Impact of intravascular ultrasound and final kissing balloon dilatation on long-term clinical outcome in percutaneous revascularization with 1-stent strategy for left main coronary artery stenosis in drug-eluting stent era.

BACKGROUND: It remains uncertain whether intravascular ultrasound (IVUS) use and final kissing balloon (FKB) dilatation would be standard care of percutaneous coronary intervention (PCI) with a simple 1-stent technique in unprotected left main coronary artery (LMCA) stenosis. This study sought to investigate the impact of IVUS use and FKB dilatation on long-term major adverse cardiac events (MACEs) in PCI with a simple 1-stent technique for unprotected LMCA stenosis. METHODS: Between June 2006 and December 2012, 255 patients who underwent PCI with 1 drug-eluting stent for LMCA stenosis were analyzed. Mean follow-up duration was 1663 ± 946 days. Long-term MACEs were defined as death, nonfatal myocardial infarction (MI) and repeat revascularizations. RESULTS: During the follow-up, 72 (28.2%) MACEs occurred including 38 (14.9%) deaths, 21 (8.2%) nonfatal MIs and 13 (5.1%) revascularizations. The IVUS examination and FKB dilatation were done in 158 (62.0%) and 119 (46.7%), respectively. IVUS use (20.3 versus 41.2%; log-rank P < 0.001), not FKB dilatation (30.3 versus 26.5%; log-rank P = 0.614), significantly reduced MACEs. In multivariate analysis, IVUS use was a negative predictor of MACEs [hazards ratio 0.51; 95% confidence interval (CI) 0.29-0.88; P = 0.017], whereas FKB dilatation (hazard ratio 1.68; 95% CI, 1.01-2.80; P = 0.047) was a positive predictor of MACEs. In bifurcation LMCA stenosis, IVUS use (18.7 versus 48.0%; log-rank P < 0.001) significantly reduced MACEs. In nonbifurcation LMCA stenosis, FKB dilatation showed a trend of increased MACEs (P = 0.076). CONCLUSION: IVUS examination is helpful in reducing clinical events in PCI for LMCA bifurcation lesions, whereas mandatory FKB dilatation after the 1-stent technique might be harmful in nonbifurcation LMCA stenosis.

Longitudinal Assessment of Safety of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices Among Medicare Beneficiaries: The SAFE-PAD Study.

Importance: Paclitaxel-coated peripheral devices have been associated with increased mortality, yet this harm signal has not been replicated outside of meta-analyses of small trials. Objective: To provide a longitudinal assessment of the safety of femoropopliteal endovascular treatment with peripheral drug-coated devices (DCDs) among Medicare beneficiaries. Design, Setting, and Participants: SAFE-PAD (Safety Assessment of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices) was a retrospective cohort study designed with the US Food and Drug Administration to evaluate the noninferiority of mortality between DCDs and non-drug-coated devices (NDCDs) for femoropopliteal revascularization performed in 2978 inpatient and outpatient facilities in the US from April 1, 2015, through December 31, 2018. Evaluation of the primary outcome was assessed through May 31, 2020. Participants were Medicare fee-for-service beneficiaries 66 years and older with 1 or more years of enrollment prior to femoropopliteal revascularization. Prespecified subgroups included low-risk cohorts, procedure location, disease severity, and device type. Inverse probability weighting was used to account for imbalances of observed characteristics. Sensitivity analyses were used to evaluate the potential influence of unmeasured confounding. Exposures: Treatment with DCDs vs NDCDs as determined by claims codes during the index procedure. Main Outcomes and Measures: The primary outcome was all-cause mortality. Secondary outcomes included repeated hospitalization, repeated lower extremity revascularization, and lower extremity amputation. Falsification end points were acute myocardial infarction, congestive heart failure, and pneumonia. Results: Of 168 553 patients, 70 584 (41.9%) were treated with a DCD. The mean (SD) age was 77.0 (7.6) years, 75 744 (44.9%) were female, 136 916 of 167 197 (81.9%) were White individuals, 85 880 of 168 553 (51.0%) had diabetes, 82 554 of 168 553 (49.0%) used tobacco, 78 665 of 168 553 (45.7%) had critical limb ischemia (CLI), and 13 296 of 168 553 (7.9%) had a prior amputation. Median follow-up was 2.72 years (interquartile range, 0.87-3.77; longest, 5.16 years). After weighting, the cumulative incidence of all-cause mortality was 53.8% with DCDs and 55.1% with NDCDs (hazard ratio [HR], 0.95; 95% CI, 0.94-0.97; noninferiority P < .001). Cox regression and instrumental variable analyses were consistent with the primary findings. No harm associated with DCDs was observed among subgroups, including those treated with stents (HR, 0.97; 95% CI, 0.95-1.00) or balloons (HR, 0.94; 95% CI, 0.92-0.96), with or without CLI (CLI: HR, 0.95; 95% CI, 0.93-0.97; non-CLI: HR, 0.97; 95% CI, 0.95-0.99), and those within the lowest quartile of total comorbidities (HR, 0.95; 95% CI, 0.92-0.99). Conclusions and Relevance: In this initial report from the SAFE-PAD cohort study, DCDs were found to be noninferior to NCDCs in respect to mortality through a median follow-up of 2.72 years. This finding remained robust in sensitivity analyses and was consistent across prespecified subgroups.

