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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.

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.

OBJECTIVE: To investigate the use of prasugrel after percutaneous coronary intervention (PCI) in African American (AA) patients presenting with acute coronary syndrome (ACS). BACKGROUND: AA patients are at higher risk for adverse cardiovascular outcomes after PCI and may derive greater benefit from the use of potent antiplatelet therapy. METHODS: Using the multicenter PROMETHEUS observational registry of ACS patients treated with PCI, we grouped patients by self-reported AA or other races. Clinical outcomes at 90-day and 1-year included non-fatal myocardial infarction (MI), major adverse cardiac events (composite of death, MI, stroke, or unplanned revascularization) and major bleeding. RESULTS: The study population included 2,125 (11%) AA and 17,707 (89%) non-AA patients. AA patients were younger, more often female (46% vs. 30%) with a higher prevalence of diabetes mellitus, chronic kidney disease, and prior coronary intervention than non-AA patients. Although AA patients more often presented with troponin (+) ACS, prasugrel use was much less common in AA vs. non-AA (11.9% vs. 21.4%, respectively, P = 0.001). In addition, the use of prasugrel increased with the severity of presentation in non-AA but not in AA patients. Multivariable logistic regression showed AA race was an independent predictor of reduced use of prasugrel (0.42 [0.37-0.49], P

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 (adjHR 0.95, 95% CI 0.60–1.52, p = 0.84 and adjHR 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.

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

OBJECTIVES To determine the prognostic impact of anemia in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR). BACKGROUND Whether the periprocedural use of bivalirudin as compared with UFH in anemic patients undergoing TAVR has an impact on outcomes remains unknown. METHODS The BRAVO-3 trial compared the use of bivalirudin versus UFH in 802 high risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence (defined as hemoglobin levels

BACKGROUND High-sensitivity C-reactive protein (hsCRP) predicts outcomes after percutaneous coronary intervention (PCI). OBJECTIVE We studied the prevalence and prognostic impact of hsCRP elevation according to age in men and women undergoing PCI. METHODS We included patients undergoing PCI at our center from 2010 until 2017, excluding those with myocardial infarction (MI) on presentation, neoplastic disease and hsCRP >10 mg/L at baseline. Elevated hsCRP was defined as >3 mg/L. The outcome of interest was major adverse cardiac events (MACE) consisting of all-cause death, MI and target vessel revascularization. The association between hsCRP elevation and outcomes was assessed using adjusted Cox models. RESULTS 10,432 men and 4,345 women were included. Elevation of hsCRP was present in 25.7% of men and 37.0% of women (p

Background: Selection of valve and procedural anticoagulant type may impact bleeding and vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We sought to compare outcomes by valve [balloon expandable (BE) or non-BE] and anticoagulant [bivalirudin vs. unfractionated heparin (UFH)] type from the BRAVO-3 trial. Methods: BRAVO-3 was a randomized multicenter trial included 500 BE-TAVR and 282 non-BE TAVR patients, randomized to bivalirudin vs. UFH. Selection of valve type was at the discretion of the operator and randomization was stratified according to device type. Total follow up was to 30 days. We examined the incidence of Bleeding Academic Research Consortium (BARC) type ≥3b bleeding, major vascular complications and all ischemic outcomes at 30-days. Outcomes were adjusted using logistic regression analysis. Results: Of the trial cohort treated, 63.9% were treated with BE valves (n=251 bivalirudin vs. n=249 UFH) and 36.1% with non-BE valves (n=140 bivalirudin vs. n=142 UFH). Patients treated with non-BE valves were older, with higher euroSCORE I. At 30 days, there were non-significant differences between the two valve types with a trend for higher adjusted risk of all-cause mortality (HR 2.07, 95% CI 0.91-4.70, p = 0.084) and major vascular complications (HR 1.78, 95% CI 0.97-3.26, p = 0.062) with non-BE compared to BE valves. A significant interaction was observed between valve and anticoagulant type, with lower risk of major vascular complications with bivalirudin compared to UFH in non-BE TAVR (p-interaction = 0.039). Conclusions: Majority of patients in the BRAVO 3 trial received BE valves. At 30-days, there were non-significant differences with a tendency for greater death and major vascular complications with non-BE vs. BE valves. A significant interaction was observed between valve type and procedural anticoagulant for lower risk of major vascular complications with bivalirudin versus UFH in non-BE TAVR. This article is protected by copyright. All rights reserved.

