Significant Difference In Major Adverse Cardiovascular Events Research Articles

Field Implementation of Remote Ischemic Conditioning in ST-Segment–Elevation Myocardial Infarction: The FIRST Study

BackgroundRemote ischemic conditioning (RIC) is a noninvasive therapeutic strategy that uses brief cycles of blood pressure cuff inflation and deflation to protect the myocardium against ischemia-reperfusion injury. We sought to compare major adverse cardiovascular events (MACE) for patients who received RIC before PCI for ST-segment–elevation myocardial infarction (STEMI) compared with standard care. MethodsWe conducted a pre- and postimplementation study. In the preimplementation phase, STEMI patients were taken directly to the PCI lab. After implementation, STEMI patients received 4 cycles of RIC by paramedics or emergency department staff before PCI. The primary outcome was MACE at 90 days. Secondary outcomes included MACE at 30, 60, and 180 days. Inverse probability of treatment weighting using propensity scores estimated causal effects independent from baseline covariables. ResultsA total of 1667 (866 preimplementation, 801 postimplementation) patients were included. In the preimplementation phase, 13.4% had MACE at 90 days compared with 11.8% in the postimplementation phase (odds ratio [OR] 0.86, 95% CI 0.62-1.21). There were no significant differences in MACE at 30, 60, and 180 days. Patients presenting with cardiogenic shock or cardiac arrest before PCI were less likely to have MACE at 90 days (42.7% pre vs 27.8% post) if they received RIC before PCI (OR 0.52, 95% CI 0.27-0.98). ConclusionsA strategy of RIC before PCI for STEMI did not reduce 90-day MACE. Future research should explore the impact of RIC before PCI for longer-term clinical outcomes and for patients presenting with cardiogenic shock or cardiac arrest.

Safety and Efficacy of Antithrombotic Strategies in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

The antithrombotic treatment of patients with atrial fibrillation (AF) and coronary artery disease, in particular with acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI), poses a significant treatment dilemma in clinical practice. To study the safety and efficacy of different antithrombotic regimens using a network meta-analysis of randomized controlled trials in this population. PubMed, EMBASE, EBSCO, and Cochrane databases were searched to identify randomized controlled trials comparing antithrombotic regimens. Four randomized studies were included (n = 10 026; WOEST, PIONEER AF-PCI, RE-DUAL PCI, and AUGUSTUS). The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used in this systematic review and network meta-analysis between 4 regimens using a Bayesian random-effects model. A pre hoc statistical analysis plan was written, and the review protocol was registered at PROSPERO. Data were analyzed between November 2018 and February 2019. The primary safety outcome was Thrombolysis in Myocardial Infarction (TIMI) major bleeding; secondary safety outcomes were combined TIMI major and minor bleeding, trial-defined primary bleeding events, intracranial hemorrhage, and hospitalization. The primary efficacy outcome was trial-defined major adverse cardiovascular events (MACE); secondary efficacy outcomes were individual components of MACE. The overall prevalence of ACS varied from 28% to 61%. The mean age ranged from 70 to 72 years; 20% to 29% of the trial population were women; and most patients were at high risk for thromboembolic and bleeding events. Compared with a regimen of vitamin K antagonist (VKA) plus dual antiplatelet therapy (DAPT; P2Y12 inhibitor plus aspirin), the odds ratios (ORs) for TIMI major bleeding were 0.58 (95% CI, 0.31-1.08) for VKA plus P2Y12 inhibitor, 0.49 (95% CI, 0.30-0.82) for non-VKA oral anticoagulant (NOAC) plus P2Y12 inhibitor, and 0.70 (95% CI, 0.38-1.23) for NOAC plus DAPT. Compared with VKA plus DAPT, the ORs for MACE were 0.96 (95% CI, 0.60-1.46) for VKA plus P2Y12 inhibitor, 1.02 (95% CI, 0.71-1.47) for NOAC plus P2Y12 inhibitor, and 0.94 (95% CI, 0.60-1.45) for NOAC plus DAPT. A regimen of NOACs plus P2Y12 inhibitor was associated with less bleeding compared with VKAs plus DAPT. Strategies omitting aspirin caused less bleeding, including intracranial bleeding, without significant difference in MACE, compared with strategies including aspirin. Our results support the use of NOAC plus P2Y12 inhibitor as the preferred regimen post-percutaneous coronary intervention for these high-risk patients with AF. A regimen of VKA plus DAPT should generally be avoided.

