Invasive therapy versus conservative therapy for patients with stable coronary artery disease: An updated meta-analysis.

BACKGROUND: Heart disease remains the leading cause of death in the United States. Although there are clear indications for revascularization in patients with acute coronary syndromes, there is debate regarding the benefits of revascularization in stable ischemic heart disease. We sought to perform a comprehensive meta-analysis to assess the role of revascularization compared to conservative medical therapy alone in patients with stable ischemic heart disease. HYPOTHESIS: There is no significant difference in all-cause mortality or cardiovascular mortality between invasive and medical arms. METHODS: We performed a systematic literature search from January 2000 to June 2020. Our literature search yielded seven randomized controlled trials. We analyzed a total of 12 013 patients (6109 in revascularization arm and 5904 in conservative medical therapy arm). Primary outcome was all-cause mortality. Secondary outcomes included major adverse cardiac events (MACE) (death, myocardial infarction [MI], or stroke), cardiovascular mortality, MI, and stroke. Additional subgroup analysis for all-cause mortality was performed comparing percutaneous coronary intervention (PCI) with bare metal stent versus conservative therapy; and PCI with drug eluting stent versus conservative therapy. RESULTS: There was no statistically significant difference in primary outcome of all-cause mortality between either arm (odds ratio [OR] = 0.95; 95% CI [confidence interval], 0.83 to 1.08; p = .84). There were statistically significant lower rates of MACE (death, MI or stroke) in the revascularization arm when compared to conservative arm. CONCLUSIONS: Our analysis did not show any survival advantage of an initial invasive strategy over conservative medical therapy in patients with stable coronary artery disease (CAD).

Ultrathin biodegradable polymer sirolimus-eluting stent versus contemporary durable polymer everolimus-eluting stent for percutaneous coronary intervention: a meta-analysis of randomized trials.

INTRODUCTION: Improvements in coronary drug-eluting stent technology has focused on reducing the long-term complications associated with the effects of the residual footprint on the vessel wall. Although many of the newer stents have exhibited noninferiority to the durable polymer everolimus-eluting stent (DP-EES), they have yet to exhibit clear superiority. We compared the performance of the latest ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) to DP-EES. METHODS: We searched the electronic databases for randomized controlled trials comparing BP-SES to DP-EES. A random effect meta-analysis was performed using the Poisson regression model. The primary end point was target lesion failure (TLF), a composite of target vessel myocardial infarction (TVMI), cardiac death and target lesion revascularization (TLR). RESULTS: There was no difference between the stents in stent thrombosis [incidence rate ratio (IRR) = 0.79, 95% confidence interval (CI) 0.58-1.06), TLR (IRR = 0.88, 95% CI 0.57-1.38), TVMI (IRR = 0.79, 95% CI 0.61-1.01), cardiac death (IRR = 0.99, 95% CI 0.76-1.29) and target vessel failure (IRR = 0.82, 95% CI 0.64-1.06). In addition, there was no difference in TLF (IRR = 0.82, 95% CI 0.64-1.06). There was evidence of reduced TLF in small vessels with BP-SES based on definition used (defined as ≤2.75 mm; IRR 0.64, 95% CI 0.46-0.91 versus ≤3 mm; IRR 1.11, 95% CI 0.90-1.36). CONCLUSION: In our study, the performance of the latest generation BP-SES was comparable to DP-EES but failed to show superiority. The possible benefit in patients with small vessels should be explored future trials.

Does the Presence of Significant Mitral Regurgitation prior to Transcatheter Aortic Valve Implantation for Aortic Stenosis Impact Mortality? - Meta-Analysis and Systematic Review.

