Achieving sustainable first door-to-balloon times of 90 minutes for regional transfer ST-segment elevation myocardial infarction.

OBJECTIVES: A network approach to transfer ST-segment elevation myocardial infarction (STEMI) patients can achieve durable first door-to-balloon times (1st D2B) for percutaneous coronary intervention (PCI) within 90 min. BACKGROUND: Nationally, a minority of STEMI patients from referral centers obtain 1st D2B in <2 h and even fewer in <90 min. METHODS: Included were transfer STEMI patients from 9 network hospitals treated in 2007 compared with 2008 to 2011 after installing the following initiatives: 1) established hospital referral system; 2) goal-oriented performance protocols; 3) expedited transport by ground or air; 4) first hospital activation of the PCI hospital catheterization laboratory; and 5) outreach coordinator and patient-level web-based feedback to the referring hospital. RESULTS: A total of 101 STEMI patients transported in 2007 were compared with 442 STEMI patients transferred after starting these initiatives for STEMI from 2008 to 2011, with the median door-in to door-out time decreased from 44 to 35 min (p < 0.0001), the median 1st D2B decreasing from 109.5 to 88.0 min (p < 0.0001), and the percentage under 90 min increased from 22.8% to 55.9% (p < 0.0001). Overall, throughout the study period (2007 to 2011), the transport times remained consistent (median 36.5 vs. 36.0 min, p = 0.98), whereas the PCI hospital D2B decreased from 20.0 to 16.0 min (p < 0.0001). Length of stay and in-hospital mortality remained low at 3.0 days and under 4%, respectively. CONCLUSIONS: A system-wide network program can achieve sustained (over 4 years) 1st D2B times of <90 min.

An integer based risk score for predicting 30-day major adverse cardiac or cerebrovascular events after percutaneous coronary intervention with drug-eluting stents: results from a large prospective multicentre registry, the STENT Group.

AIMS: Previous risk models predicting in-hospital major adverse cardiac or cerebrovascular events (MACCE) after percutaneous coronary interventions (PCI) may underestimate actual short-term post-procedure complications due to the trend toward early discharge of patients. METHODS AND RESULTS: Using a subset (N=10,679) from the STENT Group registry, a logistic regression model was developed to predict 30-day MACCE which includes death, myocardial infarction, target vessel revascularisation and stroke. An integer-based risk score was created from the model and validated in another subset (N=3,099). In the study subset, there was significant difference between in-hospital and 30-day MACCE N=443 (2.0%) vs. 131 (4.2), p<0.01, respectively. A final risk model included nine variables; absence of pre-procedural statin (odds ratio=1.3, 95% confidence interval=1.0-1.5), haemoglobin level (0.9/1 gm increase, 0.8-0.9), cardiogenic shock (4.4, 3.1-6.3), acute congestive heart failure (1.6, 1.2-2.3), left main disease (2.2, 1.3-3.7), left anterior descending artery lesion (1.3, 1.0-1.5), ostial lesion (1.6, 1.2-2.1), coronary thrombosis (2.0, 1.4-2.9) and ACC/AHA type C lesion (1.3, 1.1-1.6). The c-statistics of the final model were 0.653 and 0.692 in the study and validation subset, respectively. CONCLUSIONS: In this large real world registry of DES, in-hospital MACCE did not represent short-term post-procedure prognosis. The risk model consisting of nine variables predicted 30-day MACCE with modest discriminatory value.

Outcomes with drug-eluting versus bare-metal stents in saphenous vein graft intervention results from the STENT (strategic transcatheter evaluation of new therapies) group.

OBJECTIVES: This study compares outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in patients undergoing saphenous vein graft (SVG) intervention. BACKGROUND: The safety and efficacy of DES in patients undergoing SVG intervention is controversial. METHODS: The STENT (Strategic Transcatheter Evaluation of New Therapies) registry is a multicenter U.S. registry evaluating outcomes with DES. Our study population includes patients undergoing PCI of SVG lesions with DES (n = 785) or BMS (n = 343) who completed 9-month or 2-year follow-up. Outcomes were adjusted with propensity analyses. RESULTS: The DES patients had fewer emergent procedures but had smaller vessels and longer lesions. The DES patients had less death or myocardial infarction at 9 months (hazard ratio [HR]: 0.52, 95% confidence interval [CI]: 0.33 to 0.83, p = 0.006) and less death at 2 years (HR: 0.60, 95% CI: 0.36 to 0.98, p = 0.041). Target vessel revascularization (TVR) was less with DES at 9 months (7.2% vs. 10.0%, HR: 0.36, 95% CI: 0.22 to 0.61, p < 0.001) but was no different by 2 years (18.3% vs. 16.9%, p = 0.86), although adjusted TVR rates were lower (HR: 0.60, 95% CI: 0.40 to 0.90, p = 0.014). The DES reduced TVR at 9 months in SVG lesions with diameter <3.5 mm (8.0% vs. 17.2%, p = 0.013) but not >or=3.5 mm (6.0% vs. 6.6%, p = 0.74). CONCLUSIONS: Treatment of SVG lesions with DES vs. BMS is effective in reducing TVR at 9 months, although most of this advantage is lost at 2 years. The DES seem safe with less death or myocardial infarction, although selection bias might have affected these results. Our data suggest that DES might have short-term advantages over BMS in SVG lesions with diameter <3.5 mm.

