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The optimal therapeutic regimen after coronary drug-eluting stent implantation in patients requiring chronic oral anticoagulation (OAC) remains uncertain. Whether the degree of P2Y12-receptor inhibition is associated with increased risk of stent thrombosis (ST) in such patients is currently unclear

The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) remains in dispute, particularly after 12 months. The DAPT Score was developed from the DAPT trial to identify pts who may benefit the most from extended therapy. We sought to assess the

Objectives We investigated the outcomes of switching to bivalirudin after initial administration of heparin in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Background Unfractionated heparin (UFH) is frequently administered early in ST-segment elevation myocardial infarction. Whether the benefits of bivalirudin documented in the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial persist in patients previously administered UFH is unknown. Methods We analyzed the outcomes of the 2,357 patients from HORIZONS-AMI treated with UFH before enrollment according to their subsequent randomization to bivalirudin (switch group, n = 1,178) or UFH plus a glycoprotein IIb/IIIa inhibitor (control group, n = 1,179). Results At 30 days, major bleeding occurred in 7.6% of the switch group versus 12.3% of the control group (p = 0.0001). Switch patients had lower 30-day rates of cardiac mortality (1.6% vs. 2.9%, p = 0.04). At 2-year follow-up, switch patients experienced lower rates of major bleeding (8.4% vs. 13.0%, p = 0.0003), cardiac mortality (2.3% vs. 3.8%, p = 0.04), and reinfarction (4.0% vs. 7.1%, p = 0.0002). Two-year rates of definite/probable stent thrombosis were similar in switch and control patients (3.1% vs. 4.3%, p = 0.17). Conclusions In ST-segment elevation myocardial infarction patients who receive early treatment with UFH, switching to bivalirudin before primary percutaneous coronary intervention results in reduced rates of major bleeding and improved early and late cardiac survival.

Objectives We sought to identify patients with ST-segment elevation myocardial infarction most likely to benefit from drug-eluting stents (DES), and to evaluate the impact of routine angiographic follow-up on the apparent differences between stent types. Background DES might have greatest utility in patients who would benefit most from their antirestenotic properties. Methods We randomly assigned 3,006 patients with ST-segment elevation myocardial infarction to paclitaxel-eluting stents (PES) or to bare-metal stents (BMS). Events were assessed at 12 months and 24 months, with a subset undergoing routine angiographic follow-up at 13 months. Using well-known risk factors for restenosis and target lesion revascularization (TLR), risk groups were formed to examine the absolute differences between PES and BMS. Results Compared with BMS, PES reduced TLR at 12 months from 7.4% to 4.5% (p = 0.003). Insulin-treated diabetes mellitus (hazard ratio: 3.12), reference vessel diameter ≤3.0 mm (hazard ratio: 2.89), and lesion length ≥30 mm (hazard ratio: 2.49) were independent predictors of 12-month TLR after BMS. In patients with 2 or 3 of these baseline risk factors, PES compared with BMS markedly reduced 12-month TLR (19.8% vs. 8.1%, p = 0.003). In patients with 1 of these risk factors, the 12-month rates of TLR were modestly reduced by PES (7.3% vs. 4.3%, p = 0.02). The 12-month TLR rates were low and similar for both stents in patients with 0 risk factors (3.3% vs. 3.2%, p = 0.93). Routine 13-month angiographic follow-up resulted in a marked increase in TLR procedures (more so with BMS) so that the absolute incremental benefit of PES compared with BMS doubled from 2.9% at 12 months to 6.0% at 24 months, a difference evident in all risk strata. Conclusions Patients at high risk for TLR after BMS in ST-segment elevation myocardial infarction for whom DES are of greatest benefit may be identified. Conversely, DES may be of less clinical benefit for patients at lower risk for TLR after BMS. Routine angiographic follow-up increases the perceived clinical benefits of DES, and must be avoided to accurately estimate absolute treatment effects. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966 )

