Metal Stent Group Research Articles

Clinical Outcomes, and Long-Term Stent Patency in Patients with Malignant Biliary Obstruction: A Systematic Review and Meta-Analysis

Purpose: Endoscopic biliary drainage for malignant obstructive jaundice is a viable alternative, but its exact role and the clinical outcomes of the various available stents are subject to debate. The objective of this study was to review the literature with regard to the clinical outcomes, patency rates, and quality of life in patients requiring endoscopic palliation for malignant obstructive jaundice. Methods: Using PubMed, Medline, Embase, Current Contents, and the Cochrane Database of Systematic Reviews databases, a literature search was performed for papers published from January 1990 to December 2006. All retrieved papers comparing plastic with metallic stents for palliative biliary decompression, were rated according to the strength of evidence and analyzed. Results: A total of 566 patients were included in our analysis. 273 (48%) patients had plastic stents, and 293 (52%) had metallic stents. The age of the patients was 21–96 years, with a median age of 72.50 years. The median age for the plastic stent group was 73.01 years (36–96), and that of the metallic stent group was 72.09 years (21–94), which was not statistically significant (P= 0.84). The median time of stent patency was 187.7 days for the metal stents, and 95.1 days for the plastic stents, (P < 0.002). While the quality of life was better for all of the patients undergoing palliative endoscopic drainage, there was no evidence of a difference in the technical success, or complication rates between the two groups. However, the median patient survival was statically higher (P < 0.001) in the metal stents group than the plastic stents group (243 vs. 190 days). Conclusion: Palliative endoscopic drainage affords improved quality of life. With better patency rate and improved survival, clinicians should consider using a metal stent as the prefered option in the management of malignant biliary strictures.[figure1][figure2]FigureFigure

Sirolimus-Eluting versus Bare Stents after Suboptimal Infrapopliteal Angioplasty for Critical Limb Ischemia: Enduring 1-Year Angiographic and Clinical Benefit

To report the 1-year angiographic and clinical outcome from a prospective single-center study investigating the infrapopliteal application of sirolimus-eluting versus bare metal stents in patients with critical limb ischemia (CLI) who underwent below-the-knee endovascular revascularization. Stenting was performed as a bailout procedure for suboptimal angioplasty results (flow-limiting dissection, elastic recoil, or postangioplasty residual stenosis >30%). In the first 29 patients, infrapopliteal stenting was performed with bare metal stents (group B) and with sirolimus-eluting stents in the other 29 patients (group S). Below-the-knee angioplasty and stenting involved 65 lesions in 40 infrapopliteal arteries of 29 limbs in group B and 66 lesions in 41 infrapopliteal arteries of 29 limbs in group S. Baseline comorbidities (hyperlipidemia and symptomatic cardiac and carotid disease) were more pronounced in group S (p<0.05). At 6 months, sirolimus-eluting stents demonstrated significantly higher primary patency (OR 5.625, 95% CI 1.711 to 18.493, p = 0.004) and decreased in-stent binary restenosis (OR 0.067, 95% CI 0.021 to 0.017, p<0.001) and in-segment binary restenosis (OR 0.229, 95% CI 0.099 to 0.533, p = 0.001). After 1 year, sirolimus-eluting stents were steadily associated with increased primary patency (OR 10.401, 95% CI 3.425 to 31.589, p<0.001) and significantly less in-stent (OR 0.156, 95% CI 0.060 to 0.407, p<0.001) and in-segment (OR 0.089, 95% CI 0.023 to 0.349, p = 0.001) binary restenosis. In addition, sirolimus-eluting stents were associated with significantly fewer cumulative target lesion reinterventions at 6 months (OR 0.057, 95% CI 0.008 to 0.426, p = 0.005) and 1 year (OR 0.238, 95% CI 0.067 to 0.841, p = 0.026). No significant differences between groups B and S were noted at 1 year with respect to mortality (10.3% versus 13.8%, respectively), minor amputation (17.2% versus 10.3%), or limb salvage (100% versus 96%). The application of sirolimus-eluting stents reduces the restenosis rate in the infrapopliteal arteries and the rate of repeat endovascular procedures the first year after treatment.