Effect of Medication Co-payment Vouchers on P2Y12 Inhibitor Use and Major Adverse Cardiovascular Events Among Patients With Myocardial Infarction

Despite guideline recommendations, many patients discontinue P2Y12 inhibitor therapy earlier than the recommended 1 year after myocardial infarction (MI), and higher-potency P2Y12 inhibitors are underutilized. Cost is frequently cited as an explanation for both of these observations. To determine whether removing co-payment barriers increases P2Y12 inhibitor persistence and lowers risk of major adverse cardiovascular events (MACE). Cluster randomized clinical trial among 301 hospitals enrolling adult patients with acute MI (June 5, 2015, through September 30, 2016); patients were followed up for 1 year after discharge (final date of follow-up was October 23, 2017), with blinded adjudication of MACE; choice of P2Y12 inhibitor was per clinician discretion. Hospitals randomized to the intervention (n = 131 [6436 patients]) provided patients with co-payment vouchers for clopidogrel or ticagrelor for 1 year (median voucher value for a 30-day supply, $137 [25th-75th percentile, $20-$339]). Hospitals randomized to usual care (n = 156 [4565 patients]) did not provide study vouchers. Independent coprimary outcomes were patient-reported persistence with P2Y12 inhibitor (defined as continued treatment without gap in use ≥30 days) and MACE (death, recurrent MI, or stroke) at 1 year among patients discharged with a prescription for clopidogrel or ticagrelor. Among 11 001 enrolled patients (median age, 62 years; 3459 [31%] women), 10 102 patients were discharged with prescriptions for clopidogrel or ticagrelor (clopidogrel prescribed to 2317 [36.0%] in the intervention group and 2497 [54.7%] in the usual care group), 4393 of 6135 patients (72%) in the intervention group used the voucher, and follow-up data at 1 year were available for 10 802 patients (98.2%). Patient-reported persistence with P2Y12 inhibitors at 1 year was higher in the intervention group than in the control group (unadjusted rates, 5340/6135 [87.0%] vs 3324/3967 [83.8%], respectively; P < .001; adjusted difference, 2.3% [95% CI, 0.4% to 4.1%]; adjusted odds ratio, 1.19 [95% CI, 1.02 to 1.40]). There was no significant difference in MACE at 1 year between intervention and usual care groups (unadjusted cumulative incidence, 10.2% vs 10.6%; P = .65; adjusted difference, 0.66% [95% CI, -0.73% to 2.06%]; adjusted hazard ratio, 1.07 [95% CI, 0.93 to 1.25]). Among patients with MI, provision of vouchers to offset medication co-payments for P2Y12 inhibitors, compared with no vouchers, resulted in a 3.3% absolute increase in patient-reported persistence with P2Y12 inhibitors and no significant reduction in 1-year MACE outcomes. ClinicalTrials.gov Identifier: NCT02406677.

Polymer-free versus permanent polymer-coated drug eluting stents for the treatment of coronary artery disease: A meta-analysis of randomized trials.

Polymer-free drug eluting stents (PF-DES) were developed, in part, to overcome risk of late ischemic events observed with permanent polymer-coated DES (PP-DES). However, trial results are inconsistent with longer-term safety and efficacy of PF-DES remaining unknown. We performed a meta-analysis of randomized trials assessing outcomes of patients receiving PF-DES versus PP-DES for treatment of coronary artery disease (CAD). Electronic searches were performed for randomized trials comparing outcomes between PF-DES and PP-DES. Trials reporting major adverse cardiovascular events (MACE), myocardial infarction (MI), stent thrombosis (ST), all-cause death, target lesion/vessel revascularization (TLR/TVR), and late lumen loss (LLL) were included. Analyses were performed at longest follow-up and landmarked beyond 1-year. Twelve trials (6,943 patients) were included. There was no significant difference in MACE between PF-DES and PP-DES at longest follow-up (Odds Ratio [OR] 0.96, 95%CI 0.85-1.10, P = 0.59) or landmark analysis beyond 1-year (OR 0.96, 95%CI 0.76-1.20, P = 0.70). Although PF-DES were associated with a significant reduction in all-cause death (OR 0.85, 95%CI 0.72-1.00, P < 0.05), this effect was not present on landmark analysis beyond 1-year (OR 0.89, 95%CI 0.73-1.10, P = 0.30). There were no differences observed for MI (OR 1.00, 95%CI 0.77-1.28, P = 0.99) or ST (OR 0.95, 95%CI 0.54-1.68, P = 0.86), with similar efficacy outcomes including TVR (OR 1.07, 95%CI 0.91-1.26, P = 0.42), TLR (OR 1.03, 95%CI 0.88-1.21, P = 0.68) and angiographic LLL (pooled mean difference 0.01 mm, 95%CI -0.08 to 0.11, P = 0.76). PF-DES are as safe and efficacious as PP-DES for the treatment of patients with CAD, but do not significantly reduce late ischemic complications.

