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.

Long-term outcomes of patent foramen ovale closure or medical therapy after cryptogenic stroke: A meta-analysis of randomized trials.

OBJECTIVES: To examine long-term clinical outcomes with transcatheter patent foramen ovale (PFO) closure versus medical therapy alone in patients with cryptogenic stroke. BACKGROUND: A long-standing debate regarding the optimal approach for the management of patients with PFO after a cryptogenic stroke exists. METHODS: An electronic search was performed for randomized clinical trials (RCTs) reporting clinical outcomes with PFO closure vs. medical therapy alone after stroke. Random effects DerSimonian-Laird risk ratios (RR) were calculated. The main outcome was recurrence of stroke. Other outcomes included transient ischemic attack (TIA), new-onset atrial fibrillation/flutter (AF/AFL), major bleeding, serious adverse events, and device-related complications. All-cause mortality was also examined. RESULTS: Five RCTs with a total of 3,440 patients were included. At a mean follow-up of 4.02 ± 1.57 years, PFO closure was associated with less recurrence of stroke (RR = 0.43; 95% CI 0.19-0.91; P = .027) compared with medical therapy alone. No difference was observed between both strategies for TIA (P = .21), major bleeding (P = .69), serious adverse events (P = .35), and all-cause death (P = .48). However, PFO closure, was associated with increased new-onset AF/AFL (P < .001), risk of pulmonary embolism (P = .04), and device-related complications (P < .001). On a subgroup analysis, stroke recurrence rate remained lower in PFO closure arm regardless of the type of closure device used (Pinteraction = .50), or the presence of substantial shunt in the majority of study population (Pinteraction = .13). CONCLUSIONS: Transcatheter PFO closure reduces the recurrence of stroke compared with medical therapy alone, with no significant safety concerns. Close follow-up of patients after PFO closure is recommended to detect new-onset atrial arrhythmias.

Coronary Artery Calcium Scoring in Young Adults: Evidence and Challenges.

PURPOSE OF REVIEW: This review aims to summarize the evidence and challenges of coronary artery calcium (CAC) scoring as a screening tool for coronary artery disease (CAD) in young adults. RECENT FINDINGS: Several cohort studies have highlighted the value of CAC scoring in CAD risk assessment in young adults. The largest study to date is the Coronary Artery Risk Development in Young Adults (CARDIA) study. The study examined patients at 18-30 years of age and demonstrated that the presence of any degree of CAC was associated with a higher risk of coronary events compared to zero CAC, with an incremental increase in the risk of events with higher scores. However, it is important to note that 70% of patients screened had CAC = 0 at the age of 56. Despite the evidence that higher CAC score cutoff used in guidelines for predicting cardiovascular risk may be "falsely reassuring," however, mass screening of young adults using CAC score may be challenging. The development of prediction tools and scoring systems to identify patients at higher risk of developing CAC based on known CAD risk factors may help reduce the number needed to screen to detect patients with positive CAC.

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.

Percutaneous coronary intervention or coronary artery bypass grafting for unprotected left main coronary artery disease.

BACKGROUND: Recent trials comparing PCI with CABG for unprotected left main disease yielded discrepant evidence. OBJECTIVES: To perform an updated meta-analysis of randomized trials comparing percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) in patients with unprotected left main coronary artery disease. METHODS: Randomized trials comparing PCI versus CABG for patients with unprotected left main coronary artery disease were included. Summary estimates risk ratios (RRs) were performed with a DerSimonian and Laird model at short-term, intermediate and long-term follow-up periods (i.e., 30-days, 1-year, and >1-year). Outcomes evaluated were major adverse cardiac and cerebrovascular events (MACCE), all-cause mortality, myocardial infarction, stroke, revascularization and stent thrombosis or symptomatic graft occlusion. RESULTS: Six trials with 4,700 patients and a mean SYNTAX score of 23 were included. At short-term follow-up, the risk of MACCE was lower with PCI (RR 0.55, 95% confidence interval [CI] 0.39-0.76) driven by the lower risk of myocardial infarction (RR 0.67, 95% CI 0.46-0.99), and stroke (RR 0.38, 95% CI 0.16-0.90). The risk of MACCE was similar at the intermediate follow-up (RR 1.21, 95% CI 0.97-1.51). At long-term follow-up, PCI was associated with a higher risk of MACCE (RR 1.19, 95% CI 1.01-1.41), due to a higher risk of revascularization (RR 1.62, 95% CI 1.34-1.94), while the risk of all-cause mortality, myocardial infarction, and stroke were similar. CONCLUSIONS: In patients with unprotected left main coronary disease and low to intermediate SYNTAX score, PCI might be an acceptable alternative to CABG. © 2017 Wiley Periodicals, Inc.

