Outcome comparison of African-American and Caucasian patients with severe aortic stenosis subjected to transcatheter aortic valve replacement: a single-center experience.

OBJECTIVE: This study aimed to report the outcomes of African Americans (AAs) in the US undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). BACKGROUND: Compared to Caucasians, AAs are reported to have poorer outcomes from most cardiovascular diseases, including high complication rates after surgical aortic valve replacement. The outcomes of AAs undergoing TAVR are not well established. METHODS: Consecutive patients who underwent TAVR were included in this analysis. Patients' baseline characteristics, procedural data, in-hospital- and long-term outcomes were recorded and a comparison was performed between the AA and Caucasian cohorts. RESULTS: In a cohort of 469 consecutive patients, 51 (10.8%) were AA and 345 (74.5%) were Caucasian. The remaining patients (n = 73; 15.3%) self-reported their race as "unknown" or were from other races. Most baseline characteristics were similar between the two groups except for less men (33.3 vs. 50.1%; P = 0.016), a lower mean left ventricular ejection fraction (48.85 ± 16.35 vs. 53.24 ± 13.41%; P = 0.04) and lower rates of atrial fibrillation in AAs (15.7 vs.45.4%; P < 0.001). TAVR procedures in AAs were less frequently performed as part of a clinical trial (60.8 vs. 76.8%; P = 0.014). Most procedural and periprocedural outcome parameters were similar save for a higher rate of hemodynamic instability and postoperative need for intubation in AAs (10.4 vs. 2.5%; P = 0.018 and 29.4 vs. 16.9%; P = 0.03, respectively). This did not translate into a difference in mortality between AAs and Caucasians (30-day mortality 9.8 vs. 9.9%; P = 0.99; 1-year mortality 19.6 vs. 24.3%; P = 0.458, respectively). CONCLUSION: Unlike with other cardiovascular interventions, this study demonstrates that AA patients referred for TAVR shared similar risks and outcomes when compared to a Caucasian population.

Acquired thrombocytopenia after transcatheter aortic valve replacement: clinical correlates and association with outcomes.

AIMS: This study aimed to evaluate incidence and correlates for low platelet count after transcatheter aortic valve replacement (TAVR) and to determine a possible association between acquired thrombocytopenia and clinical outcomes. METHODS AND RESULTS: Patients undergoing TAVR from two medical centres were included in the study. They were stratified according to nadir platelet count post procedure: no/mild thrombocytopenia, ≥100 × 10(9)/L; moderate, 50-99 × 10(9)/L; and severe, <50 × 10(9)/L. A total of 488 patients composed of the study population (age 84.7 ± 7.5 years). At a median time of 2 days after TAVR, 176 patients (36.1%) developed significant thrombocytopenia: 149 (30.5%) moderate; 27 patients (5.5%) severe. Upon discharge, the vast majority of patients (90.2%) had no/mild thrombocytopenia. Nadir platelet count <50 × 10(9)/L was highly specific (96.3%), and a count <150 × 10(9)/L highly sensitive (91.2%), for predicting 30-day death (C-statistic 0.76). Patients with severe acquired thrombocytopenia had a significantly higher mortality rate at 1 year (66.7% for severe vs. 16.0% for no/mild vs. 20.1% for moderate; P < 0.001). In multivariate logistic regression, severe thrombocytopenia was independently associated with 1-year mortality (hazard ratio 3.44, CI: 1.02-11.6; P = 0.046). CONCLUSIONS: Acquired thrombocytopenia was common after TAVR and was mostly resolved at patient discharge. The severity of thrombocytopenia after TAVR could be used as an excellent, easily obtainable, marker for worse short- and long-term outcomes after the procedure.

Incidence and correlates of major bleeding after percutaneous coronary intervention across different clinical presentations.