Long-term Follow-up of the Trial of Routine Angioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI)

BackgroundThe Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI) demonstrated superiority of routine early coronary angiography (and percutaneous coronary intervention [PCI]) compared with standard therapy in fibrinolytic-treated patients with ST-segment elevation myocardial infarction (STEMI) at 30 days. The aim of the current study was to evaluate the long-term (>7 year) effects of an early invasive strategy. MethodsWe linked the study cohort and administrative datasets to assess long-term follow-up status including repeat procedures, hospitalizations, and major adverse cardiovascular events (MACE). Kaplan-Meier and Cox regression analysis were used to evaluate the relationship between randomized treatment and long-term adverse outcomes. ResultsA total of 881 patients had long-term follow-up and were included in our study. After a mean follow-up of 7.8 years, there were no significant differences in death, myocardial infarction (MI), unstable angina, stroke, transient ischemic attack (TIA), or heart failure admissions (hazard ratio [HR] 0.91; 95% confidence interval [CI] 0.73–1.13]; P = 0.41) between those randomized to an early invasive vs standard treatment strategy. Following the index hospitalization, there were no significant difference in the rates of coronary revascularization between the early invasive and the standard therapy groups (81 [19.3%] vs 76 [17.9%]; P = 0.61). ConclusionsDespite the short-term benefit and safety of an early invasive strategy in patients with STEMI receiving fibrinolysis, no statistically significant differences in MACE were observed over 7.8 years.

Use of High-Risk Coronary Atherosclerotic Plaque Detection for Risk Stratification of Patients With Stable Chest Pain

Coronary computed tomographic angiography (coronary CTA) can characterize coronary artery disease, including high-risk plaque. A noninvasive method of identifying high-risk plaque before major adverse cardiovascular events (MACE) could provide practice-changing optimizations in coronary artery disease care. To determine whether high-risk plaque detected by coronary CTA was associated with incident MACE independently of significant stenosis (SS) and cardiovascular risk factors. This prespecified nested observational cohort study was part of the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial. All stable, symptomatic outpatients in this trial who required noninvasive cardiovascular testing and received coronary CTA were included and followed up for a median of 25 months. Core laboratory assessment of coronary CTA for SS and high-risk plaque (eg, positive remodeling, low computed tomographic attenuation, or napkin-ring sign). The primary end point was an adjudicated composite of MACE (defined as death, myocardial infarction, or unstable angina). The study included 4415 patients, of whom 2296 (52%) were women, with a mean age of 60.5 years, a median atherosclerotic cardiovascular disease (ASCVD) risk score of 11, and a MACE rate of 3% (131 events). A total of 676 patients (15.3%) had high-risk plaques, and 276 (6.3%) had SS. The presence of high-risk plaque was associated with a higher MACE rate (6.4% vs 2.4%; hazard ratio, 2.73; 95% CI, 1.89-3.93). This association persisted after adjustment for ASCVD risk score and SS (adjusted hazard ratio [aHR], 1.72; 95% CI, 1.13-2.62). Adding high-risk plaque to the ASCVD risk score and SS assessment led to a significant continuous net reclassification improvement (0.34; 95% CI, 0.02-0.51). Presence of high-risk plaque increased MACE risk among patients with nonobstructive coronary artery disease relative to patients without high-risk plaque (aHR, 4.31 vs 2.64; 95% CI, 2.25-8.26 vs 1.49-4.69). There were no significant differences in MACE in patients with SS and high-risk plaque as opposed to those with SS but not high-risk plaque (aHR, 8.68 vs. 9.31; 95% CI, 4.25-17.73 vs 4.21-20.61). High-risk plaque was a stronger predictor of MACE in women (aHR, 2.41; 95% CI, 1.25-4.64) vs men (aHR, 1.40; 95% CI, 0.81-2.39) and younger patients (aHR, 2.33; 95% CI, 1.20-4.51) vs older ones (aHR, 1.36; 95% CI, 0.77-2.39). High-risk plaque found by coronary CTA was associated with a future MACE in a large US population of outpatients with stable chest pain. High-risk plaque may be an additional risk stratification tool, especially in patients with nonobstructive coronary artery disease, younger patients, and women. The importance of findings is limited by low absolute MACE rates and low positive predictive value of high-risk plaque. clinicaltrials.gov Indentifier: NCT01174550.