Early Vascular Healing Following Bioresorbable-Polymer Sirolimus-Eluting Stent Placement Compared to That with Durable-Polymer Everolimus-Eluting Stent.

A recent thinner strut drug-eluting stent might facilitate early strut coverage after its placement. We aimed to investigate early vascular healing responses after the placement of an ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) compared to those with a durable-polymer everolimus-eluting stent (DP-EES) using optical coherence tomography (OCT) imaging.This study included 40 patients with chronic coronary syndrome (CCS) who underwent OCT-guided percutaneous coronary intervention (PCI). Twenty patients each received either BP-SES or DP-EES implantation. OCT was performed immediately after stent placement (baseline) and at 1-month follow-up.At one month, the percentage of uncovered struts reduced significantly in both the BP-SES (80.9 ± 10.3% to 2.9 ± 1.7%; P < 0.001) and DP-EES (81.9 ± 13.0% to 5.7 ± 1.8%; P < 0.001) groups, and the percentage was lower in the BP-SES group than in the DP-EES group (P < 0.001). In the BP-SES group, the percentage of malapposed struts also decreased significantly at 1 month (4.9 ± 3.7% to 2.6 ± 3.0%; P = 0.025), which was comparable to that of the DP-EES group (2.5 ± 2.2%; P = 0.860). The optimal cut-off value of the distance between the strut and vessel surface immediately after the placement to predict resolved malapposed struts was ≤ 160 µm for BP-SES and ≤ 190 µm for DP-EES.Compared to DP-EES, ultrathin-strut BP-SES demonstrated favorable vascular responses at one month, with a lower rate of uncovered struts and a comparable rate of malapposed struts.

Early Vascular Response to Ultrathin Biodegradable Polymer Sirolimus-Eluting Stents for the Treatment of ST-Elevation Myocardial Infarction After Plaque Rupture.

Recent clinical studies suggest that newer-generation drug-eluting stents that combine ultrathin struts and nanocoating (biodegradable polymer sirolimus-eluting stents, BP-SES) could improve long-term clinical outcomes in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). However, the early vascular response to BP-SES in these patients has not been investigated so far.We examined this response in 20 patients with STEMI caused by plaque rupture using frequency-domain optical coherence tomography (OCT) to understand the underlying mechanisms. Plaque rupture was diagnosed by OCT before PCI with BP-SES implantation was performed. OCT was again performed before the final angiography (post-PCI) and after 2 weeks (2W-OCT).BP-SES placement caused protrusion of atherothrombotic material into the stent lumen and incomplete stent apposition in all patients. After 2 weeks, incomplete stent apposition was significantly reduced (% malapposed struts: post-PCI 4.7 ± 3.3%; 2W-OCT 0.9 ± 1.2%; P < 0.0001), and the percentage of uncovered struts also significantly decreased (% uncovered struts: post-PCI; 69.8 ± 18.3%: 2W-OCT; 29.6 ± 11.0%, P < 0.0001). The maximum protrusion area of the atherothrombotic burden was significantly reduced (post-PCI 1.36 ± 0.70 mm2; 2W-OCT 0.98 ± 0.55 mm2; P = 0.004).This study on the early vascular responses following BP-SES implantation showed rapid resolution of atherothrombotic material and progression of strut apposition and coverage. (UMIN000041324).

Comparison of Hospitalization Trends and Outcomes in Acute Myocardial Infarction Patients With Versus Without Opioid Use Disorder.

