Percutaneous Coronary Intervention Research Articles

Changes in lipid lowering therapy one year after percutaneous coronary intervention: data from the large contemporary ZON-HR registry

Abstract Background Patients who underwent percutaneous coronary intervention (PCI) should receive at least high-intensity statin therapy according to current ESC guidelines to prevent ischemic events. However, previous studies have shown that about 80% of the patients using high-intensity statin monotherapy are not reaching the low density lipoprotein- cholesterol (LDL-C) target value of below 1.4 mmol/L. This means that additional lipid lowering therapy is necessary in most patients. The ‘Zuid-Oost Netherlands Heart Registry’ (ZON-HR) is a multicentre, prospective registry designed to improve secondary prevention after PCI by a patient-tailored approach. Purpose To describe changes in lipid lowering therapy one year after PCI in the ZON-HR. Methods Since November 2020 data from all patients who underwent PCI in one of the four participating ZON-HR hospitals were included. In 4811 patients one year follow-up was completed. Patients with known discharge medication and medication at one year after PCI were included in the analyses (n=3487). Combination therapy was defined as having at least two different lipid lowering medications prescribed. The association between predefined variables and combination therapy at one year post PCI was assessed with multivariable logistic regression to adjust for baseline differences. Results The mean age of the patients was 67.7 ± 10.7 years, 72.4% was male and the baseline LDL-C value was 2.7 ± 1.1 mmol/L. While patients with an acute coronary syndrome (ACS) had higher LDL-C values at baseline, they received combination of lipid lowering therapy at discharge less often compared to patients with a chronic coronary syndrome (CCS) (7.9% vs 11.5%, p<0.001) (table 1). After one year, both ACS and CCS patients were treated more often with combination therapy (20.1% vs 23.3%, p=0.047). However, still only about 20% of the patients were receiving combination therapy one year after PCI. In the ACS population, younger patients with higher LDL-C values at baseline and previous myocardial infarction had a higher chance of receiving combination lipid lowering therapy one year after PCI (table 2). Conclusion Additional lipid lowering medication is needed, besides high-intensity statins, in order to reach the strict LDL-C target values in very high risk patients. However, the step-up from mono- to combination lipid lowering therapy only occurs in about 10% of the patients. Lipid lowering combination therapy is prescribed more often in CCS patients compared to ACS patients, both at discharge and one year after PCI.Baseline values and combination therapyPredictors combination therapy at 1 year

Complex versus non-complex, should we adjust the antiplatelet strategy to the type of percutaneous coronary intervention? Results from a real world PCI population

Abstract Background/introduction Personalized dual antiplatelet treatment (DAPT) using risk stratification is key to minimize bleeding- and ischemic events after percutaneous coronary intervention (PCI). Known ischemic risk factors include complex procedures which are integrated in the recommendation for extended DAPT in patients with additional ischemic risk factors. Purpose We aimed to provide insight whether a complex PCI (CPCI) should be regarded as an individual risk factor, regardless of other risk factors, to adjust the antiplatelet strategy. Also, we determined the effect of DAPT duration and choice of P2Y12 inhibitor on outcomes. Methods We included patients from the South East (Zuid Oost) Netherlands Heart Registry (ZON-HR) and excluded patients using oral anticoagulants. This PCI registry prospectively collects baseline-, procedural- and follow-up data including medication use and the intended DAPT duration. Patients were stratified to non-CPCI or CPCI comprising of bifurcation lesions with two stents, venagraft PCI, chronic total occlusion (CTO) or ≥ 60mm stent. Analyses were conducted using Cox regression analysis. Multivariate analysis was performed to adjust for risk factors and baseline differences. Results We included 3691 patients (842 CPCI). Table 1 demonstrates the baseline characteristics and DAPT strategy. CPCI was more often required in patients with a high ischemic risk profile based on the extensiveness of atherosclerosis and comorbidities. Non-CPCI patients more often underwent PCI for acute coronary syndrome. Outcomes are presented in table 2. Compared to non-CPCI, CPCI increased the risk of major adverse cardiac and cerebral events (MACCE) in the second half of the year as opposed to bleeding events, which more often occurred in the first months after CPCI, driven by access site bleedings (73% in CPCI versus 56% in non-CPCI, p=0.01). All-cause mortality was higher during the overall follow-up period after a CPCI compared to non-CPCI. These findings remain significant when corrected for additional risk factors in both groups. In patients with CPCI, treatment with ticagrelor or prasugrel strongly reduced MACCE between 6-12 months when compared to clopidogrel (multivariate HR: 0.28, 95% CI: 0.08-0.98), but did not influence bleeding events or all-cause mortality. No effect of extended DAPT was observed. Conclusions A CPCI is an important ischemic risk factor that could be used for risk stratification to guide antiplatelet strategy. Treatment with ticagrelor or prasugrel strongly diminished the risk of MACCE without increasing the bleeding risk in patients with a CPCI. As the risk of MACCE increases between 6-12 months after PCI while the risk of bleeding events diminishes in this period, extended DAPT from 6 to 12 months could also be considered to provide extended protection.Table 1.Table 2

Impact of the complexity of percutaneous coronary intervention on clinical outcomes in patients with atrial fibrillation: a real-world study

