Use of prasugrel and clinical outcomes in African-American patients treated with percutaneous coronary intervention for acute coronary syndromes.

OBJECTIVE: To investigate the use of prasugrel after percutaneous coronary intervention (PCI) in African American (AA) patients presenting with acute coronary syndrome (ACS). BACKGROUND: AA patients are at higher risk for adverse cardiovascular outcomes after PCI and may derive greater benefit from the use of potent antiplatelet therapy. METHODS: Using the multicenter PROMETHEUS observational registry of ACS patients treated with PCI, we grouped patients by self-reported AA or other races. Clinical outcomes at 90-day and 1-year included non-fatal myocardial infarction (MI), major adverse cardiac events (composite of death, MI, stroke, or unplanned revascularization) and major bleeding. RESULTS: The study population included 2,125 (11%) AA and 17,707 (89%) non-AA patients. AA patients were younger, more often female (46% vs. 30%) with a higher prevalence of diabetes mellitus, chronic kidney disease, and prior coronary intervention than non-AA patients. Although AA patients more often presented with troponin (+) ACS, prasugrel use was much less common in AA vs. non-AA (11.9% vs. 21.4%, respectively, P = 0.001). In addition, the use of prasugrel increased with the severity of presentation in non-AA but not in AA patients. Multivariable logistic regression showed AA race was an independent predictor of reduced use of prasugrel (0.42 [0.37-0.49], P < 0.0001). AA race was independently associated with a significantly higher risk of MI at 90-days and 1 year after PCI. CONCLUSIONS: Despite higher risk clinical presentation and worse 1-year ischemic outcomes, AA race was an independent predictor of lower prasugrel prescription in a contemporary population of ACS patients undergoing PCI.

Fractional flow reserve guided percutaneous coronary intervention results in reduced ischemic myocardium and improved outcomes.

OBJECTIVES: To determine if fractional flow reserve guided percutaneous coronary intervention (FFR-guided PCI) is associated with reduced ischemic myocardium compared with angiography-guided PCI. BACKGROUND: Although FFR-guided PCI has been shown to improve outcomes, it remains unclear if it reduces the extent of ischemic myocardium at risk compared with angiography-guided PCI. METHODS: We evaluated 380 patients (190 FFR-guided PCI cases and 190 propensity-matched controls) who underwent PCI from 2009 to 2014. Clinical, laboratory, angiographic, stress testing, and major adverse cardiac events [MACE] (all-cause mortality, recurrence of MI requiring PCI, stroke) data were collected. RESULTS: Mean age was 63 ± 11 years; the majority of patients were males (76%) and Caucasian (77%). Median duration of follow up was 3.4 [Range: 1.9, 5.0] years. Procedural complications including coronary dissection (2% vs. 0%, P = .12) and perforation (0% vs. 0%, P = 1.00) were similar between FFR-guided and angiography-guided PCI patients. FFR-guided PCI patients had lower unadjusted (14.7% vs. 23.2%, P = .04) and adjusted [OR = 0.58 (95% CI: 0.34-0.98)] risk of repeat revascularization at one year. FFR-guided PCI patients were less likely (23% vs. 32%, P = .02) to have ischemia and had lower (5.9% vs. 21.1%, P < .001) ischemic burden (moderate-severe ischemia) on post-PCI stress testing. Presence of ischemia post-PCI remained a strong predictor of MACE [OR = 2.14 (95%CI: 1.28-3.60)] with worse survival compared to those without ischemia (HR = 1.63 (95% CI: 1.06-2.51). CONCLUSION: Compared with angiography-guided PCI, FFR-guided PCI results in less repeat revascularization and a lower incidence of post PCI ischemia translating into improved survival, without an increase in complications.

Use of prasugrel vs clopidogrel and outcomes in patients with acute coronary syndrome undergoing percutaneous coronary intervention in contemporary clinical practice: Results from the PROMETHEUS study.

