Impact of drug-eluting stent-associated coronary artery spasm on 3-year clinical outcomes: A propensity score matching analysis

BackgroundIt has been reported that significant endothelial dysfunction or clinically evident vasospasm can be associated with drug-eluting stents (DESs). However, the impact of DES associated coronary artery spasm (CAS) on long-term clinical outcomes has not been fully elucidated as compared with those of patients with vasospastic angina.MethodsA total of 2797 consecutive patients without significant coronary artery lesion (<70%), who underwent the Acetylcholine (Ach) provocation test, were enrolled between Nov 2004 and Oct 2010. DES-associated spasm was defined as significant CAS in proximal or distal to previously implanted DES site at follow-up angiography with Ach test. Patients were divided into two groups (DES-CAS; n = 108, CAS; n = 1878). For adjustment, propensity score matching (PSM) was done (C-statistics = 0.766, DES-CAS; n = 102, CAS; n = 102). SPSS 20 (Inc., Chicago, Illinois) was used to analyze this data.ResultsBaseline characteristics were worse in the DES-CAS group. After PSM, both baseline characteristics and the Ach test results were balanced except higher incidence of diffuse CAS and ECG change in the DES-CAS group. During Ach test, the incidence of diffuse spasm (93.1% vs. 81.3%, p = 0.012) and ST-T change (10.7% vs. 1.9%, p = 0.010) were higher in the DES-CAS group. At 3-year, before and after adjustment, the DES-CAS group showed a higher incidence of coronary revascularization (9.8% vs. 0.0%, p = 0.001), recurrent chest pain requiring follow up coronary angiography (CAG, 24.5% vs. 7.8%, p = 0.001) and major adverse cardiac events (MACEs, 9.8% vs. 0.9%, p < 0.005).ConclusionIn this study, DES associated CAS was associated with higher incidence of diffuse spasm, ST-T change and adverse 3-year clinical outcomes. Special caution should be exercised in this particular subset of patients.     

颅内动脉瘤辅助栓塞治疗的回顾性研究

目的 探讨颅内动脉瘤的两种辅助栓塞技术与围手术期预后之间的关系.方法 回顾2006年5月至2010年12月栓塞治疗颅内动脉瘤患者围手术期预后情况,将结果转换为GOS评分,并分组统计；统计学分析两种栓塞技术与围手术期预后之间的相关性.结果 共辅助栓塞治疗动脉瘤患者148例,球囊辅助弹簧圈栓塞技术治疗55例,围手术期预后良好率74.5％,重残率20.0％,死亡率5.5％；支架辅助弹簧圈栓塞技术治疗93例,围手术期预后良好率84.9％,重残率9.7％,死亡率5.4％；两组之间存在统计学差异(P＜0.001).结论 围手术期预后支架辅助栓塞优于球囊辅助栓塞.     

Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis

Objective : To provide safety and performance goals for prospective single‐arm trials of bare metal renal artery stenting in patients with resistant hypertension associated with high grade atherosclerotic renal artery stenosis. Background : To date, there have been no US Pre‐Market Approval (PMA) bare metal renal stent device trials which have focused on improvement of blood pressure control as a primary effectiveness endpoint. Methods : Analysis of subject‐level data from three large industry sponsored pre‐market approval (PMA) trials was performed. Hypertensive patients (≥155 mmHg) with a ≥50% atherosclerotic renal artery stenosis were included. Thirty day and 9‐month systolic and diastolic blood pressure measurements, renal function and 9‐month duplex ultrasound assessment of renal artery patency were analyzed. Results : Initial data analysis of 600 patients from the 3 PMA trials identified 286 patients who met inclusion criteria. The mean baseline systolic blood pressure was 177.8 ± 19.3 mmHg with a mean 68.1% diameter renal artery stenosis. Nine months after successful stenting, the mean SBP was 156.7 ± 24.1 mmHg; the 9 month restenosis rate was 14.4%. Conclusion : Based on the statistical modeling of these data and a priori established performance criteria, the co‐primary endpoints of 9 month reduction in blood pressure and in‐stent restenosis are proposed. The reduction in blood pressure will be analyzed as a continuous variable and will be compared to this performance goal. © 2011 Wiley‐Liss, Inc.     

Current Use of Fractional Flow Reserve: A Nationwide Survey

Major medical society guidelines recommend the measurement of fractional flow reserve (FFR) as an aid in choosing percutaneous coronary intervention in patients with stable coronary artery disease. We investigated the measurement of FFR among interventionalists, analyzing operators'' attributes and decision-making processes to reveal differences in their applications of FFR and the reasons for those differences. An electronic survey study of 1,089 interventionalists was performed from 2 February through 6 March 2012, yielding 255 responses. Most respondents were >45 years old (58%), worked primarily in a community hospital (59%), and performed 10 to 30 cases per month (52%). More than half (145/253, 57%) used FFR measurement in less than one third of cases, and 39 of 253 (15%) never used it. There were no differences in use of FFR by age, practice location, or angiogram volume (P >0.05 for all). Respondents used FFR measurement more frequently than intravascular ultrasonography (73% vs 60%) to help guide the decision to stent (P <0.01). Operators reported that their primary reasons for not using FFR were lack of availability (47%) and problems with reimbursement (39%). There was no difference in FFR use by operator age, practice setting, or case volume.     

