Systematic Review on Role of Drug Eluting Stent (DES) Versus Drug-Coated Balloon (DCB) in Small Vessel Coronary Artery Disease.

PURPOSE OF REVIEW: This review aims to explain the current advancements in the treatment modalities for small vessel coronary artery disease (SVCAD) and de novo lesions post-percutaneous coronary intervention (PCI), focusing on drug-coated stents (DES) and drug-coated balloons (DCB). Its goal is to address the lack of standards in the management of these lesions and to assess the potential of DCB as a preferential treatment strategy over DES in the long term. RECENT FINDINGS: Technological advancements have improved drug-eluting stents (DES) and drug-coated balloons (DCB) which offer a more promising avenue for managing SVCAD. According to new data, DCBs, initially recognized for their efficacy in preventing restenosis within three to five years of stent placement, may offer superior outcomes compared to DES in certain clinical scenarios. This review shows that DCBs have a favorable therapeutic profile in the treatment of SVCAD, and they could be considered as an alternative to DES. Although the initial data is compelling, definitive conclusions cannot be met without further large-scale, long-term clinical trials. The implication of these findings suggests a shift in the future of SVCAD management and requires additional research to substantiate the long-term benefits of DCB use in SVCAD. Should ongoing and future studies corroborate the current evidence, DCB could emerge as the standard of care for SVCAD, significantly influencing clinical practices and future research.

To Anticoagulate or Not to Anticoagulate in COVID-19: Lessons after 2 Years.

A hypercoagulable state associated with coronavirus disease 2019 (COVID-19) has been well documented and is believed to be strongly supported by a proinflammatory state. The hypercoagulable state in turn results in increased incidence of arterial and venous thromboembolism (VTE) seen in hospitalized COVID-19 when compared with hospitalized non-COVID-19 patient cohorts. Moreover, patients with arterial or VTE and COVID-19 have higher mortality compared with COVID-19 patients without arterial or VTE. Prevention of arterial or VTE thus remains an essential question in the management of COVID-19 patients, especially because of high rates of reported microvascular and macrovascular thrombosis. This has prompted multiple randomized control trials (RCTs) evaluating different anticoagulation strategies in COVID-19 patients at various stages of the disease. Herein, we review findings from RCTs in the past 2 years of antithrombotic therapy in critically ill hospitalized patients, noncritically ill hospitalized patients, patients postdischarge from the hospital, and outpatients. RCTs in critically ill patients demonstrated therapeutic dose anticoagulation does not improve outcomes and has more bleeding than prophylaxis dose anticoagulant in these patients. Trials in noncritically ill hospitalized patients showed a therapeutic dose anticoagulation with a heparin formulation might improve clinical outcomes. Anticoagulation with a direct oral anticoagulant posthospital discharge may improve outcomes, although there is a large RCT in progress. Nonhospitalized COVID-19 patients have an insufficient burden of events to be candidates for antithrombotic therapy. Anticoagulation in pregnant and lactating patients with COVID-19, as well as antiplatelet therapy for COVID-19, is also reviewed.

Does the ISCHEMIA Trial Apply to My Patients?

PURPOSE OF REVIEW: The ISCHEMIA trial demonstrated no difference in myocardial infarction or death in patients with stable coronary disease and moderate or large ischemia territory treated either with invasive revascularization or optimal medical therapy. Whether the findings of the randomized control trial relates to real-world outcomes is uncertain. RECENT FINDINGS: Contemporary guideline-directed medical therapy has had a significant impact on the prognosis of coronary artery disease. Various observational data appear to indicate limited generalizability of the ISCHEMIA trial in different populations. Further studies are warranted to evaluate the optimal modality of therapy in patients with stable coronary disease and moderate or severe ischemia. The applicability of ISCHEMIA and ISCHEMIA-CKD trials still requires further validation.

Dual antithrombotic therapy in PCI: Potential harm in routine adoption.