BACKGROUND: Bleeding after percutaneous coronary intervention (PCI) is identified as a strong predictor for adverse events, including mortality. This study aims to compare the incidence and correlates of post-PCI bleeding across different clinical presentations. METHODS: The study included 23,943 consecutive PCI patients categorized according to their clinical presentation: stable angina pectoris (n = 6,741), unstable angina pectoris (UAP) (n = 5,215), non-ST-segment elevation myocardial infarction (NSTEMI) (n = 8,418), ST-segment elevation myocardial infarction (STEMI) (n = 2,721), and cardiogenic shock (CGS) (n = 848). RESULTS: Severity of clinical presentation was associated with a greater use of preprocedural anticoagulation, glycoprotein IIb/IIIa inhibitors, and intraaortic balloon pump (IABP). TIMI-defined major bleeding increased with increasing severity of clinical presentation: stable angina pectoris, 0.7%; UAP, 1.0%; NSTEMI, 1.6%; STEMI, 4.6%; and CGS, 13.5% (P < .001). On multivariable analysis, CGS (odds ratio [OR], 4.67; 95% CI [2.62-8.34]), STEMI (OR, 3.39; 95% CI [2.07-5.55]), and NSTEMI (OR, 2.00; 95% CI [1.29-3.10]) remained correlated with major bleeding even after adjusting for baseline and procedural differences, whereas UAP did not. The multivariable model also identified the use of IABP, female gender, congestive heart failure, no prior PCI, increased baseline hematocrit, and increased procedure time as correlates for major bleeding. CONCLUSIONS: In patients undergoing PCI, the worsening severity of clinical presentation corresponds to an increase in incidence of post-PCI major bleeding. The increased risk with CGS, STEMI, and NSTEMI persisted despite adjusting for more aggressive pharmacotherapy and use of IABP. Careful attention to antithrombotic pharmacotherapy is warranted in this high-risk population.

Does baseline hematocrit influence the assays of on-treatment platelet reactivity to clopidogrel?

BACKGROUND: High on-treatment platelet reactivity (HTPR) has been shown to be associated with adverse cardiac events in patients undergoing percutaneous coronary intervention, but the effect of baseline hematologic parameters upon platelet reactivity remains controversial. OBJECTIVE: The present study aims to evaluate the impact of hematocrit on 2 different assay methods used to assess on-treatment platelet reactivity to clopidogrel. METHODS: We tested clopidogrel on-treatment platelet reactivity in 466 consecutive patients using VerifyNow P2Y12 (VN) and light transmission aggregometry (LTA) with adenosine diphosphate (ADP) 5 and 20 µM assays 6 to 24 hours after percutaneous coronary intervention. Patients were categorized into 4 groups according to baseline hematocrit. One-year major adverse cardiac events, including death, nonfatal myocardial infarction, and definite stent thrombosis, were collected. RESULTS: Lower hematocrit was associated with higher P2Y12 reaction unit (PRU) and a higher rate of HTPR (P < .001) as measured by VN assay. No differences were seen among the 4 groups in platelet reactivity measured by LTA using ADP 5 µM (P = .23) and ADP 20 µM (P = .21). In a multivariable logistic regression model, baseline hematocrit was independently associated with PRU ≥208 (odds ratio [OR] 0.92, 95% CI 0.86-0.97, P = .005) but had no correlation with LTA ADP 5 µM ≥46% (OR 1.0, 95% CI 0.95-1.06, P = .88) or LTA ADP 20 µM ≥59% (OR 1.03, 95% CI 0.97-1.09, P = .39). In a logistic regression model, the addition of VN assay results, hematocrit, and interaction between the hematocrit and assay results had shown a significant influence on the area under curve for prediction of 1-year major adverse cardiac events compared with baseline clinical variables only for PRU (0.63 vs 0.76, P = .006) but not with LTA (0.64 vs 0.74, P = .13). CONCLUSION: Baseline hematocrit has a differential influence on results of the ex vivo platelet functional assays. Lower baseline hematocrit was independently associated with HTPR by VN but not LTA. This may affect the interpretation of platelet function testing in patients with significant anemia.

Long-term safety and efficacy of second-generation everolimus-eluting stents compared to other limus-eluting stents and bare metal stents in patients with acute coronary syndrome.

