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MACE Rate (mace + rate)
Selected AbstractsTwo-Year Clinical Registry Follow-up of Endothelial Progenitor Cell Capture Stent Versus Sirolimus-Eluting Bioabsorbable Polymer-Coated Stent Versus Bare Metal Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST Elevation Myocardial InfarctionJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 2 2010ERIC CHONG M.B.B.S., F.A.M.S., M.R.C.P. Background: Endothelial progenitor cell (EPC) capture stent is designed to promote rapid endothelization and healing and is potentially useful in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). We studied the intermediate-term efficacy and safety of EPC stent and compared that with sirolimus-eluting bioabsorbable polymer stent (CURA) and bare metal stent (BMS) in AMI patients. Methodology: Patients presenting with AMI who underwent primary PCI with the respective stents between January 2004 and June 2006 were enrolled in the single-center clinical registry. The study end-points were major adverse cardiac events (MACE) and stent thrombosis. Results: A total of 366 patients (EPC = 95, CURA = 53, BMS 218) were enrolled. Baseline demographics including age, gender, diabetes, renal impairment, predischarge left ventricular ejection fraction, and creatinine kinase level were comparable among the groups. Procedural success rate was 99.5%. Post-procedural thrombolysis in myocardial infarction (TIMI) 3 flow was achieved in EPC 91.6%, CURA 96.2%, and BMS 88.5% (P = 0.209). At 2 years, the MACE rate was EPC 13.7%, CURA 15.1%, and BMS 19.7% (P = 0.383). Target vessel revascularizations (TVR) were EPC 4.2%, CURA 9.4%, and BMS 6.0% (P = 0.439). Nonfatal myocardial infarctions were EPC 1.1%, CURA 3.8%, and BMS 4.1% (P = 0.364). One patient in the EPC group had acute stent thrombosis. There was no late stent thrombosis in the EPC group. Conclusion: EPC stent appeared to be safe and had comparable clinical efficacy with a BMS when used in the AMI setting. At 2-year follow-up, the EPC group showed favorable, single-digit TVR rate and stent thrombosis remained a low-event occurrence. (J Interven Cardiol 2010;23:101-108) [source] Coronary Artery Bypass Surgery Versus Percutaneous Coronary Intervention with Drug-Eluting Stent Implantation in Patients with Multivessel Coronary DiseaseJOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 1 2007ZHEN KUN YANG M.D. Background: Drug-eluting stents (DES) constitute a major breakthrough in restenosis prevention after percutaneous coronary intervention (PCI). This study compared the clinical outcomes of PCI using DES versus coronary artery bypass graft (CABG) in patients with multivessel coronary artery disease (MVD) in real-world. Methods: From January 2003 to December 2004, 466 consecutive patients with MVD underwent revascularization, 235 by PCI with DES and 231 by CABG. The study end-point was the incidence of major adverse cardiovascular events (MACEs) at the first 30 days after procedure and during follow-up. Results: Most preoperative characteristics were similar in the two groups, but left main disease (24.7% vs 2.6%, P<0.001) and three-vessel disease (65% vs 54%, P = 0.02) were more prevalent in CABG group. The number of coronary lesions was also greater in CABG group (3.7 ± 1.1 vs 3.3 ± 1.1, P<0.001). Despite higher early morbidity (3.9% vs 0.8%, P = 0.03) associated with CABG, there were no significant differences in composite MACEs at the first 30 days between the two groups. During follow-up (mean 25±8 months), the incidence of death, myocardial infarction, or cerebrovascular event was similar in both groups (PCI 6.3% vs CABG 5.6%, P = 0.84). However, bypass surgery still afforded a lower need for repeat revascularization (2.8% vs 10.4%, p = 0.001). Consequently, overall MACE rate (14.5% vs 7.9%, P = 0.03) remained higher after PCI. Conclusion: PCI with DES is a safe and feasible alternative to CABG for selected patients with MVD. The reintervention gap was further narrowed in the era of DES. Aside from restenosis, progression of disease needs to receive substantial