Net Adverse Cardiovascular Events Research Articles

Safety and effectiveness of glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: insights from the SPUM-ACS study.

Data on Glycoprotein IIb/IIIa inhibitors (GPI) use in real world ACS patients following the introduction of potent P2Y12 inhibitors and newer generation stents are scant. Here, we aimed to assess the utilization, effectiveness, and safety of GPI in a large prospective multi-centre cohort of contemporary ACS patients. SPUM-ACS prospectively recruited patients presenting with ACS between 2009 and 2017. The primary endpoint of the present study was major adverse cardiovascular events (MACE), a composite of all-cause death, non-fatal myocardial infarction (MI) and non-fatal stroke at one year. Secondary endpoints were defined as any bleeding events, BARC 3-5 bleeding, and net adverse cardiovascular events (NACE). A total of 4395 ACS patients were included in the analysis. GPI-treated patients had more total coronary artery occlusion (56% vs 35%, p<0.001) and thrombus (60% vs 35%, p<0.001) at angiography. Among the propensity score matched (PSM) population (1992 patients equally split into two groups), GPI-treated patients showed lower risk of MACE (PSM adjusted HR 0.70, 95% CI 0.49-0.99), but a higher risk of any (PSM adj HR 1.46, 95% CI 1.06-1.99) and major bleedings (PSM adj HR 1.73, 95% CI 1.09-2.76), resulting in a neutral effect on NACE (PSM adj HR 0.87, 95% CI 0.65-1.17). These results remained consistent across all subgroups. In patients with ACS undergoing PCI and receiving potent P2Y12 inhibitors, we observed a reduced risk of MACE and an increased risk of major bleedings at 1 year in patients treated with GPI. Although the routine use of GPI is currently not recommended, they might be considered in selected patients following a personalized balancing between ischaemic and bleeding risks.

Activated clotting time and outcomes of chronic total occlusion percutaneous coronary intervention: insights from the PROGRESS-CTO Registry.

The optimal range of activated clotting time (ACT) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We examined the association between ACT and in-hospital ischemic and bleeding outcomes in patients who underwent CTO PCI in the Prospective Global Registry for the Study of CTO Intervention. ACT values were available for 4377 patients who underwent CTO PCI between 2012 and 2023 at 29 centers. The mean ACT distribution was less than 250 seconds (19%), 250 to 349 seconds (50%), and greater than or equal to 350 seconds (31%). The incidence of ischemic events, bleeding events, and net adverse cardiovascular events (NACE) was 0.8%, 3.0%, and 3.8%, respectively. In multiple logistic regression analysis, increasing nadir ACT was associated with decreasing ischemic events (adjusted odds ratio [aOR] per 50-second increments: 0.69 [95% confidence interval (CI), 0.50-0.94; P=.017]; and increasing peak ACT was associated with increasing bleeding events (aOR per 50-second increments: 1.17 [95% CI ,1.01-1.36; P=.032]). A U-shaped association was seen between mean ACT and NACE, where restricted cubic spline analysis demonstrated that patients with a low ( less than 200 seconds) or high ( greater than 400 seconds) ACT had increasing NACE risk compared with an ACT of 200 to 400 seconds (aOR 2.06, 95% CI 1.18-3.62; P=.012). Among patients who underwent CTO PCI, mean ACT had a U-shaped relationship with NACE, where patients with a low ( less than 200 seconds) ACT (driven by ischemic events) or high ( greater than 400 seconds) ACT (driven by bleeding) had higher NACE compared with an ACT of 200 to 400 seconds.

Comparison of de-escalation of DAPT intensity or duration in East Asian and Western patients with ACS undergoing PCI: A systematic review and meta-analysis