OBJECTIVES: This study aimed to investigate the long-term safety and efficacy of everolimus-eluting stents (EES) compared with other limus-eluting stents and bare metal stents (BMS) in ACS patients. BACKGROUND: There have been concerns about the long-term safety of drug-eluting stents in the setting of acute coronary syndrome. METHODS: The study cohort included 1,612 patients presenting with acute coronary syndrome who underwent BMS, SES, E-ZES, or EES implantation. End points included probable or definite stent thrombosis and major adverse cardiovascular events (MACE), defined as a composite of all-cause death, Q-wave myocardial infarction, and target lesion revascularization up to 3 years. RESULTS: The overall MACE rates were significantly higher for both BMS and SES, but not E-ZES, when compared with EES (EES vs. BMS: HR 2.68, 95% CI 1.91-3.78, P <0.001; EES vs. SES: HR 1.75, 95% CI 1.24-2.47, P = 0.001 and EES vs. E-ZES: HR 1.08, 95% CI 0.65-1.77, P = 0.72). Stent thrombosis rates were similar for EES, E-ZES, and BMS but higher for SES throughout the 3-year follow-up (EES vs. BMS: HR 1.02, 95% CI: 0.31-3.35, P = 0.973; EES vs. SES: HR 4.90, 95% CI: 1.75-13.69, P = 0.002 and EES vs. E-ZES: HR 1.63, 95% CI 0.37-7.31, P = 0.449). CONCLUSIONS: There was an improvement in the long-term outcome for MACE with EES when compared to earlier-generation stents, but this was comparable with the 2nd-generation E-ZES. There was no additional risk of early or late stent thrombosis in EES when compared with BMS.

Intravascular ultrasound analysis to determine the relationship between high-density lipoprotein cholesterol and lesion characteristics in patients with coronary artery disease.

OBJECTIVES: This study utilized grayscale intravascular ultrasound (IVUS) to explore the relationship between high-density lipoprotein cholesterol (HDL-C) levels and culprit lesion characteristics in patients with coronary artery disease. BACKGROUND: Low HDL-C is associated with an increased risk of cardiovascular events. Previous IVUS studies have suggested a significant association between lesion characteristics and cardiovascular events. METHODS: According to HDL-C levels, 120 patients who underwent IVUS for native, de novo coronary lesions before any intervention were divided into a low HDL-C group (<40 mg/dL, n = 60) and a high HDL-C group (≥40 mg/dL, n = 60). Quantitative and qualitative IVUS analyses were performed to compare lesion characteristics. RESULTS: Quantitative IVUS measurements showed no significant differences between the 2 groups. HDL-C level was not significantly correlated with remodeling index (r = 0.03, P = 0.78). However, attenuated plaque was more frequent in the low HDL-C group (48.3% vs. 28.3%, P = 0.02) and a greater percentage of attenuated plaque was found in this group (32.5 ± 21.3% vs. 21.0 ± 11.0%, P = 0.02). Moreover, when categorized into 4 groups according to HDL-C levels, the proportion of attenuated plaque (64.7% in group with <30 mg/dL, 41.9% in group with 30-39 mg/dL, 36.4% in group with 40-59 mg/dL, and 6.3% in group with ≥60 mg/dL; P = 0.001 for trend) was significantly different among groups. On multivariate analysis, only HDL-C and male gender were independently associated with the presence of attenuated plaque at the culprit lesions. CONCLUSIONS: Patients with low levels of HDL-C may be at increased risk of having a higher incidence of attenuated plaques.

The impact of diabetes mellitus on long-term clinical outcomes after percutaneous coronary saphenous vein graft interventions in the drug-eluting stent era.

OBJECTIVES: We aimed to compare early and late clinical outcomes in diabetic and nondiabetic patients who underwent saphenous vein graft (SVG) percutaneous coronary interventions (PCI) with the use of drug-eluting stents (DES). BACKGROUND: Patients with diabetes mellitus are shown to have less favorable outcomes after SVG intervention with the use of bare metal stents. In the DES era, the impact of diabetes mellitus on restenosis and clinical outcomes post-SVG intervention is not clearly defined. METHODS: From our institutional PCI registry database, we retrospectively analyzed 477 consecutive patients with prior coronary artery bypass graft surgery undergoing SVG PCI with the implantation of DES stratified by the presence or absence of diabetes mellitus. The primary end-point was 1-year major adverse cardiac event (MACE) rate, defined as death, Q wave myocardial infarction, and target lesion revascularization. RESULTS: Baseline clinical characteristics, including mean graft age (120 ± 77 vs. 131 ± 86 months, P = 0.14), were similar between groups, save for a higher prevalence of systemic hypertension and chronic renal insufficiency, and higher body mass index in the diabetic group. Among the 604 SVG lesions treated with DES, the angiographic and procedural characteristics were well matched between groups except for the higher rate of distal protection device use (32% vs. 29%, P = 0.007) in the diabetic group. The rates of 1-year MACE (21% vs. 15%, P = 0.12) and all-cause mortality (7.6% vs. 6.7%, P = 0.86) were similar between groups. After adjustment for the relevant clinical co-variables, diabetic status was not associated with the composite end-point. CONCLUSION: In conclusion, DES, when used for the treatment of vein graft lesions, equate the short- and long-term outcomes between diabetic and nondiabetic patients, suggesting that DES should be considered the default stent in diabetic populations undergoing PCI for the treatment of SVG lesions.