Objectives Our objective was to evaluate the impact of door-to-balloon time (DBT) on mortality depending on clinical risk and time to presentation. Background DBT affects the mortality rate in ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention, but the impact may vary across subgroups. Methods The CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) and HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trials evaluated stent and antithrombotic therapy in patients undergoing primary percutaneous coronary intervention. We studied the impact of DBT on mortality in 4,548 patients based on time to presentation and clinical risk. Results The 1-year mortality rate was lower in patients with short versus long DBT (≤90 min vs. >90 min, 3.1% vs. 4.3%, p = 0.045). Short DBTs were associated with a lower mortality rate in patients with early presentation (≤90 min: 1.9% vs. 3.8%, p = 0.029) but not those with later presentation (>90 min: 4.0% vs. 4.6%, p = 0.47). Short DBTs showed similar trends for a lower mortality rate in high-risk (5.7% vs. 7.4%, p = 0.12) and low-risk (1.1% vs. 1.6%, p = 0.25) patients. Short DBTs had similar relative risk reductions in patients with early presentation in high-risk (3.7% vs. 7.0%, p = 0.08) and low-risk (0.8% vs. 1.5%, p = 0.32) patients, although the absolute benefit was greatest in high-risk patients. Conclusions Short DBTs (≤90 min) are associated with a lower mortality rate in patients with early presentation but have less impact on the mortality rate in patients presenting later. The absolute mortality rate reduction with short DBT is greatest in high-risk patients presenting early. These data may be helpful in designing triage strategies for reperfusion therapy in patients presenting to non–percutaneous coronary intervention hospitals.

Proximal LAD (PLAD) vessel diameter is rarely

Objectives Our aim was to determine whether a 600-mg loading dose of clopidogrel compared with 300 mg results in improved clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Background A 600-mg loading dose of clopidogrel compared with 300 mg provides more rapid and potent inhibition of platelet activation. Methods In the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial, 3,602 patients with STEMI undergoing primary PCI were randomized to bivalirudin (n = 1,800) or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (n = 1,802). Randomization was stratified by thienopyridine loading dose, which was determined before random assignment. Results Patients in the 600-mg (n = 2,158) compared with the 300-mg (n = 1,153) clopidogrel loading dose group had significantly lower 30-day unadjusted rates of mortality (1.9% vs. 3.1%, p = 0.03), reinfarction (1.3% vs. 2.3%, p = 0.02), and definite or probable stent thrombosis (1.7% vs. 2.8%, p = 0.04), without higher bleeding rates. Compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin monotherapy resulted in similar reductions in net adverse cardiac event rates within the 300-mg (15.2% vs. 12.3%) and 600-mg (10.4% vs. 7.3%) clopidogrel loading dose subgroups (pinteraction= 0.41). By multivariable analysis, a 600-mg clopidogrel loading dose was an independent predictor of lower rates of 30-day major adverse cardiac events (hazard ratio: 0.72 [95% confidence interval: 0.53 to 0.98], p = 0.04). Conclusions In patients with STEMI undergoing primary PCI with contemporary anticoagulation regimens, a 600-mg loading dose of clopidogrel may safely reduce 30-day ischemic adverse event rates compared with a 300-mg loading dose. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966)

Objectives The purpose of this study was to compare the 9-month clinical outcomes of patients treated with paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES) for coronary artery stenosis. Background The STENT (Strategic Transcatheter Evaluation of New Therapies) registry is the first multicenter registry in the U.S. to collect long-term outcomes of drug-eluting stents from “real-world” practice. Methods Data on all percutaneous coronary interventions in 8 U.S. hospital centers were collected in the STENT registry between 2003 and 2005. In this prospective, nonrandomized, observational study, the choice of procedures was at the physicians’ discretion. Patients who only received a PES (n = 4,671) or SES (n = 4,555) and completed 9-month follow-up (93.8% of eligible) were included for analysis. Primary end points were death, myocardial infarction (MI), and target vessel revascularization (TVR) at 9 months. Secondary outcomes included major adverse cardiac events (MACE) (any of the 3 primary end points) and stent thrombosis. Results At 9 months, death, MI, and TVR occurred in 2.2%, 2.0%, and 4.1%, respectively, of the PES group and 2.5%, 2.2%, and 4.3%, respectively, of the SES group (p = NS); MACE occurred in 7.5% of the PES group and 8.0% of the SES group (p = 0.37). After adjustments for group differences in baseline characteristics, TVR (hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.70 to 1.32; p = 0.26) and MACE (HR 0.95, 95% CI 0.81 to 1.12; p = 0.56) were similar for PES and SES. Stent thrombosis at 9 months occurred in 0.7% of both groups. Conclusions The results of this study show that clinical restenosis and MACE events after PES and SES procedures in “real-world” patients are infrequent and similar at 9 months.

