Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk.

BACKGROUND: Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug-eluting stents have been shown to be superior to bare-metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus-eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus-eluting stent in patients with HBR. METHODS AND RESULTS: This was a prospective, multicenter, binational, single-arm, open-label trial. Patients were defined as HBR according to the LEADERS-FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% (P<0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%). CONCLUSIONS: We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus-eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03877848

P4589The prognostic impact of the Medina classification in bifurcation lesion percutaneous coronary intervention

Abstract Background/Introduction The Medina classification is the most widespread method to describe bifurcation lesions. However, little is known regarding the prognostic impact of the classification. Purpose To assess the prognostic significance of the Medina classification following percutaneous coronary intervention (PCI). Methods The study included 738 consecutive patients from a prospective bifurcation registry. There were 609 patients (82.5%) with “true bifurcation” (TB) lesions (Medina class 1.0.1, 1.1.1, 0.1.1) and 129 (17.5%) in all other categories (“non-true bifurcation” = NTB). We compared rates of death and major adverse cardiac events (MACE: cardiac death, myocardial infarction, or target vessel revascularization) at 12 months and 3 years. Results Patients with TB had lower rates of previous bypass surgery (9.4% vs. 12.2%, p=0.03) and hyperlipidemia (75.2% vs. 79.0%, p=0.04). TB lesions were more likely to be calcified (33.8% vs. 28.2%, p=0.03) and ulcerated (8.9% vs. 3.4%, p&lt;0.01). At 12 months, mortality was numerically higher for TB PCI (4.1% vs. 2.0%m p=0.052) and MACE rates were higher (13.2% vs. 5.2%, p&lt;0.001). At 3 years, both all cause death (10.1% vs. 4.9%, p=0.002), as well as rates of MACE (27.2% vs. 11.6%, p&lt;0.001) were higher for TB PCI (Figure 1). After performing regression analysis, TB remained an independent predictor for poor outcomes (OR- 3.93 at 12 months, CI 1.45–10.66, p=0.007, OR-3.26 at 3 years, CI 1.47–7.25, p=0.004 for MACE). Conclusions TB lesions, according to the Medina classification, portend worse prognosis for patients undergoing bifurcation PCI. This may guide prognostication and decision making in treatment. </jats:sec

P6520Outcomes of the trans radial approach PCI in a single tertiary center over a decade of adoption and

Abstract Background/Introduction The trans-radial approach (TRA) has been increasingly adopted for the use of percutaneous coronary interventions (PCI), with reported clinical benefits. Little is known regarding the change in outcomes over time. Purpose To assess the temporal trends of TRA PCI in a single tertiary center over a decade. Methods From a database of 21,763 consecutive PCI's, we analyzed 15,429 patients in 2 periods – 2008 to 2012 (period 1) and 2013 to 2017 (period 2). We examined the proportions of use of TRA, the influence on in-hospital outcomes and adjusted long-term effects. Results The rate of TRA rose from 15.9% in period 1 to 69.1% in period 2, including in specific situations such as acute coronary syndrome, chronic total occlusion, bifurcation, calcified lesions and unprotected left main PCI. In-hospital rates of bleeding were lower for TRA vs. TFA (1.8% vs. 5.1%, overall, p&lt;0.001), as were rates of additional bleeding events in the following 12 months (1.3% vs. 2.4%, p&lt;0.001). Following multivariate analysis, use of TRA was associated with a lower 30-day and 4-year rate of the composite outcomes of death, myocardial infarction, target vessel revascularization or coronary artery bypass surgery [at 4 years, HR-0.86 (95% CI 0.77–0.96 p=0.007) during period 1 and HR-0.62 (95% CI 0.55–0.7 p&lt;0.0001) during period 2, figure 1]. Interaction analysis showed a stronger effect at the latter period (HR-0.69, 95% CI 0.59–0.81, p&lt;0.001). Figure 1 Conclusions Over a decade of follow-up, TRA has gained acceptance for different PCI scenarios, including complex patients- a course which is associated with consistent short and long-term clinical benefits. </jats:sec

