Wolfgang Bocksch

Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter

BACKGROUND We are presenting an extension of a previously published trial on the efficacy and safety of a paclitaxel-coated balloon in coronary ISR in a larger patient population and after a complete follow-up of 2 years. METHODS Hundred eight patients were enrolled in two separately randomized, double-blind multicenter trials on efficacy and safety using an identical protocol. Patients were treated by the paclitaxel-coated (3 microg/mm(2) balloon surface; Paccocath) or an uncoated balloon. The main inclusion criteria were a diameter stenosis of >or=70% and <30 mm length with a vessel diameter of 2.5-3.5 mm. The primary endpoint was angiographic late lumen loss in-segment. Secondary endpoints included binary restenosis rate and major adverse cardiovascular events (MACE). RESULTS Quantitative coronary angiography revealed no differences in baseline parameters. After six months in-segment late lumen loss was 0.81 +/- 0.79 mm in the uncoated balloon group vs. 0.11 +/- 0.45 mm (P < 0.001) in the drug-coated balloon group resulting in a binary restenosis rate of 25/49 vs. 3/47 (P < 0.001). Until 12 months post procedure 20 patients in the uncoated balloon group compared to two patients in the coated balloon group required target lesion revascularization (P = 0.001). Between 12 and 24 only two MACE were recorded, a stroke in the uncoated and a target lesion revascularization in the coated balloon group. CONCLUSION Treatment of coronary ISR with paclitaxel-coated balloon catheters persistently reduces repeat restenosis up to 2 years. (ClinicalTrials.gov Identifier: NCT00106587, NCT00409981).

Percutaneous Coronary Intervention in Patients with End-Stage Renal Disease

Patients with end-stage renal disease (ESRD) represent a growing number of patients in the cardiac catheterization laboratories worldwide. This is a consequence of the growing absolute number of ESRD patients in developed countries, better noninvasive diagnostic tools, better catheterization facilities and last-but-not-least better education of referring physicians about the incidence and prognosis of coronary artery disease (CAD) for patients with ESRD. There is growing evidence of the positive impact of coronary revascularization on long-term outcome of these patients. ESRD patients have a high comorbidity and are therefore better candidates for the less invasive approach using percutaneous coronary intervention (PCI) rather than coronary artery bypass surgery (CABG). From the view of the interventional cardiologist, ESRD patients represent one of the most challenging patient cohort concerning technical challenges and potential risk of complication for the patient. Percutaneous coronary intervention (PCI) including debulking techniques and stent implantation is the current standard therapy for patients with symptomatic single-vessel disease (SVD) and the preferred therapy for most patients with focal, polyfocal or even diffuse multi-vessel disease (MVD). Coronary bypass surgery is reserved for a decreasing number of patients with mechanically untreatable coronary lesions and unprotected left main stem stenosis. The problem of restenosis and subsequent target lesion revascularization has been decreased to a minimum by the use of drug-eluting stents (DES), even though prospective randomized trials including ESRD patients are lacking. In case of acute coronary syndromes, the need for immediate coronary angiography and subsequent revascularization by means of PCI should be pointed out.

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. Methods: Ninety‐seven patients (66 ± 7.6 years, 34/97(35.1%) diabetics, 11/97(11.3%) unstable angina) were enrolled per protocol for elective single stent deployment into native coronary de‐novo or post‐PTCA restenotic lesions (stenosis: ≥ 70%, < 100%; reference diameter ≥ 2.25 mm and <3.3 mm; lesion length ≤ 16 mm) with 13/97(13.4%) lesion type A, 64/97(66%) type B1, 20/97(20.6%) type B2). The mean reference diameter was 2.88 ± 0.42 mm, the lesion length 10.03 ± 2.93 mm, and the minimal lumen diameter 0.64 ± 0.22 mm. Results: The success rates of procedure and study stent deployment were 100% and 94.8%, respectively. In 5/97(5.2%) two stents were implanted. Follow‐up was performed clinically in 86/87(98.9%) and angiographically in 77/87(88.5%) patients after 6.1 ± 0.7 months. Major adverse cardiac events occurred in 7/87(8%) 1/87(1.2%) subacute thrombosis 10.3hrs post procedure, 1/87(1.2%) myocardial infarction, 5/87(5.7%) target lesion revascularizations. The in‐segment stenosis declined from 78 ± 7.2% to 9.4 ± 6.2% after stenting increasing to 31.9 ± 18.6% at follow‐up. The in‐segment late loss and the late loss index were 0.47 ± 0.6 mm and 0.23 ± 0.29 resulting in 6/77(7.8%) in‐segment restenoses three each of which were located either within or beyond the stent structure. The outcome was neither influenced by the prevalence of diabetes ( p = 0.4), hypercholesterolemia ( p = 1), hypertension ( p = 1), overweight ( p = 1), nor by the family history of coronary artery disease ( p = 0.7). Conclusion: The data of the paclitaxel‐eluting Coroflex™. Please stent tested in PECOPS I are within the range other available paclitaxel‐eluting stent.

