Predictors of outcomes after PCI with incomplete revascularization: Impact of CTO and LAD vessel.

BACKGROUND: Incomplete revascularization (ICR) after percutaneous coronary intervention (PCI) is associated with mortality and morbidity. AIM: We sought to investigate whether ICR in the left anterior descending artery (LAD) is worse than ICR of the right coronary artery (RCA) or left circumflex artery (LCX); and whether ICR in patients with a chronic total occlusion (CTO) is worse than in those without. METHODS: In the RIVER-PCI trial, 2651 patients with ICR after PCI were randomly assigned to ranolazine or placebo. Angiograms were assessed at an independent core laboratory in 2501 patients (94.3%). The primary endpoint was the composite of ischemia-driven revascularization or hospitalization. RESULTS: A total of 1664 patients (66.5%) had ICR involving the LAD, whereas 837 (33.5%) had ICR limited to the RCA or LCX. At median follow-up of 643 days, the primary endpoint occurred in 26.9% versus 26.5% of patients (adjusted HR [aHR]: 1.03, 95% confidence interval [CI]: 0.88-1.21). A nonrecanalized CTO was present in 854 patients (34.1%) with ICR after PCI. The primary endpoint occurred in 28.6% versus 25.9% of ICR patients with versus without a CTO (aHR: 1.10, 95% CI: 0.94-1.29). However, patients with a CTO had higher rates of ischemia-driven hospitalization without revascularization (aHR: 1.27, 95% CI: 1.04-1.56), heart failure hospitalization (aHR: 2.69, 95% CI: 1.61-4.59) and myocardial infarction (aHR: 1.46, 95% CI: 1.11-1.92) compared with those without. CONCLUSIONS: The 2-year prognosis was similar in post-PCI patients with ICR whether the LAD was versus was not involved. ICR patients with a CTO had more frequent hospitalizations for ischemia and myocardial infarctions compared with those without.

Less bleeding by omitting aspirin in non-ST-segment elevation acute coronary syndrome patients: Rationale and design of the LEGACY study.

BACKGROUND: Early aspirin withdrawal, also known as P2Y12-inhibitor monotherapy, following percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) can reduce bleeding without a trade-off in efficacy. Still the average daily bleeding risk is highest during the first months and it remains unclear if aspirin can be omitted immediately following PCI. METHODS: The LEGACY study is an open-label, multicenter randomized controlled trial evaluating the safety and efficacy of immediate P2Y12-inhibitor monotherapy versus dual antiplatelet therapy (DAPT) for 12 months in 3,090 patients. Patients are randomized immediately following successful PCI for NSTE-ACS to 75-100 mg aspirin once daily versus no aspirin. The primary hypothesis is that immediately omitting aspirin is superior to DAPT with respect to major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, while maintaining noninferiority for the composite of all-cause mortality, myocardial infarction and stroke compared to DAPT. CONCLUSIONS: The LEGACY study is the first randomized study that is specifically designed to evaluate the impact of immediately omitting aspirin, and thus treating patients with P2Y12-inhibitor monotherapy, as compared to DAPT for 12 months on bleeding and ischemic events within 12 months following PCI for NSTE-ACS.

Efficacy and safety of alirocumab and evolocumab: a systematic review and meta-analysis of randomized controlled trials.

AIMS: The effect of low-density lipoprotein cholesterol-lowering therapy with alirocumab or evolocumab on individual clinical efficacy and safety endpoints remains unclear. We aimed to evaluate the efficacy and safety of alirocumab and evolocumab in patients with dyslipidaemia or atherosclerotic cardiovascular disease. METHODS AND RESULTS: We performed a review of randomized controlled trials (RCTs) comparing treatment with alirocumab or evolocumab vs. placebo or other lipid-lowering therapies up to March 2018. Primary efficacy endpoints were all-cause death, cardiovascular death, myocardial infarction (MI), and stroke. We estimated risk ratios (RR) and 95% confidence intervals (CI) using random effect models. We included 39 RCTs comprising 66 478 patients of whom 35 896 were treated with proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors (14 639 with alirocumab and 21 257 with evolocumab) and 30 582 with controls. Mean weighted follow-up time across trials was 2.3 years with an exposure time of 150 617 patient-years. Overall, the effects of PCSK9 inhibition on all-cause death and cardiovascular death were not statistically significant (P = 0.15 and P = 0.34, respectively). Proprotein convertase subtilisin-kexin type 9 inhibitors were associated with lower risk of MI (1.49 vs. 1.93 per 100 patient-year; RR 0.80, 95% CI 0.74-0.86; I  2 = 0%; P < 0.0001), ischaemic stroke (0.44 vs. 0.58 per 100 patient-year; RR 0.78, 95% CI 0.67-0.89; I  2 = 0%; P = 0.0005), and coronary revascularization (2.16 vs. 2.64 per 100 patient-year; RR 0.83, 95% CI 0.78-0.89; I  2 = 0%; P < 0.0001), compared with the control group. Use of these PCSK9 inhibitors was not associated with increased risk of neurocognitive adverse events (P = 0.91), liver enzymes elevations (P = 0.34), rhabdomyolysis (P = 0.58), or new-onset diabetes mellitus (P = 0.97). CONCLUSION: Proprotein convertase subtilisin-kexin type 9 inhibition with alirocumab or evolocumab was associated with lower risk of MI, stroke, and coronary revascularization, with favourable safety profile.