Transgastric endoscopic ultrasonography-guided biliary drainage: results of a pilot study

Endoscopic retrograde cholangiopancreatography (ERCP) access to the biliary tract is sometimes impossible and percutaneous access has the disadvantages of increased morbidity and patient discomfort. We present our first results with an alternative technique: endoscopic ultrasonography (EUS)-guided transgastric biliary drainage. 11 patients (7 men, mean age 64 years) were referred for failed ERCP and biliary obstruction (malignancy n = 8, benign conditions n = 3). The retrograde approach via the papilla had been impossible due to surgical anatomy, duodenal stenosis, and hilar stricture with occlusion of the left side. EUS-guided drainage was done with endoscopic and fluoroscopic monitoring. After puncture of the left biliary duct a guide wire was inserted into it followed by tract dilation using a cystostome. A plastic or a metallic stent was placed through this gastrobiliary fistula for bile drainage. EUS-guided left hepaticogastrostomy was successfully performed in 10/11 cases, with one failure of guide wire insertion after puncture. Plastic and covered metal stents were inserted in seven and three patients, respectively. Complications in the plastic stent group included one early occlusion requiring stent replacement, and one transient ileus. In the metallic stent group there was one bilioma and one cholangitis, due to stent shortening. Clinically, the stent was efficacious in all 10 cases; during a mean follow-up of 213 days (range 3-610), two patients presented with stent occlusion and one with stent migration, with successful endoscopic treatment in all. EUS-guided hepaticogastrostomy is an efficient technique and could be a future alternative to percutaneous biliary drainage or palliative surgical drainage.

A Comparison of Event Rates for Patients Receiving Sirolimus Drug-Eluting vs. Bare Metal Stents

Background: Two types of stents are used to revascularize occluded coronary arteries. Bare metal stents prevent elastic recoil and negative remodeling of the vessel wall following balloon catheter stretch. Drug-eluting stents release medications that prevent the development of neointimal hyperplasia. Drug-eluting stents, however, have been purported to increase the risk of acute stent thrombosis, potentially placing patients at higher risk for major adverse cardiac events in the 12 months following stent implementation. Objective: To determine whether patients receiving a drug-eluting stent experienced a higher rate of major adverse cardiac events at one year after stent placement than did patients who received a bare metal stent, and to determine the impact of antiplatelet therapy on major adverse cardiac event rates. Methods: We conducted a retrospective chart review of patients receiving either a sirolimus-eluting or bare metal stent at the Veterans Affairs North Texas Health Care System between July and December 2003. Results: Sixty-eight patients were included in the study. There was one episode of acute stent thrombosis and no statistically significant difference in major adverse cardiac event rates at 1 year after stent placement between the groups. Clopidogrel therapy was originally prescribed for an average of 3.9 months in the drug-eluting stent group and 1 month in the bare metal stent group. The actual duration of clopidogrel therapy differed significantly from the original prescribed duration for both groups, mainly due to renewal of clopidogrel prescriptions by noncardiology practitioners. Conclusions: Patients who received a sirolimus-eluting stent did not experience an increase in major adverse cardiac events compared with patients receiving a bare metal stent.

Cholecystitis After Metallic Stent Placement in Patients With Malignant Distal Biliary Obstruction

Cholecystitis after metallic stent (MS) placement is an issue requiring attention. From our experience, cholecystitis seemed to occur mainly in patients with tumor involvement to the cystic duct orifice. The aim of the present study was to identify risk factors for cholecystitis in patients treated with covered or uncovered MS. We analyzed 246 patients who received MS placement (covered MS in 171 and uncovered in 75) between August 1997 and May 2005 for the treatment of unresectable distal malignant biliary obstruction. Causative diseases were as follows: pancreatic cancer in 162, papillary cancer in 10, bile duct cancer in 41, and metastatic nodes in 33 patients. Tumor involvement to orifice of the cystic duct (OCD) was diagnosed based on cholangiography and intraductal ultrasonography. Cholecystitis after MS placement was found in 13 patients (5.3%). There was no significant difference in the incidence of cholecystitis between covered (5.8%) and uncovered (4.0%) MS. By univariate analysis, tumor involvement of the OCD, MS placed above the papilla, and stricture located at midportion were associated significantly with cholecystitis. By multivariate analysis, only tumor involvement of the OCD was a risk factor, with an odds ratio of 47.206 (95% confidence interval, 5.84-381.60). Cholecystitis after MS placement is associated with tumor involvement to the orifice of the cystic duct, regardless of the type of stent.

Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II)

Sirolimus-eluting stents markedly reduce the risk of restenosis compared with bare metal stents. However, it is not known whether there are differences in effectiveness between bare metal and sirolimus-eluting stents in patients with total coronary occlusions. In a prospective, randomized, single-blind, 2-center trial, we enrolled 200 patients with total coronary occlusions: Half (n = 100) were randomly assigned to receive bare metal BxVelocity stents and half (n = 100) to receive sirolimus-eluting Cypher stents. The primary end point was angiographic binary in-segment restenosis rate at 6-month follow-up. Secondary end points were a composite of major adverse cardiac events, target vessel failure, binary in-stent restenosis rate, in-stent and in-segment minimal lumen diameter, percent diameter stenosis, and late luminal loss at 6-month follow-up. The sirolimus stent group showed a significantly lower in-stent binary restenosis rate of 7% compared with 36% in the bare metal stent group (P < 0.001). The in-segment binary restenosis rate was 11% in the group receiving a sirolimus stent versus 41% in the bare metal stent group (P < 0.0001), resulting in a target lesion revascularization rate of 4% in the sirolimus group versus 19% in the bare metal group (P < 0.001). Patients who received the drug-eluting stent also had significantly lower rates of target vessel revascularization, target vessel failure, and all major adverse cardiac events. In patients with total coronary occlusions, use of the sirolimus-eluting stents are superior to the bare metal stents with significant reduction in angiographic binary restenosis, resulting in significantly less need for target lesion and target vessel revascularization.

Comparison of sirolimus-eluting vs. bare-metal stents for the treatment of infrapopliteal obstructions.

Drug-eluting stents have been shown to be very effective in the treatment of coronary artery disease. In this independent, single-centre registry we assess the safety and efficacy of the sirolimus-eluting stent versus bare-metal balloon expandable stent for symptomatic infrapopliteal obstructions. A total of 60 consecutive patients with infrapopliteal arterial obstructions were treated by stent implantation into the tibial and peroneal arteries and the data was entered into a prospective registry. All patients were treated with balloon-expandable coronary stents with a stent length of 33 mm and a nominal diameter of 3.5 mm. Enrolment was limited to patients treatable with a single stent. 30 patients (56.7% male, mean age 71.4 years, 83.3% diabetics) received a sirolimus-eluting balloon-expandable stent. 30 patients (63.3% male, mean age 73.0 years, 76.6% diabetics) were treated with uncoated bare-metal stents. At follow-up, the cumulative rates of Major Adverse Events were 10.0% vs. 46.6%. The rates of major amputation, bypass surgery or Target Lesion Revascularisation (TLR) were all zero for the sirolimus group compared with 10.0%, 0% and 23.3% in the bare metal stent group. There were 7 deaths (sirolimus =3, bare metal =7). Angiographic follow-up comparing sirolimus vs. bare metal revealed stent occlusion 0% vs. 17.4%, restenosis >50% of 0% vs. 39.1% (p 0.0007) and mean degree of in-stent restenosis of 1.8+/-4.8% vs. 53+/-40.9% (p <0.0001) respectively. In this registry sirolimus-eluting stents were shown to be safe and effective in the treatment of focal infrapopliteal obstructions.

A Novel Drug-Eluting Stent Coated With an Integrin-Binding Cyclic Arg-Gly-Asp Peptide Inhibits Neointimal Hyperplasia by Recruiting Endothelial Progenitor Cells