BACKGROUND AND OBJECTIVES: We sought to determine the frequency of use and association between prasugrel and outcomes in acute coronary syndrome patients undergoing percutaneous coronary intervention (PCI) in clinical practice. METHODS: PROMETHEUS was a multicenter observational registry of acute coronary syndrome patients undergoing PCI from 8 centers in the United States that maintained a prospective PCI registry for patient outcomes. The primary end points were major adverse cardiovascular events at 90days, a composite of all-cause death, nonfatal myocardial infarction, stroke, or unplanned revascularization. Major bleeding was defined as any bleeding requiring hospitalization or blood transfusion. Hazard ratios (HRs) were generated using multivariable Cox regression and stratified by the propensity to treat with prasugrel. RESULTS: Of 19,914 patients (mean age 64.4years, 32% female), 4,058 received prasugrel (20%) and 15,856 received clopidogrel (80%). Prasugrel-treated patients were younger with fewer comorbid risk factors compared with their counterparts receiving clopidogrel. At 90days, there was a significant association between prasugrel use and lower major adverse cardiovascular event (5.7% vs 9.6%, HR 0.58, 95% CI 0.50-0.67, P<.0001) and bleeding (1.9% vs 2.9%, HR 0.65, 95% CI 0.51-0.83, P<.001). After propensity stratification, associations were attenuated and no longer significant for either outcome. Results remained consistent using different approaches to adjusting for potential confounders. CONCLUSIONS: In contemporary clinical practice, patients receiving prasugrel tend to have a lower-risk profile compared with those receiving clopidogrel. The lower ischemic and bleeding events associated with prasugrel use were no longer evident after accounting for these baseline differences.

Relationship of mitral valve annulus plane and circumflex-right coronary artery plane: Implications for Transcatheter Mitral Valve Implantation.

AIM: Transcatheter mitral valve implantation (TMVI) is a novel technology for patients with severe mitral valve disease but at high surgical risk. Imaging guidance during the procedure is critical for successful device deployment. Identification of the mitral annular plane (MAP) with fluoroscopy during the procedure is limited by lack of clearly defined landmarks. We hypothesized that a plane defined by left circumflex-right coronary arteries (LCX-RCA) would have a consistent relationship to MAP. METHODS AND RESULTS: We studied 25 patients with gated cardiac computed tomography. We identified the MAP and the LCX-RCA plane in mid systole and diastole. The distance between the two planes in prespecified four points (anterior, posterior, medial, and lateral) in the apical 2 and 3-chamber views. Alignment of the planes was described by cranial/caudal angulation for both planes in RAO 30° and LAO 90° (lateral) angulation. Mean age was 81 ± 9 years, 56% of patients had ≥2+ mitral regurgitation. In mid systole, the distances between the LCX-RCA plane and the MAP in the four points were < 5 mm in 92% of patients. In mid diastole, distances were < 5 mm in 100% of patients. In mid systole, the correlation between the caudal/cranial orientations of the 2 planes was 0.85 and 0.80 in the LAO 90° and RAO 30°, respectively (P = <0.001). In mid diastole, this was 0.92 and 0.92 in the LAO 90° and RAO 30°, respectively (P = <0.001). CONCLUSION: LCX-RCA plane has a close and consistent relationship to the MAP and can be useful to guide TMVI. Accurate imaging of mitral valve annular plane during TMVI procedure is challenging. MAP guided by fluoroscopy might be crucial to guide successful prosthesis deployment. A plane defined by the left circumflex- right coronary arteries in the atrioventricular grove has a consistent relationship with MAP; this can be used aided by pre-procedural MDCT to guide TMVI procedure. © 2016 Wiley Periodicals, Inc.

Resource utilization for transfemoral transcatheter aortic valve replacement: An international comparison.

BACKGROUND: Transfemoral transcatheter aortic valve replacement (TF-TAVR) has enjoyed a rapid diffusion in the US and Europe, but the procedure is resource intensive. OBJECTIVES: We sought to identify differences in resource utilization between a US and European center to ascertain opportunities for improvement in the performance of TF-TAVR. METHODS: All patients undergoing TF-TAVR using the Edwards SAPIEN valve series at the San Raffaele Hospital (Milan, Italy) and the Cleveland Clinic Foundation (Cleveland, OH) between January 2011 and December 2012 were included. Resource utilization was defined as preprocedural imaging, intraprocedural imaging, and personnel present during the procedure. RESULTS: A total of 158 patients from Cleveland and 113 from Milan were analyzed. Median logistic EuroScore (22.1 vs. 15.5, P = 0.013) and STS-PROM (8.9 vs. 5.0%, P < 0.001) were higher in Cleveland. Thirty-day outcomes were similar. Majority of procedures in Milan were conducted without a cardiac surgeon (79%) or an imaging specialist (99%) present during the case. There was greater reliance on endotracheal intubation (94.3 vs. 3.5%), general anesthesia (GA: 94.3 vs. 4.4%), and intraprocedural TEE (93 vs. 12.4%) in Cleveland, but shorter length of stay (mean: 6.42 vs. 11.16 days). CONCLUSIONS: We characterized resources used for patients undergoing TF-TAVR in Cleveland and Milan. Important differences included less reliance on GA and TEE and streamlining of procedural personnel in Milan, and reduced length-of-stay in Cleveland. Evolution of TF-TAVR to involve fewer operators must be balanced with the need for ready access to a comprehensive group of specialists in case of emergencies. © 2015 Wiley Periodicals, Inc.

