Bhatt, Deepak L.

Background: Direct stenting without pre-dilation or post-dilation has been advocated for saphenous vein graft percutaneous coronary intervention to decrease the incidence of distal embolization, periprocedural myocardial infarction, and target lesion revascularization. Methods: We performed a post hoc analysis of patients enrolled in the DIVA (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty; NCT 01121224) prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. Primary end point was 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization). Secondary end points included all-cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up. Results: Of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only percutaneous coronary intervention. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86–2.08]; P =0.19). During long-term follow-up (median of 2.7 years), the incidence of definite stent thrombosis (1% versus 5%; hazard ratio, 9.20 [95% CI, 1.23–68.92]; P =0.0085), the composite of definite or probable stent thrombosis (5% versus 11%; hazard ratio, 2.52 [95% CI, 1.23–5.18]; P =0.009), and target vessel myocardial infarction (8% versus 14%; hazard ratio, 1.92 [95% CI, 1.08–3.40]; P =0.023) was lower in the stent-only group. Multivariable analysis showed that a higher number of years since coronary artery bypass grafting and >1 target saphenous vein graft lesions were associated with increased target vessel failure during entire follow-up, while preintervention Thrombolysis in Myocardial Infarction-3 flow was protective. Conclusions: In patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions, there was no difference in target vessel failure at 12 months and long-term follow-up in the stent-only versus the balloon-stent group; however, the incidence of stent thrombosis was lower in the stent-only group, as was target vessel myocardial infarction. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT 01121224.

AbstractObjectivesThe aim of this study was to determine the prevalence of peripheral artery disease (PAD) and its association with in‐hospital outcomes after endovascular transcatheter aortic valve replacement (EV‐TAVR).BackgroundTAVR is an established treatment for patients at prohibitive, high, or intermediate surgical risk. PAD is a significant comorbidity in the determination of surgical risk. However, data on association of PAD with outcomes after EV‐TAVR are limited.MethodsPatients in the National Inpatient Sample who underwent EV‐TAVR between January 1, 2012 and September 30, 2015 were evaluated. The primary outcome was in‐hospital mortality.ResultsA total of 51,685 patients underwent EV‐TAVR during the study period. Of these, 12,740 (24.6%) had a coexisting diagnosis of PAD. The adjusted odds for in‐hospital mortality [OR 1.08 (95% CI 0.83–1.41)], permanent pacemaker implantation [OR 0.98 (0.85–1.14)], conversion to open aortic valve replacement [OR 1.05 (0.49–2.26)], or acute myocardial infarction [OR 1.31(0.99–1.71)] were not different in patients with versus without PAD. However, patients with PAD had greater adjusted odds of vascular complications [OR 1.80 (1.50–2.16)], major bleeding [OR 1.20 (1.09–1.34)], acute kidney injury (AKI) [OR 1.19 (1.05–1.36)], cardiac complications [aOR 1.21 (1.01–1.44)], and stroke [OR 1.39(1.10–1.75)] compared with patients without PAD. Length of stay (LOS) was significantly longer for patients with PAD [7.23 (0.14) days vs. 7.11 (0.1) days, p < 0.001].ConclusionOf patients undergoing EV‐TAVR, ~25% have coexisting PAD. PAD was not associated with increased risk of in‐hospital mortality but was associated with higher risk of vascular complications, major bleeding, AKI, stroke, cardiac complications, and longer LOS.

The optimal antithrombotic treatment regimen for patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation represents a challenge in clinical practice. In 2016, an updated opinion of selected experts from the United States and Canada on the treatment of patients with atrial fibrillation undergoing percutaneous coronary intervention was reported. After the 2016 North American consensus statement on the management of antithrombotic therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention, results of pivotal clinical trials assessing the type of oral anticoagulant agent and the duration of antiplatelet treatment have been published. On the basis of these results, this focused update on the antithrombotic management of patients with atrial fibrillation undergoing percutaneous coronary intervention recommends that a non–vitamin K antagonist oral anticoagulant be preferred over a vitamin K antagonist as the oral anticoagulant of choice. Moreover, a double-therapy regimen (oral anticoagulant plus single antiplatelet therapy with a P2Y 12 inhibitor) by the time of hospital discharge should be considered for most patients, whereas extending the use of aspirin beyond hospital discharge (ie, triple therapy) should be considered only for selected patients at high ischemic/thrombotic and low bleeding risks and for a limited period of time. The present document provides a focused updated on the rationale for the new expert consensus–derived recommendations on the antithrombotic management of patients with atrial fibrillation treated with oral anticoagulation undergoing percutaneous coronary intervention.

