visual assessment or the quantitative flow ratio (QFR)-derived pull back pressure gradient index (with a cutoff value of 0.78 to define predominant focal versus diffuse disease) and instantaneous QFR gradient per unit length (with a cutoff value of ≥0.005/mm to define a major gradient). The clinical outcome was the 2-year vessel-oriented composite outcome (VOCO).Residual disease patterns were classified into 4 groups: predominant focal without and with a major gradient (group 1 [n = 1,058] and group 2 [n = 63], respectively) and predominant diffuse without and with a major gradient (group 3 [n = 318] and group 4 [n = 168], respectively). At 2 years, VOCO was lowest in group 1 (1.4% vs 5.4% in group 2 vs 4.8% in group 3 vs 8.5% in group 4, all P 0.05), whereas there was no prognostic value for classifications by visual assessment. Physiological residual disease patterns were independently associated with VOCO and showed increased prognostic value when introduced to a model with clinical risk factors only (C index: 0.77 vs. 0.68, P = 0.008; net reclassification improvement: 0.65, P 0.001; integrated discrimination improvement: 0.020, P 0.001).Objective analysis of post-PCI QFR pull backs using the concept of 2-dimensional residual disease patterns is feasible and superior to visual assessments. The residual disease patterns were independently associated with VOCO at 2 years.

The benefits and harms of dual antiplatelet therapy (DAPT) continuation with aspirin and clopidogrel beyond 1 year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation for high ischemic or bleeding risk patients remain unclear. All consecutive patients undergoing PCI were prospectively included in the Fuwai PCI Registry from January 2013 to December 2013. We evaluated 7521 patients who were at high risk for thrombotic or hemorrhagic complications and were events free at 1 year after the index procedure. "TWILIGHT-like" patients with high risk of bleeding or ischemic events were defined by clinical and angiographic criteria. The primary ischemic outcome was major adverse cardiac and cerebrovascular events [MACCE] (a composite of all-cause death, myocardial infarction, or stroke). Median follow-up duration was 2.4 years. The risk of MACCE was significantly lower in DAPT1-year group (n = 5252) than DAPT≤1-year group (n = 2269) (1.5% vs. 3.8%; hazard ratio [HR]: 0.37; 95% confidence interval [CI]: 0.27-0.50

Background/Aim. The relation between complex percutaneous coronary intervention (PCI), high bleeding risk (HBR), and adverse events after coronary artery implantation of drug-eluting stents has been incompletely characterized. This study sought to investigate the ischemic and bleeding events after complex PCI including stratification according to HBR estimated by PARIS bleeding risk score. Methods. Between January 2013 and December 2013, 10,167 consecutive patients undergoing PCI were prospectively enrolled in Fuwai PCI Registry. Complex PCI was defined when having at least one of the following characteristics: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, treatment of chronic total occlusion, unprotected left main PCI, in-stent restenosis target lesion, and severely calcified lesion. The primary ischemic endpoint was major adverse cardiovascular events (MACE) (composite of cardiac death, myocardial infarction, definite/probable stent thrombosis, and target lesion revascularization), and primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Results. The median duration of follow-up was 29 months. In adjusted Cox regression analysis, patients having complex PCI procedures experienced higher risks of MACE (hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.38–1.92; P<0.001), compared with noncomplex PCI. In contrast, the risk of clinically relevant bleeding was statistically similar between the 2 groups (HR: 0.86 [0.66–1.11]; P=0.238). There was no statistical interaction between HBR (PARIS bleeding score ≥8 or Pinteraction=0.388) and clinically relevant bleeding (adjusted Pinteraction=0.279). Conclusions. Patients who had undergone complex PCI resulted in substantially more ischemic events, without an increase in clinically relevant bleeding risk, and these associations did not seem to be modified by HBR status. More intensified antiplatelet therapy may be beneficial for patients with complex percutaneous coronary revascularization procedures.

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.

Background: Patients undergoing complex percutaneous coronary intervention (PCI) have an increased risk of cardiovascular events. Whether potent antiplatelet therapy after complex PCI improves outcomes in patients with stable coronary artery disease (SCAD) remains unclear.Objectives: To assess the efficacy and safety of ticagrelor vs. clopidogrel in patients with SCAD undergoing complex PCI.Methods: Patients with a diagnosis of SCAD and undergoing PCI during January 2016 to December 2018 were selected from an institutional registry. The primary efficacy endpoint was major adverse cardiac events (MACE) within 12 months after PCI. The primary safety endpoint was major bleeding.Results: Among 15,459 patients with SCAD included in this analysis, complex PCI was performed in 6,335 (41.0%) patients. Of patients undergoing complex PCI, 1,123 patients (17.7%) were treated with ticagrelor. The primary efficacy outcome after complex PCI occurred in 8.6% of patients in the ticagrelor group and 11.2% in the clopidogrel group. Compared with clopidogrel, ticagrelor decreased the risk of MACE in patients undergoing complex PCI [adjusted hazard ratio (HR): 0.764; 95% confidence interval (CI): 0.615 to 0.949; p = 0.015], but not in non-complex PCI (p for interaction = 0.001). There was no significant difference in incidence of major bleeding between patients treated with ticagrelor and clopidogrel (p = 0.221), while ticagrelor was associated with an increased risk of minor bleeding (adjusted HR: 3.099; 95% CI: 2.049 to 4.687; p < 0.001).Conclusion: In patients with SCAD and undergoing complex PCI, ticagrelor could substantially reduce the risk of adverse cardiovascular outcomes without increasing the risk of major bleeding compared with clopidogrel.