Abstract Background Guideline-recommended dual antiplatelet therapy (DAPT; aspirin plus prasugrel/ticagrelor) for 12 months in acute coronary syndromes (ACS) patients undergoing PCI, leads to an excess of bleeding. This led to studies to evaluate alternatives to 12 months of high-intensity DAPT, to balance thrombotic and bleeding risks. Several trials have investigated de-escalation strategies, either by reducing DAPT intensity, through switching from potent P2Y12 inhibitors prasugrel or ticagrelor to clopidogrel, or by shortening the duration of DAPT and continuing with single antiplatelet therapy. East Asian (EA) patients exhibit higher bleeding and lower ischaemic risk compared to non-East Asians (nEA) and most studies of "de-escalation" were conducted in EA patients. We sought to compare the safety and benefit of various DAPT "de-escalation" strategies in EA and nEA populations. Methods A systematic review and meta-analysis of randomized controlled trials assessing reduction of DAPT intensity or duration in ACS patients undergoing PCI, in EA and nEA, was performed using a non-random effects model. The study was registered on PROSPERO. The primary efficacy endpoint was the occurrence of net adverse cardiovascular events (NACE), namely the composite of ischaemic endpoints (including major adverse cardiovascular events [MACE] comprising all cause death, recurrent myocardial infarction [MI] and cerebrovascular accident); secondary endpoints were trial-defined MACE and major bleeding at longest follow-up. Results Twenty- trials assessed reduction of DAPT intensity (n=12) or duration (n=11). Of these 11 were conducted exclusively in EA patients while the remaining 7 were conducted predominantly in nEA patients. Overall, reduced DAPT intensity attenuated major bleeding (odds ratio [OR] 0.78, 95% confidence interval [CI] 0.65-0.94, p=0.009), without impacting NACE or MACE. In nEA, this increased MACE (OR 1.20, 95% CI 1.09-1.31, p&amp;lt;0.0001) without impacting NACE or bleeding; whilst in EA, it reduced major bleeding (OR 0.71, 95% CI 0.53-0.95, p=0.02) without affecting NACE or MACE. Overall, DAPT abbreviation reduced NACE (OR 0.90, 95% CI 0.82-0.99, p=0.03) due to major bleeding (OR 0.69, 95% CI 0.53-0.99, p=0.006), without impacting MACE. In nEA, this strategy did not impact NACE, MACE or major bleeding; whilst in EA, it reduced major bleeding (OR 0.60, 95% CI 0.4-0.91, p=0.02) without impacting NACE or MACE. Conclusion In EA, reduction in DAPT intensity or duration can minimise bleeding, without safety concerns. In nEA, reduction in DAPT intensity may incur an ischaemic penalty, whilst DAPT abbreviation has no overall benefit. Although standard DAPT favours patients at high ischaemic risk, while shorter or less intense DAPT may benefit those at high bleeding risk, many patients have overlapping risk factors. Individualisation of DAPT strategy may be preferable to personalise care based on both ethnicity and prevailing risks.

Abstract 12054: Activated Clotting Time and Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention: Insights From the PROGRESS-CTO Registry

Introduction: The optimal range of activated clotting time (ACT) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. Methods: We examined the association between ACT and in-hospital ischemic and bleeding outcomes in patients who underwent CTO PCI in the Prospective Global Registry for the Study of CTO Intervention (PROGRESS-CTO, NCT02061436). Results: ACT values were available for 4,377 patients who underwent CTO PCI between 2012 and 2023 at 29 centers. Mean ACT distribution was: &lt;250 seconds (19%), 250-349 seconds (50%), and ≥350 seconds (31%). The incidence of ischemic events was 0.8%, bleeding events 3.0%, and net adverse cardiovascular events (NACE, composite of in-hospital all-cause mortality, myocardial infarction, stroke, urgent repeat revascularization, pericardiocentesis, and bleeding) 3.8%. In multiple logistic regression analysis, increasing nadir ACT was associated with decreasing ischemic events: adjusted odds ratio (aOR) per 50-second increments: 0.69 (95% confidence interval [CI] 0.50-0.94, p=0.017); and increasing peak ACT was associated with increasing bleeding events: aOR per 50-second increments 1.17 (95% CI 1.01-1.36, p=0.032). A U-shaped association was seen between mean ACT and NACE, where restricted cubic spline analysis demonstrated that patients with low (&lt;200 seconds) or high (&gt;400 seconds) ACT had increasing NACE risk, compared with ACT 200-400 seconds (aOR 2.06, 95% CI 1.18-3.62, p=0.012) (Figure). Conclusions: Among patients who underwent CTO PCI, mean ACT had a U-shaped relationship with NACE, where patients with low (&lt;200 seconds) ACT (driven by ischemic events) or high (&gt;400 seconds) ACT (driven by bleeding) had higher NACE compared with ACT of 200-400 seconds.

Comparison of De-escalation of DAPT Intensity or Duration in East Asian and Western Patients with ACS Undergoing PCI: A Systematic Review and Meta-analysis.

Guideline-recommended dual antiplatelet therapy (DAPT; aspirin plus prasugrel/ticagrelor) for 12 months in acute coronary syndrome (ACS) patients increases bleeding, with East Asians (EAs) exhibiting higher bleeding and lower ischemic risk, compared with non-East Asians (nEAs). We sought to compare DAPT "de-escalation" strategies in EA and nEA populations. A systematic review and meta-analysis of randomized controlled trials assessing reduction of DAPT intensity or duration in ACS patients undergoing percutaneous coronary intervention, in EA and nEA, was performed using a random-effects model. Twenty-three trials assessed reduction of DAPT intensity (n = 12) or duration (n = 11). Overall, reduced DAPT intensity attenuated major bleeding (odds ratio [OR]: 0.78, 95% confidence interval [CI]: 0.65-0.94, p = 0.009), without impacting net adverse cardiovascular events (NACE) or major adverse cardiovascular events (MACE). In nEA, this increased MACE (OR: 1.20, 95% CI: 1.09-1.31, p < 0.0001) without impacting NACE or bleeding; while in EA, it reduced major bleeding (OR: 0.71, 95% CI: 0.53-0.95, p = 0.02) without affecting NACE or MACE. Overall, abbreviation of DAPT duration reduced NACE (OR: 0.90, 95% CI: 0.82-0.99, p = 0.03) due to major bleeding (OR: 0.69, 95% CI: 0.53-0.99, p = 0.006), without impacting MACE. In nEA, this strategy did not impact NACE, MACE, or major bleeding; while in EA, it reduced major bleeding (OR: 0.60, 95% CI: 0.4-0.91, p = 0.02) without impacting NACE or MACE. In EA, reduction of DAPT intensity or duration can minimize bleeding, without safety concerns. In nEA, reduction of DAPT intensity may incur an ischemic penalty, while DAPT abbreviation has no overall benefit.

