Kissing drug eluting balloons for in‐stent restenosis complicating bifurcations treated with drug‐eluting stents

The management of in‐stent restenosis (ISR) complicating bifurcation lesions is technically challenging and implant of further stents may not be feasible. The use of drug‐eluting balloons provides an attractive option for treatment of such lesions allowing a technically simple procedure without the need for further complex stenting. The SeQuent Please paclitaxel‐eluting balloon (B. Braun, Berlin, Germany) has been shown to be superior to a paclitaxel eluting stent or balloon angioplasty for ISR complicating a bare‐metal stent. However, there is no data on the efficacy of the SeQuent Please in ISR complicating drug‐eluting stents or bifurcation lesions. We report two cases where the SeQuent Please was used in this setting with angiographic success and freedom from target vessel failure and angina at 24 months. In both cases the Sheathless Eau Cath guide (Asahi Intecc, Japan) was employed to perform a kissing‐balloon dilatation with the SeQuent Please, so allowing treatment via radial access. © 2012 Wiley Periodicals, Inc.     

Stent fracture associated with drug‐eluting stents: Clinical characteristics and implications

Objective : To evaluate the clinical characteristics and implications of stent fracture in drug‐eluting stents. Background : Approximately 2.5 million drug‐eluting stents are implanted every year worldwide. In 10 randomized controlled trials involving 2,602 patients, no incidence of stent fracture was recognized or reported. Methods : From April 2003 to December 2005, 2,728 patients underwent drug‐eluting stenting. The angiograms of all 530 patients who underwent repeat angiography were analyzed to identify the presence of stent fracture. We then documented the incidence of adverse events associated with drug‐eluting stent fracture and systematically analyzed the clinical, procedural, and structural factors, which might predispose to stent fracture. Results : Stent fracture was identified in 10 patients. None of these fractures were detectable at the time of stent placement. The median time interval from stent implantation to detection of fracture at repeat angiography was 226 days (range, 7–620 days). Adverse clinical outcomes associated with stent fracture occurred in 7 patients (6 patients had binary restenosis and 1 patient had stent thrombosis), all necessitating repeat intervention. Analysis of potential predisposing clinical, procedural, and structural factors revealed that 4 patients had excessive tortuosity in the proximal segment, and overlapping stents were used in 5 cases. All fractures occurred in sirolimus‐eluting stents. Conclusions : Stent fracture may represent a new potential mechanism of restenosis and stent thrombosis in drug‐eluting stents. Predisposing clinical and procedural factors may be vessel tortuosity and use of overlapping stents. The most important predisposing factor, however, may be stent structure, since all fractures occurred in sirolimus‐eluting stents. © 2006 Wiley‐Liss, Inc.     

Polymer‐free drug‐eluting stents for coronary artery disease

Polymer‐free drug‐eluting stents (PF‐DES) were designed with the expectation of avoiding late restenosis and thrombosis related to the polymer used in traditional DES platforms. Furthermore, due to similarities with bare metal stents after drug elution, PF‐DES has been considered as particularly suitable for patients at high bleeding risk. A variety of PF‐DES platforms have been clinically tested. Despite their theoretical advantages, PF platforms showed comparable clinical outcomes with modern permanent‐ or biodegradable polymer‐based DES up to 5 years after implantation. Use of more biocompatible polymers on the modern DES platforms is one of the reasons therefore. Their improved safety profile allows already less intensive antithrombotic regimes after DES. Hence, nowadays PF‐DES platforms can be considered as one of many DES options for percutaneous treatment of coronary artery disease.

     

Recalcitrant in‐stent restenosis of the celiac trunk treated by drug‐eluting stent

Stent implantation is an alternative, safe, and reliable strategy for the treatment of chronic mesenteric ischemia, especially for patients at high surgical risk. However, in‐stent restenosis (the Achille's hill of bare metal stent) may occur in up to 20% of cases at 6 months and 53% at 1 year. We describe a case of celiac trunk stenosis treated by bare metal stent complicated by recalcitrant in‐stent restenosis and treated by paclitaxel‐eluting stent implantation. © 2008 Wiley‐Liss, Inc.     