emphasis. [source] Baseline Clinical Characteristics and Midterm Prognosis of STE-ACS and NSTE-ACS Patients with Normal Coronary ArteriesANNALS OF NONINVASIVE ELECTROCARDIOLOGY, Issue 1 2009Lukasz Mazurkiewicz M.D. Objective: We sought to compare clinical profiles and midterm prognosis of patients with normal coronary arteries presenting with ST-elevation ACS (STE-ACS) versus non-ST-elevation ACS (nSTE-ACS). Background: There are limited data regarding ACS in patients with normal coronary arteries, and especially clinical differences between ST-ACS and nSTE-ACS patients have not been evaluated sufficiently. Methods: The study group comprised 190 patients (mean age: 53.2 years, 63.1% males, 63.6% STE-ACS) presenting with ACS and normal coronary angiograms. The participants were evaluated in terms of 42 clinical variables. MACE [cardiac death (CD) and hospitalization for angina (HA)] were the study end points. Results: STE-ACS in comparison to nSTE-ACS patients were younger (P < 0.01), were more frequently males (P < 0.01), had more often infection prior to ACS (P < 0.01), higher hsCRP on admission (P < 0.01), and greater infarct size, measured by maximal troponin I (P < 0.01). By multivariate analysis in this subgroup, predictors of outcome were hsCRP (P = 0.03) and raised troponin I (P = 0.02). nSTE-ACS in comparison to STE-ACS patients were more obese (BMI, P < 0.01), had higher LDL cholesterol (P < 0.01), fasting glucose (P = 0.03). LDL cholesterol (P = 0.02) and fasting glucose (P = 0.03) emerged as independent predictors of outcome in these patients. Mean follow-up period was 25.4 months. STE-ACS patients had twice fewer MACE rate than nSTE-ACS patients [(1-CD, 12-HA; 11%) vs (1-CD, 16-HA; 25%), respectively, log rank P < 0.01]. Conclusions: STE-ACS and nSTE-ACS patients with normal coronary arteriography have different clinical profiles. In nSTE-ACS patients more pronounced metabolic abnormalities were identified, while in STE-ACS patients inflammatory background was more significant. [source] Five-year clinical outcomes after coronary stenting of chronic total occlusion using sirolimus-eluting stents: Insights from the rapamycin-eluting stent evaluated at Rotterdam Cardiology Hospital,(Research) Registry,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2009Zhu Jun Shen MD Abstract Background: The use of drug eluting stents (DES) in patients with a successfully recanalized chronic total occlusion (CTO) has been associated with a significant decrease in the need for repeat revascularization, and a favorable short-term clinical outcome when compared with the use of bare metal stents (BMS). Our group, however, has previously reported similar rates of target lesion revascularisation (TLR) and major adverse cardiovascular events (MACE) at 3 years follow-up in patients with a successfully opened CTO who were treated with either a sirolimus eluting stent (SES) or a BMS. The objective of this report was to evaluate the outcomes of these patients at 5-years clinical follow-up. Methods and Results: A total of 140 (BMS 64, SES 76) patients with successfully opened CTOs were included. Seven patients died in the BMS group whilst nine patients died in the SES group (P = 0.90). Noncardiac death was the major component of all-cause mortality (11 noncardiac deaths vs. 5 cardiac). There were two and three myocardial infarctions (MI) in the BMS and SES group, respectively (P = 1.0). The composite of death and MI occurred in seven (10.9%) and eleven (14.5%) patients in the BMS and SES group, respectively (P = 0.53). Clinically driven TLR was performed in eight patients (12.5%) in the BMS group, and five (6.6%) in the SES group (P = 0.26). Non-TLR target vessel revascularization was performed in one patient in the BMS group, and four in the SES group (P = 0.37). The 5-year device-oriented cumulative MACE rate was 15.6% and 11.8% in the BMS and SES group, respectively (P = 0.56). Conclusion: In patients with a successfully treated CTO, clinical outcome after 5 years was similar between SES and BMS, however, clinically driven TLR was slightly higher in the BMS group. © 