Significant Differences In Myocardial Infarction Research Articles

Transcatheter aortic valve replacement outcomes in patients with high gradient versus low ejection fraction low gradient severe aortic stenosis: A meta-analysis of randomized controlled trials

BackgroundThe outcome of Low Flow-Low Gradient (LF-LG) severe aortic stenosis (AS) patients who underwent Transcatheter Aortic Valve Replacement (TAVR) procedure is not well defined. We conducted a systematic review of the literature to compare the outcomes of TAVR in LF-LG AS patients to the more traditional high gradient (HG) aortic stenosis. MethodsWe comprehensively searched for controlled randomized and non-randomized studies from 4 online databases. We are presenting the data using risk ratios (95 % confidence intervals) and measuring heterogeneity using Higgins' I2 index. ResultsOur analysis included 4380 patients with 3425 HG patients and 955 LF-LG patients from 6 cohort (5 retrospective and 1 prospective) studies. When compared to LFLG; TAVR was associated with significantly lower 30 days mortality in HG patients (5.1 % vs 7.4 %; relative risk [RR]: 0.55; 95 % confidence interval [CI]: 0.35 to 0.86; p < 0.01). Similar findings were also observed in 12-month cardiovascular (CV) mortality (5.5 % vs. 10.4 %; RR: 0.47; 95 % CI: 0.38 to 0.60; p < 0.01 and 12-month all-cause mortality (15.9 % vs 20.9 %; RR: 0.70; 95 % CI: 0.49 to 1.00; p < 0.05). There was no significant difference in myocardial infarction (MI) after TAVR between HG and LF-LG at 30 days (0.16 % vs. 0.95 %; p < 0.09) or 12 months (0.43 % vs. 0.95 %; p = 0.20). Similarly, there was no difference in stroke rates at 30 days (2.9 % vs. 2.86 %) or at 12 months (3.6 % vs. 3.06 %). Conclusions and relevancePatients with LF-LG severe AS who underwent TAVR had worse 1-year all-cause mortality, 30-day all-cause, and 1-year CV mortality when compared to TAVR in HG severe AS. There was no difference in MI or stroke rates. Therefore, with heart team discussion and informed patient decision regarding the risk and benefit, TAVR would still offer better outcomes in LFLG AS compared to conservative medical management.

Coronary Angiography, Intravascular Ultrasound, and Optical Coherence Tomography for Guiding of Percutaneous Coronary Intervention: A Systematic Review and Network Meta-Analysis.

Results from multiple randomized clinical trials comparing outcomes after intravascular ultrasound (IVUS)- and optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with invasive coronary angiography (ICA)-guided PCI as well as a pivotal trial comparing the 2 intravascular imaging (IVI) techniques have provided mixed results. Major electronic databases were searched to identify eligible trials evaluating at least 2 PCI guidance strategies among ICA, IVUS, and OCT. The 2 coprimary outcomes were target lesion revascularization and myocardial infarction. The secondary outcomes included ischemia-driven target lesion revascularization, target vessel myocardial infarction, death, cardiac death, target vessel revascularization, stent thrombosis, and major adverse cardiac events. Frequentist random-effects network meta-analyses were conducted. The results were replicated by Bayesian random-effects models. Pairwise meta-analyses of the direct components, multiple sensitivity analyses, and pairwise meta-analyses IVI versus ICA were supplemented. The results from 24 randomized trials (15 489 patients: IVUS versus ICA, 46.4%, 7189 patients; OCT versus ICA, 32.1%, 4976 patients; OCT versus IVUS, 21.4%, 3324 patients) were included in the network meta-analyses. IVUS was associated with reduced target lesion revascularization compared with ICA (odds ratio [OR], 0.69 [95% CI, 0.54-0.87]), whereas no significant differences were observed between OCT and ICA (OR, 0.83 [95% CI, 0.63-1.09]) and OCT and IVUS (OR, 1.21 [95% CI, 0.88-1.66]). Myocardial infarction did not significantly differ between guidance strategies (IVUS versus ICA: OR, 0.91 [95% CI, 0.70-1.19]; OCT versus ICA: OR, 0.87 [95% CI, 0.68-1.11]; OCT versus IVUS: OR, 0.96 [95% CI, 0.69-1.33]). These results were consistent with the secondary outcomes of ischemia-driven target lesion revascularization, target vessel myocardial infarction, and target vessel revascularization, and sensitivity analyses generally did not reveal inconsistency. OCT was associated with a significant reduction of stent thrombosis compared with ICA (OR, 0.49 [95% CI, 0.26-0.92]) but only in the frequentist analysis. Similarly, the results in terms of survival between IVUS or OCT and ICA were uncertain across analyses. A total of 25 randomized trials (17 128 patients) were included in the pairwise meta-analyses IVI versus ICA where IVI guidance was associated with reduced target lesion revascularization, cardiac death, and stent thrombosis. IVI-guided PCI was associated with a reduction in ischemia-driven target lesion revascularization compared with ICA-guided PCI, with the difference most evident for IVUS. In contrast, no significant differences in myocardial infarction were observed between guidance strategies.

