Safety and efficacy of coronary stent implantation. Acute and six month outcomes of 1,126 consecutive patients treated in 1996 and 1997 (original) (raw)
Related papers
1994
One hundred and thirty-four consecutive patients undergoing elective coronary stenting were studied to assess the relative performance of Palmaz-Schatz (PS), Gianturco-Roubin (GR), and Wiktor (W) stents. Eighty-six percent of patients underwent follow-up angiography. Initial and follow-up angiograms were assessed by a central angiographic core laboratory. Attempts were made to place 81 Palmaz-Schatz (PS) stents, 21 Gianturco-Roubin (GR), and 32 Wiktor (W) stents. PS stents were less frequently successfully deployed (88% PS vs. 100% GR vs. 97% W; P = 0.03). The final percent stenosis was greater with the GR stent (32% GR vs. 14% PS vs. 19% W; P < 0.001). The restenosis rate was lower in the PS group (PS 48.2% vs. GR 66.7% and W 68.4Oh; P = 0.044). After accounting for the effect of prior restenosis (P = 0.005) and saphenous vein site (P = 0.006) in multivariate testing, lesion severity at follow-up was still less with the Palmaz-Schatz stent (P = 0.037).
Introduction to Coronary Artery Stents and Their Pharmacotherapeutic Management
Annals of Pharmacotherapy, 1997
OBJECfIVE: To provide an introductionto coronary artery stents and their pharmacologicmanagement, including anticoagulanttherapy and newer antiplateletregimens. DATA SOURCFS: A MEDLINE and currentjournal search ofrelevant articlesthat evaluated coronary stent success rates and anticoagulation or antiplateletregimens. STUDY SELECllON: Data from the use of primarily the Palmaz-Schatz stent were included. Studies using vitamin K antagoniststhat are not commerciallyavailable in the US were excluded unless they compared an antiplateletregimen with anticoagulation using the internationalnormalized ratio (INR). DATA SYNTIIESIS: Limitations with percutaneoustransluminal coronary angioplasty (PICA), such as ischemic complicationsand restenosis,have led to the advent of intracoronarystenting. However,the placement of a stent within the coronary artery lumen is associatedwith a risk of thromboticevents. Despite current postprocedural anticoagulation and antiplateletregimens, thrombosis occurs at rates ranging from 0.6% to 21%. When anticoagulationis deemed appropriate, it should be used for 1-2 months and the lNR should be maintainedbetween 2 and 3.5. Anticoagulationappears to have no effect on the developmentof restenosis,but has been shown to cause significanthemorrhagicevents in 5-13.5% of patients. Newer data continue to define the subsets of patients who may be managed with antiplateletagents alone. Combinations of aspirin and ticlopidine or aspirin alone may be used to manage patients who fulfill the following criteria: optimal stent placement, high-pressure inflation,and adequate coronary size. CONCLUSIONS: Coronary artery stenting is a novel approach for the managementof coronary artery disease, but is associated with the complicationof stent thrombosis. Anticoagulationreduces the risk of stent thrombosis,but is associatedwith bleeding risk. Selected patients may be successfullymanaged with antiplateletagents only.