Aneurysm formation after drug‐eluting balloon treatment of drug‐eluting in‐stent restenosis: First case report

A 55‐year‐old male underwent paclitaxel‐eluting stent implantation in a bifurcation lesion of his left anterior descending artery (LAD) during an episode of unstable angina in 2008. A late in‐stent restenosis developed 15 months after implantation of the drug‐eluting stent (DES) and was treated with paclitaxel eluting balloon. Two months later, during angiography for functional assessment of the significance of lesions in the circumflex artery, an aneurysm at the place of drug‐eluting balloon (DEB) inflation was observed. The patient was left on double antiplatelet therapy and scheduled for clinical observation after 3 months and control coronary angiography after 6 months for aneurysm progression follow‐up. © 2012 Wiley Periodicals, Inc.     

Successful revascularization of re‐stenosis of lower extremity arteries with localized delivery of paclitaxel

Restenosis after percutaneous revascularization techniques is a challenging issue in patients with severe peripheral arterial disease. We report two cases where multiple revascularization techniques had been used previously, but restenosis occurred. We used an irrigation balloon to deliver paclitaxel locally into the tissues to obtain better results. © 2008 Wiley‐Liss, Inc.     

Safety and efficacy of drug‐eluting balloons in percutaneous treatment of bifurcation lesions the DEBIUT (drug‐eluting balloon in bifurcaton utrecht) registry

Aims: The transradial (TR) approach has potentially lower complication rates than transfemoral (TF) approach coronary angiography. However, it may be technically more challenging, especially in elderly patients with alterations in vascular anatomy. We thus determined success rates, procedural data, and complication rates of TR angiography in comparison to the TF approach in elderly patients in a randomized, prospective trial. Methods and results: Four hundred consecutive patients ≥75 years with known or suspected coronary artery disease were included in the study. After exclusion of 93 patients with contraindications to the radial approach, 152 patients were randomized to the TR and 155 to TF coronary angiography and intervention. In 13 patients randomized to TR, cross‐over to TF was necessary (9%). Total examination time was significantly longer for the TR approach (18.1 vs. 15.0 min, P = 0.009), but no difference was found for fluoroscopy time, number of catheters used, or amount of contrast agent. The rate of major complications (bleeding requiring surgery or transfusion, stroke) was 0% for TR and 3.2% for TF approach (P < 0.001). Minor complications occurred in 1.3% versus 5.8% of patients (P < 0.001). Conclusion: In elderly patients, TR coronary angiography and intervention has a high technical success rate and lower complication rates than the TF approach. © 2008 Wiley‐Liss, Inc.     

Intravascular ultrasound optimization of drug‐eluting stents: Still not enough data

One of the mechanisms of technical failure in the treatment of tibial artery occlusive disease includes an inability to re‐enter the true lumen of the tibial vessel distal to the occlusion following tracking of the interventional wire into the subintimal space. We report the first case using a coronary 0.014″ re‐entry system (Stingray? Chronic Total Occlusions Re‐entry System, BridgePoint Medical) in the treatment of a complex tibial artery occlusion where the antegrade approach initially failed due to this mechanism. The re‐entry system allowed completion of antegrade recanalization of the occlusion and represents an important addition to the interventional armamentarium for the treatment of complex tibial artery disease. © 2010 Wiley‐Liss, Inc.     

Drug‐eluting stents versus bare‐metal stents for treatment of bare‐metal in‐stent restenosis

