Percutaneous Coronary Intervention Population Research Articles

Outpatient PCI - early discharge PCI, single center experience

Abstract Funding Acknowledgements None. Background Percutaneous coronary intervention (PCI) has undergone rapid evolution over the last years and is currently a widely generalized therapeutic option. In the past, it was associated with a significant rate of complications, yet, with the improvement of new generation drug eluting stents, and the radial access (RA) development, PCI has become safer and simpler, with a minimum rate of complications. This allows patient’s faster discharge. Besides the pressure from the limited number of beds in wards, the improvement of PCI has given the confidence to urge outpatient PCI programs. However, there are still centers where there is no ambulatory PCI. Purpose This study aims to describe our center experience of ambulatory PCI program, in terms of safety and efficacy. Methods We analyzed our center’s retrospective cohort of 723 PCI, in 2022. Ambulatory PCI was defined as PCI with same day hospital discharge. Our inclusion criteria were patients submitted to PCI. We excluded patients with acute coronary syndromes and patients needing hospital admission for other non-coronary reasons. Results 467 (65%), of the 723 PCI were performed in ambulatory setting. Patients mean age was 67,8±11 years and 23% (n=107) were female. In 12% (n=55) of the cases, the coronary anatomy was previously known, from a differed procedure. 63% (n=298) had a normal left ventricle ejection fraction (LVEF), 6% (n=26) had a moderate depression of LVEF and 3% (n=13) had LVEF severe depression. RA was possible in 82% of the cases (n=384), and 18% (n=83) of PCI was done by femoral access (FA). The access size was 6 Fr in 77% (n=359) of the cases, 7Fr in 22% (n=105) and 8Fr in 1% (n=2). The RA hemostasis was by compression (either manually or by external device) and FA hemostasis was first intended by closing device, however in 17% of the transfemoral PCI (n=14) had to be compressed, due to device hemostasis failure. PCI was successful in 97% of the cases (n=449), with revascularization of the goal lesion. The unsuccessful PCI (3% n=18) were because uncrossable lesion in 2% (n=14), and no reflow after PCI in 1% (n=4). 6 patients had to be admitted, after planned outpatient PCI, 5 due to peripheral access complication with hemorrhage of FA (after closing device and manual compression failure) and 1 due to PCI complication, with small coronary perforation. There was a higher probability of admission in patients submitted to transfemoral PCI (p<0,05), and there was no statistically significant relation between unplanned admission and patient’s LVEF. There were no episodes of death, MACE, non-planned hospital readmission and stent failure in the ambulatory PCI population. PCI has become a predictable and reliable technique, capable to treat outpatients. Patients undergoing successful non-complex PCI, without events, can safely be discharged on the same day. Outpatient PCI helps with the functioning of inpatient care, allowing beds to be freed up for other situations.

A more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: an Italian post-maRketing study (the CAESAR registry).

The use of contemporary drug-eluting stents (DES) has significantly improved outcomes of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, concerns exist regarding the long-term proinflammatory effects of durable polymer coatings used in most DES, potentially leading to long-term adverse events. First-generation polymer-free stent technologies, such as sirolimus- and probucol-eluting stents (PF-SES), have shown an excellent safety and efficacy profile. The aim of this study was to evaluate the safety and efficacy of the new ultrathin Coroflex ISAR NEO PF-SES, in a more-comers PCI population. The CAESAR (a more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: An Italian post-maRketing study) registry is a multicenter, prospective study conducted in Italy, enrolling more-comers CAD patients undergoing PCI with the Coroflex ISAR NEO stent. Patients with left main (LM) disease, cardiogenic shock (CS), or severely reduced left-ventricular ejection fraction (LVEF) were excluded. The primary endpoint was target-lesion revascularization (TLR) at 1 year. A total of 425 patients were enrolled at 13 centers (mean age 66.9 ± 11.6 years, Diabetes mellitus 29%, acute coronary syndrome 67%, chronic total occlusion 9%). Of these, 40.9% had multivessel disease (MVD) and in 3.3% cases, the target lesion was in-stent restenosis (ISR). Clinical device success was reached in 422 (99.6%) cases. At 1 year, only two (0.5%) subjects presented ischemia-driven TLR. The 1-year rates of target vessel revascularization and MACE were 0.5% and 5.1%, respectively. Major bleeding was observed in four (1.0%) patients. In this multicenter, prospective registry, the use of a new ultrathin Coroflex ISAR NEO PF-SES in a more-comers PCI population showed good safety and efficacy at 1 year.

P2Y12 inhibitor loading time before elective PCI and the prevention of myocardial necrosis