Randomized clinical trials support the use of dual antithrombotic therapy (DAT) in PCI patients but outcomes in clinical practice are unclear. In this observational study of patients at high risk for thromboembolism and bleeding, routine use of a P2Y12 inhibitor alone compared with DAPT with OAC was associated with a significantly higher risk of ischemic events without a lower risk of bleeding. Future randomized trials and observational analyses of large registries are needed to select the ideal patient population for DAT.

Outcomes of multivessel vs culprit lesion-only percutaneous coronary intervention in patients with acute myocardial infarction complicated by cardiogenic shock: Evidence from an updated meta-analysis.

OBJECTIVES: This updated meta-analysis evaluated outcomes with multi-vessel (MV-PCI) vs culprit lesion-only percutaneous coronary intervention (CL-PCI), in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS). BACKGROUND: There is considerable debate regarding the optimal revascularization strategy in patients with AMI and CS, particularly regarding management of non-culprit lesions. METHODS: Databases were searched for studies comparing MV-PCI and CL-PCI in patients with AMI and CS. The primary outcome of interest was short-term all-cause mortality. Secondary outcomes included long-term mortality, repeat revascularization and myocardial reinfarction. Safety outcomes were stroke, acute renal failure and major bleeding. Pooled odds ratios (OR) and 95% confidence intervals (CI) were estimated using random-effects models. RESULTS: Our meta-analysis consisting of 14 studies (13 observational, 1 RCT) involving 8,552 patients showed that in comparison to CL-PCI, MV-PCI was associated with similar short-term mortality (OR 1.14; 95% CI 0.9-1.43), as well as similar long-term mortality (OR 0.94; 95% CI 0.68-1.28). There was no significant difference in the risk of myocardial reinfarction (OR 1.19; 95% CI 0.76-1.86), or repeat revascularization (OR 0.79; 95% CI 0.41-1.55) between the two groups. Compared to CL-PCI, MV-PCI was associated with a similar risk of bleeding (OR 1.13; 95% CI 0.91-1.40) and stroke (OR 1.28; 95% CI 0.84-1.96), but a higher risk of developing renal failure (OR 1.32; 95% CI 1.05-1.65). CONCLUSIONS: Our meta-analysis suggests that there is a higher risk of renal failure with no additional benefit in efficacy outcomes with MV-PCI, compared to CL-PCI in patients with AMI and CS.

Etiologies, trends, and predictors of readmission in ST-elevation myocardial infarction patients undergoing multivessel percutaneous coronary intervention.

BACKGROUND: Recent trials have shown benefits with percutaneous coronary intervention (PCI) on nonculprit coronary vessels in select ST-elevation myocardial infarction (STEMI) patients with multivessel coronary artery disease (CAD). However, readmission rates and causes in this high-risk group are unknown. Objective of this study is to explore pattern, causes and factors associated with 30-day readmission after multivessel PCI in STEMI patients. METHODS AND RESULTS: Nationwide Readmissions Data (NRD) between 2010 and 2014 was utilized to identify multivessel PCI cases in STEMI patients using appropriate ICD-9 codes. We evaluated 30-day readmission rate and factors associated with 30-day readmission. Hierarchical logistic regression model was used to identify factors associated with 30-day readmission. Among 22,257 STEMI patients who survived to discharge after multivessel PCI, 2,302 (10.3%) were readmitted within 30-days. Subsequent unresolved/aggravated cardiac issues most commonly triggered readmission (62.66%). Among cardiac causes, heart failure and ischemic heart disease were most frequent etiologies. Advancing age (OR: 1.073, 95%CI: 1.026 to 1.122, p = .002), female sex (OR: 1.36, 95%CI: 1.23 to 1.50, p < .001), comorbid conditions like chronic kidney disease (CKD; OR: 1.35, 95%CI: 1.17 to 1.57, p = .001), congestive heart failure (CHF; OR: 1.40, 95%CI: 1.24 to 1.57, p = .04), anemia (OR: 1.16, 95%CI: 1.002 to 1.34, p = .04), and utilization of a mechanical circulatory support (MCS) device (OR: 1.45, 95%CI: 1.19 to 1.77, p < .001) during the index procedure were predictive of subsequent readmission within 30 days. CONCLUSION: In this large nationally representative study, nearly one in 10 patients were readmitted within 30 days from discharge after index admission for multivessel PCI in STEMI, most commonly for cardiac causes.

