Major Adverse Cardiac Events Free Survival Research Articles

Timing of heart failure development and clinical outcomes in patients with acute myocardial infarction.

To investigate the clinical relevance of the timing of heart failure (HF) development on long-term outcome in patients with acute myocardial infarction (AMI). A total of 1,925 consecutive AMI patients were divided into 4 groups according to the timing of HF development; HF at admission (group I, n = 627), de novo HF during hospitalization (group II, n = 162), de novo HF after discharge (group III, n = 98), no HF (group IV, n = 1,038). Major adverse cardiac events (MACE) defined as the development of death, re-hospitalization, recurrent MI or revascularization were evaluated. HF was developed in 887 patients (46.1%) after an index AMI. HF was most common at the time of admission for AMI, but the development of de novo HF during hospitalization or after discharge was not uncommon. MACE was developed in 619 out of 1,925 AMI patients (31.7%). MACE was highest in group I, lowest in group IV, and significantly different among groups; 275 out of 627 patients (43.9%) in group I, 64 out of 192 patients (39.5%) in group II, 36 out of 98 patients (36.7%) in group III, and 235 out of 1,038 patients (22.6%) in group IV (P < 0.001). MACE free survival rates at 3 years were 56% in group I, 62% in group II, 64% in group III, and 77% in group IV (P < 0.001). HF was not uncommon and can develop at any time after an index AMI, and the development of HF was associated with poor prognosis. The earlier the HF has occurred after AMI, the poorer the clinical outcome was. To initiate the guideline directed optimal medical therapy, therefore, the development of HF should be carefully monitored even after the discharge from an index AMI.

Assessment of stent optimization in clinical practice using optical coherence tomography: a multicentric observational study

Abstract Background Stent under-expansion obtained at the time of percutaneous coronary intervention (PCI) has been shown to be associated with worse outcomes. Purpose We sought to define OCT assessed optimal stent expansion index which associates with lower incidence of major adverse cardiac events (MACE) during follow-up in a sample of patients stented at five high volume centers of central Europe. Methods We analyzed 370 lesions stented during the period between 2012 and 2018, with their final procedural results imaged using optical coherence tomography (OCT). QIvus Research Edition v3.1 (Medis, Leiden, NL) was used for OCT analysis. The stented segment was split in two equal halves. Stent expansion index (SEI) was calculated for both halves separately by dividing minimum stent area by the mean reference lumen area [(proximal reference area + distal reference area)/2]. Smallest of the two prevailed as the SEI of that case. MACE during post-PCI follow-up was defined as composite of all-cause death, myocardial infarction, stent thrombosis and target lesion revascularization. Data is expressed as mean±SD or median (Interquartile range). Incidence of subsequent MACE is expressed as crude rates (%). Results A total of 316 cases (370 lesions), aged 64.6±11.7 years were included for OCT analysis. Of them, 78.8% were males, 22.8% were diabetics, 75.9% were hypertensives while 35.1% had family history of coronary artery disease. 38.0% of the cases had acute coronary syndrome at presentation. 62.4% of treated lesions were complex (Type B2/C). A mean of 1.11±0.34 stents/scaffolds were implanted per treated lesion. Analyzed segment length was 20.4 (15.17, 27.0) mm. Minimal stent area (MSA) in the overall stented segment was 6.02 mm2 (4.65, 7.93). Median stent expansion index (minimum) was 0.79 (0.71, 0.86). Median follow-up duration was 557 days (326, 1,096). 47 lesions (12.7%) suffered MACE during follow-up. Receiver operating characteristic (ROC) curve analysis using Youden's rule identified 0.84 as SEI cut-off powered to predict post-PCI MACE (AUC= 0.60, sensitivity= 0.85, specificity= 0.34). MACE was observed in 38/249 (15.3%) of lesions with SEI≤0.84 and in 9/121 (7.4%) of lesions with SEI&amp;gt;0.84 (p=0.03). Univariate regression analysis of MACE revealed significant association with SEI≤0.84 (OR=2.2, 95% CI=1.1–4.8, p=0.04) Adaptive Lasso regression identified SEI≤0.84 (OR=4.1, 95% CI=1.3–12.6, p=0.02) and coronary calcification at baseline (OR=2.7, 95% CI=1.1–6.6, p=0.03) as independent predictors of MACE during follow-up. Kaplan-meier curve for MACE free survival with optimal SEI (n=121) and sub-optimal SEI (n=249) subgroups using SEI cut-off of 0.84, however showed modest separation (p=0.11). Conclusions The present study identified SEI&amp;gt;0.84 associated with lower incidence of MACE as optimal cut-off in daily practice. Along with SEI of ≤0.84, coronary calcification was also significantly associated with MACE during post PCI follow-up. Funding Acknowledgement Type of funding sources: None.