Abstract Background There is dated and conflicting data about the optimal timing of initiation of P2Y12 inhibitors in elective percutaneous coronary intervention (PCI). Peri-PCI myocardial necrosis is frequent and associated with poor outcome. Purpose We aimed to assess the impact of the P2Y12 inhibitor loading time (time from loading to PCI) on peri-procedural myocardial necrosis in the elective PCI population of the randomized ALPHEUS trial. Methods 1809 patients of the ALPHEUS trial were divided into quartiles of loading time (0 to 0.2h, 0.2 to 1.7h, 1.7 to 4.1h and 4.1 to 24h). The ALPHEUS primary outcome was used (type 4 (a or b) myocardial infarction or major myocardial injury) as well as the main secondary outcome including minor myocardial injury. The risk of events was adjusted in a multivariate model. Results Patients in the first quartile group (Q1) presented higher rates of the primary outcome (p=0.01). When compared to Q1, incidences of the primary outcome decreased in patients with longer loading times (adjOR 0.70 [0.52.-0.95]; p=0.02 for Q2; adjOR 0.65 [0.48-0.88]; p<0.01 for Q3; adjOR 0.66 [0.49-0.89]; p<0.01 for Q4). Concordant results were found for the main secondary outcome. There was no interaction with the study drug allocated by randomization (clopidogrel or ticagrelor). Bleeding complications and clinical ischemic events were rare and did not differ between groups. Conclusion In elective PCI for chronic coronary syndrome, administration of the loading dose of oral P2Y12 inhibitor at the time of PCI is associated with more frequent peri-procedural myocardial necrosis than an earlier administration.

Spontaneous coronary artery dissection: the role of Coronary CT angiography in the follow-up management

Abstract Funding Acknowledgements Type of funding sources: None. Background Spontaneous coronary artery dissection (SCAD) is one of the causes of acute coronary syndrome (ACS), myocardial infarction (MI) and sudden death (SD). Diagnosis is done with coronary angiography (CA); nevertheless, coronary computed tomography angiography (CCTA) is a new useful tool in the acute diagnosis and at follow-up. Treatment could involve a conservative approach or an invasive approach with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Purpose 1) analyze the clinical and CCTA features at baseline of patients with a SCAD diagnosis; 2) evaluate the clinical and anatomic outcome at follow-up of patients with a SCAD diagnosis treated with a conservative or invasive approach; 3) evaluate in the conservative approach treated patients the clinical and anatomic outcome of those dismissed with single or double antiplatelet therapy. Methods A retrospective analysis of 57 patients affected by SCAD followed up with Coronary CT angiography (CCTA) between 2010 and 2022. Clinical and anatomic data were collected at baseline and at the follow-up (FU). The clinical endpoints evaluated were: all cause mortality, hospitalization for cardiovascular cause, SCAD or PCI ex-novo and MI; the anatomic endpoints were: patency of coronary artery and/or stents and length dissection changing from baseline. Results 57 patients were divided in 2 groups: 46 (80,7%) patients underwent a conservative treatment and 11 (19,3%) patients a PCI treatment. Patients treated with PCI has a significative incidence of smokers (45,5% vs 15,2%; p = 0,042), peripherical arteriopathy (18,2% vs 0%; p = 0,034), higher troponin peak (40425,8 vs 13436; p = 0,011) and lower ejection fraction (51,4±11,0 vs 57,1±7,6; p = 0,050). Moreover the PCI population has a significant involvement of more than one coronary artery (72,7% vs 6,5%; p<0,001), of the proximal tracts of the coronary arteries (22,8% vs 13 %; p = 0,001) and of the truncus communis (45,4% vs 0%; p<0,001). At the follow up, there were no statistical differences for the clinical and anatomic endpoints between the conservative and invasive treated patients (p>0,05). Among patients treated with conservative therapy, there were a significant recurrence of SCAD in those treated with DAPT than in those treated with SAPT (33,3% vs 5,9%; p = 0,033). Conclusions patients with SCAD managed with PCI have more cardiovascular risk factors, a major myocardial infarction extension and a more complex coronary arteries involvement; conservative management is comparable to the PCI treatment for the clinical and anatomic endpoints evaluated; DAPT at discharge was associated with a higher rate of SCAD recurrence at follow-up.

C78 SPONTANEOUS CORONARY ARTERY DISSECTION: THE ROLE OF CORONARY CT ANGIOGRAPHY IN THE FOLLOW–UP MANAGEMENT

Abstract Background Spontaneous coronary artery dissection (SCAD) is one of the causes of acute coronary syndrome, myocardial infarction (MI) and sudden death. Although the gold standard for diagnosis is invasive coronary angiography, Coronary Computed Tomography Angiography (CCTA) is a new useful tool for the diagnosis and follow–up (FU). Treatment could involve a conservative or an invasive approach with percutaneous coronary intervention (PCI) or coronary artery bypass grafting. AIMS: 1) analyze the clinical and CCTA features at baseline of patients with SCAD; 2) evaluate the clinical and anatomic patients outcome with conservative or invasive treatment; 3) evaluate in patients treated with the conservative approach the clinical and anatomic features of those dismissed with single (SAPT) or double (DAPT) antiplatelet therapy. Methods Clinical and anatomic data of 57 patients with SCAD, followed up with CCTA enrolled retrospectively between 2010 ad 2022, were collected at baseline and at the FU. The clinical endpoints evaluated were: all causes mortality, hospitalization for cardiovascular cause, SCAD or PCI ex–novo and MI. The anatomic endpoints were: patency of coronary artery and/or stents and length dissection changing from baseline. Results 46 (80,7%) patients underwent a conservative treatment and 11 (19,3%) under PCI. Patients treated with PCI were more smokers (45,5% vs 15,2%; p=0,042), had peripherical arteriopathy (18,2% vs 0%; p=0,034), higher troponin peak (40425,8 vs 13436; p=0,011) and lower ejection fraction (51,4±11,0 vs 57,1±7,6; p=0,050). Moreover the PCI population had a significant involvement of more than one coronary artery (72,7% vs 6,5%; p<0,001), of the proximal tracts of the coronary arteries (22,8% vs 13 %; p=0,001) and of the truncus communis (45,4% vs 0%; p<0,001). At the FU, there were no statistical differences for clinical and anatomic endpoints between the two groups (p>0,05). Among patients treated with conservative therapy, there was a more significant recurrence of SCAD in those treated with DAPT than in those treated with SAPT (33,3% vs 5,9%; p=0,033). Conclusions Patients with SCAD managed with PCI have more cardiovascular risk factors, a major myocardial infarction extension and a more complex coronary arteries involvement; conservative management is comparable to the PCI treatment for the clinical and anatomic endpoints evaluated. DAPT at discharge is associated with a higher rate of SCAD recurrence at FU.