Comparison Between Drug-Coated Balloon and Stents in Large De Novo Coronary Artery Disease: A Systematic Review and Meta-Analysis of RCT Data.

Although a number of studies involving small-vessel de novo coronary disease showed clinical benefits of drug-coated balloons (DCB), the role of DCB in large vessel lesions is still unclear. We searched main electronic databases for randomized controlled trials (RCTs) comparing DCB with stents for large vessel de novo coronary artery disease. The primary endpoint was major cardiovascular adverse events (MACE), composite cardiovascular death (CD), myocardial infarction (MI), or target lesion revascularization (TLR). This study included 7 RCTs with 770 participants.DCB were associated with a marked risk reduction in MACE [Risk Ratio (RR): 0.48; 95% confidence interval [CI]: 0.24 to 0.97; P = 0.04], TLR (RR: 0.53; 95% CI: 0.25 to 1.14; P = 0.10), and late lumen loss [standard mean difference (SMD): -0.57; 95% CI: -1.09 to -0.05; P = 0.03] as compared with stents. There is no significant difference in MI (RR: 0.58; 95% CI: 0.21 to 1.54; P = 0.27), CD (RR: 0.33; 95% CI: 0.06 to 1.78; P = 0.19), and minimal lumen diameter (SMD: -0.34; 95% CI: -0.72 to 0.05; P = 0.08) between groups. In subgroup analyses, the risk reduction of MACE persisted in patients with chronic coronary syndrome (RR: 0.25; 95% CI: 0.07 to 0.89; P = 0.03), and patients receiving DCB vs. bare metal stent (RR: 0.19; 95% CI: 0.05 to 0.73; P = 0.01). In addition, there was no significant difference between the DCB group and the drug eluting stent group for MACE (RR: 0.69; 95% CI: 0.30 to 1.60; P = 0.38). DCB may be an effective therapeutic option in patients with large vessel de novo coronary artery disease.

The impacts of hypoxia-inducible factor stabilizers on laboratory parameters and clinical outcomes in chronic kidney disease patients with renal anemia: a systematic review and meta-analysis.

Renal anemia in chronic kidney disease (CKD) is associated with poor outcomes. Hypoxia-inducible factor (HIF) stabilizer, which induces endogenous erythropoietin synthesis and enhances iron mobilization, is a novel treatment for anemia in CKD. We conducted a systematic review and meta-analysis to analyze the effect of HIF stabilizers in anemic CKD patients. This meta-analysis included 43 officially published articles and 3 unpublished studies (27 338 patients). HIF stabilizer treatment significantly increased hemoglobin (Hb) level when compared with placebo (mean difference 1.19g/dL; 95% confidence interval 0.94 to 1.44g/dL; P<.001). There was no significant difference in Hb level when compared with erythropoiesis-stimulating agents (ESAs). Significant reductions of ferritin and transferrin saturation (TSAT) were observed, while total iron-binding capacity was increased in the HIF stabilizer group compared with placebo or ESAs. HIF stabilizers significantly reduced hepcidin, high-density lipoprotein, low-density lipoprotein and triglyceride levels. Acute kidney injury and thrombotic events were significantly observed in patients receiving HIF stabilizers. There were no significant differences in myocardial infarction, stroke, dialysis initiation, pulmonary hypertension and mortality between HIF stabilizer and control groups. The present meta-analysis provided evidence that HIF stabilizers increased Hb and TIBC levels and reduced hepcidin, ferritin and TSAT in CKD patients with renal anemia. Long-term follow-up studies on clinical outcomes of HIF stabilizers are still needed.

Anterior lumbar spinal fusion surgery associated with lower risk of stroke, pneumonia, and infection compared to posterior lumbar spinal fusion surgery

