Matthias Waliszewski

A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study.

OBJECTIVES This study sought to define the impact of paclitaxel-coated balloon angioplasty for treatment of drug-eluting stent restenosis compared with uncoated balloon angioplasty alone. BACKGROUND Drug-coated balloon angioplasty is associated with favorable results for treatment of bare-metal stent restenosis. METHODS In this prospective, single-blind, multicenter, randomized trial, the authors randomly assigned 110 patients with drug-eluting stent restenoses located in a native coronary artery to paclitaxel-coated balloon angioplasty or uncoated balloon angioplasty. Dual antiplatelet therapy was prescribed for 6 months. Angiographic follow-up was scheduled at 6 months. The primary endpoint was late lumen loss. The secondary clinical endpoint was a composite of cardiac death, myocardial infarction attributed to the target vessel, or target lesion revascularization. RESULTS There was no difference in patient baseline characteristics or procedural results. Angiographic follow-up rate was 91%. Treatment with paclitaxel-coated balloon was superior to balloon angioplasty alone with a late loss of 0.43 ± 0.61 mm versus 1.03 ± 0.77 mm (p < 0.001), respectively. Restenosis rate was significantly reduced from 58.1% to 17.2% (p < 0.001), and the composite clinical endpoint was significantly reduced from 50.0% to 16.7% (p < 0.001), respectively. CONCLUSIONS Paclitaxel-coated balloon angioplasty is superior to balloon angioplasty alone for treatment of drug-eluting stent restenosis. (PEPCAD DES-Treatment of DES-In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting PTCA Catheter [PEPCAD-DES]; NCT00998439).

Prospective ‘real world’ registry for the use of the ‘PCB only’ strategy in small vessel de novo lesions

Background This prospective registry assessed the safety and efficacy of paclitaxel coated balloon (PCB) angioplasty for small vessel coronary artery disease in Europe and Asia with the intention to treat lesions without additional stenting. The use of PCBs in small vessels seems to be associated with favourable outcomes; however, prospective data for the use of PCBs without stenting are limited. Methods The SeQuent Please Small Vessel ‘PCB only’ Registry was an international, prospective, multicentre registry enrolling patients with de novo lesions of small reference diameters (≥2.0 mm, ≤2.75 mm). The primary end point was clinically driven target lesion revascularisation (TLR) at 9 months. Secondary end points were acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) (death, myocardial infarction, or TLR), and the occurrence of definite lesion and vessel thrombosis. Results A total of 479 patients (66.1±10.9 years, 36.7% diabetics) were enrolled, 105 (23.5%) with an acute coronary syndrome, 41 (9.2%) with ST elevation myocardial infarction (STEMI), and 60 (14.8%) with non-STEMI. The initial procedural success rate was 99.0%; 27 patients (6%) needed additional bare metal stent implantation. TLR at 9.4±1.7 months occurred in 14 patients (3.6%), while three patients (0.6%) had vessel thrombosis in non-target lesions. There was no cardiac death or coronary artery bypass graft surgery. Conclusions To date, this is the largest prospective study with PCBs in small vessel de novo lesions in unselected patients. Rates of TLR and MACE were low, suggesting the use of PCBs may be an attractive alternative treatment option to drug eluting stents in small vessels.

Thin strut bare metal stents in patients with atrial fibrillation: Is there still a need for BMS?

This observational study assessed the 9‐month clinical outcomes in an « all comers » population with a focus on patients with atrial fibrillation (AF) after thin strut bare metal stenting.

Angiographic patterns of drug-eluting stent restenosis after treatment with drug-coated balloon versus balloon angioplasty: Late lumen loss subgroup analyses of the PEPCAD-DES study.

This report provides the results of additional late lumen loss (LLL) analyses the predefined subgroup of diabetics and post hoc analyses of selected lesion morphologies to further elucidate the efficacy of paclitaxel coated balloon (PCB) angioplasty (clinical trials identifier NCT00998439).

Drug coated balloon angioplasty in elderly patients with small vessel coronary disease.

Background: Coronary angioplasty in advanced age is associated with higher rate of comorbidities and complications. Drug coated balloon only angioplasty (DCBA) has emerged as an alternative to treat small vessel coronary disease (SVCD), of reference vessel diameters <2.8 mm, with shorter duration of dual antiplatelet (DAPT). This is the first study to assess the DCBA efficacy in an elderly population with SVCD. Methods and results: We performed a prospective study of 447 patients (334 patients aged <75 and 113 patients aged ⩾75 years old) acquired from the SeQuent Please Small Vessel ‘Paclitaxel-Coated Balloon Only’ registry. In the older age group, more patients have hypertension (89% versus 77%; p = 0.006), renal insufficiency (21% versus 6%; p < 0.001), atrial fibrillation (17% versus 7%; p = 0.001), and calcified lesions (33% versus 20%; p = 0.006). At 30 days, there was one myocardial infarction requiring target lesion revascularization (TLR) in the younger group. No major adverse cardiac event (MACE) was observed in the older group. At 9 months, the MACE rate in the younger group was 4.2% and 6.1% in the older group (p = 0.453), with TLR rates at 3.9% and 3.0% (p = 0.704) respectively. There was no cardiac death observed. Conclusion: DBCA in the elderly with SVCD is as safe and effective compared with younger patients despite more complex anatomy and comorbidities.