Objectives The goal of this work was to determine whether rheolytic thrombectomy (RT) as an adjunct to primary percutaneous coronary intervention (PCI) reduces infarction size and improves myocardial perfusion during treatment of ST-segment elevation myocardial infarction (STEMI). Background Primary PCI for STEMI achieves brisk epicardial flow in most patients, but myocardial perfusion often remains suboptimal. Distal embolization of thrombus during treatment may be a contributing factor. Methods This prospective, multicenter trial enrolled 480 patients presenting within 12 h of symptom onset and randomized to treatment with RT as an adjunct to PCI (n = 240) or to PCI alone (n = 240). Visible thrombus was not required. The primary end point was infarct size measured by sestamibi imaging at 14 to 28 days. Secondary end points included final Thrombolysis In Myocardial Infarction (TIMI) flow grade, tissue myocardial perfusion (TMP) blush, ST-segment resolution, and major adverse cardiac events (MACE), defined as the occurrence of death, new Q-wave myocardial infarction, emergent coronary artery bypass grafting, target lesion revascularization, stroke, or stent thrombosis at 30 days. Results Final infarct size was higher in the adjunct RT group compared with PCI alone (9.8 ± 10.9% vs. 12.5 ± 12.13%; p = 0.03). Final TIMI flow grade 3 was lower in the adjunct RT group (91.8% vs. 97.0% in the PCI alone group; p Conclusions Despite effective thrombus removal, RT with primary PCI did not reduce infarct size or improve TIMI flow grade, TMP blush, ST-segment resolution, or 30-day MACE.

ObjectivesThe purpose of this study was to evaluate the impact of door-to-balloon time with primary percutaneous coronary intervention (PCI) on late cardiac mortality.BackgroundThe impact of door-to-balloon time on outcomes is controversial, and the impact on late mortality has not been studied.MethodsConsecutive patients (n = 2,322) treated with primary PCI from 1984 to 2003 were prospectively identified and followed up for a median of 83 months.ResultsProlonged door-to-balloon times (0 to 1.4 h vs. 1.5 to 1.9 h vs. 2.0 to 2.9 h vs. ≥3.0 h) were associated with higher in-hospital mortality (4.9% vs. 6.1% vs. 8.0% vs. 12.2%, p < 0.0001) and late mortality (12.6% vs. 16.4% vs. 20.4% vs. 27.1% at 7 years, p < 0.0001) and were an independent predictor of late mortality by Cox regression (p = 0.0004). Prolonged door-to-balloon times (≥2 h vs. 3 h) (21.1% vs. 18.5%; HR, 0.95; 95% CI, 0.62 to 1.45; p = 0.80).ConclusionsDelays in door-to-balloon time impact late survival in high-risk but not low-risk patients and in patients presenting early but not late after the onset of symptoms. These findings have implications for the triage of patients for primary PCI.

This document was commissioned by the American College of Cardiology Foundation (ACCF) Task Force on Clinical Expert Consensus Documents (CECDs) to provide a perspective on the current state of complementary, alternative, and integrative medical therapies specifically as they relate to

ObjectivesThe purpose of this study was to determine the clinical and angiographic correlates and outcomes of patients with suboptimal coronary flow after primary percutaneous coronary interventions (PCI).BackgroundThe clinical and angiographic correlates and outcomes of Thrombolysis in Myocardial Infarction (TIMI) ≤2 flow in patients treated with primary PCI are not known.MethodsWe evaluated 3,362 patients with ST elevation myocardial infarction enrolled in various Primary Angioplasty in Myocardial Infarction trials, who underwent primary PCI.ResultsPost-procedural final TIMI ≤2 flow occurred in 232 (6.9%) patients. Multivariate analysis identified age ≥70 years (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.1 to 2.2), diabetes (OR 1.9; 95% CI, 1.3 to 2.7), symptom onset to emergency room presentation (OR 1.1; 95% CI, 1.1 to 1.2); initial TIMI ≤1 flow (OR 3.2; 95% CI, 1.9 to 5.5), and left ventricular ejection fraction

Preamble......1688 Introduction......1688 General Considerations and Perspectives......1688 Nomenclature, Definitions, and Clinical Diagnosis......1689 Obstruction to LV Outflow......1689 Genetics and Molecular Diagnosis......1690 General Considerations for Natural History and Clinical Course

To the Editor: Stent thrombosis (ST) is an infrequent but major complication after percutaneous coronary intervention (PCI) and frequently is associated with ST-segment elevation myocardial infarction (STEMI). As the population of stented patients has grown, the number of patients at risk for STEMI

Background: Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) is associated with a high risk of adverse events, but few data are available on clinical outcomes after SVG PCI with contemporary drug-eluting stents (DES), and no studies have addressed the impact of high platelet

While stent edge dissection is a known complication of percutaneous coronary intervention (PCI), the clinical features and the long-term outcomes of intravascular ultrasound (IVUS)-detected dissections have not been fully investigated. ADAPT-DES was a prospective, multicenter, registry of 8,582

