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ObjectiveFunctional complete revascularisation (FCR) has been proven to be associated with superior prognosis following percutaneous coronary intervention. Whether guideline-directed medical therapy (GDMT) still impacts clinical outcomes in patients who have achieved FCR requires further evaluation.MethodsThe study population was drawn from patients who achieved FCR in the FAVOR III China trial, defined as a quantitative flow ratio (QFR)-based residual functional Synergy between percutaneous coronary intervention with taxus and cardiac Surgery score of 0, measured only in vessels with QFR≤0.80. GDMT was defined as the combination of single or dual antiplatelet therapy, a beta-blocker and a statin, with or without an ACE inhibitor or angiotensin receptor blocker, according to contemporary guideline recommendations. Patients were categorised into the GDMT group (compliance with all 4 agents) or non-GDMT group (compliance with 0–3 agents). The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) at 3 years, a composite of death, myocardial infarction, stroke and ischaemia-driven revascularisation.ResultsAmong 3221 (85.2%) patients who achieved FCR, a total of 1964 (61.2%), 1919 (59.9%), 1545 (48.4%), 1483 (46.6%) and 1084 (35.3%) patients adhered to GDMT at 1 month, 6 months, 1 year, 2 years and 3 years, respectively. The MACCE occurred in 313 (10.2%) patients through 3 years. The rate of MACCE was similar between GDMT and non-GDMT groups within the first year, but significantly lower in the GDMT group from the second year (adjusted HR: 0.66, 95% CI: 0.51 to 0.85; p<0.01) and sustained until the third year (adjusted HR: 0.65, 95% CI: 0.50 to 0.85; p<0.01), compared with the non-GDMT group.ConclusionsIn patients who achieved FCR, the benefit of good adherence to GDMT remained significant, starting from the second year and continuing up to 3 years.Trial registration number NCT03656848.

IntroductionPatients with acute myocardial infarction (AMI) and multivessel disease are at elevated risk of recurrent events. Radial wall strain (RWS), a novel indicator derived from angiography, has emerged as a potentially useful adjunct to optical coherence tomography (OCT) for assessing plaque vulnerability. The NASCENT trial is a prospective, multicentre cohort study designed to assess the natural history of coronary plaque in this high-risk AMI population and investigate the predictive value of angiography-based RWS for lesion progression, compared with OCT-assessed vulnerable plaque.Methods and analysisFollowing successful culprit lesion revascularisation for AMI patients with multivessel disease, we assessed eligible non-culprit lesions (30%–80% diameter stenosis) in non-flow-limiting, non-infarct-related arteries (Murray law-based quantitative flow ratio >0.80) using OCT and offline RWS analysis. The primary endpoint is lesion progression at 1 year, defined as a ≥20% increase in diameter stenosis percentage measured by quantitative coronary angiography. Between April 2024 and April 2025, 131 patients were enrolled. The 1-year angiographic and OCT follow-ups will be completed by May 2026. Clinical follow-ups are planned at 1 month, 6 months, 1 year and annually up to 3 years. As the first prospective trial comparing angiography-based RWS with OCT for predicting lesion progression in the AMI population, this study may provide crucial evidence for RWS as a valuable tool for risk stratification and clinical decision-making.Ethics and disseminationThe protocol has been approved by the Institutional Review Board and Ethics Committee (Fuwai Hospital Approval No. 2023-2039) and will be conducted in accordance with the Declaration of Helsinki. Informed consent was obtained from all participants. The study results will undergo peer-reviewed publication.Trial registration numberNCT06040073.

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. 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. 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.

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.

The BIOFLOW-VI (Biotronik–Safety and Clinical Performance of the Drug Eluting Orsiro Stent in the Treatment of Subjects With De Novo Coronary Artery Lesions–VI) study evaluates the angiographic efficacy, clinical safety, and effectiveness of the ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP-SES) compared with a durable polymer everolimus-eluting stent (DP-EES). This randomized controlled clinical trial was designed to enable approval of new drug-eluting stents in China. A total of 440 eligible patients from 11 sites with up to 2 de novo native coronary artery lesions were randomly assigned to receive either BP-SES (n = 220) or DP-EES (n = 220) from July 2014 to September 2016 in this prospective, multicenter, noninferiority trial. The primary end point of 9-month in-stent late lumen loss (LLL) was 0.05 (0.02) mm in the BP-SES group versus 0.07 (0.02) mm in the DP-EES group, with a mean difference of −0.02 mm (95% CI, −0.06 to 0.03; P = 0.44; Pnoninferiority < 0.0001). At 1 year, the target lesion failure rate (cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization) was similar between the 2 groups (BP-SES 2.3% vs DP-EES 1.4%; P = 0.50). No definite or probable stent thrombosis had occurred in any of the 2 treatment arms. The randomized BIOFLOW-VI trial showed that BP-SES was noninferior to DP-EES with regard to the primary end point of 9-month in-stent LLL in a Chinese population. ClinicalTrials.gov Identifier: NCT02870985

