Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis: the three-year results of the PEPCAD II ISR study.

Aims: Treatment of bare metal in-stent restenosis with the paclitaxel-coated balloon catheter based on the PACCOCATH® technology has yielded superior six-month angiographic and one-year clinical results compared to a paclitaxel-eluting stent. The three-year clinical follow-up is presented.

Methods And Results: One hundred and thirty-one patients with coronary bare metal in-stent restenosis (>70%, length: <22 mm, vessel diameter: 2.

Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months?

Aims: The one-year outcome of lesions in small coronary arteries by using a paclitaxel-iopromide-coated (3 µg/mm²) balloon catheter (DCB) has yielded good six-month angiographic and one-year clinical data. We now report the three-year clinical follow-up.

Methods And Results: One hundred and twenty patients with >70% stenoses <22 mm in length in small coronary vessels (vessel diameter: 2.

The paclitaxel-eluting coroflex stent study II (PECOPS II) acute and 6-month clinical and angiographic follow-up, 1-year clinical follow-up.

Background And Objectives: Paclitaxel-coated stents have proven their efficacy for reducing restenosis in de novo coronary artery lesions and in-stent restenoses with superiority compared to bare metal stents. This study was performed to evaluate the procedural and 1 year results of the Paclitaxel-eluting Coroflex Please stent in coronary artery lesions.

Methods: One-hundred and twenty-nine patients (66.

Treatment of small coronary arteries with a paclitaxel-coated balloon catheter.

Background: Treatment of lesions in small coronary arteries by percutaneous transluminal coronary intervention is limited by a high recurrence rate. We assessed the use of a paclitaxel-coated balloon in this indication.

Methods: One-hundred eighteen patients with stenoses in small coronary vessels were treated by a paclitaxel-coated balloon (3 microg/mm(2)).

The paclitaxel-eluting Coroflex Please stent study (PECOPS I): the 3-year clinical follow-up.

Background: The evaluation of drug-eluting devices in humans should include longterm follow-up owing to risk of late target vessel thrombosis with the possible fatal sequel.

Methods And Results: Therefore, the three-year clinical outcome of the paclitaxel-eluting Corofiex Please stent in patients with de-novo coronary lesions was evaluated in the single-arm PECOPS I pilot study. The clinical data of 123/125 (98.

Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis.

Background: Treatment of in-stent restenosis with paclitaxel-coated balloon catheter as compared with plain balloon angioplasty has shown surprisingly low late lumen loss at 6 months and fewer major adverse cardiac events up to 2 years. We compared the efficacy and safety of a paclitaxel-coated balloon with a paclitaxel-eluting stent as the current standard of care.

Methods And Results: One hundred thirty-one patients with coronary in-stent restenosis were randomly assigned to treatment by a paclitaxel-coated balloon (3 microg/mm2) or a paclitaxel-eluting stent.

The paclitaxel-eluting Coroflex Please stent pilot study (PECOPS I) : the one-year clinical follow-up.

Background: The alleged superiority of drug-eluting stents over bare metal devices and those with passive coatings is diminished by a higher incidence of late target vessel thrombosis.

Methods And Results: Therefore, the one-year clinical outcome of the paclitaxel-eluting Coroflex Please stent in patients with denovo coronary lesions was evaluated in the single-arm PECOPS I pilot study. The clinical data of 96/97 (99%) of the patients included per protocol and of 86/87 (98.

Risk predictors and frequency of cardiovascular symptoms occurring during cardiac rehabilitation programs in phase III-WHO.

Introduction: Rehabilitation in ambulatory heart groups has become a well established part of comprehensive cardiac treatment in Germany. Identifying patients at risk for cardiovascular symptoms is important for the efficiency and safety of the program.

Methods: Questionnaires were mailed to ambulatory heart groups in the state of Hessen, Germany, and returned by 1935/13 174 (15%) patients, age 65.

The paclitaxel-eluting Coroflex Please stent pilot study (PECOPS I): acute and 6-month clinical and angiographic follow-up.

Background And Objectives: Various active stent coatings significantly reduce restenosis rates and target lesion revascularization compared to bare metal stents. Therefore, the procedural and 6-month performance of the new paclitaxel-eluting Coroflex. Please stent was investigated.

The low pressure stent observational trial on the procedural and mid-term outcome of a trapezoid-shaped coronary stent (LOPSTER).

Background: Stent design influences the procedural and mid-term results of coronary interventions. The trapezoid-shaped struts of the low pressure stent (LP-Stent) might improve the outcome by reducing the vascular trauma at deployment.

Methods: A total of 133 patients (64.

Clinical and angiographic procedural and mid-term outcome with new versus reused balloon catheters in percutaneous coronary interventions.

Background: To reduce procedural cost, cardiac centers increasingly use resterilized balloon catheters for percutaneous coronary interventions. Data addressing the procedural and mid-term outcome in a prospective randomized trial comparing new and resterilized balloons are not available.

Methods And Results: Percutaneous coronary interventions were performed at random in 238 consecutive patients with either new or 1-3 times reused balloon catheters.

Evaluation of the Coroflex Theca-Stent for reduction of restenosis (ECORI).

Background: Various stent coatings have been shown to significantly reduce restenosis rates in comparison to non-coated devices. Therefore, the short- and mid-term performance of the new polyphosphazene-coated Coroflex Theca-Stent was investigated.

Methods: 103 patients [63.

Comparison of a silicon carbide coated stent versus a noncoated stent in humans: the Tenax- versus Nir-Stent Study (TENISS).

Purpose: Stents coated with hypothrombogenic silicon carbide (a-SiC:H) exhibited low restenosis rates in the rabbit and in an observational study in humans. Thus, the clinical and angiographic outcome was assessed in a large multicenter study.

Material And Methods: Four hundred and ninety-seven patients (63.

Comparison of a silicon carbide-coated stent versus a noncoated stent in human beings: the Tenax versus Nir Stent Study's long-term outcome.

Background: Stents coated with amorphous hypothrombogenic silicon carbide (a-SiC:H) have low restenosis rates in humans. Recurrence in a-SiC:H at mid-term follow-up has been shown to be similar to a stainless steel device. The long-term outcome, however, may be different.

Change of the mechanical properties of two different balloon catheters with increasing numbers of cycles of resterilization.

An increasing number of centers are reusing PTCA catheters even though manufacturers warrant single use only. This prospective bench laboratory trial addresses the quality of PTCA balloon catheters after up to three resterilization cycles in order to determine whether a larger trial is warranted to discern whether catheters should be reused. Forty PTCA catheters from two different manufacturers (nominal diameters 1.

Restenosis rates with flexible GFX stents (REFLEX): clinical and angiographic results.

The objective of this prospective, multicenter, observational trial was to evaluate the procedural results and longterm outcomes of the flexible AVE GFX coronary stent in native coronary lesions. The trial included 137 consecutive patients (111 [81%] men, age 63.1 +/- 9.