The simulated residual quantitative flow ratio (QFR) computed from pre-intervention three-dimensional (3-D) coronary angiograms, which could theoretically predict actual post-percutaneous coronary intervention (PCI) QFR value, can be used for enhanced PCI via augmented reality. The study sought to investigate the concordance between simulated residual QFR and actual post-PCI QFR, and the prognostic value of simulated residual QFR.QFR assessment was retrospectively performed in treated vessels from the all-comers PANDA III trial. Three-step analysis was performed: 1) concordance between simulated residual QFR and post-PCI QFR; 2) prognostic value of simulated residual QFR; and 3) forecast of outcomes by virtual randomized controlled trials (RCTs) between residual QFR and angiographic guidance.Of 2989 treated vessels, 2146 (71.8%) with paired analyzable simulated residual QFR and post-PCI QFR were included. The simulated residual QFR and post-PCI QFR were strongly correlated (r = 0.976). Low simulated residual QFR (≤0.92) was independently associated with higher risk of 2-year vessel-oriented composite endpoint (adjusted hazard ratio: 5.50; 95% confidence interval: 3.03 to 10.0). Based upon 5000 iterations of virtual RCTs, simulated residual QFR-guided strategy was anticipated to have a 2.6% absolute reduction of 2-year incidence of target vessel failure compared with the angiography-guided strategy.With high consistency to actual post-PCI QFR, the simulated residual QFR computed from pre-PCI 3-D coronary angiograms and augmented reality could predict functional outcome of the procedure and 2-year prognosis. Using data from PANDA III trial, the present study forecasted superiority of residual QFR-guided PCI strategy over angiographic guidance. Clinical Trial Registration Information URL: https://www.clinicaltrials.gov; Unique identifier: NCT02017275.

Background: The prognostic implications of biomarker elevation following percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) lesions remain controversial. This study assessed the association of periprocedural myocardial injury and clinically relevant definition of periprocedural myocardial infarction with subsequent outcomes after CTO-PCI. Methods: We enrolled consecutive patients between January 2010 and December 2013 who underwent CTO-PCI at a large-volume center with serial CK-MB (creatine kinase–myocardial band) or cTnI (cardiac troponin I) measurements. The primary outcome was 5-year cardiovascular death. Results: A total of 2616 patients (2691 CTOs) with postprocedural CK-MB or cTnI undergoing PCI recanalization were included, per-lesion technical success rate was 74.4%. Postprocedural CK-MB and cTnI elevation occurred in 5.6% and 65.5% patients, respectively. For 2485 patients with serial CK-MB measurements, only postprocedural peak CK-MB ≥5× upper reference limit was associated with increased 5-year cardiovascular death (adjusted hazard ratio, 9.88 [95% CI, 3.06–31.9]). In contrast, for 1233 patients with serial cTnI measurements, no such association was present in any threshold. The Society for Cardiovascular Angiography and Interventions definition of periprocedural myocardial infarction was associated with 5-year cardiovascular death (adjusted hazard ratio, 8.45 [95% CI, 3.58–20.0]), whereas the ARC-2 (Academic Research Consortium-2) and fourth UDMI (Universal Definition of Myocardial Infarction) were not. Conclusions: In a large cohort of CTO-PCI, moderate to high levels of peak postprocedural CK-MB were prognostically significant, whereas such association was not observed in postprocedural cTnI. The Society for Cardiovascular Angiography and Intervention criteria (but not ARC-2 and fourth UDMI) were identified as clinically relevant periprocedural myocardial infarction definition following CTO-PCI. Graphic Abstract: A graphic abstract is available for this article.

Summary 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.

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.

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 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.

