Successful modeling of long term outcomes in end-stage renal disease patients undergoing percutaneous coronary intervention with drug-eluting stents.

OBJECTIVES: The objective of this study is to identify and model risk factors for major adverse cardiac events (MACE) and all-cause mortality among patients with ESRD treated with PCI using DES. BACKGROUND: Patients with end-stage renal disease (ESRD) have poor long-term outcomes after percutaneous coronary intervention (PCI) compared with non-ESRD patients. However, there is a paucity of literature regarding risk factors associated with outcomes of ESRD patients after PCI with drug-eluding stents (DES). METHODS: This retrospective cohort study includes all patients with ESRD who underwent first-time PCI with DES at a single, high-volume hospital between 1/1/2005 and 12/31/2015, with follow-up through 9/1/2019. Primary outcomes were MACE (cardiac death, myocardial infarction, or unplanned revascularization) and all-cause mortality. RESULTS: Five-year MACE was 83.0% and five-year morality was 77.9% in patients with ESRD (n = 285). Among ESRD patients, factors independently associated with MACE were C-reactive peptide level, SYNTAX score, peripheral vascular occlusive disease, hemoglobin, and treatment of a restenotic lesion (c-index = 0.66). Factors independently associated with mortality in ESRD patients were age, SYNTAX score, non-use of statins at baseline, insulin-dependent diabetes, chronic obstructive pulmonary disease (COPD), peripheral vascular occlusive disease, and platelet count (c-index = 0.65). CONCLUSIONS: Despite relatively poor 1-and 5-year outcomes among ESRD patients after PCI, risk of MACE and mortality among this cohort can be successfully modelled, which meaningfully informs clinicians regarding management of ESRD patients with coronary artery disease (CAD). Further investigations are necessary to determine whether or not outcomes might be improved through risk profile modification.

Prediabetic Patient Outcomes 8 to 15 Years After Drug-Eluting Coronary Stenting.

Guidelines suggest differential management of diabetics and nondiabetics with coronary artery disease (CAD) referred for revascularization, but pre-diabetics, who now comprise up to 20% to 30% of CAD patients, have been excluded from the diabetic group. To address this, we studied long-term cardiac outcomes in 1,323 consecutively drug-eluting stent (DES)-stented patients from prespecified local zip codes, dividing patients into normal-glycemic patients, prediabetics and diabetics, based upon conventional definitions. Patient age was 63±11 years, 65.5% male, mean baseline SYNTAX score of 10.2±6.8 and residual SYNTAX score=3.0±4.6. Only 2.9% of patients were lost to follow up at 10 years. Duration of follow up for alive patients was 124±33 mos. Major adverse cardiac events (MACE) by Kaplan Meier (KM) was similar for normal glycemics and prediabetics (42.9±2.5% vs 38.6±3.1% at 10 years, p=0.35), whereas that for diabetics was worse (56.7±2.6% at 10 years, p<0.001 vs prediabetics). KM cardiac death rates at 10 years were 14.2±1.8%, 16.0±2.4% and 31.2±2.3% for normal glycemics, prediabetics, and diabetics, respectively (p=0.34 and p<0.001 [covariate adjusted p=0.018] for prediabetics versus normal glycemics and versus diabetics, respectively). We found that prediabetics have long-term post-DES outcomes far more similar to those of normal-glycemic patients than diabetics.

End-stage renal disease as an independent risk factor for in-hospital mortality after coronary drug-eluting stenting: Understanding and modeling the risk.