Aspirin Use Prior to Coronary Artery Bypass Grafting Surgery: a Systematic Review.

PURPOSE OF REVIEW: Aspirin use before coronary artery bypass graft (CABG) surgery has been a puzzling question for years. Controversy existed regarding the overall benefits vs. risk of pre-operative aspirin use and was translated to conflicting guidelines from major societies. RECENT FINDINGS: Observational studies have suggested a reduced mortality with pre-operative aspirin use. A meta-analysis of randomized controlled trials showed increased risk of post-operative bleeding with aspirin, with no associated increased mortality risk. A recent large randomized controlled trial did not find a significant difference in bleeding risk or post-operative mortality with pre-CABG aspirin use. The results of available studies showed a beneficial effect with pre-CABG aspirin use by decreasing thrombotic complications and perioperative myocardial infarction, with an associated adverse risk of bleeding that did not affect mortality rates. Given overall benefit-risk assessment, we are in favor of pre-operative aspirin use in CABG patients.

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.

Perioperative Heparin Bridging in Atrial Fibrillation Patients Requiring Temporary Interruption of Anticoagulation: Evidence from Meta-analysis.

BACKGROUND: Patients with atrial fibrillation (AF) often require temporary interruption of warfarin for an elective operation or invasive procedure. However, the safety and efficacy of periprocedural bridging anticoagulation with unfractionated heparin (UH) or low-molecular-weight heparin (LMWH) are still unclear. We evaluated the safety of periprocedural heparin bridging in AF patients requiring temporary interruption of oral anticoagulation. METHODS: We searched the literature for trials that compared heparin bridging with no bridging in AF patients for whom warfarin was temporarily interrupted. The incidence of all-cause mortality, thromboembolism, and major and all bleeding was included, and meta-analysis was performed. RESULTS: A total of 13,808 patients with AF were included in 4 observational studies, 1 randomized trial, and 1 subgroup analysis of a randomized trial. The mean CHADS2 score for the no heparin bridging group was 2.49 and that for the heparin bridging group was 2.34. At 30 days and up to 3 months, when compared to the heparin bridging group, the no bridging group did not have any significant difference in mortality (odds ratio [OR], 1.29; 95% confidence interval [CI], .15-11.52; P = .82) or cerebrovascular accidents (OR, .93; 95% CI, .34-2.51; P = .88), but the no bridging group had significantly less major bleeding (OR, .41; 95% CI, .24-.68; P = .0006). CONCLUSION: Among AF patients with intermediate CHADS2 scores who are anticoagulated with warfarin and who required temporary interruption of warfarin for an elective surgery or procedure, periprocedural bridging with UH or LMWH was associated with a higher rate of major bleeding with no significant difference in mortality or CVA.

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.

Health resource variability in the achievement of optimal performance and clinical outcome in ischemic heart disease.

A disparity between evidence and practice in the management of ischemic heart disease is frequently observed. Guideline adherence and clinical outcomes are influenced by system, provider, and patient factors. Recently, performance improvement measures for cardiovascular disease have gained a lot of popularity worldwide. These measures may facilitate the uptake of evidence-based recommendations and improve patient outcomes. While apparently valid as quality metrics, their impacts on clinical outcomes remain limited and are areas of further research. Several methods for optimizing performance have been instituted and essentially involve three different approaches­improvement in the reporting of data on guideline adherence, providing infrastructure and tools, and providing incentives to improve guideline adherence. Public reporting of quality metrics and "pay-for-performance" are some novel performance improvement tools. The impact of these approaches on patient outcomes will be pivotal in improving cardiovascular outcomes in the future.

Cangrelor for patients undergoing percutaneous coronary intervention: evidence from a meta-analysis of randomized trials.