Till now, the prognostic value of lipoprotein(a) [Lp(a)] in patients with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI) remains controversial. We therefore conducted this study to evaluate the effect of Lp(a) levels on clinical outcomes in this population.A total of 10,059 CAD patients who underwent PCI were prospectively enrolled in this cohort study, of which 6564 patients had Lp(a) ≤30 mg/dl and 3495 patients had Lp(a) 30 mg/dl. The primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), defined as a composite of all-cause death, myocardial infarction, stroke or unplanned revascularization. Multivariate Cox regression analysis and propensity-score matching analysis were performed. After propensity-score matching, 3449 pairs of patients were identified, and post-matching absolute standardized differences were10% for all the covariates. At 2.4 years, the risk of MACCE was significantly higher in patients with elevated Lp(a) levels than those with normal Lp(a) levels in both overall population (13.0% vs. 11.4%; adjusted hazard ratio [HR] 1.142, 95% confidence interval [CI] 1.009-1.293; P = 0.040) and propensity-matched cohorts (13.0% vs. 11.2%; HR 1.167, 95%CI 1.019-1.337; P = 0.026). Of note, the predictive value of Lp(a) levels on MACCE tended to be more evident in individuals65 years or those with left main and/or three-vessel disease. On the contrary, elevated Lp(a) levels had almost no effect on clinical outcomes in patients ≤65 years (PIn CAD patients who underwent PCI, elevated Lp(a) levels were positively related to higher risk of MACCE at 2.4-year follow-up, especially in patients65 years and those with left main and/or three-vessel disease.not applicable.

Aims Current guidelines recommend a heart team in the decision-making for patients with complex coronary artery disease (CAD). However, the decision-making stability of these teams has not been evaluated and the optimum protocol is unknown. We assessed inter-team agreement for revascularization decision-making and influencing factors to inform the development of a heart team protocol. Methods and results This sequential, explanatory mixed methods study included (i) a cross-sectional quantitative study to assess inter-team agreement on treatment strategy for retrospectively enrolled complex CAD patients and (ii) a qualitative study that used semi-structured interviews with heart team members to identify factors influencing decision-making discrepancy. We randomly selected 101 complex CAD patients. Sixteen specialists were randomly assigned to four heart teams to make decisions for these patients. The primary outcome kappa of inter-team decision-making agreement was moderate (kappa 0.58). Factors influencing decision-making were generated through inductive thematic analysis and were summarized by 3 themes (specialist quality, team composition, and meeting process) and 10 subthemes. Recommendations of heart team implementation were generated based on qualitative and quantitative data at five levels: specialist selection, specialist training, team composition, team training, and meeting process. A detailed protocol on the integration of guidelines, previous experience, and recommendations was generated to establish and deploy a qualified heart team. Conclusion Agreement between heart teams for revascularization decision-making in complex CAD patients was moderate. Potential factors associated with decision discrepancies were summarized and recommendations were generated. A detailed heart team protocol was designed and should be validated in future.

This study aimed to assess the risk stratification value of the SYNTAX Score II (SS II) in consecutive PCI patients and to analyze whether the predictive ability of SS II was consistent in patients with complex and non-complex coronary artery disease.SS II was designed for patients with complex coronary artery disease and has been validated by a number of studies in such patients.The SS II for PCI was assessed in 10,072 consecutive patients who underwent PCI in Fuwai Hospital from January to December 2013. The patients were stratified according to SS II tertiles and divided into two subgroups: one-vessel or two-vessel disease (1 or 2VD) group (n = 5,709) and left main (LM) and/or three-vessel disease (3VD) group (n = 4,363). The endpoint was 30-month all-cause death following PCI procedure.The high SS II group showed significantly higher 30-month mortality. Multivariate analyses showed that in the all-patients cohort and the two subgroups, SS II was an independent predictor of 30-month mortality (P 0.0001). Based on receiver operating characteristic curves analysis, SS II showed moderate discrimination ability for 30-month mortality (C-statistics = 0.68, Hosmer-Lemeshow test P value.05) and appeared to have better discrimination ability in the LM and/or 3VD subgroup (C-statistics = 0.631 vs. 0.722 for 1 or 2VD and LM and/or 3VD subgroups).SS II was able to risk-stratify patients and predict 30-month mortality in all PCI patients. The discrimination ability of SS II appeared to be better in the LM and/or 3VD subgroup.

We aimed to investigate the impact of target vessel on clinical outcomes in chronic total occlusion (CTO) revascularization versus no CTO revascularization. This multicenter, retrospective, cohort study involves patients with ≥1 CTO. After classification based on different CTO target vessels or multiple CTOs, patients were further categorized as the CTO revascularization group and the no CTO revascularization group based on treatment received. The primary outcome was a composite of death, myocardial infarction, stroke, repeated revascularization, and hospital admission due to ischemic symptoms. From August 2016 to August 2017, 1712 eligible patients were consecutively enrolled. Chronic total occlusion revascularization was associated with lower risk of 1-year major adverse cardiovascular and cerebrovascular events (MACCEs; adjusted hazard ratio [HR]: 0.36; 95% CI: 0.20-0.67; P = .001) compared with no CTO revascularization in left anterior descending (LAD) CTO patients. The benefit of CTO revascularization was not evident among those with left circumflex (LCX; adjusted HR: 0.51; 95% CI: 0.23-1.10; P = .087), right coronary artery (RCA; adjusted HR: 1.17; 95% CI: 0.59-2.33; P = .648), and multiple CTOs (adjusted HR: 1.00; 95% CI: 0.41-2.44; P = .994). Revascularization for LAD CTO, but not LCX, RCA, or multiple CTOs, was associated with lower risk of 1-year MACCEs compared with no CTO revascularization.