Background: Patients with diabetes mellitus (DM) are considered to increase the risk of thrombosis and bleeding. However, whether DM is an independent risk factor for events in patients anticoagulated with bivalirudin during elective percutaneous coronary intervention (PCI) is not clear. Methods: Patients anticoagulated with bivalirudin during elective PCI from January 2017 to August 2018 in 3 centers were enrolled. The primary endpoint of thrombotic events was major adverse cardiac and cerebrovascular events (MACCE, including all-cause death, myocardial infarction, ischemic revascularization, stent thrombosis, and stroke); the primary endpoint of bleeding events was Bleeding Academic Research Consortium (BARC) 2, 3 or 5 bleeding. Results: 1152 patients were finally enrolled. After one-year follow-up, 89 (7.7%) MACCE and 21 (1.8%) BARC 2, 3 or 5 bleeding occurred. Multivariate Cox regression analysis showed DM was not an independent risk factor for MACCE (hazard ratio [HR]: 1.029, 95% confidence interval [CI]: 0.674-1.573, P = .893), but peripheral artery disease (PAD) history (HR: 2.200, 95%CI: 1.290-3.751, P = .004) was an independent risk factor for MACCE. DM was not an independent risk factor for BARC 2, 3 or 5 bleeding (HR: 0.732, 95%CI: 0.293-1.831, P = .505), but PAD history (HR: 3.029, 95%CI: 1.102-8.332, P = .032) and low hemoglobin level (HR = 0.972, 95%CI: 0.947-0.998, P = .036) were independent risk factors for BARC 2, 3 or 5 bleeding. Conclusions: DM was not an independent risk factor for one-year thrombotic and bleeding events in patients anticoagulated with bivalirudin during elective PCI. More attention should be paid to PAD history and hemoglobin level to identify high-risk patients.

This study compared the long term outcomes in patients with unprotected left main coronary artery (LMCA) disease who underwent stenting under the guidance of intravascular ultrasound (IVUS) or conventional angiography at a large single center. The primary outcome was the composite of all-cause death and myocardial infarction (MI) at 3 years. Target vessel revascularization (TVR) at 3 years was one of the secondary outcomes. Between January 2004 and December 2011, a total of 1,899 patients who underwent IVUS-guided (n = 713, 37.5%) or conventional angiography-guided (n = 1186, 62.5%) stenting were included. At 3 years, the unadjusted primary outcome trended lower in the IVUS-guided group versus the angiography-guided (6.9% vs. 8.4%, p = 0.22) although the TVR was similar between two groups (6.0% vs. 6.0%, p = 0.97). However, after adjustment for differences in baseline risk factors, IVUS-guidance was associated with significantly lower incidence of the composite of all-cause death and MI (hazard ratio [HR]: 0.65; 95% confidence interval [CI]: 0.50 to 0.84; p = 0.001), although there was still no significant difference in TVR between the two groups (HR: 1.09; 95% CI: 0.84 to 1.42; p = 0.53). IVUS guidance has benefits in improving the long-term prognosis for unprotected LMCA stenting.

Abstract Background: The FAVOR (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) III China trial demonstrated that percutaneous coronary intervention (PCI) lesion selection using quantitative flow ratio (QFR) measurement, a novel angiography-based approach for estimating fractional flow reserve, improved two-year clinical outcomes compared with standard angiography guidance. This study aimed to assess the cost-effectiveness of QFR-guided PCI from the perspective of the current Chinese healthcare system. Methods: This study is a pre-specified analysis of the FAVOR III China trial, which included 3825 patients randomized between December 25, 2018, and January 19, 2020, from 26 centers in China. Patients with stable or unstable angina pectoris or those ≥72 hours post-myocardial infarction who had at least one lesion with a diameter stenosis between 50% and 90% in a coronary artery with a ≥2.5 mm reference vessel diameter by visual assessment were randomized to a QFR-guided strategy or an angiography-guided strategy with 1:1 ratio. During the two-year follow-up, data were collected on clinical outcomes, quality-adjusted life-years (QALYs), estimated costs of index procedure hospitalization, outpatient cardiovascular medication use, and rehospitalization due to major adverse cardiac and cerebrovascular events (MACCE). The primary analysis calculated the incremental cost-effectiveness ratio (ICER) as the cost per MACCE avoided. An ICER of ¥10,000/MACCE event avoided was considered economically attractive in China. Results: At two years, the QFR-guided group demonstrated a reduced rate of MACCE compared to the angiography-guided group (10.8% vs. 14.7%, P <0.01). Total two-year costs were similar between the groups (¥50,803 ± 21,121 vs. ¥50,685 ± 23,495, P = 0.87). The ICER for the QFR-guided strategy was ¥3055 per MACCE avoided, and the probability of QFR being economically attractive was 64% at a willingness-to-pay threshold of ¥10,000/MACCE avoided. Sensitivity analysis showed that QFR-guided PCI would become cost-saving if the cost of QFR were below ¥3682 (current cost: ¥3800). Cost-utility analysis yielded an ICER of ¥56,163 per QALY gained, with a 53% probability of being cost-effective at a willingness-to-pay threshold of ¥85,000 per QALY gained. Conclusion: In patients undergoing PCI, a QFR-guided strategy appears economically attractive compared to angiographic guidance from the perspective of the Chinese healthcare system. Trial Registration: ClinicalTrials.gov, NCT03656848.