Racial disparity with on-treatment platelet reactivity in patients undergoing percutaneous coronary intervention.

BACKGROUND: On-treatment platelet reactivity to clopidogrel is variable and in part genetic dependent. In African American (AA) patients, the relation between on-treatment platelet reactivity to clopidogrel and the factors that influence this interaction is unknown. The present study aims to evaluate on-treatment platelet reactivity to clopidogrel in AA patients and its interaction to race and CYP2C19*2 loss of function mutation. METHODS: The study cohort included 289 consecutive patients presenting for percutaneous coronary intervention who were entered into a prospective observational registry. High on-treatment platelet reactivity (HTPR) was defined as P2Y12 reaction units (PRU) ≥208 with VerifyNow P2Y12 assay and >50% by vasodilator-stimulated phosphoprotein phosphorylation assay platelet reactivity index (VASP PRI) measured 6 to 24 hours postprocedure. CYP2C19*2 (rs4244285) genotype was analyzed by real-time polymerase chain reaction. RESULTS: The prevalence of HTPR by both PRU (56% vs 35%, P = .003) and VASP PRI (67% vs 45%, P = .002) is more common in AAs compared with whites, respectively. African American patients had higher on-treatment mean PRU (207 ± 110 vs 160 ± 102, P = .002) and VASP PRI (49 ± 26 vs 38 ± 26, P = .004). African Americans also had a higher prevalence of CYP2C19*2 allele carrier status compared with whites (43% vs 29%, P = .04). African American race (P = .008) and CYP2C19*2 allele status (P = .02) independently had significant effects on PRU and VASP. Multivariable logistic regression analysis has shown that both CYP2C19*2 allele carrier status and AA race were independent correlates of HTPR for PRU ≥208. CONCLUSIONS: African American patients undergoing percutaneous coronary intervention not only have a higher prevalence of HTPR to clopidogrel but also have higher CYP2C19*2 allele carrier status compared with whites. Careful selection of antiplatelet agents should be considered in an AA population at higher risk for ischemic complications.

Second-generation everolimus-eluting stents compared to first-generation drug-eluting stents in patients treated for multivessel disease.

OBJECTIVE: This study aimed to compare the safety and efficacy of everolimus-eluting stents (EES) to first-generation drug-eluting stents (DES) in multivessel disease (MVD). BACKGROUND: Second-generation EES have demonstrated superiority over first-generation DES for single-vessel disease, although the merits of EES in MVD are less established. METHODS: A cohort of 1,285 patients (3,124 lesions) with ≥ 2 diseased vessels were treated with either first-generation DES (n = 1,002) or EES (n = 283). The rates of death, myocardial infarction, target lesion revascularization, target vessel revascularization, definite stent thrombosis, and major adverse cardiac events (MACE), defined as the combined incidence of target vessel revascularization, death, and non-fatal myocardial infarction, were compared at 1 year. RESULTS: Baseline characteristics were similar except for a lower left ventricular ejection fraction and a lower incidence of stable angina pectoris in the first-generation DES group (P = 0.001 and 0.013, respectively). At 1 year, the MACE rate was lower in the EES group (9.5P% vs. 15.7%; P = 0.01). Multivariable analysis demonstrated that EES use predicted a higher chance of freedom from MACE at 1 year (hazard ratio 0.58 [0.38-0.87]; P = 0.009; 95% confidence interval). CONCLUSIONS: The use of EES in patients with MVD is safe with signals for improved effectiveness compared to first-generation DES. Randomized trials comparing new-generation DES to coronary artery bypass grafting surgery are warranted.

Review: Stent fracture in the drug-eluting stent era.

Stent fracture has been recognized as one cause of stent failure and has been associated with in-stent restenosis and stent thrombosis, even in 2nd-generation drug-eluting stents. Given the wide use of drug-eluting stents and paucity of contemporary data available concerning stent fracture, we reviewed clinical studies and the Food and Drug Administration's Manufacturer and User Device Experience (MAUDE) database to analyze the current trends, mechanisms, predictors, outcomes and treatment for stent fracture.