P3609Temporal trends of the management and outcomes of patients after myocardial infarction according to the risk for recurrent cardiovascular events

Abstract Background Following Myocardial Infarction (MI), patients are at increased risk for recurrent cardiovascular events, particularly during the immediate period. Yet some patients are at higher risk than others, owing to their clinical characteristics and comorbidities, these high-risk patients are less often treated with guideline-recommended therapies. Aim To examine temporal trends in treatment and outcomes of patients with MI according to the TIMI risk score for secondary prevention (TRS2°P), a recently validated risk stratification tool. Methods A retrospective cohort study of patients with an acute MI, who underwent percutaneous coronary intervention and were discharged alive between 2004–2016. Temporal trends were examined in the early (2004–2010) and late (2011–2016) time-periods. Patients were stratified by the TRS2°P to a low (≤1), intermediate (2) or high-risk group (≥3). Clinical outcomes included 30-day MACE (death, MI, target vessel revascularization, coronary artery bypass grafting, unstable angina or stroke) and 1-year mortality. Results Among 4921 patients, 31% were low-risk, 27% intermediate-risk and 42% high-risk. Compared to low and intermediate-risk patients, high-risk patients were older, more commonly female, and had more comorbidities such as hypertension, diabetes, peripheral vascular disease, and chronic kidney disease. They presented more often with non ST elevation MI and 3-vessel disease. High-risk patients were less likely to receive drug eluting stents and potent anti-platelet drugs, among other guideline-recommended therapies. Evidently, they experienced higher 30-day MACE (8.1% vs. 3.9% and 2.1% in intermediate and low-risk, respectively, P&lt;0.001) and 1-year mortality (10.4% vs. 3.9% and 1.1% in intermediate and low-risk, respectively, P&lt;0.001). During time, comparing the early to the late-period, the use of potent antiplatelets and statins increased among the entire cohort (P&lt;0.001). However, only the high-risk group demonstrated a significantly lower 30-day MACE (P=0.001). During time, there were no differences in 1-year mortality rate among all risk categories. Temporal trends in 30-day MACE by TRS2°P Conclusion Despite a better application of guideline-recommended therapies, high-risk patients after MI are still relatively undertreated. Nevertheless, they demonstrated the most notable improvement in outcomes over time. </jats:sec

Acute kidney injury definition following PCI and cardiovascular outcomes

Abstract Background Acute kidney injury (AKI) is a complication of percutaneous coronary intervention (PCI), known to increase rates of adverse medical events. We aimed to identify the optimal definition of AKI in predicting of adverse cardiovascular outcomes and mortality post PCI. Methods From a large registry of patients undergoing PCI between 2006–2018 (n=25,690) at two hospitals, consecutive patients were assessed for the presence of AKI according to four different definitions: a relative elevation of ≥25% or ≥50%; or an absolute elevation of ≥0.3 mg/dL or ≥0.5 mg/dL in serum creatinine at 48 hours post PCI. We assessed the calculated rates of AKI according to the different definitions. The discriminant capacity for 30-day and 1-year mortality and MACE (MACE: all-cause death, myocardial infarction, target-vessel revascularization and coronary artery bypass graft surgery) of each definition was calculated using ROC curves and AUCs. Results Data of 15,153 patients was available for final analysis. Rates of AKI were 12.1%, 3.2%, 8.1% and 3.9% according to the four definitions, respectively. The discriminant capacity of adverse outcomes was highest among those defined as AKI according to the third definition - an absolute elevation of ≥0.3 mg/dL in serum creatinine with an AUC of 0.82 (95% CI 0.80–0.84) for 30-day mortality (P value = 0.036) and an AUC of 0.78 (CI 0.76–0.79) for 30 days MACE. Conclusions An absolute elevation of ≥0.3 mg/dL in serum creatinine 48 hours post PCI predicts overall mortality and MACE most accurately. Funding Acknowledgement Type of funding sources: None. </jats:sec