Results from the International Silver Graft Registry for high-risk patients treated with a metallic-silver impregnated vascular graft

The purpose of this postmarket surveillance registry was to document the efficacy of a vascular prosthesis coated with metallic silver in high-risk patients undergoing vascular reconstructions. Patency (primary endpoint) and freedom from graft infection (secondary endpoint) data were assessed at a minimum of 12 months in patients with significant co-morbidity and/or confirmed graft infections or infected native vessels. Between November 2006 and December 2009, 230 patients with high-risk factors underwent aortic, peripheral and/or extra-anatomic reconstructions with Silver Graft® (SG) in six German, one French and one Polish vascular center. All participating centers used the metallic silver-coated polyester graft (SG) in various diameters and lengths including tubular and bifurcate vascular grafts. Doppler ultrasound follow-ups to determine graft patency were planned at 12 months or done at an earlier time in case the patient became symptomatic. A total of 230 patients were studied. Ten of these 230 patients had graft infections at baseline whereas the remaining 220 subjects had significant risk factors such as coronary artery disease (62.7%, 138/220), vascular access in scar tissue (27.3%, 60/220), Fontaine III/IV (38.2%, 84/220), chronic renal insufficiency (26.8%, 59/220) and diabetes (21.0%, 46/220). The long-term follow-up at 15.5 ± 8.3 months revealed a secondary patency rate of 93.2% (205/220) and an ‘all cause’ mortality rate of 18.6% (41/220). There was a freedom from de novo graft infection rate of 95.9% (211/220) in the high-risk group without graft infections at baseline. One regraft infection occurred distal of the revisional reconstruction in the 10 patients with graft infection at baseline. The presence of perigraft fluid at follow-up and Fontaine III/IV at baseline were found to be predictors for graft patency whereas perigraft fluid presence was the only predictor for de novo graft infections. This registry revealed favorable patency and freedom from de novo infections rates in a ‘high-risk’ population with significant co-morbidities.

Polymer-free sirolimus-eluting stents in a large-scale all-comers population

Objective The objective of this study was to assess the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug-eluting stent (PF-SES) in an unselected patient population with a focus on acute coronary syndrome (ACS). Furthermore, stable coronary artery disease (CAD) with short (≤6 months) versus long (>6 months) dual antiplatelet therapy (DAPT) were also studied. Methods Patients who received PF-SES were investigated in an unselected large-scale international, single-armed, multicenter, ‘all comers’ observational study. The primary endpoint was the 9-month target lesion revascularisation (TLR) rate, whereas secondary endpoints included the 9-month major adverse cardiac events (MACE) and procedural success rates. A priori defined subgroups such as patients with ACS, diabetes, lesion subsets and procedural characteristics relative to DAPT were investigated. Results A total of 2877 patients of whom 1084 had ACS were treated with PF-SES (1.31±0.75 stents per patient). At 9 months, the accumulated overall TLR rate was 2.3% (58/2513). There was no significant difference between ACS and stable CAD (2.6% vs 2.1%, p=0.389). However, the overall MACE rate was 4.3% (108/2513) with a higher rate in patients with ACS when compared with the stable CAD subgroup (6.1%, 58/947 vs 3.2%, 50/1566, p<0.001). Conclusions PF-SES angioplasty is safe and effective in the daily clinical routine with low rates of TLR and MACE in an unselected patient population. Our data are in agreement with prior clinical findings that extended DAPT duration beyond 6 months do not improve clinical outcomes in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575). Trial registration number NCT02629575.

Results From the International Drug Coated Balloon Registry for the Treatment of Bifurcations. Can a Bifurcation Be Treated Without Stents