Hybrid coronary revascularization versus coronary artery bypass grafting in patients with multivessel coronary artery disease: A meta-analysis.

OBJECTIVES: This meta-analysis evaluated the effectiveness of hybrid coronary revascularization (HCR) compared to coronary artery bypass grafting (CABG) for the treatment of multivessel coronary artery disease (MVCAD). BACKGROUND: HCR involves a combination of surgical and percutaneous techniques, which in selected patients may present an alternative to conventional CABG. METHODS: Databases were searched through June 30, 2016, and studies comparing HCR with CABG for treatment of MVCAD were selected. We calculated summary odds ratios (ORs) and 95% CIs with the random-effects model. The primary outcome of interest was the occurrence of major adverse cardiac and cerebrovascular events (MACCE), defined as a composite of all cause mortality, myocardial infarction, and stroke. RESULTS: The analysis included 2,245 patients from 8 studies (1 randomized controlled trial and 7 observational studies). The risk of MACCE with HCR and CABG were 3.6% and 5.4%, respectively (OR, 0.53; 95% CI, 0.24-1.16). Compared to CABG group, patients in HCR group had similar risk of all cause mortality (OR, 0.85; 95% CI, 0.38-1.88), myocardial infarction (OR, 0.72; 95% CI, 0.31-1.64), stroke (OR, 0.53; 95% CI, 0.23-1.20), and repeat revascularization (OR, 1.28; 95% CI, 0.58-2.83). The need for postoperative blood transfusions (OR, 0.29; 95% CI, 0.14-0.59) and hospital stay (weighted mean difference -1.20 days; 95% CI -1.52 to -0.88 days) was significantly lower in the HCR group. CONCLUSION: HCR appears to be safe, and has similar outcomes when compared with conventional CABG. HCR can be a suitable alternative to conventional CABG in select patients with MVCAD. © 2017 Wiley Periodicals, Inc.

Variant Angina and Aborted Sudden Cardiac Death.

PURPOSE OF REVIEW: Variant angina, which is characterized by recurrent chest pain and transient ECG changes along with angiographic evidence of coronary artery spasm, generally has a favorable prognosis. However, episodes of ischemia caused by vasospasm may lead to potentially life-threatening ventricular arrhythmias and cardiac arrest, even in patients with no history of prior cardiac disease. This review describes the epidemiology, pathogenesis, clinical spectrum, and management of variant angina, as well as outcomes in patients who present with aborted sudden cardiac death (ASCD). RECENT FINDINGS: Contrary to prior opinions, evidence from recent observational studies indicate that patients with variant angina presenting with ASCD face a worse prognosis than those without this type of presentation. Predictors of ASCD include age, hypertension, hyperlipidemia, family history of sudden cardiac death, multi-vessel spasm, and left anterior descending artery spasm. Medical therapy alone with calcium channel blockers and nitrates may not be sufficiently protective in these patients and there is lack of concrete data on the optimal management strategy. Current guidelines recommend implantable cardiac defibrillator (ICD) therapy in patients who are survivors of cardiac arrest caused by ventricular fibrillation or unstable ventricular tachycardia after reversible causes are excluded, and should strongly be considered in these patients. Although medical therapy is absolutely imperative for patients with variant angina and a history of ASCD, ICD therapy in these patients is justified. Further large-scale studies are required to determine whether ICD therapy can improve survival in this high-risk group of patients.

SYNTAX Score and Outcomes of Coronary Revascularization in Diabetic Patients.