Major adverse cardiovascular events in patients after acute myocardial infarction treated invasively and different patterns of glucometabolic disturbances evaluated at mid-term follow-up

Objective: To assess the impact of glucometabolic status (GS) evaluated at hospital discharge and at mid-term follow-up visit (FU-visit) on major adverse cardiovascular events (MACE) in patients (pts) with acute myocardial infarction (AMI) treated invasively.Material and Methods: Study encompassed 368 AMI-pts treated invasively, in whom GS was assessed by 2-hour post load glycemia at hospital discharge and at FU-visit after 6 months. Patients were divided into two groups with respect to GS at hospital discharge: abnormal glucose tolerance (AGT, n=149), normal glucose tolerance (NGT, n=219). Each of those groups was divided into two subgroups with respect to GS at FU-visit: persistent AGT (pAGT, n=101), transient AGT (tAGT, n=48), newly detected AGT (newAGT, n=114), persistent NGT (pNGT, n=105). Median follow-up duration after FU-visit was 24.5 months.Results: There was a trend towards more subjects with MACE in AGT than NGT group (24.2% vs. 16%; p=0.051). More AGT-pts were hospitalized due to decompensated heart failure (6% vs. 0.5%; p=0.002). However, there were no significant differences in MACE between subjects with pAGT and tAGT, including heart failure hospitalizations. Among NGT-pts there were no significant differences in particular MACE between newAGT-pts and pNGT-pts.Conclusions: In AMI-pts treated invasively, who had abnormal glucose tolerance at hospital discharge, the improvement in glucometabolic status after 6 months was not related to lower risk of hospitalization due to decompensated heart failure.

Bivalirudin versus Heparin plus Glycoprotein IIb/IIIa Inhibitors in Women Undergoing Percutaneous Coronary Intervention: A Meta-Analysis of Randomized Controlled Trials.

Bivalirudin has been shown to be safe and efficacious compared with heparin plus glycoprotein IIb/IIIa inhibitor (GPI) in patients undergoing percutaneous coronary intervention (PCI). Whether bivalirudin would have the beneficial effects in female patients undergoing PCI remains unknown. We searched the literature for randomized controlled trials that assessed bivalirudin versus heparin plus GPI therapy in female patients undergoing PCI. The primary efficacy end point was major adverse cardiovascular events (MACE) within 30 days. The secondary efficacy end points were 30-day incidence of all-cause mortality, myocardial infarction (MI), urgent/ischemia-driven revascularization of target vessel. The safety end point was major bleeding up to 30 days. A total of 4,501 female patients were included in five randomized trials. No significant difference in MACE emerged between bivalirudin and heparin plus GPI at 30 days (8.15% vs 8.76%, RR 0.94, 95% CI 0.77–1.16, P = .57). There were no significant differences in rates of mortality (1.28% vs 1.91%, RR 0.74, 95% CI 0.45–1.20, P = .22), MI (5.46% vs 5.25%, RR 1.02, 95% CI 0.79–1.32, p = .88), or target vessel revascularization (2.13% vs 1.65%, RR 1.43, 95% CI 0.88–2.30, P = .15). Compared with heparin plus GPI, bivalirudin was associated with a significant reduction in 30-day major bleeding (5.32% vs 9.20%, RR 0.58, 95% CI 0.47–0.72, P < .0001). In conclusion, bivalirudin is associated with a significant reduction in 30-day major bleeding without increased ischemic events compared with heparin plus GPI in female patients undergoing PCI.