Effect of diabetes mellitus on long-term outcomes after repeat drug-eluting stent implantation for in-stent restenosis

BackgroundWhether diabetes mellitus (DM) is a predictor of long-term adverse clinical outcomes after repeat drug eluting stent (DES) implantation for DES in-stent restenosis (ISR) remains controversial. We sought to evaluate the effect of DM on the long-term clinical outcomes in patients undergoing repeat DES implantation for DES-ISR lesions.MethodsIn the present study, 254 patients with DES-ISR were divided into DM or non-DM groups according to the presence or absence of DM. All patients received repeat 2nd generation DES implantation for DES-ISR. The occurrences of major adverse cardiac events (MACEs) over a 2-year follow-up period were compared between the two groups. MACEs were defined as cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). MACE free survival was investigated with Kaplan-Meier curve analysis. Cox regression analysis was used to identify factors associated with MACEs.ResultsBaseline clinical characteristics were similar between groups, except for the prevalence of early restenosis (lower) in the DM group. Differences in angiographic and procedural characteristics were not significant between groups. The rates of 2-year MACE (30.9 vs. 26.0%; P = 0.453) and TLR (24.7 vs. 19.7%; P = 0.411) were similar between groups. MACE-free survival and TLR-free survival were also similar between groups (P = 0.441 and P = 0.807). Subgroup analysis suggested a significant difference in the MACE (39.0 vs.15.3%, P < 0.001) and TLR occurrence (30.5 vs.8.2%, P < 0.001) and TLR-free survival (lower in early subgroup, P < 0.001) between early and late occurrence of ISR in the non-DM group of patients but not in the DM group. After adjustment for all significant clinical variables, Cox regression analysis indicated that DM was not associated with MACEs (hazard ratio [HR] 1.531, 95% confidence interval [CI] 0.882-2.658, P =0.130). Non-focal type ISR and early ISR were predictors of MACEs (HR 2.671, 95% CI 1.468-4.858,P = 0.001; HR 4.703, 95% CI 2.725-8.117, P < 0.001, respectively).ConclusionsPatients with DM have similar 2-year clinical outcomes to patients without DM when repeat 2nd generation DES was used for treatment of DES-ISR. DM is not the predictor of long-term prognosis in patients undergoing repeat 2nd generation DES for DES-ISR.

Abstract 12889: Drug-Eluting Stents in the Treatment of Saphenous Vein Graft Disease: Disappointing Outcome During Long-term Follow-up

Introduction: Drug-eluting stents (DES) have been shown to have superior short term outcomes in the treatment of saphenous vein graft (SVG) disease compared to bare metal stents. Hypothesis: The goal of this study was to assess the long term clinical outcome of all patients with SVG disease treated with DES. Methods: 183 consecutive patients undergoing SVG intervention with DES were evaluated. Post-procedure, antiplatelet therapy included aspirin indefinitely and dual antiplatelet therapy for a minimum of 1 year. Major adverse cardiac events (MACE) were assessed at a mean follow-up of 5 years. MACE was defined as any of the following: death, stroke, myocardial infarction, repeat bypass surgery, repeat target vessel revascularization, or stent thrombosis. Results: The study population consisted of 149 men and 34 women with a mean age of 69 ± 10 years. Diabetes was present in 83 (45%) and acute coronary syndromes were present in 116 (63%). Mean SVG age was 12 ± 6 years. Diffuse disease (≥ 30 mm of treated disease and/or 3 or more lesions in a single vessel) was present in 37%. A total of 243 lesions were treated with 395 DES. Procedural techniques during DES deployment included direct stenting in 50%, pretreatment with intracoronary nicardipine in 49%, and use of a distal protection device in 38%. Kaplan Meier analysis of long-term MACE free survival is shown in the Figure. Although only 18% of patients had a MACE at one year, continued events were common after the first year. At 49 months, 50% of the patients had one or more MACE. Event free survival which was 82% at 1 year was only 41% at 5 years. MACE free survival after first and second generation DES were similar. Conclusions: The long-term outcome after percutaneous intervention of aortocoronary bypass vein grafts continues to present a clinical challenge. Within 5 years after DES placement for SVG disease, fewer than half of the patients remain event free.