Identification and treatment of the vulnerable coronary plaque.

Acute coronary syndrome mostly arises from rupture or erosion of a vulnerable plaque. Vulnerable plaques typically appear as lipid-rich plaques with a thin cap, called thin-cap fibroatheromas. Various intracoronary imaging techniques can be used to detect vulnerable plaques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT) and near-infrared spectroscopy (NIRS), each visualizing different high-risk plaque characteristics. IVUS and its post-processing techniques, such as virtual histology IVUS, can primarily be used to identify calcified and soft plaques, while OCT is also able to quantitatively measure the cap thickness. The addition of NIRS allows the exact measurement of lipid content in the plaque. Non-invasive imaging techniques to identify vulnerable plaques, such as computed tomography, are less often used but are evolving and may be of additional diagnostic use, especially when prophylactic treatments for vulnerable plaques are further established. Pharmacological treatment with lipid-lowering or anti-inflammatory medication leads to plaque stabilization and reduction of cardiovascular events. Moreover, the implantation of a stent or scaffold for the local treatment of vulnerable plaques has been found to be safe and to stabilize high-risk plaque features. The use of drug-coated balloons to treat vulnerable plaques is the subject of ongoing research. Future studies should focus on non-invasive imaging techniques to adequately identify vulnerable plaques and further randomized clinical studies are necessary to find the most appropriate treatment strategy for vulnerable plaques.

DEtection of ProxImal Coronary stenosis in the work-up for Transcatheter aortic valve implantation using CTA (from the DEPICT CTA collaboration).

OBJECTIVES: Computed tomography angiography (CTA) is performed routinely in the work-up for transcatheter aortic valve implantation (TAVI), and could potentially replace invasive coronary angiography (ICA) to rule out left main (LM) and proximal coronary stenosis. The objectives were to assess the diagnostic yield and accuracy of pre-TAVI CTA to detect LM and proximal coronary stenosis of ≥ 50% and ≥ 70% diameter stenosis (DS). METHODS: The DEPICT CTA database consists of individual patient data from four studies with a retrospective design that analyzed the diagnostic accuracy of pre-TAVI CTA to detect coronary stenosis, as compared with ICA. Pooled data were used to assess diagnostic accuracy to detect coronary stenosis in the left main and the three proximal coronary segments on a per-patient and a per-segment level. We included 1060 patients (mean age: 81.5 years, 42.7% male). RESULTS: On ICA, the prevalence of proximal stenosis was 29.0% (≥ 50% DS) and 15.7% (≥ 70% DS). Pre-TAVI CTA ruled out ≥ 50% DS in 51.6% of patients with a sensitivity of 96.4%, specificity of 71.2%, PPV of 57.7%, and NPV of 98.0%. For ≥ 70% DS, pre-TAVI CTA ruled out stenosis in 70.0% of patients with a sensitivity of 96.7%, specificity of 87.5%, PPV of 66.9%, and NPV of 99.0%. CONCLUSION: CTA provides high diagnostic accuracy to rule out LM and proximal coronary stenosis in patients undergoing work-up for TAVI. Clinical application of CTA as a gatekeeper for ICA would reduce the need for ICA in 52% or 70% of patients, using a threshold of ≥ 50% or ≥ 70% DS, respectively. KEY POINTS: • Clinical application of CTA as a gatekeeper for ICA would reduce the need for ICA in 52% or 70% of TAVI patients, using a threshold of ≥ 50% or ≥ 70% diameter stenosis. • The diagnostic accuracy of CTA to exclude proximal coronary stenosis in these patients is high, with a sensitivity of 96.4% and NPV of 98.0% for a threshold of ≥ 50%, and a sensitivity of 96.7% and NPV of 99.0% for a threshold of ≥ 70% diameter stenosis. • Atrial fibrillation and heart rate did not significantly affect sensitivity and NPV. However, a heart rate of < 70 b/min during CTA was associated with a significantly improved specificity and PPV.