Abstract Background Atrial fibrillation (AF) always coexisted with percutaneous coronary intervention (PCI), and complex PCI has increased in recent years. However, limited data exist on clinical outcomes in patients with AF and underwent complex PCI. Purposes We aimed to explore the prognosis of patients with AF who had underwent PCI. Methods This was a prospective, observational study which enrolled 1132 participants consecutively. Complex PCI was defined as PCI performed to ≥ 3 separate major coronary vessels; ≥3 stents implanted; ≥3 lesions treated; or total stented > length 60 mm. The primary endpoint was defined as major adverse cardiovascular event (MACE) including all-cause death, spontaneous myocardial infarction (MI), stroke, systemic embolism or ischemia-driven revascularization. Major bleeding events were defined according to Thrombolysis in Myocardial Infarction (TIMI) criteria. Results A total of 1132 patients who underwent PCI with AF were enrolled. The mean age was 66.6 ±8.9, and 75.1% were male. 320 participants (28.2%) were undergoing complex PCI. During a median follow-up of 1045 days, the primary outcome occurred in 52 of 320 patients (16.2%) in the complex PCI group and 105 of 812 patients (12.9%) in the non-complex PCI group (adjusted hazard ratio: 1.31; 95% confidence interval: 1.08-1.58; P = 0.007), driven by higher rate of MI ( aHR=2.17, 95%CI, 1.00-4.70 and ischemic driven revascularization (aHR=1.86, 95%CI, 1.01-3.45). TIMI major bleeding events were more commonly observed in complex PCI group (aHR=1.15, 95%CI, 1.01-1.31). Conclusion The complexity of PCI was an independent risk factor of adverse clinical outcomes, especially in MI, revascularization and TIMI major bleeding events in patients with AF.K-M curves of eventsK-M curves of events

The usefulness of IVUS and OCT in patients treated with rotational atherectomy

Abstract Background Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have been shown to improve clinical outcomes of percutaneous coronary interventions (PCIs) in selected subsets of patients. Purpose To investigate whether the use of OCT or IVUS during PCI with rotational atherectomy (RA-PCI) will increase odds for successful revascularization defined as thrombolysis in myocardial infarction (TIMI) 3 flow. Methods Data were obtained from the national registry of PCIs (ORPKI) maintained by the Association of Cardiovascular Interventions (AISN) of the Polish Cardiac Society. The dataset includes PCIs spanning from January 2014 to December 2021 Results A total of 6,522 RA-PCIs were analyzed, out of which 708 (10.9%) were guided by IVUS and 86 (1.3%) by OCT. The postprocedural TIMI 3 flow was achieved significantly more often in RA-PCIs guided by intravascular imaging (98.7% vs 96.6%, p<0.0001). Multivariable analysis revealed that using of IVUS and OCT was independently associated with an increased chance of achieving postprocedural TIMI 3 flow by 67% (odds ratio (OR), 1.67; 95% confidence interval (CI): 1.40–1.99; p<0.0001) and 66% (OR, 1.66; 95% CI: 1.09–2.54; p=0.02), respectively. Other factors associated with successful revascularization were as follows: previous PCI (OR, 1.72; p<0.0001) and coronary artery bypass grafting (OR, 1.09; p=0.002), hypertension (OR, 1.14; p<0.0001), fractional flow reserve assessment during angiogram (OR, 1.47; p<0.0001), bifurcation PCI (OR, 3.06; p<0.0001), and stent implantation (OR, 19.6, p<0.0001). Conclusions PCIs with rotational atherectomy guided by intravascular imaging modalities (IVUS or OCT) are associated with a higher procedural success rate compared to angio-guided procedures.

Percutaneous coronary intervention versus coronary arterial bypass grafting in patients with left main coronary artery disease and chronic kidney disease: a systematic review and meta-analysis

Abstract Background Left main coronary artery disease (LMCAD), defined as a stenosis of >50%, is a potentially lethal condition that should be treated intensively by either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) depending on the anatomy. The presence of chronic kidney disease (CKD) complicates LMCAD, acting as a potential worsening factor for this group of patients, as well as impairing the effectiveness and outcomes of both revascularization treatments. Purpose This systematic review and meta-analysis aims to comprehensively compare the outcomes of PCI and CABG in patients with LMCAD and CKD. Methods A systematic search of the available literature was conducted in PubMed, Embase, and CENTRAL. Studies that compared PCI versus CABG in patients with LMCAD and CKD were included. The primary endpoints comprised major adverse cardiac and cerebrovascular events (MACCE) and all-cause death, while secondary endpoints included components of MACCE, such as myocardial infarction (MI), stroke and new revascularization events. The results were qualitatively and quantitatively synthesized and pooled hazard ratios (HR) were calculated. The statistical analysis was conducted in R. Results A total of 767 titles were initially retrieved, with five studies finally included in the analysis (n = 2,337 patients). The pooled analysis revealed that patients treated with PCI experienced more MACCE (HR: 1.50, 95% CI: 1.26-1.78, p < 0.001), an outcome primarily driven by MI (HR: 1.75, 95% CI: 1.17-2.62, p = 0.01) and revascularization rates (Hazard Ratio: 3.66, 95% CI: 1.84-7.30, p < 0.001), while no significant difference was shown in stroke rates (HR: 0.70, 95% CI: 0.40-1.22, p = 0.21). A trend towards increased all-cause death was observed for the PCI group, although this outcome slightly failed to reach statistical significance (HR: 1.30, 95% CI: 1.00-1.68, p = 0.05). Conclusion The present systematic review and meta-analysis indicated that PCI appears inferior to CABG in patients with LMCAD and CKD, with respect to most long-term outcomes. This includes higher rates of MACCE, and particularly MI and new events of revascularization for patients undergoing PCI, while all-cause death was marginally higher for this group. Further randomized controlled trials are needed to provide more robust evidence for guiding revascularization strategies in this high-risk population.