Overview of the Food and Drug Administration circulatory system devices panel meetings on WATCHMAN left atrial appendage closure therapy.

The WATCHMAN left atrial appendage closure (LAAC) technology is a percutaneously delivered permanent cardiac implant placed in the LAA. This device is designed to reduce the risk of stroke and systemic embolism in warfarin-eligible patients with nonvalvular atrial fibrillation. The first circulatory system device panel reviewed the Embolic Protection in Patients With Atrial Fibrillation (PROTECT AF) study in 2009, and a "not approvable" letter was issued by the US Food and Drug Administration (FDA) based on safety concerns. Subsequently, the FDA, collaboratively with the sponsor, designed a new Prospective Randomized Evaluation of the WATCHMAN LAAC Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy (PREVAIL) trial to address the earlier study limitations. A second panel was convened in December 2013 to review the results of PREVAIL and additional long-term follow-up data from PROTECT AF. The second panel voted favorably 13 to 1 that the benefits of the WATCHMAN LAAC therapy do outweigh the risks for use in patients who meet the criteria specified in the proposed indication. Subsequently, and during the premarket approval review, updated data from the PREVIAL study revealed more ischemic strokes in the WATCHMAN group, corresponding to a total of 13 ischemic strokes in the WATCHMAN group versus 1 in the control group. As a result of these strokes, the FDA called for a third panel to assess the benefit-risk profile of the WATCHMAN device. This summary aims to describe the discussions and recommendations made during the panel meetings.

Clinical outcomes of first- and second-generation drug-eluting stents in patients undergoing rotational atherectomy for heavily calcified coronary lesions.

BACKGROUND: There is paucity of data regarding the clinical outcome of second generation drug- eluting stents (DES) post rotational atherectomy (RA) for heavily calcified coronary lesions (HCCL). METHODOLOGY: The study cohort comprised 99 (116 lesions) consecutive patients who underwent RA for HCCL at our institution and received either a first generation DES (40 patients, 53 lesions) or a second generation DES (59 patients, 63 lesions). The analyzed clinical parameters were the 12-month rates of death (all cause and cardiac), Q-wave MI, target lesion revascularization (TLR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, Q-wave MI, or TLR. RESULTS: The two groups were well matched for their baseline characteristics except for a lower left ventricular ejection fraction in the second generation DES group (46.0±23.0% vs. 55.0±9.0%; p=0.02). The group receiving second generation DES had more type C lesions (81.0% vs. 58.8%; p=0.01), shorter stent length (19.9±6.1 mm vs. 22.7±7.3 mm; p=0.04) and was more likely to undergo stent postdilatation (52.4% vs. 23.1%; p=0.001). The 1-year analyzed clinical parameters were similar in the two groups: all cause death (8.5% vs. 10.3%; p=1.0), cardiac death (8.5% vs. 2.5%; p=0.40), Q-wave MI (0% vs. 0%), TLR (3.6% vs. 2.7%; p=1.0), ST (0% vs. 0%), and MACE (11.9% vs. 12.8%; p=1.0). The 1-year MACE-free survival rate was also similar in the two cohorts. CONCLUSION: The use of second generation DES, following RA for HCCL, is associated with similar short and long-term clinical outcomes to first generation DES.

Stent thrombosis is not increased following percutaneous coronary intervention in patients with non-insulin dependent diabetes mellitus taking metformin.

OBJECTIVE: Recent studies have suggested that metformin may inhibit endothelialization following limus-eluting stent (LES) placement and may increase the risk of stent thrombosis. Therefore, we assessed the impact of metformin on stent thrombosis and major adverse cardiovascular events (MACE) in non-insulin-dependent diabetes mellitus (NIDDM) patients who receive drug-eluting stents (DES). METHODS: We assessed the impact of metformin and stent type on stent thrombosis, MACE, and death in NIDDM patients following DES placement. Of the 1201 patients included, 74.8% received LES, 25.2% received paclitaxel-eluting stents (PES), and 55% were taking metformin. RESULTS: There was no difference in stent thrombosis, regardless of stent type or metformin use. While Kaplan-Meier curves demonstrated reduced MACE (p = 0.007) and death (p = 0.006) with metformin use, multivariate analysis demonstrated that stent type and metformin use were not associated with outcome. CONCLUSION: In NIDDM patients, metformin use or stent type following DES placement did not increase stent thrombosis and MACE rates.