Performance of the academic research consortium high-bleeding risk criteria in patients undergoing PCI for acute myocardial infarction.

Patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) are at increased risk for thrombotic and bleeding complications compared to patients with chronic coronary syndrome (CCS). The academic research consortium (ARC) recently suggested a set of criteria to identify patients at high bleeding risk (HBR). We sought to evaluate the performance of the ARC-HBR criteria among patients undergoing PCI according to clinical presentation. We included all consecutive patients undergoing PCI at a tertiary-care center. Patients were deemed at HBR if they fulfilled ≥ 1 major or ≥ 2 minor ARC-HBR criteria. The primary bleeding endpoint was a composite of in-hospital or post-discharge bleeding at 1-year follow-up. Secondary outcomes included all-cause death and myocardial infarction. Out of 6068 patients, 1391 (22.9 %) presented with AMI and were more often at HBR than those with CCS (46.9 % vs. 43.0 %, p = 0.01). HBR patients had a higher risk for the primary bleeding endpoint than non-HBR, irrespective of the clinical indication for PCI (AMI: 19.5 % vs. 5.5 %; HR 3.86, 95 % CI 2.63-5.69; CCS: 6.8 % vs. 2.6 %; HR 2.65, 95 % CI 1.92-3.68; p-interaction = 0.11). Secondary outcomes followed a similar trend. After multivariable adjustment, AMI presentation remained significantly associated with increased risk for bleeding at 1 year (HR 1.64, 95 % CI 1.13-2.38, p = 0.01). The ARC-HBR criterion associated with the highest bleeding risk was severe/end-stage chronic kidney disease in AMI and moderate/severe anemia in CCS. The ARC-HBR framework successfully identified AMI and CCS patients with increased risk for bleeding complications at 1 year post-PCI. Figure prepared with BioRender.

Current State and Future Perspectives of Artificial Intelligence for Automated Coronary Angiography Imaging Analysis in Patients with Ischemic Heart Disease.

PURPOSE OF REVIEW: Artificial intelligence (AI) applications in (interventional) cardiology continue to emerge. This review summarizes the current state and future perspectives of AI for automated imaging analysis in invasive coronary angiography (ICA). RECENT FINDINGS: Recently, 12 studies on AI for automated imaging analysis In ICA have been published. In these studies, machine learning (ML) models have been developed for frame selection, segmentation, lesion assessment, and functional assessment of coronary flow. These ML models have been developed on monocenter datasets (in range 31-14,509 patients) and showed moderate to good performance. However, only three ML models were externally validated. Given the current pace of AI developments for the analysis of ICA, less-invasive, objective, and automated diagnosis of CAD can be expected in the near future. Further research on this technology in the catheterization laboratory may assist and improve treatment allocation, risk stratification, and cath lab logistics by integrating ICA analysis with other clinical characteristics.

Evolution of antithrombotic therapy in patients undergoing percutaneous coronary intervention: a 40-year journey.

Since its introduction in 1977, percutaneous coronary intervention has become one of the most commonly performed therapeutic procedures worldwide. Such widespread diffusion, however, would have not been possible without a concomitant evolution of the pharmacotherapies associated with this intervention. Antithrombotic agents are fundamental throughout the management of patients undergoing coronary stent implantation, starting from the procedure itself to the long-term prevention of cardiovascular events. The last 40 years of interventional cardiology have seen remarkable improvements in both drug therapies and device technologies, which largely reflected a progressive understanding of the pathophysiological mechanisms of coronary artery disease, as well as procedure- and device-related adverse events. The purpose of this article is to provide an overview of the important milestones in antithrombotic pharmacology that have shaped clinical practice of today while also providing insights into knowledge gaps and future directions.

Long-Term Safety and Efficacy of Durable Polymer Cobalt-Chromium Everolimus-Eluting Stents in Patients at High Bleeding Risk: A Patient-Level Stratified Analysis From Four Postapproval Studies.

