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.     

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.     

Pulmonary artery stents: Long‐term follow‐up

Objectives: Determine the long‐term outcomes of branch pulmonary artery (PA) stents. Background: PA stents in congenital heart disease effectively relieve stenoses in the short‐term. Published long‐term data are limited. Methods : Patients enrolled in an FDA IDE protocol from 1989–92 were included. Clinical follow‐up and catheterization data were evaluated. Patients were included if >5 year follow‐up data was available or if mortality occurred following the initial procedure. Results : There were five deaths: four due to progression of their underlying heart disease, and one from a complication during a follow‐up catheterization. Clinical data for 43 surviving patients demonstrated 39 patients (91%) are in NYHA class I or II. Seven patients underwent surgical intervention during the follow‐up period (five RV‐PA conduit, two Fontan revisions), but none addressed PA stenosis. Final repeat catheterizations were performed in 36 patients (55 stents) 7.2 ± 4.3 years post stent insertion with 1.2 ± 0.9 further procedures with stent dilations. In this subgroup, the minimum vessel diameter increased from 4.7 ± 1.8 to 13.4 ± 2.4 mm (P < 0.001), and the pressure gradient improved from 41 ± 25 to 9 ± 11 mm Hg (P < 0.001). Higher initial gradient and smaller balloons were associated with a final stent diameter of <14 mm (P = 0.030 and 0.046). Jailed vessels occurred in 49% of stents with abnormal angiographic flow in 18/55. Six repeat catheterizations resulted in complications, including the one procedural death. Conclusion : Stents implants for PA stenoses provide effective improvement in vessel caliber in the long‐term. Although repeat interventions are necessary, this procedure reduces RV pressure and provides an important alternative to surgery for residual PA obstruction. © 2009 Wiley‐Liss, Inc.     

Decreased risk of stent fracture‐related restenosis between paclitaxel‐eluting stents and sirolimus eluting stents: Results of long‐term follow‐up

Objective: To compare the outcomes between paclitaxel‐eluting stents (PES) and sirolimus‐eluting stents (SES) for the treatment of drug‐eluting stent (DES) fracture. Background: DES fracture is considered as an important predictor of in‐stent restenosis (ISR). However, little data are available evaluating the optimal treatment for this complication of coronary stenting. Methods: From January 1, 2004 to December 31, 2008, patients with DES ISR treated with a second DES were identified and evaluated for stent fracture. Stent fracture was defined by the presence of strut separation in multiple angiographic projections, assessed by two independent reviewers. Target lesion revascularization (TLR) at 6 and 12 months were the primary end points. Results: Of 131 lesions with DES ISR treated with a second DES, we found 24 patients (24 lesions, 18.2%) with angiographically confirmed stent fracture. Of these, 20 patients (20 lesions) treated with either PES (n = 11/55%) or SES (n = 9/45%) were included in the study. TLR at 6 months occurred in 9% of patients treated with PES and 22% of those treated with SES (P = 0.41). After 12 months, TLR was 9% and 55.5%, respectively (P = 0.024). Conclusions: This study demonstrates a high incidence of stent fracture in patients presenting with DES ISR in need of further treatment with another DES. The suggested association between treatment of stent fracture‐associated DES ISR with PES as compared with SES, and better long‐term outcomes, is in need of confirmation by larger prospective registries and randomized trials. © 2011 Wiley Periodicals, 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.

     

Sirolimus‐ versus paclitaxel‐eluting stents for coronary bifurcations intervention

Backgrounds : Relative efficacy and safety of sirolimus‐eluting stents (SES) compared with paclitaxel‐eluting stents (PES) remains controversial. It is unknown whether there are different effect and safety in coronary bifurcation treatment between SES and PES. Objectives : The meta‐analysis was performed to compare the clinical outcomes of SES and PES in coronary bifurcation intervention. Methods : Five head‐to‐head clinical trials of SES versus PES in coronary bifurcation intervention were included. A total of 2,567 patients were involved in the meta‐analysis. Mean follow‐up period ranged from 6 to 35 months. The primary end points were the need for target lesion revascularization (TLR) and main‐branch restenosis. Secondary end points were target vessel revascularization (TVR), cardiac death, major adverse cardiac events (MACE), and stent thrombosis. Results : Compared with PES, SES significantly reduced the risk of TLR (5.3% vs. 10.6%, odds ratio (OR) 0.52; 95% confidence interval (CI) = 0.38–0.70, P < 0.001), main‐branch restenosis (4.59% vs. 12.59%, OR 0.31; 95% CI = 0.18–0.55, P < 0.001) and TVR (7.05% vs. 12.57%, OR 0.58; 95% CI = 0.42–0.81, P = 0.001) in coronary bifurcation intervention. In addition, SES group also had a significantly lower incidence of MACE (8.20% vs. 14.13%, OR 0.58; 95% CI = 0.40–0.84, P = 0.004) than PES group. However, there were no statistical difference with respect to the incidence of cardiac death (1.64% vs. 1.09%, P = 0.19) and stent thrombosis (0.84% vs. 1.08%, P = 0.64) between SES and PES groups. Conclusions : Compared with PES, SES reduced the incidence of TLR, main‐branch restenosis and MACE in coronary bifurcation intervention, while the risk of stent thrombosis was similar between SES and PES groups. © 2011 Wiley Periodicals, Inc.     

