Does black ethnicity influence the development of stent thrombosis in the drug-eluting stent era?

BACKGROUND: It has been suggested that black race predicts stent thrombosis (ST) after drug-eluting stent implantation. Whether socioeconomic status or comorbid conditions confound the contribution of black race to the development of ST is unclear. METHODS AND RESULTS: We compared 1594 black patients who underwent drug-eluting stent implantation with 5642 nonblack patients. Overall, 108 definite STs were reported. Multivariable Cox regression analysis was performed with adjustment for comorbidities, including median household income as a marker of socioeconomic status, to assess the impact that black race may have on the development of ST. On univariable analysis, black patients were younger (63.43±12.42 versus 65.15±12.59 years; P<0.001) and more likely to have a history of hypertension (89.8% versus 81.7%; P<0.001), diabetes mellitus (45.5% versus 30.8%; P<0.001), chronic renal insufficiency (19.2% versus 10.7%; P<0.001), and congestive heart failure (18.7% versus 13.1%; P<0.001). Clopidogrel compliance at the time of the ST event was higher in the black than in the nonblack population (87.5% versus 77.8%; P=0.068). After multivariable analysis, including adjustment for median income and clopidogrel compliance, black race emerged as a strong predictor of definite late ST. CONCLUSIONS: Black race is an independent predictor of definite drug-eluting stent ST. Because clopidogrel compliance was higher in black patients and socioeconomic status was not associated with ST, further investigation into the potential mechanisms of this influence of race on ST must be pursued.

Correlates and causes of death in patients with severe symptomatic aortic stenosis who are not eligible to participate in a clinical trial of transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation is currently being evaluated in patients with severe aortic stenosis who are considered high-risk surgical candidates. This study aimed to detect incidences, causes, and correlates of mortality in patients ineligible to participate in transcatheter aortic valve implantation studies. METHODS AND RESULTS: From April 2007 to July 2009, a cohort of 362 patients with severe aortic stenosis were screened and did not meet the inclusion/exclusion criteria necessary to participate in a transcatheter aortic valve implantation trial. These patients were classified into 2 groups: group 1 (medical): 274 (75.7%): 97 (35.4%) treated medically and 177 (64.6%) treated with balloon aortic valvuloplasty; and group 2 (surgical): 88 (24.3%). The medical/balloon aortic valvuloplasty group had significantly higher clinical risk compared with the surgical group, with significantly higher Society of Thoracic Surgeons score (12.8±7.0 versus 8.5±5.1; P<0.001) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (42.4±22.8 versus 24.4±18.1; P<0.001). The medical/balloon aortic valvuloplasty group had a higher New York Heart Association functional class, incidence of renal failure, and lower ejection fraction. During median follow-up of 377.5 days, mortality in the medical/balloon aortic valvuloplasty group was 102 (37.2%), and during median follow-up of 386 days, mortality in the surgical group was 19 (21.5%). Multivariable adjustment analysis identified renal failure (hazard ratio [HR]: 5.60), New York Heart Association class IV (HR: 5.88), and aortic systolic pressure (HR: 0.99) as independent correlates for mortality in the medical group, whereas renal failure (HR: 7.45), Society of Thoracic Surgeons score (STS; HR: 1.09) and logistic EuroSCORE (HR: 1.45) were correlates of mortality in the in the surgical group. CONCLUSIONS: Patients with severe symptomatic aortic stenosis not included in transcatheter aortic valve implantation trials do poorly and have extremely high mortality rates, especially in nonsurgical groups, and loss of quality of life in surgical groups.

Incidence, correlates, and clinical impact of nuisance bleeding after antiplatelet therapy for patients with drug-eluting stents.