Background. The prognostic significance of CTO in the non-IRA in patients with AMI has been under dispute. Relevant long-term follow-up studies are lacking. Hypothesis. CTO in the non-IRA is an independent predictor of poor long-term prognosis in patients with AMI. Methods. We prospectively enrolled 2336 patients with AMI who received emergent percutaneous coronary intervention successfully from January 2006 to May 2011. Our primary endpoints included death from cardiovascular causes, recurrent myocardial infarction, stroke, and target-vessel revascularization. We adopted Cox regression analysis adjusted for confounders to analyze the impact of CTO in the non-IRA on long-term mortalities. Results. We identified 628 (27.6%) subjects with CTO in the non-IRA among 2282 AMI patients. After a mean follow-up duration of 134.3 months, we found the CTO group had significantly higher MACCE rate than the group without CTO (30.4% versus 24.3%, P = 0.004 ). CTO in the non-IRA independently predicted 11-year MACCE in the male AMI subgroup (hazard ratio 1.28, 95% confidence interval 1.06 to 1.54, P = 0.01 ) and in the male NSTEMI subgroup (hazard ratio 1.53, 95% confidence interval 1.09 to 2.15, P = 0.02 ). In the CTO group, three-vessel disease independently predicted 11 year MACCE (hazard ratio 2.05, 95% confidence interval 1.29 to 3.28, P = 0.002 ). Conclusions. Our long-term observational study supported the association between CTO in the non-IRA and poorer prognosis in AMI patients undergoing primary PCI. We identified the group with the three-vessel disease as a high-risk subgroup in patients with CTO in the non-IRA.

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.

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

© 2021 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC By-NC-ND License (http://creativecommons.org/licenses/by-nc-nd/4), The authors developed a global chronic total occlusion crossing algorithm following 10 steps: 1) dual angiography; 2) careful angiographic review focusing on proximal cap morphology, occlusion segment, distal vessel quality, and collateral circulation; 3) approaching proximal cap ambiguity using intravascular ultrasound, retrograde, and move-the-cap techniques; 4) approaching poor distal vessel quality using the retrograde approach and bifurcation at the distal cap by use of a dual-lumen catheter and intravascular ultrasound; 5) feasibility of retrograde crossing through grafts and septal and epicardial collateral vessels; 6) antegrade wiring strategies; 7) retrograde approach; 8) changing strategy when failing to achieve progress; 9) considering performing an investment procedure if crossing attempts fail; and 10) stopping when reaching high radiation or contrast dose or in case of long procedural time, occurrence of a serious complication, operator and patient fatigue, or lack of expertise or equipment. This algorithm can improve outcomes and expand discussion, research, and collaboration.

To compare the prognostic implication of post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) assessment in patients with and without diabetes enrolled in the all-comers, multicenter, randomized controlled PANDA III trial.All treated vessels in PANDA III trial were retrospectively assessed for post-PCI QFR. Vessels with available post-PCI QFR were further stratified into DM and non-DM cohorts, and prognostic performance of post-PCI QFR was compared in 2 cohorts. The primary outcome was 2-year vessel-oriented composite endpoint (VOCE), defined as composite of vessel-related cardiac death, vessel-related non-procedural myocardial infarction, and ischemia-driven target vessel revascularization.Of 2,989 treated vessels, 2,227 (74.5%) with available post-PCI QFR were included, while 548 were presence of DM and 1,679 were not. The performance of post-PCI QFR to predict 2-year VOCE were moderate in both DM (area under the curve [AUC] 0.77, 95% confidence interval [CI]: 0.68 to 0.87) and non-DM cohorts (AUC 0.74, 95% CI: 0.67 to 0.82), while between-cohorts AUC difference was not significant (ΔAUC 0.03, P = 0.65). After multivariate adjustment, vessels with suboptimal post-PCI QFR results (≤0.92) were associated with higher risk of 2-year VOCE in both DM (adjusted HR 6.24, 95% CI: 2.40 to 16.2) and non-DM cohorts (adjusted HR 5.92, 95% CI: 3.28 to 10.7) without significant interaction (P for interaction 0.91).This study, the first to directly compare clinical value of post-PCI QFR assessments in patients with and without DM, showed that a higher post-PCI QFR value was associated with improved long-term prognosis regardless of the presence of DM. Clinical Trial Registration Information URL: https://www.gov; Unique identifier: NCT02017275.