BACKGROUND: Long-term outcomes in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention with a drug-eluting stent are unclear. Therefore, we aimed to evaluate long-term adverse events in HBR patients undergoing percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent implantation. METHODS: We analyzed stratified data from 4 all-comers postapproval registries. Patients with at least 1 of the following criteria were categorized as HBR: age ≥75 years, history of major bleeding (MB), history of stroke, chronic oral anticoagulant use, chronic kidney disease, anemia, or thrombocytopenia. Additionally, in a separate analysis, patients were categorized according to the recently published Academic Research Consortium HBR criteria. The Kaplan-Meier method was used for time-to-event analyses. Coronary thrombotic events (CTE) included myocardial infarction or definite/probable stent thrombosis. MB was defined according to the TIMI (Thrombolysis in Myocardial Infarction) or GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) scales. Impact of CTE and MB on subsequent risk of mortality was assessed using multivariable Cox regression with MB and CTE included as time-updated covariates. RESULTS: Of the total 10 502 patients included, 3507 (33%) were identified as HBR. Compared with non-HBR patients, those at HBR had more comorbidities, higher lesion complexity, and a higher risk of 4-year mortality (Hazard Ratio [HR] 4.38 [95% CI, 3.76-5.11]). Results were qualitatively similar when using Academic Research Consortium criteria to define HBR. Risk of mortality was increased after CTE (HR 5.02 [95% CI, 3.93-6.41]), as well as after MB (HR 4.92 [95% CI, 3.82-6.35]). Of note, this effect was consistent across the spectrum of bleeding risk (P-interaction test 0.97 and 0.06, respectively). CONCLUSIONS: Compared with the non-HBR population, HBR patients experienced worse 4-year outcomes after percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent. Both CTE and MB had a significant impact on subsequent risk of mortality irrespective of bleeding risk.

Safety and efficacy of the bioabsorbable polymer everolimus-eluting stent versus durable polymer drug-eluting stents in high-risk patients undergoing PCI: TWILIGHT-SYNERGY.

BACKGROUND: Data examining the safety and efficacy of the bioabsorbable polymer (BP) drug-eluting stent (DES) as compared with durable polymer (DP) DES in high-risk patients undergoing percutaneous coronary intervention (PCI) remain limited. METHODS: We conducted a pre-specified analysis among patients enrolled in the TWILIGHT trial treated with the SYNERGY BP-DES or a DP-DES. Following successful PCI and 3 months of ticagrelor plus aspirin, patients were randomized to aspirin or placebo for 1 year; DES choice was at physician discretion. The primary endpoint was target lesion failure (TLF) [composite of cardiac death, target vessel myocardial infarction (MI), clinically driven target lesion revascularization (TLR) or definite/probable stent thrombosis (ST)]. RESULTS: Among enrolled participants (N = 9,006), 653 were treated exclusively with the SYNERGY BP-DES and 6,404 with a comparator DP-DES. Over 15 months, TLF rates were 6.4 and 6.1% among those receiving a SYNERGY BP-DES and a DP-DES, respectively (adjusted HR 0.93; 95% CI 0.64-1.35; p = .72). The effect of ticagrelor monotherapy on Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding and the composite of all-cause death, MI or stroke was uniform across DES groups (both pint > .10). CONCLUSIONS: The safety and efficacy profile of the SYNERGY BP-DES is comparable to that of contemporary DP-DES in high-risk patients undergoing PCI. Compared to ticagrelor plus aspirin, the effect of ticagrelor monotherapy is consistent among patients receiving SYNERGY BP-DES or DP-DES.

Radial versus femoral access for coronary interventions: An updated systematic review and meta-analysis of randomized trials.

OBJECTIVE: It is still debated if benefits associated with radial versus femoral access for coronary angiography and percutaneous coronary interventions (PCI) are due to the access site selection itself, operator expertise or other underlying mechanisms. METHODS: We searched PubMed, Embase, and meeting abstracts for randomized trials comparing radial versus femoral access site for coronary angiography and PCI. Primary safety endpoint was major bleeding. Coprimary efficacy endpoints were stroke and myocardial infarction (MI). This study is registered with PROSPERO. RESULTS: We identified 31 trials (30,096 patients, PCI performed in 21,225 patients). Radial compared to femoral access was associated with a significant risk reduction in major bleeding (OR 0.53, 95%CI 0.42-0.66, I2  = 3.3%). Findings were consistent regardless of clinical characteristics or whether coronary angiography was performed with or without PCI. The benefit of radial access was significantly increased in studies published before 2010 and in patients with chronic coronary syndrome. Risk for stroke (OR 1.11, 95%CI 0.76-1.64, I2  = 0%) and MI (OR 0.90, 95%CI 0.79-1.04, I2  = 0%) were comparable between the groups. Risk for mortality and vascular complications were significantly lower with radial than femoral access. CONCLUSION: In patients undergoing coronary angiography and PCI, radial access is associated with a significant risk reduction in bleeding, vascular complications, and mortality compared to femoral access. The risk of stroke or MI were comparable in patients with radial or femoral access.