Comparison of acute elastic recoil between the SAPIEN-XT and SAPIEN valves in transfemoral-transcatheter aortic valve replacement.

BACKGROUND: The SAPIEN-XT is a newer generation balloon-expandable valve created of cobalt chromium frame, as opposed to the stainless steel frame used in the older generation SAPIEN valve. We sought to determine if there was difference in acute recoil between the two valves. METHODS: All patients who underwent transfemoral-transcatheter aortic valve replacement using the SAPIEN-XT valve at the Cleveland Clinic were included. Recoil was measured using biplane cine-angiographic image analysis of valve deployment. Acute recoil was defined as [(valve diameter at maximal balloon inflation) - (valve diameter after deflation)]/valve diameter at maximal balloon inflation (reported as percentage). Patients undergoing SAPIEN valve implantation were used as the comparison group. RESULTS: Among the 23 mm valves, the mean (standard deviation-SD) acute recoil was 2.77% (1.14) for the SAPIEN valve as compared to 3.75% (1.52) for the SAPIEN XT valve (P = 0.04). Among the 26 mm valves, the mean (SD) acute recoil was 2.85% (1.4) for the SAPIEN valve as compared to 4.32% (1.63) for the SAPIEN XT valve (P = 0.01). Multivariable linear regression analysis demonstrated significantly greater adjusted recoil in the SAPIEN XT valves as compared to the SAPIEN valves by 1.43% [(95% CI: 0.69-2.17), P < 0.001]. However, the residual peak gradient was less for SAPIEN XT compared to SAPIEN valves [18.86 mm Hg versus 23.53 mm Hg (P = 0.01)]. Additionally, no difference in paravalvular leak was noted between the two valve types (P = 0.78). CONCLUSIONS: The SAPIEN XT valves had significantly greater acute recoil after deployment compared to the SAPIEN valves. Implications of this difference in acute recoil on valve performance need to be investigated in future studies.

Single center TAVR experience with a focus on the prevention and management of catastrophic complications.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an important treatment option for patients with severe symptomatic aortic stenosis (AS) who are inoperable or at high risk for complications with surgical aortic valve replacement. We report here our single-center data on consecutive patients undergoing transfemoral (TF) TAVR since the inception of our program, with a special focus on minimizing and managing complications. METHODS: The patient population consists of all consecutive patients who underwent an attempted TF-TAVR at our institution, beginning with the first proctored case in May 2006, through December 2012. Clinical, procedural, and echocardiographic data were collected by chart review and echo database query. All events are reported according to Valve Academic Research Consortium-2. RESULTS: During the study period, 255 patients with AS had attempted TF-TAVR. The procedure was successful in 244 (95.7%) patients. Serious complications including aortic annular rupture (n = 2), coronary occlusion (n = 2), iliac artery rupture (n = 1), and ventricular embolization (n = 1) were successfully managed. Death and stroke rate at 30 days was 0.4% and 1.6%, respectively. One-year follow-up was complete in 171 (76%) patients. One-year mortality was 17.5% with a 3.5% stroke rate. Descending aortic rupture, while advancing the valve, was the only fatal procedural event. There were 24.4% patients with ≥2+ aortic regurgitation. CONCLUSIONS: TAVR can be accomplished with excellent safety in a tertiary center with a well-developed infrastructure for the management of serious complications. The data presented here provide support for TAVR as an important treatment option, and results from randomized trials of patients with lower surgical risk are eagerly awaited.

Predicting vascular complications during transfemoral transcatheter aortic valve replacement using computed tomography: a novel area-based index.