585 SPONTANEOUS CORONARY ARTERY DISSECTION: THE ROLE OF CORONARY CT ANGIOGRAPHY IN THE FOLLOW-UP MANAGEMENT

Abstract Background Spontaneous coronary artery dissection (SCAD) is one of the causes of acute coronary syndrome (ACS) and sudden death (SD). This condition predominantly affects young women with a few or no conventional risk factors for CAD. Diagnosis is traditionally made with invasive coronary angiography (ICA); nevertheless, coronary computed tomography angiography (CCTA) is going to be a new useful tool in the acute diagnosis and at follow-up in these patients. Conventional treatment could involve a conservative approach with medical therapy or an invasive approach with percutaneous coronary intervention (PCI). Methods We retrospectively analyzed data of 57 SCAD patients followed up with Coronary CT angiography (CCTA) at our centre. Clinical and angiographic (invasive and non invasive) data were collected at baseline and at the follow-up. The primary outcome was a composite of all cause mortality and hospitalization for cardiovascular cause evaluated at 1690,7±1082,3 days; the secondary outcome was the evaluation of the vessels with CCTA at 777,9 ± 271,6 days. Results 57 patients were divided in 2 groups: 46 patients underwent a conservative treatment (80,7%) and 11 patients a PCI treatment (19,3%). The first group is composed of 15,2% male and the second of 27,3% male (p=0,387), mean age is 52,8±11,1 years vs 48,0±10,7 years (p=0,201). Patients treated with PCI has a significative higher incidence of smoking habits (45,5% vs 15,2%; p=0,042), peripheral arteriopathy (18,2% vs 0%; p=0,034), higher troponin peak (40425,8 vs 13436; p=0,011) and lower ejection fraction (51,4±11,0 vs 57,1±7,6; p=0,050). Moreover the PCI population has a more common involvement of 2 vessels (72,7% vs 6,5%; p<0,001), of the left main coronary artery (45,4% vs 0%; p<0,001) and of the circumflex coronary artery (45,4% vs 2,2%; p=0,001). At the follow up, there were no statistical differences for the primary and secondary outcomes between the 2 groups (p>0,05). Among patients treated with conservative therapy, there were a more frequent recurrence of SCAD in those treated with DAPT than in those treated with SAPT (33,3% vs 5,9%; p=0,033). Conclusions in patients with SCAD, conservative management is comparable to PCI treatment in terms of clinical and angiographic outcomes. Among patients treated with conservative therapy, DAPT at discharge was independently associated with a higher rate of SCAD recurrence at follow-up.

Low-density lipoprotein cholesterol levels and long-term bleeding in patients undergoing percutaneous coronary intervention: 5-year outcomes from a large cohort study

Abstract Aims Recent research reported that lower low-density lipoprotein cholesterol (LDL-C) is associated with more in-hospital bleeding in acute coronary syndrome (ACS) patients. However, the association between lower LDL-C levels and long-term bleeding in percutaneous coronary intervention (PCI) patients remains unclear. Methods A total of 10724 patients treated with PCI enrolled in ourhospital from January 2013 to December 2013. The primary endpoint was the Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding at 5 years. The secondary endpoint was intracranial hemorrhage. Taking the LDL-C value of 1.8 mmol/L (70 mg/dL) or 1.4 mmol/L (55 mg/dL) as cut-off points, patients were grouped to analyse, respectively. Results Among 9697 PCI patients treated with dual antiplatelet therapy finally enrolled, a total of 411 BARC type 2, 3 or 5 bleedings and 42 intracranial hemorrhage were recorded during a follow-up of 5 years. With LDL-C value of 1.8 mmol/L as cut-off point, multivariate Cox regression showed that lower LDL-C level was not associated with the risk for bleeding [hazard ratio (HR): 1.166, 95% confidence interval (CI): 0.879–1.549]. The result was consistent (HR: 1.185; 95% CI: 0.713–1.968) in a 1:4 propensity-score matching cohort (n=1285). For further study, we performed subgroup analysis which showed that lower LDL-C was not associated with the risk for bleeding in ACS (HR: 1.140; 95% CI: 0.846–1.535) or non-ACS patients (HR: 1.284; 95% CI: 0.909–1.813). With LDL-C value of 1.4 mmol/L as cut-off point, Cox regression showed that lower LDL-C level was not associated with the risk for bleeding in total population, ACS or non-ACS patients (P>0.05). The result was consistent in a 1:4 propensity-score matching cohort (n=760) (P>0.05). As for secondary endpoint, lower LDL-C level was not associated with the risk for intracranial hemorrhage whether the LDL-C value is 1.8 or 1.4 mmol/L as the cut-off point (P>0.05). Conclusions To the best of our knowledge, we firstly report lower LDL-C level (whether the LDL-C value is 1.8 or 1.4 mmol/L as the cut-off point) was not the independent risk factor of long-term bleeding in PCI population and ACS or non-ACS subgroup populations. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): CAMS Innovation Fund for Medical Sciences (CIFMS); Young and middle-aged talents in the XPCC Science and Technology Project