Novel stents loaded with an integrin-binding cyclic Arg-Gly-Asp peptide (cRGD) were analyzed for their potential to limit coronary neointima formation and to accelerate endothelialization by attracting endothelial progenitor cells (EPCs). Re-endothelialization is important for healing after arterial injury. Effects of cRGD on EPC number, recruitment in flow, and invasion were analyzed in vitro. A durable polymer coating containing 67 microg cRGD per stent was developed for Guidant Tetra stents. Twelve cRGD-loaded polymer, 12 unloaded polymer, and 12 bare metal stents were deployed in porcine coronary arteries. Quantification of cRGD in peri-stent tissue was established by high-performance liquid chromatography (HPLC) and mass spectrometry (MS). Histomorphometry and immunostaining were performed after 4 and 12 weeks. Recruitment of labeled porcine EPCs was assessed 7 days after intracoronary infusion. The cRGD clearly supported the outgrowth, recruitment, and migration of EPCs in vitro. At 4 weeks, there was no difference for mean neointimal area and percent area stenosis in the cRGD-loaded, polymer, or bare metal stent group. At 12 weeks, neointimal area (2.2 +/- 0.3 mm2) and percent area stenosis (33 +/- 5%) were significantly reduced compared with polymer stents (3.8 +/- 0.4 mm2, 54 +/- 6%; p = 0.010) or bare metal stents (3.8 +/- 0.3 mm2, 53 +/- 3%; p < 0.001). The HPLC/MS confirmed cRGD tissue levels of 1 to 3 mug/stent at 4 weeks, whereas cRGD was not detectable at 12 weeks. Staining for CD34 and scanning electron microscopy indicated enhanced endothelial coverage on cRGD-loaded stents at 4 weeks associated with a significant increase in the early recruitment of infused EPCs. Stent coating with cRGD may be useful for reducing in-stent restenosis by accelerating endothelialization.

C-Reactive Protein, Clinical Outcome, and Restenosis Rates After Implantation of Different Drug-Eluting Stents

Sirolimus-eluting stents (SESs), paclitaxel-eluting stents (PESs), and dexamethasone-eluting stents (DEXs) have anti-inflammatory properties; thus, the decreased in-segment restenosis rate observed with the use of these stents might be related to a weaker postprocedural inflammatory response. One hundred sixty consecutive patients with stable coronary artery disease who underwent successful single-vessel/lesion coronary artery stenting were prospectively studied. Thin-strut bare metal stents were deployed in 39 patients, SESs in 30, PESs in 61, and DEXs in 30. The 4 groups were similar with respect to demographic and angiographic variables and prevalence of risk factors. C-reactive protein (CRP) was measured at baseline and 24 and 48 hours after the procedure. Maximal increase in CRP was calculated as the increase in CRP at 48 hours/CRP compared with baseline. Angiographic follow-up was performed after 12.9 +/- 1.3 months or sooner, if needed, on the basis of clinical evidence. All patients presented a postprocedural increase in CRP that peaked at 48 hours (median 10.0 mg/L). Maximal CRP increase was similar across the 4 groups (medians 3.5 mg/L in the bare metal stent group, 3.6 mg/L in the SES group, 4.0 mg/L in the PES group, 3.5 mg/L in the DEX group, p = 0.45). Incidences of angiographic binary restenosis (>50% lumen diameter decrease) were 20.5% in the bare metal stent group, 3.3% in the SES group, 4.9% in the PES group, and 36.6% in the DEX group (p = 0.0004 for SES and PES groups vs bare metal stent and DEX groups). Postprocedural increase in CRP was significantly correlated with clinical and angiographic outcomes. In conclusion, the acute postprocedural systemic inflammatory response induced by drug-eluting stent implantation appears to be similar to that induced by bare metal stents. However, the restenosis rate is lower for SESs and PESs than for DEXs and bare metal stents. Thus, the decreased incidence of stent restenosis that was observed after SES and PES deployment is unlikely to be related to a decreased acute systemic inflammatory response, but rather to an increased local resistance to inflammatory mediators.