BACKGROUND: Mitral regurgitation (MR) is commonly encountered in patients with severe aortic stenosis (AS). However, its independent impact on mortality in patients undergoing transcatheter aortic valve implantation (TAVI) has not been established. METHODS: We performed a systematic search for studies reporting characteristics and outcome of patients with and without significant MR and/or adjusted mortality associated with MR post-TAVI. We conducted a meta-analysis of quantitative data. RESULTS: Seventeen studies with 20,717 patients compared outcomes and group characteristics. Twenty-one studies with 32,257 patients reported adjusted odds of mortality associated with MR. Patients with MR were older, had a higher Society of Thoracic Surgeons score, lower left ventricular ejection fraction, a higher incidence of prior myocardial infarction, atrial fibrillation, and a trend towards higher NYHA class III/IV, but had similar mean gradient, gender, and chronic kidney disease. The MR patients had a higher unadjusted short-term (RR = 1.46, 95% CI 1.30-1.65) and long-term mortality (RR = 1.40, 95% CI 1.18-1.65). However, 16 of 21 studies with 27,777 patients found no association between MR and mortality after adjusting for baseline variables. In greater than half of the patients (0.56, 95% CI 0.45-0.66) MR improved by at least one grade following TAVI. CONCLUSION: The patients with MR undergoing TAVI have a higher burden of risk factors which can independently impact mortality. There is a lack of robust evidence supporting an increased mortality in MR patients, after adjusting for other compounding variables. MR tends to improve in the majority of patients post-TAVI.

Meta-Analysis Comparing Double Versus Triple Antithrombotic Therapy in Patients With Atrial Fibrillation and Coronary Artery Disease.

Atrial fibrillation (AF) and concomitant coronary artery disease (CAD) create a therapeutic dilemma as the risk of bleeding with triple antithrombotic therapy (TATT) must be balanced against the risk of ischemic events with double antithrombotic therapy (DATT). The aim of this meta-analysis is to compare the efficacy and safety of DATT versus TATT in AF and CAD. MEDLINE, Cochrane, and ClinicalTrials.gov databases were searched for relevant articles published from inception to May 1, 2019. Studies comparing the safety and efficacy of DATT versus TATT in patients with AF and CAD were included. Among 9 studies, where 6,104 patients received DATT and 7,333 patients received TATT, there was no statistically significant difference in the outcomes of mortality, nonfatal myocardial infarction, stent thrombosis, and stroke. There was a lower rate of major bleeding in DATT (risk ratio [RR] 0.64 [95% confidence interval [CI] 0.54 to 0.75]; p <0.001). There was no significant difference in stent thrombosis (RR 1.52 [95% CI 0.97 to 2.38]; p = 0.07). However, subgroup analysis of trials with direct oral anticoagulant use demonstrated a borderline higher rate of stent thrombosis in DATT (RR 1.66 [95% CI 1.01 to 2.73]; p = 0.05). In conclusion, DATT showed no difference in the outcomes of mortality, stroke, nonfatal myocardial infarction, and stent thrombosis compared with TATT. DATT demonstrated a lower rate of major bleeding. DATT demonstrated a borderline higher rate of stent thrombosis in the subgroup analysis of trials with direct oral anticoagulant which needs to be evaluated in further studies.

Meta-Analysis Comparing Dual Antiplatelet Therapy Versus Single Antiplatelet Therapy Following Transcatheter Aortic Valve Implantation.