BACKGROUND: Computed tomography (CT) imaging has not been systematically studied for predicting vascular complications during transcatheter aortic valve replacement (TAVR). METHODS: Clinical data were obtained from the electronic medical record and analysis was performed for each individual patient's iliofemoral CT angiogram. Sheath : femoral artery diameter ratio (SFAR) and sheath : femoral artery area ratio (SFAAR) were defined as the ratio of the sheath outer diameter to the femoral minimal lumen diameter (MLD) and sheath area to the femoral minimal lumen area (MLA), respectively. RESULTS: A total of 255 patients underwent TF-TAVR with a 30-day mortality of 0.4% and 30-day stroke rate of 1.6%. Twenty-eight (11%) patients suffered a vascular complication, the majority of whom (82%) were managed percutaneously. Receiver operating characteristic (ROC) curve analysis demonstrated an SFAAR of 1.35 to predict the occurrence of vascular complications with a sensitivity of 78.6%. By comparison, similar analysis using SFAR provided a value of 1.45 with sensitivity of 64.2%. Multivariable modeling confirmed SFAR [OR (95% CI): 8.3(1.8-39.1)] and log-transformed SFAAR [OR (95% CI): 40.1 (2.4-650.0)] as significant predictors of vascular complication. CONCLUSIONS: Using CT analysis, an SFAR of 1.45 and an SFAAR of 1.35 are each significant predictors of vascular complications among patients undergoing TF-TAVR. Utilization of CT-based area may provide a more accurate screen for patients undergoing evaluation for TF-TAVR as it takes into consideration the elliptical nature of the vessel. © 2014 Wiley Periodicals, Inc.

'Smoker's paradox' in young patients with acute myocardial infarction.

1. Of the patients suffering from acute myocardial infarction (AMI), smokers are younger than non-smokers, which may be a major confounding factor causing 'smoker's paradox'. Therefore, in the present study we evaluated the 'smoker's paradox' in young patients with AMI.2. In all, 1218 young AMI patients (≤ 45 years of age), comprising 990 smokers and 228 non-smokers, were enrolled in the present study. In-hospital and 8 months clinical outcomes were compared between the smokers and non-smokers. 3. Baseline clinical characteristics showed that smokers were more likely to be male (97.9% vs 72.4%; P < 0.001) and had a higher rate of ST-segment elevation myocardial infarction (71.3% vs 59.5%; P = 0.001) than non-smokers. Clinical outcomes showed that smokers had lower rates of in-hospital cardiac death (0.8% vs 3.5%; P = 0.004), total death (0.8% vs 3.5%; P = 0.004) and 8 months cardiac death (1.1% vs 3.9%; P = 0.006) and total death (1.3% vs 4.4%; P = 0.005) than non-smokers. Multivariable logistic analysis showed that current smoking was an independent protective predictor of 8 months cardiac death (odds ratio (OR) 0.25; 95% confidence interval (CI) 0.07-0.92; P = 0.037) and total death (OR 0.26; 95% CI 0.09-0.82; P = 0.021). Subgroup analysis in patients who underwent percutaneous coronary intervention after AMI showed that current smoking was an independent protective predictor of 8 months total major adverse cardiac events (OR 0.47; 95% CI 0.23-0.97; P = 0.041). 4. Current smoking seems to be associated with better clinical outcomes in young patients with AMI, suggesting the existence of the 'smoker's paradox' in this particular subset of patients.

Standard versus high loading doses of clopidogrel in Asian ST-segment elevation myocardial infarction patients undergoing percutaneous coronary intervention: insights from the Korea Acute Myocardial Infarction Registry.

BACKGROUND: The optimal loading dose of clopidogrel in Asian patients with ST-segment elevation myocardial infarction (STEMI) has not been fully investigated. We compared bleeding, vascular complications, and midterm outcomes of a 300-mg versus a 600-mg loading dose of clopidogrel in a large series of Korean patients with STEMI undergoing primary percutaneous coronary intervention (PCI). METHODS: A total of 2,664 STEMI patients (age 61.96 ± 11.91 years, men 70.4%) who underwent primary PCI were enrolled in this study. The patients were divided into a standard loading dose group (300 mg; n = 1,447 patients) and a high loading dose group (600 mg; n = 1,217 patients). Bleeding and vascular complications, and in-hospital and clinical outcomes up to 12 months were compared between the 2 groups. RESULTS: In-hospital bleeding and vascular complications were similar between the 2 groups. There were no differences in bleeding and vascular complications and in 1- and 12-month clinical outcomes, including mortality, myocardial infarction, repeated PCI, and major adverse cardiac events, between the 2 groups. These findings were consistent even after the propensity score-matched analysis. CONCLUSIONS: The standard loading dose of clopidogrel may be as safe and similarly effective as the high loading dose in Asian STEMI patients undergoing primary PCI.