Directly Measured vs. Calculated Low-Density Lipoprotein Cholesterol Does Not Identify Additional Individuals With Coronary Artery Disease and Diabetes at Higher Risk of Adverse Events: Insight From a Large Percutaneous Coronary Intervention Cohort in Asia.

BackgroundThe objective of our study was to assess whether calculated low-density lipoprotein cholesterol (LDL-C) is inferior to direct LDL-C (dLDL-C) in identifying patients at higher risk of all-cause mortality, recurrent acute myocardial infarction (AMI), and major adverse cardiovascular event (MACE).MethodsA total of 9,751 patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) in the Fuwai PCI registry were included. DLDL-C was measured by the selective solubilization method (Kyowa Medex, Tokyo, Japan). Correct classification was defined as the proportion of estimated LDL-C in the same category as dLDL-C based on dLDL-C levels: less than 1.4, 1.4–1.8, 1.8–2.6, 2.6–3.0, and 3.0 mmol/L or greater.ResultsUnderestimation of LDL-C was found in 9.7% of patients using the Martin/Hopkins equation, compared with 13.9% using the Sampson equation and 24.6% with the Friedewald equation. Cox regression analysis showed compared the correct estimation group, underestimation of LDL-C by the Martin/Hopkins equation did not reduce all-cause mortality (HR 1.26, 95% CI: 0.72–2.20, P = 0.4), recurrent AMI (HR 1.24, 95% CI: 0.69–2.21, P = 0.5), and MACE (HR 1.02, 95% CI: 0.83–1.26, P = 0.9). Similarly, the overestimated group did not exacerbate all-cause mortality (HR 0.9, 95% CI: 0.45–1.77, P = 0.8), recurrent AMI (HR 0.63, 95% CI: 0.28–1.44, P = 0.3), and MACE (HR 1.07, 95% CI: 0.86–1.32, P = 0.6). The results of the diabetes subgroup analysis were similar to those of the whole population.ConclusionCompared with dLDL-C measurement, misclassification by the Martin/Hopkins and Sampson equations was present in approximately 20% of patients. However, directly measured vs. calculated LDL-C did not identify any more individuals in the PCI population with increased risk of all-cause mortality, recurrent AMI, and MACE, even in high-risk patients such as those with diabetes.

The comparison of efficacy and safety between transradial and transfemoral approach for chronic total occlusions intervention: a meta-analysis

This meta-analysis compared the outcomes of transradial access (TRA) and transfemoral access (TFA) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in recent decades. We searched multiple databases for articles published between January 1, 2015, and December 31, 2020. Six observational studies with 11,736 patients were analyzed. Data included baseline demographics, Japan-chronic total occlusion (J-CTO) score, sheath size, PCI vessel, retrograde method, procedural time, fluoroscopy time, and contrast volume. The more prevalent target CTO vessel was the left coronary artery in the TRA group and the right coronary artery in the TFA group. Higher J-CTO score, longer procedural time, and more contrast volume were seen in the TFA group. In comparison, the TRA group had better procedural success rate (odds ratio (OR), 0.846; 95% confidence interval (CI) 0.749–0.956) and less vascular complications (OR, 0.323; 95% CI 0.203–0.515), but similar retrograde success rate (OR, 0.965; 95% CI 0.382–2.435). In-hospital death (OR, 0.527; 95% CI 0.187–1.489) and major adverse cardiovascular events (OR, 0.729; 95% CI 0.504–1.054) did not differ between the groups. Overall, fewer vascular complications and higher procedural success rates were noted in the TRA CTO PCI population. However, similar retrograde success rates and clinical outcomes were noted between the groups.

Self-reported non-adherence to P2Y12 inhibitors in patients undergoing percutaneous coronary intervention: Application of the medication non-adherence academic research consortium classification.

AimsThe Non-adherence Academic Research Consortium (NARC) has recently developed a consensus-based standardized classification for medication non-adherence in cardiovascular clinical trials. We aimed to assess the prevalence of NARC-defined self-reported non-adherence to P2Y12 inhibitors and its impact on clinical outcomes in patients undergoing percutaneous coronary intervention (PCI).Methods and resultsUsing a standardized questionnaire administered at 1 year after PCI, we assessed the 4 NARC-defined non-adherence levels including type, decision-maker, reasons, and timing within the Bern PCI registry. The primary endpoint was the patient-oriented composite endpoint (POCE) defined as a composite of death, myocardial infarction, stroke, and any revascularization at 1 year. The recommended P2Y12 inhibitor duration was 12 months. Among 3,896 patients, P2Y12 inhibitor non-adherence was observed in 647 (17%) patients. Discontinuation was permanent in the majority of patients (84%). The decision was mainly driven by a physician (94%), and rarely by patients (6%). The most frequent reason was risk profile change (43%), followed by unlisted reasons (25%), surgery (17%), and adverse events (14%). Non-adherence occurred early (<30 days) in 21%, late (30–180 days) in 45%, and very late (>180 days) in 33%. The majority of POCE events (n = 421/502, 84%) occurred during adherence to the prescribed P2Y12 inhibitor. Permanent discontinuation, doctor-driven non-adherence, and risk profile change emerged as independent predictors for POCE.ConclusionsIn real-world PCI population treated with 1-year DAPT, non-adherence was observed in nearly one-fifth of patients. Non-adherence to P2Y12 inhibitors was associated with worse clinical outcomes, while the risk was related to underlying contexts.ClinicalTrials.gov identifierNCT02241291.