The Paclitaxel-Eluting Coroflex™ Please Stent Pilot Study (PECOPS I)

BackgroundThe 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 resultsTherefore, 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 (98.9%) of those treated per protocol were available 13.1 ± 1.8 months following stent deployment. In the inclusion and treatment per protocol groups the incidence of cardiac deaths was 1/96 (1%) and 1/86 (1.2%), of myocardial infarction 3/96 (3.1%) and 1/86 (1.2%), and of target lesion revascularization 9/96 (9.4%) and 8/86 (9.3%). In patients enrolled per protocol two early thromboses (2.1%) occurred one of which two days after premature discontinuation of clopidogrel. In patients treated per protocol one thrombosis was observed after 10 hours. The one-year event-free survival was 83/96 (86.5%) in patients enrolled per protocol and 75/86 (87.2%) in those treated per protocol.ConclusionThe one-year clinical outcome of PECOPS I was within the range of other paclitaxel-eluting coronary stents. The relative small number of patients enrolled in PECOPS I precludes to infer any further conclusions.

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 (66.2 +/- 8.2 years, 31.0% diabetics, 20.2% unstable angina, 41.8% multivessel disease) were enrolled per protocol for elective single stent deployment into native de novo or post-PTCA restenotic coronary lesions.The mean reference diameter was 2.84 +/- 0.43 mm, the lesion length 12.51 +/- 4.6 mm, and the minimal lumen diameter 0.75 +/- 0.29 mm. Follow-up was performed clinically in 129/129 (100%) after 6 and 12 months and angiographically in 120/129 (93%) patients after 6 months. RESULTS The success rates of the procedure and deployment were 100% and 95.3%, respectively. The in-stent late loss and the late-loss index were 0.27 +/- 0.59 mm and 0.17 +/- 0.40 resulting in binary in-stent restenoses in 16/120 (13.3%) subjects and in-segment restenoses in 20/120 (16.7%) subjects. Major adverse cardiac events occurred in 23/129 (17.8%) during the first 6 months of follow-up with 3/129 (2.3%) myocardial infarctions, 1/129 (0.8%) secondary to stent thrombosis. From 6 to 12 months, 2/129 (1.6%) nonlesion related PCI were performed. CONCLUSION The data of the Paclitaxel-eluting Coroflex Please stent evaluated in PECOPS II are within the range of the other currently available Paclitaxel-eluting stent.

Pericardial effusion as primary manifestation of Takayasu arteritis.

Takayasu arteritis (TA) is a chronic vasculitis, affecting young women in 80-90% of cases with greatest prevalence in Asians. As exudative pericarditis is an extremely rare, but a possible manifestation of TA, we report on a young women who presented with recurrent febrile pericardial effusion as primary manifestation of TA.

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 paclitaxeleluting 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 (98.4%) of all patients included were available 3.05 ± 0.12 years following stent deployment. In the intention‐to‐treat analysis the incidence of cardiac death was 9/123 (7.3%), of myocardial infarction 4/123 (3.3%), and of in‐segment target lesion revascularization 14/123 (11.4%). Target lesion revascularizations tended (p = 0.30) to occur less frequently (9/96 (16.6%)) in those patients in whom the stent length was longer than the lesion (4.80 ± 2.71 mm) compared to 5/27 (18.5%) in those patients in whom the stent was shorter than the lesion (−3.0 ± 2.43 mm). Stent thromboses occurred in 2/123 (1.6%) patients during the first 6 months, one of which two days after premature discontinuation of clopidogrel. The total 3‐year MACE rate was 22/123 (17.9%). Conclusion: The present study describes the paclitaxel‐eluting Corotlex Please stent as a safe device with good long term performance when deployed in native coronary arteries. The occurrence of late major adverse events and late thromboses in particular seem to be very low.

Influence of Different Lipid-Lowering Strategies on Plaque Volume and Plaque Composition in Patients with Coronary Artery Disease: Role of Intravascular Ultrasound Imaging

Lipid-lowering therapy has a significant impact on the prognosis and clinical course of coronary artery disease (CAD). Slowdown of plaque progression and plaque stabilization are the major cardiac goals of any lipid-lowering strategy. Until now, intravascular ultrasound imaging (IVUS) has been the only in vivo imaging modality which allows serial analysis of plaque burden and plaque composition on a volumetric basis. Several serial IVUS studies have shown that chronic statin therapy could decrease or even halt plaque growth. Moreover, aggressive lipid-lowering therapy using statins changes plaque composition over time. There is evidence that changes in plaque composition might explain the positive prognostic impact of statin therapy in patients with CAD. Beyond clinical endpoint studies, serial volumetric IVUS studies will become the standard to prove the efficacy of new lipid-lowering strategies in the future.