OBJECTIVES The goal of this study was to compare the impact of primary stenting or percutaneous transluminal coronary angioplasty (PTCA) on health-related quality of life (HRQOL) in patients undergoing direct angioplasty for acute myocardial infarction (AMI). BACKGROUND Previous studies have demonstrated that coronary stenting reduces clinical and angiographic restenosis compared with PTCA. However, the impact of stenting on HRQOL from the patient’s perspective remains unknown. METHODS We administered the Seattle Angina Questionnaire and the Medical Outcomes Study Short-form Survey at 1, 6 and 12 months after initial treatment to all North American patients in the Stent-Primary Angioplasty for Myocardial Infarction trial (Stent-PAMI) (n = 509)—a randomized trial comparing primary stenting to conventional PTCA for patients with AMI. RESULTS At one month, most HRQOL measures were similar for the two groups, but stent patients reported less bodily pain than PTCA patients (p = 0.03). At six-month follow-up, stenting resulted in significant improvements in several dimensions of HRQOL including reduced anginal frequency and bodily pain as well as improved disease perception (all p ≤ 0.03) and a trend towards better anginal stability (p = 0.056). By 12-month follow-up, however, none of these differences remained statistically significant. These differences in HRQOL were largely explained by the greater need for ischemia-driven target-vessel repeat revascularization procedures in PTCA patients during the first six months (16.0% vs. 6.2%, p CONCLUSIONS In patients undergoing revascularization for AMI, initial stent placement is associated with improvements in several dimensions of health status during the first six months of follow-up. In the absence of differences in mortality, these findings add to the overall argument in favor of initial stenting in patients treated with mechanical reperfusion for myocardial infarction.

This document has been developed as a Clinical Expert Consensus Document (CECD), combining the resources of the American College of Cardiology (ACC) and the Society for Cardiac Angiography and Interventions (SCA&I). It is intended to provide a perspective on the current state of cardiac

OBJECTIVES We sought to characterize the presenting characteristics of patients with previous coronary artery bypass graft surgery (CABG) and acute myocardial infarction (AMI) and to determine the angiographic success rate and clinical outcomes of a primary percutaneous transluminal coronary angioplasty (PTCA) strategy. BACKGROUND Patients who have had previous CABG and AMI comprise a high risk group with decreased reperfusion success and increased mortality after thrombolytic therapy. Little is known about the efficacy of primary PTCA in AMI. METHODS Early cardiac catheterization was performed in 1,100 patients within 12 h of onset of AMI at 34 centers in the prospective, controlled Second Primary Angioplasty in Myocardial Infarction trial (PAMI-2), followed by primary PTCA when appropriate. Data were collected by independent study monitors, end points were adjudicated and films were read at an independent core laboratory. RESULTS Of 1,100 patients with AMI, 58 (5.3%) had undergone previous CABG. The infarct-related vessel in these patients was a bypass graft in 32 patients (55%) and a native coronary artery in 26 patients. Compared with patients without previous CABG, patients with previous CABG were older and more frequently had a previous myocardial infarction and triple-vessel disease. Coronary angioplasty was less likely to be performed when the infarct-related vessel was a bypass graft rather than a native coronary artery (71.9% vs. 89.8%, p = 0.001); Thrombolysis in Myocardial Infarction trial (TIMI) flow grade 3 was less frequently achieved (70.2% vs. 94.3%, p < 0.0001); and in-hospital mortality was increased (9.4% vs. 2.6%, p = 0.02). As a result, mortality at six months was 14.3% versus 4.1% in patients with versus without previous CABG (p = 0.001). By multivariate analysis, independent determinants of late mortality in the entire study group were advanced age, triple-vessel disease, Killip class and post-PTCA TIMI flow grade

Objectives. The purpose of this study was to evaluate the importance of time to reperfusion for outcomes after primary angioplasty for acute myocardial infarction.Background. Survival benefit of thrombolytic therapy for acute myocardial infarction is strongly dependent on time to treatment. Recent observations suggest that time to treatment may be less important for survival with primary angioplasty.Methods. Consecutive patients (n = 1,352) with acute myocardial infarction treated with primary angioplasty were followed for up to 13 years. Paired acute and follow-up ejection fraction data were obtained at cardiac catheterization in 606 patients.Results. Reperfusion was achieved within 2 h in 164 patients (12%). Thirty-day mortality was lowest with early reperfusion (4.3% at 6 h). Thirty-day–plus late cardiac mortality was also lowest with early reperfusion (9.1% at 6 h). Improvement in left ventricular ejection fraction was greatest in the early reperfusion group and relatively modest after 2 h (6.9% at