Sex Differences Among Patients Receiving Edoxaban vs Vitamin K Antagonist for Atrial Fibrillation After TAVR

BackgroundIn the ENVISAGE-TAVI AF (Edoxaban vs Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation–Atrial Fibrillation) trial, edoxaban was noninferior to vitamin K antagonists (VKA) for a composite outcome of ischemic and bleeding complications but increased major bleeding in patients with atrial fibrillation after successful transcatheter aortic valve replacement. Women are at higher risk of bleeding and stroke than men after transcatheter aortic valve replacement. It is unclear whether the effect of edoxaban on these complications varies in relation to sex. ObjectivesThis study was to assess the effect of edoxaban vs VKA according to sex in the ENVISAGE-TAVI AF trial. MethodsThe primary outcomes were net adverse cardiovascular events (NACE) and major bleeding, assessed considering the effective time on study medication (safety analysis). ResultsOut of 1,377 patients, 658 (47.8%) were women. Risks for ischemic and major bleeding outcomes were similar between women and men. Edoxaban compared to VKA was associated with a similar risk of NACE in women (HR: 1.16; 95% CI: 0.81-1.65) and men (HR: 1.08; 95% CI: 0.76-1.53; P for interaction = 0.820) and a higher risk of major bleeding in both sexes (P for interaction = 0.170). The risk increase of major bleeding was attenuated in women (HR: 1.11; 95% CI: 0.69-1.79) as compared to men (HR: 1.75; 95% CI: 1.07-2.85). There were no treatment-related differences for ischemic complications in both sexes. ConclusionsEdoxaban compared to VKA was associated with a similar risk of NACE and higher risk of major bleeding in both sexes. The increase in bleeding complications with edoxaban was attenuated in women.

Trend, Predictors, and Outcomes of Transcatheter Aortic Valve Implantation in Patients With End-Stage Renal Disease: Insights From the Nationwide Readmissions Database

BackgroundTranscatheter aortic valve implantation (TAVI) is the standard of care for patients with severe aortic valve stenosis (AS). However, evidence on its safety in patients with end-stage renal disease (ESRD) is limited. MethodsThe Nationwide Readmissions Database (NRD) from 2015 to 2019 was queried to identify patients undergoing TAVI in ESRD versus patients with no ESRD. The in-hospital, 30-day and 180-day outcomes were assessed using a propensity-score matched (PSM) analysis to calculate adjusted odds ratios (aOR). ResultsA total of 198,816 underwent TAVI, of which 34,546 patients (TAVI-ESRD 16,986 vs. non-ESRD 17,560) were selected using PSM analysis. The adjusted odds of net adverse cardiovascular events (NACE) (aOR 1.65, 95 % CI 1.49–1.82), in-hospital mortality (aOR 2.99, 95 % CI 2.52–3.55), major bleeding (aOR 1.21, 95 % CI 1.05–1.40), postprocedural cardiogenic shock (aOR 1.54, 95 % CI 1.11–2.13), and need for permanent pacemaker implantation (PPM) (aOR 1.24, 95 % CI 1.15–1.38) were significantly higher in TAVI-ESRD patients compared with non-ESRD patients at index admission. There was no significant difference in the odds of stroke (aOR 1.09, 95 % CI 0.86–1.34) and cardiac tamponade (aOR 1.06, 95 % CI 0.78–1.45) between the two groups. At 30- and 180-day follow-up, the odds of readmission, NACE, and mortality remained high in TAVI-ESRD patients. ConclusionESRD patients undergoing TAVI have a high risk of NACE, in-hospital mortality, and major bleeding compared with patients with no ESRD.

PRECISE-DAPT and ARC-HBR Predict in-Hospital Outcomes in Patients Who Underwent Percutaneous Coronary Intervention

Bleeding events result in morbidity and mortality in patients who underwent percutaneous coronary intervention (PCI). There are limited data on the predicting bleeding complications in patients who underwent stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) and Academic Research Consortium for High Bleeding Risk (ARC-HBR) scores' ability to predict in-hospital outcomes in patients who underwent PCI. Consecutive patients who underwent PCI at tertiary centers from January 2016 to March 2018 were identified and the bleeding risk scores were calculated. The primary end point was the National Cardiovascular Data Registry-defined in-hospital bleeding stratified by low versus high predicted bleeding risk. The major and net adverse cardiovascular events were also examined. The discriminatory ability of the risk models was determined using receiver operating characteristic curves. Among 3,659 patients studied, the in-hospital major bleeding was 3.3% (n=121). The patients characterized as high bleeding risk by either criterion had significantly higher bleeding rates than those meeting the low-risk criteria (ARC-HBR 5.4% vs 3.3%, p <0.001; PRECISE-DAPT 5.8% vs 2.4%, p <0.001), and higher major adverse cardiovascular events and net adverse clinical events. These risk estimates showed moderate and similar predictive ability (ARC-HBR high-risk area under the receiver operating characteristic curve [AUC] 0.62, PRECISE-DAPT ≥25 AUC 0.61, p=0.49), with no incremental benefit to adding the estimates (AUC 0.60). The subgroup analysis revealed that women had higher bleeding rates than men (5.53% vs 2.39%, p <0.001); however, the predictive ability of the criteria were similar in women and men. The patients identified as having a high bleeding risk by the PRECISE-DAPT and the ARC-HBR criteria before PCI are at high risk for in-hospital bleeding and adverse outcomes independent of gender. The 2 scores have moderate predictive ability for bleeds. Further study is needed to determine strategies to reduce risk in this population.