Plasma Catestatin in Patients with Acute Coronary Syndrome

Objectives: To measure plasma catestatin levels in patients with acute coronary syndrome and investigate whether there is an association between catestatin levels and long-term outcome. Methods: Patients (n = 170) with suspected acute coronary syndrome who underwent emergency coronary angiography were enrolled, including 46 with acute ST-segment elevation myocardial infarction (STEMI), 89 with unstable angina pectoris (UAP), and 35 without coronary artery disease (CAD). All patients were followed for 2 years to measure the occurrence of major adverse cardiovascular events (MACEs), including death from a cardiovascular cause, recurrent acute myocardial infarction, or hospital admission for heart failure or revascularization. Results: On average, the plasma catestatin levels in patients with STEMI (0.80 ± 0.62 ng/ml) and UAP (0.99 ± 0.63 ng/ml) were significantly lower than the levels seen in the control group with no evidence of CAD (1.38 ± 0.98 ng/ml; p = 0.001). In multivariable linear regression, body mass index, presence of hypertension, and type of CAD were independently related to the plasma catestatin level. However, there were no significant differences in MACEs between patients with high and low levels of catestatin. Conclusions: The plasma catestatin levels in patients with STEMI and UAP were lower than the levels seen in patients without CAD.

Characteristics and Outcomes of Patients Presenting With Hypertensive Urgency in the Office Setting.

The prevalence and short-term outcomes of hypertensive urgency (systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg) are unknown. Guidelines recommend achieving blood pressure control within 24 to 48 hours. However, some patients are referred to the emergency department (ED) or directly admitted to the hospital, and whether hospital management is associated with better outcomes is unknown. To describe the prevalence of hypertensive urgency and the characteristics and short-term outcomes of these patients, and to determine whether referral to the hospital is associated with better outcomes than outpatient management. This retrospective cohort study with propensity matching included all patients presenting with hypertensive urgency to an office in the Cleveland Clinic Healthcare system from January 1, 2008, to December 31, 2013. Pregnant women and patients referred to the hospital for symptoms or treatment of other conditions were excluded. Final follow-up was completed on June 30, 2014, and data were assessed from October 31, 2014, to May 31, 2015. Hospital vs ambulatory blood pressure management. Major adverse cardiovascular events (MACE) consisting of acute coronary syndrome and stroke or transient ischemic attack, uncontrolled hypertension (≥140/90 mm Hg), and hospital admissions. Of 2 199 019 unique patient office visits, 59 836 (4.6%) met the definition of hypertensive urgency. After excluding 851 patients, 58 535 were included. Mean (SD) age was 63.1 (15.4) years; 57.7% were women; and 76.0% were white. Mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) was 31.1 (7.6); mean (SD) systolic blood pressure, 182.5 (16.6) mm Hg; and mean (SD) diastolic blood pressure, 96.4 (15.8) mm Hg. In the propensity-matched analysis, the 852 patients sent home were compared with the 426 patients referred to the hospital, with no significant difference in MACE at 7 days (0 vs 2 [0.5%]; P = .11), 8 to 30 days (0 vs 2 [0.5%]; P = .11), or 6 months (8 [0.9%] vs 4 [0.9%]; P > .99). Patients sent home were more likely to have uncontrolled hypertension at 1 month (735 of 852 [86.3%] vs 349 of 426 [81.9%]; P = .04) but not at 6 months (393 of 608 [64.6%] vs 213 of 320 [66.6%]; P = .56). Patients sent home had lower hospital admission rates at 7 days (40 [4.7%] vs 35 [8.2%]; P = .01) and at 8 to 30 days (59 [6.9%] vs 48 [11.3%]; P = .009). Hypertensive urgency is common, but the rate of MACE in asymptomatic patients is very low. Visits to the ED were associated with more hospitalizations, but not improved outcomes. Most patients still had uncontrolled hypertension 6 months later.

Same or Different Drug-Eluting Stent Re-Implantation for Drug-Eluting Stent Restenosis: An Assessment Including Second-Generation Drug-Eluting Stents.