Discrepancies in medical care are well known to adversely affect patients with opioid abuse disorders (OUD), including management and outcomes of acute myocardial infarction (AMI) in patients with OUD. We used the National Inpatient Sample was queried from January 2006 to September 2015 to identify all patients ≥18 years admitted with a primary diagnosis of AMI (weighted N = 13,030; unweighted N = 2,670) and concomitant OUD. Patients using other nonopiate illicit drugs were excluded. Propensity matching (1:1) yielded 2,253 well-matched pairs in which intergroup comparison of invasive revascularization strategies and cardiac outcomes were performed. The prevalence of OUD patients with AMI over the last decade has doubled, from 163 (2006) to 326 cases (2015) per 100,000 admissions for AMI. The OUD group underwent less cardiac catheterization (63.2% vs 72.2%; p <0.001), percutaneous coronary intervention (37.0% vs 48.5%; p <0.001) and drug-eluting stent placement (32.3% vs 19.5%; p <0.001) compared with non-OUD. No differences in in-hospital mortality/cardiogenic shock were noted. Among subgroup of ST-elevation myocardial infarction patients (26.2% of overall cohort), the OUD patients were less likely to receive percutaneous coronary intervention (67.9% vs 75.5%; p = 0.002), drug-eluting stent (31.4% vs 47.9%; p <0.001) with a significantly higher mortality (7.4% vs 4.3%), and cardiogenic shock (11.7% vs 7.9%). No differences in the frequency of coronary bypass grafting were noted in AMI or its subgroups. In conclusion, OUD patients presenting with AMI receive less invasive treatment compared with those without OUD. OUD patients presenting with ST-elevation myocardial infarction have worse in-hospital outcomes with increased mortality and cardiogenic shock.

Long-Term Results After Drug-Eluting Versus Bare-Metal Stent Implantation in Saphenous Vein Grafts: Randomized Controlled Trial.

Background Efficacy data on drug-eluting stents (DES) versus bare-metal stents (BMS) in saphenous vein grafts are controversial. We aimed to compare DES with BMS among patients undergoing saphenous vein grafts intervention regarding long-term outcome. Methods and Results In this multinational trial, patients were randomized to paclitaxel-eluting or BMS. The primary end point was major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target-vessel revascularization at 1 year. Secondary end points included major adverse cardiac events and its individual components at 5-year follow-up. One hundred seventy-three patients were included in the trial (89 DES versus 84 BMS). One-year major adverse cardiac event rates were lower in DES compared with BMS (2.2% versus 16.0%, hazard ratio, 0.14; 95% CI, 0.03-0.64, P=0.01), which was mainly driven by a reduction of subsequent myocardial infarctions and need for target-vessel revascularization. Five-year major adverse cardiac event rates remained lower in the DES compared with the BMS arm (35.5% versus 56.1%, hazard ratio, 0.40; 95% CI, 0.23-0.68, P<0.001). A landmark-analysis from 1 to 5 years revealed a persistent benefit of DES over BMS (hazard ratio, 0.33; 95% CI, 0.13-0.74, P=0.007) in terms of target-vessel revascularization. More patients in the BMS group underwent multiple target-vessel revascularization procedures throughout the study period compared with the DES group (DES 1.1% [n=1] versus BMS 9.5% [n=8], P=0.013). Enrollment was stopped before the target sample size of 240 patients was reached. Conclusions In this randomized controlled trial with prospective long-term follow-up of up to 5 years, DES showed a better efficacy than BMS with sustained benefits over time. DES may be the preferred strategy in this patient population. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00595647.

Comparison of Durable-Polymer- and Biodegradable-Polymer-Based Newer-Generation Drug-Eluting Stents in Patients with Acute Myocardial Infarction and Prediabetes After Successful Percutaneous Coronary Intervention.

Hyperglycemia is an important risk factor for poor clinical outcomes in patients with acute myocardial infarction (AMI). The relative superiority of the long-term clinical outcomes of durable-polymer (DP) -based and biodegradable-polymer (BP) -based newer-generation drug-eluting stents (DESs) after successful percutaneous coronary intervention (PCI) in patients with AMI and prediabetes is not well established. We compared the clinical outcomes in such patients between DP-based and BP-based newer-generation DESs.A total of 4,377 patients with AMI and prediabetes were divided into the following two groups: the DP-DES group (n = 3,775; zotarolimus-eluting stents [ZES; n = 1,546] and everolimus-eluting stents [EES; n = 2,229]) and the BP-DES group (n = 602; biolimus-eluting stents [BES]). The primary endpoint was the occurrence of major adverse cardiac events (MACEs), defined as all-cause death, recurrent myocardial infarction (re-MI), or any repeat revascularization. The secondary endpoint was the occurrence of stent thrombosis (ST).The 2-year adjusted hazard ratio (aHR) of MACEs for ZES versus EES, ZES versus BES, EES versus BES, and ZES/EES versus BES (aHR: 1.125; 95% confidence interval [CI], 0.834-1.518; P = 0.440) were similar. The cumulative incidence of ST was also comparable between the DP-DES and BP-DES groups (aHR: 1.407; 95% CI, 0.476-4.158; P = 0.537). Moreover, the 2-year aHRs of all-cause death, CD, re-MI, target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR were similar.Patients with AMI and prediabetes who received DP-DES or BP-DES during PCI showed comparable safety and efficacy during the 2-year follow-up period.