Transient vs In-Hospital Persistent Acute Kidney Injury in Patients With Acute Coronary Syndrome

BackgroundThe occurrence of acute kidney injury (AKI) among patients with acute coronary syndrome (ACS) undergoing invasive management is associated with worse outcomes. However, the prognostic implications of transient or in-hospital persistent AKI may differ. ObjectivesThe aim of this study was to evaluate the prognostic implications of transient or in-hospital persistent AKI in patients with ACS. MethodsIn the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial, 203 subjects were excluded because of incomplete information or end-stage renal disease, with a study population of 8,201 patients. Transient and persistent AKI were defined as renal dysfunction no longer or still fulfilling the AKI criteria (>0.5 mg/dL or a relative >25% increase in creatinine) at discharge, respectively. Thirty-day coprimary outcomes were the out-of-hospital composite of death, myocardial infarction, or stroke (major adverse cardiovascular events [MACE]) and net adverse cardiovascular events (NACE), defined as the composite of MACE or Bleeding Academic Research Consortium type 3 or 5 bleeding. ResultsPersistent and transient AKI occurred in 750 (9.1%) and 587 (7.2%) subjects, respectively. After multivariable adjustment, compared with patients without AKI, the risk for 30-day coprimary outcomes was higher in patients with persistent AKI (MACE: adjusted HR: 2.32; 95% CI: 1.48-3.64; P < 0.001; NACE: adjusted HR: 2.29; 95% CI: 1.48-3.52; P < 0.001), driven mainly by all-cause mortality (adjusted HR: 3.43; 95% CI: 2.03-5.82; P < 0.001), whereas transient AKI was not associated with higher rates of MACE or NACE. Results remained consistent when implementing the KDIGO (Kidney Disease Improving Global Outcomes) criteria. ConclusionsAmong patients with ACS undergoing invasive management, in-hospital persistent but not transient AKI was associated with higher risk for 30-day MACE and NACE. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox [MATRIX]; NCT01433627)

518 DUAL ANTIPLATELET THERAPY DE-ESCALATION MODALITIES IN ACUTE CORONARY SYNDROME PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION

Abstract Background Dual antiplatelet therapy (DAPT) is usually recommended for 12 months after an acute coronary syndrome (ACS). A major drawback of DAPT is represented by an increased risk of bleeding events, which have a detrimental impact on short and long-term prognosis. To minimize this risk, bleeding modulation strategies can be adopted, including de-escalating to a lower intensity DAPT regimen (i.e., halving the dose of a potent P2Y12-inhibitor or switching to clopidogrel). Whether either DAPT de-escalation modality is associated with improved clinical outcomes is unknown. Purpose To investigate the role of DAPT de-escalation in ACS patients undergoing PCI as compared to standard DAPT, and to indirectly compare two DAPT de-escalation modalities (i.e., by halving P2Y12-inhibitor dose or switching from a potent P2Y12-inhibitor to clopidogrel) by means of a network meta-analysis using standard DAPT as a common comparator. Methods MEDLINE, Cochrane and Web Of Science were searched for randomised trials of DAPT de-escalation strategies in ACS patients undergoing PCI. The primary outcome was all-cause death, while secondary outcomes included net adverse cardiovascular events (NACE), major adverse cardiovascular events (MACE), and their individual components. A network meta-analysis was performed to indirectly compare different DAPT de-escalation modalities (i.e., halving the dose of a potent P2Y12-inhibitor or switching to clopidogrel). Results A total of 12,813 from ten studies were included for the purposes of this analysis. In the pairwise meta-analysis, there were no significant differences between DAPT de-escalation and standard DAPT in terms of all-cause death (risk ratio [RR] 0.85, 95% confidence interval [CI] 0.62 to 1.18), MACE (RR 0.83, 95% CI 0.69 to 1.00), cardiovascular death (RR 0.78, 95% CI 0.56 to 1.07), myocardial infarction (RR 0.80, 95% CI 0.58 to 1.09), stent thrombosis (RR 0.74, 95% CI 0.37 to 1.47) and major bleeding (RR 0.88, 95% CI 0.66 to 1.17). Compared to standard DAPT, de-escalation was associated with a lower risk of NACE (RR 0.76, 95% CI 0.68 to 0.85), clinically relevant bleeding (RR 0.65, 95% CI 0.51 to 0.84) and minor bleeding (RR 0.63, 95% CI 0.54 to 0.74). In the indirect comparison, there were no significant differences between de-escalation by switching to clopidogrel and de-escalation by halving the P2Y12-inhibitor dose in terms of all-cause death (RR 1.24, 95% CI 0.51 to 2.99), NACE (RR 1.10, 95% CI 0.81 to 1.48), MACE (RR 1.10, 95% CI 0.59 to 2.06) and clinically relevant bleeding (RR 1.16, 95% CI 0.60 to 2.21). Conclusions DAPT de-escalation was associated with a lower risk of NACE, clinically relevant bleeding and minor bleeding compared to standard DAPT in ACS patients undergoing PCI. There is no consensus on the optimal DAPT de-escalation modality and further research in this field is warranted since halving the dose of a potent P2Y12-inhibitor and switching to clopidogrel resulted to be similar in terms of net clinical benefit and both ischemic and bleeding events, therefore representing two viable options in ACS patients undergoing PCI.