Multivessel versus single vessel spasm, as assessed by the intracoronary acetylcholine provocation test, in Korean patients.

1. Coronary artery spasm (CAS) is known to be a major cause of myocardial ischaemia. Multivessel coronary spasm (MVS) in particular is likely to induce more severe and prolonged myocardial ischaemia than single vessel spasm (SVS). 2. In the present study, a total of 1082 consecutive patients without significant coronary artery disease who underwent an acetylcholine (ACh) provocation test between March 2004 and April 2009 were investigated. Patients were divided into three groups: an MVS group (n = 275), an SVS group (n = 376) and a non-CAS group (n = 431). Differences in clinical and angiographic characteristics following the ACh provocation test were evaluated between the MVS, SVS and non-CAS groups. 3. At baseline, patients in the MVS group had the highest prevalence of peripheral artery disease (PAD), hyperlipidaemia, smoking and old age, as well as the highest triglyceride levels. Calcium channel blockers were most frequently prescribed in MVS patients before the ACh test. During the ACh test, the highest prevalence of chest pain, ischaemic electrocardiogram changes, baseline spasms and diffuse and severe spasms were observed in the MVS group. The response rate to lower ACh doses that induce CAS was also higher in the MVS group. Multivariate analysis showed that the presence of PAD (odds ratio (OR) 2.0; P = 0.006) and baseline spasm (OR 1.4; P = 0.045) were independent predictors of ACh-induced MVS. 4. In conclusion, ischaemic symptoms, diffuse and severe spasm and baseline spasm were more frequently associated with MVS patients, suggesting more intensive medical therapies and close clinical follow up would be required for this patient group.

Triple versus dual antiplatelet therapy in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

BACKGROUND: Whether triple antiplatelet therapy is superior or similar to dual antiplatelet therapy in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention in the era of drug-eluting stents remains unclear. METHODS AND RESULTS: A total of 4203 ST-segment elevation myocardial infarction patients who underwent primary percutaneous coronary intervention with drug-eluting stents were analyzed retrospectively in the Korean Acute Myocardial Infarction Registry (KAMIR). They received either dual (aspirin plus clopidogrel; dual group; n=2569) or triple (aspirin plus clopidogrel plus cilostazol; triple group; n=1634) antiplatelet therapy. The triple group received additional cilostazol at least for 1 month. Various major adverse cardiac events at 8 months were compared between these 2 groups. Compared with the dual group, the triple group had a similar incidence of major bleeding events but a significantly lower incidence of in-hospital mortality. Clinical outcomes at 8 months showed that the triple group had significantly lower incidences of cardiac death (adjusted odds ratio, 0.52; 95% confidence interval, 0.32 to 0.84; P=0.007), total death (adjusted odds ratio, 0.60; 95% confidence interval, 0.41 to 0.89; P=0.010), and total major adverse cardiac events (adjusted odds ratio, 0.74; 95% confidence interval, 0.58 to 0.95; P=0.019) than the dual group. Subgroup analysis showed that older (>65 years old), female, and diabetic patients got more benefits from triple antiplatelet therapy than their counterparts who received dual antiplatelet therapy. CONCLUSIONS: Triple antiplatelet therapy seems to be superior to dual antiplatelet therapy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with drug-eluting stents. These results may provide the rationale for the use of triple antiplatelet therapy in these patients.

Low-molecular-weight heparin versus unfractionated heparin in acute ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention with drug-eluting stents.