BackgroundPrior studies, comparing anterior and posterior approaches to lumbar fusion surgery, found similar fusion rates and clinical outcomes, but are limited by sample size. Further evaluation of the postoperative complications of each approach is necessary. MethodsThe MSpine database by PearlDiver was queried using ICD-9, ICD-10, and CPT codes to identify patients who had undergone single-level anterior or posterior lumbar interbody fusion surgery. Readmission rates, ileus, lower extremity DVT, infection, pneumonia, and stroke were used to compare post-operative complications of an anterior vs. posterior approach. Results112,023 patients were included in this study, with 38,529 (34.4%) in the anterior group (ALIF/LLIF) and 73,494 (65.6%) in the posterior group (PLIF/TLIF). At both 30 and 90-days postoperative, patients undergoing an anterior approach to lumbar interbody fusion had a higher odds ratio of lower extremity DVT (30-day OR: 1.19, 90-day OR: 1.16; P<0.05) and ileus complication (30-day OR: 1.87, P= <.05; 90-day OR: 1.81, P<.05). At both 30 and 90-days postoperative, patients undergoing a posterior approach had a higher odds ratio of stroke (30-day: OR: 0.79, 90-day OR: 0.87; P<0.05), transfusion (30-day OR: 0.66, 90-day OR: 0.69; P<.05), infection (30-day OR: 0.88, 90-day OR: 0.91; P <.05), and pneumonia (30-day OR: 0.85, 90-day OR: 0.90; P<.05). There was no statistically significant difference in myocardial infarction or pulmonary embolism between both approaches at 30 and 90-days postoperative. ConclusionsAnterior and posterior approaches for lumbar interbody fusion were associated with differences in postoperative complications at 30 and 90-days. The complication profiles associated with each approach can inform surgeon treatment decisions based on patient profiles.

Invasive and conservative treatment of spontaneous coronary artery dissection: a meta-analysis

Background. This study aims to compare clinical outcomes of SCAD patients initially managed with medical therapy (conservative approach) versus intervention strategy. Materials and methods. We identified relevant studies by performing a systematic search in the PubMed, Google Scholar, Web of Science databases available from 1994 until 2021. The search was conducted using PICO tool (Patient, Intervention, Comparison, Outcome). Results and Discussion. 25 studies involving 2577 patients with SCAD were included. Mean age of patients was 49,2 years, 1985 (77,0 %) were female. The primary conservative strategy performed in 1593 (61,8 %) cases. Mean follow-up duration was 28,5 months. The conservative therapy showed benefit when assessing the overall mortality (OR 0,48; CI 0,27–0,86, p = 0,01) and revascularization frequency (OR 0,43; 95 % CI 0,22–0,81, p = 0.01). Statistically significant differences in myocardial infarction (OR 1,05; 95 % CI 0,66–1,66, p = 0,85) or recurrent SCAD (OR 1,1; 95 % CI 0,7–1,72, p = 0,69) were not revealed. Conclusion. The primary conservative strategy of SCAD therapy is associated with lower overall mortality and further revascularization, but not MI and recurrent SCAD. Further research is needed to clarify the best therapeutic approach in patients with SCAD.

Impact of sex on long-term outcomes following mitral valve repair

IntroductionPrevious studies have identified inferior outcomes for women undergoing mitral valve (MV) surgery compared to men, although the cause of this discrepancy has not been identified. We look to isolate surgical approach to identify any impact that sex has on outcomes in order to better inform clinical decision making. Materials and methodsIn this propensity matched, retrospective, single-center study, outcomes were compared between males and females undergoing a MV repair between 2004 and 2018. The primary outcome was defined as mortality at any point in the follow-up period. Secondary outcomes included stroke, myocardial infarction (MI), repeat revascularization, complications arising from the initial procedure, and postoperative cardiac remodeling. ResultsA total of 188 males and 188 females were included after propensity matching. At a median follow up time of 7.6 years, there were 25 deaths in the male group (26.8%) and 23 in the female group (28.2%) (p = 0.771). There were no significant differences in MI, stroke, post-operative pacemaker insertion, or rehospitalization following MV repair. Left ventricular (LV) size for males was reduced from an initial 55.6 ± 7.3 mm to 49.9 ± 7.4 mm (p < 0.001), and for females from an initial 51.5 ± 7 mm to 46.9 ± 7.1 mm (p < 0.001). LV ejection fraction (LVEF) was reduced with a preoperative LVEF for males of 57.7% ± 8.9% and 53.7% ± 9.6% postoperatively (p = 0.002), and LVEF for females of 57.8% ± 9.1% preoperatively and 54.8% ± 9.2% postoperatively (p < 0.001). Left atrial (LA) volume was reduced from an initial 51 ± 22 ml/m2 to 43.7 ± 25.2 ml/m2 (p < 0.001), and 50.9 ± 19.2 ml/m2 to 44.2 ± 19.8 ml/m2 (p < 0.001), for males and females respectively. LA diameter was reduced for males from an initial 49.7 ± 9.7 mm to 47.3 ± 9.4 mm (p = 0.043), and from 48 ± 8.7 mm to 44.3 ± 9.1 mm for females postoperatively (p = 0.017). ConclusionsCurrent literature demonstrates inferior outcomes for females when compared to males undergoing MV surgery with patients undergoing a variety of surgical approaches. The results of this study suggest that surgical intervention for a subset of patients, those undergoing repair of the MV, is safe and offers similar outcomes for males and females.

Indirect comparison of the efficacy and safety of alirocumab and evolocumab: a systematic review and network meta-analysis.