265 PROGNOSTIC ROLE OF VITAMIN D DEFICIENCY IN STEMI PATIENTS UNDERGOING PRIMARY PERCUTANEOUS CORONARY INTERVENTION

Abstract Background and Aims The pandemic proportion of vitamin D deficiency has raised particular concerns on its association with mortality and cardiovascular disease (CVD). However, the independent and causative role of hypovitaminosis D in CVD is still debated. Few data have been reported, so far, among STEMI patients undergoing primary percutaneous coronary intervention (pPCI), that was therefore the aim of the present study. Methods A consecutive cohort of patients admitted for STEMI treated with pPCI were included. The levels of 25(OH)D were assessed at admission by chemiluminescence immunoassay kit LIAISON® Vitamin D assay (Diasorin Inc). Hypovitaminosis D was defined for 25(OH)D &amp;lt; 10 ng/ml. The primary study endpoint was net adverse cardiovascular events (a composite of death, recurrent MI and target vessel revascularization) at the longest available follow-up. Secondary endpoints were overall mortality, major bleedings or the individual components of the primary endpoint. Results We included 136 patients divided according to tertiles values of 25(OH)D (&amp;lt; 12.98 ng/ml, n=44; 12.98-22.1 ng/ml, n=41; ≥ 22.1 ng/ml, n=51). The prevalence of renal failure (p=0.047) and coronary calcifications inversely related with vitamin D. Lower vitamin D levels were associated with “no reflow” (10.3% vs 6.7% vs 0%, p=0.04), with increased use of adenosine. At a mean follow-up of 305± 217 days (mean + SD), the primary endpoint (NACE) was slightly increased in patients with lower vitamin D values (adjusted HR [95% CI] = 3.07 [0.85-11.1], p = 0.09). Similar results were observed for ischemic events (MACE: adjusted HR [95% CI] = 2.78 [0.68-11.48], p = 0.16). However, when considering separately patients with severe hypovitaminosis D (&amp;lt;10 ng/ml), we found a significant increase in the risk of NACE and MACE (adjusted HR [95% CI] = 5.17 [1.42-18.8], p = 0.01 and HR = 4.75 [1.14-19.7], p = 0.03, respectively). Conclusion The present study shows that among patients with STEMI undergoing pPCI, extremely low levels of vitamin D are independently associated with impaired outcomes. Future dedicated studies will shed light on the prognostic implications of hypovitaminosis D in these patients and the potential therapeutic perspectives.

Abstract 11266: Trend, Predictors and Outcomes of Transcatheter Aortic Valve Implantation in Patients With End-Stage Renal Disease: Insights From the Nationwide Readmissions Database

Background: Evidence on the safety of transcatheter aortic valve implantation (TAVI) in End-stage renal disease (ESRD) patients is limited. Methods: The Nationwide Readmissions Database (NRD) from 2015-2019 was queried to identify patients undergoing TAVI in ESRD versus patients with no ESRD. The in-hospital, 30-day, and 180-day outcomes were assessed using a propensity-score matched (PSM) analysis to calculate adjusted odds ratios (aOR). Results: A total of 198,816 underwent TAVI, of which 34,546 patients (TAVI-ESRD:16,986 vs non-ESRD:17,560) were selected on PSM analysis. The adjusted odds of net adverse cardiovascular events (NACE) (aOR 1.65, 95% CI 1.49-1.82), in-hospital mortality (aOR 2.99, 95% CI 2.52-3.55), major bleeding (aOR 1.21, 95% CI 1.05-1.40), postprocedural cardiogenic shock (aOR 1.54, 95% CI 1.11-2.13), permanent pacemaker implantation (PPM) (aOR 1.24, 95% CI 1.15-1.38) were significantly higher in TAVI-ESRD patients compared with non-ESRD patients at index admission. There was no significant difference in the odds of stroke (aOR 1.09, 95% CI 0.86-1.34) and cardiac tamponade (aOR 1.06, 95% CI 0.78-1.45) between two groups. Table 1. At 30-day follow-up, TAVI-ESRD patients had higher odds of major bleeding while there was no significant difference in outcomes of stroke, cardiac tamponade and PPM implantation between the two groups up to 180-day follow-up, Table 2. On trend analysis, the rate of utilization of TAVI in ESRD has significantly increased to 30% by 2019. Conclusion: The rate of utilization of TAVI in ESRD has significantly increased in recent years despite the higher risk of NACE, in-hospital mortality, major bleeding and PPM implantation.