ENDOSCOPIC STENT DRAINAGE FOR MALIGNANT BILIARY OBSTRUCTION: THE KOREAN EXPERIENCE

Endoscopic biliary drainage (EBD) is the treatment of choice for biliary obstruction caused by unresectable pancreaticobiliary malignancies. Clogging is an unsolved problem of the plastic stent. A self‐expanding metal stent (SEMS) was developed to overcome this limitation. Total resource utilization was reported to be lower with SEMS compared with plastic stents in the West. However, in Korea, the average total cost is estimated to be higher in the metal stent group. The use of SEMS should be indicated if the survival is expected to be more than 3 months. Covered SEMS was introduced to overcome the problem of tumor ingrowth into the uncovered stent. Patency rates for covered SEMS tended to be greater than uncovered SEMS, but the complication rate in covered SEMS was higher than uncovered SEMS due to migration, occlusion of the cystic duct, of a contralateral hepatic duct, or of pancreatic duct. Stents without clogging or migration, with antitumor or biodegradable properties are being investigated. For unresectable hilar cholangiocarcinoma (HC) of Bismuth type III or IV, unilateral percutaneous transhepatic biliary drainage (PTBD) and subsequent internal stent causes less cholangitis and longer patency than EBD or PTBD alone. However, the result with EBD is good if the Bismuth type of biliary obstruction is I or II. Photodynamic therapy may improve survival of patients with unresectable cholangiocarcinoma. Preoperative biliary drainage is not usually necessary except for HC. Procedure‐related complication and inflammation of the operative field resulting from endoscopic nasobiliary drainage or endoscopic retrograde biliary drainage are expected to cause surgical difficulties and to affect postoperative complications.

Sirolimus-Eluting Versus Bare Stents for Bailout After Suboptimal Infrapopliteal Angioplasty for Critical Limb Ischemia: 6-Month Angiographic Results From a Nonrandomized Prospective Single-Center Study

To report the 6-month angiographic results from a prospective single-center study investigating the efficacy and outcome of sirolimus-eluting stents used for bailout after infrapopliteal revascularization of patients with critical limb ischemia (CLI). Twenty-nine patients (21 men; mean age 68.7 years) underwent infrapopliteal revascularization with bare metal stents (group B) implanted for bailout in 65 lesions (38 stenoses and 27 occlusions) in 40 infrapopliteal arteries. Another 29 patients (21 men; mean age 68.8 years) underwent infrapopliteal bailout stenting with sirolimus-eluting stents (group S) in 66 lesions (46 stenoses and 20 occlusions) in 41 vessels. Preliminary 6-month angiographic and clinical results were analyzed. Hyperlipidemia and symptomatic cardiac and carotid diseases were more pronounced in group S (p<0.05). Technical success was 96.6% (28/29 limbs) in group B versus 100.0% in group S (p=0.16). Six-month primary patency was 68.1% in group B versus 92.0% in group S (p<0.002). Binary in-stent and in-segment restenosis rates were 55.3% and 66.0%, respectively, in patients with bare stents versus 4.0% and 32.0%, respectively, in patients treated with the sirolimus-eluting stents (both p<0.001). The target lesion re-intervention rate at 6 months was 17.0% in group B versus 4.0% in group S (p=0.02). Limb salvage was 100% in both groups. Six-month mortality and minor amputation rates were 6.9% and 17.2%, respectively, in group B versus 10.3% and 3.4%, respectively, in group S (p=0.32 and p=0.04, respectively). Sirolimus-eluting stents seem to restrict neointimal hyperplasia in the infrapopliteal vascular bed.

Time course of release of inflammatory markers after coronary stenting: comparison between bare metal stent and sirolimus-eluting stent

High levels of release of inflammatory markers after coronary angioplasty are predictors of late restenosis. Sirolimus-eluting stent reduces the risk of restenosis. To compare the release of inflammatory markers after coronary angioplasty with sirolimus-eluting stent and bare metal stent. Sixteen patients with a proximal left anterior descending coronery artery stenosis were randomly assigned to receive either bare metal stent (n = 8) or sirolimus-eluting stent (n = 8). We measured simultaneously aortic and coronary sinus concentrations of the von Willebrand factor antigen, tumor necrosis factor-alpha and interleukin-6 before, immediately and after 2 h after stenting. High-sensitivity C-reactive protein and troponin-I circulating levels were measured before and 6 and 24 h after coronary angioplasty. Before stenting, all values were similar in both groups. The coronary sinus change of the von Willebrand factor antigen level between baseline and 2 h after stenting was + 20.1 +/- 26.9% in the bare metal stent group and -5.7 +/- 23.02% in the sirolimus-eluting stent group (P < 0.05). We observed a significant increase in the von Willebrand factor antigen (from 132.8+/-58.8 to 169 +/- 40.7%, P < 0.05) systemic concentrations 24 h after stenting in the bare metal stent group but not in the sirolimus-eluting stent group (from 140.6+/-84% to 136 +/- 39.5%), P = NS). The present study shows that a difference in the release of inflammatory markers can be detected after coronary stenting with bare metal stent or sirolimus-eluting stent. The lower release of the von Willebrand factor antigen in the coronary sinus 2 h after the procedure and the lower systemic concentrations of the von Willebrand factor antigen 24 h after stenting in the sirolimus-eluting stent group are likely to reflect a reduced production of the von Willebrand factor antigen at the site of the vascular injury.