Comparison of Neointimal Response between Durable-Polymer Everolimus-Eluting Stent and Bioabsorbable-Polymer Everolimus-Eluting Stent for Severely Calcified Lesions Requiring Rotational Atherectomy.

Clinical outcomes after percutaneous coronary intervention (PCI) for severely calcified lesions remain poor. The purpose of this study was to investigate the neointimal response after everolimus-eluting stents (EES) for severely calcified lesions treated with rotational atherectomy (RA) using optical coherence tomography (OCT).We retrospectively analyzed 34 lesions in which PCI was performed with EES deployment following RA and OCT was performed immediately after PCI and at follow-up (nine months). The EES was either durable-polymer (DP) EES (22 lesions) or bioabsorbable polymer (BP) -EES (12 lesions). Strut coverage and malapposition were evaluated at 1-mm intervals of cross-section (CS) by serial OCT analysis. Malapposed strut was defined as having the distance from luminal border > 100 µm.A total of 11,823 struts immediately after PCI and 11,720 struts at follow-up were analyzed. Immediately after PCI, the strut-level analysis showed no significant differences in the percentage of malapposed struts between the DP-EES group and the BP-EES group. At follow-up, the BP-EES group showed a more prevalent covered strut compared with the DP-EES group (strut-level analysis: 95% versus 97%, P = 0.045; CS-level analysis: 97% versus 100%, P < 0.01; lesion-level analysis: 27% versus 83%, P < 0.01, respectively).In severely calcified lesions requiring RA, the BP-EES group achieved better neointimal coverage than the DP-EES group at nine months. Additional prospective studies are needed.

Impact of ultra-long sirolimus-eluting stents on coronary artery lesions: one-year results of real-world FLEX-LONG Study.

BACKGROUND: The FLEX-LONG study assessed the safety and clinical outcomes of ultra-long (44 mm/48 mm) biodegradable polymer-coated Supraflex (Sahajanand Medical Technology Pvt. Ltd., Surat, India) sirolimus-eluting stents (SES) in real-world patients with complex, long coronary artery lesions. METHODS: It was an investigator-initiated, retrospective, non-randomized, observational and single-center study, which evaluated one-year results of 141 patients who had undergone implantation of at least one ultra-long (44 mm/48 mm) Supraflex SES. The incidence of major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR), at one-year follow-up was considered as primary outcome. Stent thrombosis was analyzed as a safety outcome. RESULTS: The mean age of the study population was 56.2±9.6 years and 78.0% (110/141) patients were male. The study analyzed high risk patients, including 62 (44.0%) hypertensive and 60 (42.6%) diabetic patients. Total 147 target lesions were treated, including 25 (17.0%) total occlusions. Total 51 (34.7%) and 96 (65.3%) Supraflex SES of 44 mm and 48 mm were implanted, respectively. Average stent length and diameter were 46.6±1.9 mm and 3.4±0.2 mm, respectively. One-year follow-up was obtained in 100% of patients. There was one probable stent thrombosis after three weeks. At one-year follow-up, 99.3% of patients remained event free. CONCLUSIONS: The results of the FLEX-LONG study support the use of ultra-long (44 mm/48 mm) Supraflex SES, in the treatment of high-risk real-world patients. The stent appeared to be safe and effective at one-year with low clinical events in complex, long coronary artery lesions.

The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System.

BACKGROUND: A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis. METHODS AND RESULTS: Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline. CONCLUSIONS: Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis.

Long-term clinical outcomes in patients with unstable angina undergoing percutaneous coronary interventions in a contemporary registry data from Poland.