Background Dual-antiplatelet therapy (DAPT) exceeding 1 year may increase a bleeding risk despite reducing the risk of ischemic events. The benefits and harms of prolonging DAPT with aspirin and clopidogrel beyond 1 year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation for patients with high-risk for bleeding or an ischemic event remain unknown. Method Between January 2013 and December 2013, all consecutive patients undergoing PCI were prospectively included in the Fuwai PCI Registry. We evaluated 7521 patients who were at high risk for ischemic or hemorrhagic complications and were events free (no death, myocardial infarction [MI], stroke, stent thrombosis [ST], any revascularization, or major bleeding) at 1 year after the index procedure. Subjects were divided into 2 groups: DAPT>1-year group (n=5252) and DAPT≤1-year group (n=2269). Patients at high-risk for ischemic or bleeding events were defined as having at least one additional clinical feature and one angiographic feature according to TWILIGHT trial criteria. The clinical criteria for high risk were age≥65 years, female sex, troponin-positive ACS, established vascular disease, diabetes mellitus that was being treated with medication, and CKD. Angiographic criteria included multivessel coronary artery disease, total stent lengthd≥30 mm, a thrombotic target lesion, a bifurcation lesion treated with two stents, an obstructive left main or proximal left anterior descending lesion, and a calcified target lesion treated with atherectomy. The primary outcome was major adverse cardiac and cerebrovascular events [MACCE] (a composite of all-cause death, MI, or stroke). Results During a median follow-up of 30 months after the index procedure, DAPT>1-year was associated with a reduction in risk for MACCE compared with DAPT≤1-year (1.5% vs. 3.8%; adjusted hazard ratio [HR]: 0.36; 95% confidence interval [CI]: 0.27–0.50; P1-year group than the DAPT≤1-year group (1.6% versus 4.5%; HR, 0.34; 95% CI, 0.22–0.52; P Conclusions DAPT continuation with aspirin and clopidogrel beyond 1-year after DES implantation resulted in a significantly lower rate of MACCE, with no higher risk of clinically relevant bleeding in patients who were at high-risk for ischemic or bleeding events. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (CIFMS)

Background The relation between complex percutaneous coronary intervention (PCI), high bleeding risk (HBR), and adverse events after coronary artery implantation of drug-eluting stents has been incompletely characterized. This study sought to investigate the ischemic and bleeding events after complex PCI including a stratification according to HBR estimated by PARIS bleeding risk score. Methods Between January 2013 and December 2013, 10,167 consecutive patients undergoing PCI were prospectively enrolled in Fuwai PCI Registry. Complex PCI was defined when having at least one of the following characteristics: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, treatment of chronic total occlusion, unprotected left main PCI, in-stent restenosis target lesion, and severely calcified lesion. The primary ischemic endpoint was major adverse cardiovascular events (MACE) [composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis], and primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Results The median duration of follow-up was 29 months. In adjusted Cox regression analysis, patients having complex PCI procedures experienced higher risks of MACE (hazard ratio [HR]: 1.63, 95% confidence interval [CI]: 1.38–1.92; P Conclusions Patients who had undergone complex PCI resulted in substantially more ischemic events, without an increase in clinically relevant bleeding risk; and these associations did not seem to be modified by HBR status. More intensified antiplatelet therapy may be beneficial for patients with complex percutaneous coronary revascularization procedures. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences

Background: The potential impact of quantitative flow ratio (QFR) based functional Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) score (FSS QFR ) on prognostication and revascularization strategy choice has not been fully investigated, and the discriminant ability of FSS QFR needs further validation. Methods: QFR was retrospectively analyzed in left main or patients with multivessel coronary artery disease from the PANDA III trial. A total of 607 patients with analyzable QFR in all vessels were included. FSS QFR was counted by summing the individual scores only in ischemia-producing lesions (vessel QFR ≤0.8). Patients were stratified according to tertiles of SYNTAX score (SS), and 3 groups of FSS were divided by the same cutoff score. The primary end point was 2-year major adverse cardiac events (a composite of cardiac death, any myocardial infarction, or ischemia-driven revascularization). Results: After calculating the FSS QFR , 16% (96/607) of study patients moved from higher-risk group by SS to lower-risk group. In the low, intermediate, and high FSS QFR group, the cumulative incidence of 2-year major adverse cardiac events was 9.1%, 13.5%, and 22.3% ( P =0.0004), and the rate of a composite of cardiac death or myocardial infarction (3.8%, 7.3%, and 13.7%, P =0.0006) was also increased. Compared with SS, FSS QFR significantly improved risk classification and prognostication (area under the curve of the receiver-operating characteristics 0.65 versus 0.62, P =0.0009). Moreover, 6% (38/607) of patients, for whom coronary artery bypass grafting would be recommended according to SS, converted to favor percutaneous coronary intervention after FSS QFR calculation. After multivariate adjustment, FSS QFR was an independent predictor of 2-year major adverse cardiac events (adjusted hazard ratio, 1.05 [95% CI, 1.02–1.07]; P =0.0001). Conclusions: Among patients with left main or multivessel coronary artery disease, FSS QFR showed applicability in prognostication and revascularization strategy choice. An improved scoring system combining anatomy and physiology (FSS QFR ) discriminated the risk of adverse events modestly better than anatomic assessment (SS) alone. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02017275. Graphic Abstract: A graphic abstract is available for this article.