BACKGROUND: Whether low-molecular-weight heparin (LMWH) is superior to unfractionated heparin (UFH) in acute ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) remains unclear. METHODS: A total of 3,372 STEMI patients who underwent primary PCI with DESs received either LMWH (n = 1,531 patients, subcutaneous enoxaparin 1 mg/kg, bid for 3-5 days plus reduced dose of UFH [50 U/kg] during PCI) or UFH alone (n = 1,841 patients, intravenous bolus injection of 5,000 U, followed by 24,000 U/d infusion for at least 48 hours). The bleeding events and clinical outcomes during in-hospital and at 8 months were compared. RESULTS: The incidences of major and minor bleeding events were similar between the 2 groups. Multivariable Cox regression analysis showed that LMWH group had lower incidences of cardiac death (adjusted odds ratio [OR] 0.55, 95% CI 0.39-0.77, P < .001), total death (adjusted OR 0.50, 95% CI 0.37-0.68, P < .001), and total major adverse cardiac events (adjusted OR 0.77, 95% CI 0.62-0.95, P = .017) at 8 months as compared with UFH group. Similar results were obtained across different subgroups including different DESs, age, and sex. CONCLUSIONS: The LMWH enoxaparin combined with reduced dose of UFH (50 U/kg) administration as an adjunctive antithrombotic therapy in STEMI patients undergoing primary PCI with DESs seems to be safe and efficacious. However, randomized clinical trials are needed to confirm this conclusion.

Clinical characteristics and mid-term outcomes of acute myocardial infarction patients with prior cerebrovascular disease in an Asian population: Lessons from the Korea Acute Myocardial Infarction Registry.

1. The aim of the present study was to evaluated the impact of prior cerebrovascular disease (CVD) on the clinical characteristics and mid-term clinical outcomes of patients with acute myocardial infarction (AMI) in the era of drug-eluting stents. 2. Data from 12 914 patients with acute myocardial infarction who were enrolled in the Korea Acute Myocardial Infarction Registry were analysed retrospectively from November 2005 to December 2007. Prior CVD was defined as having had one or more events of ischaemic or haemorrhagic stroke or a transient ischaemic attack. 3. Of the 12 914 patients reviewed, 906 (7.0%) were found to have had prior CVD. Patients with CVD were older, were more likely to be women and were more likely to have hypertension and diabetes than those without CVD. Patients with prior CVD presented more often with non-ST-segment elevation myocardial infarction and higher Killip class than those without CVD. Furthermore, patients with CVD received less percutaneous coronary intervention (PCI) or thrombolysis compared with those without CVD. Although intensive medical therapy was equal in both groups, clinical outcomes at 8 months showed that patients with CVD had a higher incidence of cardiac death (adjusted odds ratio (OR) 1.42; 95% confidence interval (CI) 1.14-1.76; P = 0.002) and total death (adjusted OR 1.50; 95% CI 1.25-1.81; P < 0.001) than those without CVD. 4. In conclusion, patients with prior CVD presented with worse clinical characteristics on admission and were less likely to receive PCI or thrombolysis than those without CVD. Given the poorer mid-term clinical outcomes, more intensive and aggressive management shouldis recommended for patients with prior CVD to improve their long-term clinical outcome.

Lack of clinical benefit of improved angiographic results with sirolimus-eluting stents compared with paclitaxel and zotarolimus-eluting stents in patients with acute myocardial infarction undergoing percutaneous coronary intervention.

BACKGROUND: There is limited information regarding the angiographic and clinical outcomes among the different drug-eluting stents (DESs) in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: A total 355 consecutive AMI patients who underwent PCI with a sirolimus- (SES, n=116) or paclitaxel- (PES, n=153) or zotarolimus-eluting stent (ZES, n=86) were enrolled. The 6-month angiographic and 1-year clinical outcomes were compared among the 3 groups. At 6 months, there was a trend toward a higher incidence of binary restenosis in the PES group (SES: 8.6%, PES: 19.8%, ZES: 8.3%, P=0.052). Percentage of restenosis was higher in the PES group compared with SES, but was similar to ZES (SES: 18.75 +/-18.16%, PES: 29.32 +/-24.16%, ZES: 23.91 +/-17.03%, P=0.006). Late loss was lower in the SES group compared with PES and ZES (SES: 0.44 +/-0.52, PES: 0.83 +/-0.87, ZES: 0.75 +/-0.63, P<0.001). However, clinical outcomes, including mortality, MI, repeat PCI and major adverse cardiac events, were not different among the 3 groups. CONCLUSIONS: The angiographic benefit of SES did not translate into a clinical benefit for up to 1 year in AMI patients.

Peripheral arterial disease is associated with coronary artery spasm as assessed by an intracoronary acetylcholine provocation test.