Predictors and outcomes of procedural failure of percutaneous coronary intervention of a chronic total occlusion-A subanalysis of the EXPLORE trial.

OBJECTIVE: To evaluate predictors of procedural success of percutaneous coronary intervention (PCI) of chronic total coronary occlusions (CTOs) in a non-infarct-related artery following ST-segment elevation myocardial infarction (STEMI), and demonstrate the effect on left ventricular functionality (LVF), infarct size (IS), and pro-arrhythmic electrocardiogram (ECG) parameters. BACKGROUND: Predictors of unsuccessful revascularization of a CTO are numerous, although following STEMI, these are lacking. Besides, effects of failed CTO PCI (FPCI) on the myocardium are unknown. METHODS: This is a subanalysis of the EXPLORE trial, in which 302 STEMI patients with a concurrent CTO were randomized to CTO PCI (n = 147) or no-CTO PCI (NPCI, n = 154). For the purpose of this subanalysis, we divided patients into successful CTO PCI (SPCI, n = 106), FPCI (n = 41), and NPCI (n = 154) groups. Cardiac magnetic resonance imaging and angiographic data were derived from the EXPLORE database, combined with ECG parameters. To gain more insight, all outcomes were compared with patients that did not undergo CTO PCI. RESULTS: In multivariate regression, only CTO lesion length >20 mm was an independent predictor of procedural failure (OR 3.31 [1.49-7.39]). No significant differences in median left ventricular ejection fraction, left ventricular end-diastolic volume, IS, and the pro-arrhythmic ECG parameters such as QT-dispersion, QTc-time, and TpTe-intervals were seen between the SPCI and FPCI groups at 4 months follow-up. CONCLUSION: This subanalysis of the EXPLORE trial has demonstrated that a CTO lesion length >20 mm is an independent predictor of CTO PCI failure, whereas procedural failure did not lead to any adverse effects on LVF nor pro-arrhythmic ECG parameters.

Impact of sex on long-term cardiovascular outcomes of patients undergoing percutaneous coronary intervention for acute coronary syndromes.

BACKGROUND: Women with acute coronary syndrome (ACS) generally present with more comorbidities and experience worse clinical outcomes compared with males. However, it is unclear whether this represents genuine sex-related difference or stems from clinical, procedural and socioeconomic factors. METHODS: We analyzed consecutive patients undergoing percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI), non-STEMI or unstable angina at a single tertiary-care center. Exclusion criteria were unknown sex, age < 18 years and PCI with bare metal stent or without stent placement. The study population was stratified according to sex. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) defined as the composite of death, spontaneous myocardial infarction, or stroke at 1 year. Secondary endpoints were individual components of MACCE, target vessel revascularization (TVR) and clinically significant bleeding. RESULTS: Of the 7362 patients included, 5031 (68.3%) were men and 2331 (31.7%) women. Women were older and presented with a higher burden of comorbidities while men had more complex coronary anatomy. The incidence of 1 year MACCE was significantly higher among women (8.0% versus 5.6%; p < 0.01) compared to men. Women also experienced a higher rate of bleeding (2.3% vs. 1.4%; p = 0.02) while there were no differences between groups in terms of TVR (8.1% vs. 7.8%; p-value = 0.83). Differences in outcomes were attenuated after multivariable adjustment. Findings were consistent across ACS subgroups. CONCLUSIONS: In a contemporary ACS population treated with drug-eluting stents, women experienced a higher crude rate of 1-year MACCE. This was no longer apparent after accounting for baseline imbalances.

Impact of target vessel choice on outcomes following percutaneous coronary intervention in patients with a prior coronary artery bypass graft.