Transradial versus trans-femoral access site in high-speed rotational atherectomy in Sweden

BackgroundRadial artery is the preferred access site in contemporary percutaneous coronary intervention (PCI). However, limited data exist regarding utilization pattern, safety, and long-term efficacy of transradial artery access (TRA) PCI in heavily calcified lesions using high-speed rotational atherectomy (HSRA). MethodsAll patients who underwent HSRA-PCI in Sweden between 2005 and 2016 were included. Outcomes were major adverse cardiac events (MACE, including death, myocardial infarction (MI) or target vessel revascularisation (TVR)), in-hospital bleeding and restenosis. Inverse probability of treatment weighting was used to adjust for the non-randomized access site selection. ResultsWe included 1479 patients of whom 649 had TRA and 782 transfemoral artery access (TFA) HSRA-PCI. The rate of TRA increased significantly by 18% per year but remained lower in HSRA-PCI (60%) than in the overall PCI population (85%) in 2016.TRA was associated with comparable angiographic success but significantly lower risk for major (adjusted OR 0.16; 95% CI 0.05–0.47) or any in-hospital bleeding (adjusted OR 0.32; 95% CI 0.13–0.78). At one year, the adjusted risk for MACE (HR 0.87; 95% CI 0.67–1.13) and its individual components did not differ between TRA and TFA patients. The risk for restenosis did not significantly differ between TRA and TFA HSRA-PCI treated lesions (adjusted HR 0.92; 95% CI 0.46–1.81). ConclusionHSRA-PCI by TRA was associated with significantly lower risk for in-hospital bleeding and equivalent long-term efficacy when compared with TFA. Our data support the feasibility and superior safety profile of TRA in HSRA-PCI.

Angiography-derived physiology guidance vs usual care in an All-comers PCI population treated with the healing-targeted supreme stent and Ticagrelor monotherapy: PIONEER IV trial design

Current ESC guidelines recommend the use of intra-coronary pressure guidewires for functional assessment of intermediate-grade coronary stenoses. Angiography-derived quantitative flow ratio (QFR) is a novel method of assessing these stenoses, and guiding percutaneous coronary intervention (PCI). The PIONEER IV trial is a prospective, all-comers, multi-center trial, which will randomize 2,540 patients in a 1:1 ratio to PCI guided by angiography-derived physiology or usual care, with unrestricted use in both arms of the Healing-Targeted Supreme sirolimus-eluting stent (HT Supreme). The stent's fast, biologically healthy, and robust endothelial coverage allows for short dual-antiplatelet therapy (DAPT); hence the antiplatelet regimen of choice is 1-month DAPT, followed by ticagrelor monotherapy. In the angiography-derived physiology guided arm, lesions will be functionally assessed using on-line QFR, with stenting indicated in lesions with a QFR ≤0.80. Post-stenting, QFR will be repeated in the stented vessel(s), with post-dilatation or additional stenting recommended if the QFR<0.91 distal to the stent, or if the delta QFR (across the stent) is >0.05. Usual care PCI is performed according to standard clinical practice. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization with a non-inferiority risk-difference margin of 3.2%, at 1-year post-procedure. Clinical follow-up will be up to 3 years. The PIONEER IV trial aims to demonstrate non-inferiority of QFR-guided PCI to usual care PCI with respect to POCE at 1-year in patients treated with HT Supreme stents and ticagrelor monotherapy. ClinicalTrials.gov UNIQUE IDENTIFIER: NCT04923191 CLASSIFICATIONS: Interventional Cardiology.

Mehran 2 Contrast-Associated Acute Kidney Injury Risk Score: Is it Applicable to the Asian Percutaneous Coronary Intervention Population?

Contrast-associated acute kidney injury (CA-AKI) can occur after percutaneous coronary intervention (PCI). The Mehran score is the gold standard for predicting CA-AKI risk, and it has recently been updated. The Mehran 2 CA-AKI risk score, based on existing variables in patients undergoing PCI, can accurately differentiate the risk of CA-AKI. This study aimed to verify whether the new Mehran score is applicable to the Asian PCI population. The study included the clinical data of 2487 patients undergoing PCI from August 2020 to February 2022. The goodness-of-fit test (Hosmer-Lemeshow) was used to evaluate the correction ability of the Mehran 2 score, and the area under the receiver operating characteristic curve (ROC) was used to evaluate the accuracy of the Mehran 2 score in predicting CA-AKI. CA-AKI occurred in 28 of 2487 patients, with an incidence rate of 1.12%. The proportion of high risk factors for AKI in the cohort was lower than that in the Mehran 2 cohort (a large contemporary PCI cohort to develop the Mehran 2 score). The Mehran 2 risk score had excellent goodness-of-fit (χ2 = 5.320, df = 6, P = 0.503) and high predictive accuracy (area under the ROC curve 0.836, P < 0.0001). The Mehran 2 score shows good predictive and correction performance in the Asian population and has good clinical application value. The inclusion of the Mehran 2 risk score in patients hospitalised for coronary angiography appears to be good practice.