BACKGROUND: Both unstable angina and non-ST-segment elevation myocardial infarction (NSTEMI) are still classified together in non-ST-elevation acute coronary syndromes despite the fact they substantially differ in both clinical profile and prognosis. The aim of the present study was to evaluate contemporary clinical characteristics and outcomes of unstable angina patients after percutaneous coronary intervention (PCI) in comparison with stable angina and NSTEMI in Swietokrzyskie District of Poland in years 2015-2017. METHODS: A total of 7187 patients after PCI from ORPKI Registry (38% with diagnosis of unstable angina) were included into the analysis. Impact of clinical presentation (unstable angina, stable angina, NSTEMI, STEMI) on three-year outcomes were determined. RESULTS: Unstable angina patients were older than stable angina but younger than NSTEMI individuals. In unstable angina group, the percentage of previous myocardial infarction (MI), PCI or coronary artery bypass grafting (CABG) was the highest among all analyzed groups. In three-year observation, the risk of death as well as MI and MACE in unstable angina after PCI was higher than stable angina angina but considerably lower than in the NSTEMI group. Multivariate analysis confirmed that prognosis in NSTEMI was substantially worse in comparison with unstable angina [relative risk (RR) 1.365, 95% confidence interval (CI): 1.126-1.655, P = 0.0015]. On the contrary in unstable angina and stable angina patients, the impact of diagnosis on mortality risk was similar (RR 1.189, 95% CI: 0.932-1.518, P = 0.1620). Parallel results were observed in respect of MI and MACE. Independent predictors of death or MACE were: age, kidney disease, hypertension, diabetes, previous stroke or previous PCI. CONCLUSION: Three-year prognosis in unstable angina was considerable better in comparison with NSTEMI. On the contrary, after adjustment for baseline differences, the outcomes (death, MI, MACE) in unstable angina and stable angina patients were comparable.

One-Year Late Lumen Loss between A Polymer-Coated Paclitaxel-Eluting Stent (Eluvia) and a Polymer-Free Paclitaxel-Coated Stent (Zilver PTX) for Femoropopliteal Disease.

AIM: Paclitaxel-eluting stents' (Eluvia and Zilver PTX) effectiveness has been recently reported for femoropopliteeal (FP) lesions. However, there is no evaluation of one-year late lumen loss (LLL). Therefore, we evaluated one-year LLL after implantation with Eluvia or Zilver PTX. METHODS: This was a multicenter, prospective study. Patients who had symptomatic de novo lesions in the native FP artery were enrolled. The primary endpoint was one-year angiographic LLL, and the secondary endpoints were binary restenosis and target lesion revascularization (TLR) at one year. RESULTS: From December 2015 to December 2016, 48 patients (Eluvia, 36 patients; Zilver PTX, 12 patients) were enrolled. No significant difference was found in baseline and lesion characteristics between both groups. One-year, LLL was significantly lower in the Eluvia group (0.60 {plus minus}0.80 mm) than in the Zilver PTX group (1.74 {plus minus}0.89 mm) (P=0.0003). Negative LLL was observed only in the Eluvia group (0% vs. 23%, p=0.096). The binary restenosis rate was significantly lower than in the Zilver PTX group (0% vs. 16.7%, P=0.012). The one-year TLR in the Eluvia group tended to be lower (0% vs. 8.3%, P=0.08). Stent thrombosis was not observed in either group. CONCLUSION: One-year LLL in the Eluvia group was significantly lower than that in the Zilver PTX group for FP lesions.

Risks of noncardiac surgery early after percutaneous coronary intervention.

BACKGROUND: Prior registry data suggest that 4%-20% of patients require noncardiac surgery (NCS) within 2 years of percutaneous coronary intervention (PCI). Contemporary data on NCS after PCI in the United States among women and men are limited. We determined the rate of early hospital readmission for NCS and associated outcomes in a large cohort of patients who underwent PCI in the United States. METHODS: Adults undergoing PCI between January 1 and June 30, 2014, were identified from the Nationwide Readmission Database. Patients readmitted for NCS within 6 months of PCI were identified. Outcomes of interest were in-hospital death, myocardial infarction (MI), and bleeding defined by International Classification of Diseases, Ninth Revision, codes. RESULTS: Among 221,379 patients who underwent PCI and survived to hospital discharge, 3.5% (n = 7,696) were readmitted for NCS within 6 months post-PCI, and 41% of these hospitalizations were elective. Early NCS was complicated by MI in 4.7% of cases, and 21% of perioperative MIs were fatal. Bleeding was recorded in 32.0% of patients. All-cause mortality occurred in 4.4% of patients (n = 339) readmitted for surgery. The risk of death or MI was greatest when NCS was performed within the first month after PCI. CONCLUSIONS: Despite clear guidelines to avoid surgery early after PCI, NCS was performed in 1 of every 29 patients with recent PCI, corresponding to as many as ~30,000 patients each year nationwide. Surgical mortality and perioperative MI were high in this setting. Strategies to minimize perioperative thrombotic and bleeding risks during readmission for NCS after PCI are necessary.