Outcomes with drug-eluting stents versus bare metal stents in acute ST-elevation myocardial infarction: results from the Strategic Transcatheter Evaluation of New Therapies (STENT) Group.

OBJECTIVES: This study compares outcomes with drug-eluting stents (DES) versus bare metal stents (BMS) in patients with ST-elevation myocardial infarction (STEMI). BACKGROUND: DESs have been effective in elective percutaneous coronary intervention (PCI), but their safety and efficacy in patients with STEMI have not been well studied. METHODS: The STENT Registry is a multicenter United States registry evaluating outcomes of DES. Our study population includes patients with STEMI treated with either a DES or BMS who completed 9-month or 2-year follow-up. Outcomes were adjusted using propensity score analysis. RESULTS: DES patients were younger, had less prior infarction and prior bypass surgery, but had smaller vessels and longer lesions. After adjusting for differences in baseline variables, there were no significant differences between DES and BMS in death, reinfarction, or major adverse cardiac events (MACE). DES had lower rates of stent thrombosis at 9 months (1.0% vs. 2.7%, HR 0.40 [0.17-0.95]) and lower rates of target vessel revascularization (TVR) at 9 months (4.0% vs. 7.5%, HR 0.55 [0.34-0.88]) and 2 years (8.0% vs. 11.3%, HR 0.57 [0.35-0.92]). There was a nonsignificant increase in stent thrombosis with DES versus BMS from 1 to 2 years (1.1% vs. 0.3%, P = 0.28). CONCLUSIONS: Our data suggest that DES used with primary PCI for STEMI are more effective than BMS in reducing TVR and are safe for up to 2 years. Whether DES are safe beyond 2 years and whether the reduction in TVR is enough to justify their use in STEMI will have to wait for the results of large randomized trials.

Outcomes and complications with off-label use of drug-eluting stents: results from the STENT (Strategic Transcatheter Evaluation of New Therapies) group.

OBJECTIVES: This study evaluates outcomes and complications in patients treated with drug-eluting stents (DES) for "off-label" indications. BACKGROUND: Drug-eluting stents have been effective in randomized trials, but their safety and efficacy for off-label indications has not been well studied. METHODS: The STENT (Strategic Transcatheter Evaluation of New Therapies) Registry is the largest multicenter U.S. registry evaluating outcomes of DES. Off-label indications included ostial, left main, long, bifurcation, and in-stent restenotic lesions, saphenous vein grafts, chronic total occlusions, small or large vessels, multilesion or multivessel percutaneous coronary interventions, and ST-segment elevation myocardial infarction. Outcomes were adjusted using Cox proportional hazards regression and propensity analyses. RESULTS: Drug-eluting stents were used in an off-label manner in 59% of patients. The patients who received off-label treatment were more often male, had a higher incidence of prior infarction and bypass surgery, and lower ejection fractions. Off-label versus "on-label" use of DES was associated with higher rates of death, myocardial infarction, target vessel revascularization, major adverse cardiac events, and stent thrombosis at 9 months and 2 years. Off-label use of DES compared with off-label use of bare-metal stents (BMS) had lower rates of death, myocardial infarction, target vessel revascularization, and major adverse cardiac events at 9 months and 2 years and lower rates of stent thrombosis at 9 months. CONCLUSIONS: Off-label use of DES is associated with higher event rates compared with on-label use of DES, which is consistent with a higher risk clinical and lesion profile. However, event rates with off-label use of DES are lower compared with off-label use of BMS. Pending results from randomized trials, our data support the use of DES for off-label indications in selected patients.

Comparative clinical outcomes of paclitaxel- and sirolimus-eluting stents: results from a large prospective multicenter registry--STENT Group.

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

AngioJet experience from the multi-center STENT Registry.

OBJECTIVE: To explore the utilization and clinical outcomes of AngioJet Rheolytic thrombectomy from the Strategic Transcatheter Evaluation of New Therapies (STENT) multi-center prospective registry from May 2003 through December 2005. METHODS: Prospective consent was sought for all consecutive percutaneous coronary intervention (PCI) patients at all institutions and achieved in 84% of all patients. Of these, clinical follow-up at 9 months was achieved in 94% of eligible patients at all institutions. RESULTS: Of a total of 9,707 patients, AngioJet was utilized in 3-4% of all procedures, including 12-14% of all procedures with thrombolysis in myocardial infarction (TIMI) grade 3 thrombus or greater and 10-12% of acute evolving MI patients. Nine-month clinical outcomes showed similar mortality rates for patients treated with AngioJet (5.0%) versus those with no thrombectomy (6.5%) for patients with thrombus grade 3 or greater, despite the higher clinical risk profile of the AngioJet patient population due to a higher percentage of cardiogenic shock and larger thrombus. CONCLUSION: The results of this larger, multi-center registry indicate that AngioJet thrombectomy, when selected in general clinical practice for high risk patients with thrombus, results in non-significant numerically lower rate of mortality with no indication of safety issues.

How to integrate a lactation consultant in an outpatient clinic environment.

Successful efforts in improving breastfeeding initiation rates at an urban teaching hospital prompted the hospital to create a lactation consultant (LC) position in the outpatient setting to focus on breastfeeding duration. This article reviews the complexity of the clinic setting, with the challenges and benefits of the consultant's first year in one of the hospital's outpatient clinics. Preliminary data collected by the consultant suggest that patients counseled by the LC in the outpatient clinic setting have longer breastfeeding duration rates.