BACKGROUND: Nuisance bleeding (NB) after dual antiplatelet therapy (DAPT) is not well characterized despite its potential to impact patient compliance. We therefore aimed to evaluate the incidence, correlates, and clinical impact of NB after DAPT after drug-eluting stent (DES) implantation. METHODS: Included were 2,948 patients with DES implantation who were discharged on DAPT for 12 months. New bleeding classifications were used: alarming bleeding, internal bleeding, and NB. RESULTS: After excluding patients with alarming bleeding (9 [0.3%]) and internal bleeding (128 [4.3%]), the 2,811 remaining patients were divided into 2 groups: those with NB (812 [28.9%]) and those without (1,999 [71.1%]). Patients with NB were significantly younger (63.0 +/- 11.4 vs 65.2 +/- 11.6 years, P < .001), were more often white (82.0% vs 69.6%, P < .001), had lower body mass indices (29.2 +/- 6.1 vs 29.8 +/- 6.0 kg/m(2), P = .01), and a lower prevalence of diabetes (25.5% vs 34.8%, P < .001) compared to those without NB. At 1 year, the rate of major adverse cardiac events was higher in the NB group compared to the nonbleeding group (77 [9.4%] vs 134 [6.7%], P = .02). In the NB group, 46 patients (5.7%) stopped 1 or both antiplatelet therapies. Thirty-five (4.3%) discontinued clopidogrel, 16 (2.0%) stopped aspirin, and 5 (0.61%) stopped both as a result of the reported NB. Multivariable analysis detected younger age, lower body mass index, white race, and without diabetes as correlates associated with NB while on clopidogrel therapy. CONCLUSION: Nuisance bleeding is common in patients on prolonged DAPT post-DES implantation and can impact compliance. Nuisance bleeding appears to have important clinical implications and, if confirmed in prospective trials, should be added to the safety end points assessing new antiplatelet agents.

Impact of intravascular ultrasound guidance in patients with acute myocardial infarction undergoing percutaneous coronary intervention.

OBJECTIVES: The aim of this study was to examine the utility of routine intravascular ultrasound (IVUS) guidance in patients with acute myocardial infarction (MI) undergoing percutaneous coronary intervention (PCI) with stent implantation. BACKGROUND: Stent thrombosis (ST) is a serious complication of PCI with stent implantation for patients presenting with acute MI. Mechanical factors such as incomplete stent expansion and smaller stent diameters are known to correlate with ST and restenosis. IVUS guidance for stent deployment is reported to reduce these events in stable patients. METHODS: We analyzed a cohort of 905 consecutive patients who underwent primary PCI for acute MI and were discharged alive. The clinical outcomes of 382 patients who underwent IVUS-guided PCI were compared to those of 523 patients who did not. Patients who presented with cardiogenic shock and rescue PCI were excluded. The primary composite endpoint of death, MI, and target lesion revascularization at 1-year follow-up was systematically indexed and a propensity score was performed with regard to the use of IVUS-guided PCI. RESULTS: Patients undergoing IVUS-guided PCI were older, more diabetic and hypertensive, but presented with less history of previous MI. The severity of coronary artery disease was balanced between both groups. The number of treated lesions and stents used was higher in the IVUS-guided group, with a longer procedural duration. The overall rates of the composite primary outcome were similar (14.5% vs. 14.3%, P = 0.94) as were the rates of definite and probable stent thrombosis at 1 year (2.1% vs. 2.1%, P = 0.99) in the IVUS-guided and no-IVUS groups, respectively. After multivariate and propensity score adjustment, IVUS guidance was not an independent predictor for the primary endpoint. CONCLUSION: This study does not support the routine use of IVUS guidance for stent deployment in patients who present with acute MI and undergo primary PCI.

Does on- versus off-hours presentation impact in-hospital outcomes of ST-segment elevation myocardial infarction patients transferred to a tertiary care center?

OBJECTIVES: To determine whether in-hospital outcome differs for transferred patients with ST-segment elevation myocardial infarction (STEMI) presenting during business (ON) hours vs. after (OFF) hours. BACKGROUND: Door-to-device (DTD) time is a prognostic factor in patients with STEMI and is longer during OFF hours. However, the in-hospital mortality is controversial. METHODS: This registry study included 786 consecutive patients with STEMI referred for primary percutaneous coronary intervention to a tertiary care center with an on-site cardiac catheterization team 24 hrs a day/7 days (24/7) a week. ON hours were defined as weekdays 8 a.m. to 5 p.m., while OFF hours were defined as all other times, including holidays. The primary outcomes were in-hospital death, reinfarction, and length of stay (LOS). RESULTS: ON hours (29.5%, n = 232) and OFF hours (70.5%, n = 554) groups had similar demographic and baseline characteristics. A significantly higher proportion of patients presenting ON hours had a DTD time ≤120 min compared to OFF hours patients (32.6% vs. 22.1%, P = 0.007). The rates of in-hospital death (8.2% vs. 6%), reinfarction (0% vs. 1.1%), and mean LOS (5.7 ± 6 vs. 5.7 ± 5) were not significantly different in the ON vs. OFF hours groups, all P = nonsignificant. CONCLUSION: In a tertiary care center with an on-site cardiac catheterization team 24/7, there are no differences in in-hospital outcomes of transferred patients with STEMI during ON vs. OFF hours.