Although alirocumab and evolocumab have both been associated with improved outcomes in patients with dyslipidaemia or established atherosclerotic cardiovascular disease, data on their respective performances are scarce. This study aimed at providing an indirect comparison of the efficacy and safety of alirocumab vs. evolocumab. We conducted a systematic review and network meta-analysis of randomized trials comparing alirocumab or evolocumab to placebo with consistent background lipid-lowering therapy up to November 2018. We estimated the relative risk (RR) and the 95% confidence intervals (CIs) using fixed-effect model in a frequentist pairwise and network meta-analytic approach. A total of 30 trials, enrolling 59 026 patients were included. Eligibility criteria varied significantly across trials evaluating alirocumab and evolocumab. Compared with evolocumab, alirocumab was associated with a significant reduction in all-cause death (RR 0.80, 95% CI 0.66-0.97) but not in cardiovascular death (RR 0.83, 95% CI 0.65-1.05). This study did not find any significant differences in myocardial infarction (RR 1.15, 95% CI 0.99-1.34), stroke (RR 0.96, 95% CI 0.71-1.28), or coronary revascularization (RR 1.13, 95% CI 0.99-1.29) between the two agents. Alirocumab was associated with a 27% increased risk of injection site reaction compared to evolocumab; however, no significant differences were found in terms of treatment discontinuations, systemic allergic reaction, neurocognitive events, ophthalmologic events, or new-onset of or worsening of pre-existing diabetes. Alirocumab and evolocumab share a similar safety profile except for injection site reaction. No significant differences were observed across the efficacy endpoints, except for all-cause death, which may be related to the heterogeneity of the studied populations treated with the two drugs.

Association between Atrial Fibrillation, Myocardial Infarction, Heart Failure and Mortality in Patients with Nontuberculous Mycobacterial Infection: a nationwide population-based study

NTM infection demonstrates an increasing incidence and prevalence. We studied the impact of NTM in cardiovascular events. Using the Korean nationwide database, we included newly diagnosed 1,730 NTM patients between 2005 and 2008 and followed up for new-onset atrial fibrillation (AF), myocardial infarction (MI), heart failure (HF), ischemic stroke (IS), and death. Covariates-matched non-NTM subjects (1:5, n = 8,650) were selected and analyzed. Also, NTM infection was classified into indolent or progressive NTM for risk stratification. During 4.16 ± 1.15 years of the follow-up period, AF, MI, HF, IS, and death were newly diagnosed in 87, 125, 121, 162, and 468 patients. In multivariate analysis, NTM group showed an increased risk of AF (hazard ratio [HR] 2.307, 95% confidence interval [CI] 1.560–3.412) and all-cause death (HR 1.751, 95% CI 1.412–2.172) compared to non-NTM subjects, whereas no significant difference in MI (HR 0.868, 95% CI 0.461–1.634), HF (HR 1.259, 95% CI 0.896–2.016), and IS (HR 1.429, 95% CI 0.981–2.080). After stratification, 1,730 NTM patients were stratified into 1,375 (79.5%) indolent NTM group and 355 (20.5%) progressive NTM group. Progressive NTM showed an increased risk of AF and mortality than indolent NTM group. Screening for AF and IS prevention would be appropriate in these high-risk patients.

P5367Indirect comparison of the safety and efficacy of alirocumab and evolocumab: from a comprehensive meta-analysis of 30 randomized controlled trials

Abstract Background Alirocumab and evolocumab, two proprotein convertase subtilisin–kexin type 9 inhibitors, have both been associated with improved outcomes in patients with atherosclerotic cardiovascular disease in addition to standard lipid-lowering therapies. However, their comparative safety and efficacy profiles are unknown. Purpose To compare the safety and efficacy of alirocumab versus evolocumab. Methods We conducted a systematic review and network meta-analysis of placebo-controlled randomized trials available up to November 2018 evaluating the safety and efficacy of alirocumab and evolocumab. We estimated risk ratio and 95% confidence intervals using fixed effect model in a frequentist pairwise and network metanalytic approach. The primary safety endpoints were any adverse events leading to treatment-discontinuation, injection site reaction, systemic allergic reaction, neurocognitive events, ophthalmologic events and new-onset of diabetes mellitus (DM) or worsening of pre-existing DM. The primary efficacy endpoints were all-cause and cardiovascular (CV) death, myocardial infarction (MI) and stroke. This study was registered in PROSPERO (CRD42018090768). Results A total of 30 trials, enrolling 59,026 patients were included in this analysis, of whom 13,607 received alirocumab and 17,931 received evolocumab. Mean weighted follow-up time was 2.5 years, with an exposure time of 144,907 patients-years. Eligibility criteria varied significantly across trials evaluating alirocumab and evolocumab. There were no significant differences between alirocumab and evolocumab in terms of safety endpoints, except for injection site reaction with a 27% increased risk of injection site reaction with alirocumab compared to evolocumab (Figure). Compared with evolocumab, alirocumab was associated with a reduction of all-cause death but not CV death. There were no significant differences in MI or stroke between alirocumab and evolocumab. Conclusion Alirocumab and evolocumab share a similar safety profile. No significant differences were observed across the efficacy endpoints, except for all-cause death, which may be related to heterogeneity of the studied populations between the two drugs.