NT-proANP and NT-proBNP circulating levels as predictors of cardiovascular outcome following coronary stent implantation.

Natriuretic peptides are diagnostic/prognostic biomarkers in major cardiovascular diseases. We aimed at assessing the predictive role of N-terminal pro-A-type (NT-proANP) and pro-B-type (NT-proBNP) natriuretic peptides levels toward cardiovascular outcome in both stable and unstable coronary artery disease (CAD) patients after percutaneous coronary intervention (PCI) in a non-primary PCI setting. A total of 395 patients undergoing PCI with stent implantation for either stable angina (SA) or non ST-elevation acute coronary syndrome (NSTE-ACS) were enrolled. Pre-procedural NT-proANP and NT-proBNP levels were measured. Occurrence of major adverse cardiac events (MACEs), composite of cardiac death, non-fatal myocardial infarction, and clinically driven target lesion revascularization (c-TLR), was the endpoint of the study. Follow up mean time was 48.53±14.69months. MACEs occurred in forty-four patients (11%) during follow up. Both NT-proANP levels [3170 (2210-4630) vs 2283 (1314-3913) fmol/mL, p=0.004] and NT-proBNP levels [729 (356-1353) vs 511 (267-1006) fmol/mL, p=0.04] were significantly higher in patients with MACEs compared to patients without MACEs. Similar results were found when considering hard MACEs (myocardial infarction and cardiac death). NT-proANP levels were significantly higher in patients with c-TLR compared with patients without c-TLR [3705 (2766-5184) vs 2343 (1340-3960) fmol/mL, p=0.021]. At multivariate analysis, NT-proANP levels were a significant predictor of MACEs (HR 1.09, 95% CI 1.03-1.18, p=0.04). Kaplan-Meyer curves revealed that patients with elevated NT-proANP levels (>2.100fmol/mL) had a lower MACE free survival (p=0.003). Both NT-proANP and NT-proBNP levels were higher in CAD patients experiencing MACEs following PCI in a non-primary setting. Notably, only NT-proANP levels significantly affected prognosis after PCI.

Abstract 13826: Patient Characteristics and Prognosis of OCT Verified Calcified Nodules in Acute Coronary Syndrome

Backgrounds: Pathological studies have shown that calcified nodule (CN) is one of important causes for acute coronary syndrome (ACS). Optical coherence tomography (OCT) is able to identify CN in vivo. No data, however, is available for prognosis of CN. Purpose: The purpose of this study was to investigate the prognosis of CN. Methods: This study consisted of 492 patients with ACS on native coronary artery who underwent pre-PCI OCT to explore the culprit artery. Patients were divided into a CN group and a non-CN group according to OCT findings. The OCT criterion of CN was defined when fibrous cap disruption was detected over a calcified plaque characterized by protruding calcification, superficial calcium, and the presence of substantive calcium proximal and/or distal to the lesion. The primary end-point was overall survival. The secondary end-point was composite of major adverse cardiac events (MACE) including cardiac death, non-fetal myocardial infarction (MI), and unstable angina pectoris (uAP). Results: The prevalence of OCT-CN was 4.5% (n=22). Patients with CN were significantly older (CN: 75.4±9.0 vs. non-CN: 66.7±11.3, p&lt;0.01), and more likely to female (CN: 50% vs. non-CN: 23%, p&lt;0.01). Compared with non-CN patients, hypertension (CN: 95% vs. non-CN: 71%, p&lt;0.01), and hemodialysis (CN: 18% vs. non-CN: 3%, p&lt;0.01) were more common in CN. Mean follow-up period was 25.4 (range 1-60) month. During the period, cardiac death occurred in 19 (CN: 1, non-CN: 18), non-cardiac death in 15 (CN: 3, non-CN: 12), non-fatal MI in 7 non-CNs, and uAP in 11 non-CNs. Kaplan-Meier curve showed significantly low overall survival in CN (Figure A, p&lt;0.05), while MACE were similar in both groups (Figure B, p=0.42). Conclusions: The prevalence of OCT-CN was 4.5%. Patients with CN were older, and had more co-morbidities including hypertension and kidney dysfunction. The overall survival was significantly poor in patients with CN, although the MACE free survival were similar between groups.