Abstract 10942: Comparison of Long-Term Prognostic Impact of 6 Major Cardiovascular Drugs in Patients Following Coronary Intervention; Analysis from the Registry Database with the 35-Year History

Introduction: The evidence-based optimal medical therapy has been encouraged in the treatment of patients with coronary artery disease. However, as follow-up periods are limited (-5 years) in the most of randomized trials, prognostic efficacy of drugs in longer time period has not been fully evaluated. Therefore, this registry-based study aimed to simultaneously address the long-term prognostic impact of 6 major classes of cardiovascular (CV) drugs, beta-blockers (BBs), calcium channel blockers (CCBs), angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), Statins and Non-aspirin antiplatelets following percutaneous coronary intervention (PCI). Methods and Results: This is an analyses of single center prospective registry with lengthy history launched in 1984. Consecutive 6,299 patients underwent first PCI between 1984 and 2018 were included and CV mortality was set as the endpoint. Median and the range of follow-up period is 8.8, 0-28.9 years, respectively. Cox proportional hazard analyses adjusted by age, gender, BMI, diabetes and cardiac and renal function simultaneously evaluated the prognostic impacts of 6 major CV drugs in the entire population and patients with acute coronary syndrome (ACS). Among 6 drugs, ARBs (Hazard Ratio (HR): 0.72, 95% confidence interval (95% CI): 0.55-0.93, p=0.01), Non-aspirin antiplatelets (0.67, 0.53-0.86, p=0.002) and Statins (0.56, 0.44-0.7, p&lt;0.001) were significantly associated with reduced risk of CV mortality in the entire PCI population ( Figure A ). In ACS patients (n=1,790), only Statins at PCI predicted the reduced risk of CV mortality (HR: 0.44, 95%CI 0.28-0.68 p&lt;0.001) ( Figure B ). Conclusions: This long-term PCI registry-based analyses demonstrated the significant prognostic efficacy of ARBs, antiplatelets other than aspirin and statins. In ACS patients, only Statins, not other 5 classes of major CV drugs, were associated with reduced risk of CV mortality.

Ischemic and Bleeding Events After First Major Bleeding Event in Patients Undergoing Coronary Stent Implantation

There is a scarcity of data on ischemic and bleeding events in patients who experienced major bleeding after percutaneous coronary intervention (PCI). Moreover, there also is a shortage of data on comparative outcomes between patients with and without interruption of an antithrombotic drug after major bleeding. We evaluated the incidence and prognostic impacts of ischemic (myocardial infarction or ischemic stroke) and bleeding (Bleeding Academic Research Consortium type 3 or 5) events after major bleeding in 12,691 consecutive patients who underwent first PCI in the Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI registry cohort-3. In the entire cohort, incidence of the first ischemic event and bleeding event was 2.3 per 100 person-years and 3.8 per 100 person-years, respectively. Major bleeding (Bleeding Academic Research Consortium type 3) occurred in 2,142 patients during a median follow-up of 5.7 years. In patients with major bleeding, cumulative 30-day, 1-year, and 5-year incidence of an ischemic event was 2.6%, 4.8%, and 13.2% (3.2 per 100 person-years), respectively, whereas that of a bleeding event was 6.3%, 16.1%, and 29.2% (8.5 per 100 person-years), respectively. Ischemic and bleeding events were independently associated with mortality (hazard ratio 2.36, 95% confidence interval 1.87 to 2.96, p <0.001, and hazard ratio 2.85, 95% confidence interval 2.42 to 3.37, p <0.001). The cumulative 180-day incidence of ischemic and bleeding events was not significantly different between patients with and without interruption of an antithrombotic drug in patients with major bleeding. In conclusion, the incidence of an ischemic event after the first major bleeding was approximately 1/3 of that of recurrent major bleeding, and the rates of ischemic and bleeding events after the first major bleeding were higher than the rates of first events in the general PCI population. Both ischemic events and bleeding events were strongly associated with subsequent mortality. The incidence of ischemic and recurrent bleeding events was not different between patients with and without interruption of an antithrombotic drug.

The PRECISE-DAPT score and 5-year outcomes after percutaneous coronary intervention: a large-scale, real-world study from China.