Chemoembolization and radioembolization

Chemoembolization and radioembolization are at the core of the treatment of patients with hepatocellular carcinoma who cannot receive potentially curative therapies such as transplantation, resection or percutaneous ablation. They differ in the mechanism of action (ischaemia and increase cytotoxic drug exposure for chemoembolization, internal irradiation for radioembolization) and may target different patient populations. Chemoembolization with cytotoxic drug-eluting beads is a more standardized although not necessarily more effective way of performing chemoembolization. Cytoreduction is achieved in most patients but complete tumor ablation may be achieved and lead to extended survival. Grade 1 level of evidence support the use of chemoembolization for the treatment of patients in the early and intermediate stages while grade 2 evidence supports the use of radioembolization for the treatment of patients in intermediate to advanced stages. Selecting the best candidates for both techniques is still a work in progress that ongoing clinical trials are trying to address.     

Single vs multivessel treatment during primary angioplasty: results of the multicentre randomised HEpacoat™ for cuLPrit or multivessel stenting for Acute Myocardial Infarction (HELP AMI) Study

DESIGN: Prospective randomized, multicentre study. RATIONALE: Recanalisation of the culprit lesion is the main goal of primary angioplasty for acute myocardial infarction. With the exception of cardiogenic shock, staged procedures are performed in the presence of multivessel disease. The study hypothesis is that with modern non-thrombogenic stents (heparin coated) complete revascularization with multivessel treatment can be safely achieved during the primary angioplasty procedure with a lower need of subsequent revascularization procedures and at a lower cost. ENDPOINTS: PRIMARY: 12-month incidence of repeat revascularization (any revascularization, infarct related artery as well as non-infarct-related artery). SECONDARY: (1) in hospital repeat revascularization, reinfarction and death; (2) total hospital cost (including a 12 months follow-up period). METHODS: 69 patients with ST elevation Acute Myocardial Infarction (AMI), &lt;12 hours after symptoms onset, undergoing primary angioplasty, with documented multivessel disease and both culprit lesion and 1 to 3 other lesions suitable for stent implantation. Unbalanced randomization between culprit lesion treatment only ( n??=?17) and complete multivessel treatment (n?=?52, with 71 additional lesions treated).RESULTS: The two groups were well balanced in terms of clinical characteristics, number of diseased vessels and angiographic characteristics of the culprit lesion. In the complete multivessel treatment group 2.36?±?0.64 lesions per patient were treated using 2.73?±?0.78 heparin coated stents (1.00 lesions and 1.29?±?0.61 stents in the culprit treatment group, bothp?&lt;?0.001). The duration of the procedure increased from 53?±?21?min (culprit treatment group) to 69?±?32?min (p?=?0.032) and the amount of contrast used from 242?±?102?ml (culprit treatment group) to 341?± 163?ml (multivessel complete treatment),p?=?0.025. A similar low incidence of in-hospital major adverse cardiac events was observed in the 2 groups (0 and 3.8% in culprit and multivessel treatment groups,p?=?0.164). The increase in the incidence of new revascularisation in the culprit treatment group at 12 month follow-up was not significant (35 vs 17%,p?=?0.247) but was sufficient to compensate the initial higher in-hospital cost, with a similar 12 month hospital cost in the 2 groups (&euro;22 330?±?&euro;13 653 vs &euro;20 382?±?&euro;11 671,p?=?0.231).CONCLUSION: Multivessel treatment during primary PTCA was safe in this controlled trial. However, when only the culprit lesion was initially treated, the need for subsequent clinically driven revascularization remained low and no clinical or economical advantages were obtainable with a more aggressive initial approach. In clinical practice, a staged approach to multivessel treatment during primary angioplasty avoids to treat unnecessarily non clinically relevant lesions. (Int J Cardiovasc Intervent 2004; 6: 128-133)     

Safety and efficacy of drug-eluting stents and bare metal stents in acute coronary syndrome

Compared with medical therapy, percutaneous coronary intervention has been shown to reduce the rates of death and recurrent ischemia in patients presenting with acute coronary syndromes (ACS). In the current interventional era, both drug-eluting stents (DES) and bare-metal stents (BMS) have been widely used, despite the fact that the use of DES in the context of ACS was initially an “off-label” indication and that ACS has been associated with stent thrombosis (ST). In contrast to the wealth of data available for the use of DES in patients with ST-elevation myocardial infarction, data regarding the performance of DES in non–ST-elevation ACS is restricted to a handful of registries with conflicting data. The aim of this review was to summarize the safety and efficacy of DES in the entire spectrum of ACS.