OBJECTIVES: To evaluate and compare characteristics and clinical outcomes of percutaneous coronary intervention (PCI) among target vessel types in patients with a prior coronary artery bypass graft (CABG) surgery. BACKGROUND: Patients with a prior CABG often require repeat revascularization with PCI. Graft PCI has been associated with worse outcomes compared to native vessel PCI, yet the optimal PCI strategy in prior CABG patients remains unknown. METHODS: We stratified prior CABG patients who underwent PCI at a tertiary-care center between 2009 and 2017 by target vessel type: native vessel, venous graft, and arterial graft. The primary outcome of major adverse cardiac events (MACE) was a composite of all-cause death, myocardial infarction, stent thrombosis, or target vessel revascularization up to 1 year post-PCI. RESULTS: Prior CABG patients (n = 3983) represented 19.5% of all PCI interventions during the study period. PCI was most frequently performed on native vessels (n = 2928, 73.5%) followed by venous (n = 883, 22.2%) and arterial grafts (n = 172, 4.3%). Procedural success and complications were similar among the groups; however, slow- and no-reflow phenomenon was more common in venous graft PCI compared to native vessel PCI (OR 4.78; 95% CI 2.56-8.95; p < 0.001). At 1 year, there were no significant differences in MACE or in its individual components. CONCLUSIONS: Target vessel choice did not appear to affect MACE at 1 year in a large cohort of patients with prior CABG undergoing PCI. Whether PCI of surgical grafts versus native arteries truly results in similar outcomes warrants further investigation in randomized controlled trials.

Incidence, predictors and clinical impact of permanent pacemaker insertion in women following transcatheter aortic valve implantation: Insights from a prospective multinational registry.

OBJECTIVES: To describe the incidence, predictors, and clinical impact of permanent pacemaker insertion (PPI) following transcatheter aortic valve replacement (TAVR) in women. BACKGROUND: Data on pacemaker insertion complicating TAVR in women are scarce. METHODS: The Women's International Transcatheter Aortic Valve implantation (WIN-TAVI) is a prospective registry evaluating the safety and efficacy of TAVR in women. We included patients without preprocedural pacemakers and divided them into two groups: (1) PPI and (2) no-PPI. We identified PPI predictors using logistic regression and studied its clinical impact on the Valve Academic Research Consortium (VARC)-2 efficacy and safety endpoints. RESULTS: Out of 1019 patients, 922 were included in the analysis. Post-TAVR PPI occurred in 132 (14.3%) patients. Clinical and procedural characteristics were similar in both groups. Pre-existing right bundle branch block (RBBB) was associated with a high risk of post-TAVR PPI (OR 3.62, 95% CI 1.85-7.06, p < 0.001), while implantation of balloon-expandable prosthesis was associated with a lower risk (OR 0.47, 95% CI 0.30-0.74, p < 0.001). Post-TAVR PPI prolonged in-hospital stay by a median of 2 days (11 [9-16] days in PPI vs. 9 [7-14] days in no-PPI, p = 0.005), yet risks of VARC-2 efficacy and safety endpoints at 1 year were similar in both groups (adj HR 0.95, 95% CI 0.60-1.52, p = 0.84 and adj HR 1.22, 95% CI 0.83-1.79, p = 0.31, respectively). CONCLUSION: Pacemaker implantation following TAVR is frequent among women and is associated with pre-existing RBBB and valve type. PPI prolongs hospital stay, albeit without any significant impact on 1-year outcomes.

Preprocedural anemia in females undergoing transcatheter aortic valve implantation: Insights from the WIN-TAVI registry.

OBJECTIVES: To assess the impact of anemia on clinical outcomes in female patients enrolled in the Women's InterNational transcatheter aortic valve implantation (WIN-TAVI) registry. BACKGROUND: Anemia is highly prevalent among females who constitute half of TAVI candidates, yet, its clinical significance remains poorly investigated. METHODS: Patients were divided into three groups according to preprocedural hemoglobin (Hb) level: (1) no anemia (Hb ≥12 g/dl), (2) mild-to-moderate anemia (10 ≤ Hb <12 g/dl), and (3) severe anemia (Hb <10 g/dl). The primary outcome was the occurrence of Valve Academic Research Consortium (VARC)-2 efficacy endpoint, a composite of mortality, stroke, myocardial infarction (MI), hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. RESULTS: Hemoglobin level was available in 877 (86.1%) patients: 412 (47.0%) had no anemia, 363 (41.4%) had mild-to-moderate anemia, and 102 (11.6%) had severe anemia. The latter group had a higher prevalence of cardiovascular risk factors. Compared with patients without anemia, severe anemia was associated with a greater risk of VARC-2 efficacy endpoint (adj HR 1.71, 95% CI: 1.02-2.87, p = .04), all-cause death (adj HR 2.36, 95% CI: 1.31-4.26, p = .004) and a composite of death, MI or stroke (adj HR 1.88, 95% CI: 1.10-3.22, p = .02) at 1 year. Moreover, an increased risk of late mortality (adj HR 1.15, 95% CI: 1.02-1.30, p = .03) was observed with every 1 g/dl decrease in hemoglobin level. CONCLUSION: Severe anemia in females undergoing TAVI was independently associated with increased rates of VARC-2 efficacy endpoint and mortality at 1 year.