Intravascular Ultrasound Characterization of the “Black Hole” Phenomenon After Drug-Eluting Stent Implantation

An intraluminal echolucent tissue, dubbed "black hole," has been identified by intravascular ultrasonography after intracoronary brachytherapy. This study reports the characteristics and incidence of the black hole in patients treated with drug-eluting stent implantation using a sirolimus-eluting stent (SES). We included intravascular ultrasound data from the Compassionate Use of Sirolimus-Eluting Stent (SECURE, n = 61 lesions) registry, a study involving patients in whom previous brachytherapy had failed, and the DIABETES trial (n = 165 lesions), a multicenter, randomized study comparing SES versus bare metal stents in diabetic patients. Intravascular ultrasound follow-up was scheduled at 8 months (SECURE trial, post-brachytherapy population) and 9 months (DIABETES trial). In the SECURE population, a black hole was observed in 10 patients (19.6%). Seven black hole segments had significant intimal hyperplasia (> 10%). A black hole accounted for 27% of total intraluminal tissue. In the DIABETES trial, 2 patients (2.5%) in the SES group and none in the bare metal stent group showed echolucent intimal hyperplasia. In conclusion, a black hole occurred frequently after implantation of a SES in patients in whom intracoronary brachytherapy had previously failed. Black holes were also identified in a nonirradiated population, although the incidence was lower than in the post-brachytherapy patients. Bare metal stents were not associated with this phenomenon.

Pancreaticoduodenectomy After Placement of Endobiliary Metal Stents

Contemporary treatment programs for patients with potentially resectable pancreatic cancer often involve preoperative therapy. When the duration of preoperative therapy exceeds 2 months, the risk of plastic endobiliary stent occlusion increases. Metal stents have much better patency but may complicate subsequent pancreaticoduodenectomy (PD). We evaluated rates of perioperative morbidity, mortality, and stent complications in 272 consecutive patients who underwent PD at our institution from May 2001 to November 2004. Of these 272 patients, 29 (11%) underwent PD after placement of a metal stent, 141 underwent PD after placement of a plastic stent, 10 had PD after biliary bypass without stenting, and 92 had PD without any form of biliary decompression. No differences were found between the Metal Stent group and all other patients in median operative time, intraoperative blood loss, or length of hospital stay. No perioperative deaths occurred in the Metal Stent group versus 3 (1.2%) deaths in the other 243 patients. The incidence of major perioperative complications was similar between the two groups, including the rates of pancreatic fistula, intra-abdominal abscess, and wound infection. Furthermore, there were no differences in the perioperative morbidity or mortality rates between patients who underwent preoperative biliary decompression with a stent of any kind (metal or plastic) and those patients who underwent no biliary decompression at all. Metal stent-related complications occurred in 2 (7%) of 29 patients during a median preoperative interval of 4.1 months; in contrast, 75 (45%) of the 166 patients who had had plastic stents experienced complications, including 98 stent occlusions, during a median preoperative interval of 3.9 months (P < 0.001). We conclude that the use of expandable metal stents does not increase PD-associated perioperative morbidity or mortality, and as such an expandable metal stent is our preferred method of biliary decompression in patients with symptomatic malignant distal bile duct obstruction in whom surgery is not anticipated, or in whom there is a significant delay in the time to surgery.