The present American College of Cardiology/American Heart Association guidelines (Grade IIb, level of evidence C) recommend dual antiplatelet therapy (DAPT) with aspirin and clopidogrel for 6 months followed by lifelong aspirin after transcathter aortic valve implantation (TAVI). However, studies that have compared DAPT to single antiplatelet therapy (SAPT) after TAVI have questioned this recommendation as DAPT has been associated with more bleeding events compared with SAPT. We performed a meta-analysis of all the trials that compared DAPT to SAPT in patients who underwent TAVI. Three randomized trials and 4 nonrandomized studies were included. The primary endpoint was the rate of ischemic stroke. Secondary end points were the rates of myocardial infarction, life threatening bleeding (LTB), significant bleeding (LTB and major bleeding), and death. The Mantel-Haenszel random effects model was used to calculate the combined odds ratios (OR) and 95% confidence intervals (CI) for outcomes at 30days and up to 6 to 12months follow-up. The LTB (OR 2.73, 95% CI 1.31 to 5.69, p = 0.007) and significant bleeding rates (OR 2.76, 95% CI 1.57 to 4.85, p = 0.0004) were significantly higher in DAPT arm at 30days. Significant bleeding (OR 2.24, 95% CI 1.33 to 3.79, p = 0.002) was still significantly higher in the DAPT arm but there was only a nonsignificant trend toward higher LTB (OR 1.93 95% CI 0.61 to 6.03, p = 0.26) at 6 to 12 month follow up. There was no difference in mortality, ischemic stroke and myocardial infarction at 30days or 6 to 12month follow up. In conclusion, our meta-analysis shows that DAPT after TAVI does not confer any additional benefit over SAPT in TAVI.

Inpatient mortality and its predictors after pericardiocentesis: An analysis from the Nationwide Inpatient Sample 2009-2013.

BACKGROUND: National registries have provided data on in-hospital outcomes for several cardiac procedures. The available data on in-hospital outcomes and its predictors after pericardiocentesis are mostly derived from single center studies. Furthermore, the outcomes after pericardiocentesis for iatrogenic pericardial effusion and the impact of procedural volume on in-hospital outcomes in the United States are largely unknown. METHODS: We used national inpatient database files for the years 2009-2013 to estimate the inpatient outcomes after pericardiocentesis in all-comers and in the subgroups with iatrogenic effusion. We also studied the impact of hospital procedural volume, among other predictors, on inpatient mortality. RESULTS: About 64,070 (95%CI 61 008-67 051) pericardiocentesis were performed in the United States during 2009-2013. Of these, 57.15% (56.02-58.26%) of the pericardiocentesis were in hemodynamically unstable patients. Percutaneous cardiac procedures were performed in 17.7% of patients (percutaneous coronary intervention (PCI) 4.02%, electrophysiologic procedures 13.58%, and structural heart intervention (SHI) 0.76%). Overall inpatient mortality was 12.30% (95%CI 11.66-12.96%). Inpatient mortality after PCI, electrophysiologic procedures, SHI and cardiac surgery were 27.67% (95%CI 24-31.67%), 7.8% (95%CI 6.67-9.31%), 22.36% (95%CI 15.06-31.85%) and 18.97% (95%CI 15.84-22.57%), respectively. There was an inverse association between hospital procedural volume and inpatient mortality, with a mortality of 14.01% (12.84-15.26%) at the lowest and 10.82% (9.44-12.37%) at highest quartile hospitals by procedure volume (ptrend = 0.001). CONCLUSION: The inpatient mortality after pericardiocentesis is high, particularly when associated with PCI and SHI.

A Meta-Analysis Comparing Percutaneous Coronary Intervention With Drug-Eluting Stents Versus Coronary Artery Bypass Grafting in Unprotected Left Main Disease.

Coronary artery bypass grafting (CABG) is the preferred revascularization strategy for unprotected left main disease (UPLMD). Multiple small-scale trials and registry data showed that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is a noninferior strategy with a Class IIa American College of Cardiology/American Heart Association recommendation in patients with high surgical risk and favorable anatomy. However, 2 recent large-scale randomized trials showed conflicting evidence. We conducted a meta-analysis of the existing data to compare outcomes of PCI with DES versus CABG for UPLMD. Four randomized and 8 nonrandomized trials involving 10,284 patients were included. Primary end point was composite of death, stroke, or myocardial infarction (MI) at 3 years or longer. Secondary end points were MACCE (Major Adverse Cardiac and Cerebrovascular Events) and its individual components (death, stroke, MI, or repeat revascularization). Mantel-Haenszel random effects model was used to calculate combined odds ratio for outcomes. A separate analysis of randomized data was also performed. There was no significant difference in primary composite outcome between PCI and CABG. However, MACCE was significantly higher in PCI, primarily driven by significantly high repeat revascularization. A subgroup analysis stratified by Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score showed that MACCE and repeat revascularization were not significantly different between PCI and CABG in low to intermediate SYNTAX score (<33), whereas they were significantly higher in PCI with higher SYNTAX score. Thus, although CABG remains the preferred method of treatment in UPLMD, PCI with DES can be considered as a reasonable alternative in patients with favorable anatomy and high surgical risk.