Background— A significant proportion of patients requiring aortic valve replacement (AVR) have undergone prior coronary artery bypass grafting (CABG). Reoperative heart surgery is associated with increased risk. Data on relative utilization and comparative outcomes of transcatheter (TAVR) versus surgical AVR (SAVR) in patients with prior CABG are limited. Methods and Results— We queried the 2012 to 2014 National Inpatient Sample databases to identify isolated AVR hospitalizations in adults with prior CABG. In-hospital outcomes of TAVR versus SAVR were compared using propensity-matched analysis. Of 147 395 AVRs, 15 055 (10.2%) were in patients with prior CABG. The number of TAVRs in patients with prior CABG increased from 1615 in 2012 to 4400 in 2014, whereas the number of SAVRs decreased from 2285 to 1895 ( P trend <0.001). There were 3880 records in each group in the matched cohort. Compared with SAVR, TAVR was associated with similar in-hospital mortality (2.3% versus 2.4%; P =0.71) but lower incidence of myocardial infarction (1.5% versus 3.4%; P <0.001), stroke (1.4% versus 2.7%; P <0.001), bleeding complications (10.6% versus 24.6%; P <0.001), and acute kidney injury (16.2% versus 19.3%; P <0.001). Requirement for prior permanent pacemaker was higher in the TAVR cohort, whereas the incidence of vascular complications and acute kidney injury requiring dialysis was similar in the 2 groups. Average length of stay was shorter in patients undergoing TAVR. Conclusions— TAVR is being increasingly used as the preferred modality of AVR in patients with prior CABG. Compared with SAVR, TAVR is associated with similar in-hospital mortality but lower rates of in-hospital complications in this important subset of patients.

VA Cooperative Studies Program #571 (DIVA) was designed to evaluate the efficacy of drug‐eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure when compared with bare‐metal stents (BMS) in participants undergoing stenting of de novo SVG lesions. Participants undergoing clinically indicated stenting of de novo SVG lesions were randomized in a 1:1 ratio to DES or BMS. Randomization was stratified by presence/absence of diabetes mellitus and the number of target SVG lesions (1 vs ≥2) within each participating site. At sites that did not routinely administer 12‐months of dual antiplatelet therapy after SVG stenting participants without acute coronary syndromes received 1 month of open‐label clopidogrel, followed by 11 months of clopidogrel for those assigned to DES and 11 months of placebo for those assigned to BMS. The primary endpoint was the 12‐month incidence of target‐vessel failure (defined as the composite of cardiac death, target‐vessel myocardial infarction, or target‐vessel revascularization). Secondary endpoints included the incidence of other clinical endpoints and the incremental cost‐effectiveness of DES relative to BMS. Due to lower‐than‐anticipated target‐vessel failure rates, target enrollment was increased from 519 to 762. The study had randomized 599 participants when recruitment ended in December 2015. The DIVA trial will provide clarity on the appropriate stent type for de novo SVG lesions.

Background Healthcare resources vary geographically, but associations between hospital‐based resources and acute stroke quality and outcomes remain unclear. Methods and Results Using Get With The Guidelines‐Stroke and Dartmouth Atlas of Health Care data, we examined associations between healthcare resource availability, stroke care, and outcomes. We categorized hospital referral regions with high‐, medium‐, or low‐resource levels based on the 2006 national per‐capita availability median of 6 relevant acute stroke care resources. Using multivariable logistic regression, we examined healthcare resource level and in‐hospital quality and outcomes. Of 1 480 308 admitted ischemic stroke patients (2006–2013), 28.8% were hospitalized in low‐, 44.4% in medium‐, and 26.9% in high‐resource hospital referral regions. Quality‐of‐care/timeliness metrics, adjusted length of stay, and in‐hospital mortality were similar across all resource levels. Conclusions Significant variation exists in regional availability of healthcare resources for acute ischemic stroke treatment, yet among Get With the Guidelines‐Stroke hospitals, quality of care and in‐hospital outcomes did not differ by regional resource availability.