Background Dual antiplatelet therapy is recommended after coronary stenting to prevent thrombotic complications, yet the benefits and risks of treatment beyond 1 year are uncertain. Methods Subjects were enrolled after a drug-eluting coronary stent procedure. After 12 months of thienopyridine (clopidogrel bisulfate [Plavix] or prasugrel [Effient/Efient]) with aspirin, subjects were randomized to continued thienopyridine or placebo for another 18 months; all continued aspirin. The co-primary effectiveness end points were stent thrombosis and major adverse cardiovascular and cerebrovascular events (a composite of death, myocardial infarction, or stroke) at 12 to 30 months. The primary safety end point was moderate or severe bleeding. Results Subjects (N=9,961) were randomized to continued thienopyridine or placebo. Continued thienopyridine reduced stent thrombosis (0.4% vs. 1.4%, hazard ratio 0.29, 95% confidence interval [CI] 0.17-0.48, P<0.001) and major adverse cardiovascular and cerebrovascular events (4.3% vs. 5.9%, hazard ratio 0.71, 95% CI 0.59-0.85, P<0.001). Myocardial infarction was reduced (2.1% vs. 4.1%, hazard ratio 0.47, P<0.001). Rates of all-cause mortality in the continued thienopyridine and placebo groups were 2.0 and 1.5%, respectively (hazard ratio 1.36, 95% CI 1.00-1.85, P=0.052). Moderate or severe bleeding was increased with continued thienopyridine (2.5% vs. 1.6%, P=0.001). An elevated hazard for stent thrombosis and myocardial infarction was observed in both groups during the 3 months following thienopyridine discontinuation. Conclusion Dual antiplatelet therapy beyond one year after drug-eluting stent placement significantly reduced the risks of stent thrombosis and major adverse cardiovascular and cerebrovascular events compared with aspirin alone, but was associated with increased bleeding.

clinicaltrials.gov Identifier: NCT00645918.

Background-In patients undergoing percutaneous coronary intervention (PCI) in the modern era, the incidence and prognostic implications of acute renal failure (ARF) are unknown. Methods and Results-With a retrospective analysis of the Mayo Clinic PCI registry, we determined the incidence of, risk factors for, and prognostic implications of ARF (defined as an increase in serum creatinine [Cr] Ͼ0.5 mg/dL from baseline) after PCI. Of 7586 patients, 254 (3.3%) experienced ARF. Among patients with baseline Cr Ͻ2.0, the risk of ARF was higher among diabetic than nondiabetic patients, whereas among those with a baseline Cr Ͼ2.0, all had a significant risk of ARF. In multivariate analysis, ARF was associated with baseline serum Cr, acute myocardial infarction, shock, and volume of contrast medium administered. Twenty-two percent of patients with ARF died during the index hospitalization compared with only 1.4% of patients without ARF (PϽ0.0001). After adjustment, ARF remained strongly associated with death. Among hospital survivors with ARF, 1-and 5-year estimated mortality rates were 12.1% and 44.6%, respectively, much greater than the 3.7% and 14.5% mortality rates in patients without ARF (PϽ0.0001). Conclusions-The overall incidence of ARF after PCI is low. Diabetic patients with baseline Cr values Ͻ2.0 mg/dL are at higher risk than nondiabetic patients, whereas all patients with a serum Cr Ͼ2.0 are at high risk for ARF. ARF was highly correlated with death during the index hospitalization and after dismissal.

BACKGROUND Questions persist concerning the comparative effectiveness of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG). The American College of Cardiology Foundation (ACCF) and the Society of Thoracic Surgeons (STS) collaborated to compare the rates of long-term survival after PCI and CABG. METHODS We linked the ACCF National Cardiovascular Data Registry and the STS Adult Cardiac Surgery Database to claims data from the Centers for Medicare and Medicaid Services for the years 2004 through 2008. Outcomes were compared with the use of propensity scores and inverse-probability-weighting adjustment to reduce treatment-selection bias. RESULTS Among patients 65 years of age or older who had two-vessel or three-vessel coronary artery disease without acute myocardial infarction, 86,244 underwent CABG and 103,549 underwent PCI. The median follow-up period was 2.67 years. At 1 year, there was no significant difference in adjusted mortality between the groups (6.24% in the CABG group as compared with 6.55% in the PCI group; risk ratio, 0.95; 95% confidence interval [CI], 0.90 to 1.00). At 4 years, there was lower mortality with CABG than with PCI (16.4% vs. 20.8%; risk ratio, 0.79; 95% CI, 0.76 to 0.82). Similar results were noted in multiple subgroups and with the use of several different analytic methods. Residual confounding was assessed by means of a sensitivity analysis. CONCLUSIONS In this observational study, we found that, among older patients with multivessel coronary disease that did not require emergency treatment, there was a long-term survival advantage among patients who underwent CABG as compared with patients who underwent PCI. (Funded by the National Heart, Lung, and Blood Institute.)