The efficacy and safety of prolonged (>1-year) dual antiplatelet therapy (DAPT) duration in high-risk patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) remain unknown. All patients undergoing PCI at Fuwai hospital between January 2013 and December 2013 were prospectively enrolled into the Fuwai PCI registry. A total of 3,696 high-risk diabetics patients with at least one additional atherothrombotic risk factor were screened for inclusion. The primary efficacy outcome was the composite of all-cause mortality, myocardial infarction, or stroke. The median follow-up duration was 887 days. 69.8% of DM patients were on DAPT at 1 year without discontinuation. Based on multivariate Cox regression model and inverse probability of treatment weighting (IPTW) analysis, long-term (>1-year) DAPT reduced the risk of primary efficacy outcome (1.7% vs 4.1%; adjusted hazard ratio [adjHR]: 0.382, 95% confidence interval [CI]: 0.252 to 0.577; IPTW-HR: 0.362 [0.241 to 0.542]), as well as cardiovascular death and definite/probable stent thrombosis, compared with short-course (≤1-year) DAPT. Risk of the safety end point of clinically relevant bleeding (adjHR: 0.920 [0.467 to 1.816]; IPTW-HR: 0.969 [0.486 to 1.932]) was comparable between longer DAPT and shorter DAPT. A lower number of net clinical benefit adverse outcomes was observed with >1-year DAPT versus ≤1-year DAPT (adjHR: 0.471 [0.331 to 0.671]; IPTW-HR: 0.462 [0.327 to 0.652]), which appeared increasingly favorable in those with multiple atherothrombotic risk characteristics. In high-risk patients with DM receiving PCI who were event free at 1 year, DAPT prolongation resulted in significant reduction in the risk of ischemic events not offset by increase of clinically meaningful bleeding events, thereby achieving a net clinical benefit. Extending DAPT beyond the period mandated by guidelines seems reasonable in high-risk DM patients not deemed at high bleeding risk.

Background During coronavirus disease 2019 (COVID-19) epidemic, reducing the number of invasive procedure and choosing conservative medication strategy for patients with non-ST-segment elevation myocardial infarction (NSTEMI) is unavoidable. Whether this relatively conservative strategy will impact in-hospital outcome for NSTEMI patients remains unclear. Methods and results The current study included all consecutive NSTEMI patients who visited the emergency department in Fuwai Hospital from February 1 to March 31, 2020 and all the NSTEMI patients in the same period of 2019 as a historical control. Very-high-risk patients were defined as clinical presentation of heart failure, cardiac shock, cardiac arrest, recurrent chest pain, and life-threatening arrhythmias. The primary outcome was in-hospital major adverse cardiac events (MACE), defined as a composite of all-cause death, recurrent myocardial infarction, or heart failure. A total of 115 NSTEMI patients were enrolled since the outbreak of COVID-19, and a total of 145 patients were included in the control group. There was a tendency toward higher MACE risk in 2020 compared with 2019 (18.3% vs. 11.7%, p = .14). Among very-high-risk patients, early percutaneous coronary intervention (PCI) strategy in 2019 was associated with reduced MACE risk compared with delayed PCI in 2020 (60.6% [20/33] in 2020 vs. 27.9% [12/43] in 2019, p = .01). Conclusions COVID-19 pandemic results in a significant reduction in immediate/early PCI and a trend toward higher adverse event rate during hospitalization, particular in very-high-risk patients.