OBJECTIVES This observational study assessed the 9-month clinical outcomes in patients with coronary bifurcation lesions suitable for drug-coated balloon (DCB) angioplasty. It was the intention to use DCBs without additional stenting (DCB-only strategy) in selected patients for this chosen strategy. Bail-out main branch (MB) and/or side branch (SB) stenting, however, were permissible when flow limiting dissections or excessive recoil occurred. BACKGROUND A multitude of interventional strategies have been studied to treat bifurcation lesions. With the availability of DCB angioplasty, investigators have been using this interventional tool with the optional implantation of bare metal stents (BMS). METHODS This study is an international, prospective, multicenter registry enrolling patients with coronary bifurcation lesions including a side branch ≥2 mm in diameter. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit bifurcation lesion of any Medina classification type were recruited. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included 9-month major adverse cardiac events (death, myocardial infarction, or TLR), technical success, in-hospital outcomes and vessel thrombosis rates. RESULTS A total 127 patients 66.1 ± 10.1 years of age were enrolled. Demographic characteristics were 80.3% (102/127) male gender, 31.5% (40/127) diabetes, 91.3% (116/127) hypertension, 7.1% (9/127) ST-elevation myocardial infarction (STEMI), and 9.4% (12/127) non ST-elevation myocardial infarction (NSTEMI). The 130 lesions were treated with 184 DCBs and 64 BMS. In 53.8% (70/130) of all lesions the DCB-only strategy could be used while 34.6% (45/130) of lesions had at least 1 stent (BMS) in the main branch, 8.5% (11/130) had at least 1 stent in the side branch and 3.1% (4/130) needed at least 1 stent in the main and side branch. 94.5% patients (121/127) were available for follow-up after 9.8 ± 2.0 months. The TLR rate was 4.6% in the absence of any thrombotic events in the treated vessels whereas the 9-month MACE rate was 6.2%. CONCLUSION This observational study suggests that the DCB-only strategy is safe and effective to treat selected bifurcations while benefiting from a shortened dual antiplatelet therapy (DAPT).

Treatment of drug-eluting stents in-stent restenosis with paclitaxel-coated balloon angioplasty: Insights from the French "real-world" prospective GARO Registry

BACKGROUND Data about paclitaxel-eluting balloon (PCB) angioplasty to treat drug-eluting stents (DES) in-stent restenosis (ISR) were mainly collected in selected patient populations in the setting of randomized trials. The main goal of this prospective registry was to confirm the positive findings of these studies in an unselected population in clinical practice. METHODS Consecutive patients with DES-ISR treated by PCB angioplasty were recruited in this prospective real-world registry. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) a composite of death, myocardial infarction (MI) and TLR and the occurrence of target vessel revascularization. RESULTS A total of 206 patients (67.7 ± 10.2 years, 80.6% male, 41.3% diabetics) with 210 lesions were recruited. Unstable coronary artery disease was present in 55.3% of patients. The time from DES implantation to DES-ISR was 3.0 ± 2.4 years. Quantitative analyses revealed that patterns of treated DES-ISR were focal in 55.7% and diffuse in 44.3%. The reference diameter was 2.76 ± 0.64 mm. The 9-month follow-up rate was 90.8% (187/206). At 9 months, the TLR rate was 7.0% (13/187) whereas the rates for MACE, MI and cardiac death were 10.7% (20/187), 4.8% (9/187) and 2.1% (4/187) respectively. Results were consistent in patients with paclitaxel and non-paclitaxel-eluting stents (PES) ISR. CONCLUSION This large prospective registry demonstrated acceptable rates of TLR and MACE at 9 months after treatment of DES-ISR by PCB angioplasty. PCB angioplasty was equally effective in patients with PES-ISR and non PES-ISR.

Incidence and Predictors of reCurrent Restenosis After Drug-coated Balloon Angioplasty for Restenosis of a drUg-eluting Stent: The ICARUS Cooperation

INTRODUCTION AND OBJECTIVES The incidence and predictors of recurrent restenosis after drug-coated balloon (DCB) angioplasty for drug-eluting stent (DES) restenosis remain poorly studied. We sought to evaluate the incidence and predictors of recurrent restenosis among participants in randomized controlled trials receiving DCB angioplasty for DES restenosis. METHODS The clinical and lesion data of individuals enrolled in 6 randomized controlled trials of DCB angioplasty for DES restenosis were pooled. All patients included in this report were assigned to receive paclitaxel-coated balloon angioplasty with the SeQuent Please DCB (B Braun, Melsungen, Germany). The current analysis focused on participants with available follow-up angiography at 6 to 9 months. The incidence of recurrent restenosis, defined as diameter restenosis ≥ 50% in the in-segment area at follow-up angiography, and its clinical and angiographic predictors were evaluated. RESULTS A total of 546 patients were combined in a single dataset. Angiographic follow-up at 6 to 9 months was available for 484 patients (88.6%) with 518 treated lesions. Recurrent restenosis was detected in 101 (20.8%) patients. On multivariable analysis, lesion length (OR, 1.58; 95%CI, 1.10-2.26; P=.012 for 5mm increase) and vessel size (OR, 1.42; 95%, 1.12-1.79; P=.003 for 0.5mm reduction) were independently associated with recurrent restenosis. CONCLUSIONS In the largest cohort to date of individuals with angiographic surveillance after DCB angioplasty for DES restenosis, we demonstrated that recurrent restenosis occurs in approximately 1 out of 5 patients. Predictors of recurrent restenosis are increased lesion length and small vessel size.