Rare Presentation of Lupus Myocarditis With Acute Heart Failure-A Case Report.

Systemic lupus erythematosus is an autoimmune disease with diffuse organ involvement. The cardiac complications include pericarditis, myocarditis, pulmonary hypertension, coronary vasculitis, and Libman-Sacks endocarditis. Symptomatic lupus myocarditis presenting with left ventricular dysfunction, acute heart failure, and pulmonary edema, although rare, is a life-threatening complication. We report the occurrence of acute lupus myocarditis in a 38-year-old postpartum female who had a cesarean section a week before presentation for preeclampsia. Initially she was managed for pneumonia but later found to have acute pericarditis and myocarditis related to systemic lupus erythematosus. She had a complicated hospital course including acute respiratory failure and cardiogenic shock. She was started on pulse dose steroids besides the treatment for heart failure and had a dramatic improvement within days.

A case of palpable purpura and nephropathy: Occam's Razor or Hickam's Dictum.

Vasculitis causing palpable purpura, nephropathy, and hematologic abnormalities is a well-known entity. However, sometimes, vasculitis may not be the primary cause but is part of a systemic disease. Literature suggests that infections like HIV can induce nephropathy and antineutrophilic cytoplasmic antibody-positive vasculitis, which is different from the well-known entity of "antineutrophilic cytoplasmic antibody-associated vasculitis." We present a 46-year-old female patient with a history of intravenous drug abuse who reported with a rash, swelling, and palpable purpura of the lower extremities. Peripheral smear showed no evidence of disseminated intravascular coagulation or thrombotic thrombocytopenic purpura; metabolic profile showed acute kidney injury. She was found to be HIV- and hepatitis C-positive. Immunologic workup was positive for both MPO and PR3 antineutrophilic cytoplasmic antibodies and negative for cryoglobulins; complement levels were low. Skin biopsy showed leukocytoclastic vasculitis but kidney biopsy was negative for any immunologic involvement; it showed only glomerulosclerosis. Thus, it was thought that nephropathy and vasculitis, in this case, are two distinct pathologic processes, both induced by infection (HIV and/or hepatitis C). The patient responded to low-dose steroid therapy. She was later started on the definitive therapy, the highly active antiretroviral therapy regimen. This case illustrates the fact that low-dose steroids can still be a good alternative in acute situations in patients at risk from immunosuppression.

Fixing the "broken heart": pharmacologic implications.

Broken-heart syndrome also known as Left ventricular apical ballooning syndrome or Stress-induced cardiomyopathy or Takotsubo cardiomyopathy is an important clinical entity, which presents clinically, similar to acute coronary syndrome with an acute onset of chest pain, ST-T changes in electrocardiogram, and moderate cardiac enzyme elevation. Recent studies have shown that it accounts for 1%-2% of cases of ST-elevation infarction. An episode of intense emotional or physiologic stress has been reported before its presentation and is presumed to be the triggering factor in the pathogenesis. The pathophysiology of this syndrome still remains unclear, and management is mostly empiric and supportive. In this review, we have discussed various pathophysiologic mechanisms underlying this cardiomyopathy and their pharmacological implications and role of medications such as aspirin, beta blockers, angiotensin-converting enzyme inhibitors, and statins for patients presenting with this syndrome in treatment and prevention.