Cangrelor is a new parenteral adenosine diphosphate P2Y12 receptor inhibitor with rapid, profound and reversible inhibition of platelet activity. The aim of this meta-analysis was to evaluate efficacy and safety of this new agent in patients undergoing percutaneous coronary intervention (PCI). We searched PubMed, Cochrane Library, EMBASE, Web of Science and CINAHL databases from the inception through April 2013. Randomized controlled trials (RCTs) comparing cangrelor with control (clopidogrel/placebo) were selected. We used the random-effects models to calculate the risk ratio. The primary efficacy outcome was risk of myocardial infarction, and the primary safety outcome was TIMI major bleeding at 48 h. Three RCTs included a total of 25,107 participants. Effects of Cangrelor were not different against comparators for myocardial infarction (MI) (Risk ratio [RR] 0.94, 95% confidence interval [CI] 0.78-1.13) and all-cause mortality (RR 0.72, 95% CI 0.36-1.43). However, cangrelor significantly reduced the risk of ischemia-driven revascularization (RR 0.72, 95% CI 0.52-0.98), stent thrombosis (RR 0.60, 95% CI 0.44-0.82) and Q wave MI (RR 0.53, 95% CI 0.30-0.92) without causing extra major bleeding (Thrombolysis in Myocardial infarction criteria) and severe or life-threatening bleeding (Global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries criteria). Separate analysis against only clopidogrel also showed similar findings except Q wave MI outcome. Use of cangrelor during PCI might reduce the risk of ischemia-driven revascularization and stent thrombosis, without causing extra major bleeding.

Contemporary Trends, Predictors and Outcomes of Perforation During Percutaneous Coronary Intervention (From the NCDR Cath PCI Registry).

Coronary artery perforation (CP) is a rare but potentially life-threatening complication of percutaneous coronary intervention (PCI). Given the marked increase in high-risk and complex PCIs, careful review and understanding of PCI complications may help to improve procedural and clinical outcomes. Our aim was to study the trends, predictors and outcomes of CP in the contemporary era. This cross-sectional multicenter analysis included data collected from institutions participating in the National Cardiovascular Data Registry CathPCI Registry between July 2009 and June 2015. Multivariable logistic regression models were created to identify predictors of CP and compare the in-hospital outcomes of CP and non-CP patients. Of 3,759,268 PCIs performed during the study period, there were 13,779 CP (0.37%). During the study period, the proportion of PCI that developed CP remained unchanged (0.33% to 0.4%) (p for trend 0.16). Chronic total occlusion (CTO) PCI as percentage of total PCI volume increased over the study period (3% to 4%) (p for trend <0.001) with a concomitant significant increase in CTOs with perforation (1.2% to 1.5%, p for trend = 0.02). CTO PCI (Odds Ratio [OR] 2.59) female gender (OR 1.38), saphenous vein graft PCI (OR 1.2), ACC Type C lesion (1.48), cardiogenic shock on presentation (1.15), and use of atherectomy (laser/ rotational) (OR 2.38) were significant predictors of CP. CP patients had significantly higher rates of cardiogenic shock (7.73% vs 1.02%), tamponade (9.6% vs 0.05%) and death (4.87% vs 1.14%) compared with those without CP. Strongest predictors of any adverse events amongst CP were cardiogenic shock (OR 3.93), cardiac arrest (OR 2.02) and use of atherectomy device (OR 2.5). Use of covered stents was also strongly associated with adverse events (OR 3.67) reflecting severity of these CPs. CP in CTO PCI had higher rates of any adverse event than non-CTO CP (26.8% vs 22%, p < 0.001). However non-CTO CP had higher rates of coronary artery bypass grafting (CABG) (urgent, emergent, or salvage) (5.8% vs 4.5%, p = 0.03) and death (6.9% vs 5.6%, p = 0.04). CP in CABG PCI had fewer adverse events compared with those without previous CABG (16.1% vs 24.7%). In a large real world experience, we identified several clinical and procedural factors associated with increased risk of CP and adverse outcomes. The trends in CP remained constant over the study period.

Outcome of catheter ablation for ventricular tachycardia in patients with ischemic cardiomyopathy: A systematic review and meta-analysis of randomized clinical trials.