Abstract 15350: In-Hospital Outcomes of Transcatheter Aortic Valve Implantation in Patients With Peripheral Arterial Disease: Insights From the Nationwide Readmissions Database

Introduction: Peripheral arterial disease (PAD) is associated with higher inpatient mortality among patients undergoing endovascular procedures. There is a paucity of data on the impact of PAD on clinical outcomes among patients undergoing transcatheter aortic valve implantation (TAVI). HypothesisPAD does not alter the clinical outcomes among patients undergoing TAVI. Methods: The National Readmission Database (NRD) from 2015-2019 was utilized to select patients with PAD undergoing TAVI. The adjusted odds ratio (OR) of net adverse cardiovascular events (NACE), its components (mortality, stroke), and major post-procedure complications were compared using a propensity-score-matched (PSM) analysis. Results: Using PSM, a total of 14,925 TAVI patients, 7,386 with PAD and 7,539 with no PAD were selected. At index admission, patients with PAD had significantly higher odds of NACE (5.10% vs 3.30% OR 1.60, 95% CI 1.36 to 1.88), and in-hospital mortality (2.10% vs. 0.50% OR 4.10, 95% CI 2.88-5.83) compared with patients without PAD. However, the odds of stroke (OR 1.00, 95% CI 0.74 to 1.35), major bleeding (OR 1.15, 95% CI 0.91-1.45), acute kidney injury (OR 0.98, 95% CI 0.90-1.08), cardiac tamponade (OR 0.88, 95% CI 0.59-1.32), valvular complications (OR 1.15, 95% CI 0.78-1.69), and cardiogenic shock (OR 1.62, 95% CI 0.97-2.70) were not significantly different between the two groups. Contrary to the index admission, there was no significant difference in the 30-day outcomes of patients with PAD and without PAD undergoing TAVI. Conclusion: TAVI in patients with PAD might be associated with a higher risk of NACE, and in-hospital mortality during the hospitalization of the index procedure. However, these complications attenuated at a follow-up of 30-days. The risk of other post-procedure complications remained similar between the two groups.

The Performance of Risk Scores for Bleeding and Ischemia as Outcome Predictors in Acute Myocardial Infarction Patients with End-Stage Renal Disease.

In patients with end-stage renal disease (ESRD), acute myocardial infarction (AMI) increases the risks of cardiovascular events, death, and bleeding. Several scores have been developed for predicting ischemic and bleeding outcomes in AMI patients, but none have been validated specifically for ESRD patients. To compare and validate different risk scores as predictors of ischemic and bleeding outcomes in AMI patients with ESRD. This retrospective study enrolled 340 patients who had received percutaneous coronary intervention for AMI while undergoing maintenance hemodialysis for ESRD. Ischemic risk scores (TIMI-STEMI, TIMI-NSTEMI, GRACE, DAPT) and bleeding risk scores (PRECISE-DAPT, CRUSADE, ACUITY, ACTION, SWEDEHEART) were calculated. The ischemic outcome mainly focused on major adverse cardiovascular events (MACEs) within 14 days after hospitalization, and the bleeding outcome was 14-day major bleeding according to the CRUSADE criteria. The GRACE score was superior in discriminating ischemic outcomes, especially in 14-day MACEs [area under curve (AUC) 0.791, p < 0.001]. None of the scores could ideally discriminate 14-day CRUSADE major bleeding, while the PRECISE- DAPT score had the best discriminative power (AUC 0.636, p < 0.001). Either GRACE score > 222 or PRECISE-DAPT score > 48 was associated with higher net adverse cardiovascular events (a composite of 14-day MACEs and 14-day CRUSADE major bleeding). In AMI patients with ESRD, the GRACE score can effectively discriminate the risk of short-term ischemic events. None of the scores could ideally discriminate the bleeding risk, but a high PRECISE-DAPT score still represented a higher rate of bleeding events.

Radial vs Femoral Access in ACS Patients Undergoing Complex PCI Is Associated With Consistent Bleeding Benefit and No Excess of Risks.