Although historically the intra-aortic balloon pump has been the only mechanical circulatory support device available to clinicians, a number of new devices have become commercially available and have entered clinical practice. These include axial flow pumps, such as Impella(®); left atrial to femoral artery bypass pumps, specifically the TandemHeart; and new devices for institution of extracorporeal membrane oxygenation. These devices differ significantly in their hemodynamic effects, insertion, monitoring, and clinical applicability. This document reviews the physiologic impact on the circulation of these devices and their use in specific clinical situations. These situations include patients undergoing high-risk percutaneous coronary intervention, those presenting with cardiogenic shock, and acute decompensated heart failure. Specialized uses for right-sided support and in pediatric populations are discussed and the clinical utility of mechanical circulatory support devices is reviewed, as are the American College of Cardiology/American Heart Association clinical practice guidelines.

P ercutaneous coronary intervention (PCI) has traditionally been performed using femoral arterial access.1 Risks associated with transfemoral PCI (f-PCI) include access site bleeding and major vascular complications, which are associated with a risk of subsequent morbidity, mortality, and costs.2 Alternative vascular access sites for PCI include the brachial, radial, and ulnar arteries.3 Data from singlecenter and small randomized trials comparing transradial PCI (r-PCI) with the femoral approach suggested a lower rate of bleeding and vascular complications associated with r-PCI. 4 More recently, a large randomized trial of patients with acute coronary syndrome (ACS) undergoing coronary angiography or intervention, demonstrated that both radial and femoral approaches were equally effective and safe, with a lower rate of vascular complications in the radial approach cohort. 5 In addition, the high-risk subgroup of patients with ST-segment elevation myocardial infarction had a reduction in cardiovascular events, driven by an apparent reduction in mortality in the r-PCI group. A subsequent meta-analysis of observational and randomized studies showed that r-PCI was associated with a 78% reduction in bleeding in comparison with f-PCI. 6 Despite this growing body of evidence, data fromBackground-Radial access for percutaneous coronary intervention (r-PCI) is associated with reduced vascular complications; however, previous reports have shown that <2% of percutaneous coronary intervention (PCI) procedures in the United States are performed via the radial approach. Our aims were to evaluate temporal trends in r-PCI and compare procedural outcomes between r-PCI and transfemoral PCI. Methods and Results-We conducted a retrospective cohort study from the CathPCI registry (n=2 820 874 procedures from 1381 sites) between January 2007 and September 2012. Multivariable logistic regression models were used to evaluate the adjusted association between r-PCI and bleeding, vascular complications, and procedural success, using transfemoral PCI as the reference. Outcomes in high-risk subgroups such as age ≥75 years, women, and patients with acute coronary syndrome were also examined. The proportion of r-PCI procedures increased from 1.2% in quarter 1 2007 to 16.1% in quarter 3 2012 and accounted for 6.3% of total procedures from 2007 to 2012 (n=178 643). After multivariable adjustment, r-PCI use in the studied cohort of patients was associated with lower risk of bleeding (adjusted odds ratio, 0.51; 95% confidence interval, 0.49-0.54) and lower risk of vascular complications (adjusted odds ratio, 0.39; 95% confidence interval, 0.31-0.50) in comparison with transfemoral PCI. The reduction in bleeding and vascular complications was consistent across important subgroups of age, sex, and clinical presentation. Conclusions-There has been increasing adoption of r-PCI in the United States. Transradial PCI now accounts for 1 of 6 PCIs performed in contemporary clinical practice. In comparison with traditional femoral access, transradial PCI ...

Our goal was to examine the incidence and consequences of stent loss during percutaneous coronary intervention (PCI) and the retrieval techniques used. We retrospectively reviewed 11,773 consecutive PCI cases involving stents performed at our institution between January 1994 and March 2004 to identify cases of stent loss. Stent loss occurred in 38 of 11,773 PCI procedures involving stents (0.32%; 95% CI = 0.23-0.44%). Mean age of the patients was 67 +/- 11 years and 82% were men. Stent loss occurred more frequently in lesions with calcification and/or significant proximal angulation. In three patients, the stent was crushed and covered with another stent without attempting retrieval. Stent retrieval was attempted in 35 of 38 cases and was successful in 30 (86%). The following retrieval methods were used (more than one method was used in some cases): advancing a balloon through the stent, inflating the balloon, and withdrawing the stent (45%); twirling two wires around the stent (5%); loop snare (26%); biliary forceps (12%); Cook retained fragment retriever (10%); and basket retrieval device (2%). Patients in whom stent loss occurred had a higher incidence of bleeding requiring transfusion (24% vs. 7%; P < 0.001) and more often required emergency coronary artery bypass surgery (5% vs. 0.4%; P < 0.001). No patients in whom the stent was crushed or deployed in the coronary artery had any major cardiac complication. Stent loss during PCI occurs infrequently. Lost stents can be successfully retrieved in the majority of cases using a variety of retrieval techniques, yet stent loss is associated with an increased risk of complications. Stent deployment or crushing may be a good alternative to retrieval.

This study demonstrates that endothelin immunoreactivity is enhanced in the coronary and systemic circulation in humans with coronary endothelial dysfunction. Moreover, acetylcholine further increased coronary endothelin concentration in patients with coronary endothelial dysfunction and was associated with coronary vasoconstriction. These observations strongly support a role for endothelin as an early participant in and marker for coronary endothelial dysfunction in humans.