OBJECTIVES: We sought to compare in-hospital outcomes between patients with and without end-stage renal disease (ESRD) undergoing coronary drug-eluting stent (DES) placement and to model risk of in-hospital adverse postpercutaneous coronary intervention (PCI) events in ESRD patients. BACKGROUND: The effect of ESRD on the risk of in-hospital complications after DES PCI is relatively unclear, as is the ability to prospectively stratify risk in this population. METHODS: Consecutive patients undergoing first-time DES between April 1, 2003 and June 30, 2018 at a single tertiary care hospital were included in a prospective registry. Outcomes in those with ESRD were compared to those without ESRD. The primary endpoint was in-hospital all-cause mortality; secondary endpoints included in-hospital major adverse cardiac events (MACE)-defined as cardiac death, myocardial infarction, or unplanned revascularization-and major bleeding. Multivariate logistic regression modeling was used to identify factors associated with each outcome and to generate risk scores. RESULTS: Among 18,134 patients in the study population, 382 (2.1%) had ESRD. ESRD was associated with increased risk of in-hospital mortality (7.1 vs. 2.9%, p < .001), in-hospital MACE (6.3 vs. 2.1%, p < .001), and major bleeding (12.0 vs. 2.6%, p < .001). After multivariable risk adjustment, ESRD was independently associated with in-hospital mortality (odds ratio: 1.83, 95% confidence interval: 1.04-3.23, p = .04) but not MACE or major bleeding. Among patients with ESRD, risks of MACE and major bleeding were successfully modeled (c-statistics = .72 and .85, respectively). CONCLUSIONS: ESRD is independently associated with increased risk of in-hospital mortality after coronary DES. Future studies are necessary to validate risk models derived to identify high-risk ESRD patients.

Association of adoption of transradial access for percutaneous coronary intervention in ST elevation myocardial infarction with door-to-balloon time.

OBJECTIVES: We aimed to study adoption of transradial primary percutaneous coronary intervention (TR-PPCI) for ST elevation myocardial infarction (STEMI) ("radial first" approach) and its association with door-to-balloon time (D2BT). BACKGROUND: TR-PPCI for STEMI is underutilized in the United States due to concerns about prolonging D2BT. Whether operators and hospitals adopting a radial first approach in STEMI incur prolonged D2BT is unknown. METHODS: In 1,272 consecutive cases of STEMI with PPCI at our hospital from January 1, 2011, to December 31, 2016, we studied TR-PPCI adoption and its association with D2BT including a propensity matched analysis of similar risk TR-PPCI and trans-femoral primary PCI (TF-PPCI) patients. RESULTS: With major increases in hospital-level TR-PPCI (hospital TR-PPCI rate: 2.6% in 2011 to 79.4% in 2016, p-trend<.001) and operator-level TR-PPCI (mean operator TR-PPCI rate: 2.9% in 2011 to 81.1% in 2016, p-trend = .005), median hospital level D2BT decreased from 102 min [81, 142] in 2011 to 84 min [60, 105] in 2016 (p-trend<.001). TF crossover (10.3%; n = 57) was not associated with unadjusted D2BT (TR-PPCI success 91 min [72, 112] vs. TF crossover 99 min [70, 115], p = .432) or D2BT adjusted for study year and presenting location (7.2% longer D2BT with TF crossover, 95% CI: -4.0% to +18.5%, p = .208). Among 273 propensity-matched pairs, unadjusted D2BT (TR-PPCI 98 [78, 117] min vs. TF-PPCI 101 [76, 132] min, p = .304), and D2BT adjusted for study year and presenting location (5.0% shorter D2BT with TR-PPCI, 95% CI: -12.4% to +2.4%, p = .188) were similar. CONCLUSIONS: TR-PPCI can be successfully implemented without compromising D2BT performance.

Comparison of Long-Term Clinical Outcomes After Drug-Eluting Stenting in Blacks-vs-Whites.