Comparison of outcomes after percutaneous coronary intervention among different coronary subsets (stable and unstable angina pectoris and ST-segment and non-ST-segment myocardial infarction).

Percutaneous coronary intervention in the setting of acute myocardial infarction is known to predict stent thrombosis (ST). This study aims to compare the ST rates across different coronary subsets. This was an observational cohort study from a large, single-center registry. Included were 12,198 consecutive patients who underwent percutaneous coronary intervention with stenting. Patients were categorized according to their clinical presentation: stable angina pectoris (SAP, n = 3,700), unstable angina pectoris (UAP, n = 2,845), non-ST-segment elevation myocardial infarction (NSTEMI, n = 4,083), and ST-segment elevation myocardial infarction (STEMI, n = 1,570). The study end points were ST rates at 1 year. Patients with STEMI were younger with a lower prevalence of cardiovascular risk factors, except for smoking. More type C lesions were treated in STEMI, whereas drug-eluting stents were used less frequently in patients with STEMI compared with the other groups. Definite ST at 1 year was highest in patients with STEMI (1.4%; vs SAP, 0.4%; UAP, 0.5%; NSTEMI, 0.5%; p <0.001). One-year definite/probable ST rates were SAP, 0.8%; UAP, 1.1%; NSTEMI, 1.4%; and STEMI, 3.2% (p <0.001). On multivariable analysis, STEMI independently predicts definite ST (hazards ratio [HR] 3.07, 95% confidence interval [CI] 1.32 to 7.10), whereas both STEMI (HR 3.36, 95% CI 1.84 to 6.12) and NSTEMI (HR 2.04, 95% CI 1.20 to 3.07) were independent predictors of definite/probable ST. Clopidogrel cessation was the strongest predictor of ST (definite ST, HR 17.00, 95% CI 7.54 to 38.31; definite/probable ST, HR 4.69, 95% CI 2.39 to 9.20). In conclusion, in patients who underwent percutaneous coronary intervention, the acuity of clinical presentation corresponds to an increase in ST incidence. Adherence to clopidogrel is critical to prevent ST in patients who underwent percutaneous coronary intervention, especially in STEMI.

Impact of early versus late clopidogrel discontinuation on stent thrombosis following percutaneous coronary intervention with first- and second-generation drug-eluting stents.

Premature antiplatelet therapy discontinuation (ATD) after drug-eluting stent (DES) implantation is known to predict stent thrombosis (ST). However, recent data suggest that a shorter antiplatelet therapy duration is safe with newer generation DESs. The study aimed to compare the impact of early and late clopidogrel ATDs on ST in a real-world registry of first- and second-generation DES use. A total of 6,236 patients who underwent DES implantation were analyzed retrospectively: 4,217 received first-generation DESs (sirolimus- and paclitaxel-eluting stents) and 2,019 received second-generation DESs (everolimus-eluting stents). Within each DES cohort, patients were categorized into timing of clopidogrel discontinuation within 1 year: early (<3 months), late (3 to 12 months), and continued. ST rates and clinical outcomes at 1 year were analyzed. There were 341 patients (8.1%) in the first-generation DES group and 126 patients (6.2%) in the second-generation DES group who discontinued clopidogrel within the first year. Definite and probable ST rates were 3.8% for early ATD, 2.5% for late ATD, and 0.5% for continued (p = 0.001) in the first-generation DES cohort, whereas there were no definite or probable ST events in early and late ATDs and 0.5% for continued in the second-generation DES cohort. Major adverse cardiac event rates were 9.9% for early ATD, 5.6% for late ATD, and 0.9% for continued (p <0.001) in the first-generation DES cohort and 5.5% for early ATD, 7.4% for late ATD, and 1.5% for continued (p <0.001) in the second-generation DES cohort. In conclusion, ATD within the first year is associated with increased ST events with first-generation DESs, whereas ATD appears safe with second-generation DESs with regard to ST. However, ATD is associated with greater mortality and major adverse cardiac events in both first- and second-generation DESs. Thus, this study supports ATD if required based on physician discretion with the use of second-generation DESs but cannot rule out potential benefit for longer duration of dual antiplatelet therapy even when second-generation DESs are used.

Transfer distance effect on reperfusion: timeline of ST-elevation patients transferred for primary percutaneous coronary intervention.

