Ahmed N. Mahmoud

Outcomes With Intravascular Ultrasound-Guided Stent Implantation: A Meta-Analysis of Randomized Trials in the Era of Drug-Eluting Stents.

Background—In the era of drug-eluting stents, it is unknown if intravascular ultrasound (IVUS) guidance for percutaneous coronary intervention should be routinely endorsed. This study aimed to determine if IVUS-guided stent implantation is associated with improved outcomes. Methods and Results—Randomized trials that reported clinical outcomes and compared routine IVUS-guided stent implantation with an angiography-guided approach in the era of drug-eluting stents were included. Summary estimates were constructed primarily using the Peto model. Seven trials with 3192 patients were analyzed. The mean length of the coronary lesions was 32 mm. At a mean of 15 months, routine IVUS-guided percutaneous coronary intervention was associated with a reduction in the risk of major adverse cardiac events (6.5% versus 10.3%; odds ratio, 0.60; 95% confidence interval, 0.46–0.77; P<0.0001), mainly because of reduction in the risk of ischemia-driven target lesion revascularization (4.1% versus 6.6%; odds ratio, 0.60; 95% confidence interval, 0.43–0.84; P=0.003). The risk of cardiovascular mortality (0.5% versus 1.2%; odds ratio, 0.46; 95% confidence interval, 0.21–1.00; P=0.05), and stent thrombosis (0.6% versus 1.3%; odds ratio, 0.49; 95% confidence interval, 0.24–0.99; P=0.04) also appeared to be lower in the IVUS-guided group. Conclusions—In the era of drug-eluting stents for diffuse coronary lesions, IVUS-guided percutaneous coronary intervention is superior to angiography-guided percutaneous coronary intervention in reducing the risk of major adverse cardiac events. This is primarily because of reduction in the risk of ischemia-driven target lesion revascularization. This analysis also suggests that risk of cardiovascular mortality and stent thrombosis might be lower with an IVUS-guided approach.

Cardiovascular outcomes with sodium–glucose cotransporter-2 inhibitors in patients with type II diabetes mellitus: A meta-analysis of placebo-controlled randomized trials

BACKGROUND The impact of sodium-glucose cotransporter-2 (SGLT-2) inhibitors on cardiovascular outcomes in patients with type II diabetes mellitus (DM) is not well established. METHODS We searched electronic databases from inception through July 2016 for randomized, placebo-controlled trials, involving SGLT-2 inhibitors. Fixed-effects summary odds ratios (OR) were constructed using Peto model. RESULTS Eighty-one trials with a total of 37,195 patients were included. The mean follow-up was 89weeks. Compared with placebo, SGLT-2 inhibitors were associated with a lower risk of all-cause mortality (OR 0.72; 95% CI 0.59-0.86; P<0.001), cardiovascular mortality (OR 0.67; 95% CI 0.53-0.84; P=0.001), and heart failure (OR 0.67; 95% CI 0.51-0.87; P=0.003), but a similar risk of myocardial infarction (OR 0.89; 95% CI 0.74-1.09; P=0.29) and stroke/transient ischemic attack (OR 1.09; 95% CI 0.87-1.37; P=0.47). The reduction in all-cause mortality was noticed with empagliflozin (OR 0.66; 95% CI 0.54-0.81; P<0.001), but not with other SGLT-2 inhibitors (ORdapagliflozin 1.37; 95% CI 0.71-2.62; P=0.35; ORcanagliflozin 0.82; 95% CI 0.41-1.68; P=0.59; ORluseogliflozin 4.6; 95% CI 0.07-284.25; P=0.47; and ORipragliflozin 4.73; 95% CI 0.08-283.14; P=0.46) (Pinteraction=0.19). Potential harm was observed with dapagliflozin on cardiovascular mortality (OR 2.15, 95% CI 0.92-5.04, P=0.08). CONCLUSIONS In patients with type II DM, SGLT-2 inhibitors appeared to reduce both all-cause and cardiovascular mortality, primarily due to reduction in the risk of heart failure. The benefit was only seen with empagliflozin. There was suggestion of potential harm with dapagliflozin, thus future trials are needed to ascertain the cardiovascular safety of other agents in this class.