Self-Expanding Metal Stents Versus Plastic Prostheses in the Palliation of Malignant Dysphagia

Malignant dysphagia due to esophagogastric cancer is associated with poor overall prognosis. Placements of self-expandable metal stents or plastic tubes are established methods as palliative treatment options. As an alternative and/or complementary therapy, radiologic techniques (external beam radiation/brachytherapy) and locally endoscopic techniques (laser, APC-beamer, PDT) are often used. STUDY AND GOALS: Retrospective trial of 153 patients treated in our department between 1993 and 2001. Forty-five patients received a plastic tube (Group A) and 108 patients were treated with metal stents (Group B). Both groups were compared for improvement of dysphagia score, survival, recurrent dysphagia and complications. Stent placement was successful in 41 of 45 (93%) patients of Group A and 107 of 108 (99%) of Group B. The median dysphagia score improved significantly in Group A (from 3.03 to 1.55, P = 0.010) and Group B (from 2.77 to 1.44, P = 0.009). Recurrent dysphagia was noted in 12 of 45 (27%) patients of Group A and 27 of 108 (25%) patients of Group B. Median survival time after stent insertion was 78 days (Group A) and 113 days (Group B). Overall complications occurred in 15 of 45 (33%) patients of Group A and 28 of 108 (26%) patients of Group B. However, significantly (P = 0.05) more major complications were seen in Group A than in Group B (22% vs. 9%). Our results indicate a marginal clinical benefit for metal stents versus plastic tubes in malignant dysphagia in the long run. However, metal stents seem to be safer and associated with a prolonged improvement of dysphagia score.

Comparison of a Polymer-Based Paclitaxel-Eluting Stent With a Bare Metal Stent in Patients With Complex Coronary Artery Disease

Compared with bare metal stents, drug-eluting stents reduce restenosis in noncomplex lesions. The utility of drug-eluting stents has not been evaluated in more difficult stenoses. To investigate the safety and efficacy of the polymer-based, slow-release paclitaxel-eluting stent in a patient population with more complex lesions than previously studied. Prospective, placebo-controlled, double-blind, multicenter randomized trial conducted from February 2003 to March 2004 at 66 academic and community-based institutions with 1156 patients who underwent stent implantation in a single coronary artery stenosis (vessel diameter, 2.25-4.0 mm; lesion length, 10-46 mm), including 664 patients (57.4%) with complex or previously unstudied lesions (requiring 2.25-mm, 4.0-mm, and/or multiple stents) and 9-month clinical and angiographic follow-up. Patients were randomly assigned to receive 1 or more bare metal stents (n = 579) or identical-appearing paclitaxel-eluting stents (n = 577). Ischemia-driven target vessel revascularization at 9 months. Baseline characteristics were well matched. Diabetes was present in 31% of patients. The mean (SD) reference vessel diameter was 2.69 (0.57) mm, the reference lesion length was 17.2 (9.2) mm, and 78% of lesions were type B2/C. A mean (SD) of 1.38 (0.58) stents (total mean [SD] length, 28.4 [13.1] mm) were implanted per lesion; 33% of lesions required multiple stents. Stents that were 2.25 mm and 4.0 mm in diameter were used in 18% and 17% of lesions, respectively. Compared with bare metal stents, paclitaxel-eluting stents reduced the 9-month rate of target lesion revascularization from 15.7% to 8.6% (P<.001) and target vessel revascularization from 17.3% to 12.1% (P = .02). Similar rates were observed for cardiac death or myocardial infarction (5.5% for bare metal stent group vs 5.7% for paclitaxel-eluting stent group) and stent thrombosis (0.7% in both groups). Angiographic restenosis was reduced from 33.9% to 18.9% in the entire study cohort (P<.001), including among patients receiving 2.25-mm stents (49.4% vs 31.2%; P = .01), 4.0-mm stents (14.4% vs 3.5%; P = .02), and multiple stents (57.8% vs 27.2%; P<.001). Compared with a bare metal stent, implantation of the paclitaxel-eluting stent in a patient population with complex lesions effectively reduces clinical and angiographic restenosis.

Utilization of Drug-Eluting Stents in the Veterans Health Administration

Little is known about how drug-eluting stents (DESs) are used and perform in everyday clinical practice. This report identifies factors associated with the use of DESs in the Veterans Health Administration and compares mortality and the need for coronary artery bypass graft surgery in patients who received DESs or bare metal stents. There was rapid adoption of DESs from the end of 2002 to September 2004, when 52% of percutaneous coronary interventions used DESs. Ten-day death rates in DES and bare metal stent groups were similar (0.8% vs 1.1%), as were 10-day bypass surgery rates (0.2% vs 0.4%). In summary, in a large health care system, DESs were used widely with low rates of death and bypass surgery.