The PRECISE-DAPT (predicting bleeding complications in patients undergoing stent implantation and subsequent dual-antiplatelet therapy) score is recommended by guidelines for predicting out-of-hospital bleeding in patients after percutaneous coronary intervention (PCI). However, the long-term prognostic value of the PRECISE-DAPT score in patients after PCI remains unclear. We performed a prospective study of 10724 patients who underwent PCI throughout 2013 in Fuwai Hospital. The bleeding endpoint was Bleeding Academic Research Consortium 2, 3, or 5 bleeding. The ischaemic endpoints were all-cause death and major adverse cardiovascular and cerebrovascular events (MACCE). After a 5-year follow-up, 10 109 patients were finally analysed. A total of 415 (4.11%) patients experienced bleeding, 364 (3.60%) experienced all-cause death, and 2049 (20.27%) had MACCE. Using Cox regression, the risks of bleeding [hazard ratio (HR): 1.721, 95% confidence interval (CI): 1.180-2.511, P=0.005], MACCE (HR: 1.607, 95% CI: 1.347-1.917, P<0.001), and all-cause-death (HR: 3.902, 95% CI: 2.916-5.221, P<0.001) in patients with a high score were significantly higher than those in patients with a low score. The PRECISE-DAPT score showed prognostic value for 5-year events of bleeding (C-statistic: 0.566, 95% CI: 0.537-0.594), MACCE (C-statistic: 0.540, 95% CI: 0.527-0.553), and all-cause death (C-statistic: 0.673, 95% CI: 0.644-0.702). After 5 years of follow-up, the PRECISE-DAPT score has a statistically significant predictive value for long-term bleeding events in the Chinese PCI population, and also some prognostic value for death and MACCE. In this real-world, large-sample study, the PRECISE-DAPT (predicting bleeding complications in patients undergoing stent implantation and subsequent dual-antiplatelet therapy) score shows a statistically significant 5-year predictive value for bleeding in Chinese patients with percutaneous coronary intervention and dual-antiplatelet therapy. The study also shows that the PRECISE-DAPT score has moderate predictive value for all-cause death.

Sex Differences Among Patients With High Risk Receiving Ticagrelor With or Without Aspirin After Percutaneous Coronary Intervention

Shortened dual antiplatelet therapy followed by potent P2Y12 receptor inhibitor monotherapy reduces bleeding without increasing ischemic events after percutaneous coronary intervention (PCI). To explore sex differences and evaluate the association of sex with outcomes among patients treated with ticagrelor monotherapy vs ticagrelor plus aspirin. This was a prespecified secondary analysis of TWILIGHT, an investigator-initiated, placebo-controlled randomized clinical trial conducted at 187 sites across 11 countries. Study participants included patients who underwent successful PCI with drug-eluting stents, were planned for discharge with ticagrelor plus aspirin, and who had at least 1 clinical and at least 1 angiographic feature associated with high risk of ischemic or bleeding events. Data were analyzed from May to July 2020. At 3 months after PCI, patients adherent to ticagrelor and aspirin without major adverse event were randomized to either aspirin or placebo for an additional 12 months along with ticagrelor. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding at 12 months after randomization. The primary ischemic end point was a composite of death, myocardial infarction, or stroke. Of 9006 enrolled patients, 7119 underwent randomization (mean [SD] age, 63.9 [10.2] years; 5421 [76.1%] men). Women were older (mean [SD] age, 65.5 [9.6] years in women vs 63.4 [10.3] years in men) with higher prevalence of chronic kidney disease (347 women [21.2%] vs 764 men [14.7%]). The primary bleeding end point occurred more often in women than men (hazard ratio [HR], 1.32; 95% CI, 1.06-1.64; P = .01). After multivariate adjustment, incremental bleeding risk associated with female sex was no longer significant (adjusted HR, 1.20; 95% CI, 0.95-1.52; P = .12). Ischemic end points were similar between sexes. Ticagrelor plus placebo vs ticagrelor plus aspirin was associated with lower risk of BARC type 2, 3, or 5 bleeding in women (adjusted HR, 0.62; 95% CI, 0.42-0.92; P = .02) and men (adjusted HR, 0.57; 95% CI, 0.44-0.73; P < .001; P for interaction = .69). Ischemic end points were similar between treatment groups in both sexes. These findings suggest that the higher bleeding risk in women compared with men was mostly attributable to baseline differences, whereas ischemic events were similar between sexes. In this high-risk PCI population, the benefits of early aspirin withdrawal with continuation of ticagrelor were generally comparable in women and men. ClinicalTrials.gov Identifier: NCT02270242.

Budget impact analysis of antiplatelet therapy with cangrelor in patients with acute coronary artery disease undergoing percutaneous coronary intervention in Belgium

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Ferrer, Barcelona, Spain Background Cangrelor is a novel, intravenous, potent, fast onset, direct-acting, P2Y12 receptor antagonist that blocks adenosine diphosphate-induced platelet activation and aggregation with a half-life of 3-6 min. Co-administered with acetylsalicylic acid, it is indicated for reducing thrombotic cardiovascular events in patients with coronary artery disease (CAD) (ST-elevation myocardial infarction (STEMI), non-STEMI, stable CAD) undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) prior to PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable. Purpose To assess the economic implications of incorporating cangrelor into the hospital formulary for the acute care of CAD patients undergoing PCI in Belgium. Methods A budget impact model (BIM) was developed. The 3-year pharmacological and clinical event costs of two hypothetical scenarios, without and with cangrelor in the formulary for the total PCI population (base case) in Belgium were compared. Also, the primary PCI (STEMI) and a PCI population with special needs (e.g., unable to swallow) were assessed as complementary setups. Epidemiological, efficacy (stent thrombosis, myocardial infarction (MI), ischaemia-driven revascularization, death), safety (Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria) and costs (€, 2019) data were based on clinical trials, meta-analyses and on Belgian registries. Only the pharmacological costs of pre-treatment (preload) with oral P2Y12 inhibitors and glycoprotein IIb-IIIa inhibitors (GPI) for bail-out were considered. One-way sensitivity analysis established the effect of uncertainty on BIM results. Results The model assumes that the primary PCI population grows from 4,790 to 4,935 adults (age 68 years, mean) over three years in Belgium. Pre-treatment with oral P2Y12 inhibitors increases from 3,544 to 3,652 patients, and uptake of cangrelor rises from 20.60% to 38.30% in the same period. The number of primary PCI patients receiving cangrelor grows from 730 to 1,399. At current usage of antithrombotics and at existing pharmacological and management costs, adding cangrelor into the hospital formulary represents 1.1 million euros over 3 years in Belgium. 6 additional stent thromboses, 3 ischaemia-driven revascularisations and 2 cardiovascular related deaths are avoided while three extra minor bleedings occur over 3 years. Similar pharmacoeconomic findings emerge in the base case and complementary setups. Results are most sensible to the percentage of patients on GPI bail-out. Conclusions Under BIM assumptions, introducing cangrelor for the acute care of CAD patients undergoing primary PCI represents a safe and affordable option in Belgium, particularly when the required control of thrombosis is not certain with oral pre-treatment.