Catheterization and Cardiovascular Interventions, 2001
This prospective study was designed to evaluate the feasibility, safety, predictive factors of success, and 6-month follow-up of stent implantation without balloon predilatation (direct stenting) in 250 patients undergoing elective stent implantation. Balloon dilatation prior to stent implantation was a prerequisite to facilitate passage and deployment of the stent. Stent technology has changed tremendously, resulting in stents with improved properties, which may allow stent placement without prior balloon dilatation. Patients with coronary lesions suitable for elective stent implantation were included in this trial. Coronary interventions were undertaken predominantly via the transradial route using 6 Fr guiding catheters. Direct stent implantation was attempted using AVE GFX II coronary stent delivery systems. Upon failure, predilatation was undertaken before reattempting stent implantation. Patient data and ECGs were obtained from case records and from personal or telephone interviews 6 months after the procedure. Values were presented as mean ؎ standard deviation. Student's t-test, two-tailed at 5% level of significance, was used to compare the difference of two means. Multivariate logistic regression analysis was performed to establish predictive factors for failure of direct stenting. Two hundred and sixty-six direct stent implantations were attempted in 250 patients. Direct stenting was successful in 226 (85%) cases. Out of 40(15%) cases where direct stenting failed, balloon predilatation facilitated stent implantation in 39. In one lesion, stent implantation was not possible despite adequate predilatation. Predictive factors for failure of direct stenting on multivariate analysis were LCx lesions (P < 0.01), complex lesions (P < 0.01), and longer stents (P < 0.001). Minimal luminal diameter and percentage diameter stenosis of lesions in the successful and the failure group were not significantly different (0.94 ؎ 0.39 mm vs. 0.84 ؎ 0.41 mm, P ؍ NS, and 70.2 ؎ 11.2 vs. 73.2 ؎ 11.2, P ؍ NS). Stent loss occurred in five (2.0%) cases, with successful retrieval in four. One stent was lost permanently in a small branch of the radial artery. Post-percutaneous coronary intervention (post-PCI) myocardial infarction occurred in four (1.6%) patients. There were no other in-hospital events. Six-month-follow up information was obtained in 99% of patients. Subacute stent thrombosis was noted in four (1.6%) cases. Target vesselrelated myocardial infarction rate was 3.2%, of which half was caused by subacute stent thrombosis. The overall reintervention rate (coronary artery bypass grafting or PCI) was 9.7%. Target lesion revascularization by PCI occurred in only 4.0%. At 6 months, overall mortality was 2.0%, of which 1.2% was due to coronary events. Direct stent implantation is safe and feasible in the majority of cases with low rate of complications. Unfavorable factors include circumflex lesion, more complex lesion morphology, and increasing length of stent. Severity of stenosis does not appear to be of predictive value. Long-term outcome is favorable with a low target lesion revascularization rate. Cathet Cardiovasc Intervent 2001;52:443-448.
Clinical impact of stent construction and design in percutaneous coronary intervention
American Heart Journal, 2004
Convincing end point data demonstrating the anatomic and clinical superiority of stent placement compared with balloon angioplasty together with significant improvement in stenting technique and poststent management have resulted in an explosion in stenting procedures and the emergence of more than 40 stent types with disparate designs and material composition in clinical use. Structural nuances in design, composition, and coating of different stent models, however, have been shown to have a major influence on the risk of stent thrombosis, the degree of vessel wall injury, and subsequent intimal proliferation in the experimental model. There is now substantial amount of evidence to indicate that the same relationship between stent structural characteristics and vessel wall outcome holds true in humans. This article provides an up-to-date overview of the clinical impact of stent construction and design, including the clinical performance of drug-eluting stents.
Catheterization and Cardiovascular Diagnosis, 1992
We studied 100 patients who had coronary implantation of Palmaz-Schatz stents in our institution from November 1989 until March 1991. A total of 126 standard and 6 short stents were implanted. The patients' mean age was 58 ± 5 years, and 97 were males. The indications were lesions with high risk of restenosis (29 patients), restenosis (27 patients), suboptimal result of angioplasty (24 patients), dissection (16 patients), and recanalized chronic total occlusion (6 patients). In 17 patients a brachial cut-down approach was used. Stents were correctly placed in 98 patients. Stent related complications occurred in 9 patients: major ischemic complications in 7 patients (acute myocardial infarction in 2 patients, emergency bypass surgery in 3 patients and emergency angio-plasty in 2 patients); in 3 of these patients there was a subacute closure of the stent and in 2 patients there were delivery problems. Vascular complications at the site of arterial puncture occured in 3 patients (some patients had more than one complication). A learning curve was observed. There was a decrease in the complication rate with the higher number of patients treated: 28% for the first 50 patients and 6% for the last 50 patients. Clinical follow-up was available in all patients. Of the 92 patients eligible for follow-up (7 ± 2 months), 69 patients were asymptomatic and 23 had recurrence of angina: 19 patients for stent restenosis and 4 patients for coronary artery disease progression. Follow-up angiogram was done in 79/92 (86%) patients: 21 had restenosis (27%). Restenosis rate was higher in patients with multiple stents 40% (6/15) than with the single stent 23% (15/64), and when the indications were for dissection 35% (6/17). These differences did not reach statistical significance. The global incidence of restenosis appears to be lower when compared to balloon coronary angloplasty, although there is no garantee these populations are comparable. Stenting seems to be a good alternative to coronary angioplasty in lesions which are not considered ideal for the balloon dilatation and to treat occlusive dissections. The use of multiple and partial overlapping stents is associated with a high restenosis rate. These impressions need to be tested in a large, randomized, multicenter study. © 1992 Wiley-Liss, Inc.