Association Between Residual Platelet Reactivity on Clopidogrel Treatment and Severity of Coronary Atherosclerosis: Intrinsic Hypercoagulability as a Mediator.

INTRODUCTION: High on-treatment residual platelet reactivity (HRPR) was associated with greater atherosclerosis burden. We examined whether intrinsic hypercoagulability (IHC) could be attributed to that association in patients treated by drug-eluting stents. METHODS: This retrospective observation enrolled a total of 891 coronary artery disease (CAD) subjects. Platelet and coagulant reactivity was measured by thrombelastography. At least 24 h after a 300-mg dose of clopidogrel, adenosine diphosphate (ADP)-induced maximum amplitude of clot strength (MAadp) > 47 mm represented HRPR. Thrombin-induced platelet-fibrin clot strength (MAthrombin) and blood fibrinogen surrogated intrinsic coagulability. Using mediation analysis to evaluate the effect of IHC on the relationship between the number of narrowed coronaries and HRPR on clopidogrel. RESULTS: More HRPR on clopidogrel and higher intrinsic coagulability were observed in more severe coronary atherosclerosis, especially in the three-vessel disease. After adjustment for confounding factors, the number of narrowed coronaries (ORadj = 1.343, 95% CI 1.063-1.695, p = 0.013), MAthrombin (ORadj = 1.106, 95% CI 1.058-1.157, p < 0.001), and fibrinogen (ORadj = 1.003, 95% CI 1.001-1.005, p = 0.012) were all independent positive predictors for HRPR. MAthrombin and fibrinogen were meaningful mediators for the significant positive association of the number of narrowed vessels and HRPR on clopidogrel, which were enhanced by around 30% and 43%, respectively, for this effect. CONCLUSIONS: This is the first study to demonstrate that the positive correlation between the number of stenotic coronaries and HRPR on clopidogrel may be partly attributed to IHC, which may enhance the risk stratification, guide more precise coagulation in multi-vessel disease after drug-eluting stents, and therefore deserve further study.

Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation-Individual patient data pooled analysis from 6 randomized controlled trials.

BACKGROUND: Drug-eluting stents (DESs) have improved clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Nevertheless, adverse events related to previously treated lesion still occur. We sought to evaluate the incidence and predictors of target lesion failure (TLF) in patients undergoing contemporary DES implantation. METHODS: Patient-level data from 6 prospective, randomized trials were pooled, and DES treatment outcomes were analyzed at up to 5 years. Primary outcome was TLF (cardiac death, target lesion revascularization, or target vessel myocardial infarction). Cox proportional-hazards model was used to identify predictors of TLF. RESULTS: Overall, 10,072 patients were included in the analysis. TLF rate was 1.7%, 4.3%, and 11.9% at 30 days, 1 year, and 5 years, respectively. The only independent predictor of TLF at 30 days was stent length (hazard ratio [HR] 1.017, 95% CI 1.011-1.024, P < .0001). Moderate/severe calcification, stent length and post procedural diameter sthenosis were predictors between 30 days to 1 year but not at 1 to 5 years. Reference vessel diameter was the only lesion-related predictor at 5 years (P = .003). Clinical predictors of TLF between 30 days and 1 year were diabetes and hypertension (P < .01 for both), and between 1 and 5 years, diabetes (HR 1.40, 95% CI 1.13-1.73, P = .002), prior coronary artery bypass grafting (HR 2.52, 95% CI 1.92-3.30, P < .0001), and prior PCI (HR 1.29, 95% CI 1.02-1.64, P = .04) predicted TLF. CONCLUSIONS: Predictors of TLF vary in the early, late, and very late postprocedural periods. Reference vessel diameter was the only lesion-related predictor of long-term TLF; clinical predictors were diabetes, prior coronary artery bypass grafting, and prior PCI.

Gender differences of in-hospital outcomes in patients undergoing percutaneous coronary intervention in the drug-eluting stent era.