1. Both peripheral arterial disease (PAD) and coronary artery spasm (CAS) are associated with endothelial dysfunction. Thus, a higher incidence of CAS may be expected in patients with PAD. In the present study, we evaluated the incidence and characteristics of CAS in patients with PAD. 2. A total of 78 patients with PAD and 241 age- and gender-matched patients without PAD who had chest pain with normal coronary appearance on coronary angiograms underwent intracoronary acetylcholine (ACh) provocation test. Acetylcholine was injected into the left coronary artery in incremental doses of 20, 50 and 100 microg/min. Significant CAS was defined as a transient > 70% luminal narrowing with concurrent chest pain and/or ST segment changes. 3. Patients with PAD had a significantly higher incidence of ACh-induced significant CAS than those without PAD (60.3 vs 34.0%, respectively P < 0.001), as well as chest pain and ST segment changes during the ACh provocation test. Patients with PAD were more sensitive to lower doses of ACh and had a higher incidence of multivessel spasm than those without PAD. Multivariable logistic analysis showed that age, current smoking, PAD and myocardial bridge were independent predictors of ACh-induced significant CAS. Moreover, of these factors, PAD was the strongest independent predictor (odds ratio 4.25; confidence interval 1.33-13.54; P = 0.014). 4. In patients with chest pain, the presence of arterial disease at another site should still push the clinician towards treating the chest pain as angina, even if the coronary anatomy is normal on a coronary angiogram.

Use of prasugrel vs clopidogrel and outcomes in patients with and without diabetes mellitus presenting with acute coronary syndrome undergoing percutaneous coronary intervention.

BACKGROUND: Clinical trial data studies suggest superiority of prasugrel over clopidogrel in patients with diabetes. However, the use, safety and efficacy profile of prasugrel in unselected diabetic patients presenting with acute coronary syndromes (ACS) remain unclear. METHODS: PROMETHEUS was a prospective multicenter observational study of 19,919 ACS PCI patients enrolled between 2010 and 2013. The primary endpoint was 90-day major adverse cardiovascular events (MACE), comprising all-cause death, myocardial infarction, stroke or unplanned revascularization. The safety endpoint was bleeding requiring hospitalization. RESULTS: We identified 7580 (38%) subjects with and 12,329 (62%) without diabetes. Diabetic patients were older and had significantly higher rates of cardiovascular risk factors. However, they were less likely to receive prasugrel (18.2% vs. 21.7%). Use of prasugrel did not increase with the severity of clinical presentation in diabetics, whereas, among non-diabetics, prescription of prasugrel was higher in NSTEMI and STEMI compared to unstable angina. The 90-day and 1-year adjusted risk of MACE was greater in diabetics (at 1 year: 22.7% vs. 16.5%; HR 1.22 [1.14-1.33], p < 0.001). At 1 year, the risk of bleeding was also higher in diabetics (4.9% vs. 4.1%, HR 1.19 [1.01-1.39], p = 0.035). After multivariable adjustment, use of prasugrel was associated with a lower risk of death in diabetic patients both at 90 days and 1 year. CONCLUSIONS: Use of prasugrel in diabetic patients with PCI-treated ACS was lower than in non-diabetics despite their high-risk profile and the severity of their clinical presentation. In diabetics, prasugrel was associated with a lower adjusted risk of 90-day death compared with clopidogrel.

Meta-Analysis of Usefulness of Anticoagulation After Transcatheter Aortic Valve Implantation.

Since the advent of bioprosthetic valves, the implications of long-term anticoagulation after valve replacement are unclear. There are very little data on outcomes of long-term anticoagulation after transcatheter aortic valve implantation (TAVI). Our aim was to conduct a systematic review of literature regarding anticoagulation after TAVI. The existing literature on anticoagulation after bioprosthetic valve replacement was thoroughly reviewed, including the most recent American College of Cardiology/American Heart Association 2017 guidelines for management of valvular disease, which is based on sparse, nonrandomized retrospective data. A systematic review of MEDLINE, EMBASE, and Cochrane CENTRAL databases was conducted to retrieve articles reporting outcomes on anticoagulation after TAVI, and 5 articles were retrieved. Pooled analysis revealed lower bleeding rates in the anticoagulated group (22% vs 35%, p = 0.006). Stroke and mortality were inconsistently reported by the studies. The data regarding outcomes of patients on anticoagulation after TAVI are sparse. Systematic collection of anticoagulation data in the existing registries and future trials should be strongly considered in patients undergoing TAVI.

Frequency and factors associated with inappropriate for intervention cardiac catheterization laboratory activation.