Catheterization and Cardiovascular Interventions, 2004
The purpose of this study is to demonstrate safety and effectiveness of the S-Stent in de novo coronary lesions treated with conventional percutaneous coronary balloon angioplasty. Between January 2000 and June 2001, 120 patients were prospectively enrolled at four study centers. Patients were treated with coronary stenting in a total of 137 lesions. Procedural success was achieved in 100% of 137 attempted lesions. Clinical success was 99.8%. In-hospital mortality was 0.8%; myocardial infarction occurred in 0.8% and stent thrombosis in 0.8%. After stent implantation, the minimal lumen diameter increased from 0.92 ± 0.43 to 2.74 ± 0.36 mm (P < 0.0001) and the percent diameter stenosis decreased from 68.0 ± 16.2 to 4.5 ± 12.0 (P < 0.0001). At 6-month follow-up, the percent diameter stenosis was 33.5 ± 21.3 and the angiographic restenosis rate was 16.5%. Target lesion revascularization was required in 12 patients (10.1%). We conclude that the use of S-Stent for coronary intervention resulted in a high procedural success rate and low angiographic restenosis at 6 months after implantation. Catheter Cardiovasc Interv 2004;62:439–444. © 2004 Wiley-Liss, Inc.
Long-Term Follow-Up After Angiographically Successful Coronary Stenting
Japanese Heart Journal, 2004
The purpose of the study was to compare the impacts of angiographically successful direct stent implantation and conventional stent implantation (stent implantation following predilatation) on long-term major cardiac events. The authors prospectively studied 40 patients who had successful direct stent implantation and 46 patients who had successful conventional stent implantation. The end-point of the study was defined as the occurrence of a major cardiac event, including recurrent angina, acute myocardial infarction, death, and target vessel revascularization. The demographic and clinical characteristics of the study groups were similar, except the indication of percutaneous angioplasty, which was more frequently unstable angina in the conventional stent group (63% vs 38%, P: 0.03). Procedural minor complications were more frequent in conventional stent implantation, and there was also a positive correlation between the conventional stent implantation and procedural minor complications (r = 0.231, P: 0.03), and postprocedural troponin elevation (r = 0.221, P: 0.04). The incidences of major cardiac events including recurrent angina, acute myocardial infarction, death, death or myocardial infarction, and target vessel revascularization were not different between the study groups during the long-term follow-up period (21 ± 7.1 months for direct stent group and 20 ± 7.5 months for conventional stent group). Overall end-points occurred in 9 patients (22%) in the direct stent group and in 9 patients (19%) in the conventional stent group. Kaplan-Meier survival analysis showed that there was no difference in event-free survival between the patients treated with direct stent implantation and conventional stent implantation (log-rank: 1.52, P = 0.21). Two-vessel intervention and hypertension were found to be related with long-term major cardiac events (r = 0.214, P: 0.048, r = 0.206, P: 0.04, respectively). In addition to the procedural advantages, direct stent implantation may also provide comparable results with conventional stent implantation concerning the late cardiac events following successful percutaneous coronary angioplasty.