PURPOSE OF REVIEW: This review describes the dynamic relationship between diabetes mellitus (DM) and coronary artery disease (CAD) with respect to different revascularization strategies and how angiographic tools such as the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score can supplement clinical decision-making. RECENT FINDINGS: The SYNTAX score characterizes the anatomical extent of CAD in terms of the number of lesions, functional importance, and complexity. Studies not limited to patients with DM suggest that percutaneous coronary intervention (PCI) is a reasonable alternative to coronary artery bypass grafting (CABG) in patients with low-medium SYNTAX scores, while patients with high SYNTAX scores should be revascularized with CABG if operable. Similar findings were also observed for diabetes patients with multivessel disease in retrospective pooled analysis. The SYNTAX II score combines anatomical and clinical risk to improve upon the decision regarding the optimal revascularization strategy. The SYNTAX II score can be applied to patients with DM. The SYNTAX scores provide guidance to clinicians faced with determining the optimal revascularization strategy in patients with DM and advanced CAD. Using a heart team approach, the information can be considered along with other factors that influence PCI or CABG risk.

Therapeutic Options for In-Stent Restenosis.

PURPOSE OF REVIEW: In-stent restenosis (ISR) is a complex disease process that became apparent shortly after the introduction of stents into clinical practice. This review seeks to define in-stent restenosis (ISR) as well as to summarize the major treatment options that have been developed and studied over the past two decades. RECENT FINDINGS: Recent developments in drug-coated balloons and bioresorbable vascular scaffolds have added new potential treatments for ISR. Two recent network meta-analyses performed a head-to-head comparison of all the various treatment modalities in order to identify the best approach to management of ISR. Current data suggests that repeat stenting with second-generation drug-eluting stents is most likely to lead to the best angiographic and clinical outcomes. In situations where repeat stenting is not preferable, drug-coated balloon therapy seems to be a reasonably effective alternative.

Intravascular ultrasound-guided vs angiography-guided drug-eluting stent implantation in complex coronary lesions: Meta-analysis of randomized trials.

The relative outcomes of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) compared with angiography-guided PCI with drug-eluting stent (DES) in complex lesions have not been established. We sought to compare the efficacy and safety of IVUS-guided PCI with angiography-guided PCI in patients with complex coronary lesions treated with DES. METHODS: Electronic databases were searched to identify all randomized trials comparing IVUS-guided vs angiography-guided DES implantation. We evaluated major adverse cardiac events (MACE), all-cause and cardiovascular death, myocardial infarction, target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis outcomes at the longest reported follow-up. Random-effects modeling was used to calculate pooled relative risk (RR) and 95% CIs. RESULTS: Eight trials comprising 3,276 patients (1,635 IVUS-guided and 1,641 angiography-guided) enrolling only patients with complex lesions were included. Mean follow-up was 1.4±0.5years. Compared with angiography-guided PCI, patients undergoing IVUS-guided PCI had significantly lower MACE (RR 0.64, 95% CI 0.51-0.80, P=.0001), TLR (RR 0.62, 95% CI 0.45-0.86, P=.004), and TVR (RR 0.60, 95% CI 0.42-0.87, P=.007). There were no significant differences for stent thrombosis, cardiovascular death, or all-cause death. In meta-regression analysis, IVUS-guided PCI was of greatest benefit in reducing MACE in patients with acute coronary syndromes, diabetes, and long lesions. CONCLUSIONS: The present meta-analysis demonstrates a significant reduction in MACE, TVR, and TLR with IVUS-guided DES implantation in complex coronary lesions.

Risk of contrast-induced acute kidney injury in ST-elevation myocardial infarction patients undergoing multi-vessel intervention-meta-analysis of randomized trials and risk prediction modeling study using observational data.