Better Outcomes with New P2Y12 Antiplatelet Agents in ACS Patients in Australia

Objective: To determine the outcome of patients who received new P2Y12 antiplatelet agents (Ticagrelor or Prasugrel) compared with Clopidogrel following successful percutaneous intervention (PCI) for acute coronary syndrome (ACS). Methods: Retrospective analysis on patients undergoing successful PCI for ACS between January 2006 and June 2017. Follow-up was after one year with letter, phone call and file review. Results: 4941 patients (76% male) underwent successful PCI (57% BMS vs 43% DES) for ACS. In addition to aspirin, 87% of patients received Clopidogrel compared with 13% treated with new agents (mean age 64.4 and 59.3 years respectively). The use of new P2Y12 agents increased from 3.2% in 2010 to 28.5% in 2017. In 2017, new P2Y12 agents were used in 58% of STEMI, 32% of NSTEMI and 10% of unstable angina patients. Univariate analysis demonstrated that new P2Y12 agents were associated with lower incidence of death (2.44% vs 4.58% p = 0.01) and major adverse cardiac events (MACE) (7.46% vs 9.90% p = 0.04) but increased bleeding risk (BARC 2–3) (2.13% vs 1.05% p = 0.0176) at 1 year. There was no significant difference in myocardial infarction (2.74% vs 2.85% p = 0.87) or target lesion revascularisation (2.28% vs 3.13% p = 0.2). On multivariate analyses (including STEMI, cardiac arrest and shock), the new agents were an independent predictor of lower mortality (HR 1.85; 95%CI 1.11–3.28). Conclusions: The use of new P2Y12 agents in ACS was associated with lower mortality and MACE, but higher bleeding events. The higher bleeding rates with new P2Y12 agents may partly explain why these agents were under-utilised.

Influence of proton pump inhibitors on clinical outcomes in coronary heart disease patients receiving aspirin and clopidogrel

Background:Proton pump inhibitors (PPIs) are usually prescribed to protect against gastrointestinal bleeding in patients on dual antiplatelet therapy. This meta-analysis reviewed clinical outcomes in patients taking aspirin and clopidogrel, with and without concomitant PPIs to address concerns of adverse reactions.Methods:We searched PubMed, Embase, and the Cochrane Library for articles published between January 1, 2010 and April 11, 2017. The primary end points were major adverse cardiovascular events and gastrointestinal bleeding. Secondary end points were myocardial infarction, stent thrombosis, revascularization, cardiogenic death, and all-cause mortality.Results:The meta-analysis included 33,492 patients in 4 randomized controlled trials and 8 controlled observational studies. Overall, patients taking PPIs had statistical differences in major adverse cardiovascular events [odds ratio (OR) 1.17 (95% confidence interval [CI] 1.07–1.28); P = .001; I2 = 28.3%], gastrointestinal bleeding [OR 0.58 (95% CI 0.36–0.92); P = .022; I2 = 80.6%], stent thrombosis [OR 1.30 (95% CI 1.01–1.68); P = .041; I2 = 0%], and revascularization [OR 1.20 (95% CI 1.04–1.38); P = .011; I2 = 5.1%], compared those not taking PPIs. There were no significant differences in myocardial infarction [OR 1.03 (95% CI 0.87–1.22); P = .742; I2 = 0%], cardiogenic death [OR 1.09 (95% CI 0.83–1.43); P = .526; I2 = 0%], or all-cause mortality [OR 1.08 (95% CI 0.93–1.25); P = .329; I2 = 0%).Conclusions:Among the patients taking aspirin and clopidogrel, the results indicated that the combined use of PPIs increased the rates of major adverse cardiovascular events, stent thrombosis, and revascularization.

Abstract 21117: Comparison of Clinical Outcomes Between Clopidogrel and New P2Y12 Antagonist in Acute Myocardial Infarction Patients Treated With Percutaneous Coronary Intervention