Background: Prior studies have suggested that patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR) are at higher risk for adverse cardiovascular events. Whether procedural bivalirudin compared to unfractionated heparin (UFH) has a beneficial effect on early outcomes in these patients is unknown. We examined for the effect of baseline or new-onset AF within 30 days of TAVR and explored for the effect of bivalirudin vs. UFH by AF status, on 30-day outcomes from the BRAVO 3 trial. Methods: The BRAVO-3 trial multicenter randomized trial included 802 patients undergoing transfemoral TAVR randomized to bivalirudin or UFH. We compared AF and no-AF groups and examined for 30-day Bleeding Academic Research Consortium (BARC) type ≥3b bleeding, major vascular complications and all ischemic endpoints. Adjusted outcomes were analyzed using logistic regression methods. Results: Of the study population, 41.4% (n=332) patients had baseline or new-onset AF within 30 days of TAVR, whereas 58.6% (n= 470) had no AF. Patients with AF had greater prevalence of renal dysfunction, lower left ventricular ejection fraction and higher euroSCORE I compared to their counterparts without AF. Among AF and no-AF patients, there were no significant baseline differences between bivalirudin and UFH groups. At 30 days the incidence of death (6.0% vs. 4.5%, p = 0.324) and stroke (3.9% vs. 2.6%, p = 0.274) was similar in AF vs. no-AF patients. However, new-onset AF (n=38) was associated with significantly greater crude risk of 30-day stroke compared to no AF (HR 4.49, 95% CI 1.37-14.67). Regardless of AF status, there were no differences in 30-day death (p-int = 0.652) or stroke (p-int= 0.066) by anticoagulation type. Conclusions: Prior or new-onset AF within 30 days of transfemoral TAVR is noted in more than one-third of patients. Despite greater baseline comorbidities than non-AF patients, AF was not associated with greater risk of adjusted 30-day outcomes. In the BRAVO 3 trial, early outcomes were similar regardless of anticoagulant strategy in each group. This article is protected by copyright. All rights reserved.

Objectives This study sought to investigate the clinical outcomes of patients with and without peripheral artery disease (PAD) in the BRAVO‐3 trial with respect to the effect of bivalirudin versus unfractionated heparin (UFH). Background PAD is found frequently in patients undergoing transcatheter aortic valve replacement (TAVR) and is reported to confer an increased risk of adverse events. It is unknown whether patients with and without PAD may demonstrate a differential response to bivalirudin versus UFH. Methods BRAVO‐3 was a randomized multicenter trial comparing transfemoral TAVR with bivalirudin versus UFH (31 centers, n = 802). Major adverse cardiovascular events (MACE) were a composite of 30‐day death, myocardial infarction, or cerebrovascular accidents (CVA). Net adverse cardiovascular events (NACE) were a composite of major bleeding or MACE. Results The total cohort included 119 patients with PAD. Vascular complications occurred significantly more frequently in patients with PAD both in‐hospital (25.2 vs. 16.7%; OR 1.68) and at 30 days (29.4 vs. 17.3%; OR 1.99). No significant differences were observed regarding mortality, NACE, MACE, major bleeding or CVA with bivalirudin versus UFH among patients with or without PAD. In patients with PAD, bivalirudin was associated with an increased risk of minor vascular complications at 30 days. Conclusions Patients with PAD undergoing transfemoral TAVR did not exhibit an increased risk of any major adverse events, according to the procedural anticoagulant randomization. However, patients treated with Bivalirudin had significantly higher rates of minor vascular complications.