OBJECTIVES: This study aims to establish if transfer distance impacts the outcome of ST-elevation myocardial infarction (STEMI) patients transferred to a percutaneous coronary intervention (PCI). BACKGROUND: Regional emergency care systems were designed to decrease delays in reperfusion of patients but the effect of transfer distance on outcome is less established. METHODS: We compare the characteristics and outcomes of STEMI patients transferred from a distance >25 miles (GT25) to those transferred from distances ≤25 miles (LT25) by utilizing data from a regional STEMI care network in the greater Washington DC area. RESULTS: Within the transferred patients (n=1065), 609 patients (57%) were transferred from GT25 (median distance 36 miles), while 456 (43%) were transferred from LT25 (median distance 13 miles). Most of the baseline characteristics between the groups were similar. Door-to-balloon (DTB) was defined as the time elapsed from the presentation to the center without PCI capability to flow restoration in the culprit artery. No differences were noted in the median DTB (GT25: 158min [122-213] vs. 149 [118-219]; p=0.5) or in in-hospital mortality (8% vs. 7.2%; p=0.617). By implementing the regional STEMI care network, a constant decrease in DTB was noted throughout its years of operation. CONCLUSIONS: For STEMI patients presenting to a non-PCI capable center, a network care system for PCI mitigates the distance factor on DTB time. This is turn translates into comparable outcomes.

Operator learning curve for transradial percutaneous coronary interventions: implications for the initiation of a transradial access program in contemporary US practice.

OBJECTIVES: Our study aimed to assess the characteristics and outcomes of transfemoral approach (TFA) versus the initial steps of a transradial approach (TRA) program and to assess the learning curve of TRA in contemporary, US practice. BACKGROUND: When compared to TFA, TRA has been shown to lower bleeding and vascular complications during percutaneous coronary intervention (PCI). However, use of TRA is still low. There are limited data regarding the characteristics of TRA learning curve, especially in an era with designated TRA equipment. METHODS: Consecutive patients undergoing PCI in a single US center were divided into two cohorts according to vascular access approach: the last 250 TFA patients prior to the establishment of a TRA program and the initial 239 TRA patients following the establishment of a TRA program. Subgroup analysis of the TRA group, which was divided into five sequential case groups of 50 cases per group, was performed in order to assess TRA learning curve. RESULTS: Overall, the baseline characteristics of TFA vs. TRA groups were comparable. Fluoroscopy time was significantly longer during TRA procedures (18±11 vs. 15±8min, respectively, p=0.002); however, contrast use was lower during TRA procedures (161±72 vs. 180±63ml, respectively, p=0.002). In-hospital outcomes were similar between the two groups, with low frequencies of mortality, myocardial infarction, and stent thrombosis. Subanalysis of TRA group for learning curve assessment showed no major differences in patient demographics among the five subgroups. In the initial cases, more PCI was performed among non-acute cases (62% in patients 1-50 vs. 8-27% in patients 51-239, p<0.001). Despite these differences, characteristics of the treated vessels were similar between groups. There was no significant change in fluoroscopy time or in the amount of iodinated contrast volume delivered. Similarly, no differences in procedural, in-hospital, and long-term outcomes were documented. CONCLUSIONS: Adopting TRA as a default is feasible for high-volume operators without significant learning curve effects.

Intra-stent tissue evaluation within bare metal and drug-eluting stents > 3 years since implantation in patients with mild to moderate neointimal proliferation using optical coherence tomography and virtual histology intravascular ultrasound.

OBJECTIVE: We aimed to compare neointimal tissue characteristics between bare-metal stents (BMS) and drug-eluting stents (DES) at long-term follow-up using optical coherence tomography (OCT) and virtual histology intravascular ultrasound (VH-IVUS). BACKGROUND: Neoatherosclerosis in neointima has been reported in BMS and in DES. METHODS: Thirty patients with 36 stented lesions [BMS (n=17) or DES (n=19)] >3years after implantation were prospectively enrolled. OCT and VH-IVUS were performed and analyzed independently. Stents with ≥70% diameter stenosis were excluded. RESULTS: The median duration from implantation was 126.0months in the BMS group and 60.0months in the DES group (p <0.001). Lipid-laden intima (58.8% vs. 42.1%, p=0.317), thrombus (17.6% vs. 5.3%, p=0.326), and calcification (35.3% vs. 26.3%, p=0.559) did not show significant differences between BMS and DES. When divided into 3 time periods, the cumulative incidence of lipid-laden neointima from >3years to <9years was similar between BMS and DES (42.9% vs. 42.1%, p=1.000). Furthermore, it continued to gradually increase over time in both groups. OCT-derived thin-cap fibroatheroma (TCFA) was observed in 17.6% of BMS- and 5.3% of DES-treated lesions (p=0.326). No stents had evidence of intimal disruption. The percentage volume of necrotic core (16.1% [9.7, 20.3] vs. 9.7% [7.0, 16.5], p=0.062) and dense calcium (9.5% [3.8, 13.6] vs. 2.7% [0.4, 4.9], p=0.080) in neointima tended to be greater in BMS-treated lesions. Intra-stent VH-TCFA (BMS vs. DES 45.5% vs. 18.2%, p=0.361) did not differ significantly. CONCLUSION: At long-term follow-up beyond 3 years after implantation, the intra-stent neointimal tissue characteristics appeared similar for both BMS and DES.