We examined the long-term outcomes of implanting a different type of drug-eluting stent (DES), including second-generation DES, for treatment of DES-in stent restenosis (ISR). Treatment for DES-ISR has not been standardized. The subjects were 80 patients with 89 lesions underwent DES implantation for DES-ISR. The patients were divided into the group of patients receiving the same DES for DES-ISR (Homo-stent: 24 patients, 25 lesions) and a different DES for DES-ISR (Hetero-stent: 56 patients, 64 lesions). The primary endpoint was survival free of major adverse cardiovascular events (MACE), including cardiac death, myocardial infarction, and target vessel revascularization (TVR). The secondary endpoint was late loss at 8-12 months follow-up. In the subgroup of patients who were treated with second-generation DES for DES-ISR, we also assessed the survival free of MACE. During a mean follow-up of 45.1 ± 21.2 months, 26 patients experienced MACE. There was no significant difference in the survival free of MACE (Log rank P = 0.17). In the sub-analysis of second generation DES, MACE was significantly higher in the Homo-stent group compared to the Hetero-stent group (Log rank P = 0.04). Late loss was significantly higher in the Homo-stent group than in the Hetero-stent group (0.86 ± 1.03 vs. 0.38 ± 0.74 mm, P = 0.03). This trend was prominent in the first-generation DES group. Although there was no significant difference in MACE between the Hetero-stent and the Homo-stent groups including both first and second-generation DES, the sub-analysis demonstrated different DES implantation for DES-ISR significantly improved the MACE rate among patients treated with second-generation DES. (J Interven Cardiol 2016;29:311-318).

Dual antiplatelet therapy tailored on platelet function test after coronary stent implantation: a real-world experience.

Patients' response to dual antiplatelet therapy (DAPT) is subject to variations and its monitoring allows to individualize this therapy. In this study, we evaluated if a strategy of tailored DAPT after platelet function testing could reduce high on-treatment platelet reactivity (HPR) and improve outcome of patients treated with stent implantation. In 257 patients undergoing percutaneous angioplasty, platelet function was measured by light transmittance aggregometry (LTA) using 10 µM/L adenosine-diphosphate (ADP) and 1 mM arachidonic acid (AA) as agonists. Patients with HPR by ADP (≥70%) were switched to double-dose clopidogrel, ticlopidine, prasugrel or ticagrelor; in patients with HPR by AA (≥20%) acetylsalicylic acid dose was increased if not contraindicated. Platelet function analysis was repeated 48 hours after therapy variation. At 20-month follow-up major adverse cardiovascular events (MACE) and bleedings were assessed. HPR was detected in 97/257 (37.7%) patients: 69/257 (26.8%) had HPR by ADP and 71/257 (27.6%) had HPR by AA. In patients with HPR by ADP or by AA, tailored DAPT determined a significant reduction in residual platelet reactivity. No significant difference in MACE or bleeding occurrence was documented in HPR patients treated with tailored DAPT vs. those without HPR. HPR patients treated with tailored DAPT had significant lower follow-up MACE and deaths vs. 139 HPR patients not switched, even after propensity score analysis. These results suggest that a DAPT tailored on platelet testing can improve antiplatelet response in HPR patients, possibly reducing their thrombotic events to a level similar to non-HPR patients, without increasing the risk of bleeding.

Abstract W P269: High vs. Moderate-intensity Statin Therapy After Ischemic Stroke: Findings from PROSPER

Background: Current treatment guidelines recommend high-intensity statin therapy for patients with a history of stroke. However, older patients with higher comorbidity were under-represented in trials and dosing varies in clinical practice. We compared the effectiveness of high vs moderate-intensity statins on clinical outcomes in older patients from the GWTG-Stroke registry. Methods: We studied statin-naïve ischemic stroke patients ≥65 years from GWTG-Stroke linked to Medicare claims from 2008-2011 who were discharged on statins. Outcomes included home time days (days alive and not in acute or post-acute care facility), major adverse cardiovascular events (MACE), mortality, all-cause, stroke and CV readmission within 2 years of discharge. We estimated unadjusted and adjusted associations between statin intensity and outcomes using negative binomial and Cox proportional hazards models. Inverse-weighted estimates of the probability of high-intensity statin (IPW) were used to adjust for treatment selection. Results: Of 29,631 ischemic stroke patients discharged on statins, 9,145 (31%) received high-intensity statins. Patients receiving high-intensity statins were younger and had higher LDL-C compared with patients on moderate-intensity statins. The high-intensity statin group had 5 fewer home time days and higher all-cause readmission within 2 years, but other observed outcomes were similar (Table). Except for a slightly higher hazard of all-cause readmission with high-intensity statin use, there were no significant differences in MACE, hemorrhagic stroke, or other outcomes after IPW adjustment (Table). Conclusions: We found no differences in MACE or home time days within 2 years of initiation of high vs. moderate-intensity statin therapy following ischemic stroke. These findings can inform patients and clinicians regarding the risk-benefit associated with statin dosing after ischemic stroke.