Background: Recent studies have suggested new P2Y12 antagonists (prasugrel /ticagrelor) are more effective in high thrombotic conditions than conventional clopidogrel The aim of this study was to compare the clinical outcomes between clopidogrel abd new P2Y12 antagonist in acute myocardial infarction patients treated with percutaneous coronary intervention (PCI). Methods: Between November 2011 and January 2016, a total of 11,731 AMI patients treated with PCI (7580 patients were prescribed clopidogrel and 4151 patients new P2Y12 antagonists) were enrolled in the Korean Acute Myocardial Infarction Registry-National Institute of Health (KAMIR-NIH) database. Propensity score matching was performed to adjust for differences in baseline clinical variables. The primary endpoints were major adverse cardiovascular and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial infarction, target-lesion revascularization (TLR), and stroke. Results: After propensity matching (4151 pairs), the rate of MACCEs were more frequently occurred in the clopidogrel group than in the new P2Y12 (8.2% vs. 6.4%, p=0.002). The difference in MACCE between two groups was driven by cardiac death (4.7% vs. 3.3%, p&lt;0.001). There was no significant difference in myocardial infarction (0.7% vs. 0.6%, p=0.783), TLR (2.4% vs. 1.8%, p=0.337), and stroke (0.8% vs. 0.7%, p=0.336). However, the incidences of Thrombolysis In Myocardial Infarction (TIMI) minor bleeding showed a trend toward a lower incidence in the clopidogrel group (13.8% vs. 17.3%, p=0.057). Conclusion: Our study shows that new P2Y12 antagonist was associated lower rate of MACCE and cardiac mortality in AMI patients treated with PCI.

Redo aortic valve surgery versus transcatheter valve-in-valve implantation for failing surgical bioprosthetic valves: consecutive patients in a single-center setting.

Due to a considerable rise in bioprosthetic as opposed to mechanical valve implantations, an increase of patients presenting with failing bioprosthetic surgical valves in need of a reoperation is to be expected. Redo surgery may pose a high-risk procedure. Transcatheter aortic valve-in-valve implantation is an innovative, less-invasive treatment alternative for these patients. However, a comprehensive evaluation of the outcome of consecutive patients after a valve-in-valve TAVI [transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV)] as compared to a standard reoperation [surgical aortic valve redo-operation (SAV-in-SAV)] has not yet been performed. The goal of this study was to compare postoperative outcomes after TAV-in-SAV and SAV-in-SAV in a single center setting. All SAV-in-SAV and TAV-in-SAV patients from January 2001 to October 2014 were retrospectively reviewed. Patients with previous mechanical or transcatheter valves, active endocarditis and concomitant cardiac procedures were excluded. Patient characteristics, preoperative data, post-procedural complications, and 30-day mortality were collected from a designated database. Mean values ± SD were calculated for all continuous variables. Counts and percentages were calculated for categorical variables. The Chi-square and Fisher exact tests were used to compare categorical variables. Continuous variables were compared using the t-test for independent samples. A 2-sided P value <0.05 was considered statistically significant. A total of 102 patients fulfilled the inclusion criteria, 50 patients (49%) underwent a transcatheter valve-in-valve procedure, while 52 patients (51%) underwent redo-surgery. Patients in the TAV-in-SAV group were significantly older, had a higher mean logistic EuroSCORE and exhibited a lower mean left ventricular ejection fraction than patients in the SAV-in-SAV group (78.1±6.7 vs. 66.2±13.1, P<0.001; 27.4±18.7 vs. 14.4±10, P<0.001; and 49.8±13.1 vs. 56.7±15.8, P=0.019 respectively). Postoperative pacemaker implantation and chest tube output were higher in the SAV-in-SAV group compared to the TAV-in-SAV group [11 (21%) vs. 3 (6%), P=0.042 and 0.9±1.0 vs. 0.6±0.9, P=0.047, respectively]. There was no significant difference in myocardial infarction, stroke or dialysis postoperatively. Thirty-day mortality was not significantly different between the two groups [TAV-in-SAV2 (4%) vs. SAV-in-SAV0, P=0.238]. Kaplan-Meier (KM) 1-year survival was significantly lower in the TAV-in-SAV group than in the SAV-in-SAV group (83% vs. 96%, P<0.001). The present investigation shows that both groups, irrespective of different baseline comorbidities, show very good early clinical outcomes. While redo surgery is still the standard of care, a subgroup of patients may profit from the transcatheter valve-in-valve procedure.

Outcomes after percutaneous coronary intervention with stents in patients treated with thoracic external beam radiation for cancer.