Sirolimus-eluting stents versus paclitaxel-eluting stents in patients with chronic renal insufficiency.

BACKGROUND: Chronic renal insufficiency (CRI) is associated with an increased incidence of restenosis and stent thrombosis. Drug-eluting stents (DES), when compared to bare metal stents (BMS), reduce the incidence of restenosis in these patients. This study aimed to examine whether there are differences in clinical outcome after implantation of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) in patients with CRI who are subjected to coronary intervention. METHODS: A cohort of 570 patients with CRI who underwent intervention with DES (346 with SES and 224 with PES) were followed clinically up to 1 year and the clinical events were recorded and compared between groups. RESULTS: Baseline and procedural characteristics were similar, with a slightly higher number of diseased vessels in the SES group as compared to the PES group (2.3 +/- 0.9 vs 2.1 +/- 0.9, P = 0.06). The overall rates of major adverse cardiac events (MACE) and stent thrombosis were similar. The PES group had lower revascularization rates when compared to the SES group. After covariate adjustment, however, there was no difference seen in target vessel revascularization between stent types (hazard ratio [HR]: 2.3 [0.8-6.2], P = 0.110). The strongest predictor of death and MACE at 1 year was the number of diseased vessels. CONCLUSIONS: Patients with CRI who undergo PCI with either SES or PES have similar repeat revascularization rates and acceptable stent thrombosis rates, although they continue to have high MACE and death rates.

The clinical significance of hematocrit values before and after percutaneous coronary intervention.

BACKGROUND: The presence of anemia before percutaneous coronary intervention (PCI) and/or the development of bleeding or anemia after PCI has been shown to increase mortality and morbidity rates. However, the definition of severe anemia varies among reports. In this context, the roles of hematocrit at baseline and hematocrit drop after PCI, both treated as continuous variables, have not yet been described in the risk assessment of patients undergoing PCI. METHODS: We analyzed 6,025 consecutive patients who underwent PCI from 2003 to 2007 at our institution. In the entire population, we analyzed by multivariable Cox analysis the clinical value of both hematocrit at baseline and hematocrit drop after PCI as continuous variables. The primary end point was the composite of death and myocardial infarction at 1-year follow-up. RESULTS: The rate of the 1-year composite end point death/myocardial infarction increased continuously every time hematocrit at baseline decreased and/or hematocrit dropped after PCI. After multivariable adjustment using the relevant covariables, both hematocrit at baseline (hazard ratio = 0.92, P < .001) and hematocrit drop after PCI (hazard ratio = 1.11, P < .001) strongly predicted the primary end point at 1-year follow-up. CONCLUSION: Hematocrit at baseline and the drop after PCI should be recognized as important risk factors for adverse outcomes after PCI. The inclusion of hematocrit or hemoglobin values as continuous variables in a risk-stratification scheme should be strongly considered.

The role of percutaneous circulatory assist devices in acute myocardial infarction and high-risk percutaneous coronary intervention in the 21st century.

Although the use of percutaneous circulatory assist devices is gaining increasing acceptance as an adjunct to percutaneous coronary intervention (PCI) in patients with cardiogenic shock, their role in patients with acute myocardial infarction (MI) without hemodynamic compromise and elective high-risk PCI remains controversial. This is reflected by the lack of formal recommendations by the international bodies regarding the use of such devices outside the setting of cardiogenic shock. The purpose of this article was to review the current evidence for the use of these devices in patients presenting with acute MI without cardiogenic shock and in those undergoing elective high-risk PCI.

Safety and efficacy of clopidogrel reloading in patients on chronic clopidogrel therapy who present with an acute coronary syndrome and undergo percutaneous coronary intervention.