Patients of different racial backgrounds may have socioeconomic, cultural, or genetic differences that impact outcomes after percutaneous coronary intervention (PCI). There are limited data beyond 2 to 3 years for Blacks to inform discussions and perhaps improve outcomes. We studied consecutive limus-stent treated patients, having their first PCI at our institution January 2003 to March 2010 in 2 cohorts; Cohort 1: standard 3-year follow-up (n = 3,782, 12.4% Blacks) and Cohort 2: from nearby zip codes with intended detailed follow-up through 8 to 13 years (n = 616, 31.8% Blacks). The primary outcomes of interest were mortality and death/MI/revascularization (DMIR) (Cohort 1) or major adverse cardiac events (cardiac DMIR) (Cohort 2). In all cohorts, Blacks had a higher prevalence of many risk factors. In Cohort 1, 3-year mortalities were 14.6% and 9.6% (p = 0.001) and DMIR were 32.1% and 25.0% (p = 0.001), for Blacks and Whites, respectively. In Cohort 2, over 9.5 ± 2.0 years, treatment intensity was as high or higher for Blacks, but they continued to have higher low-density lipoprotein-cholesterol and blood pressure values. Major adverse cardiac events and mortality at 10 years were higher for Blacks (59.0% vs 48.1%, p = 0.024 and 44.3% vs 23.0%, p < 0.001). Differences in outcomes, except 10 year mortality, were not significantly different after adjustment for baseline characteristics. Blacks have a higher risk profile at the time of PCI and worse long-term outcomes after drug-eluting stent, most of which is explained by baseline differences.

Utilization and outcomes of polytetrafluoroethylene covered stents in patients with coronary artery perforation and coronary artery aneurysm: Single center 15-year experience.

OBJECTIVES: Determine the outcomes of polytetrafluoroethylene (PTFE) covered stents for coronary artery perforation (CAP) and coronary artery aneurysm (CAA). BACKGROUND: PTFE covered stents have been used for treatment of potentially life-threatening CAP and CAA. The short and long-term outcomes of the PTFE covered stent for CAP and CAA have not been well studied. METHODS: We performed a retrospective study of PTFE covered stents that were placed in the patients from 2003 to 2017. Short term outcomes included in-hospital mortality, pericardial effusion, cardiac tamponade, and length of stay. Long-term outcomes included target lesion revascularization (TLR), in-stent restenosis (ISR), and long-term mortality. RESULTS: Fifty-three PTFE covered stents were placed in 32 patients of which there were 24 patients with a CAP with a mean age of 75 ± 8 years. Two patients died in-hospital, with no additional deaths at 30 days. The rate of ISR was 25%, with estimated rates of TLR of 2.6% (3 years) and 17.8% (5 years). The median survival was 55.6 months, with survival at 10 years estimated to be 30.9%. Eight patients received a PTFE covered stent for CAA with a mean age of 59 ± 15 years with no in-hospital or 30-day mortality. Median follow-up of 49 months showed no evidence of TLR. The all-cause mortality was 12% at 1 year and 38% at 3 years. CONCLUSIONS: PTFE covered stents is an effective option in patients with CAP and CAA. The long-term outcomes may be related to the pathology of the disease rather than the stent itself.

Effect of Shorter Door-to-Balloon Times Over 20 Years on Outcomes of Patients With Anterior ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention.

Cardiovascular disease remains the most common cause of mortality. We studied the change in outcomes for anterior ST-elevation myocardial infarction (STEMI) between 1995 and 2014. Over the past 20 years, 1,658 patients presenting to our center with anterior STEMI underwent primary percutaneous coronary intervention within 12 hours of presentation. We divided these into 4 quartiles, 1995 to 1999 (n = 312), 2000 to 2004 (n = 408), 2005 to 2009 (n = 428), and 2010 to 2014 (n = 510). Across the 4 quartiles, mean age decreased (64.4, 62, 60.3, and 60 years, p <0.01). In all groups, there was a significant rise in prevalence of smoking, hypertension, and obesity. The median length of hospital stay decreased (6, 4.4, 4.2, and 3.6 days, p <0.01), as did the median door-to-balloon time (DBT) (217, 194, 135, and 38 minutes, p <0.01). Thirty-day and 1-year mortality improved over time (14.4%, 11.8%, 8.4%, and 7.8%; and 20.5%, 16.4%, 15.9%, and 13.9%) (p = 0.01 both). Also, 3-year mortality improved (25.3%, 21.6%, 21.3%, and 16.5%, p = 0.02). After adjusting for age, gender, co-morbidities, ejection fraction, clinical shock, and mitral regurgitation, shorter DBT was associated with lower long-term mortality (compared with DBT <60 minutes; 60 to 90 minutes hazard ratio [HR] 1.67, 95% confidence interval [CI] 0.93 to 3.00, p = 0.084; 90 to 120 minutes, HR 1.74, 95% CI 1.02 to 2.95, p = 0.04; >120 minutes, HR 1.91, 95% CI 1.23 to 2.96, p = 0.004). In conclusion, over the past 2 decades, long-term outcomes improved in patients presenting with anterior STEMI associated with shortening of DBT.