BACKGROUND: Current ventricular tachycardia (VT) management in patients with ischemic cardiomyopathy (ICM) includes optimal medical therapy, ICDs device therapy, and antiarrhythmic medications. Data about outcomes of catheter ablation (CA) in these patients is scarce. We aimed to perform a meta-analysis of RCTs to compare outcomes of CA vs conventional management of VT in ICM patients who had ICD. METHODS: A systematic review and meta-analysis of published RCTs between January 1970 and December 2016 were performed. Random effects DerSimonian-Laird risk ratios (RR) were calculated. Sensitivity analyses using fixed-effects summary odds ratios (OR) were performed using Peto model. Outcomes of interest were: all-cause mortality (ACM), cardiovascular death (CVD), CV disease-related hospitalization, VT storms, and ICD shocks. RESULTS: 4 RCTs were identified (521 patients (261 had CA), mean age: 66.4 ±â€¯1.7 years, 91.5% male, mean follow-up: 19 months). No difference observed between VT ablation and conventional management regarding ACM (RR 0.94, 95% CI, 0.66-1.32, p = 0.70) or CVD (RR 0.82, 95% CI, 0.52-1.29, p = 0.39). VT ablation was associated with less CV disease-related hospitalization (RR 0.72, 95% CI, 0.54-0.96, p = 0.02), VT storms (RR 0.71, 95% CI, 0.52-0.97, p = 0.03), and trend towards reducing ICD shocks (RR 0.59, 95% CI, 0.34-1.05, p = 0.07). In sensitivity analysis using fixed-effects OR, CA was associated with significant reduction in ICD shocks. CONCLUSION: In patients with ICM, VT ablation reduced CV disease-related hospitalization, VT storms, and ICD shocks when compared to conventional management with no mortality benefit over a relatively short mean follow-up period.

Long-term outcomes of drug-eluting stents versus bare metal stents in saphenous vein graft interventions. Evidence from a meta-analysis of randomized controlled trials.

BACKGROUND: The optimal stent for use in saphenous vein graft (SVG) intervention is still debatable. Multiple randomized trials have compared drug-eluting stents (DES) to bare metal stents (BMS) in SVG interventions with conflicting results. METHODS: Authors searched the online databases for randomized controlled trials (RCTs) comparing DES to BMS in SVG percutaneous coronary interventions (PCI). We performed a meta-analysis using a random effects model to calculate the odds ratio for outcomes of interest. RESULTS: Authors studied six RCTs that included 1592 patients undergoing PCI of SVG. The mean follow up was 42 months. Patients mean age was the same in both groups: 70.3 years in the DES group (approximately 93.3% male) and 70.3 years in the BMS group (approximately 93.8% male). Vein graft age was 13.4 years in the DES PCI arm vs. 13.4 years in the BMS PCI arm. Four of the six trials reported data on embolic protection device use: 67% (303/452) in the DES arm vs. 67.9% (309/455) in the BMS arm. The primary outcome of long-term all-cause mortality was not different between DES vs. BMS (15.2% vs. 14.1%, OR 1.12, 95% CI 0.67-1.88; P = 0.66). Secondary outcomes were also similar between DES and BMS: major adverse cardiovascular events (31.6% vs. 33.1%, OR 0.79, 95% CI 0.45-1.38; P = 0.41); cardiac death (9% vs. 8.6%, OR 1.12, 95% CI 0.55-2.30; P = 0.75); myocardial infarction (8% vs. 9.5%, OR 0.84, 95% CI 0.47-1.51; P = 0.57); target lesion revascularization (16.4% vs. 14.4%, OR 0.98, 95% CI 0.50-1.92; P = 0.95); and target vessel revascularization (19% vs. 19.4%, OR 0.75, 95% CI 0.41-1.34; P = 0.33). CONCLUSION: At a mean follow-up of 42 months, no difference was observed in clinical outcomes between DES and BMS in SVG interventions.

Long-Term Outcomes With Transcatheter Aortic Valve Replacement in Women Compared With Men: Evidence From a Meta-Analysis.

OBJECTIVES: This study sought to examine long-term outcomes with transcatheter aortic valve replacement (TAVR) in women versus men. BACKGROUND: TAVR is commonly performed in women. Previous studies have shown conflicting results with respect to sex differences in outcomes with TAVR. In addition, short-term outcomes have primarily been reported. METHODS: Electronic search was performed until March 2017 for studies reporting outcomes with TAVR in women versus men. Random effects DerSimonian-Laird risk ratios were calculated. Outcomes included all-cause mortality and major cardiovascular events at short- (30 days) and long-term (>1 year) follow-up. RESULTS: Seventeen studies (8 TAVR registries; 47,188 patients; 49.4% women) were analyzed. Women were older but exhibited fewer comorbidities. At 30 days, women had more bleeding (p < 0.001), vascular complications (p < 0.001), and stroke/transient ischemic attack (p = 0.02), without difference in all-cause (p = 0.19) or cardiovascular mortality (p = 0.91) compared with men. However, female sex was associated with lower all-cause mortality at 1 year (risk ratio: 0.85; 95% confidence interval: 0.79 to 0.91; p < 0.001), and longest available follow-up (mean 3.28 ± 1.04 years; risk ratio: 0.86; 95% confidence interval: 0.81 to 0.92; p < 0.001), potentially caused by less moderate/severe aortic insufficiency (p = 0.001), and lower cardiovascular mortality (p = 0.009). The female survival advantage remained consistent across multiple secondary analyses. The risk of stroke, moderate/severe aortic insufficiency, and all-cause mortality seemed to vary based on the type of valve used; however, without significant subgroup interactions. CONCLUSIONS: Despite a higher upfront risk of complications, women derive a better long-term survival after TAVR compared with men.