The clinical safety and efficacy of clopidogrel reloading in patients receiving long-term clopidogrel therapy who present with acute coronary syndromes and undergo percutaneous coronary intervention have not yet been evaluated. The study cohort comprised 1,368 consecutive patients receiving long-term clopidogrel therapy (75 mg/day) who had presented with acute coronary syndromes and underwent coronary artery stent implantation. In total, 926 patients were given a 600-mg clopidogrel loading dose (reload cohort) before cardiac catheterization, while 442 patients were not reloaded (no-reload cohort). Patients who had presented with cardiogenic shock or stable angina were excluded. The 2 cohorts were well matched for the conventional risk factors for coronary artery disease. The analyzed clinical end points of death (1.1% vs 0.9%, p = 0.77), death or Q-wave myocardial infarction (0.9% vs 0.9%, p = 1.0), target lesion revascularization (0.2% vs 0.8%, p = 0.45), target vessel revascularization (1.1% vs 1.1%, p = 1.0), and major adverse cardiac events (2.0% vs 1.8%, p = 0.8) were similar between the no-reload and reload groups at 30 days. The in-hospital rates of major bleeding and gastrointestinal bleeding were also similar between the 2 cohorts. There were no cases of definite stent thrombosis. In conclusion, patients receiving long-term clopidogrel therapy who present with acute coronary syndromes do not gain any clinical benefit from additional reloading with clopidogrel.

Relation between clopidogrel discontinuation and early cardiovascular events after percutaneous coronary intervention with drug-eluting stents.

AIMS: Clopidogrel discontinuation after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has been reported to correlate with stent thrombosis. Whether these events are a consequence of the rebound phenomenon or a lack of protection in unhealed vessels is unclear. This study aimed to determine the link between clopidogrel cessation and cardiovascular events after PCI with DES. METHODS AND RESULTS: The population included 1,903 patients who underwent PCI with DES implantation from 2003 to 2007. We compared patients who stopped their clopidogrel within the first month (group 1, n=97), from one to six months (group 2, n=344), from six to 12 months (group 3, n=468), and after 12 months (group 4, n=994) following the PCI. In each group, the composite of death, myocardial infarction and stent thrombosis at 30 days and between 31 and 60 days after clopidogrel cessation was indexed. Baseline characteristics were similar among groups. The event rate observed in the 0-30 day interval following cessation was higher only in group 1 (5.2%) compared to all other groups: 1.2% (group 2), 0.9% (group 3) and 0.6% (group 4) (p=0.004). The event rates from 31 to 60 days following cessation were low and similar among the four groups. When the elapsed time between the index PCI and the clopidogrel cessation was analysed as a continuous variable, the probability of events occurring within the first 30 days became similar to that observed in the 31-60 day interval following cessation after a minimum of 10.2 months. CONCLUSIONS: Cardiac events seen immediately after clopidogrel cessation are not related to a rebound phenomenon, but are more likely influenced by the lack of healing at the time of cessation, which decreases over time. This increased risk related to the lack of healing seems to disappear after 10.2 months.

Hybrid strategy of a bare metal stent combined with a drug-eluting stent versus exclusive drug-eluting stent implantation for multivessel percutaneous coronary intervention.

AIMS: This study aimed to examine the strategy of hybrid percutaneous coronary intervention (PCI) -bare metal stent (BMS) and drug-eluting stent (DES)- versus exclusive DES implantation for patients undergoing multivessel PCI. METHODS AND RESULTS: A cohort of 2,065 patients who underwent PCI (698 hybrid, 1,367 exclusive DES) were followed clinically up to one year. The primary outcome was target vessel revascularisation-major adverse cardiac events (TVR-MACE). Patients presenting with cardiogenic shock, anaemia (haematocrit <25), and bypass graft PCI were excluded. Only patients with ≥ 2 stents in two different lesions were analysed for this study. Baseline and procedural characteristics were similar. Major in-hospital complications and subacute stent thrombosis rates were similar. At one year, there was no difference in TVR-MACE (hybrid 17.2% vs. DES 14.6%, p=0.128). On multivariable analysis, hybrid PCI was not a predictor of TVR-MACE. The strongest predictors of TVR-MACE at one year were hypertension and African American race. Cumulative stent thrombosis rates at one year were similar in both groups. CONCLUSIONS: Patients who undergo hybrid PCI have similar composite in-hospital and 1-year outcomes as those who undergo exclusive DES PCI. The hybrid stent approach should be considered for patients with multivessel PCI since it can lower the procedure cost without increasing adverse events.