Comparison of the efficacy of drug-eluting stents versus bare-metal stents for the treatment of left main coronary artery disease.

Background:Recent studies reported that percutaneous coronary intervention with stent implantation was safe and feasible for the treatment of left main coronary artery (LMCA) disease in select patients. However, it is unclear whether drug-eluting stents (DESs) have better outcomes in patients with LMCA disease compared with bare-metal stent (BMS) during long-term follow-up in Chinese populations.Methods:From a perspective multicenter registry, 1136 consecutive patients, who underwent BMS or DES implantation for unprotected LMCA stenosis, were divided into two groups: 1007 underwent DES implantation, and 129 underwent BMS implantation. The primary outcome was the rate of major adverse cardiac events (MACEs), including cardiovascular (CV) death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years postimplantation.Results:Patients in the DES group were older and more likely to have hyperlipidemia and bifurcation lesions. They had smaller vessels and longer lesions than patients in the BMS group. In the adjusted cohort of patients, the DES group had significantly lower 5 years rates of MACE (19.4% vs. 31.8%, P = 0.022), CV death (7.0% vs. 14.7%, P = 0.045), and MI (5.4% vs. 12.4%, P = 0.049) than the BMS group. There were no significant differences in the rate of TLR (10.9% vs. 17.8%, P = 0.110) and stent thrombosis (4.7% vs. 3.9%, P = 0.758). The rates of MACE (80.6% vs. 68.2%, P = 0.023), CV death (93.0% vs. 85.3%, P = 0.045), TLR (84.5% vs. 72.1%, P = 0.014), and MI (89.9% vs. 80.6%, P = 0.029) free survival were significantly higher in the DES group than in the BMS group. When the propensity score was included as a covariate in the Cox model, the adjusted hazard ratios for the risk of CV death and MI were 0.41 (95% confidence interval [CI]: 0.21–0.63, P = 0.029) and 0.29 (95% CI: 0.08–0.92, P = 0.037), respectively.Conclusions:DES implantation was associated with more favorable clinical outcomes than BMS implantation for the treatment of LMCA disease even though there was no significant difference in the rate of TLR between the two groups.

Long-term outcomes of coronary artery bypass grafting patients supported preoperatively with an intra-aortic balloon pump

Most studies describing the outcome of coronary artery bypass grafting patients supported preoperatively with an intra-aortic balloon pump (IABP) have reported early results. The purpose of our study was to evaluate the early and long-term results. Of 2658 isolated coronary artery bypass grafting procedures performed from 1996 to 2001, 215 were supported preoperatively with an IABP. The indications for IABP insertion were cardiogenic shock in 18 (8.4%), acute evolving myocardial infarction in 38 (17.7%), clinical instability in 84 (39.1%), and critical coronary lesions in 75 (34.9%). Operative mortality was 12.6%. The mortality of the cardiogenic shock patients was greater (22.2%; P=.174). Logistic regression analysis showed patient age (odds ratio, 1.057; 95% confidence interval, 1.010-1.108) and cardiopulmonary bypass (CPB) time (odds ratio, 1.020; 95% confidence interval, 1.008-1.031) were associated with increased operative mortality. An increased number of bypass grafts had a protective effect (odds ratio, 0.241; 95% confidence interval, 0.113-0.515). The actual early mortality was lower than the logistic EuroSCORE calculated mortality (12.6% vs 32.8%, P<.0001). The mean follow-up was 8±4 years. The Kaplan-Meier 10-year survival was 49%. The Cox adjusted overall (early and late) survival and major adverse cardiac events-free survival of the different IABP subgroups was similar. Cox analyses showed peripheral vascular disease, off-pump coronary artery bypass surgery, age, CPB time, female gender, and fewer bypass grafts were associated with decreased survival. In patients supported preoperatively with an IABP, better early and long-term results were strongly related to younger age, a shorter CPB time, and a greater number of bypass grafts. Avoiding the use of CPB (off pump) in these emergency cases is not recommended.