Objectives : We compared the long‐term outcomes of drug‐eluting stents (DES) versus bare‐metal stents (BMS) for treatment of bare‐metal in‐stent restenosis (ISR). Background : There are no randomized trials or observational studies directly comparing the safety and efficacy of DES versus BMS for treatment of bare‐metal ISR. Methods : We examined data on all patients who underwent percutaneous coronary intervention (PCI) for ISR at Cleveland Clinic between 05/1999 and 06/2007. We compared the efficacy and safety of DES to BMS for treating bare‐metal ISR. The primary end point was a composite of death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were individual components of the primary endpoint. Results : Of the 931 patients identified over 8 years, 706 had bare‐metal ISR and met our study criteria. Of the 706 patients with bare‐metal ISR, 362 were treated with DES and 344 with BMS. There were 230 cumulative events for a median follow‐up of 3.2 years. After adjusting for 27 variables, DES were associated with lower primary endpoint compared to BMS for treatment of bare‐metal ISR (21% vs. 45%, adjusted hazard ratio [HR] 0.63; 95% confidence interval [CI], 0.42–0.95; P = 0.03). The individual secondary endpoint of death (8% vs. 24%, P = 0.005) favored DES, but MI (3% vs. 8%, P = 0.31), and TLR (13% vs. 20%, P = 0.23) failed to reach statistical significance. Conclusions : In our multivariate analysis of patients with bare‐metal ISR, DES use was associated with significantly lower death, MI, or TLR when compared to BMS. © 2010 Wiley‐Liss, Inc.     

Treatment of drug‐eluting stent restenosis: An emerging challenge

Drug eluting stent (DES) restenosis has emerged as a significant clinical entity owing to the increasing use of DES in complex lesions and patients. However, to date, there is a paucity of studies that have addressed the management of DES restenosis and the resulting outcome, leaving the interventional cardiologist with a therapeutic dilemma. The purpose of this paper is therefore to provide a consise review of available data's dealing with the treatment of DES restenosis, including the outcome of patients treated for DES restenosis, the prognostic importance of the angiographic pattern and the available therapeutic modalities. © 2009 Wiley‐Liss, Inc.     

An evidence‐based approach to the use of rotational and directional coronary atherectomy in the era of drug‐eluting stents: When does it make sense?

Advances in percutaneous interventions have profoundly changed the way we manage patients with coronary and peripheral arterial disease. Though the use of stents, particularly drug‐eluting stents, is the preferred method for revascularization because of ease of use and lower restenosis rates, there are many short comings. Ostial and bifurcation lesions as well as heavily calcified and tortuous arteries remain problematic. Mechanical debulking with rotational and direct coronary atherectomy may be beneficial in these situations. In this review, we present the general concepts of mechanical debulking and attempt to summarize the available data on its use in the setting of drug‐eluting stents. In addition, we will discuss its special role in the management of peripheral arterial disease. © 2008 Wiley‐Liss, Inc.     

Outcomes of diabetics receiving bare‐metal stents versus drug‐eluting stents

Objectives : We sought to determine if differences existed in in‐hospital outcomes, long‐term rates of target vessel revascularization (TVR), and/or long‐term mortality trends between patients with diabetes mellitus undergoing percutaneous coronary intervention (PCI) with either a drug‐eluting stent(s) (DES) or a bare metal stent(s) (BMS). Background : Short‐ and long‐term clinical outcomes of patients with diabetes mellitus undergoing PCI with DES versus BMS remain inconsistent between randomized‐controlled trials (RCTs) and observational studies. Methods : Data were collected prospectively on diabetics undergoing PCI with either DES or BMS from January 2000 to June 2008. Demographic information, medical histories, in‐hospital outcomes, and long‐term TVR and mortality trends were obtained for all patients. Results : A total of 1,319 patients were included in the study. Diabetics receiving DES had a significant reduction in index admission MACE compared to diabetics receiving BMS. Using multivariable adjustment, after a mean follow‐up of 2.5 years (maximum 5 years), diabetics who received DES had a 38% decreased risk of TVR compared to diabetics with BMS [HR 0.62 (95% CI: 0.43–0.90)]; diabetics with DES had an insignificant adjusted improvement in long‐term survival compared to diabetics with BMS [HR 0.72 (95% CI: 0.52–1.00)]. These long‐term survival and TVR rates were confirmed using propensity scoring. Conclusions : The use of DES when compared with BMS among diabetics undergoing PCI is associated with significant improvement in long‐term TVR, with an insignificant similar trend in all‐cause mortality. The long‐term results of this observational study are consistent with prior RCTs after adjusting for confounding variables. © 2010 Wiley‐Liss, Inc.