Clinical profile, prognostic implication, and response to treatment of pulmonary hypertension in patients with severe aortic stenosis.

The incidence, correlates, and prognostic implications of pulmonary hypertension (PH) are unclear in patients with severe aortic stenosis (AS). We studied 509 patients with severe AS evaluated for transcatheter aortic valve implantation (TAVI). Patients were divided into groups based on pulmonary artery systolic pressure (PASP): group I, 161 (31.6%) with PASP <40 mm Hg; group II, 175 (34.3%) with PASP 40 to 59 mm Hg; and group III, 173 (33.9%) with PASP ≥ 60 mm Hg. Group III patients were more symptomatic and had higher creatinine levels and higher left ventricular end-diastolic pressure. Transpulmonary gradient was >12 mm Hg in 17 patients (10.5%), 31 patients (17.7%), and 80 patients (46.2%) in groups I through III, respectively. In a median follow-up of 202 days (73 to 446) mortality rates were 35 (21.7%), 69 (39.3%), and 85 (49.1%) in groups I through III, respectively (p <0.001). Immediately after TAVI, in patients with PASP >40 mm Hg there was significant decrease in PASP (63.1 ± 16.2 to 48.8 ± 12.4 mm Hg, p <0.0001), which remained at 1 year (50.1 ± 13.1 mm Hg, p = 0.04). After surgical aortic valve replacement there was a significant immediate decrease in PASP (66.1 ± 16.3 to 44.7 ± 14.2 mm Hg, p <0.0001), which persisted at 3 to 12 months (44.8 ± 20.1 mm Hg, p <0.001). In patients who underwent balloon aortic valvuloplasty, PASP decreased immediately after the procedure (63.2 ± 14.8 to 51.8 ± 17.1 mm Hg, p <0.0001), yet at 3 to 12 months pressure returned to baseline levels (57.4 ± 17.0 mm Hg, p = 0.29). In conclusion, patients with severe AS have a high prevalence of PH, and in patients with severe AS increased PASP is associated with increased mortality. Surgical aortic valve replacement and TAVI are effective treatments for these patients and result in a significant PASP decrease.

Three-year outcomes following sirolimus- versus paclitaxel-eluting stent implantation in an unselected population with coronary artery disease (from the REWARDS Registry).

The Registry Experience at the Washington Hospital Center with Drug-Eluting Stents (REWARDS) study includes unselected patients with coronary artery disease treated with sirolimus-eluting stents (SESs; n = 2,392) or paclitaxel-eluting stents (PES; n = 1,119). This study aimed to examine the long-term safety profile of the 2 stents in a "real-world" population, especially in relation to stent thrombosis, and to compare differences in the diabetic cohort. Patients were followed for 3 years with regard to major adverse cardiac events (MACEs), including death, Q-wave myocardial infarction, and target lesion revascularization. Rates of stent thrombosis were also studied. Baseline characteristics were similar between stents. Although MACE rates at 3 years were similar (SES 28.1% vs PES 28.9%, p = 0.62), there was a significant difference in unadjusted rates of target lesion revascularization (SES 15.6% vs PES 12.6%, p = 0.03), death (SES 15.7% vs PES 19.0%, p = 0.02), and Q-wave myocardial infarction (SES 0.8% vs PES 2.1%, p = 0.003). After multivariable Cox regression to adjust for confounders, there was no significant difference in overall MACEs. Incidence of stent thrombosis was higher in the SES group (SES 2.2% vs PES 1.6%, p = 0.22), but this was not statistically significant (hazard ratio 1.6, 95% confidence interval 0.8 to 2.9, p = 0.17). Overall, diabetics had a higher MACE rate, but there was no difference between insulin- and noninsulin-dependent diabetics. In conclusion, at 3 years, PES and SES achieved similar results in MACEs and stent thrombosis. This should foster confidence that SES or PES can be compared to second-generation drug-eluting stents without concerns for safety or efficacy.

Insurance type influences the use of drug-eluting stents.