Two-year outcomes of bioresorbable vascular scaffold versus drug-eluting stents in coronary artery disease: a meta-analysis.

BACKGROUND: Data regarding long-term clinical outcomes with everolimus-eluting bioresorbable vascular scaffold (BVS) versus second-generation drug-eluting stents (DES) are scarce. METHODS: We searched online databases until October 2016 for studies comparing BVS versus DES reporting outcomes at 2 years of follow-up. We performed a meta-analysis comparing BVS with DES across the spectrum of coronary artery disease (CAD). Random effects model OR was calculated for outcomes of interest including device-oriented composite events (DOCE; defined as composite of cardiac mortality, target vessel myocardial infarction (TV-MI), and ischaemia-driven target lesion revascularisation (TLR)), all-cause mortality, definite stent thrombosis, TV-MI and TLR. RESULTS: A total of 2360 patients enrolled in five studies met criteria for inclusion in this analysis. At 2 years, BVS was associated with higher rates of DOCE (6.9% vs 4.5%, OR=1.53; 95% CI 1.06 to 2.23; p=0.02), absolute risk increase (ARI) 2.4%, relative risk increase (RRI) 53%, TV-MI (4% vs 1.8%, OR=1.94; 95% CI 1.02 to 3.67; p=0.04), ARI 2.2%, RRI 122% and definite stent thrombosis (2.1% vs 0.6%, OR=3.39; 95% CI 1.46 to 7.88; p=0.005), ARI 1.5%, RRI 250% compared with DES. No differences in all-cause mortality (OR=0.86; 95% CI 0.26 to 2.81; p=0.80) and TLR (OR=1.44; 95% CI 0.81 to 2.54; p=0.21) were observed between both groups. CONCLUSIONS: BVS may be associated with worse long-term clinical outcomes compared with DES. Randomised clinical trials are encouraged to expeditiously report long-term safety and efficacy outcomes and identify predictors of adverse events with BVS compared with DES.

Bivalirudin versus heparin in women undergoing percutaneous coronary intervention: A systematic review and meta-analysis of randomized clinical trials.

BACKGROUND: The anticoagulant of choice during percutaneous coronary intervention (PCI) in women is not well established. METHODS: An electronic search was conducted for trials that randomized patients undergoing PCI to bivalirudin versus heparin, and reported outcomes of interest in women. Random effects DerSimonian-Laird risk ratios (RR) were calculated. Main outcome was net adverse clinical events (NACE) at 30-days. Other outcomes included major adverse cardiac events (MACE), all-cause mortality, myocardial infarction (MI), target vessel revascularization (TVR), and major bleeding at 30-days. 1-year all-cause mortality and MACE were also examined. RESULTS: Nine trials that randomized women undergoing PCI to bivalirudin (n=3960) versus heparin (n=4050) were included. At 30-days, bivalirudin was associated with reduced risk of NACE (RR=0.85; 95% CI 0.73-0.98; p=0.03), mainly driven by reduction in major bleeding (RR=0.59; 95% CI 0.49-0.71; p<0.001) compared with heparin. No difference in MACE (p=0.92), all-cause mortality (p=0.23), MI (p=0.86); or TVR (p=0.53) was demonstrated between both groups. At 1-year, the risk of MACE and all-cause mortality was similar in both groups. On a subgroup analysis, the benefit associated with bivalirudin appeared to be less evident when Glycoprotein IIb/IIIa inhibitors (GPI) was used as bailout therapy with heparin, however without significant interaction. Furthermore, in STEMI population, no difference in NACE, MACE, or major bleeding was observed between both groups. CONCLUSION: In women undergoing PCI, bivalirudin is associated with reduced risk of major bleeding and NACE compared with heparin especially when GPI is routinely used.