Background Proton pump inhibitors (PPI) may decrease the availability of clopidogrel by competitive antagonism, leading to a potential increase in ischemic events. Methods We evaluated patients from the all-comer PARIS registry treated with dual antiplatelet therapy (DAPT) with aspirin and clopidogrel following coronary stenting for outcomes stratified by PPI use. Two-year major adverse cardiovascular events (MACE), composite of cardiac death, myocardial infarction, definite or probable stent thrombosis or target lesion revascularization (TLR), and net adverse cardiac events (NACE), composite of MACE or Bleeding Academic Research consortium (BARC) type 3 or 5 bleeding were assessed. We also explored associations between PPI use and patterns of 2-year DAPT cessation. Results The cohort comprised 4635 patients (23% PPI users) with mean age 64.4 ±11.4 years. Two year adjusted risk of MACE (HR: 1.27, 95% CI: 1.04–1.55), NACE (HR: 1.21, 95% CI: 1.01–1.44) and TLR (HR: 1.33, 95% CI: 1.04–1.71) were significantly higher in PPI users vs. non-users, without a difference in bleeding. Although the incidence of 2-year DAPT discontinuation and interruption was similar, DAPT disruption was significantly lower among PPI users vs. non-users (10.0% vs. 14.7%, P

Young women undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) experience greater adverse events than men, potentially due to under-treatment. We sought to compare the 1-year outcomes by sex in patients ≤55 years of age from a contemporary PCI cohort. : PROMETHEUS was a retrospective multicenter observational US study comparing outcomes in clopidogrel and prasugrel treated patients following ACS PCI. MACE was defined as a composite of death, myocardial infarction, stroke or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Hazard ratios were generated using multivariable Cox proportional hazards regression. : The study cohort included 4,851 patients of which 1,162 (24.0%) were women and 3,689 (76.0%) were men. In this cohort, the prevalence of diabetes (41.0 vs. 27.9%) and chronic kidney disease (12.7 vs. 7.2%) was higher among women compared with men. Irrespective of sex, prasugrel was used in less than one-third of patients (31.8% in men vs. 28.1% in women, P = 0.01). Unadjusted, 1-year MACE (21.1% vs. 16.2%, P : Women ≤ 55 years of age undergoing ACS PCI have significantly greater comorbidities than young men. Despite a higher risk clinical phenotype in women, prasugrel use was significantly lower in women than men. Female sex was associated with a significantly higher risk of 1-year MACE and bleeding than male sex, findings that are attributable to baseline differences. © 2016 Wiley Periodicals, Inc.

In the drug eluting stent (DES) era, repeat in-stent restenosis (ISR) of the same coronary lesion, despite percutaneous coronary intervention (PCI), is a rare but challenging problem that has not been reported. We aim to describe what we propose as the occurrence of "resistant"-ISR (R-ISR) in the DES era, including angiographic patterns and outcomes. We defined R-ISR as the recurrence of an ISR episode after successful treatment of the same lesion. We identified 276 consecutive patients with 291 lesions who had R-ISR between May 2003 and June 2012. Quantitative coronary angiography (QCA) was performed for the first and second ISR episodes. Outcomes at one year, including death, myocardial infarction (MI), and target lesion failure (TLF), were analyzed. Patients with R-ISR had a high frequency of diabetes (62%), chronic kidney disease (39%), bifurcation lesions (51%), and moderate to severe calcified lesions (52%). The most common pattern of R-ISR was focal (77%). R-ISR lesions were treated with DES implantation (55%) or balloon-only strategy (45%). The mortality rate and TLF at 2-years were 9.3% and 51% respectively. The overall 2-year TLF rate did not vary with the originally implanted stent, angiographic pattern (focal versus diffuse), or revascularization strategy. R-ISR appears to consist predominantly of focal lesions and occurs in patients at high clinical and angiographic risk, conceivably owing to their unique diabetic and coronary calcification profile. Clinical outcomes are suboptimal irrespective of angiographic pattern or treatment strategy, indicating the recalcitrant nature of the disease, and need for aggressive treatment of cardiovascular risk factors and novel interventional approaches. In the drug eluting stent (DES) era, repeat in-stent restenosis (ISR) of the same lesion, despite percutaneous coronary intervention, is a rare and challenging problem. We described the "resistant"-ISR (R-ISR) phenomena in the DES era, i.e. the recurrence of an ISR after a successful treatment of that same episode. We identified 276 consecutive patients with R-ISR, who presented with a high clinical and angiographic risk, conceivably owing to their unique diabetic and coronary calcification profile. The most common pattern of R-ISR was focal. The overall 2-year TLF rate exceeded 50% and did not vary significantly with the original stent implanted, angiographic pattern, or type of percutaneous revascularization. © 2016 Wiley Periodicals, Inc.