Background Whether the underlying risk of high bleeding risk (HBR) influences the relationship of high thrombotic risk (HTR) features with adverse events after drug-eluting stent implantation remains unclear. The purpose of this study was to evaluate (1) the prognostic effect of ESC guideline-endorsed HTR features on long-term clinical outcomes and (2) whether the outcomes of HTR versus non-HTR features vary by HBR status. Methods Ten thousand one hundred sixty-seven consecutive patients who underwent percutaneous coronary intervention between January 2013 and December 2013 were prospectively enrolled in Fuwai PCI Registry. Patients who are at HTR were defined as: diffuse multivessel disease in diabetic patients, chronic kidney disease, at least three stents implanted, at least three stents lesions treated, bifurcation with two stents implanted, total stent length > 60 mm, or treatment of chronic total occlusion. The definition of HBR was based on the Academic Research Consortium for HBR criteria. The primary ischemic outcome was major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, target vessel revascularization and stent thrombosis. The primary bleeding outcome was clinically relevant bleeding, defined according to Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding. Results With a 2.4-year median follow-up, 4430 patients (43.6%) having HTR experienced a significantly higher risk of MACE (hazard ratio [HR] adjust: 1.56, 95% confidence interval [CI]: 1.34–1.82; P adjust: 1.52 [1.27–1.83]; P adjust: 0.85 [0.66–1.08]; P = 0.174). Associations between HTR and adverse events were similar in HBR and non-HBR groups, without evidence of interaction (all Pinteraction > 0.05); however, adverse event rates were highest among subjects with both HTR and HBR. Conclusions ESC guideline-endorsed HTR was associated with significantly increased risk of MACE without any significant differences in clinically relevant bleeding. The presence of HBR does not emerge as a modifier of cardiovascular risk for patients at HTR, suggesting more potent and longer antiplatelet therapy may be beneficial for this patient population.

The ischemic/bleeding trade-off of continuing dual antiplatelet therapy (DAPT) beyond 1 year after PCI for patients with high thrombotic risk (HTR) as endorsed by 2018 ESC/EACTS myocardial revascularization guidelines remain unknown. Patients undergoing coronary stenting between January 2013 and December 2013 from the prospective Fuwai registry were defined as HTR if they met at least 1 ESC/EACTS guideline-endorsed HTR criteria. A total of 4578 patients who were at HTR and were events free at 1 year after the index procedure were evaluated. The primary efficacy outcome was major adverse cardiac and cerebrovascular events (MACCE) (composite of all-cause death, myocardial infarction, or stroke). Median follow-up period was 2.4 years. > 1-year DAPT with clopidogrel and aspirin significantly reduced the risk of MACCE compared with ≤ 1-year DAPT (1.9% vs. 4.6%; hazard ratio (HR): 0.38; 95% confidence interval (CI): 0.27–0.54; P

Patients who underwent complex percutaneous coronary intervention (PCI) are known to be at high risk for both ischemic and bleeding complications. The risk/benefit tradeoff of extending dual antiplatelet therapy (DAPT) >12 months with clopidogrel and aspirin for TWILIGHT-like patients who are at high risk of bleeding or ischemic events and undergo complex PCI is unclear. Eight thousand three hundred and fifty-eight consecutive patients fulfilling the "TWILIGHT-like" criteria who underwent PCI from January 2013 to December 2013 were prospectively enrolled in Fuwai PCI Registry. We identified 2,677 of "TWILIGHT-like" complex PCI patients who were events free at 1 year after the index procedure. "TWILIGHT-like" patients were identified based on at least 1 clinical and 1 angiographic feature. Median follow-up was 29 months. Risk of primary efficacy outcome, major adverse cardiac and cerebrovascular events (composite of all-cause death, myocardial infarction, or stroke), was reduced with DAPT >12 months versus DAPT≤ 12 months (hazard ratio [HR]adj 0.374, 95% confidence interval [CI] 0.235 to 0.595; HRmatched 0.292 [0.151 to 0.561]; HRIPTW 0.356 [0.225 to 0.562]), with directional consistency for cardiovascular death and definite/probable stent thrombosis. In contrast, >12-month DAPT was comparable to ≤12-month DAPT for the risk of clinically relevant bleeding ([HR]adj 1.189, 95% CI 0.474 to 2.984; HRmatched 1.577 [0.577 to 4.312]; HRIPTW 1.239 [0.502 to 3.059]). Importantly, there was also a significant net benefit in favor of prolonged DAPT treatment. In conclusion, among "TWILIGHT-like" patients after complex PCI, continuing duration of DAPT> 12 months was associated with a net clinical benefit and lower rates of ischemic events without increasing the risk of clinically relevant bleeding than DAPT≤ 12 months, suggesting that long-term DAPT may have a favorable risk-benefit ratio in this high-risk population.