Outcomes of percutaneous coronary interventions after transcatheter aortic valve replacement

Abstract Background The number of percutaneous coronary interventions (PCI) after transcatheter aortic valve replacement (TAVR) is expected to increase with the extension of this treatment toward younger and lower-risk patients. However, little is known about the prognosis of this evolving subset of patients. Purpose This study aims to assess the clinical outcomes of patients undergoing PCI after TAVR. Methods Patients undergoing PCI after TAVR were retrospectively included from 20 centers across 7 European Countries from July 2008 to November 2023. The patients and procedural characteristics at the time of PCI, post-discharge antithrombotic regimen, and clinical outcomes were collected by each center. The primary endpoint was major adverse cardiovascular events (MACE), a composite of cardiovascular death, myocardial infarction, or stroke. Results A total of 464 patients underwent PCI at a median interval of 106 days (interquartile range: 40-502) after TAVR (45.4% balloon-expandable, 49.6% self-expandable, and 5.0% mechanically-expandable valve). The cohort had a mean age of 80.9±6.2 years, a mean Euroscore II of 5.5±6.2, and 48% had undergone prior PCI or coronary artery bypass graft. Indications for PCI included chronic coronary syndrome (64.6%), non-ST elevation myocardial infarction (20.5%), unstable angina (7.9%), ST elevation myocardial infarction (5.7%), and other acute reasons (1.2%). PCI was complex in approximately 20% of the cases and radial access was utilized only in about 47.4% of them. Still, PCI success rate was 96.7%, achieving complete revascularization in 70.5% of cases. There were 19 periprocedural myocardial infarctions (4.3%). The predominant antithrombotic regimen was 12-month dual antiplatelet therapy (49.1% of patients). MACE incidence over one year of follow-up was 11.8% (95% CI: 9.0%-15.4%), with no differences among TAVR valve types (p-value=0.260). The incidences of the individual component of MACE were 8.7% for cardiovascular deaths, 5.3% for myocardial infarctions, and 2.3% for strokes. Conclusion At present, patients undergoing PCI after TAVR represents a high-risk subgroup. Nonetheless, elucidating actionable factors could potentially improve their outcomes. This preliminary analysis did not reveal any association with the type of implanted valve.

Percutaneous coronary intervention of in-stent restenosis: A three-arm analysis from SWEDEHEART

Abstract Background During the last decades, there have been substantial improvements in treatment techniques for percutaneous coronary intervention (PCI). Yet, in-stent restenosis (ISR) continues to pose significant challenges as they account for 10% of all PCI cases and are associated with worse outcome compared to de-novo lesions. When assessing ISR with PCI, balloon angioplasty with drug-coated balloons (DCB) is frequently used. Purpose Despite frequent use of DCB, there is a lack of long-term data ensuring the safety of DCB for ISR as no randomized trial has extended beyond a 3-year follow-up. We aimed to study the long-term outcome and conducted a nationwide three-arm investigation on the outcome of ISR, comparing DCB with drug-eluting stents (DES) or plain old balloon angioplasty (POBA) within a 5-year follow-up. Methods We conducted a nationwide analysis using the SWEDEHEART (Swedish Web System for Enhancement of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry. The SWEDEHEART registry was used to include any ISR undergoing coronary angiography between June 11, 2013, and December 31, 2020. Target lesion revascularization (TLR) was the primary outcome. Secondary outcomes included all-cause mortality, myocardial infarction, and any PCI. The outcomes were analysed using a multivariable Cox regression model. Results A total of 9304 segments from 7987 patients were eligible. Compared to POBA, the use of DCB was associated with lower rates of TLR, hazard ratio (HR) 0.62 (95% confidence interval [CI]: 0.50-0.78), all-cause mortality, HR 0.60 (95% CI: 0.50-0.72), and any PCI, HR 0.78 (95% CI: 0.66-0.93). No difference was observed for myocardial infarction. Compared to DES, the use of DCB was associated with higher rates of TLR, HR 1.24 (95% CI: 1.08-1.42). No difference was observed for all-cause mortality, cardiovascular mortality, myocardial infarction, or any PCI. Conclusions In this nationwide analysis including any ISR undergoing PCI, the use of DCB showed superior outcomes compared to POBA within 5 years but higher rates of repeat revascularizations compared to DES. While DES demonstrated lower TLR rates than DCB, the lack of mortality differences indicates that DCB is a viable option, particularly for patients where DES might not be suitable, but that DES should be considered as the first line strategy.Table 1.5-year outcomeFigure 1.Kaplan-Meier curves

Intravascular imaging-guided PCI in patients with acute myocardial infarction and cardiogenic shock

Abstract Background There are no clinical data regarding efficacy of intravascular imaging-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI in patients with acute myocardial infarction (AMI) and cardiogenic shock. Purpose The current study sought to evaluate the impact of intravascular imaging-guided PCI in patients with AMI and cardiogenic shock. Methods Among a total of 28,732 patients from the nationwide pooled registry of KAMIR-NIH and KAMIR-Ⅴ, a total of 1,833 patients (6.4%) with AMI and cardiogenic shock who underwent PCI of the culprit vessel were selected. The primary endpoint was major adverse cardiovascular events (MACE) at 1 year, a composite of cardiac death, MI, repeat revascularization, and definite or probable stent thrombosis. Results Among the study population, 375 patients (20.5%) underwent intravascular imaging-guided PCI and 1,458 patients (79.5%) underwent angiography-guided PCI. Intravascular imaging-guided PCI showed significantly lower risk of 1-year MACE compared with angiography-guided PCI (19.5% vs 28.2%; adjusted hazard ratio [HR], 0.59; 95% confidence interval [CI], 0.45-0.77; P<0.001), mainly driven by lower risk of cardiac death (13.7% vs. 24.0%; adjusted HR, 0.53; 95% CI, 0.39-0.72; P<0.001). These results were consistent in propensity score matching (HR, 0.68; 95% CI, 0.46-0.99), inverse probability weighting (HR, 0.61; 95% CI, 0.45-0.83), and Bayesian analysis (odds ratio, 0.66, 95% credible interval, 0.49-0.88). Conclusion In AMI patients with cardiogenic shock, intravascular imaging-guided PCI was associated with lower risk of MACE at 1-year than angiography-guided PCI, mainly driven by the lower risk of cardiac death. Further randomized controlled trial is warranted to confirm these findings.Central illustration

