Search

The primary objective of the present study was to assess the feasibility and the safety of the Seaquence TM stent (CathNet-Science) deployment for the treatment of coronary artery disease and the event-free survival of patients treated with this coronary stent. The study was conducted as a multicenter, prospective, observational registry. Patients with stable or unstable angina pectoris who were candidates for percutaneous coronary intervention with elective stenting of one single de novo lesion in a native coronary artery ≥3 mm in diameter were included in the study. Clinical follow-up was performed at 1 month and 9 months. Major adverse coronary events (MACE), that is, cardiac death, myocardial infarction, and target vessel revascularization (re-PTCA or CABG), were recorded over a period of 9 months. Using this stent, a 99% in-hospital success rate was achieved. A total of 17 patients presented MACE (8.7%) during the whole follow-up period and target lesion revascularization was needed for 14 (7.1%) patients. Using multivariate analysis only some clinical parameters (patients treated for unstable angina, with a history of CABG or of female gender) were found as independent predictors of MACE after coronary stenting. Procedural related factors, angiographic characteristics, or reference diameter were not found to influence clinical outcome. Because the study was performed in patients with a high proportion of complex lesions (relative highrisk nonselected population with nearly one third calcified lesions, many long and type B2 and C lesions) we can conclude that the coronary Seaquence TM stent can be considered as a stent of reference in routine practice. (J Interven Cardiol 2004;17:9‐15)

The aim of this trial was to compare cutting balloon angioplasty (CBA) with conventional balloon angioplasty (i.e., percutaneous transluminal coronary angioplasty [PTCA]) for the treatment of patients with coronary in-stent restenosis (ISR).Retrospective studies suggest CBA might be superior to conventional PTCA in the treatment of ISR.The Restenosis Cutting Balloon Evaluation Trial (RESCUT) is a multicenter, randomized, prospective European trial including 428 patients with all types of ISR (e.g., focal, multifocal, diffuse, proliferative).In both groups, the majority of ISR lesions were shorter than 20 mm. The length of restenotic stents was similar (CBA: 18.6 +/- 9.7 mm; PTCA: 18.3 +/- 8.7 mm). The number of balloons used to treat ISR was lower in the CBA group: only one balloon was used in 82.3% of CBA cases, compared with 75% of PTCA procedures (p = 0.03). Balloon slippage was less frequent in the CBA group (CBA 6.5%, PTCA 25%; p0.01). There was a trend toward a lower need for additional stenting in the CBA group (CBA 3.9%, PTCA 8.0%; p = 0.07). At seven-month angiographic follow-up, the binary restenosis rate was not different between the groups (CBA 29.8%, PTCA 31.4%; p = 0.82), with a similar pattern of recurrent restenosis. Clinical events at seven months were also similar.Cutting balloon angioplasty did not reduce recurrent ISR and major adverse cardiac events, as compared with conventional PTCA. However, CBA was associated with some procedural advantages, such as use of fewer balloons, less requirement for additional stenting, and a lower incidence of balloon slippage.

The role of stent implantation in small coronary arteries is still controversial. The MICROSCOPE study (Ministenting in small coronary arteries, a prospective evaluation) is a multicenter registry addressed to prospectively evaluate the immediate and mid-term clinical and angiographic results of elective stenting of lesions located in coronary arteries with an angiographic reference diameteror = 2.75 mm.A total of 146 patients (160 lesions) were included in the study. The percentage of complex lesions (B2 and C lesions) was 49.3%. The clinical indications for stent implantation were: stable angina (55.0%), unstable angina (24.6%), and clinical evidence of myocardial ischemia in asymptomatic patients (20.4%); 60% of patients had multivessel disease. Stent deployment could be performed in 96.2% of lesions. The baseline reference diameter was 2.12 +/- 0.36 mm. In all cases the Ministent (Cordis, a JJ Company, Miami, FL, USA), specifically designed for small coronary arteries, was employed. The stent was pre-mounted on low profile balloons available in three different diameters (2.25, 2.50 and 2.75 mm) and three different lengths (11, 15 e 26 mm).The primary endpoint of successful stent-assisted angioplasty in all study vessels without major adverse cardiac events was achieved in 95.8% of the patients. The minimal lumen diameter increased from 0.64 +/- 0.24 to 2.02 +/- 0.43 mm and the dimensions of the stenosis (expressed as a percentage of the diameter of the coronary vessel) decreased from 68.6 +/- 10.8 to 16.2 +/- 10.7% (30% standard deviation in all cases). After the procedure all the patients received double antiplatelet therapy for 4 weeks. Post-procedural complications were limited to 2 patients (1.3%) who had a non-Q wave myocardial infarction at 6 months of follow-up; 13 patients (11%) required target lesion revascularization. No patient died following the procedure. Angiographic control was performed in 44% of lesions. The minimal lumen diameter decreased to 1.12 +/- 0.47 mm and the percent stenosis increased to 45.9 +/- 23.2%. The incidence of binary restenosis (stenosisor = 50%) was 41%.Elective stenting of small coronary arteries with the Ministent can be safely performed and is associated with a low incidence of acute or subacute stent thrombosis. The mid-term results indicate a high rate of angiographic restenosis but a low need of target vessel revascularization. These data suggest that stenting cannot be considered the treatment of choice for unselected lesions located in coronary arteries with a small reference diameter, but represents a safe solution if unsatisfactory results are obtained with balloon angioplasty alone.