Mechanical Thrombectomy for Acute Ischemic Stroke: A Meta-Analysis of Randomized Trials

BACKGROUND Acute ischemic stroke is a leading cause of serious disability and death worldwide. Individual randomized trials have shown possible benefits of mechanical thrombectomy after usual care compared with usual care alone (i.e., intravenous thrombolysis) in the management of acute ischemic stroke patients. OBJECTIVES This study systematically determined if mechanical thrombectomy after usual care would be associated with better outcomes in patients with acute ischemic stroke caused by large artery occlusion. METHODS The authors included randomized trials that compared mechanical thrombectomy after usual care versus usual care alone for acute ischemic stroke. Random effects summary risk ratios (RR) were constructed using a DerSimonian and Laird model. RESULTS Nine trials with 2,410 patients were available for analysis. Compared with usual care alone, mechanical thrombectomy was associated with a higher incidence of achieving good functional outcome, defined as a modified Rankin scale (mRS) of 0 to 2 (RR: 1.45; 95% confidence interval [CI]: 1.22 to 1.72; p < 0.0001) and excellent functional outcome defined as mRS 0 to 1 (RR: 1.67; 95% CI: 1.27 to 2.19; p < 0.0001) at 90 days. There was a trend toward reduced all-cause mortality with mechanical thrombectomy (RR: 0.86; 95% CI: 0.72 to 1.02; p = 0.09). The risk of symptomatic intracranial hemorrhage was similar with either treatment modality (RR 1.06: 95% CI: 0.73 to 1.55; p = 0.76). CONCLUSIONS In acute ischemic stroke due to large artery occlusion, mechanical thrombectomy after usual care was associated with improved functional outcomes compared with usual care alone, and was found to be relatively safe, with no excess in intracranial hemorrhage. There was a trend for reduction in all-cause mortality with mechanical thrombectomy.

Transcatheter Patent Foramen Ovale Closure After Cryptogenic Stroke: An Updated Meta-Analysis of Randomized Trials

Paradoxical embolism from a patent foramen ovale (PFO) mediated right-to-left shunt is a well-described mechanism of ischemic stroke [(1)][1]. In a patient level meta-analysis of the earlier 3 randomized trials, percutaneous PFO closure was superior to medical therapy for secondary prevention of

Complete versus culprit-only revascularization in patients with multi-vessel disease undergoing primary percutaneous coronary intervention: A meta-analysis of randomized trials

BACKGROUND The best approach for revascularization of multi-vessel coronary disease in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) is controversial. METHODS We searched the Medline and Web of Science databases, the Cochrane Register of Controlled Trials, and major conference proceedings for clinical trials that randomized STEMI patients with multi-vessel disease to a complete versus culprit-only revascularization strategy. Random effects summary risk ratios (RR) were constructed using a DerSimonian-Laird model. RESULTS A total of 6 trials met our selection criteria, which yielded 1,190 patients. The mean follow-up duration was 20.5 months. The incidence of major adverse cardiac events was significantly reduced in the complete revascularization group versus the culprit-only revascularization group (RR 0.57, 95% confidence interval (CI) 0.41-0.78, p < 0.001). This was due to a lower risk of urgent revascularization with complete revascularization (RR 0.55, 95% CI 0.35-0.86, p = 0.01). A non-significant reduction was observed with complete versus culprit-only revascularization for the combined outcome of mortality or myocardial infarction (RR 0.56, 95% CI 0.30-1.04, p = 0.06). CONCLUSION Complete revascularization of significant coronary lesions at the time of primary PCI in patients with STEMI and multi-vessel disease was associated with better outcomes. This was primarily due to a reduction in the need for urgent revascularization. Larger trials are needed to determine if complete revascularization reduces death or myocardial infarction.

Complete Versus Culprit-Only Revascularization for Patients With Multi-Vessel Disease Undergoing Primary Percutaneous Coronary Intervention: An Updated Meta-Analysis of Randomized Trials: Complete versus Culprit PCI in STEMI

To perform an updated meta‐analysis to determine whether complete revascularization of significant coronary lesions at the time of primary percutaneous coronary intervention (PCI) would be associated with better outcomes compared with culprit‐only revascularization.

Long-Term Efficacy and Safety of Everolimus-Eluting Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Metallic Stents: A Meta-Analysis of Randomized Trials.