Comparison of C-reactive protein levels after coronary stenting with bare metal versus sirolimus-eluting stents

We evaluated C-reactive protein increases after implantation of bare metal stents in 200 patients and sirolimus-eluting stents in 100 patients. The magnitude of change in C-reactive protein was comparable between groups. Clinical follow-up showed a relation between the postprocedural C-reactive protein increase and outcome that was significant in the bare metal stent group, which accounted for the most of events, but not in the sirolimus-eluting stent group.

The impact of the introduction of drug-eluting stents on the clinical practice of surgical and percutaneous treatment of coronary artery disease

Sirolimus-eluting stents (SES) have recently been shown to reduce restenosis in selected patients. The impact of this new stent on the use of coronary bypass graft (CABG) surgery or percutaneous coronary intervention (PCI) in clinical practice is yet unknown. Therefore, we investigated the impact of SES on the clinical practice of CABG and PCI in a series of unselected consecutive patients. Between April and October 2002, a policy of SES implantation for all procedures has been instituted in our hospital. In total, 798 patients were referred to PCI and 275 to CABG (SES group). A control group was composed of all interventions (806 PCI and 314 CABG) performed during the preceding 6 months (pre-SES). The main outcome was the occurrence of major adverse cardiac events (MACE) at 15 months. In the SES era, a significant shift was noted in the PCI group towards more multi-vessel stenting (28 vs. 24%; P<0.05), more bifurcation stenting (18 vs. 7%; P<0.0001), and the use of more stents (1.9 vs. 1.5; P<0.05). In the PCI elective patients, a shift was noted towards more three-vessel disease (pre-SES: 16% vs. SES: 23%; P=0.02). Furthermore, we observed a shift in the CABG group towards more impaired LV function (pre-SES: 34% vs. SES: 41%; P=0.02) and towards more three-vessel disease (pre-SES: 67% vs. SES: 75%; P=0.03). Overall, the cumulative MACE percentages at 1 year after coronary revascularization (PCI and CABG combined) decreased from 16.8 to 13.8% (P=0.03). The cumulative MACE percentages in the pure SES group and the pre-SES bare metal stent group at 12 months were 15.6 and 19.8%, respectively (P<0.01). The introduction of the SES has certainly had an impact on the treatment strategy of coronary artery disease (CAD). Increased use of these stents allows more complex coronary anatomy to be treated by PCI, and results in lower repeat revascularization rates.

Technique of left main stenting is dependent on lesion location and distal branch protection

The purpose of this study was to review our experience with left main stenting and evaluate initial results with drug-eluting stents (DESs). Drug-eluting stents delivered with contemporary techniques could change the traditional surgical approach to patients with significant left main disease. One hundred sixty-one patients underwent left main stenting (100 bare metal, 61 drug-eluting) after being excluded from surgery. In group A, disease was confined to the ostium or main stem; in group B, disease involved the bifurcation. Patients were classified as either unprotected (U) or protected (P) depending on the presence of a patent bypass graft. Study endpoints were any major adverse cardiac event (MACE). In-hospital MACE was 6% with no deaths; 74% of patients in group A underwent direct stenting, whereas 89% of the patients in group B had predilatation performed prior to stent implantation. A total of 98% of patients in BU had kissing balloon inflations after stent deployment; provisional side-branch stenting was required in one patient. V-stenting was performed in 13% of patients in group BU. The 1-year mortality in the bare metal stent group was 9% with the majority of deaths in group BU. There was one noncardiac death in the DES group at 6 months and five patients (8.2%) underwent target vessel revascularization for restenosis. Event-free survival at 6 months in group BU treated with DESs was 87%. Significant left main disease presents a spectrum of angiographic abnormalities and different interventional techniques are required depending on lesion location and distal protection. Although in-hospital complications with left main stenting were low in this single-center study, follow-up events were common in patients treated with bare metal stents. A randomized multicenter trial will be required to determine whether drug-eluting stents will improve survival in patients with left main disease.