Objectives. The second Primary Angioplasty in Myocardial Infarction (PAMI-II) study evaluated the hypothesis that primary percutaneous transluminal coronary angioplasty (PTCA), with subsequent discharge from the hospital 3 days later, is safe and cost-effective in low risk patients. Background. In low risk patients with myocardial infarction (MI), few data exist regarding the need for intensive care and noninvasive testing or the appropriate length of hospital stay. Methods. Patients with acute MI underwent emergency catheterization with primary PTCA when appropriate. Low risk patients (age ≤70 years, left ventricular ejection fraction >45%, one- or two-vessel disease, successful PTCA, no persistent arrhythmias) were randomized to receive accelerated care (admission to a nonintensive care unit and day 3 hospital discharge without noninvasive testing [n = 237] or traditional care [n = 234]). Results. Patients who received accelerated care had similar in-hospital outcomes but were discharged 3 days earlier (4.2 ± 2.3 vs. 7.1 ± 4.7 days, p = 0.0001) and had lower hospital costs ($9,658 ± 5,287 vs. $11,604 ± 6,125 p = 0.002) than the patients who received traditional care. At 6 months, accelerated and traditional care groups had a similar rate of mortality (0.8% vs. 0.4%, p = 1.00), unstable ischemia (10.1% vs. 12.0%, p = 0.52), reinfarction (0.8% vs. 0.4%, p = 1.00), stroke (0.4% vs. 2.6%, p = 0.07), congestive heart failure (4.6% vs. 4.3%, p = 0.85) or their combined occurrence (15.2% vs. 17.5%, p = 0.49). The study was designed to detect a 10% difference in event rates; at 6 months, only a 2.3% difference was measured between groups, indicating an actual power of 0.19. Conclusions. Early identification of low risk patients with MI allowed safe omission of the intensive care phase and noninvasive testing, and a day 3 hospital discharge strategy, resulting in substantial cost savings.

Objectives. The goals of this study were to examine the safety and feasibility of a routine (primary) stent strategy in acute myocardial infarction (AMI). Background. Limitations of reperfusion by primary percutaneous transluminal coronary angioplasty (PTCA) in AMI include in-hospital recurrent ischemia or reinfarction in 10% to 15% of patients, restenosis in 37% to 49% and late infarct-related artery reocclusion in 9% to 14%. By lowering the residual stenosis and sealing dissection planes created by PTCA, primary stenting may further improve short- and long-term outcomes after mechanical reperfusion. Methods. Three hundred twelve consecutive patients treated with primary PTCA for AMI at nine international centers were prospectively enrolled. After PTCA, stenting was attempted in all eligible lesions (vessel size 3.0 to 4.0 mm; lesion length ≤2 stents; and the absence of giant thrombus burden after PTCA, major side branch jeopardy or excessive proximal tortuosity or calcification). Patients with stents were treated with aspirin, ticlopidine and a 60-h tapering heparin regimen. Results. Stenting was attempted in 240 (77%) of 312 patients, successfully in 236 (98%), with Thrombolysis in Myocardial Infarction grade 3 flow restored in 230 patients (96%). Patients with stents had low rates of in-hospital death (0.8%), reinfarction (1.7%), recurrent ischemia (3.8%) and predischarge target vessel revascularization for ischemia (1.3%). At 30-day follow-up, no additional deaths or reinfarctions occurred among patients with stents, and target vessel revascularization was required in only one additional patient (0.4%). Conclusions. Primary stenting is safe and feasible in the majority of patients with AMI and results in excellent short-term outcomes.

Objectives. A large, international, multicenter, prospective, randomized trial was performed to determine the role of prophylactic intraaortic balloon pump (IABP) counterpulsation after primary percutaneous transluminal coronary angioplasty (PTCA) in acute myocardial infarction (AMI). Background. Previous studies have suggested that routine IABP use after primary PTCA reduces infarct-related artery reocclusion, augments myocardial recovery and improves clinical outcomes. Methods. Cardiac catheterization was performed in 1,100 patients within 12 h of onset of AMI at 34 clinical centers. Clinical and angiographic variables were used to stratify patients undergoing primary PTCA into high and low risk groups. High risk patients were then randomized to 36 to 48 h of IABP (n = 211) or traditional care (n = 226). The study had 80% power to detect a reduction in the primary end point from 30% to 20%. Results. There was no significant difference in the predefined primary combined end point of death, reinfarction, infarct-related artery reocclusion, stroke or new-onset heart failure or sustained hypotension in patients treated with an IABP versus those treated conservatively (28.9% vs. 29.2%, p = 0.95). The IABP strategy conferred modest benefits in reduction of recurrent ischemia (13.3% vs. 19.6%, p = 0.08) and subsequent unscheduled repeat catheterization (7.6% vs. 13.3%, p = 0.05) but did not reduce the rate of infarct-related artery reocclusion (6.7% vs. 5.5%, p = 0.64), reinfarction (6.2% vs. 8.0%, p = 0.46) or mortality (4.3% vs. 3.1%) and was associated with a higher incidence of stroke (2.4% vs. 0%, p = 0.03). IABP use did not result in enhanced myocardial recovery as assessed by paired admission to predischarge and 6-week rest and exercise left ventricular ejection fraction. Conclusions. In contrast to previous studies, a prophylactic IABP strategy after primary PTCA in hemodynamically stable high risk patients with AMI does not decrease the rates of infarct-related artery reocclusion or reinfarction, promote myocardial recovery or improve overall clinical outcome. (J Am Coll Cardiol 1997;29:1459–67)