Patient characteristics and clinical outcome in acute myocardial infarction related cardiogenic shock according to vascular access site for PCI

Abstract Background / Introduction The optimal vascular access site for percutaneous coronary interventions (PCI) in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) remains uncertain. While observational data favor trans-radial access (TRA) due to lower complication rates and mortality, trans-femoral (TFA) PCI offers advantages such as shorter access and procedure times, along with quicker escalation to mechanical circulatory support (MCS). Purpose In this study, we aimed to investigate factors associated with a transfemoral approach and compare mortality rates between TRA and TFA in AMI-CS patients undergoing PCI. Methods Data from a nationwide registry of AMI-CS patients undergoing PCI (2017-2021) were analyzed. We compared patient demographics, procedural details, and outcomes between TRA and TFA groups. Logistic regression identified access site factors and radial-to-femoral cross-over predictors. Propensity score matched (PSM) analysis examined the impact of access site on mortality. Results Of 1562 patients, 45% underwent TRA PCI, with an increasing trend over time. TFA patients were more often female, had a history of coronary artery bypass grafting (CABG), lower blood pressure, higher resuscitation and intubation rates, and elevated lactate levels. After PSM, 30-day mortality was lower in TRA (33% vs. 46%, p <0.001). Predictors for cross-over included left coronary artery interventions, multivessel PCI, and MCS initiation. Conclusion Significant differences exist between TRA and TFA PCI in AMI-CS. TFA was more common in patients with worse hemodynamics and was associated with higher 30-day mortality compared to TRA. TRA should be the default access, given its feasibility and favorable outcomes in many patients.Baseline characteristicsPredictors for femoral access

Elevated levels of plasma inactive stromal cell derived factor-1a predict long-term adverse outcomes in diabetic patients with coronary artery disease

Abstract Background Because of the significantly increased cardiovascular risk by complicating type 2 diabetes (T2D) in patients with coronary artery disease (CAD), the appropriate risk estimation is crucial in patients with T2D following percutaneous coronary intervention (PCI). Nevertheless, there is no established biomarker which can precisely predict outcomes in this particular population. Although stromal cell derived factor-1α (SDF-1α) has been suggested to play a key role in the pathogenesis of T2D, the prognostic impact of SDF-1α in the secondary prevention of CAD is yet to be elucidated. In particular, the ability of SDF-1α isoforms in outcome prediction in this population has not been assessed. Purpose The aim of present study was to investigate the prognostic implication of three isoforms of SDF-1α, such as total, active, and inactive forms of SDF-1α in diabetic patients following PCI. Methods This single-center retrospective analysis involved consecutive patients with T2D who underwent PCI for the first time between 2008 and 2018 (n=849). Primary and secondary outcome measures were all-cause death and the composite of cardiovascular death, non-fatal myocardial infarction, and ischemic stroke (3P-MACE), respectively. For determining plasma levels of SDF-1α, we measured not only total, but also the active type of SDF-1α by ELISA. Inactive isoform of the SDF-1α was calculated by subtracting the active isoform from total SDF-1α. Participants were divided into two groups according to the median of three forms of plasma SDF-1α levels (total SDF-1α: 2270 pg/mL, active SDF-1α: 686 pg/mL, inactive SDF-1α: 1537 pg/mL) at PCI procedure and the incidence and risk of subsequent endpoints following PCI were assessed. Results Kaplan-Meier analyses revealed increased risk of both all-cause death and 3P-MACE in patients with elevated levels of inactive SDF-1α (Figure 1). Constantly, multivariate Cox hazard analyses adjusted by age, sex, body mass index (>25), acute coronary syndrome, and chronic kidney disease (≥ stage 3) repeatedly indicated the 1 higher log-transformed inactive SDF-1α was significantly associated with increased risk of all-cause death (hazard ratio (HR): 2.21, 95% confidence interval (CI): 1.05–4.67, p=0.04) and 3P-MACE (HR: 2.30, 95% CI: 1.01–5.09, p=0.04). However, neither of total and active SDF-1α reached statistical significance (Figure 2). Furthermore, the addition of inactive SDF-1α to baseline models in multivariate Cox proportional hazard analysis significantly enhanced both the net reclassification improvement (NRI) and the integrated discrimination improvement (IDI) for all-cause death (NRI 0.29, p=0.009; IDI 0.007, p=0.03) and 3P-MACE (NRI 0.38, p=0.001; IDI 0.007, p=0.01) while adding total and active SDF-1α did not improve them. Conclusion In diabetic patients following PCI, elevated levels of plasma inactive SDF-1α, not total and active isoforms, might be a useful indicator of adverse outcomes.

Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention for acute myocardial infarction with cardiogenic shock

Abstract Background Intravascular ultrasound (IVUS) potentially improves short and long-term clinical outcomes of percutaneous coronary intervention (PCI). However, evidence regarding its efficacy in patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI) is limited. Objectives This study investigated the impact of IVUS-guided PCI in patients with AMI and CS. Methods From the pooled data based on a series of Korean AMI registries during 2011–2020, we identified 1,418 consecutive patients who underwent PCI with second generation drug-eluting stent (DES) for AMI and CS. The primary endpoint was the 1-year rate of target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction, and ischemic-driven target lesion revascularization. Results Among the patients, 294 (20.7%) and 1,124 (79.3%) underwent IVUS-guided and angiography-guided PCI with second generation DES implantation, respectively. No significant difference was observed in the 1-year TLF between both groups after IPTW analysis (hazard ratio 0.93, 95% confidence interval 0.65–1.34, p=0.70) (Figure A). Additionally, the adjusted landmark analysis for TLF at 30 days and between 30 days and 1 year after PCI demonstrated no significant difference between the groups (Figure B). Conclusions In patients with AMI and CS who underwent PCI with second-generation DES, IVUS-guided PCI did not improve clinical outcomes with respect to 1-year TLF compared with angiography-guided PCI.Figure

Both fibrosis-4 index and fibrosis-5 index can predict the prognosis of patients after percutaneous coronary intervention

Abstract Backgrounds: The Fibrosis-4 (FIB-4) index and Fibrosis-5 (FIB-5) index are non-invasive indicators reflecting liver fibrosis. Previous studies show their association with acute heart failure and myocardial infarction prognosis. However, there are few reports on the relationship between the two indices and the prognosis of patients after percutaneous coronary intervention (PCI). Purpose This study aims to explore and compare the predictive value of both indices for PCI patient prognosis. Method Data for this study were obtained from a retrospective cohort comprising patients admitted to and discharge d from 72 secondary and tertiary hospitals between 2010 and 2023. Inclusion criteria comprised patients undergoing PCI during hospitalization. The initial test results of these patients after admission were collected, and the FIB-4 (FIB-4 = age (years) × aspartate aminotransferase (AST [U/L]) / (platelets [10^9/L] × alanine aminotransferase [ALT {U/L}]½) and FIB-5 (FIB-5 = [albumin (g/L) × 0.3 + platelet count (10^9/L) × 0.05] - [alkaline phosphatase (U/L) × 0.014 + AST/ALT ratio × 6 + 14]) indices were calculated. Patients were divided into low (N = 83082), medium (N = 16618), and high (N = 7932) FIB-4 groups, as well as low (N = 18642), medium (N = 12106), and high (N = 76884) FIB-5 groups based on predefined cutoff values. The primary endpoint was one-year cardiovascular mortality, with secondary endpoints including one-year all-cause mortality and one-year recurrent myocardial infarction. Results The study included 107,632 patients after PCI whose FIB-4 index and FIB-5 index could be simultaneously calculated during hospitalization. Multivariable Cox regression analysis revealed that compared to the low FIB-4 group, both the high FIB-4 group (aHR 1.935; 95%CI 1.592-2.353) and the medium FIB-4 group (aHR 1.487; 95%CI 1.251-1.768) had an increased risk of one-year cardiovascular death (P0.05). Conclusions The present study indicated that both FIB-4 and FIB-5 could be used to predict the prognosis of patients after PCI. High FIB-4 index and low FIB-5 index were predictive factors for 1-year cardiovascular death, 1-year all-cause death, and 1-year recurrent myocardial infarction in patients after PCI, with no statistical difference in predictive value between the two.

The safety and efficacy of indobufen or aspirin combined with clopidogrel in patients with acute myocardial infarction after percutaneous coronary intervention

Abstract Background Currently, the standard treatment for patients who have undergone percutaneous coronary intervention (PCI) following acute myocardial infarction (MI) involves dual antiplatelet therapy (DAPT) with a combination of asprin and clopidogrel. However, the potential benefits of aspirin were limited by an increased risk of bleeding. The safety and efficacy of indobufen, an alternative antiplatelet agents to aspirin, in patients with AMI after PCI are yet to be thoroughly investigated. Methods This retrospective study was conducted at a single center and utilized propensity score matching. The enrollment spanned from January 2019 to June 2022, incorporating patients who experienced AMI following PCI. The participants were categorized into two groups based on their medication: the aspirin DAPT group and the indobufen DAPT group. The primary endpoint focused on net adverse clinical event (NACE) at one year, defined as a composite outcome, including cardiac death, recurrence of MI, definite or probable stent thrombosis (ST), target lesion revascularization (TLR), ischemic stroke and Bleeding Academic Research Consortium (BARC) criteria type 2, 3, or 5. Results A total of 1451 patients were enrolled in this study, with 258 assigned to the indobufen DAPT group and 1193 to the aspirin DAPT group. Following 1:1 propensity score matching, 224 patients were retained in each group and postmatching absolute standardized differences were consistantly below 10% for all covariates (Figure 1). The primary endpoint occurred in 58 (25.9%) individuals in indobufen DAPT group and 52 (23.2%) in the aspirin DAPT group (HR 1.128, 95% CI 0.776-1.639, p = 0.527, Figure 2). Specifically, no significant differences were observed in either the efficacy endpoint (MACCE, 20.1% vs. 14.7%, HR 1.392, 95% CI 0.893-2.170, p = 0.146) or the safety endpoint (BARC 2,3 or 5, 8.04% vs. 10.30%, HR 0.779, p=0.427). Conclusions The results of our study reveal no noteworthy distinctions in primary and secondary endpoints between the two groups. This finding indicates that the efficacy and safety of indobufen may be comparable to aspirin in Chinese patients with AMI after PCI, supporting its consideration as a potential substitute for aspirin in patients with AMI after PCI.