Cause of death within 30 days of percutaneous coronary intervention in an era of mandatory outcome reporting.

OBJECTIVES: This study sought to ascertain causes of death and the incidence of percutaneous coronary intervention (PCI)-related mortality within 30 days. BACKGROUND: Public reporting of 30-day mortality after PCI without clearly identifying the cause may result in operator risk avoidance and affect hospital reputation and reimbursements. Death certificates, utilized by previous reports, have poor correlation with actual cause of death and may be inadequate for public reporting. METHODS: All patients who died within 30 days of a PCI from January 2009 to April 2011 at a tertiary care center were included. Causes of death were identified through detailed chart review using Academic Research Consortium consensus guidelines and compared with reported death certificates. The causes of death were divided into cardiac and noncardiac and PCI and non-PCI-related categories. RESULTS: Of the 4,078 PCI, 81 deaths (2%) occurred within 30 days. Of these, 58% died of cardiac and 42% of noncardiac causes. However, only 42% of 30-day deaths were attributed to PCI-related complications. Patients with non-PCI-related, compared with PCI-related, death presented with a higher incidence of cardiogenic shock (15 of 47 [32%] vs. 2 of 34 [6%]; p < 0.01) and cardiac arrest (19 of 47 [40%] vs. 1 of 34 [3%]; p < 0.01). Death certificates had only 58% accuracy (95% confidence interval: 45% to 72%) for classifying patients as experiencing cardiac versus noncardiac death. CONCLUSIONS: Less than one-half of 30-day deaths are attributed to a PCI-related complication. Death certificates are inaccurate and do not report PCI-related deaths, which may represent a better marker of PCI quality.

Management of the patient with diabetes and coronary artery disease: a contemporary review.

Diabetes mellitus is a metabolic disease with microvascular and macrovascular complications, and is well known to increase the risk of coronary atherosclerosis. Despite recent reductions in the prevalence of coronary artery disease and cardiovascular events in the USA, persons with diabetes remain up to four-times as likely to die of cardiovascular disease than the general population. Diabetes is associated with an atherogenic lipid profile, induces a hypercoagulable state, and increases coronary plaque volume, progression and instability. Medicinal and procedural treatments in the patient with diabetes should be multifactorial, targeting and managing the many coexisting risk factors that contribute to atherosclerosis. This type of treatment is complex and should be individualized, and guided by a careful review of recent literature. Here we discuss important clinical data and their impact on up-to-date recommendations for the management of coronary artery disease in the patient with Type 2 diabetes mellitus.

Successful thrombectomy for acute coronary thromboembolism during Heartmate II ventricular support.

Complications of hemostasis account for the most common adverse events during continuous-flow ventricular assist device support for advanced heart failure. Successful management of acute coronary thromboembolism during HeartMateII device support has not been described in the literature. We present a case of acute coronary thromboembolism of the left main trunk associated with angina and ventricular tachycardia, successfully treated with aspiration and rheolytic thrombectomy and systemic anticoagulation. The postprocedural management of acute coronary syndromes during axial flow ventricular assist device recipients may be complicated by disorders of primary hemostasis and a long-term tendency for bleeding.

Percutaneous coronary revascularization in coronary artery disease: lessons from a single center experience.