Quantitative flow ratio (QFR) is a novel approach to derive fractional flow reserve (FFR) from coronary angiography. This study sought to evaluate the reproducibility of QFR when analyzed in independent core laboratories. All interrogated vessels in the FAVOR II China Study were separately analyzed using the AngioPlus system (Pulse medical imaging technology, Shanghai) by two independent core laboratories, following the same standard operation procedures. The analysts were blinded to the FFR values and online QFR values. For each interrogated vessel, two identical angiographic image runs were used by two core laboratories for QFR computation. In both core laboratories QFR was successfully obtained in 330 of 332 vessels, in which FFR was available in 328 vessels. Thus, 328 vessels ended in the present statistical analysis. The mean difference in contrast-flow QFR between the two core laboratories was 0.004 ± 0.03 (p = 0.040), which was slightly smaller than that between the online analysis and the two core laboratories (0.01 ± 0.05, p < 0.001 and 0.01 ± 0.05, p = 0.038). The mean difference of QFR with re-spect to FFR were comparable between the two core laboratories (0.002 ± 0.06, p = 0.609, and 0.002 ± 0.06, p = 0.531). Receiver operating characteristic curve analysis showed that diagnostic accuracies of QFR analyzed by the two core laboratories were both excellent (area under the curve: 0.970 vs. 0.963, p = 0.142), when using FFR as the reference standard. The present study showed good inter-core laboratory reproducibility of QFR in assessing functionally-significant stenosis. It suggests that QFR analyses can be carried out in different core labo-ratories if, and only if, highly standardized conditions are maintained.

Functional complete revascularization (CR) after percutaneous coronary intervention (PCI) as determined by classic residual functional SYNTAX score (c‐rFSS) has been associated with improved prognosis. In this study, the c‐rFSS algorithm is optimized for a novel modified rFSS (m‐rFSS) and prognostic implications of this novel scoring is determined. The m‐rFSS algorithm is updated for 2 clinical scenarios, i.e., 1) lesions with suboptimal functional results, and 2) angiographic diameter stenosis <50% but functionally significant stenoses, which are not scored by c‐rFSS. The major outcome is a 2‐year major adverse cardiac event (MACE). A total of 1,555 patients analyzable for both c‐rFSS and m‐rFSS are included. After calculating m‐rFSS, 12.0% (187/1,555) of patients with c‐rFSS‐based functional CR (c‐rFSS = 0) are reclassified as having m‐rFSS‐based incomplete revascularization (IR, m‐rFSS>0); thus, 377 (21.7%) patients have c‐rFSS‐based functional IR whereas 524 (33.7%) has m‐rFSS‐based IR. Patients with m‐rFSS‐based functional IR (m‐rFSS>0) show a significantly higher risk for major MACE outcome (20.8% vs 5.9%; adjusted hazard ratio 3.32, 95% confidence interval: 2.34–4.71) than patients with functional CR (m‐rFSS = 0). The m‐rFSS is more predictive of 2‐year MACE than c‐rFSS (difference in C‐index 0.07, p < 0.001). In this study, we optimized the classic scoring algorithm to develop a novel scoring system (m‐rFSS), and revascularization completeness determined by m‐rFSS is markedly associated with a 2‐year prognosis. The modified residual functional SYNTAX score (m‐rFSS) algorithm was updated for 2 clinical scenarios: 1) lesions with suboptimal functional results, and 2) angiographic diameter stenosis <50% but functionally significant stenoses, which were not scored by classic rFSS or rSS. CR = complete revascularization; IR = incomplete revascularization; PCI = percutaneous coronary intervention; QFR = quantitative flow ratio.