OBJECTIVES: Ascertaining risk of contrast induced acute kidney injury (CI-AKI) in ST-segment elevation myocardial infarction (STEMI) patients undergoing multi-vessel percutaneous coronary intervention (MV-PCI). BACKGROUND: Complete revascularization may improve outcomes in STEMI patients with multi-vessel disease. However, a practice of MV-PCI may be associated with a higher risk of CI-AKI. We aimed to evaluate the risk of CI-AKI in patients with STEMI and MV-PCI and examine the accuracy of a validated risk score. METHODS: We searched PubMed, Cochrane Library, EMBASE, EBSCO, Web of Science, and CINAHL databases from inception through August 31, 2016 for randomized studies comparing CI-AKI rates with MV-PCI and infarct-related artery (IRA) only PCI during index hospitalization. A random effects model was used to estimate the risk ratio (RR) and respective 95% confidence intervals (CI). We queried the Nationwide Inpatient Sample (NIS) to assess the ability of the Mehran risk score to accurately predict the incidence of CI-AKI in patients undergoing MV-PCI. RESULTS: Four randomized studies (N = 1,602) were included in the final analysis. The risk of CI-AKI was low and no difference was observed with MV-PCI (1.45%) compared with IRA-only (1.94%) (RR 0.73, 95% CI 0.34-1.57; P = 0.57). From 2009 to 2012, excluding shock, there were 11,454 MV-PCI for STEMI patients in the NIS. The Mehran risk score accurately discriminated 78% of the patients who developed CI-AKI in this cohort (c-statistic of 0.78, P = 0.002). CONCLUSIONS: MV-PCI in STEMI is not associated with a higher risk of CI-AKI and the Mehran risk score can identify patients at higher risk for this complication. © 2017 Wiley Periodicals, Inc.

Transcatheter versus surgical aortic valve replacement in intermediate-risk patients: Evidence from a meta-analysis.

OBJECTIVES: We performed a meta-analysis to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in comparison to surgical aortic valve replacement (SAVR) in intermediate-risk patients. BACKGROUND: TAVR is an established treatment option in high-risk patients with severe aortic valve stenosis (AS). There are fewer data regarding efficacy of TAVR in intermediate-risk patients. METHODS: Databases were searched through April 30, 2016 for studies that compared TAVR with SAVR for the treatment of intermediate-risk patients with severe AS. We calculated summary risk ratios (RRs) and 95% confidence intervals (CIs) with the random-effects model. RESULTS: The analysis included 4,601 patients from 7 studies (2 randomized and 5 observational). There was no significant difference in all-cause mortality between the two groups after mean follow-up of 1.15 years [14.7% with TAVR vs 15.4% with SAVR; RR 0.93; 95% CI 0.77-1.12]. TAVR resulted in lower rates of acute kidney injury [number needed to treat (NNT) = 26], major bleeding (NNT = 4), and atrial-fibrillation (NNT = 6), but higher rates of major vascular complications [number needed to harm (NNH)= 18], and moderate/severe aortic regurgitation (NNH = 13). The rate of permanent-pacemaker implantation was significantly higher with TAVR in observational studies (RR 2.31; 95% CI 1.22-2.81), but not in RCTs (RR 1.21; 95% CI 0.93-1.56). No significant difference in the rate of stroke or myocardial infarction was observed. CONCLUSIONS: Our analysis of mid-term results showed that TAVR has similar clinical efficacy to SAVR in intermediate-risk patients with severe AS, and can be a suitable alternative to surgical valve replacement. © 2017 Wiley Periodicals, Inc.

Is multivessel intervention in ST-elevation myocardial infarction associated with early harm? Insights from observational data.

OBJECTIVES: Appraisal of evidence for recommendations for multivessel coronary intervention in ST-elevation myocardial infarction (STEMI). BACKGROUND: Multi-vessel disease (MVD) is common in patients with ST-segment elevation myocardial infarction (STEMI). Published observational data has suggested that multi-vessel percutaneous coronary intervention (MVPCI) at the time of initial hospitalization for STEMI may be harmful in contrast to evidence from recent randomized trials. METHODS: We queried the nationwide inpatient sample (NIS) to identify characteristics of hemodynamically stable STEMI patients undergoing MVPCI on index admission and subsequent mortality in raw and adjusted models. To compare our results with published observational data, we searched multiple databases from inception through July 15, 2015. RESULTS: From 2009-2012, excluding cardiac arrest or cardiogenic shock, there were 11,454 MVPCI and 157,011 single-vessel PCI (SVPCI) for STEMI patients in the NIS. Compared to SVPCI, MVPCI on index admission was not associated with higher in-hospital mortality in unadjusted or propensity-adjusted models (MVPCI 1.91% vs. SVPCI 5.32%, P < 0.001). Our analysis of index hospitalization MVPCI versus infarct-related artery (IRA)-only PCI in the meta-analysis of observational studies (19 studies, N = 76,399) demonstrated no difference in in-hospital mortality with MVPCI compared with IRA-only PCI (OR 0.87, 95% CI 0.65-1.17; P = 0.37), with confirmation in study sequential analysis. CONCLUSIONS: MVPCI is uncommonly performed during index hospitalization in hemodynamically stable STEMI patients, likely reflecting widespread adherence to prior guidelines. Based on observational data, there does not appear to be early harm associated with MVPCI on the index admission in hemodynamically stable STEMI patients. © 2016 Wiley Periodicals, Inc.