OBJECTIVES: To determine the role of percutaneous coronary intervention (PCI) and its impact on mortality in coronary artery disease (CAD). BACKGROUND: It's unclear whether PCI provides benefit in patients with CAD outside of acute settings. We sought to determine the role of PCI and its effect on mortality in patients with similar entry criteria to prior RCTs and compare outcomes with medical treatment. METHODS: Using institutional diagnostic catheterization database of consecutive patients undergoing coronary angiography from 1/2004 to 1/2010, we examined records for patients with a positive stress test and >70% coronary stenosis or symptoms of angina and >80% coronary stenosis. We excluded those with acute coronary syndromes, low ejection fraction (EF), history of CABG, and CABG following index catheterization. We stratified patients by treatment and performed unadjusted and propensity matched analyses. The outcome was all-cause mortality obtained from the social security death index. RESULTS: We identified 3,375 patients using study inclusion criteria. Mean age was 65 ± 11 years and 69% (n = 2,332) were men. Mean EF was 55% ± 8%. In the unadjusted cohort, 1,265 patients received medical management and 2,110 received PCI. The unadjusted analysis revealed significantly better survival in PCI patients (P < 0.0001) (HR: 0.51; 95% confidence interval (CI), 0.41-0.63). Propensity matching was performed for 1,580 patients and analysis showed better survival among patients receiving PCI (0 = 0.04) (HR: 0.74; 95% CI, 0.55-0.98). PCI continued to show better survival after excluding patients with malignancy (P = 0.03) and unstable angina (P = 0.007). CONCLUSIONS: This single center registry analysis demonstrated better survival in stable CAD patients undergoing PCI compared to medical management alone. These data suggest there may be a benefit of PCI beyond symptom relief. Future randomized trials are needed to further understand the role of PCI in broader patient populations.

Arteriotomy closure device safety after percutaneous coronary intervention in the direct thrombin inhibitor era: a comparative study.

OBJECTIVES: To investigate the safety and risk of vascular complications of arteriotomy closure devices (ACD) with the direct thrombin inhibitor bivalirudin in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: ACDs and manual compression have been shown to have a similar risk of complications in the setting of PCI with heparin ± glycoprotein (GP) IIb/IIIa inhibitor usage. In many centers bivalirudin is becoming the most frequent type of anticoagulation used during PCI. We sought to determine the risk of vascular complications using Angio-Seal, Perclose, and manual compression for groin hemostasis using predominantly bivalirudin. METHODS: Our institution's interventional database retrospectively identified 14,354 consecutive patients undergoing PCI from 2000 to 2008. Patients were grouped by the adjunctive anticoagulation used (bivalirudin vs. heparin + GP IIb/IIIa inhibitors) as well as ACD employed. The incidence of complications was evaluated using multivariable analysis to account for baseline differences between groups. RESULTS: Patients undergoing PCI with adjunctive bivalirudin had significantly fewer complications overall, regardless of closure method (2.9% vs. 8.7%, P < 0.001). The Perclose group had significantly fewer complications than the Angio-Seal and manual compression groups (3.9% vs. 5.6% vs. 9.0%, P < 0.001) respectively; the Angio-Seal group had significantly fewer complications than manual compression. Multivariable analysis also identified age ≥ 65, female gender, BMI ≤ 26, and operator as independent predictors of complications. CONCLUSIONS: The use of adjunctive bivalirudin during PCI was associated with fewer vascular complications. In addition, the Perclose and Angio-Seal devices had significantly fewer complications than manual compression and women ≥ 65 are at highest risk.

Comparison of outcomes of unprotected left main versus multivessel coronary artery interventions.