Background— Data regarding the long-term efficacy and safety of everolimus-eluting bioresorbable vascular scaffolds (BVS) compared with everolimus-eluting stents are limited. This meta-analysis aimed to compare the long-term outcomes with both devices. Methods and Results— Randomized trials reporting clinical outcomes beyond 1 year and comparing BVS with everolimus-eluting stents were included. Summary estimates risk ratios (RRs) were constructed. The primary efficacy outcome was target lesion failure, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization, and the primary safety outcome was definite or probable stent/scaffold thrombosis. Six trials with 5392 patients were included (mean follow-up, 25 months). BVS had a higher rate of target lesion failure (RR, 1.33; 95% confidence interval [CI], 1.11–1.58) driven by the higher rates of target vessel myocardial infarction (RR, 1.65; 95% CI, 1.26–2.17) and target lesion revascularization (RR, 1.39; 95% CI, 1.08–1.78). The risk of definite or probable stent/scaffold thrombosis (RR, 3.22; 95% CI, 1.89–5.49) and very late stent/scaffold thrombosis (>1 year; RR, 4.78; 95% CI, 1.66–13.8) was higher with BVS. The risk of cardiac and all-cause mortality was similar in both groups. Conclusions— Compared with everolimus-eluting stents, BVS is associated with increased risk of target lesion failure driven by the increased rates of target vessel myocardial infarction and ischemia-driven target lesion revascularization in these studies (mean follow-up, 25 months). The risk of definite or probable stent/scaffold thrombosis and very late stent/scaffold thrombosis seems to be higher with BVS. Further information from randomized trials is critical to evaluate clinical outcomes with BVS on complete resolution of the scaffold.

Ranolazine in Cardiac Arrhythmia.

Ranolazine utilization in the management of refractory angina has been established by multiple randomized clinical studies. However, there is growing evidence showing an evolving role in the field of cardiac arrhythmias. Multiple experimental and clinical studies have evaluated the role of ranolazine in prevention and management of atrial fibrillation, with ongoing studies on its role in ventricular arrhythmias. In this review, we will discuss the pharmacological, experimental, and clinical evidence behind ranolazine use in the management of various cardiac arrhythmias.

Critical Appraisal of Bivalirudin versus Heparin for Percutaneous Coronary Intervention: A Meta-Analysis of Randomized Trials

Percutaneous coronary intervention with bivalirudin plus bail-out glycoprotein IIb/IIIa inhibitors has been shown to be as effective as unfractionated heparin plus routine glycoprotein IIb/IIIa inhibitors in preventing cardiac ischemic events, but with a lower bleeding risk. It is unknown whether bivalirudin would have the same beneficial effects if compared with heparin when the use of glycoprotein IIb/IIIa inhibitors was similar between treatment arms. We searched the MEDLINE, Web of Science, and Cochrane databases from inception until March 2015 for randomized trials that compared bivalirudin to heparin in patients undergoing percutaneous coronary intervention. We required that the intended use of glycoprotein IIb/IIIa inhibitors was similar between the study groups. Summary estimates were principally constructed by the Peto method. Fifteen trials met our inclusion criteria, which yielded 25,824 patients. Bivalirudin versus heparin was associated with an increased hazard of stent thrombosis (odds ratio [OR] 1.49, 95% confidence interval [CI] 1.15-1.92, P = .002, I2 = 16.9%), with a similar hazard of myocardial infarction (OR 1.09, 95% CI 0.98-1.22, P = .11, I2 = 35.8%), all-cause mortality (OR 0.88, 95% CI 0.72-1.08, P = .21, I2 = 31.5%) and major adverse cardiac events (OR 1.04, 95% CI 0.94-1.14, P = .46, I2 = 53.9%). Bivalirudin was associated with a reduced hazard of major bleeding (OR 0.80, 95% CI 0.70-0.92, P = .001, I2 = 63.5%). The dose of heparin in the control arm modified this association; when the dose of unfractionated heparin in the control arm was ≥ 100 units/kg, bivalirudin was associated with a reduction in major bleeding (OR 0.55, 95% CI 0.45-0.68, P < .0001), but when the dose of unfractionated heparin was ≤ 75 units/kg, bivalirudin was not associated with reduction in bleeding (OR 1.09, 95% CI 0.91-1.31, P = .36). Among patients undergoing PCI, bivalirudin was associated with an increased hazard of stent thrombosis. Bivalirudin may be associated with a reduced hazard of major bleeding; however, this benefit was no longer apparent when compared with a dose of unfractionated heparin ≤ 75 units/kg.

Routine invasive versus selective invasive strategies for Non-ST-elevation acute coronary syndromes: An Updated meta-analysis of randomized trials.

To perform an updated systematic review comparing a routine invasive strategy with a selective invasive strategy for patients with non‐ST‐elevation acute coronary syndromes (NSTE‐ACS) in the era of stents and antiplatelet therapy.