Most studies on gender difference of the in-hospital outcome of percutaneous coronary intervention (PCI) were performed in the pre-drug-eluting stents (DES) era. This study was performed to investigate whether gender influences the in-hospital outcome of PCI in the DES era.A total of 44,967 PCI procedure between January and December of 2014 from the nationwide PCI registry database in Korea were analyzed. The study population was male predominant (70.2%). We examined the association of gender with unadjusted and adjusted in-hospital mortality and composite events of PCI, including mortality, nonfatal myocardial infarction, stent thrombosis, stroke, urgent repeat PCI and bleeding requiring transfusion.Most of the study patients (91.3%) received DES. The incidence rates of in-hospital mortality (2.95% vs 1.99%, P <.001) and composite events (7.01% vs 5.48%, P <.001) were significantly higher in women compared to men. Unadjusted analyses showed that women had a 1.49 times higher risk of in-hospital mortality and a 1.30 times higher risk of composite events than men (P <.001 for each). After adjustment for potential confounders, female gender was not a risk factor for mortality (P = .258), but the risk of composite events remained 1.20 times higher in women than in men (P = .008).Among patients undergoing PCI in the contemporary DES era, female gender was associated with an increased risk of in-hospital composite events, but not in-hospital mortality. More careful attention should be emphasized to minimize procedure-related risks and to improve prognosis in women undergoing PCI.

Disparities In The Use Of Drug-eluting Stents For Diabetic Patients With ST-elevation Acute Myocardial Infarction Assisted In the Public versus Private Network - VICTIM Register / Disparidades no Uso de Stents Farmacológicos para Pacientes Diabéticos com Infarto Agudo do Miocárdio com Supradesnivelamento do Segmento ST Assistidos na Rede Pública versus Privada - Registro VICTIM

Abstract Background: Primary angioplasty (PA) with placement of either bare metal or drug-eluting stents (DES) represents the main strategy in the treatment of ST-elevation myocardial infarction (STEMI). Diabetic patients, however, represent a special population in STEMI, with high rates of restenosis and unfavorable clinical outcomes, and with the use of DES, level of evidence A and indication class II, being indicated to reduce these damages. Objectives: To evaluate the DES rate of use in patients with STEMI and in the subgroup of diabetics assisted in the public versus private health network in Sergipe. Methods: This is a population-based, cross-sectional study with a quantitative approach using the data from the VICTIM Register. These were collected in the only four hospitals with capacity to perform PA in Sergipe, from December 2014 to March 2017. Results: A total of 707 patients diagnosed with STEMI were evaluated, of which 589 were attended at SUS and 118 at the private network. The use of DES in PA was lower in SUS compared to the private network in both the total sample (10.5% vs 82.4%, p<0.001) and in subgroup diabetic patients (8.7% vs 90.6%, p < 0.001), respectively. In all hypotheses tested, the level of significance was 5% (p < 0.05). Conclusions: The study reveals a disparity in the use of DES during the performance of PA between the public and private network, both in the total sample and the subgroup for diabetics, with lower rates for SUS users, demonstrating the challenges that need to be overcome in order to achieve quality improvements of the services provided.

Resumo Fundamento: A angioplastia primária (AP) com colocação de stent, seja ele convencional ou farmacológico, representa a principal estratégia no tratamento do infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAMCSST). Os pacientes diabéticos, entretanto, representam população especial no IAMCSST, com altas taxas de reestenose e desfechos clínicos desfavoráveis, devendo-se indicar o uso de stents farmacológicos (SF), nível de evidência A e classe de indicação II, para redução destes danos. Objetivo: Avaliar a taxa de uso de SF em pacientes com IAMCSST e no subgrupo dos diabéticos assistidos na rede pública versus privada de saúde em Sergipe. Métodos: Trata-se de um estudo populacional, transversal, com abordagem quantitativa, que utilizou os dados do Registro VICTIM. Estes foram coletados nos quatro únicos hospitais com capacidade para realizar AP em Sergipe, no período de dezembro de 2014 a março de 2017. Em todas as hipóteses testadas, o nível de significância adotado foi de 5% (p < 0,05). Resultados: Foram avaliados 707 pacientes diagnosticados com IAMCSST, dos quais 589 foram atendidos pelo SUS e 118 pela rede privada. O uso de SF na AP foi menor no SUS em comparação com a rede privada, tanto no total da amostra (10,5% vs 82,4%; p < 0,001) quanto no subgrupo dos pacientes diabéticos (8,7% vs 90,6%; p < 0,001), respectivamente. Conclusões: O estudo revela disparidade no uso de SF durante a realização de AP entre a rede pública e privada, tanto na amostra total quanto no subgrupo dos diabéticos, com menores taxas para usuários do SUS, demonstrando os desafios que necessitam ser vencidos para se atingir melhorias na qualidade dos serviços prestados.

The pCONUS HPC: 30-Day and 180-Day In Vivo Biocompatibility Results.