Left main coronary artery (LMCA) percutaneous coronary intervention (PCI) has emerged as an appealing alternative to bypass surgery for significant LMCA disease, especially in high-risk candidates. PCI for unprotected LMCA stenosis is currently designated a class IIb indication. Direct comparisons between unprotected LMCA PCI and multivessel PCI are lacking. We aimed to determine the incremental risk associated with unprotected LMCA PCI compared to multivessel PCI. We queried the Cleveland Clinic PCI database to identify patients who underwent unprotected LMCA PCI from 2003 through 2009 and compared these to patients undergoing multivessel PCI in the same period. Patients undergoing PCI for acute myocardial infarction were excluded. Mortality was derived using the Social Security Death Index. Short-term (≤30-day) mortality rates in the LMCA PCI group (n = 468, 1.9%) were similar to the death rate in the multivessel PCI group (n = 1,973, 1.3%, p = 0.3). There was no significant difference in adjusted mortality between the 2 study groups. Stratifying LMCA PCI by the number of concomitant vessel territories treated, there was no significant difference in mortality in any LMCA PCI category (LMCA only, LMCA + 1-vessel PCI, LMCA + multivessel PCI) compared to multivessel PCI. In conclusion, there was comparable short-term and long-term mortality in the LMCA PCI and multivessel PCI groups. LMCA stenting did not appear to incur incremental risk compared to multivessel PCI.

Enhanced prediction of mortality after percutaneous coronary intervention by consideration of general and neurological indicators.

OBJECTIVES: This study sought to improve methodology for predicting post-percutaneous coronary intervention (PCI) mortality. BACKGROUND: Recently, an increased proportion of post-PCI deaths caused by noncardiac causes has been suggested, often in rapidly triaged patients resuscitated from sudden cardiac death or presenting with cardiogenic shock. Older risk adjustment algorithms may not adequately reflect these issues. METHODS: Consecutive patients undergoing PCI from 2000 to 2009 were randomly divided into training (n = 8,966) and validation (n = 8,891) cohorts. The 2010 ACC-NCDR (American College of Cardiology-National Cardiovascular Data Registry) mortality algorithm was applied to the training cohort and its highest risk decile, separately. Variables describing general and neurological status at admission were then tested for their additional predictive capability and new algorithms developed. These were tested in the validation cohort, using receiver-operator characteristic curve, Hosmer-Lemeshow, and reclassification measures as principal outcome measures. RESULTS: In-hospital mortality was 1.0%, of which 52.2% had noncardiac causes or major contributions. Baseline model C-statistics for the total and upper decile training cohorts were 0.904 and 0.830. The Aldrete score (addressing consciousness, respiration, skin color, muscle function, and circulation) and neurology scores added incremental information, resulting in improved validation cohort C-statistics (entire group: 0.883 to 0.914, p < 0.001; high-risk decile: 0.829 to 0.874, p < 0.001). Reclassification of the ACC-NCDR <90th and ≥90th risk percentiles by the new score yielded improved mortality prediction (p < 0.001 and p = 0.033, respectively). CONCLUSIONS: Half of in-hospital deaths in this series were of noncardiac causation. Prediction of in-hospital mortality after PCI can be considerably improved over conventional models by the inclusion of variables describing general and neurological status.

Sand flies of Nicaragua: a checklist and reports of new collections.

Sand flies within the genus Lutzomyia serve as the vectors for all species of the protozoan parasite Leishmania in the New World. In this paper, we present a summary of the 29 species of Lutzomyia and one of Brumptomyia previously reported for Nicaragua and report results of our recent collections of 565 sand flies at eight localities in the country from 2001-2006. Lutzomyia longipalpis was the predominant species collected within the Pacific plains region of western Nicaragua, while Lutzomyia cruciata or Lutzomyia barrettoi majuscula were the species most frequently collected in the central highlands and Atlantic plains regions. The collection of Lutzomyia durani (Vargas & Nájera) at San Jacinto in July 2001 is a new record for Nicaragua. Leishmaniasis is endemic to Nicaragua and occurs in three forms: cutaneous, mucocutaneous and visceral leishmaniasis. Cutaneous infections are the most prevalent type of leishmaniasis in Nicaragua and they occur in two different clinical manifestations, typical cutaneous leishmaniasis and atypical cutaneous leishmaniasis, depending on the species of the infecting Leishmania parasite. The distribution of sand flies collected during this study in relation to the geographic distribution of clinical forms of leishmaniasis in the country is also discussed.