Efficiency, Safety, and Long‐Term Follow‐up of Retrograde Approach for CTO Recanalization: Initial (Belgrade) Experience with International Proctorship

Retrograde approach increases the success rate for percutaneous recanalization of complex chronic total occlusion (CTO) of coronary arteries. The purpose of this study was to describe our initial experience of retrograde percutaneous coronary intervention for CTO program, focusing on its safety and feasibility, and long-term clinical follow-up. The study was a single center retrospective registry which included a total of 40 patients, of 590 CTO treated patients (6.7%), between January 2008 and October 2011, who underwent retrograde approach for CTO recanalization. Mean occlusion duration was 37.8 ± 40.3 months. Overall success recanalization rate was 87.5% (35/40). Septal collaterals were used to access the occlusion in all cases (100%). Retrograde guidewire crossing of collateral channels was successful in 36/40 (90.0%) patients with success rate of CTO recanalization in these patients of 97.2%. Retrograde approach as the primary strategy was applied in 23/40 (57.5%) patients, retrograde approach immediately after antegrade failure attempt was performed in 8/40 (20.0%) patients, and retrograde approach as elective procedure, after previously failed antegrade attempt, was performed in 9/40 (22.5%) patients. The success rate of these strategies was: 87.0% (20/23 patients) for primary, 87.5% (7/8 patients) for retrograde immediately after antegrade failure, and 88.9% (8/9 patients) for retrograde after previous failed antegrade attempt, respectively. Total in-hospital major adverse cardiac events (MACE) rate was 5.0% (2 non-Q-wave myocardial infarctions). The MACE free survival at median follow-up of 20 months was 89% (95% CI: 78-100%). This study has demonstrated that adequate training and international proctorship for this complex and demanding technique is a necessity and prerequisite to achieve high overall success rates, with acceptable complication rates and excellent long-term survival rate.

Effect of coronary bifurcation angle on clinical outcomes in Chinese patients treated with crush stenting: a subgroup analysis from DKCRUSH-1 bifurcation study

Background Bifurcation angles may have an impact on the clinical outcomes of crush stenting. We sought to compare high (≥60°) with low (&lt;60°) bifurcation angle in patients who underwent either classical or double kissing (DK) crush stenting for bifurcation lesions from the DKCRUSH-1 data base. Methods There were 212 patients with 220 lesions, some with low-angle (n=138) and some with high-angle (n=74). Angiography was indexed at 8-month after procedure. Primary endpoint was the occurrence of major adverse cardiac events (MACEs), defined as cardiac death, myocardial infarction and target lesion revascularization (TLR). Secondary endpoint included late lumen loss, the rate of restenosis, and final kissing balloon inflation (FKBI). Results At 8 months, clinical follow-up was 100%; angiographic follow-up was 75% in the low-angle group and 83.3% in the high-angle group. There were no significant differences in the FKBI between the high-angle group (91.43%) and the low-angle group (82.39%). In the high angle group, there was a significant difference in contrast volume used (P=0.005) but no significant difference in acute gain, minimum lumen diameter (MLD), late loss and diameter stenosis in the pre-bifurcation segment, post-bifurcation segment or side branch. When lesions were assigned into with-(n=133) and without-FKBI (n=42), significant side-branch late loss was seen in the group without-FKBI ((0.65±0.49) mm vs (0.47±0.62) mm, P=0.02), with a resultant greater restenosis rate (37.68% vs 18.32%, P=0.001). No difference was detected in the MACE free survival rate between the high and low angle groups (82.39% vs 82.36%, P=0.84). The rate of stent thrombosis tended to be higher in the lower-angle group although there was no significant difference (P=0.38). The TLR free survival rate was 87.2% in the with-FKBI group vs 73.5% in the without-FKBI group (P=0.001). Cox regression analysis showed that the independent predictors for target vessel revascularization were the side branch stent MLD post stenting (hazard ratios (HR) 1.028, 95% CI 2.357–16.233, P=0.002), lack of FKBI (HR 4.910, 95% CI 4.706–8.459, P=0.001) and unsatisfactory kissing (HR 3.120, 95% CI 2.975–5.431, P=0.001). Conclusions Bifurcation angles do not influence the clinical outcome of crush stenting. Successful final kissing balloon inflation, regardless of bifurcation angles, can predict TLR.