Universitaets-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany, LeBauer CV Research Foundation, Greensboro, NC, Lehigh Valley Health Network, Allentown, PA, 4 Pinehurst Cardiology, Pinehurst, NC, 5 Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, United States, 6 Columbia University / Cardiovascular Research Foundation, New York, NY, 7 Ohio State University, Dublin, OH, 8 Mount Sinai Hospital, New York, NY, 9 Wellmont CVA Heart Institute, Kingsport, TN, Cardiovascular Research Foundation, NY, NY, Lebauer Cardiovascular Research Foundation, Greensboro, NC, Columbia University, New York, United States, 13 Charite Campus Benjamin Franklin, Berlin, Germany, 14 Cardiovascular Research Foundation, New York, NY, 15 UniversitatsHerzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany

1 Charite Campus Benjamin Franklin, Berlin, Germany, 2 LeBauer CV Research Foundation, Greensboro, NC, 3 Lehigh Valley Health Network, Allentown, PA, 4 Pinehurst Cardiology, Pinehurst, NC, 5 Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, United States, 6 Columbia University / Cardiovascular Research Foundation, New York, NY, Ohio State University, Dublin, OH, Mount Sinai Hospital, New York, NY, Wellmont CVA Heart Institute, Kingsport, TN, 10 Universitats-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany, 11 Cardiovascular Research Foundation, New York, New York, 12 Columbia University Medical Center and the Cardiovascular Research Foundation, New York, United States, 13 Lebauer Cardiovascular Research Foundation, Greensboro, NC, Columbia University, New York, United States, Cardiovascular Research Foundation, New York, NY

drug-eluting stent (DES) implantation. Methods: Between July 2008 and May 2012, we performed PCI for 321 ISR lesions using POBA (67 lesions, POBA group), PCB (149 lesions, PCB group), and DES (105 lesions, DES group). The morphological assessment of neointimal tissue at the minimum lumen area site as to restenotic tissue structure (homogeneous, heterogeneous, or layered type) using OCT was performed. We examined the association between tissue structure and mid-term (6-8 months) results including ISR and target lesion revascularization (TLR) rates. Results: The patients were 263 men and 58 women, and the mean age was 68.9 9.6 years. The mean follow-up period was 209 38 days. The association of tissue structure with ISR and TLR rates in each groups is shown in the figure. The ISR rates of lesions with homogeneous and layered structure were significantly lower in the PCB and DES groups than in the POBA group, whereas there were no differences between 3 groups in heterogeneous structure.

Objectives.The purpose of this study was to evaluate the importance of late infarct-related artery patency for recovery of left ventricular function and late survival after primary angioplasty for acute myocardial infarction.Background.Infarct-related artery patency is thought to improve late survival by its effect on preservation of left ventricular function. Patency may also enhance late survival by preventing left ventricular dilation and reducing arrhythmias, independent of myocardial salvage. However, most studies have not shown patency to be an independent predictor of survival when late left ventricular function is taken into account.Methods.We followed up 576 hospital survivors of acute myocardial infarction treated with primary angioplasty for 5.3 years. Ejection fraction and infarct-related artery patency were determined at follow-up catheterization at 6 months. Predictors of late cardiac survival were determined using Cox regression models.Results.Patients with patent arteries had more improvement and a better late ejection fraction than patients with occluded arteries (56.3% vs. 47.9%, p = 0.001). In patients with acute ejection fraction

Mechanical reperfusion was introduced as a reperfusion strategy for ST-segment elevation acute myocardial infarction (AMI) in the mid- and late 1980s and offered advantages over thrombolytic therapy in achieving higher infarct artery patency rates with less re-occlusion. With the publication of the