Sand flies of Nicaragua: a checklist and reports of new collections

Sand flies within the genus Lutzomyia serve as the vectors for all species of the protozoan parasite Leishmania in the New World. In this paper, we present a summary of the 29 species of Lutzomyia and one of Brumptomyia previously reported for Nicaragua and report results of our recent collections of 565 sand flies at eight localities in the country from 2001-2006. Lutzomyia longipalpis was the predominant species collected within the Pacific plains region of western Nicaragua, while Lutzomyia cruciata or Lutzomyia barrettoi majuscula were the species most frequently collected in the central highlands and Atlantic plains regions. The collection of Lutzomyia durani (Vargas & Nájera) at San Jacinto in July 2001 is a new record for Nicaragua. Leishmaniasis is endemic to Nicaragua and occurs in three forms: cutaneous, mucocutaneous and visceral leishmaniasis. Cutaneous infections are the most prevalent type of leishmaniasis in Nicaragua and they occur in two different clinical manifestations, typical cutaneous leishmaniasis and atypical cutaneous leishmaniasis, depending on the species of the infecting Leishmania parasite. The distribution of sand flies collected during this study in relation to the geographic distribution of clinical forms of leishmaniasis in the country is also discussed.

Drug-eluting stent fracture and acute coronary syndrome.

BACKGROUND: Coronary stent fracture is an underrecognized entity but has been reported more frequently in the drug-eluting stent (DES) era. Nevertheless, the clinical implications of coronary stent fracture remain unclear. METHODS AND MATERIALS: A literature search for reports of DES fracture was conducted via MEDLINE, and the US Food and Drug Administration Manufacturer and User facility Device Experience (MAUDE) database was accessed via the internet and interrogated for reports of stent fracture between January 1, 2003, and April 30, 2008. Each report was reviewed, and clinical information was extracted for analysis. RESULTS: The MEDLINE search identified 202 cases of coronary DES fracture, with 95% of cases involving Cypher sirolimus-eluting stents. Clinical information regarding patient presentation was available in 96 cases. Patients presented with ST-elevation myocardial infarction (STEMI) or stent thrombosis in six cases (6%) and with unstable angina or non-STEMI (NSTEMI) in 40 cases (42%). The MAUDE database search identified 337 stent fracture reports, with 97% of cases involving Cypher stents. Clinical information regarding patient presentation was available 193 cases. Patients presented with STEMI or stent thrombosis in 24 cases (12%) and with unstable angina or NSTEMI in 36 cases (19%). CONCLUSIONS: Most reports of drug-eluting stent fracture involve Cypher stents. DES fracture can be associated with stent thrombosis, myocardial infarction and angina. However, whether the incidence of such events reported in the literature and in the MAUDE database is representative of all patients experiencing stent fracture remains unclear.

Long-term impact of drug-eluting stents versus bare-metal stents on all-cause mortality.

OBJECTIVES: Our purpose was to examine the incidence of all-cause mortality among drug-eluting stents (DES) and bare-metal stents (BMS) while adjusting for many confounding factors generally not considered in prior studies. BACKGROUND: DES use in the U.S. declined by up to 50% in recent years, primarily due to concerns about late stent thrombosis and possibly increased mortality. However, recent data suggest that DES are as safe as BMS and may actually be associated with a lower incidence of myocardial infarction and mortality. METHODS: All patients undergoing percutaneous coronary intervention with a DES or BMS alone from March 1, 2003, to June 30, 2007, at a tertiary care center were assessed. Multivariable Cox proportional hazards modeling was performed for overall and propensity-matched patients. Socioeconomic status was calculated using U.S. Census 2000 data. The primary end point was all-cause mortality. RESULTS: There were a total of 832 deaths over a 4.5-year interval among 8,032 patients. Of these, 6,053 received a DES and 1,983 patients had a BMS. All-cause mortality was significantly lower in unadjusted and adjusted Cox proportional models with DES (hazard ratio: 0.62, 95% confidence interval: 0.53 to 0.73; p < 0.001). Similarly, in the propensity-matched group, DES remained associated with lower mortality compared with BMS (adjusted hazard ratio: 0.54, 95% confidence interval: 0.45 to 0.66; p < 0.001). CONCLUSIONS: DES were associated with lower mortality in this "real-world" setting. However, despite multiple adjustments, potential confounding may still play a role.