2009 Wiley-Liss, Inc. [source] A randomized comparison of sirolimus-eluting versus bare metal stents in the treatment of diabetic patients with native coronary artery lesions: The DECODE study,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2008Charles Chan MD Abstract Objective: To compare the effects of sirolimus-eluting (SES) versus bare metal stents (BMS) on 6-month in-stent late luminal loss (LLL) and 1-year major adverse cardiac events (MACE) in diabetics undergoing percutaneous coronary interventions. Background: In studies of unselected patients, coronary restenosis rates have been lower with SES than with BMS. Comparisons of SES versus BMS in diabetics with more than one stenosis or more than one vessel disease are few. Methods: This open-label trial randomly assigned 200 diabetics with de novo coronary artery stenoses to receive up to three SES versus BMS in a 2:1 ratio. The patients underwent repeat coronary angiography at 6 months after the index procedure and were followed-up for 1 year. The primary study endpoint was in-stent LLL at 6 months. Results: Between August 2002 and May 2004, 83 patients (mean age = 60 years) with 128 lesions (mean = 1.5 per patient) were enrolled at four U.S. and seven Asian medical centers. Enrollment was terminated early by the Safety Monitoring Board because of a statistically significant difference in rates of clinical endpoints. The mean in-stent LLL at 6 months was 0.23 mm in SES versus 1.10 mm in BMS recipients (P < 0.001). At 12 months, 8 patients (15%) assigned to SES had experienced MACE versus 12 patients (41%) assigned to BMS (P = 0.006). Conclusions: In diabetics, the mean 6-month in-stent LLL was significantly smaller, and 12-month MACE rate significantly lower, after myocardial revascularization with SES than with BMS. © 2008 Wiley-Liss, Inc. [source] Adjunctive use of the Rinspiration system for fluidic thrombectomy during primary angioplasty: The Rinspiration international registry,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 2 2008Marco De Carlo MD Abstract Background: Atherothrombotic embolization during primary percutaneous coronary intervention (PCI) induces microvascular obstruction and reduces myocardial tissue reperfusion. A variety of thrombectomy devices have been evaluated as an adjunct to primary PCI in patients with ST-elevation myocardial infarction (STEMI) to reduce distal embolization. Results have been inconsistent and difficult to predict. The aim of this study was to investigate the safety and efficacy of an innovative thrombectomy device, the Rinspiration System, which simultaneously "rinses" the vessel with turbulent flow and aspirates thrombus. Methods: We prospectively enrolled 109 patients at six academic institutions in three countries referred for primary or rescue PCI for STEMI presenting within 12 hr of symptom onset. The primary endpoint was ,50% ST-segment elevation resolution (STR) measured 60 min after PCI by continuous elctrocardiographic recording, Secondary end points included STR > 70% at 60 min, final TIMI flow, myocardial blush score, and 30-day major adverse cardiac events (MACE). Results: Mean symptom-to-PCI time was 4.7 ± 2.7 hr. Rinspiration was successfully delivered in 98% of cases. Final TIMI three flow was achieved in 89% of patients and myocardial blush ,2 in 78%. Rates of STR , 50% and >70% at 60 min were 97 and 80%, respectively. No device-related complications were observed. Thirty-day MACE rate was 4.6%. Conclusions: This international multicenter registry demonstrates that the adjunctive use of Rinspiration during primary PCI is safe and feasible. The excellent STR data compare favorably with results of previous trials using different devices for thrombus management, indicating a potential clinical benefit. © 2008 Wiley-Liss, Inc. [source] Long-term outcomes of bifurcation lesions after implantation of drug-eluting stents with the "mini-crush technique"CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2007Alfredo R. Galassi MD, FSCAI Abstract Objectives: To evaluate clinical and angiographic long-term outcome of "the