Clinical outcome based on functional complete revascularization in patients with three-vessel coronary artery disease: The FAME 3 Trial

Abstract Background Anatomic complete revascularization after angiography-guided percutaneous coronary intervention (PCI) is associated with improved clinical outcomes. The impact of functional complete revascularization (PCI of all fractional flow reserve (FFR) positive lesions) in patients with 3-vessel coronary artery disease (3VD) amenable to PCI or coronary artery bypass grafting (CABG) is unknown. Purpose To investigate the clinical impact of functional complete revascularization after FFR-guided PCI in the FAME 3 trial Methods The FAME 3 trial is a multicenter, international, randomized study comparing FFR-guided PCI with CABG in patients with angiographic 3VD. This pre-specified sub-study evaluated the impact of functional complete revascularization after PCI on the primary endpoint of death, myocardial infarction (MI), or stroke at 3 years. The degree of functional complete revascularization was quantified by calculating the residual functional SYNTAX score (rFSS), defined as the residual anatomic SYNTAX score based on post-PCI angiography minus any FFR-negative deferred lesions. Results Of the 757 patients treated with FFR-guided PCI, the rFSS could be calculated by the core laboratory in 81% (n=601). Among the angiographically significant lesions, PCI was deferred based on FFR in 17% (51 % of patients had deferral of at least one lesion). The patients were divided into two groups according to acceptable functional complete revascularization: rFSS 0-8 (63%) and functional incomplete revascularization: rFSS>8 (37%). The cumulative incidence of death, MI, or stroke at 3 years was significantly lower in patients with rFSS 0-8 (9% vs. 17%, Hazard ratio[HR]:0.5, 95% confidence interval[CI]:0.3-0.8, p=0.006) compared with rFSS>8. In comparison with the CABG arm, the patients with rFSS 0-8 had similar outcome (HR:0.97, 95%CI:0.6-1.5, p=0.87), while in those with rFSS >8 outcome was worse (HR:1.9, 95%CI: 1.3-2.8, p=0.002) (Figure). There was no difference in death, MI or stroke in CABG patients with or without anatomic complete revascularization. In a multivariate-adjusted model, rFSS>8 showed a significant association with death, MI or stroke at three years (adjusted HR: 1.83, 95% CI: 1.09-3.09, p=0.02). Conclusions Acceptable functional complete revascularization with FFR-guided PCI in patients with 3VD is an independent predictor of death, MI or stroke at three years and can be achieved in 63% of patients resulting in similar outcomes compared with CABG.

Placebo-controlled efficacy of 17 anti-anginal drugs and percutaneous coronary intervention for first-line treatment of stable angina: systematic review & meta-analysis of 5153 patients from 53 trials

Abstract Background Percutaneous coronary intervention (PCI) for stable angina is currently recommended for patients with residual symptoms despite maximal anti-anginal medication. Placebo-controlled data demonstrating efficacy of PCI has recently become available. Purpose We evaluated the placebo-controlled efficacy of anti-anginal agents and PCI, as monotherapies for stable angina. Methods We performed a systematic review and meta-analysis of placebo-controlled randomised controlled trials (RCTs) of anti-anginal agents (17 medications across 7 drug classes [beta-blocker, dihydropyridine (DHP) calcium channel blocker (CCB), non-DHP CCB, ivabradine, nicorandil, nitrates and ranolazine]), and PCI, which reported the placebo-controlled treatment effect on standardised exercise duration in patients with stable angina, who were receiving no background anti-anginal medications. We searched MEDLINE, EMBASE, and Cochrane CENTRAL from database inception to 01 December 2023. Relevant systematic reviews and reference lists were inspected to identify publications which had not been identified in the primary searches. Two independent reviewers extracted the data and assessed the risk of bias of included studies. Intention-to-treat data were used. Meta-analyses were carried out using random-effects methods and reported using the PRISMA guidelines. The primary outcome was mean difference in total exercise time with treatment compared with placebo. A pairwise comparison of all anti-anginal medications and PCI was performed to evaluate their relative placebo-controlled efficacy on total exercise time. Results A total of 52 trials were eligible, evaluating 83 treatment arm comparisons of anti-anginal monotherapy (2408 patients) and placebo (2444 patients). The number of trials per medication class ranged from one (ivabradine) to 19 (non-DHP CCBs). All classes improved exercise time compared to placebo, with mean increment ranging from 22.4 seconds (95% confidence interval, 0.8 to 44.0, p=0.04) for ranolazine, to 76.5 seconds (63.2 to 89.8, p<0.0001) for DHP CCBs (Figure 1). There was substantial heterogeneity in exercise time increment between drug classes (I2 98%, p<0.0001). However, across all classes, there was a clear dose-response relationship (b-coefficient 24.8, 15.8 to 33.9, <0.0001). The only trial which compared PCI (151 patients) to placebo (150 patients) showed a placebo-controlled exercise duration increment of 59.5 seconds (16 to 103, P=0.001). This was comparable to the global mean effect across all anti-anginal medications (59, 39 to 79, P<0.0001). Conclusions Each anti-anginal drug class showed a clear increase in placebo-controlled exercise time, with varying effect sizes between classes. The DHP CCB class showed the largest effect size, and ivabradine and ranolazine showed the smallest. The effect of PCI monotherapy was similar to the mean anti-anginal medication monotherapy effect.Figure 1

Demographic, clinical characteristics, managements strategies and in-hospital outcomes of patients enrolled in prospective nationwide SCAD registry