OBJECTIVES: We sought to examine the effect of insurance type upon the likelihood of receiving a drug-eluting stent (DES). BACKGROUND: Recent guidelines suggest that consideration of a patient's resources should play a role in decisions to use DES. Previous studies have also documented disparities in both access to care and cardiovascular outcomes according to race, insurance, and socioeconomic status. The effect of insurance status upon the decision to use DES is unclear. METHODS: Patients undergoing percutaneous coronary intervention (PCI) with stenting from April 2003 to June 2009, the so-called DES era, were retrospectively analyzed. Multivariable logistic regression was performed separately for patients <65 years and patients > or =65 years, with receipt of > or =1 DES during PCI as the outcome variable of interest. Insurance type was categorized as private, Medicare, Medicaid, and uninsured, based upon the primary insurance at discharge. Data regarding duration of clopidogrel therapy at 1 month, 6 months, and 1 year was also collected. RESULTS: Among the 12,584 patients who underwent PCI with stenting, 6,157 (48.9%) had private insurance, 5,689 (45.2%) had Medicare, 467 (3.7%) had Medicaid, and 271 (2.2%) were uninsured at the time of hospital discharge. There were no significant differences by insurance type in duration of dual antiplatelet therapy at 1 year. Both multivariable logistic regressions showed that Medicaid patients (odds ratio [OR]: 0.60; 95% confidence interval [CI]: 0.46 to 0.78 for age <65 years; OR: 0.45; 95% CI: 0.24 to 0.85 for age > or =65 years) and patients without insurance (OR: 0.57; 95% CI: 0.42 to 0.78 for age <65 years; OR: 0.20; 95% CI: 0.05 to 0.86 for age > or =65 years) were less likely to receive DES. CONCLUSIONS: Insurance status has a significant impact upon the decision to use DES. Efforts to address this disparity should focus on the patient-provider level.

Impact of chronic obstructive pulmonary disease on acute-phase outcome of myocardial infarction.

Several reports have alluded to the adverse effect of chronic obstructive pulmonary disease (COPD) on long-term prognosis of patients with myocardial infarction (MI). Little information is available, however, regarding the effects of a decrease in cardiopulmonary reserve imposed by COPD on in-hospital outcome of acute MI. This study aimed to evaluate the impact of COPD on acute-phase outcome of patients with acute MI. From a cohort of 3,249 consecutive patients with ST-elevation MI who underwent primary or rescue percutaneous coronary intervention, 365 patients were identified as having coexistent COPD. Their clinical presentation and in-hospital outcome were compared to those of 2,884 patients without COPD. The primary end point was a composite of in-hospital death or cardiogenic shock on presentation. Patients with COPD were older (p <0.001), more often women (p <0.001), and smokers (p <0.001). They had higher prevalence of chronic renal insufficiency (p <0.001), systemic hypertension (p = 0.001), and diabetes mellitus (p = 0.01). Patients with COPD had higher rates of the composite end point of death or cardiogenic shock (p <0.0001). After multivariate analysis, COPD remained a strong independent predictor of the composite end point of death or cardiogenic shock (p = 0.008). In conclusion, COPD is a very strong predictor of hemodynamic compromise resulting in death or cardiogenic shock in patients presenting with ST-elevation MI. This observation suggests that hemodynamic and pulmonary consequences of COPD decrease the capacity of the circulatory system to adjust to the effects of acute MI. Recognition of the potential for combined therapy is vital.

Prognosis of asymptomatic coronary artery disease after percutaneous coronary intervention.

The appropriate treatment for asymptomatic patients with obstructive coronary stenoses is controversial. The effect of percutaneous coronary intervention (PCI) on the prognosis of such patients is unknown. The present study compared the 1-year outcomes of patients with stable coronary artery disease (CAD) with regard to the presence or absence of symptoms after elective PCI. A total of 1,944 consecutive patients with stable CAD who had undergone elective PCI were studied. They were divided into 2 groups according to symptom status: asymptomatic (n = 1,052) and symptomatic (n = 892). A 1-year follow-up evaluation was conducted by office visit and telephone interview. The end points consisted of all-cause mortality, nonfatal myocardial infarction, and target vessel revascularization. Patients without angina pectoris were older, predominantly men, and more frequently had chronic renal insufficiency, a previous myocardial infarction, a coronary artery bypass graft, and a lower left ventricular ejection fraction. The 1-year mortality rate was greater in the asymptomatic patients (43 [4.1%] vs 16 [1.8%], p = 0.003). The incidence of nonfatal myocardial infarction and target vessel revascularization was similar in the 2 groups (15 [1.5%] vs 12 [1.4%], p = 0.85; and 69 [6.7%] vs 68 [7.7%], p = 0.39, respectively). On multivariate analysis, the absence of symptoms was a strong independent predictor of 1-year mortality (p = 0.017). In conclusion, in patients with stable CAD undergoing elective PCI, the absence of symptoms was associated with an increase in 1-year mortality.