Does Surgical Repair of Moderate Ischemic Mitral Regurgitation Improve Survival? A Systematic Review.

Mitral regurgitation (MR) is one of the common complications in myocardial infarction (MI) patients. Almost half of the post MI patients have MR (ischemic MR)(17) which is moderate to severe (grade II-IV). Whether there is a mortality benefit of performing mitral valve repair (MVR) along with coronary artery bypass grafting (CABG) in patients with post MI moderate MR remains inconclusive. Literature search was done from PubMed, Google scholar, Ovid, and Medline databases. Studies which included post MI patients with moderate ischemic MR and reported mortality outcomes of performing CABG and MVR were chosen for the systematic review. Our preliminary literature search identified 194 studies, of which 11 studies met our inclusion criteria. Nine studies showed no survival benefit of performing simultaneous MVR and CABG. One study demonstrated survival benefit of performing CABG plus MVR only in the New York Heart Association (NYHA) class III-IV, and one study suggested survival benefit of performing CABG plus MVR as compared to CABG alone in patient with ischemic MR irrespective of preoperative NYHA functional class. Review of current literature showed mixed results in terms of improvement in functional status but failed to show any survival benefit of performing MVR along with CABG. Limitations of studies include small sample size, difference in baseline demographic variables, and short follow-up period which might influence the outcome of the study. Prospective randomized studies are required to establish clear benefit of performing MVR simultaneously with CABG.

Endovascular therapy for acute ischaemic stroke: a systematic review and meta-analysis of randomized trials.

AIMS: Evidence from randomized controlled trials (RCTs) evaluating possible benefits of endovascular therapy (EVT) for acute ischaemic stroke has shown conflicting results. The purpose of this meta-analysis was to systematically examine clinical outcomes in RCTs comparing the use of intravenous (IV) fibrinolysis alone to IV fibrinolysis plus EVT, for the treatment of acute ischaemic stroke. METHODS AND RESULTS: We selected English language RCTs, comparing EVT plus IV tissue-type plasminogen activator (tPA) (if eligible) with IV tPA alone in eligible patients for the treatment of acute ischaemic stroke. The primary endpoint was good functional outcome [modified Rankin Scale (mRS) of 0-2]. Other major endpoints of interest were all-cause mortality and symptomatic intracerebral haemorrhage (sICH). The meta-analysis included 8 RCTs that randomized 2423 patients with large-vessel, anterior-circulation stroke. EVT significantly improved the rate of functional independence (90-day mRS of 0-2) when compared with IV fibrinolysis [odds ratio (OR) 1.73, 95% confidence interval (CI) 1.18-2.53, number needed to treat (NNT) = 9.3]. The all-cause mortality was lower with EVT compared with the control group; however, the result did not reach statistical significance (OR 0.89, 95% CI 0.68-1.15). The rate of sICH was not higher with EVT (OR 1.07, 95% CI 0.73-1.56). Analyses from only the recent trials (reported in 2014-15) showed further benefit (OR of mRS 0-2: 2.42, 95% CI 1.91-3.08, NNT = 5) with similar safety results. CONCLUSION: In centres with advanced systems of stroke care, EVT significantly improved functional outcomes (without compromising safety) in patients with acute ischaemic stroke due to anterior circulation, large artery occlusion, compared with standard therapy.