Meta-Analysis of the Cardiovascular Outcomes with Dipeptidyl Peptidase 4 Inhibitors: Validation of the Current FDA Mandate

Earlier meta-analyses have demonstrated a significant reduction in major adverse cardiovascular events (MACE) with dipeptidyl peptidase 4-inhibitor (DPPI) use, as compared with placebo or alternative anti-diabetic therapies. However, the large phase III/IV trials, namely SAVOR-TIMI 53 and the EXAMINE trials, failed to demonstrate any significant differences in MACE between DPPI and placebo. We aimed to perform an updated meta-analysis of randomized controlled trials (RCTs) to investigate the differences in cardiovascular death, myocardial infarction (MI), and stroke between DPPI and placebo/alternative agents. We searched the MEDLINE, EMBASE, and Cochrane databases for relevant phase III/IV RCTs. Unpublished trials with results available on national clinical trials registers were also included. RCTs with follow-up duration ≥24 weeks were included if they compared DPPI with placebo or an alternative anti-diabetic agent. A total of 82 RCTs including 73,678 patients were included. We did not observe any significant difference in the pooled odds of cardiovascular death, MI, or stroke in the composite DPPI arm as compared with the control arm. Similarly, the pooled odds of all-cause death and MACE were statistically similar between the two groups. None of the clinical outcomes studied demonstrated evidence of statistical heterogeneity or publication bias. Due to a larger sample size and a longer duration of follow-up, both SAVOR-TIMI 53 and EXAMINE trials had a considerably larger contribution to the pooled estimates in our meta-analysis, driving the updated pooled estimates towards null for all clinical outcomes assessed. DPPI use was not associated with increased incidence of cardiovascular mortality, MI, stroke, or MACE compared with placebo or alternative anti-diabetic agents.

META-ANALYSIS OF THE CARDIOVASCULAR OUTCOMES WITH DIPEPTIDYL PEPTIDASE 4 INHIBITORS: VALIDATION OF THE CURRENT FDA MANDATE

Background Earlier meta-analyses have demonstrated a significant reduction in major adverse cardiovascular events (MACE) with dipeptidyl peptidase 4-inhibitor (DPPI) use, as compared with placebo or alternative anti-diabetic therapies. However, the large phase III/IV trials, namely SAVOR-TIMI 53 and the EXAMINE trials, failed to demonstrate any significant differences in MACE between DPPI and placebo. We aimed to perform an updated meta-analysis of randomized controlled trials (RCTs) to investigate the differences in cardiovascular death, myocardial infarction (MI), and stroke between DPPI and placebo/alternative agents.

Efficacy and safety of intravascular ultrasound-guided percutaneous coronary intervention

Objective. Inclusion of intravascular ultrasound-guided (IVUS) guided percutaneous coronary intervention (PCI) has yet to achieve mainstream in invasive cardiology due to relative high cost of the procedure, ambiguous results in real world studies and steep learning curve. As a tool, IVUS has showed to be irreplaceable in examination of stent apposition, edge dissections and the plaque composition. Purpose of study was to examine efficacy and safety of IVUS-guided PCI vs. angiographically-guided PCI as a novel procedure. Methods. Total of 35 patients was examined by IVUS prior to stent placement and the acquired data was used to determine adequate stent size and length: percentage of stenosis, minimal luminal diameters (MLD), cross-sectional area (CSA) and distal referent diameter. Post PCI IVUS examination was repeated and CSA, residual stenosis and MLD were acquired. Also, stent size and length, deployment pressure and usage of additional post-dilatations were noted. Control group consisted of 35 match pairs with similar demographics, same vessel segment stented and same stent type used. Additional data was acquired from registry regarding acute complications and follow up at six months was also performed regarding target vessel revascularisation (TVR), major adverse cardiovascular events (MACE) and death. Results. Difference was observed in stent sizing, residual stenosis, post-dilatation and MLD in IVUS group. Also, TVR was 36% lower in IVUS group with no significant difference in MACE and death. Conclusion. Intravascular ultrasound-guided percutaneous coronary intervention in our center, upon introduction of the method, has shown reasonable safety and efficacy compared to conventional angiographically-guided percutaneous coronary intervention.