Abstract Spontaneous coronary artery dissection (SCAD) is an uncommon yet increasingly recognized cause of acute coronary syndrome (ACS), particularly in young to middle-aged women. This multicentric, prospective nation-wide registry aimed to elucidate the demographic characteristics, clinical presentation, management strategies, and outcomes of patients with SCAD. A total of 95 patients with SCAD were enrolled in 10 centers, with females constituting 81% of the cohort, and with an average age of 49.7±11.9 years. Among the traditional risk factors, prior hypertension was observed in 49%, followed by hyperlipidemia in 43%, diabetes mellitus in 9% and prior or current smoking in 47% of patients. The presentation of SCAD as ST-elevation myocardial infarction (STEMI) was predominant, occurring in 61% of cases, with the left anterior descending artery (LAD) being the most involved vessel (68%). Regarding the classification of SCAD, type 2 SCAD was the most frequent (53%), followed by type 1 (24%) and type 4 (16%). Notably, involvement of the distal segment of the culprit artery was observed in 68% of cases, while baseline TIMI 3 flow was noted in 52% of patients. Percutaneous coronary intervention (PCI) was performed in 52% of cases, with pre-interventional TIMI 0-2 flow (62% Vs. 28%; p<0.05) and proximal artery involvement (41% Vs. 13%; p<0.05) being more prevalent compared to conservatively managed patients. Final stent implantation was performed in 67% of PCI cases, with TIMI 3 flow restoration in 76% of patients undergoing PCI. The average left ventricular ejection fraction prior to discharge was 51±9.9%. In-hospital mortality was reported in three female patients, undergoing attempted PCI with left main and LAD involvement. The use of antiplatelet therapy was widespread, with aspirin administered to 98% and P2Y12 inhibitors to 75% of patients at discharge. Data from this prospective nationwide multicentric SCAD registry show that SCAD occurs predominantly in relatively young female patients, with moderately prevalent traditional cardiovascular risk factors, usually presents as STEMI, with good overall survival rates despite half of the patients managed conservatively. PCI was often attempted in SCAD lesion with compromised arterial flow and located proximally, with lower rates of stent implantation and procedure success compared to traditionally observed rates in primary PCI. This underscores the importance of heightened awareness and tailored management approaches for this unique subset of ACS patients in order to refine risk stratification, optimize treatment strategies, and improve outcomes in this population.

Percutaneous revascularization in late-presenting STEMI with absence of viability: effects on left ventricular remodeling and scar

Abstract Introduction In patients with ST-elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) should be conducted within 12 hours of symptom onset. The potential benefits attributable to late reperfusion in STEMI fall under the "open artery hypothesis" where the stunned peri-infarction zone after revascularization would restore blood supply and contractility. Purpose To estimate the differences on the LV ejection fraction (LVEF), indexed LV end-systolic volume (iLVESV) and scar in patients with STEMI without viabilitity randomized to optimal medical therapy (OMT) alone or OMT and a late percutaneous coronary intervention (PCI) performed between 24 hours and 30 days after the event. Methods Patients with non-reperfused STEMI were evaluated from September 2021 to June 2022 at a tertiary cardiology hospital. The patients underwent Cardiac Magnetic Resonance (CMR) to assess myocardial viability and were classified as non-viable if they had only 1 wall segment with less than fifty percent thickness of the affected wall with late gadolinium enhancement. The patients were randomized to PCI or OMT alone. CMR was repeated at 6 months to evaluate LVEF, iLVESV and fibrosis. This summary presents a planned partial analysis of the 6-month results (N=51). Descriptive statistics analysis included central and dispersion estimators, or absolute and relative frequencies. To explore the differences between groups and time, Mann-Whitney and Wilcoxon tests were run, and results were given as point-estimates and confidence intervals at 95% (95% CI). A significance level of 5% was adopted for inferential analysis. Results 51 patients (60±11 years, 71% male) were included in the analysis. Of this total, 24 were randomized to PCI + OMT, and 27 to isolated OMT. The groups showed balanced distribution regarding clinical characteristics and initial CMR parameters (LVEF, iLVESV, and fibrosis). The difference in LVEF at the end of 6 months between the OMT and PCI groups was 2.07%, favoring the OMT group; however, this difference was not significant (p= 0.677, 95% CI: -5 to 10). Between the groups, the difference at the end of 6 months in iLVESV was -6.82 ml/m², also without statistical significance (p= 0.858, 95% CI: -19 to 11). There was a significant reduction in the amount of fibrosis in both PCI group with -14.68g (p= 0.011) and in the OMT group with -12.57g (p= 0.009). Detailed results are presented in Table 1. Conclusion Despite a significant reduction in fibrosis in both groups, there was no superiority observed in late PCI compared to isolated OMT in reducing reverse remodeling and fibrosis in patients with non-viable STEMI when compared to isolated OMT.Remodeling changes.

The use of allopurinol in prophylaxis against contrast-induced nephropathy in patients undergoing percutaneous coronary intervention

Abstract Background Contrast-induced nephropathy (CIN) is a serious complication after percutaneous coronary intervention (PCI). Inflammation and development of reactive oxygen species are among the postulated mechanisms of CIN. Allopurinol with anti-inflammatory action could be a preventive method of CI-AKI. Aim of the work To determine the effect of adding allopurinol to hydration in the prevention of CIN in patients undergoing PCI, with or without hyperuricemia. Methods One hundred and seven patients with moderate to high Mehran score undergoing elective PCI were randomly allocated to the allopurinol (n=52) or the control group (n=55). Those in the allopurinol group (hyperuricemic n=25, and normouricemic n= 27) received allopurinol 300 mg one day and one hour before PCI beside intravenous hydration (1 ml/kg/hour) normal saline, a maximum of 100 ml/hour for 12 hours pre and post coronary angiography. Patients in the control group (hyperuricemic n=26 and normouricemic n=29), received the same intravenous hydration only. Serum creatinine and urea were measured before and 48 hours after the procedure while the uric acid level was measured before the procedure only. CIN was defined by a percentage increase in serum creatinine of ≥25% or absolute serum creatinine ≥0.5 mg/dl, 48 hours after PCI. Results The mean age of the studied patients was 59.6 ± 9.1 years old, 59% were male. No difference between both groups regarding baseline characteristics or medications. Average Mehran score was 9.0 ± 1.2. CIN was observed in 5 patients in the allopurinol group (9.6%) and 15 patients in the control group (27.3%) (P = 0.017). There was no significant difference between both groups regarding the contrast volume (179.8 ± 68.1 vs. 153.8 ± 57.9 ml, p: 0.052). Hyperuricemia had no significant effect on increasing the incidence of CI-AKI either in patients with or without CKD (p=0.964). Conclusion Allopurinol on the top of hydration was found to decrease the incidence of CIN following PCI in patients with moderate to high Mehran score for CIN. The anti-inflammatory action of allopurinol could be the mechanism of this favorable effect, as baseline uric acid didn't affect the results. Further multi-center study with a larger sample size is needed to offer more definite results.