ObjectivesThis study sought to describe the economic outcomes from a prospective multicenter registry of primary coronary angioplasty.BackgroundInterest in coronary angioplasty without preceding thrombolytic therapy as a primary reperfusion strategy has increased as a result of three recent randomized trials showing outcomes equivalent to or better than standard thrombolytic therapy.MethodsThe Primary Angioplasty Registry enrolled 270 patients with acute myocardial infarction at six private tertiary care medical centers. Baseline and follow-up medical costs and counts of resources consumed were collected from enrollment to the 6-month follow-up visit. Correlates and predictors of cost were identified with multivariable linear regression modeling.ResultsNinety-five percent of patients had a revascularization procedure during the baseline hospital period: 85% had coronary angioplasty only; 4% had coronary bypass surgery only; 6% had both procedures. The total mean baseline hospital cost (not charge) was $13,113, with mean physician fees of $5,694. During the follow-up period, repeat coronary angiography was performed in 21% of patients, whereas 13% had repeat angioplasty and 3% bypass surgery. Mean hospital follow-up costs were $3,174, with mean physician fees of $1,443. Independent correlates of higher baseline hospital costs included older age (p = 0.049), anterior infarction (p = 0.03), initial Killip class (p < 0.0001), more severe coronary disease (p = 0.0015), need for bypass surgery alone or in addition to angioplasty (p < 0.0001) and recurrent ischemia (p < 0.0001).ConclusionsCosts of primary angioplasty for patients with acute myocardial infarction eligible for thrombolysis were strongly influenced by infarction- and procedure-related complications but only modestly influenced by patient selection factors.

Previous IVUS studies examining correlates of drug-eluting stent (DES) thrombosis were retrospective and in small patient cohorts. ADAPT-DES was a prospective, multicenter, real-world registry of 8,575 consecutive pts at 11 international centers treated with percutaneous coronary intervention (PCI

Absrac Caegor: 7. CI - Adjuc harmacologyreseao Number: 2536-627Auhors: Ajay J. Kirtane, Thomas Stuckey, Helen Parise, Bernhard Witzenbichler, Giora Weisz, Michael Rinaldi, Franz-Josef Neumann, David Metzger, Timothy Henry, David Cox, Peter Duffy, Bruce Brodie, Ernest Mazzaferri, Ecaterina Cristea, Roxana Mehran, Gregg Stone, Columbia University Medical Center / New York-Presbyterian Hospital, New York, NY, USA, Cardiovascular Research Foundation, New York, NY, USABackground: aes wh dabees mellus (M) udergog se mlaao have creased o-reame laele reacv (H), whch ma corbue o a greaer rs o os-rocedural hromboc eves.Objectives and Methods: AAT-E was a 8,575 ae rosecve, mulceer observaoal sud o useleced aes udergog drug-elug se mlaao; roue laele uco esg was erormed wh he VerNow 212 o-o-care assa ollowg clodogrel loadg. We sough o exame he assocao bewee H ad se hromboss (T) accordg o dabec saus.Results: A oal o 2,778 erolled aes (32.%) had M. aes wh M had hgher laele reacv us (U) comared o o-M aes (mea U 219.1 vs. 175.7, 208: 56.8% vs. 37.2%, 208 = 2.83 (95% CI 0.87-9.20), =0.08) ad o-M aes (H or U>208 = 3.63 (95% CI 1.28-10.26), =0.02), alhough he secic was low boh aes wh ad whou M (3.3% each grou).Conclusions: aes wh M have more reue H ad hgher 30-da raes o T ha aes whou M, ad H was assocaed wh a ~3-old creased haard o 30-da T deede o dabec saus. However, due ar o low overall eve raes, he redcve caac o H or 30-da T s modes boh aes wh ad whou M.