Commercial versus PARTNER study experience with the transfemoral Edwards SAPIEN valve for inoperable patients with severe aortic stenosis.

In patients with aortic stenosis who cannot have surgery, transcatheter aortic valve replacement using the Edwards SAPIEN valve has been shown to improve survival rate and is approved for commercial use in the United States. This study aims to assess the clinical profile, procedural characteristics, and in-hospital complications in patients treated with a commercial SAPIEN valve outside the clinical trial context. We retrospectively analyzed 69 consecutive patients who underwent transcatheter aortic valve replacement with a commercial SAPIEN valve compared with 55 Placement of AoRTic traNscathetER valves (PARTNER) trial patients from cohort B enrolled in the same institution by the same Heart Team. Compared with the commercial group, patients in the PARTNER cohort B had higher mean Society of Thoracic Surgeons score (10 ± 5 vs 9 ± 4, p = 0.04) and a lower rate of peripheral arterial disease (19% vs 44%, p = 0.004). Most patients in the commercial group had the procedure under conscious sedation (83% vs 66%, p = 0.03). Planned surgical cut down for vascular access was rare in the commercial group (1.4% vs 46%, p <0.001). The overall rates of major vascular complications, life-threatening or major bleeding, and blood transfusions were lower in commercial group (7.2% vs 27%, p = 0.003; 2.9% vs 16%, p = 0.01; and 28% vs 60%, p <0.001, respectively). In-hospital all-cause mortality (5.8% vs 9.1%, p = 0.51) and stroke rates (7.2% vs 14.5%, p = 0.19) were not statistically different between groups. The median length of hospitalization (p <0.001) and postprocedural length of stay (p = 0.01) was shorter in the commercial group. In conclusion, transfemoral commercial use of the Edwards SAPIEN valve for inoperable patients shows similar in-hospital mortality and stroke rates compared with PARTNER cohort B. The refinements in the procedure such as more conscious sedation, experience of the operators, and careful vascular planning in the commercial group led to lesser vascular and bleeding complications and shorter length of stay.

Correlates for mortality in patients presented with acute myocardial infarct complicated by cardiogenic shock.

OBJECTIVE: This study aimed to explore the correlates for mortality in patients treated with both primary percutaneous coronary intervention (PCI) and intra-aortic balloon pump counter-pulsation (IABP). BACKGROUND: Acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) is associated with high mortality rates. METHODS: From a cohort of patients with AMI, treated with both primary PCI and IABP and who met strict definitions for CS to identify correlates associated with mortality, the study compared patients who died in-hospital to those who survived to discharge. RESULTS: A cohort of 93 patients met the inclusion/exclusion criteria. Of them, 66.7% were male, and the average age was 64.96±13.06years. The overall in-hospital mortality rate for this cohort was 33%. The baseline characteristics were balanced save for older average age and left ventricular ejection fraction in those who died (p=0.049 and p=0.014, respectively). Insertion of IABP pre-PCI and cardiac arrest at the catheterization lab were more frequent in those who died (p=0.027 and p=0.008, respectively). The insertion of IABP pre-PCI, cardiac arrest at the cath lab, and lower ejection fraction were correlated with in-hospital mortality (ORs 2.68, 5.93, and 0.02, respectively). CONCLUSIONS: In the era of primary PCI and IABP as standard of care in AMI complicated by CS, patients with low EF, those who necessitate IABP insertion pre-PCI, and those who necessitate cardiopulmonary resuscitation during PCI are at higher risk for in-hospital mortality and should be considered for more robust hemodynamic support devices with an attempt to improve their prognosis.