mini-crush" technique for treating bifurcation lesions. Background: Despite proven efficacy of drug-eluting stent (DES) within most lesions subsets, bifurcation lesions continue to exhibit high restenosis rate using current DES stenting technique. Methods: We report a new stenting technique which was employed in 45 consecutive patients (52 lesions) between April 2004 and July 2005 to treat true bifurcation lesions using DES in both branches. Results: Using this technique procedural success was obtained in 100% of cases, without complications and with excellent angiographic result in 96.1% and 98.1% of main vessel and side branch. Preprocedure reference vessel diameter and minimal lumen diameter (MLD) were 2.68 ± 0.48 and 0.90 ± 0.55 mm for the main branch, respectively and 2.28 ± 0.34 and 1.14 ± 0.47 mm for the side branch, respectively. Postprocedure MLD was 2.56 ± 0.39 mm for the main branch and 2.16 ± 0.29 mm for the side branch. There were no in-hospital major adverse cardiac events (MACE). At 72 days after procedure there was one case of side branch stent thrombosis (2.2%), which resulted in non Q-wave MI. Angiographic follow up was obtained in 100% of patients at 7.5 ± 1.3 months. Target lesion revascularization (TLR) was 12.2%; no death and Q-wave MI were observed; reference vessel diameter and MLD for the main branch were 2.79 ± 0.51 and 1.99 ± 0.65 mm respectively and for the side branch 2.28 ± 0.40 and 1.63 ± 0.48 mm respectively. Restenosis rate in the main branch was 12.2% while in the side branch was 2.0%. Conclusions: In-hospital outcome indicates that the mini-crush technique for bifurcation lesions with DES can be easily performed. It provides very low total MACE rate and restenosis at 8-month follow-up. These results confirmed the advantage of this specific technique to give complete coverage of the ostium of the side branch using two stents technique. © 2007 Wiley-Liss, Inc. [source] Use of Taxus polymer-coated paclitaxel-eluting stents for treatment of in-stent restenosis in real world patients: Results of clinical and angiographic follow-up at six months in a single-center registryCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2006Victor Y. Lim MRCP Abstract Objective:To evaluate the safety and efficacy of Taxus paclitaxel-eluting stents in a real world group of unselected patients with coronary in-stent restenosis (ISR) lesions. Methods: This is a prospective single-center registry of a consecutive series of 94 patients with 104 ISR lesions, without previous brachytherapy, over a period of 1 year. Quantitative coronary angiographic analyses were performed at baseline and at 6-month angiographic follow-up. Clinical follow-up were obtained at 6 months. Results:Pre-intervention mean reference vessel diameter was 2.62 ± 0.50 mm and mean lesion length was 13.95 ± 6.78 mm. Baseline ISR patterns were mostly either Type I focal (32.7%) or Type II diffuse intrastent (48.1%). At 6-month angiographic follow-up, the in-stent and in-segment binary restenosis was 3.8% (4/105) and 7.6% (8/105) respectively, and the in-stent and in-segment late loss was 0.30 ± 0.50 mm and 0.57 ± 0.54 mm, respectively. Seven of these eight restenosed lesions had a diffuse or proliferative ISR pattern prior to intervention. Lesions that restenosed had longer mean stent length per lesion (37.3 mm vs. 22.5 mm in nonrestenosed group; P = 0.001) and more likely to have had a pattern of total occlusion pre-intervention (25.0% vs. 3.1% in nonrestenosed group; P = 0.046). At 6-month clinical follow-up, the MACE rate was 8.5% and target lesion revascularization rate was 7.4%. There was no death but subacute stent thrombosis occurred in 1 patient (1.1%) at 3 days after intervention. Conclusions: Paclitaxel-eluting Taxus stent for the treatment of ISR effectively suppresses recurrent neointimal proliferation, and was safe and efficacious at 6-month follow-up. © 2006 Wiley-Liss, Inc. [source] Improved survival with drug-eluting stent implantation in comparison with bare metal stent in patients with severe left ventricular dysfunctionCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 