Short- and long-term outcomes in diabetes patients undergoing percutaneous coronary intervention with bivalirudin compared with heparin and glycoprotein IIb/IIIA inhibitors: A meta-analysis of randomized trials.

BACKGROUND: Diabetes patients undergoing percutaneous coronary intervention (PCI) have more complications than nondiabetes patients, including increased long-term mortality. Use of bivalirudin versus heparin and glycoprotein IIb/IIIa inhibitors (GPI) in diabetes patients undergoing PCI and its effect on long-term mortality were evaluated in few randomized trials, but with conflicting results. METHODS: We searched the literature for randomized controlled trials that compared heparin and GPI therapy with bivalirudin in diabetes patients undergoing PCI. The incidence of major adverse cardiovascular events (MACE), death from any cause, myocardial infarction (MI), urgent revascularization, major and minor bleeding (at 30 days), as well as all-cause mortality at 1 year were included, and meta-analysis was performed. RESULTS: A total of 5,137 patients with diabetes were included in four randomized trials. At 30 days, bivalirudin, compared with heparin and GPI, caused less major bleeding (odds ratio (OR), 0.68; 95% confidence interval (CI), 0.52-0.89; P = 0.005) and less minor bleeding (OR, 0.48; 95% CI, 0.41-0.57; P < 0.00001) and similar rates of MACE (OR, 0.87; 95% CI, 0.70-1.08; P = 0.21), MI (OR, 0.87; 95% CI, 0.68-1.10; P = 0.25), and urgent revascularization (OR, 1.12; 95% CI, 0.76-1.65; P = 0.57). Death from any cause at 30 day was numerically lower with bivalirudin use but not statistically significant (OR, 0.72; 95% CI, 0.46-1.13; P = 0.15). Mortality at 1 year was significantly lower in diabetes patients treated with bivalirudin compared with heparin and GPI (OR, 0.72; 95% CI, 0.52-0.99; P = 0.04). A secondary analysis suggests that the major bleeding benefit with bivalirudin may be driven by mandated use of GPI in heparin arm. CONCLUSION: Among patients with diabetes undergoing PCI, bivalirudin caused less major and minor bleeding compared with heparin and GPI, with similar rates of MACE, death, MI, and urgent revascularization at 30 days, but significantly lower mortality rates at 1 year.

New oral anticoagulants in patients with cancer: current state of evidence.

Effectiveness of new oral anticoagulants (NOAC) in patients with cancer is not clearly defined. There remain concerns of doubtful benefit and chances of potential harm with newer agents. In this meta-analysis, we evaluated the efficacy and safety of NOAC in patients with cancer. PubMed, Cochrane Library, EMBASE, Web of Science, and CINAHL databases were searched from January 01, 2001 through February 28, 2013. Randomized controlled trials reporting efficacy and safety data of NOACs (rivaroxaban, dabigatran, and apixaban) with control (low-molecular-weight heparin/vitamin K antagonists/placebo) for patients with cancer were included. Primary efficacy outcome was venous thromboembolism (VTE) or VTE-related death, and primary safety outcome was clinically relevant bleeding. We used random-effects models. Six trials randomized 19,832 patients, and 1197 patients had cancer. Risk of VTE or VTE-related death was not significantly different with NOAC versus control [odds ratio (OR), 0.80; 95% confidence interval (CI), 0.39-1.65] in patients with cancer. Separate analysis for individual effects showed similar results for rivaroxaban (OR, 1.08; 95% CI, 0.60-1.94) and dabigatran (OR, 0.91; 95% CI, 0.21-3.91). Clinically relevant bleeding was not higher with NOAC compared with control (OR, 1.49; 95% CI, 0.82-2.71); individual effect of rivaroxaban showed similar results. No statistically significant difference of efficacy and safety with NOAC was found between patients with and without cancer. Rivaroxaban might be equally effective and safe as vitamin K antagonist in patients with cancer. Dabigatran is as effective as comparator; however, safety profile of dabigatran is unknown. Randomized trials of new anticoagulants specific to the cancer population are necessary, and NOAC also need to be evaluated against low-molecular-weight heparin.