A randomised trial of paclitaxel-eluting balloon after bare metal stent implantation vs. bare metal stent in ST-elevation myocardial infarction (the PEBSI study).

AIMS: Our aim was to assess the safety and efficacy of paclitaxel-eluting balloon (PTX-B) treatment after bare metal stent (BMS) implantation in patients undergoing primary angioplasty. METHODS AND RESULTS: After BMS implantation, patients were randomised (1:1) to treatment with a PTX-B or no PTX-B treatment (BMS group). The primary endpoint was in-stent late luminal loss (LLL) at nine-month follow-up. OCT was carried out on the first 20% of consecutive patients included in the study. Two hundred and twenty-three patients were randomised (BMS: 112, PTX-B: 111). At nine months, median LLL was 0.80 mm (interquartile range [IQR] 0.36-1.26) in the BMS group vs. 0.31 mm (IQR 0.00-0.58) in the PTX-B group, p<0.0001. Binary restenosis was significantly lower in the PTX-B group: 29.8% vs. 2.2%, p<0.0001, 95% confidence interval (CI): 3.2-54.2. Nine-month OCT showed good strut coverage in both groups but greater in the BMS group (100±0.0% vs. 99.52±1.11%, p=0.03) with very low rates of malapposed struts per lesion. One-year MACE was significantly lower in the PTX-B group (12.5% vs. 3.6%, p=0.016). CONCLUSIONS: PTX-B after successful BMS implantation resulted in less LLL and better clinical outcomes as compared with a BMS-only strategy. This was associated with good stent strut coverage and very low rates of malapposed struts.

The Guideliner™ catheter for stent delivery in difficult cases: tips and tricks.

INTRODUCTION: Stent delivery in complex coronary anatomy with severe calcification and tortuosity is still a common cause of percutaneous coronary interventions (PCI) failure. Recently, a new support rapid exchange catheter, the Guideliner, has been designed specifically for device delivery. METHODS: From June 2010 to December 2010, we performed 10 cases using the Guideliner catheter to improve backup support and facilitate stent delivery: 2 emergent PCI for ST elevation myocardial infarction, and 8 stable elective PCI. In 3 cases the operator chose the femoral access, in 2 cases crossover from radial to femoral access was needed, and the other cases were performed radially. In 2 cases PTCA with drug-eluting balloon was performed; in the other cases second-generation drug-eluting stent was implanted. RESULTS: One case, the first one, failed, as stent could not be delivered to the target lesion. The other 9 cases were performed successfully. Three proximal dissections were detected and sealed with stent implantation. In 2 cases, we had stent damage due to the passage of the stent through the Guideliner metal collar. Another stent had to be used. CONCLUSIONS: In our experience, the Guideliner catheter is safe to use and helps device delivery in difficult settings. We describe here our experience with the Guideliner catheter for stent delivery and backup support; we discuss its utility and drawbacks in acute and stable clinical settings. Moreover, the aim of this article is to help interventional cardiologists using the device in difficult lesions to avoid potential complications.

Aggressive plaque modification with rotational atherectomy and/or cutting balloon before drug-eluting stent implantation for the treatment of calcified coronary lesions.

INTRODUCTION: Calcified coronary lesions may be associated with stent underexpansion, malapposition, and high rates of restenosis. The use of drug-eluting stents (DES) in such lesions has not been fully addressed in the major trials. We sought to examine the outcomes of patients who were treated with plaque modification (PM) to facilitate DES implantation. METHODS: We analyzed 164 calcified coronary lesions in 145 consecutive patients who underwent aggressive PM with either rotational atherectomy (RA) and/or cutting balloon (CB) before DES implantation. CB was used in moderate calcified lesions and RA alone or followed by CB in severe calcified lesions. RESULTS: Patients were 68.7 +/- 10.1 years old, 47% were diabetic, 34% had left ventricular ejection fraction (LVEF) < or =50%, and 39% had 3-vessel disease. Ninety-five percent of lesions were classified as B2/C, 100% as moderately/severely calcified. PM was achieved by using CB in 57% and by RA alone or followed by CB in 43%. In 100%, a DES was implanted. There was no failure to deliver a stent. At 15 +/- 11 months follow-up, the overall major adverse cardiac events (MACE) rate was 9.6% (3.4% cardiac death, 2.3% myocardial infarction, and 3.4% target lesion revascularization [TLR]). The only independent predictor of MACE was LVEF < or =50% (odds ratio 3.88; 95% confidence interval: 1.15-13.1; P = 0.03). The incidence of stent thrombosis (ST) was 2.1%. There were no significant differences in MACE and TLR based on the type of PM used. CONCLUSIONS: In this population at high risk of restenosis, aggressive PM by CB and/or RA before DES implantation provides excellent mid-term outcomes with only 3.4% TLR and 2.1% ST.

Reduction in door-to-needle time to meet clinical guideline recommendations. Outcomes after 1 year.

The aim of this study was to reduce the door-to-needle time in patients with ST-elevation acute myocardial infarction by setting up a chest pain service. We compared the door-to-needle time and outcomes at the end of first year of follow-up in patients who received fibrinolysis in the 2 years before implementation of the service (Group 1) and those who received fibrinolysis in the 2 years after its creation (Group 2). In Group 1, the median door-to-needle time was 40 min (P(25-75), 23-52 min); in Group 2, it was 27 min (P(25-75), 15-43 min; P=.003). In addition, the use of reperfusion therapy increased from 55.2% in Group 1 to 64.7% in Group 2 (P< .01). After a follow-up period of 1 year, there was no difference in the rate of revascularization, hospital readmission, reinfarction or cardiovascular mortality.