BACKGROUND: Current guidelines emphasize timely coronary intervention with a door to balloon time of ≤90min for favorable survival impact after STEMI. Efforts to achieve these targets may result in unnecessary emergent angiography for inappropriate activations. OBJECTIVE: Evaluate the frequency, trend and factors which are significantly associated with inappropriate for intervention cardiac catheterization laboratory (CCL) activation. METHODS: We analyzed 1764 consecutive emergent CCL activation for possible ST segment elevation myocardial infarction (STEMI) between 7/2005 and 8/2013. Inappropriate for intervention activation was defined as negative STEMI (incorrect diagnosis: insignificant coronary lesion, not requiring any intervention) and inappropriate patients (true STEMI but poor CCL candidacy). RESULTS: Inappropriate for intervention CCL activation occurred in 317 patients (17.9%): 292 incorrect diagnosis (negative STEMI diagnosis), 25 inappropriate patients, with no difference in the frequency based on time of the day (18.6% regular hours vs. 17.6% off-hours, p=0.6). On multivariable analysis, female gender (OR 1.9 [1.2-3.0]), African American race (OR 1.9[1.3-2.7]), and prior coronary artery bypass graft surgery (OR 3.6 [2.3-5.5]) were significantly associated with incorrect diagnosis (negative STEMI diagnosis) (all p<0.005) and hyperlipidemia (OR 0.2 [0.1-0.3]), tobacco use (OR 0.2 [0.1-0.3]), and stroke/TIA (OR 0.2 [0.1-0.4]) had a significant inverse association (all p<0.001). ST Elevation with no reciprocal depression and pericarditis/myocarditis were the most common ECG finding and etiology respectively. CONCLUSION: Inappropriate for intervention CCL activation is not uncommon and should be closely monitored to maximize resource utilization. Females, African American patients with few or no risk factors and patients presenting ST elevation but no reciprocal depression constitute a population that may require attention.

Percutaneous Intervention for Myocardial Infarction After Noncardiac Surgery: Patient Characteristics and Outcomes.

BACKGROUND: Few studies have explored percutaneous coronary intervention (PCI) in perioperative myocardial infarction (PMI), even though PMI is a major cause of mortality in patients undergoing urgent/emergent noncardiac surgery. OBJECTIVES: This study sought to describe the angiographic characteristics and outcomes in patients presenting to the cardiac catheterization laboratory for myocardial infarction sustained after undergoing noncardiac surgery, with a detailed analysis of those undergoing PCI. METHODS: We included all patients presenting to the catheterization laboratory at our institution after PMI from 2003 to 2012, who had noncardiac surgery within the previous 7 days. Data from patients who underwent PCI were analyzed using both standard regression and time-to-event survival analysis. RESULTS: From 2003 to 2012, 1,093 patients with 3,832 person-years of follow-up underwent diagnostic coronary angiography, of whom 281 (40 ST-segment elevation myocardial infarction [STEMI] and 241 non-ST-segment elevation myocardial infarction [NSTEMI] cases) underwent PCI. Using Kaplan-Meier survival analysis, we found 30-day mortality was 5.2% and 1-year mortality was 15% in the overall population. In the PCI subpopulation, we estimated 30-day mortality to be 11.3%. The 30-day death rate in the STEMI cohort was 31.2% and 8.5% in the NSTEMI cohort of the PCI subpopulation. Stepwise logistic regression revealed the following factors as strong predictors of 30-day mortality after PCI: bleeding event after PCI (odds ratio [OR]: 4.33; 95% confidence limits (CL): 1.52 to 12.30), peak troponin T level (OR: 1.20; 95% CL: 1.08 to 1.34), and underlying peripheral vascular disease (OR: 4.86; 95% CL: 1.66 to 14.22). Cox proportional hazard analysis of survival data showed that increasing age (hazard ratio [HR]: 1.03; 95% CL: 1.01 to 1.04), bleeding after PCI (HR: 2.31; 95% CL: 1.61 to 3.32), renal insufficiency (HR: 2.26; 95% CL: 1.51 to 3.39]), and vascular surgery (HR: 1.48; 95% CL: 1.02 to 2.15]) were all significant predictors of long-term mortality after PCI. CONCLUSIONS: Perioperative MI has a markedly high mortality rate, despite PCI. Bleeding event, peak troponin T level, and peripheral vascular disease predict mortality within 30 days of PCI in this patient population. Similarly, older age, vascular surgery, bleeding event, and renal dysfunction strongly predict long-term mortality after PCI in the setting of PMI.