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

There are controversies on optimal stenting strategy regarding true left main (LM) bifurcation lesions. The present study compared 1- and 2-stenting strategy for patients with true LM bifurcation lesions as differentiated by DEFINITION criteria. 928 patients with true LM bifurcation lesions (Medina 1,1,1 or 0,1,1) treated with DES were enrolled consecutively. 297 (32.0%) patients were identified as complex LM bifurcation, and 631 (68.0%) patients into simple LM bifurcation group according to DEFINTION criteria. Patients in complex vs. simple LM bifurcation group had significantly higher major adverse cardiac event (MACE, including cardiac death, myocardial infarction [MI] and ischemia-driven target vessel revascularization) rate at 30 days (7.8% vs. 4.0%, p = 0.01), 1 year (10.3% vs. 6.4%, p = 0.04), and numerically at 3 years (14.2% vs. 10.1%, p = 0.07), which was mainly driven by increased MI. Moreover, patients in the 2-stent strategy group had strong trend towards lower incidence of cardiac death in both complex LM bifurcation group (2.0% vs. 5.9%, p = 0.08) and simple LM bifurcation group (1.9% vs. 4.5%, p = 0.07). In conclusion, the complex bifurcation lesion criteria established in DEFINITION study was able to risk-stratify LM bifurcation patients. Two-stent technique yielded numerically lower 3-year cardiac mortality regardless of LM bifurcation complexity.

Dual antiplatelet therapy (DAPT) score emerged as a tool for quantification of ischemia and bleeding risks. However, there was discrepancy of the prediction ability of DAPT score in previous studies. We aimed to assess the utility of DAPT score in a large-scale cohort of consecutive percutaneous coronary intervention (PCI) patients. This study enrolled 9,114 patients who had undergone PCI at Fuwai Hospital in 2013, adhered to DAPT and were event-free within the first 12 months following PCI. The endpoints included primary ischemic endpoints (major adverse cardiovascular and cerebrovascular events, and myocardial infarction and/or stent thrombosis), and bleeding endpoint from 12 through 24 months after PCI. Patients were classified into low (score

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

Objectives The purpose of this study was to assess the prognostic significance of the residual SYNTAX score (rSS) in a large-scale cohort of consecutive percutaneous coronary intervention (PCI) patients and to analyze whether residual proximal left anterior descending coronary artery (pLAD) lesions affect the prognosis of patients with same or similar rSS levels. Background The rSS, measured after PCI, has been assessed as an independent predictor of long-term clinical outcome and a tool for quantification of incomplete revascularization, and still needs to be validated in various PCI populations. When using rSS to determine an objective level of reasonable incomplete revascularization, it is currently undefined whether a pLAD lesion deserves more attention. Methods The calculations of baseline SYNTAX scores (bSS) and rSS were performed in 10,343 consecutive patients undergoing PCI in Fuwai Hospital from January 2013 to December 2013. The primary endpoint was major adverse cardiac events (MACE), defined as a composite of all-cause death, myocardial infarction (MI), and any revascularization. Secondary endpoints included the individual components of the MACE, cardiac death, and all-cause death/MI. Results MACE and cardiac death rates were significantly higher among patients with residual pLAD stenosis ≥70%. rSS and residual pLAD stenosis ≥70% were both strong independent predictors of MACE. Compared with rSS, rSS plus residual pLAD stenosis was superior in predicting 30-month MACE (P = .0016). Conclusions rSS is a strong independent predictor of long-term adverse clinical outcomes. Residual pLAD lesions affect the prognosis of patients with same or similar rSS levels.

BACKGROUND Acquired thrombocytopenia is associated with an increased risk of adverse events of patients with acute coronary syndrome. However, data on its long-term prognostic significance are limited. The aim of our study was to investigate the association between acquired thrombocytopenia and long-term clinical outcomes. METHODS We examined 8,271 consecutive patients who underwent elective percutaneous coronary intervention (PCI) at Fuwai Hospital from January 2013 to December 2013. Acquired thrombocytopenia was defined as a platelet count of

Objectives To detect the impact of side branch (SB) lesion length on acute SB occlusion after main vessel (MV) stenting. Methods Five hundred sixteen consecutive patients with 524 bifurcation lesions undergoing one-stent techniques were studied. Multivariate logistic regression analysis was performed to identify independent predictors of acute SB occlusion. The lesions were also further divided into two groups according to the median SB lesion length. The incidences of SB occlusion and lesion characteristics in the two subgroups were compared. Results The SB lesion length was not significantly different between lesions with and without SB occlusion. In the SB occlusion group, the distance between the position of the minimal lumen diameter and SB ostium was significantly shorter than that in the non-SB occlusion group (1.76 ± 1.04 mm vs. 2.72 ± 2.65 mm; P = 0.0003). Multivariate logistic regression analysis showed that high BA before stenting, plaque accumulation located on the same side as the SB, the Thrombolysis In Myocardial Infarction (TIMI) flow grade of the SB before stenting, and the DS of the SB before MV stenting were independently predictive of SB occlusion. Conclusions SB lesion length cannot be regarded as an independent predictor of acute SB occlusion after MV stenting.