The comparative effectiveness of transradial (TRA) compared with transfemoral (TFA) access in acute coronary syndrome (ACS) patients undergoing complex percutaneous coronary intervention (PCI) remains unclear. Among 8404 ACS patients in the Minimising Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX (MATRIX)-Access trial, 5233 underwent noncomplex (TRA: n= 2590; TFA: n= 2643) and 1491 complex (TRA: n= 777; TFA: n= 714) PCI. Co-primary outcomes were major adverse cardiovascular events (MACE, the composite of all-cause mortality, myocardial infarction, or stroke) and the composite of MACE and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding (net adverse cardiovascular events [NACE]) at 30 days. Rates of 30-day MACE (HR 0.94, 95% CI 0.72-1.22) or NACE (HR 0.89, 95% CI 0.69-1.14) did not significantly differ between groups in the complex PCI group, whereas both primary end points were lower (HR 0.84, 95% CI 0.70-1.00; HR 0.83, 95% CI 0.70-0.98; respectively) with TRA among noncomplex PCI patients, with negative interaction testing (Pint= 0.473 and 0.666, respectively). Access-site BARC type 3 or 5 bleeding was lower with TRA, consistently among complex (HR 0.18, 95% CI 0.05-0.63) and noncomplex (HR 0.41, 95% CI 0.20-0.85) PCI patients, whereas the former group had a greater absolute risk reduction of 1.7% (number needed to treat: 59) owing to their higher absolute risk. Among ACS patients, PCI complexity did not affect the comparative efficacy and safety of TRA vs TFA, whereas the absolute risk reduction of access-site major bleeding was greater with TRA compared with TFA in complex as opposed to noncomplex PCI.

Sirolimus-coated balloon versus everolimus-eluting stent in de novo coronary artery disease: Rationale and design of the TRANSFORM II randomized clinical trial.

Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is a widely adopted strategy for the treatment of de novo coronary artery disease. DES implantation conveys an inherent risk for short- and long-term complications, including in-stent restenosis and stent thrombosis. Drug-coated balloons are emerging as an alternative approach to fulfill the "leaving nothing behind" principle and avoid long-term DES-related complications. TRANSFORM II is an investigator-initiated, multicenter, noninferiority, randomized clinical trial, testing a sirolimus-coated balloon (SCB) versus the standard of care for native coronary vessels with a 2-3 mm diameter, in terms of 12-month target lesion failure (TLF; primary endpoint) and net adverse cardiovascular events (coprimary endpoint). Patients undergoing PCI will be randomized to be treated with either SCB or new-generation everolimus-eluting stent and will be followed up clinically for up to 60 months. Assuming a TLF rate of 8% at 12 months with DES, a sample size of 1325 patients was chosen to ensure an 80% power to detect a 1.5% lower incidence in the SCB group with a type I error rate of 0.05. The TRANSFORM II trial is registered on clinicaltrials.gov (identification number NCT04893291). Several substudies, including an optical coherence tomography assessment at 9 months (intracoronary imaging substudy), will investigate the study device in different clinical and lesion settings. The randomized TRANSFORM II trial will determine whether a novel SCB is noninferior to a current everolimus-eluting stent when adopted for the treatment of de novo lesions in coronary vessels with a diameter between 2 and 3 mm.

Dual Antiplatelet Therapy After Drug-Eluting Stents Implantation in East Asians: A Network Meta-Analysis of Randomized Controlled Trials.

Dual antiplatelet therapy (DAPT) is essential to prevent the risk of ischemia events, but it is difficult to avoid concurrent bleeding events. East Asians are associated with a higher tendency of bleeding than Caucasians, which may affect the DAPT duration. Therefore, this network meta-analysis to explore optimum DAPT duration for East Asians. The related randomized controlled trials that compared the different DAPT duration in East Asian patients were included by searching PubMed, EMBASE, and Cochrane Library database. The outcomes included myocardial infarction, stent thrombosis, all-cause death, stroke, and major bleeding. In addition, net adverse cardiac and cardiovascular events was defined as a composite outcome in this study. We calculated the odds ratio (OR) and 95% confidence intervals for end point events by the fixed effects model in the Bayesian's network frame. We included a total of 12 randomized controlled trials with 30,640 patients. Compared with 12-month DAPT, 1- to 3-month DAPT is effective in myocardial infarction (OR 0.72, 0.46-1.08), stents thrombosis (OR 1.27, 0.59-2.84), all-cause death (OR 0.91, 0.65-1.28), and stroke (OR 0.89, 0.57-1.39). The 1- to 3-month DAPT was associated with a lower risk of major bleeding compared with 12-month DAPT (OR 0.55, 0.4-0.76), 6-month DAPT (OR 0.54, 0.31-0.94), and >12-month DAPT (OR 0.43, 0.28-0.65). In addition, more than 12 months of DAPT did not reduce the incidence of myocardial infarction (OR 0.75, 0.51-1.11) and increased the risk of major bleeding (OR 1.28, 0.88-1.87) compared with 12-month DAPT. The 1- to 3-month DAPT was more secure and effective than the other 3 DAPT strategies. Although East Asians have a higher risk of bleeding, more than 12 months of DAPT does not increase this incidence of major bleeding.

Watchman FLX vs. Watchman 2.5 in a Dual-Center Left Atrial Appendage Closure Cohort: the WATCH-DUAL study.