Coronary revascularization in diabetic patients: Current state of evidence.

Although diabetic patients constitute an increasing number of individuals undergoing percutaneous coronary intervention (PCI) and surgical revascularization, they experience worse outcomes than nondiabetic patients. The optimal coronary revascularization strategy in the diabetic population remains unclear in view of advancements in pharmacotherapy and technology of both PCI and surgical revascularization. Data to guide decision making are limited regarding the current choice between coronary artery bypass graft surgery and PCI using drug-eluting stents and newer antiplatelet agents in diabetic patients with multivessel coronary artery disease. The present article summarizes the current state of evidence for coronary revascularization in the diabetic population.

Comparison of low molecular weight heparin with unfractionated heparin during percutaneous coronary interventions: a meta-analysis.

To conduct a meta-analysis of the current evidence to evaluate the safety and efficacy of low molecular weight heparin (LMWH) as compared to unfractionated heparin (UFH). Several studies have demonstrated the therapeutic advantage of LMWH over UFH in the medical management of acute coronary syndromes. However, evidence comparing the 2 in percutaneous coronary interventions (PCI) is inconclusive. Previously published meta-analysis did not include some large-scale trials. We performed a systematic literature search for randomized clinical trials that compared LMWH and UFH in urgent or elective PCI. Studies that evaluated efficacy end points [composite of nonfatal myocardial infarction (MI) and death with or without target vessel revascularization] and bleeding end points were included. Studies were excluded if they involved coadministration of thrombolytics. Data were extracted on an intention-to-treat basis. Heterogeneity of the studies was analyzed by Cochran Q statistics. The Mantel-Haenszel fixed-effect model was used to calculate combined relative risks for outcomes where studies were homogenous and the random effect model when the studies were heterogenic. Fourteen studies involving 12,394 patients were included. The efficacy and bleeding risk of LMWH in patients undergoing PCI were comparable with UFH. A subgroup analysis of studies using intravenous or intraarterial administration of LMWH, demonstrated them to be safer than UFH with comparable efficacy. LMWH is at least as efficacious and safe as UFH in patients undergoing PCI. Additionally, evidence suggests that LMWH, when used intravenously, is associated with lower bleeding risks when compared with UFH.

Outcomes of nonemergent percutaneous coronary intervention with and without on-site surgical backup: a meta-analysis.

Despite major advances in percutaneous coronary intervention (PCI) techniques, the current guidelines recommend against elective PCI at hospitals without on-site cardiac surgery backup. Nonetheless, an increasing number of hospitals without on-site cardiac surgery in the United States have developed programs for elective PCI. Studies evaluating outcome in this setting have yielded mixed results, leaving the question unanswered. Hence, a meta-analysis comparing outcomes of nonemergent PCI in hospitals with and without on-site surgical backup was performed. A systematic review of literature identified four studies involving 6817 patients. Three clinical end points were extracted from each study and included in-hospital death, myocardial infarction, and the need for emergency coronary artery bypass grafting. The studies were homogenous for each outcome studied. Therefore, the combined relative risks (RRs) across all the studies and the 95% confidence intervals (CIs) were computed using the Mantel-Haenszel fixed-effect model. A two-sided alpha error less than 0.05 was considered to be statistically significant. Compared with facilities with on-site surgical backup, the risk of in-hospital death (RR, 2.7; CI, 0.6-12.9; P = 0.18), nonfatal myocardial infarction (RR, 1.3; CI, 0.7- 2.2; P = 0.29), and need of emergent coronary artery bypass grafting (RR, 0.46; CI, 0.06- 3.1; P = 0.43) was similar in those lacking on-site surgical backup. The present meta-analysis suggests that there is no difference in the outcome with regard to risk of nonfatal myocardial infarction, need for emergency coronary artery bypass grafting, and the risk of death in patients undergoing elective PCI in hospitals with and without on-site cardiac surgery backup.