Lumen‐apposing metal stents for endoscopic ultrasonography‐guided interventions

Lumen‐apposing metal stents (LAMS) are integrated in a single‐step delivery platform and can be deployed under endoscopic ultrasound‐guidance for the drainage of intra‐abdominal fluid collections, decompression of obstructed ductal systems, establishment of anastomosis or creation of fistulous tracts between organs that can facilitate further endoscopic interventions if required. A unique feature of LAMS is their ability to approximate the adjoining structures, thereby minimizing the potential for leak and perforation. Consequently, the innovation has advanced our ability to carry out complex therapeutic interventions and obviate the need for high‐risk surgical procedures, particularly in morbid patients. However, a keen awareness of the technical design of LAMS and its implication on treatment effect is important to minimize adverse events and to improve clinical outcomes. This review outlines the technical approach to placement of LAMS, procedural challenges, adverse events, current clinical indications and emerging applications.     

Four‐year clinical outcome of sirolimus‐ and paclitaxel‐eluting stents compared to bare‐metal stents for the percutaneous treatment of stable coronary artery disease

Background : There are limited data on the long‐term safety and efficacy profile of coronary stent implantation in patients with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). Objective : We aimed to assess the 4‐year clinical outcome in patients who received a bare‐metal stent (BMS), sirolimus‐eluting stent (SES), or a paclitaxel‐eluting stent (PES) for the percutaneous treatment of stable angina in our center during 2000–2005. Methods : In the study period, a total of 2,449 consecutive patients (BMS = 1,005; SES = 373; and PES = 1071) underwent a PCI as part of three historical PCI‐cohorts for stable angina and were routinely followed for the occurrence of major adverse cardiac events (MACE). Results : At 4 years follow‐up, 264 BMS patients (26.8%) had a MACE, compared to 75 SES patients (20.9%) and 199 PES patients (23.9%). Multivariate analysis showed that SES and PES were superior to BMS with respect to MACE [hazard ratio (HR) = 0.62, 95% confidence interval (CI): 0.47–0.81; HR = 0.67, 95% CI: 0.55–0.82, respectively]. The occurrence of MACE was significantly lower in the SES and PES population, primarily due to less target‐vessel revascularization (TVR) procedures (HR = 0.53, 95% CI: 0.37–0.75; HR = 0.71, 95% CI: 0.62–0.81, respectively). The occurrence of early, late, and very late stent thrombosis was equally rare with each stent type. There were no significant differences between SES and PES on death, myocardial infarction, TVR, and MACE. Conclusion : These findings suggest that SES and PES result in decreased TVR procedures and MACE compared to BMS at 4 years follow‐up. SES or PES implantation should be the preferred choice over BMS for patients with stable CAD undergoing PCI. © 2010 Wiley‐Liss, Inc.     

Comparison of long‐term outcomes of drug‐eluting stents and bare metal stents for saphenous vein graft stenosis

Objective : Our aim was to compare the long‐term outcomes between drug‐eluting stents and bare‐metal stents for saphenous vein graft stenosis. Background : The ideal type of stent to treat saphenous vein graft stenosis has not been clearly established. Short‐term randomized controlled trial results comparing drug‐eluting stents with bare‐metal stents for saphenous vein graft stenosis are conflicting, intermediate‐term retrospective studies and meta‐analyses at two years suggest no difference in outcomes, and there are no long term follow‐up studies. The need for long term follow‐up data has become emerged with concern over late stent thrombosis. Methods : 246 saphenous vein graft patients undergoing stenting from August 2002–December 2008 were studied. Overall survival and event‐free survival were compared by Kaplan‐Meier method. Hazard ratios (HR) were calculated by Cox‐proportional hazards models. Results : We treated 133 patients with DES (median follow‐up four years) and 113 patients with BMS (median follow‐up four years) for SVG stenosis. Overall survival (77.0% ± 3.9% vs. 70.6% ± 4.6%, log‐rank P = 0.60) and MACE‐free survival (57.5% ± 4.6% vs. 56.8% ± 4.9, log‐rank P = 0.70) were not significantly different between the DES and BMS groups. Although BMS was associated with increased risk of target lesion revascularization (TLR) (freedom from TLR 85.2% ± 3.5% vs. 90.0% ± 3.0%, HR 2.07, 95% CI 0.97–4.42, log‐rank P = 0.05), there was no significant difference in the freedom from myocardial infarction (86.7% ± 3.3% vs. 88.7% ± 3.2%, log‐rank P = 0.39) or target vessel revascularization (77.1% ± 4.2% vs. 76.1% ± 4.2%, log‐rank P = 0.33) between the two groups. Conclusions : Although mortality is not statistically different between DES and BMS for SVG stenosis, BMS is associated with increased risk of revascularization, thus suggesting the superiority of DES over BMS in the long term. © 2011 Wiley Periodicals, Inc.