The study sought to determine whether rapid access to medical care and reperfusion results in a better prognosis in patients with in-hospital compared with out-of-hospital stent thrombosis (ST) in patients with ST-segment elevation myocardial infarction (STEMI) in the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial.Whether the prognosis of in-hospital and out-of-hospital ST are similar is uncertain, with conflicting data reported from prior studies.A total of 3,602 STEMI patients undergoing primary percutaneous coronary intervention (PCI) were randomized to bivalirudin (n = 1,800) versus unfractionated heparin (UFH) plus a glycoprotein IIb/IIIa inhibitor (GPI) (UFH+GPI; n = 1,802). Stents were implanted in 3,202 patients, 156 (4.9%) of whom developed Academic Research Consortium definite/probable ST during 3-year follow-up. We investigated the 1-year clinical outcomes after ST in 54 patients with in-hospital ST compared with 102 patients with out-of-hospital ST.One year after the ST event, patients with in-hospital compared with out-of-hospital ST had significantly greater mortality (27.8% vs. 10.8%, p0.01); most deaths in both groups occurred within 1 week of the ST event. Patients with in-hospital ST also had higher rates of major bleeding (21.2% vs. 6.0%, p0.01), but a lower rate of myocardial infarction (56.6% vs. 77.5%, p0.01). Subgroup analysis within both in-hospital and out-of-hospital ST groups indicated that subacute ST had the highest mortality. By multivariable analysis, 1-year mortality was significantly increased in patients with in-hospital compared with out-of-hospital ST (adjusted hazard ratio: 4.62, 95% confidence interval: 1.98 to 10.77, p0.01). Additional correlates of increased mortality after an ST event included diabetes and randomization to UFH+GPI (vs. bivalirudin).Following primary PCI for STEMI, more than one-third of all ST events during 3-year follow-up occurred during the index hospital phase. Mortality and major bleeding were significantly higher after in-hospital ST compared with out-of-hospital ST. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction; NCT00433966).

We investigated the outcomes of switching to bivalirudin after initial administration of heparin in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.Unfractionated heparin (UFH) is frequently administered early in ST-segment elevation myocardial infarction. Whether the benefits of bivalirudin documented in the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial persist in patients previously administered UFH is unknown.We analyzed the outcomes of the 2,357 patients from HORIZONS-AMI treated with UFH before enrollment according to their subsequent randomization to bivalirudin (switch group, n = 1,178) or UFH plus a glycoprotein IIb/IIIa inhibitor (control group, n = 1,179).At 30 days, major bleeding occurred in 7.6% of the switch group versus 12.3% of the control group (p = 0.0001). Switch patients had lower 30-day rates of cardiac mortality (1.6% vs. 2.9%, p = 0.04). At 2-year follow-up, switch patients experienced lower rates of major bleeding (8.4% vs. 13.0%, p = 0.0003), cardiac mortality (2.3% vs. 3.8%, p = 0.04), and reinfarction (4.0% vs. 7.1%, p = 0.0002). Two-year rates of definite/probable stent thrombosis were similar in switch and control patients (3.1% vs. 4.3%, p = 0.17).In ST-segment elevation myocardial infarction patients who receive early treatment with UFH, switching to bivalirudin before primary percutaneous coronary intervention results in reduced rates of major bleeding and improved early and late cardiac survival.

We sought to identify patients with ST-segment elevation myocardial infarction most likely to benefit from drug-eluting stents (DES), and to evaluate the impact of routine angiographic follow-up on the apparent differences between stent types.DES might have greatest utility in patients who would benefit most from their antirestenotic properties.We randomly assigned 3,006 patients with ST-segment elevation myocardial infarction to paclitaxel-eluting stents (PES) or to bare-metal stents (BMS). Events were assessed at 12 months and 24 months, with a subset undergoing routine angiographic follow-up at 13 months. Using well-known risk factors for restenosis and target lesion revascularization (TLR), risk groups were formed to examine the absolute differences between PES and BMS.Compared with BMS, PES reduced TLR at 12 months from 7.4% to 4.5% (p = 0.003). Insulin-treated diabetes mellitus (hazard ratio: 3.12), reference vessel diameter ≤3.0 mm (hazard ratio: 2.89), and lesion length ≥30 mm (hazard ratio: 2.49) were independent predictors of 12-month TLR after BMS. In patients with 2 or 3 of these baseline risk factors, PES compared with BMS markedly reduced 12-month TLR (19.8% vs. 8.1%, p = 0.003). In patients with 1 of these risk factors, the 12-month rates of TLR were modestly reduced by PES (7.3% vs. 4.3%, p = 0.02). The 12-month TLR rates were low and similar for both stents in patients with 0 risk factors (3.3% vs. 3.2%, p = 0.93). Routine 13-month angiographic follow-up resulted in a marked increase in TLR procedures (more so with BMS) so that the absolute incremental benefit of PES compared with BMS doubled from 2.9% at 12 months to 6.0% at 24 months, a difference evident in all risk strata.Patients at high risk for TLR after BMS in ST-segment elevation myocardial infarction for whom DES are of greatest benefit may be identified. Conversely, DES may be of less clinical benefit for patients at lower risk for TLR after BMS. Routine angiographic follow-up increases the perceived clinical benefits of DES, and must be avoided to accurately estimate absolute treatment effects. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966).