Safety and efficacy of overlapping sirolimus-eluting versus paclitaxel-eluting stents.

BACKGROUND: The short-term and long-term safety and efficacy of paclitaxel versus sirolimus-overlapping drug-eluting stents (DES) is unknown. We sought to examine the clinical consequences of overlapping sirolimus versus paclitaxel DES. METHODS: We reviewed catheterization reports from April 2003 to May 2005 for all patients who underwent percutaneous coronary revascularization with DES. All patients were followed-up for at least 1 year. Patients were included if they received only 2 single-type overlapping stent (eg, sirolimus-sirolimus) during the index procedure. The end points included early (inhospital and 30-day) and late composite of all-cause mortality, stent thrombosis, myocardial infarction, and target lesion revascularization. RESULTS: A total of 282 individuals met our study criteria. Of these, 188 had sirolimus and 94 had paclitaxel-overlapping DES. There were 78 events for a median follow-up of 24 months for the composite end point. No statistically significant differences between overlapping sirolimus and paclitaxel DES were seen for inhospital, 30-day (16% vs 23%, respectively; P = .13), and long-term (25% vs 33%, respectively; P = .16) composite end points. In addition, in Kaplan-Meier and Cox proportional hazard analysis, no significant differences for the composite end point were noted. CONCLUSIONS: In this analysis, there were no significant differences in safety or efficacy between the 2 types of overlapping DES. Trends toward more events with overlapping paclitaxel stents should be evaluated in an adequately powered randomized controlled trial.

Efficacy of a novel procedure sheath and closure device during diagnostic catheterization: the multicenter randomized clinical trial of the FISH device.

BACKGROUND: The aim of vascular closure devices is to safely secure the arterial access site at the conclusion of catheterization procedures, thereby increasing patient comfort and decreasing time to hemostasis and ambulation. The FISH (femoral introducer sheath and hemostasis) device is novel in that the access sheath and closure component are incorporated onto the same system. METHODS: The FISH pivotal investigation was conducted at 8 catheterization laboratories throughout the United States. Eligible diagnostic patients were randomized (2 to 1) to the FISH device versus manual compression and assessed for time to hemostasis and time to ambulation. Half of the participants underwent ultrasonographic evaluation at 30-day follow up. Enrollment for an interventional cohort is ongoing and will be reported at a later date; however, the interventional patients enrolled to date were combined with the diagnostic patients to comprise the safety data of the trial. RESULTS: Overall, 191 patients were randomized to the FISH device and 106 patients to manual compression. Most patients received a 6 Fr sheath (approximately 70%), while the remaining patients received a 5 or 8 Fr sheath. Twenty-seven patients who received the FISH device were converted to manual compression due to anticipated suboptimal hemostasis. Among the diagnostic patients, the mean time to hemostasis was 8.9 minutes for the FISH device, compared to 17.2 minutes for manual compression (p < 0.0001). Similarly, the mean time to ambulation was 2.4 hours for the FISH device, compared to 4.3 hours for manual compression (p < 0.0001). Among the total cohort, there was 1 death and 1 episode of major access-site-related bleeding that required transfusion occurred in the FISH group (1.1%), compared to no serious adverse safety events in the manual compression group (p = 1.0). For the FISH group, there were 5 minor adverse safety events; 3 access-site hematomas and 2 pseudoaneurysms treated with thrombin injection, and in the manual compression group, there was 2 access-site hematomas and 1 pseudoaneurysm treated with thrombin injection (p = 1.0). CONCLUSION: Among diagnostic patients with good sheath placement and favorable femoral anatomy, the FISH device is superior in achieving time to hemostasis and ambulation compared to manual compression. At 30 days, there is no apparent difference in serious or minor adverse vascular events with the use of the FISH device.