Budget impact analysis of antiplatelet therapy with cangrelor in patients with acute coronary artery disease undergoing percutaneous coronary intervention in Portugal

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Ferrer, Barcelona, Spain Background Cangrelor is a novel, intravenous, potent, fast onset, direct-acting, P2Y12 receptor antagonist that blocks adenosine diphosphate-induced platelet activation and aggregation with a half-life of 3-6 min. Co-administered with acetylsalicylic acid, it is indicated for reducing thrombotic cardiovascular events in patients with coronary artery disease (CAD) (ST-elevation myocardial infarction (STEMI), non-STEMI, stable CAD) undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) prior to PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable. Purpose To assess the economic implications of incorporating cangrelor into the hospital formulary for the acute care of CAD patients undergoing PCI in Portugal. Methods A budget impact model (BIM) was developed. The 3-year pharmacological and clinical event costs of two hypothetical scenarios, without and with cangrelor in the formulary for the total PCI population (base case) in Portugal were compared. Also, the primary PCI (STEMI) and a PCI population with special needs (ie. unable to swallow) were assessed as complementary setups. Epidemiological, efficacy (stent thrombosis, myocardial infarction (MI), ischaemia-driven revascularization, death), safety (Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria) and costs (€, 2019) data were based on clinical trials, meta-analyses and on Portuguese registries. Only the costs of pre-treatment with oral P2Y12 inhibitors and glycoprotein IIb-IIIa inhibitors (GPI) for bail-out were considered. One-way sensitivity analysis established the effect of uncertainty on BIM results. Results The model assumes that the total PCI population grows from 13,422 to 14,370 adults (age 65 years, mean) over three years in Portugal. Pre-treatment with oral P2Y12 inhibitors increases from 9,932 to 10,634 patients, and uptake of cangrelor rises from 0.80% to 1.40% in the same period. The number of total PCI patients receiving cangrelor grows from 79 to 149. At current usage of antithrombotics and at existing pharmacological and management costs, adding cangrelor into the hospital formulary represents 115 thousand € over 3 years in Portugal. Results are most sensible to the percentage of patients on GPI bail-out. Conclusions Under BIM assumptions, introducing cangrelor for the acute care of CAD patients undergoing PCI represents a safe and affordable option in Portugal, particularly when the required control of thrombosis is not certain with oral pre-treatment.

Impact of Chronic Kidney Disease on Chronic Total Occlusion Revascularization Outcomes: A Meta-Analysis.

Objectives: To examine the impact of revascularization and associated clinical outcomes of chronic kidney disease (CKD) chronic total occlusion (CTO) and non-CKD CTO groups. Background: The influence of CKD on clinical outcomes after percutaneous coronary intervention (PCI) for CTO lesions is unknown, and there is no systemic review of this topic to date. Methods: We searched the PubMed, Embase, ProQuest, ScienceDirect, Cochrane Library, ClinicalKey, Web of Science, and ClinicalTrials Databases for articles published between 1 January 2010 and 31 March 2020. CKD was defined as estimated glomerular filtration rate of <60 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease formula. Data included demographics, lesion distributions, incidence of contrast-induced nephropathy (CIN), acute kidney injury (AKI), procedural success rate, mortality, and target lesion revascularization (TLR)/target vessel revascularization (TVR). Results: Six studies were ultimately included in this systematic review. A high prevalence (25.5%; range, 19.6–37.9%) of CKD was noted in the CTO population. In the non-CKD group, outcomes were better: less incidence of CIN or AKI (odds ratio (OR), 2.860; 95% confidence interval (CI), 1.775–4.608), higher procedural success rate (OR, 1.382; 95% CI, 1.036–1.843), and lower long-term mortality (OR, 4.502; 95% CI, 3.561–5.693). The incidence of TLR/TVR (OR, 1.118; 95% CI, 0.888–1.407) did not differ between groups. Conclusions: In the CKD CTO PCI population, a lower procedural success rate, a higher incidence of CIN or AKI, and higher in-hospital and long-term mortality rate were noted due to more complex lesions and more comorbidities. However, the incidence of TLR/TVR did not differ between groups.