Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome.

We investigated if acute coronary syndrome (ACS) rather than stable coronary artery disease (SCAD) presentation is an outcome modifier with respect to the duration of dual-antiplatelet therapy (DAPT) in patients undergoing coronary stenting. In the Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia (PRODIGY) trial, a total of 1465 (74.3%) patients presented ACS whereas 505 (25.7%) had SCAD and were randomized to 6- or 24-month DAPT. At 24 months, the composite of death, myocardial infarction (MI), or cerebrovascular accident (CVA) did not differ between the long- and short-term DAPT arms in both ACS (11.1 vs. 11.7%; P = 0.67) and SCAD (7.5 vs. 4.8%; P = 0.21) patients, respectively. Long-term DAPT was associated with a 75% increase of Bleeding Academic Research Consortium (BARC)-class 2, 3, or 5 bleeding in ACS [7.1 vs. 4.1%; hazard ratio (HR) 1.75, 95% confidence interval (CI) 1.11–2.74, P = 0.015; number needed to treat for harm (NNTH): 33.3] and a five-fold increase in SCAD (8.2 vs. 1.6%; HR 5.37, 95% CI 1.84–15.74, P = 0.002; NNTH: 15.1) patients, with a borderline quantitative interaction (P_INT = 0.056). As a result, net adverse cardiovascular events (death, MI, CVA, BARC class 2, 3, or 5 bleeding) were more than doubled in SCAD patients receiving 24-month DAPT, whereas they did not differ in ACS patients (P_INT = 0.024). This analysis suggests that clinical presentation may be a treatment modifier with respect to DAPT duration after stenting consistent with the hypothesis that SCAD—but not ACS—patients are exposed to a significant increase in bleeding and net adverse clinical events when treated with 24-month compared with 6-month therapy. clinicaltrials.gov Identifier: NCT00611286. http://clinicaltrials.gov/ct2/show/NCT00611286?term=prodigy&rank=2.

Studies in patients with acute coronary syndrome (ACS) undergoing invasive management showed conflicting conclusions regarding the effect of access site on outcomes. To summarize evidence from recent, high-quality trials that compared clinical outcomes occurring with radial versus femoral access in invasively managed adults with ACS. English-language publications in MEDLINE, EMBASE, and Cochrane databases between January 1990 and August 2015. Randomized trials of radial versus femoral access in invasively managed patients with ACS. Two investigators independently extracted the study data and rated the risk of bias. Of 17 identified randomized trials, 4 were high-quality multicenter trials that involved a total of 17 133 patients. Pooled data from the 4 trials showed that radial access reduced death (relative risk [RR], 0.73 [95% CI, 0.59 to 0.90]; P = 0.003), major adverse cardiovascular events (RR, 0.86 [CI, 0.75 to 0.98]; P = 0.025), and major bleeding (RR, 0.57 [CI, 0.37 to 0.88]; P = 0.011). Radial procedures lasted slightly longer (standardized mean difference, 0.11 minutes) and had higher risk for access-site crossover (6.3% vs. 1.7%) than did femoral procedures. Heterogeneity in outcomes definitions and potential treatment modifiers across studies, including operator experience in radial procedures and concurrent anticoagulant regimens. Compared with femoral access, radial access reduces mortality, major adverse cardiovascular events, and major bleeding in patients with ACS undergoing invasive management. None. (PROSPERO registration number: CRD42015022031).

Contemporary evidence supports device-based transcatheter interventions for the management of patients with structural heart disease. These procedures, which include aortic valve implantation, mitral or tricuspid valve repair/implantation, left atrial appendage occlusion, and patent foramen ovale closure, profoundly differ with respect to clinical indications and procedural aspects. Yet, patients undergoing transcatheter cardiac interventions require antithrombotic therapy before, during, or after the procedure to prevent thromboembolic events. However, these therapies are associated with an increased risk of bleeding complications. To date, challenges and controversies exist regarding balancing the risk of thrombotic and bleeding complications in these patients such that the optimal antithrombotic regimens to adopt in each specific procedure is still unclear. In this review, we summarize current evidence on antithrombotic therapies for device-based transcatheter interventions targeting structural heart disease and emphasize the importance of a tailored approach in these patients.