The aim of this study was to assess outcomes after percutaneous coronary intervention (PCI) with stents in patients treated with thoracic external beam radiation therapy (EBRT). Thoracic EBRT for cancer is associated with long-term cardiotoxic sequelae. The impact of EBRT on patients requiring coronary stents is unclear. We analyzed outcomes after PCI in cancer survivors treated with curative thoracic EBRT before and after stenting between 1998 and 2012. Reference groups were propensity-matched cohorts with stenting but no EBRT. Primary endpoint was target lesion revascularization (TLR), a clinical surrogate for restenosis. Secondary endpoints included myocardial infarction (MI) and cardiac and overall mortality. We identified 115 patients treated with EBRT a median 3.6 years after stenting (group A) and 45 patients treated with EBRT a median 2.2 years before stenting (group B). Long-term mean TLR rates in group A (3.2 vs. 6.6%; hazard ratio: 0.6; 95% confidence interval: 0.2 to 1.6; p = 0.31) and group B (9.2 vs. 9.7%; hazard ratio: 1.2; 95% confidence interval: 0.4 to 3.4; p = 0.79) were similar to rates in corresponding control patients (group A: 1,390 control patients; group B: 439 control patients). Three years post-PCI, group A had higher overall mortality (48.6% vs. 13.9%; p < 0.001) but not MI (4.8% vs. 4.3%; p = 0.93) or cardiac mortality (2.3% vs. 3.6%; p = 0.66) rates versus control patients. There were no significant differences in MI, cardiac, or overall mortality rates in group B. Thoracic EBRT is not associated with increased stent failure rates when used before or after PCI. A history of PCI should not preclude the use of curative thoracic EBRT in cancer patients or vice versa. Optimal treatment of cancer should be the goal.

Differences in Ischemic and Hemorrhagic Recurrence Rates among Race-Ethnic Groups in the PRoFESS Secondary Stroke Prevention Trial

Epidemiological studies show that vascular risk factors are the same across the world but their effect vary between different race-ethnic groups. However, few studies have evaluated differences in recurrent stroke rates in various race-ethnicities. In >20 000 patients spanning 35 countries encompassing most race-ethnicities, we evaluated the incidence of ischemic and hemorrhagic strokes and myocardial infarction in patients within the context of the largest secondary stroke prevention trial (Prevention Regimen for Effectively Avoiding Secondary Strokes) to identify any significant differences. There were 20 332 patients with a recent ischemic stroke randomized in a factorial design to receive the antiplatelet agent clopidogrel vs. aspirin plus extended-release dipyridamole, and 80 mg of the anthypertensive telmisartan vs. placebo. The primary outcome for the trial was the time to any recurrent stroke. Statistical analysis was used to detect race-ethnic differences in recurrent vascular events. Mean patient age was 66 (±8·6) years and 36% were women. The study included 58% European/Caucasian, 33% Asians, 5% Latin/Hispanic, and 4% Black African. There were 74% of patients that were hypertensive, and average systolic and diastolic blood pressure was 144·1/83·8 mmHg. There was at least one significant difference in the overall test of all race-ethnic groups in myocardial infarction and symptomatic intracerebral hemorrhage occurrence. In the Kaplan-Meier hemorrhage and stroke-free survival curves, Asians showed a significantly higher recurrence of ischemic stroke risk in the 135-150 mmHg and greater than 150 mm Hg blood pressure groups, and a greater risk of hemorrhage recurrence in the greater than 150 mmHg blood pressure group. We found a significant difference in myocardial infarction and symptomatic intracerebral hemorrhage recurrence among different race-ethnic groups. The risk of recurrent ischemic and hemorrhagic stroke was greater in Asians with high blood pressure.

Seven-Year Clinical Outcomes of Sirolimus-Eluting Stent Versus Bare-Metal Stent: A Matched Analysis From A Real World, Single Center Registry

The aim of this study is to compare clinical outcomes for seven years, between sirolimus-eluting stent (SES) and bare metal stent (BMS). During the BMS and drug-eluting stent (DES) transition period (from April 2002 to April 2004), 434 consecutive patients with 482 lesions underwent percutaneous coronary intervention, using BMS or SES. Using propensity score matching, 186 patients with BMS and 166 patients with SES were selected. Seven year clinical outcomes of major adverse cardiac events (MACE), such as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization (TVR), and angiographic definite stent thrombosis (ST) were compared. At one-year follow up, patients with SES showed significantly lower MACE (9.1% in BMS vs 3.0% in SES, P = 0.024). However, cumulative MACE for 7 yr was not significantly different between two groups (24.7% in BMS vs 17.4% in SES, P = 0.155). There was no significant difference in MI, TVR, death and ST. The TVR were gradually increased from 1 to 7 yr in SES, on the contrary to that of BMS. In conclusion, although SES showed better clinical outcomes in the early period after implantation, it did not show significant benefits in the long-term follow up, compared with that of BMS.