The risk factors for in-stent restenosis following drug-eluting stent implantation in end-stage renal disease patients receiving renal replacement therapy

Abstract Background Chronic renal disease is a recognized risk factor for in-stent restenosis (ISR) following percutaneous coronary intervention (PCI) with a drug-eluting stent (DES). However, the specific risk of ISR among individuals with end-stage renal disease (ESRD) remains unclear or insufficiently studied. Purpose It is imperative to identify the risk factors associated with ISR among patients with ESRD and coronary artery disease following the implantation of DES. This identification is crucial for generating evidence-based strategies aimed at preventing ISR. Methods ESRD patients undergoing renal replacement therapy with concomitant coronary artery disease who underwent PCI with their initial DES implantation at our hospital between January 2013 and December 2022 were included in the study cohort. Clinical data, laboratory test results, and PCI specifics were compared between patients with and without ISR. Univariate and multivariate analyses utilizing Cox proportional hazard regression were employed to identify independent risk factors for DES-ISR. Results Among the 321 patients with ESRD who underwent PCI with DES implantation, totaling 874.5 patient-years of follow-up, 53 cases of ISR occurred during this period, yielding an incidence rate of 6.1 per 100 patient-years. Several baseline characteristics, angiographic findings, and procedural details were found to elevate the risk of ISR significantly. These included underlying diabetes mellitus, peripheral artery disease (PAD), high serum parathyroid hormone levels, LDL-C levels, acute coronary syndrome as the clinical presentation, the presence of triple vessel disease, duration of dual antiplatelet therapy less than 1 year, target lesion involving the left main (LM) or left anterior descending (LAD) artery, target vessel size less than 3 mm, ostial lesion, bifurcation lesion, number of stents implanted equal to or more than 3, and stent size less than 3 mm. In the multivariate Cox proportional hazard model, bifurcation lesion (HR 14.70, 95% CI 4.66-46.38), PCI of LM or LAD (HR 5.29, 95% CI 1.14-24.60), target vessel size less than 3 mm (HR 4.10, 95% CI 1.77-9.50), PAD (HR 3.92, 95% CI 1.52-10.08), and ostial lesion (HR 2.92, 95% CI 1.16-7.38) were identified as independent risk factors for ISR (all p-values < 0.05). Conclusions Among ESRD patients with coronary artery disease, bifurcation lesion, PCI involving the LM or LAD, target vessel size less than 3 mm, PAD, and ostial lesion are identified as independent risk factors for ISR. These findings hold significance in enhancing risk stratification and decision-making concerning treatment planning for this population.Univariate analysis risk factors for ISR

Factors associated with 30-day mortality in patients receiving mechanical circulatory support for cardiogenic shock

Abstract Introduction Mechanical circulatory support (MCS) is often deployed in patients with refractory cardiogenic shock complicating acute myocardial infarction (AMI-CS). Nevertheless, the mortality rate in these patients remains utterly high, around 50%. Purpose The aim of this study was to identify patient characteristics associated with 30-day mortality in patients receiving MCS for AMI-CS. Methods In the Netherlands, all patients undergoing percutaneous coronary intervention (PCI) are prospectively entered in the Netherlands Heart Registration (NHR). Additional data were retrieved for all CS patients between 2017-2021 in 14 Dutch hospitals, including MCS usage. Survivors and non-survivors amongst MCS treated patients were compared to identify patient characteristics associated with 30-day mortality. In addition, multivariate logistic regression analysis on imputed data was performed to quantify these associations in adjustment for confounders. Results MCS was deployed in 516 (23.3%) of all AMI-CS patients. MCS patients had a mean age of 64.2 (± 12.5) years and 74.6% were male. An intra-aortic balloon pump (IABP) was used in 49.0% of the patients. Impella, extracorporeal membrane oxygenation (ECMO) and multiple devices were used in 18.2%, 13.2% and 18.4% respectively. The overall 30-day mortality rate was 55.0%. At baseline, MCS survivors were younger (62.8 vs 65.2, p=0.03), had diabetes less often (18.4 vs. 28.0, p=0.02), and presented with a higher mean arterial pressure (MAP) (77.9 vs. 71.7, p<0.01). An out-of-hospital cardiac arrest (OHCA) preceded in 34.3% of the survivors versus 42.0% of the non-survivors (p=0.09). Survivors also had lower admission levels of lactate (5.0 vs. 7.8, p<0.01), glucose (12.1 vs. 15.2, p<0.01) and creatinine (94 vs. 115, p<0.01). Multivessel disease (MVD) was present less frequently in survivors compared to non-survivors (62.1% vs. 74.2%, p<0.01). In-hospital cardiac arrest (IHCA) occurred less often in survivors both prior to PCI (8.2% vs. 18.0%, p<0.01) and during PCI (22.8% vs. 34.6%, p<0.01). After multivariate logistic regression, higher age (OR 1.04, 95%CI: 1.02-1.05), resuscitation prior to (OR 2.11, 95 %CI: 1.09-4.09) or during PCI (OR 1.58, 95% CI: 1.01-2.47) and the presence of MVD (OR 2.07, 95% CI: 1.32-3.25) were independently associated with 30-day mortality in AMI-CS patients who received MCS. Conclusion In AMI-CS patients who received MCS, older age, the occurrence of an IHCA prior to or during PCI, and the presence of MVD were independently associated with an increased 30-day mortality.Figure 1.Table 1.