BACKGROUND: Endovascular stents are commonly used during neurointerventional procedures; however, the concomitant use of dual anti-platelet treatment (DAPT) can limit their use. There is a need to develop stent coatings that mitigate requirement for DAPT. METHODS: The hydrophilic polymer coating is a novel glycan-based multilayer polymer that inhibits platelet adhesion. After Institutional Animal Care and Use Committee approval, 18 New Zealand white rabbits (mean weight 4.02 ± 0.51 kg) were commenced on DAPT (ASA 10 mg/kg/day and clopidogrel 10 mg/kg/day). A bare nitinol pCONUS and coated pCONUS HPC were implanted into the common carotid arteries of each rabbit. Histological examinations were performed at 30 days (n = 9) and 180 days (n = 8) to assess the acute and chronic inflammatory reactions to the pCONUS HPC. Wilcoxon/Kruskal-Wallis and ANOVA were used with p value < 0.05 considered as significant. RESULTS: There is no statistically significant difference in inflammation within the intima/media or adventitia at 30 days (p = 0.3901 and p = 1, respectively) or at 180 days (p = 0.144 and p = 1, respectively) between pCONUS and pCONUS HPC cohorts. There is no significant difference in the presence of granulomas or giant cells between the cohorts at either 30 days (p = 1 and p = 0.8363) or 180 days (p = 1.00 and p = 0.149). At 30 days and 180 days, there was near-complete endothelialisation of the stent struts and no significant difference between the pCONUS or pCONUS HPC (p = 0.7832 and p = 0.334, respectively). CONCLUSION: pCONUS HPC stents do not elicit an acute or chronic inflammatory response in vivo with no significant difference in the tissue response to bare nitinol pCONUS stents or pCONUS HPC stents.

Association of Survival With Femoropopliteal Artery Revascularization With Drug-Coated Devices.

Importance: In a recent meta-analysis of randomized clinical trials, femoropopliteal artery revascularization with paclitaxel drug-coated devices was associated with increased long-term all-cause mortality compared with non-drug-coated devices. However, to our knowledge, these findings have not been replicated in other data sources and may be subject to confounding from missing data associated with patient withdrawal and loss to follow-up. Objective: To evaluate differences in all-cause mortality between patients who were treated with drug-coated devices vs non-drug-coated devices for femoropopliteal artery revascularization. Design, Setting, and Participants: This nationwide, multicenter retrospective cohort study included 16 560 Centers for Medicare and Medicaid Services beneficiaries who were admitted for femoropopliteal artery revascularization from January 1, 2016, to December 31, 2016. All-cause mortality was analyzed through September 30, 2017. Exposures: Drug-coated devices (drug-eluting stent [DES] or drug-coated balloon [DCB]) compared with non-drug-coated devices (bare metal stent or uncoated percutaneous transluminal angioplasty balloon). Main Outcomes and Measures: The primary outcome was all-cause mortality analyzed through the end of follow-up. Results: Among 16 560 patients treated at 1883 hospitals, the mean (SD) age was 72.9 (11) years, 7734 (46.7%) were men, 12 232 (73.9%) were white, 8222 (49.7%) currently or had previously used tobacco, 9817 (59.3%) had diabetes, and 8450 (51.0%) had critical limb ischemia (CLI). Drug-coated devices were used in 5989 participants (36.2%). The median follow-up was 389 days (interquartile range, 277-508 days). Among all patients, treatment with drug-coated devices was associated with a lower cumulative incidence of all-cause mortality compared with treatment with non-drug-coated devices through 600 days postprocedure (32.5% vs 34.3%, respectively; log-rank P = .007). Similar survival trends were observed when treatment was stratified by using a DCB alone or DES with or without DCB. After multivariable adjustment, drug-coated devices were not associated with a difference in all-cause mortality compared with non-drug-coated devices (hazard ratio [HR], 0.97; 95% CI, 0.91-1.04; P = .43). These findings were consistent among those with CLI (HR, 0.93; 95% CI, 0.85-1.01; P = .09) or without CLI (HR, 0.94; 95% CI, 0.85-1.03; P = .20), and for those treated with DCB alone (HR, 0.94; 95% CI, 0.86-1.03; P = .17) or DES with or without DCB (HR, 0.97; 95% CI, 0.89-1.06; P = .48). Conclusions and Relevance: In this large nationwide analysis of Centers for Medicare and Medicaid Services beneficiaries, there was no evidence of increased all-cause mortality following femoropopliteal artery revascularization with drug-coated devices compared with non-drug-coated devices.