No studies have compared Watchman 2.5 (W2.5) with Watchman FLX (FLX) devices to date. We aimed at comparing the FLX with W2.5 devices with respect to clinical outcomes, left atrial appendage (LAA) sealing properties and device-related thrombus (DRT). All consecutive left atrial appendage closure (LAAC) procedures performed at two European centres between November 2017 and February 2021 were included. Procedure-related complications and net adverse cardiovascular events (NACE) at 6 months after LAAC were recorded. At 45-day computed tomography (CT) follow-up, intra- (IDL) and peri- (PDL) device leak, residual patent neck area (RPNA), and DRT were assessed by a Corelab. Out of 144 LAAC consecutive procedures, 71 and 73 interventions were performed using W2.5 and FLX devices, respectively. There were no differences in terms of procedure-related complications (4.2% vs. 2.7%, P = 0.626). At 45-day CT, the FLX was associated with lower frequency of IDL [21.3% vs. 40.0%; P = 0.032; odds ratio (OR): 0.375; 95% confidence interval (CI): 0.160-0.876; P = 0.024], similar rate of PDL (29.5% vs. 42.0%; P = 0.170), and smaller RPNA [6 (0-36) vs. 40 (6-115) mm2; P = 0.001; OR: 0.240; 95% CI: 0.100-0.577; P = 0.001] compared with the W2.5 group. At 45 days, rate of DRT as detected by CT and/or transoesophageal echocardiography (TOE), was higher with W2.5 (6.0% vs. 0%, P = 0.045). At 6-month follow-up, NACE did not differ between groups. In this cohort of consecutive LAACs, FLX as compared to W2.5, was associated with similar procedure-related complications and 6-month NACE, but with improved LAA neck coverage, and lower IDL and DRT.

Short Duration of DAPT Versus De-Escalation After Percutaneous Coronary Intervention for AcuteCoronarySyndromes.

The aim of this study was to compare short dual antiplatelet therapy (DAPT) and de-escalation in a network meta-analysis using standard DAPT as common comparator. In patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), shortening DAPT and de-escalating to a lower potency regimen mitigate bleeding risk. These strategies have never been randomly compared. Randomized trials of DAPT modulation strategies in patients with ACS undergoing PCI were identified. All-cause death was the primary outcome. Secondary outcomes included net adverse cardiovascular events (NACE), major adverse cardiovascular events, and their components. Frequentist and Bayesian network meta-analyses were conducted. Treatments were ranked on the basis of posterior probability. Sensitivity analyses were performed to explore sources of heterogeneity. Twenty-nine studies encompassing 50,602 patients were included. The transitivity assumption was fulfilled. In the frequentist indirect comparison, the risk ratio (RR) for all-cause death was 0.98 (95%CI: 0.68-1.43). De-escalation reduced the risk for NACE (RR: 0.87; 95%CI: 0.70-0.94) and increased major bleeding (RR: 1.54; 95%CI: 1.07-2.21). These results were consistent in the Bayesian meta-analysis. De-escalation displayed a >95% probability to rank first for NACE, myocardial infarction, stroke, stent thrombosis, and minor bleeding, while short DAPT ranked first for major bleeding. These findings were consistent in node-split and multiple sensitivity analyses. In patients with ACS undergoing PCI, there was no difference in all-cause death between short DAPT and de-escalation. De-escalation reduced the risk for NACE, while short DAPT decreased major bleeding. These data characterize 2 contemporary strategies to personalize DAPT on the basis of treatment objectives and risk profile.

The current status and outcomes of in-hospital P2Y12 receptor inhibitor switching in Korean patients with acute myocardial infarction.

Background/AimsWhile switching strategies of P2Y12 receptor inhibitors (RIs) have sometimes been used in acute myocardial infarction (AMI) patients, the current status of in-hospital P2Y12RI switching remains unknown.MethodsOverall, 8,476 AMI patients who underwent successful revascularization from Korea Acute Myocardial Infarction Registry-National Institute of Health (KAMIR-NIH) were divided according to in-hospital P2Y12RI strategies, and net adverse cardiovascular events (NACEs), defined as a composite of cardiac death, non-fatal myocardial infarction (MI), stroke, or thrombolysis in myocardial infarction (TIMI) major bleeding during hospitalization were compared.ResultsPatients with in-hospital P2Y12RI switching accounted for 16.5%, of which 867 patients were switched from clopidogrel to potent P2Y12RI (C-P) and 532 patients from potent P2Y12RI to clopidogrel (P-C). There were no differences in NACEs among the unchanged clopidogrel, the unchanged potent P2Y12RIs, and the P2Y12RI switching groups. However, compared to the unchanged clopidogrel group, the C-P group had a higher incidence of non-fatal MI, and the P-C group had a higher incidence of TIMI major bleeding. In clinical events of in-hospital P2Y12RI switching, 90.9% of non-fatal MI occurred during pre-switching clopidogrel administration, 60.7% of TIMI major bleeding was related to pre-switching P2Y12RIs, and 71.4% of TIMI major bleeding was related to potent P2Y12RIs. Only 21.6% of the P2Y12RI switching group switched to P2Y12RIs after a loading dose (LD); however, there were no differences in clinical events between patients with and without LD.ConclusionsIn-hospital P2Y12RI switching occurred occasionally, but had relatively similar clinical outcomes compared to unchanged P2Y12RIs in Korean AMI patients. Non-fatal MI and bleeding appeared to be mainly related to pre-switching P2Y12RIs.