Impact of insulin treated and non-insulin-treated diabetes compared to patients without diabetes on 1-year outcomes following contemporary PCI.

OBJECTIVE: We compared 1-year outcomes in insulin-treated diabetes mellitus (ITDM) and non-ITDM patients compared to nondiabetic (DM) patients following contemporary percutaneous coronary intervention (PCI). BACKGROUND: ITDM is associated with extensive atherosclerotic disease and worse cardiovascular prognosis compared to non-ITDM patients. METHODS: We evaluated PCI patients at a large tertiary center from 2010 to 2016, grouped according to diabetes and treatment status at baseline. One-year major adverse cardiac events (MACE) were defined as a composite of death, myocardial infarction (MI), or target vessel revascularization. Outcomes were adjusted using multivariable Cox regression methods. RESULTS: During the study period, 16,889 patients underwent PCI including 13.7% ITDM, 34.0% non-ITDM, and 52.3% non-DM patients. Patients with DM were younger, including more females and non-white patients, with higher body mass index and greater prevalence of prior revascularization and chronic kidney disease. Compared to others, ITDM patients more often presented with acute coronary syndrome, in-stent restenosis, or severe lesion calcification. There were no differences in discharge rates of dual antiplatelet therapy and statins, whereas beta-blockers were more commonly prescribed in DM patients. At 1-year, both ITDM and non-ITDM patients had greater risk of MACE compared with non-DM patients, and ITDM conferred greater adjusted risk than non-ITDM (ITDM = HR: 2.11, 95% CI [1.79,2.50]; non-ITDM = HR: 1.27, 95%CI [1.09,1.47]). CONCLUSIONS: The negative prognostic effect of DM following contemporary PCI is heightened in the presence of insulin treatment, compared to non-DM patients. Focus on secondary prevention, prescription of and adherence to optimal medical therapy is necessary for post-PCI risk reduction.

Impact of stent diameter on outcomes following percutaneous coronary intervention with second-generation drug-eluting stents: Results from a large single-center registry.

BACKGROUND: In patients treated with bare metal stents and first-generation drug-eluting stents (DES) smaller stent diameter (SD) has been associated with worse long term outcomes after percutaneous coronary intervention (PCI). Data on the impact of small SD on outcomes after PCI with second-generation DES is scarce. METHODS: Consecutive patients treated with second-generation DES between 2010 and 2016 were included in a single tertiary center. Patients were grouped according to SD: ≤2.50 mm, 2.75 ≤ 3.00 mm, 3.25 ≤ 3.50 mm, and >3.50 mm. One-year event rates were estimated using the Kaplan-Meier method and adjusted hazard ratios were generated using Cox regression analysis. The primary endpoint was major adverse cardiac events (MACE; death, myocardial infarction [MI], or target vessel revascularization [TVR]). RESULTS: Of the 17,607 patients who underwent PCI with second-generation DES, 32.6% (n = 5,741) had SD ≤2.5 mm, 39.1% (n = 6,890) had SD 2.75 ≤ 3.0 mm, 22.2% (n = 3,910) had SD 3.25 ≤ 3.5 mm, and 6.1% (n = 1,066) had SD >3.5 mm. At 1 year, MACE rates were 10.5%, 9.5%, 8.0%, and 8.0%, respectively, with increasing SD (p = .006). TVR rates decreased with increasing SD (7.2%, 5.8%, 4.7%, and 3.3%, respectively [p < .0001]) whereas rates of MI across SD groups were comparable (1.7%, 1.9%, 2.0%, and 1.5%, respectively [p = .60]). After multivariable adjustment, smaller SD remained associated with higher rates of MACE, TVR, and target lesion revascularization. CONCLUSION: In a large cohort of patients undergoing PCI with second-generation DES, smaller SD was associated with increased MACE, driven by higher rates of repeat revascularization. Further research into the optimal treatment of small coronary arteries is warranted.

