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.

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.

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.

Real-world bare metal stenting: identification of patients at low or very low risk of 9-month coronary revascularization.

The high cost of drug-eluting stents (DESs) has made identification of patients who are at low risk for subsequent revascularization after treatment with bare metal stents (BMSs) highly desirable. Previous reports from randomized trials suffer from biases induced by restricted entry criteria and protocol-mandated angiographic follow-up. Between 1994 and 2001, 5,239 consecutive BMS patients, excluding those with coil stents, technical failure, brachytherapy, staged procedure, or stent thrombosis within 30 days, were prospectively identified from a large single-center tertiary-referral-center prospective registry for long-term follow-up. We sought to identify characteristics of patients with very low (< or = 4%) or low (4-10%) likelihood of coronary revascularization 9 months after BMS. Nine-month clinical follow-up was obtained in 98.2% of patients. Coronary revascularization was required in 13.4% and did not differ significantly by stent type. On the basis of multivariate analysis identifying 11 independent correlates and previous reports, 20 potential low-risk patient and lesion groups (228 +/- 356 patients/groups) were identified (e.g, patients with all of the following: native vessel, de novo, reference diameter > or = 3.5 mm, lesion length < 5 mm, no diabetes, not ostial in location). Actual and model-based outcomes were analyzed. No group had both predicted and observed 9-month revascularization < or = 4% (very low risk). Conversely, 19 of 20 groups had a predicted and observed revascularization rate of 4-10% (low risk). In the real-world setting, the need for intermediate-term revascularization after BMS may be lower than expected, but it may be very difficult to identify patients at very low risk. Conversely, if the benefits of DESs are attenuated in routine practice, many groups of patients treated with BMSs may have nearly comparable results.

Triple antiplatelet therapy does not increase femoral access bleeding with vascular closure devices.

BACKGROUND: The use of arteriotomy closure devices (CDs) to achieve hemostasis after femoral artery access in percutaneous coronary intervention is steadily increasing. However, the safety information with these devices in the era of triple antiplatelet therapy is limited. METHODS: We reviewed prospectively collected data from the Do Tirofiban and ReoPro Give Similar Efficacy Outcomes Trial (TARGET), where all patients received aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitor therapy. At the treating physician's discretion, manual compression (MC) or a vascular hemostasis device was selected following femoral angiography. Patients receiving MC were to have sheaths removed 2 to 6 hours postprocedure when the activated clotting time was < or = 175 seconds. RESULTS: Of 4809 patients, 4736 had femoral access, and 985 of these had a CD (Perclose 47%, Angio-Seal 43%, VasoSeal 5%, and other 5%). The MC and CD groups were similar regarding most demographic characteristics, including age, systolic blood pressure, and weight, but those with MC were more often female, diabetic, and had history of peripheral vascular disease. Patients with a CD had a lower ischemic event rate suggesting they were a lower risk cohort overall. There were no differences in major bleeding at the access site (0.4% vs 0.5%, P =.588), minor bleeding at the access site (1.9% vs. 3.1%, P =.142) or transfusions (0.8% vs 1.0%, P =.513) between the MC and CD groups, respectively. CONCLUSIONS: In contemporary percutaneous coronary intervention practice, with appropriate patient selection, a CD can be safely utilized despite aggressive polypharmacy for procedural anticoagulation.

Evidence that angiotensin-converting enzyme inhibitor use diminishes the need for coronary revascularization after stenting.

Restenosis after stenting, in contrast to balloon angioplasty, is predominantly due to neointima formation. Angiotensin-converting enzyme (ACE) inhibitors diminish neointima formation in animal models of arterial injury. In an observational study, 1,598 patients who were treated from 1994 to 1997 with coronary stents and prospectively followed for clinical events were divided into 2 groups: those receiving ACE inhibitors at the time of stenting (n = 345) and those who did not (n = 1,253). Multivariate logistic regression was used to adjust for imbalances between populations with regard to elements relevant to risk of 12-month coronary revascularization, which was the primary study end point. After adjustment, ACE inhibitor usage remained significantly protective against revascularization (odds ratio [OR] 0.46, 95% confidence interval 0.29 to 0.73, p = 0.001). Protection was not observed in patients treated with balloon angioplasty alone during the same period (OR 1.06, p = 0.33), which is consistent with the results of prior randomized trials. ACE inhibitors appear to decrease late revascularization, possibly due to a reduction in restenosis after coronary stenting.