3 2006FACC, Giuseppe Gioia MD Abstract OBJECTIVE: We examined the efficacy of drug-eluting stent (DES) implantation (Sirolimus or Paclitaxel) in patients with ischemic cardiomyopathy and severe left ventricular (LV) dysfunction and compared the outcome with a similar group of patients undergoing bare metal stent (BMS) implantation. BACKGROUND: Patients with severe LV dysfunction are a high risk group. DES may improve the long term outcomes compared with BMS. METHODS: One hundred and ninety one patients (23% women) with severe LV dysfunction (LV ejection fraction ,35%) underwent coronary stent implantation between May 2002 and May 2005 and were available for follow-up. One hundred and twenty eight patients received DES (Sirolimus in 72 and Paclitaxel in 54) and 63 patients had BMS. Patients with acute S-T elevation myocardial infarction (STEMI) were excluded. The primary endpoint was cardiovascular mortality. A composite endpoint of major adverse cardiac events (MACE) including cardiovascular mortality, myocardial infarction (MI), and target vessel revascularization (TVR) was the secondary endpoint. RESULTS: Mean follow-up was 420 ± 271 days. No differences were noted in age (69 ± 10 years vs. 70 ± 10 years, P = NS), number of vessel disease (2.3 ± 0.7 vs. 2.2 ± 0.8, P = NS), history of congestive heart failure (47% vs. 46%, P = NS), MI (60% vs. 61%, P = NS), or number of treated vessels (1.3 ± 0.5 vs. 1.3 ± 0.6, P = NS) for the DES and BMS group, respectively. Diabetes was more common among DES patients (45% vs. 25%, P = 0.01). The left ventricular ejection fraction (LVEF) was similar between the two groups (28% ± 6% vs. 26% ± 8%, P = NS for the DES and BMS, respectively). During the follow-up, there were a total of 25 deaths of which two were cancer related (2 in DES group). There were 23 cardiac deaths, 8/126 (6%) which occurred in the DES group and 15/63 (24%) in the BMS group (P = 0.05 by log-rank test). MACE rate was 10% for the DES group and 41% for the BMS group (P = 0.003). NYHA class improved in both groups (from 2.5 ± 0.8 to 1.7 ± 0.8 in DES and from 2 ± 0.8 to 1.4 ± 0.7 in the BMS, P = NS). CONCLUSION: Compared with bare-metal stents, DES implantation reduces mortality and MACE in high risk patients with severe left ventricular dysfunction. © 2006 Wiley-Liss, Inc. [source] Outcome in the real-world of coronary high-risk intervention with drug-eluting stents (ORCHID),A single-center study comparing CypherÔ sirolimus-eluting with TaxusÔ paclitaxel-eluting stentsCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 5 2006S. Kumar MRCP Abstract Objective: We present real world experience from a single center registry comparing the 6-month outcome of percutaneous coronary intervention (PCI) in unselected high-risk individuals using either sirolimus-eluting (SES) or paclitaxel-eluting stents (PES). Methods/Results: We compared clinical outcome at 6 months follow-up in two cohorts of 156 consecutive patients(total n = 312) who underwent SES (June 2002,Februrary 2003) and PES(march 2003,July 2003) implantation. The primary endpoint was a composite of major adverse cardiac events (MACE). Baseline clinical characteristics were well matched. The 6-month target vessel revascularization (TVR) rates were 1.9% (SES) and 2.6% (PES) and MACE rates were similar in the two groups (SES 4.5% vs. PES 3.2%, P = NS). In the PES group, intervention for multivessel disease, bifurcation lesions and in small vessels was more common, and for in-stent restenosis less common, reflecting the impact of drug eluting stents on indications for PCI. The incidence of sub-acute stent thrombosis, related to inadequate antiplatelet therapy in 3 of the 6 cases, was 0.95% with no difference between the two groups. Conclusion: This study confirms the safety and efficacy of SES and PES in unselected high risk patients undergoing PCI. Clinical outcomes of both stents are equivalent at 6 months with low rates of MACE and TVR. These data provide important complementary information to forthcoming randomized studies. © 2006 Wiley-Liss., Inc. [source] | ||||||||||