The impact of chronic kidney disease in women undergoing transcatheter aortic valve replacement: Analysis from the Women's INternational Transcatheter Aortic Valve Implantation (WIN-TAVI) registry.

BACKGROUND: The prevalence of both chronic kidney disease (CKD) and aortic stenosis (AS) increase with age. Although baseline CKD is frequent in patients undergoing transcatheter aortic valve replacement (TAVR), its significance among women is largely unknown. METHODS: Women's INternational Transcatheter Aortic Valve Implantation (WIN-TAVI) is a multinational, prospective registry of women undergoing TAVR for severe AS. We included patients with available baseline estimated glomerular filtration rate (eGFR) and completed 1-year follow-up. Patients were categorized into three groups based on their eGFR: No CKD (normal kidney function to stage 2 CKD: eGFR ≥60 ml/min/1.73 m2 ); (b) mild CKD (stage 3a CKD: eGFR = 45-59 ml/min/1.73 m2 ); and (c) moderate/severe CKD (stage ≥3b CKD: eGFR <45 ml/min/1.73 m2 ). All events were adjudicated according to the Valve Academic Research Consortium (VARC)-2 criteria. RESULT: Out of 852 women undergoing TAVR, 326 (38.3%) had no CKD, 225 (26.4%) had mild CKD, and 301 (35.3%) had moderate/severe CKD. Women with higher stage of CKD at baseline were more likely to have a history of hypertension, diabetes, atrial fibrillation, anemia, chronic lung disease, hemodialysis, prior percutaneous coronary intervention, and pacemaker implantation. After multivariate adjustment, moderate/severe CKD was associated with a greater risk of 1-year VARC-2 safety endpoints [hazard ratio (HR) 1.68, 95% confidence interval (CI): 1.10-2.60], all-cause death (HR 2.00, 95% CI: 1.03-3.90), and composite of death, myocardial infarction, stroke or life-threatening bleeding (HR 1.70, 95% CI: 1.04-2.76). There were no differences in 30-day and 1-year VARC-2 efficacy and 30-day VARC-2 safety outcomes. CONCLUSION: CKD is associated with substantial and independent risk for mortality and morbidity at 1-year follow-up in women undergoing TAVR.

The importance of the Heart Team evaluation before transcatheter aortic valve replacement: Results from the BRAVO-3 trial.

BACKGROUND/OBJECTIVES: Clinicians use validated scores to risk-stratify patients undergoing transcatheter aortic valve replacement (TAVR). However, evaluation by the Heart Team often deems patients to be at higher risk than their formal scores suggest. We sought to assess clinical outcomes of TAVR patients defined as high-risk by the Heart Team's assessment versus the patient's logistic EuroSCORE (LES). METHODS: The BRAVO-3 trial randomized patients at high risk (LES ≥ 18, or deemed inoperable by the Heart Team) to TAVR with periprocedural anticoagulation with unfractionated heparin versus bivalirudin. Endpoints included net adverse cardiac events (NACE: the composite of all-cause mortality, MI, stroke, or bleeding), major adverse cardiovascular events (MACE: death, MI, or stroke), the individual components of MACE, major vascular complications, BARC ≥ 3b bleeding and VARC life-threatening bleeding at 30 days. We compared patients deemed high-risk based on LES ≥ 18 versus high-risk by the Heart Team despite lower LES. RESULTS: A total of 467/800 (58.4%) patients were deemed high-risk by the Heart Team despite LES < 18. After multivariable analysis, there were no differences in the odds of endpoints between groups (NACE, ORLES≥18 : 1.32, 95% CI 0.86-2.02, p = .21; MACE, ORLES≥18 : 1.27, 95% CI 0.72-2.25, p = .41; major vascular complications, ORLES≥18 : 0.97, 95% CI 0.65-1.44, p = .88; BARC ≥3b, ORLES≥18 : 1.38, 95% CI 0.82-2.33, p = .23; and VARC life-threatening bleeding, ORLES≥18 : 0.99, 95% CI 0.69-1.41, p = .95). CONCLUSION: Patients undergoing TAVR and labeled high-risk by LES ≥ 18 or Heart Team assessment despite LES < 18 have comparable short-term outcomes. Assignment of high-risk status to over 50% of patients is attributable to Heart Team's clinical assessment.