Drug-eluting Stent Stent Implantation Research Articles

Long-term prognosis of drug eluting stents implantation in elderly patients with unprotected left main coronary artery disease

Objective: To analyze the clinical characteristics and long-term prognosis of implantation of drug-eluting stents (DES) for elderly patients with unprotected left main artery (ULM) disease. Methods: A total of 414 patients (327 males and 87 females) who underwent DES implantation were enrolled in the Department of Cardiology, Beijing Anzhen Hospital from January 2005 to March 2010, with a mean age of (61.5±10.7) years old. The patients were divided into two groups according to age: 300 cases in the group of age <70 years old, and 114 cases in the group of age ≥70 years old. The clinical characteristics and long-term prognosis of two groups were compared. Results: In the group of age ≥ 70 years old, the proportion of female was higher (31.6% vs 17.0%, P=0.001) and the incidence of chronic total occlusion (CTO) (P=0.020), hypertension (P=0.018) and cerebrovascular disease (P=0.013) were higher than those in the group of <70 years old. All-cause mortality and cardiac mortality were also higher than those in the group of <70 years old (P=0.025, P=0.013). The follow-up period was (21.4±9.6) months. After adjusting for multiple clinical factors, there were no statistical differences of incidence of the total major adverse cardiac and cerebral events (MACCE), myocardial infarction, cerebrovascular events, and revascularization recurrence between the two groups. But all-cause mortality (HR=3.790, 95%CI: 1.271-11.298, P=0.017) and cardiac mortality (HR=17.424, 95%CI: 2.440-124.410, P=0.004) in the group of age ≥70 years old were still remarkably higher than those in the group of <70 years old. Conclusions: Age is an independent risk factor for increased mortality after DES stent implantation in ULM disease. DES stent implantation in age ≥70 years old patients with ULM disease is considered feasible, but it needs to be treated with caution.

Multivariable prediction model to estimate the probability of restenosis at proximal edge after 2nd-generation drug-eluting-stent implantation: development and internal validation using a quantitative coronary angiography from the post-marketing surveillance studies of everolimus-eluting stent in Japan

Edge restenosis has still been reported after second-generation drug-eluting stent (DES) implantation. It was more likely attributable to post-procedural angiographic results than to the patient's background. The aim of this study was to develop and internally validate a prediction model for restenosis in proximal edge after 2nd-generation DES stent implantation using angiographic data. Data were obtained from several post-marketing surveillance (PMS) studies of the cobalt-chromium everolimus-eluting stent (CoCr-EES) and platinum-chromium everolimus-eluting stent (PtCr-EES), second-generation DES, in Japan. Angiographic analysis was conducted at baseline and after 8 or 12months. We focused on the proximal edge of angiographic analysis. The main outcome was restenosis defined as ≥ 50% diameter stenosis at follow-up. The predictive performance of the prediction model based on multivariable logistic regression was assessed in terms of discrimination and calibration, which were internally validated by the bootstrap method. We also performed decision curve analysis to assess threshold of predicted probability of restenosis at which additional intervention was considered. Among 2053 lesions in 1860 patients, restenosis rates in proximal edge was 2.8%. The final model was constructed with % post-procedural diameter stenosis (DS) and post-procedural reference diameter (RD) as strong predictors for edge restenosis. Discrimination and calibration were satisfactory with optimism-corrected C-statistics 0.75. Predicted probability between 0.03 and 0.24 was preferable threshold for restenosis treatments. Our prediction model can be used to obtain valid prediction for restenosis in proximal edge, assisting to know complete stent coverage of lesion.

Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data.

BackgroundMore than 600 000 coronary stents are implanted during percutaneous coronary interventions (PCIs) annually in the United States. Because no real‐world surveillance system exists to monitor their long‐term safety, claims data are often used for this purpose. The extent to which adverse events identified with claims data can be reasonably attributed to a specific medical device is uncertain.Methods and ResultsWe used deterministic matching to link the NCDR (National Cardiovascular Data Registry) CathPCI Registry to Medicare fee‐for‐service claims for patients aged ≥65 years who underwent PCI with drug‐eluting stents (DESs) between July 1, 2009 and December 31, 2013. We identified subsequent PCIs within 1 year of the index procedure in Medicare claims as potential safety events. We linked these subsequent PCIs back to the NCDR CathPCI Registry to ascertain how often the revascularization could be reasonably attributed to the same coronary artery as the index PCI (ie, target vessel revascularization). Of 415 306 DES placements in 368 194 patients, 33 174 repeat PCIs were identified in Medicare claims within 1 year. Of these, 28 632 (86.3%) could be linked back to the NCDR CathPCI Registry; 16 942 (51.1% of repeat PCIs) were target vessel revascularizations. Of these, 8544 (50.4%) were within a previously placed DES: 7652 for in‐stent restenosis and 1341 for stent thrombosis. Of 16 176 patients with a claim for acute myocardial infarction in the follow‐up period, 4446 (27.5%) were attributed to the same coronary artery in which the DES was implanted during the index PCI (ie, target vessel myocardial infarction). Of 24 288 patients whose death was identified in claims data, 278 (1.1%) were attributed to the same coronary artery in which the DES was implanted during the index PCI.ConclusionsMost repeat PCIs following DES stent implantation identified in longitudinal claims data could be linked to real‐world registry data, but only half could be reasonably attributed to the same coronary artery as the index procedure. Attribution among those with acute myocardial infarction or who died was even less frequent. Safety signals identified using claims data alone will require more in‐depth examination to accurately assess stent safety.

Impact of Drug-Eluting Stent Implantation for Femoropopliteal In-Stent Occlusion

Purpose: To compare optimal balloon angioplasty with nitinol stenting and drug-eluting stent (DES) implantation for femoropopliteal in-stent occlusion (ISO). Methods: A dual center, retrospective study was performed from January 2004 to December 2014 encompassing 110 ISOs after bare nitinol stenting for a femoropopliteal lesion in 100 patients (mean age 72.7±10.1 years; 58 men). These patients underwent optimal balloon angioplasty with implantation of a bare stent (conventional group, n=79) or a DES (n=21). The primary endpoint was recurrent in-stent restenosis (Re-ISR); secondary endpoints were recurrent target lesion revascularization (Re-TLR), reocclusion, and major adverse limb events (MALE). Re-ISR or reocclusion was defined as ISR or occlusion after TLR. Restenosis was defined as a peak systolic velocity ratio >2.4 on a duplex scan or >50% stenosis on angiography. Univariate Cox regression analysis was used to identify any relationships between patient and procedure variables and the occurrence of Re-ISR; the results are presented as the hazard ratio (HR) and the 95% confidence interval (CI). Results: The mean follow-up period was 34.9±27.4 months. At 2 years, Kaplan-Meier estimated freedom from Re-ISR rates were 79.3% in the DES group and 20.2% in the conventional group, respectively (p<0.001). The rates of freedom from Re-TLR, reocclusion, and MALE at 2 years were 85.7%, 85.9%, and 85.7% in the DES group and 27.1%, 42.5%, and 25.3% in the conventional group, respectively (p<0.001, p=0.006, and p<0.001, respectively). Univariate analysis showed only postprocedure stenosis (HR 1.04, 95% CI 1.02 to 1.07, p<0.001) as a predictor of Re-ISR. Postprocedure ABI (HR 0.06, 95% CI 0.01 to 0.30, p<0.001) and DES use (HR 0.20, 95% CI 0.07 to 0.44, p<0.001) were associated with a lower likelihood of developing Re-ISR. Conclusion: In this small comparative study, DES stent implantation gives more favorable outcomes than conventional treatment for ISO after femoropopliteal stenting.