Efetividade e segurança dos stents farmacológicos em um serviço de cardiologia em Curitiba-PR
Arquivos Brasileiros De Cardiologia, 2010
Background: The effectiveness and safety of drug-eluting stents (DES) have still been questioned. Objective: The objective of this study was to evaluate the effectiveness and safety of these stents, as well as the incidence of target lesion revascularization (TLR), in addition to identifying possible variables influencing the need for TLR. Methods: A total of 203 patients from Hospital Costantini who were clinically followed up for one to 3 years were selected. Results: The sample characteristics were as follows: 470 lesions; 171 (84.24%) male patients; 54 (26.6%) had diabetes; 131 (64.35%) had hypertension; 127 (62.56%), dyslipidemia; 40 (19.70%) were smokers; and 79 (38.92%) had a family history of coronary artery disease. Also: 49 (24.14%) patients presented with stable angina; 58 (28.57%), unstable angina; and 6 (2.96%), myocardial infarction. Eighty five (41.87%) patients were asymptomatic, and 146 (71.92%), had multivessel disease. As for the characteristics of the lesions, 77.45% were B2/C (AHA/ACC). Taxus was implanted in 73.62% of the patients. Stents with diameter > 2.5 mm were used in 381 (81.96%) patients. The stent length was < 30 mm in 67.87% of the lesions, with a mean of 2.3 stents per patient. After follow-up, 19 patients (9.3%) underwent TLR. Four patients died (1.97%), two of them of MI (0.98%), one of stroke (0.49%), and one of abdominal aneurysm (0.49%). Also, one patient died of late thrombosis (0.49%), and one of reinfarction (0.49%). In the statistical analysis carried out, only the bifurcation lesions variable reached values close to the statistical significance level, with p < 0.06. Conclusion: In conclusion, drug-eluting stents have good effectiveness and safety profiles; the incidence of TLR was 9.3%, and we did not identify a variable correlated with the need for TLR. (Arq Bras Cardiol. 2010; [online]. ahead print, PP.0-0) Key words: Drug-eluting stents/utilization; effectiveness; safety/economics; diagnostic services; Curitiba (PR); Brazil. coronary angioplasty (PTCA). Palmaz et al 3 and Sigwart et al 4 were the first to use the percutaneous treatment by means of a solid structure-a coronary endoprosthesis, the stent-which kept the dilated vessel lumen open. This was a major landmark in interventional cardiology, with the purpose of combating restenosis. In 1995, the idea emerged of using drugs capable of preventing the restenotic process using the stent itself as the drug-delivery vehicle 5. Polymers were used as the drug bond, and thus the successful triad of pharmacological stents was formed: stent, polymer and drug. Revascularization of a previously treated lesion, known as target lesion revascularization, has been associated with the assessment of percutaneous treatment effectiveness, whereas thrombosis is associated with stent safety. Therefore, although this safety has been recently questioned 6 , several meta-analyses were later carried out and demonstrated the effectiveness and safety of drug-eluting stents in comparison to bare metal stents 7-9. In a single-center registry from Ontario, Canada 7 , a decrease in the frequency of repeat revascularization procedures was observed in high-risk patients using drug-eluting stents in comparison to bare metal stents; no differences were observed as regards death and infarction. The objective of the present study was to evaluate the effectiveness and safety of drug-eluting stents in the
Revista Espanola de Cardiologia, 2013
First generation drug-eluting stents have considerably reduced in-stent restenosis and broadened the applications of percutaneous coronary interventions for the treatment of coronary artery disease. The polymer is an integral part of drug-eluting stents in that, it controls the release of an antiproliferative drug. The main safety concern of first generation drug-eluting stents with permanent polymers-stent thrombosis-has been caused by local hypersensitivity, delayed vessel healing, and endothelial dysfunction. This has prompted the development of newer generation drug-eluting stents with biodegradable polymers or even polymer-free drug-eluting stents. Recent clinical trials have shown the safety and efficacy of drug-eluting stents with biodegradable polymer, with proven reductions in very late stent thrombosis as compared to first generation drug-eluting stents. However, the concept of using a permanent metallic prosthesis implies major drawbacks, such as the presence of a foreign material within the native coronary artery that causes vascular inflammation and neoatherosclerosis, and also impedes the restoration of the vasomotor function of the stented segment. Bioresorbable scaffolds have been introduced to overcome these limitations, since they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage. This update article presents the current status of these new technologies and highlights their future perspectives in interventional cardiology.