Differences in valve morphology between patients with bicuspid and tricuspid aortic valve

Abstract Background Bicuspid aortic valve (BAV) patients represent a significant minority of severe aortic stenosis (AS) patients undergoing transcutaneous aortic valve implantation (TAVI). These patients demonstrate anatomic differences compared to tricuspid aortic valve (TAV). Ethnicity is associated with different valve morphologies characterized by Siever's classification. Purpose We aim to evaluated the prevalence of BAV subtypes and the differences in valve morphology and aortic root dimensions between BAV and TAV in patients undergoing computed tomography (CT) before TAVI. Methods In five Israeli medical centers, 131 patients with BAV and 674 patients with TAV underwent CT angiography. BAV morphology was defined according to the number of commissures and raphe, following Siever's classification. Aortic root dimensions were measured at the level of the aortic annulus, sinus of Valsalva (SOV), and sino-tubular junction (STJ). Finally, Agatston score unit (AU) for valve calcification was evaluated. Results Type 0 accounted for 27% (36/131), Type IA for 63% (82/131), Type IC for 9% (12/131), and Type 2 for 1% (1/131). Calcium score in BAV patients was significantly higher compared to TAV patients, 4000±1897 vs. 2152±1216 AU; respectively (P&amp;lt;0.001). Distance from the annulus to the left main coronary artery was greater in BAV patients compared to TAV (13.8±3.6 mm vs. 12.8±2.8 mm; respectively, P&amp;lt;0.001), similar distance from annulus to right coronary artery was observed in BAV and TAV patients (16.7±3.7 mm vs. 15±3 mm; respectively, P&amp;lt;0.001). Aortic annulus perimeter was greater in BAV than TAV patients (79.3±11mm vs. 73±8.7mm, respectively, P&amp;lt;0.001), as well as SOV perimeter (35.7±4.5mm vs. 32±3.7mm, respectively, P&amp;lt;0.001), and STJ perimeter (32.3±5mm vs. 27±3.3 mm; respectively, P&amp;lt;0.001). Conclusion In Israel, AS patients showed more frequently type 1A BAV. BAV patients have larger aortic root dimensions and higher calcium burden than TAV patients. Funding Acknowledgement Type of funding source: None </jats:sec

Characteristics of aortic root and vascular anatomy in bicuspid versus tricuspid aortic valve stenosis in patients undergoing transcatheter aortic valve implantation

Abstract Background Transcatheter aortic valve implantation (TAVI) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS). Objectives This study sought to compare aortic root and ilio-femoral artery characteristics and clinical outcomes in patients with bicuspid versus tricuspid AS from the Bicuspid AS TAVI multicenter registry. Methods 88 patients with bicuspid AS and 213 matched patients with tricuspid AS were referred for pre-procedural computed tomography (CT) evaluation before TAVI. We performed a detailed assessment of aortic root anatomy: size of the annulus, sinus of Valsalva (SoV), sino-tubular junction (STJ); we also determined the dimensions of aorta, left subclavian, and ilio-femoral arteries. Results Patients with bicuspid AS had significantly larger aortic root dimensions, (annulus mean diameter: 25.5±2.9 mm vs. 23.7±2.4 mm, SoV mean diameter: 35.3±4.7 mm vs. 32±4.4mm, STJ mean diameter: 31.5±4.9 mm vs. 27.6±3.5 mm; respectively) than patients with tricuspid AS (P value for all &amp;lt;0.001), even after adjustment for their larger BSA and height. Dimensions of ascending aorta, left subclavian artery, and ilio-femoral arteries were also consistently larger in bicuspid than in tricuspid AS morphology. Conclusions Patients with bicuspid AS had significantly larger aortic root dimensions, larger ascending aorta, subclavian artery and ilio-femoral arteries even after adjustment for their BSA and height. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Rabin Medical Center </jats:sec