Complications and outcome of balloon aortic valvuloplasty in high-risk or inoperable patients.

OBJECTIVES: This study aimed to determine the success, complications, and survival of patients after balloon aortic valvuloplasty (BAV). BACKGROUND: The introduction of transcatheter aortic valve implantation (TAVI) BAV has led to a revival in the treatment of patients with severe aortic stenosis. METHODS: A cohort of 262 patients with severe aortic stenosis underwent 301 BAV procedures. Of these, 39 (14.8%) patients had ≥2 BAV procedures. Clinical, hemodynamic, and follow-up mortality data were collected. RESULTS: The cohort mean age was 81.7 ± 9.8 years, and the mean Society of Thoracic Surgeons and logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 13.3 ± 6.7 and 45.6 ± 21.6, respectively. BAV was performed as a bridge to TAVI or to surgical aortic valve replacement in 28 patients (10.6%) and for symptom relief in 234 (89.4%). The mean aortic valve area (AVA) increased from 0.58 ± 0.3 cm(2) to 0.96 ± 0.3 cm(2) (p < 0.001). Of these, 111 (45.0%) had final AVA >1 cm(2), and in 195 patients (79%), AVA increased by >40%. De novo BAV resulted in a higher mean increase in AVA 0.41 ± 0.24 cm(2) versus 0.28 ± 0.24 cm(2) in redo BAV (p = 0.003). Serious adverse events occurred in 47 patients (15.6%), intraprocedural death in 5 (1.6%), stroke in 6 (1.99%), coronary occlusion in 2 (0.66%), severe aortic regurgitation in 4 (1.3%), resuscitation/cardioversion in 5 (1.6%), tamponade in 1 (0.33%), and permanent pacemaker in 3 (0.99%). A vascular complication occurred in 21 patients (6.9%); 34 (11.3%) had a post-procedure rise in creatinine >50%; and 3 (0.99%) required hemodialysis. During median follow-up of 181 days, the mortality rate was 50% (n = 131). The mortality rate in the group with final AVA >1 cm(2) was significantly lower than in the group with final AVA of <1 cm(2) (36.4% vs. 57.9%, p < 0.001). Final AVA was associated with lower mortality (hazard ratio: 0.46, p = 0.03). BAV as a bridge to TAVI or surgical aortic valve replacement had a better outcome compared with BAV alone: mortality rate 7 (25%) versus 124 (52.9%), respectively (p < 0.0001). CONCLUSIONS: Long-term survival is poor after BAV alone. BAV as a bridge to percutaneous or surgical aortic valve replacement is feasible, safe, and associated with better outcome than BAV alone.

Correlates and consequences of gastrointestinal bleeding complicating percutaneous coronary intervention.

Gastrointestinal bleeding (GIB) complicating percutaneous coronary intervention (PCI) results in high mortality, but clinical factors associated with and long-term outcomes of GIB are poorly understood. We sought to examine clinical and procedural factors associated with GIB complicating PCI. We also examined the impact of GIB on 30-day mortality and 1-year major adverse cardiac events (MACEs). Patients undergoing PCI from January 2000 to January 2010 were retrospectively analyzed for the occurrence of in-hospital GIB. Multivariable logistic regression and Cox proportional hazards regression were used to identify predictors of in-hospital GIB and 30-day mortality. Landmark analysis of patients surviving to hospital discharge was performed to assess the impact of GIB on 1-year MACEs. Of 20,621 patients who underwent PCI, 147 (0.72%) who developed in-hospital GIB were identified. Variables associated with increased risk of GIB included older age, shock, acute myocardial infarction, chronic renal insufficiency, lower baseline hematocrit, and glycoprotein IIb/IIIa inhibitors; bivalirudin decreased the risk. Unadjusted 30-day mortality rate of patients with GIB was 20.5% compared to 2.4% of patients without GIB. After multivariable adjustment, GIB and shock (and an interaction between the 2) were the most important correlates of 30-day mortality. In the population surviving to discharge, however, GIB was not associated with adjusted mortality or MACEs. In conclusion, GIB complicating PCI has a dramatic impact on 30-day mortality, and bivalirudin was associated with lower rates of GIB.