Comparison of Additional Versus No Additional Heparin During Therapeutic Oral Anticoagulation in Patients Undergoing Percutaneous Coronary Intervention

Uninterrupted oral anticoagulation (OAC) therapy can be the preferred strategy in patients with atrial fibrillation at moderate to high risk of thromboembolism undergoing percutaneous coronary intervention (PCI). To evaluate the need for additional heparins in addition to therapeutic peri-PCI OAC, we assessed bleeding complications and major adverse cardiac and cerebrovascular events in 414 consecutive patients undergoing PCI during therapeutic (international normalized ratio 2 to 3.5) periprocedural OAC. Patients were divided into those with no (n = 196) and with (n = 218) additional use of periprocedural heparins. No differences in major adverse cardiac and cerebrovascular events (4.1% vs 3.2%, p = 0.79) or major bleeding (1.0% vs 3.7%, p = 0.11) were detected, but access site complications (5.1% vs 11.0%, p = 0.032) were less frequent in those without additional heparins. When adjusted for propensity score, patients with additional heparins had a higher risk of access site complications (odds ratio 2.6, 95% confidence interval 1.1 to 6.1, p = 0.022) without any increased risk of any other adverse event. Analysis of 1-to-1 propensity-matched pairs showed a significantly higher risk of access site complication in patients receiving additional AC (13.1% vs 5.7%, p = 0.049). In conclusion, therapeutic warfarin treatment seems to provide sufficient AC for PCI. Additional heparins are not needed and may increase access site complications.

Off-pump versus on-pump coronary artery bypass grafting for ischaemic heart disease

Coronary artery bypass grafting (CABG) is performed both without and with cardiopulmonary bypass, referred to as off-pump and on-pump CABG respectively. However, the preferable technique is unclear. To assess the benefits and harms of off-pump versus on-pump CABG in patients with ischaemic heart disease. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (Issue 1, 2011), MEDLINE (OVID, 1950 to February 2011), EMBASE (OVID, 1980 to February 2011), Science Citation Index Expanded on ISI Web of Science (1970 to February 2011) and CINAHL (EBSCOhost, 1981 to February 2011) on 2 February 2011. No language restrictions were applied. Randomised clinical trials of off-pump versus on-pump CABG irrespective of language, publication status and blinding were selected for inclusion. For statistical analysis of dichotomous data risk ratio (RR) and for continuous data mean difference (MD) with 95% confidence intervals (CI) were used. Trial sequential analysis (TSA) was used for analysis to assess the risk of random error due to sparse data and to multiple updating of accumulating data. Eighty-six trials (10,716 participants) were included. Ten trials (4,950 participants) were considered to be low risk of bias. Pooled analysis of all trials showed that off-pump CABG increased all-cause mortality compared with on-pump CABG (189/5,180 (3.7%) versus 160/5144 (3.1%); RR 1.24, 95% CI 1.01 to 1.53; P =.04). In the trials at low risk of bias the effect was more pronounced (154/2,485 (6.2%) versus 113/2,465 (4.6%), RR 1.35,95% CI 1.07 to 1.70; P =.01). TSA showed that the risk of random error on the result was unlikely. Off-pump CABG resulted in fewer distal anastomoses (MD -0.28; 95% CI -0.40 to -0.16, P <.00001). No significant differences in myocardial infarction, stroke, renal insufficiency, or coronary re-intervention were observed. Off-pump CABG reduced post-operative atrial fibrillation compared with on-pump CABG, however, in trials at low risk of bias, the estimated effect was not significantly different. Our systematic review did not demonstrate any significant benefit of off-pump compared with on-pump CABG regarding mortality, stroke, or myocardial infarction. In contrast, we observed better long-term survival in the group of patients undergoing on-pump CABG with the use of cardiopulmonary bypass and cardioplegic arrest. Based on the current evidence, on-pump CABG should continue to be the standard surgical treatment. However, off-pump CABG may be acceptable when there are contraindications for cannulation of the aorta and cardiopulmonary bypass. Further randomised clinical trials should address the optimal treatment in such patients.

Ecological Studies and Cardiovascular Outcomes Research

Is it better to have a heart attack in the United States or Canada? Ecological studies are epidemiological evaluations in which the unit of analysis is populations, or groups of people, rather than individuals.1 They can answer important questions such as the question posed above that cannot easily be answered using any other form of study design. Ecological studies are conducted by researchers in a variety of disciplines, including outcomes researchers, to study potential causal associations between 1 or more exposure and outcome variables. They are frequently used where alternative study designs are not possible (eg, randomized control trials), such as when investigating the effect of geographical and temporal factors on disease incidence or the effect of a government policy change on health outcomes. In this overview, we provide an introduction to the use of ecological studies in cardiovascular outcomes research, drawing on published examples from our group and others. It is important for clinicians to be aware of both the potential strengths and weaknesses of this type of study design. Because ecological studies are ubiquitous in the medical literature, it is not possible to review all published cardiovascular ecological studies in a systematic manner. Individual-level variables are properties of each person whereas ecological variables are properties of groups, organizations, or places.1,2 All ecological studies are potentially prone to the so-called “ecological fallacy,” which is a term for the biases that may occur when the association that exists between variables at an aggregate level may not represent the true association that exists at an individual level.3 On the other hand, the ecological fallacy may be offset by avoidance of the “individualistic fallacy” whereby one assumes that individual patients are unaffected by the neighborhood in which they live or the setting in which they are treated.4 Complete …