Background Randomized clinical trials evaluating the role of thrombus aspiration (TA) in patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) have yielded contrasting results. Therefore, the efficacy and safety of TA in STEMI is unclear. Objective We sought to evaluate the efficacy and safety of TA during PPCI for STEMI compared with conventional PPCI alone. Methods We included study-level data from 25 randomized, controlled trials, involving 21,733 patients with STEMI and PPCI. The primary efficacy endpoint was major adverse cardiac events (MACE) according to study definitions; the primary safety endpoint was stroke. Results The mean weighted follow-up time across studies was 8.2 months. Compared with conventional PPCI, TA was associated with significant lower risk for MACE [relative risk (RR): 0.91; 95% confidence interval (CI): 0.83–1.00; P = 0.042). However, this benefit in MACE was counterbalanced by a significant increase in the risk for stroke (RR: 1.58; 95% CI: 1.11–2.25; P = 0.011). There were no differences in the risk of myocardial infarction (RR: 0.94; 95% CI: 0.78–1.12; P = 0.486), target vessel revascularization (RR: 0.93; 95% CI: 0.82–1.04; P = 0.2), and definite or probable stent thrombosis (RR: 0.84; 95% CI: 0.66–1.07; P = 0.148). TA was associated with an ostensible lower risk for all-cause mortality, which did not reach statistical significance (RR: 0.88; 95% CI: 0.78–1.00; P = 0.059). Conclusions Compared with conventional PPCI for STEMI, adjunctive TA reduces the risk of subsequent MACE. However, the benefit in MACE is counterbalanced by an increased risk in stroke. Considering the above potential risks and benefits, TA should be considered in selected patients lesions rather than routinely. © 2015 Wiley Periodicals, Inc.

Objectives To compare the discriminatory value of differing risk scores for predicting clinical outcomes following PCI in routine practice. Background Various risk scores predict outcomes after PCI. However, these scores consider markedly different factors, from purely anatomical (SYNTAX risk score [SRS]) to purely clinical (ACEF, modified ACEF [ACEFmod], NCDR), while other scores combine both elements (Clinical SYNTAX score [CSS], NY State Risk Score [NYSRS]). Methods Patients with triple vessel and/or LM disease with 12 month follow-up were studied from a single center PCI registry. Exclusion criteria included STEMI presentation, prior revascularization and shock. Clinical events at 12 months were compared to baseline risk scores, according to score tertiles and area under receiver-operating-characteristic curves (AUC). Results We identified 584 eligible patients (69.8±12.3yrs, 405 males). All scores were predictive of mortality, with the SRS being least predictive (AUC=0.66). The most accurate scores for mortality were the CSS and ACEF (AUC=0.76 for both: P = 0.019 and 0.08 vs. SRS, respectively). For TLR, while the SRS trended toward being positively predictive (P = 0.075), several scores trended towards a negative association, which reached significance for the NCDR (P = 0.045). The SRS and CSS were the only scores predictive of MI (both P

Objective To determine the impact of suture-mediated vascular closure devices (VCDs) on net adverse clinical events (NACEs) after balloon aortic valvuloplasty (BAV). Background Ischemic and bleeding complications are common following transfemoral BAV; however, previous studies have been single center and limited by varying definitions of major bleeding. Methods The Effect of Bivalirudin on Aortic Valve Intervention Outcomes (BRAVOs) study was a retrospective observational study conducted at two high-volume academic centers over a 6-year period designed to compare the effect of bivalirudin versus unfractionated heparin. This is a subanalysis of 428 consecutive patients who underwent BAV (with 10–13 French sheaths) to compare the effect of hemostasis with VCDs versus manual compression utilizing standardized definitions. NACE was defined as the composite of major bleeding and major adverse clinical events (MACEs). All events were adjudicated by an independent clinical events committee who were blinded to antithrombin use. Results Preclosure was performed in 269 (62.8%) of patients. While bivalirudin was used more frequently in those with pre-closure (60.6% vs. 37.7%, P