Safety and in-hospital outcomes of bivalirudin use in dialysis patients undergoing percutaneous coronary intervention.

Chronic dialysis-dependent patients undergoing percutaneous coronary intervention (PCI) are at a greater risk of bleeding and ischemic events. Bivalirudin has been associated with fewer bleeding complications than unfractionated heparin (UFH) in patients undergoing PCI in various clinical settings. These studies, however, have systematically excluded patients dependent on chronic dialysis. We sought to assess the safety, bleeding rates, and in-hospital outcomes of bivalirudin use compared to UFH use alone in patients requiring dialysis and undergoing PCI. A retrospective analysis of 396 dialysis-dependent patients undergoing PCI from January 2000 to March 2009 was performed. Patients treated with a dose-adjusted bivalirudin regimen (n = 267) were compared to those treated with UFH alone (n = 129). The primary end point of major bleeding (hematocrit decrease > or = 15%, gastrointestinal or intracerebral bleeding) and the composite end point of in-hospital death, nonfatal Q-wave myocardial infarction, and urgent target vessel revascularization were compared between groups. The baseline characteristics were similar between the 2 groups, except for the proportion of men and nonsmokers and body mass index, which were greater in patients treated with bivalirudin. The rate of major bleeding was similar between the bivalirudin and UFH groups (3.4% vs 3.1%, respectively, p = 0.9). The rate of the composite end point (death, Q-wave myocardial infarction, urgent target vessel revascularization) was not significantly different between the 2 groups (1.8% for bivalirudin vs 0.8% for UFH group, p = 0.7). After adjustment, bivalirudin use was not associated with major bleeding (odds ratio 1.23, 95% confidence interval 0.37 to 4.13, p = 0.7). In conclusion, a dose-adjusted bivalirudin anticoagulation regimen for patients requiring chronic dialysis undergoing PCI seems to be as safe and as effective as UFH use alone. These results do not suggest the superiority of bivalirudin over UFH.

Long-term prognostic value of preprocedural C-reactive protein after drug-eluting stent implantation.

C-reactive protein (CRP) elevation is associated with an adverse cardiovascular prognosis after bare metal stent implantation. Data have suggested a similar association between preprocedural CRP and adverse events after drug-eluting stent (DES) implantation. The present study was designed to address whether such a relation exists after DES placement. After excluding patients presenting with an acute coronary syndrome with troponin I elevation, we analyzed the data from 936 consecutive patients who had undergone DES implantation from 2003 to 2007 and had a preprocedural CRP measurement. The patients were divided into 3 groups according to the preprocedural CRP level (<1.31, 1.31-3.76, and >3.76 mg/L). The primary end point was the composite of death and Q-wave myocardial infarction (QWMI) at 2 years of follow-up. Target vessel revascularization was also assessed. The rate of death/QWMI was not significantly different statistically among the CRP tertiles during the in-hospital period (0.6% vs 0.0% vs 0.6%, p = 0.5) or at 1 year of follow-up (1.9% vs 2.9% vs 4.5%, p = 0.2). At 2 years, death/QWMI had occurred in 2.9% of patients in the lowest, 5.2% in the middle, and 8.8% in the highest tertile (p = 0.006). The incidence of target vessel revascularization was similar in the 3 groups at 2 years of follow-up (13.2% vs 14.9% vs 16.9%, p = 0.5). On multivariate analysis, the upper tertile of CRP was an independent predictor of death/QWMI at 2 years (hazard ratio 2.5, 95% confidence interval 1.1 to 5.4, tertile 3 vs tertile 1, p = 0.006). In conclusion, high preprocedural CRP levels are associated with an increased risk of death and QWMI after DES implantation at long-term follow-up but not acutely. The CRP levels were not related to target vessel revascularization. Thus, an elevated CRP level in this population appears to be more of a marker of global cardiovascular risk than a predictor of post-DES-related complications.