Estudo randomizado e comparativo da intervenção coronária percutânea com stents recobertos por titânio-óxido nítrico ou de aço inoxidável em pacientes com doença arterial coronária: estudo RIO

BACKGROUND: Stent coating with titanium-nitride oxide (Titan) has been shown to reduce neointimal hyperplasia in both animals and humans. A prospective, randomized, clinical study was designed to compare the incidence of major adverse cardiac events (MACE) after two years in patients with the Titan stent versus the stainless steel stent. METHODS: Two hundred patients (228 stenosis) submitted to stent implantation between October 2005 and May 2006 were randomized into two groups: I) Bare metal stent (100); II) Titan (100) and followed clinically. MACE was defined as a composite of death, acute myocardial infarction or clinically driven revascularization of target lesion. MACE and angina free survival after 2 years were compared between the two groups. RESULTS: All procedures were successful in both groups. Baseline clinical and angiographic characteristics were similar in both groups. Mean follow-up period was 482 ± 264 days. After 30 days, MACE was 2% in group I and 1% in group II (P = 0.32). MACE free survival at 2 years was significantly better in the Titan group than in the bare metal stent group (93.6% vs. 82.4%; P = 0.036) as well as angina free survival (84% vs. 71%; P = 0.02). CONCLUSIONS: Revascularization with Titan stent in chronic coronary artery disease is safe, effective, and reduces the incidence of MACE and angina after two years when compared with the bare metal stent.

Partial vs Full Coverage for Tandem Lesions in Culprit Vessel During Primary Coronary Intervention in Patients With Acute ST-Elevation Myocardial Infarction The PERFECT-AMI Study

The efficacy of partial vs full coverage for tandem lesions in the culprit vessel during primary percutaneous coronary intervention (PCI) after ST-elevation myocardial infarction (STEMI) was compared in the present study. The 76 patients with STEMI and tandem lesions in the culprit vessel were randomized to receive stent implantation for an occluded/culprit lesion only (partial group) or complete coverage of lesions (full group). After PCI, patients in the partial group had more complete ST-segment resolution (STR) at 90 min (60.5% vs 28.9%, P=0.006), Thrombosis In Myocardial Infarction (TIMI) flow grade 3 (68.4% vs 28.9%, P=0.001), and myocardial blush grade 3 (42.1% vs 15.8%, P=0.04) than those in the full group. At 6 months, the major adverse cardiac events-free survival rate did not differ significantly between groups, but left ventricular (LV) ejection fraction was improved in the partial group. Multivariate analysis revealed pre-procedural TIMI flow grade >1 and door-to-balloon time <90 min were positively associated with complete STR at 90 min, whereas full coverage for tandem lesions was an independent factor for poor STR (odds ratio 2.58, 95% confidence interval 1.08-5.42, P=0.03). For acute STEMI patients with tandem lesions in the culprit vessel, primary stenting for the occluded lesion only is beneficial in improving myocardial perfusion and LV function.

Interventional therapy of coronary artery disease in China: retrospective and perspective

Interventional therapy of coronary artery disease in China: retrospective and perspective

Long term efficacy and safety of Chinese made sirolimus eluting stents: results, including off label usage, from two centres over three years

Multiple randomized clinical trials have demonstrated that drug eluting stents can significantly reduce the rates of restenosis and subsequent adverse events across lesion and patient. We investigated the medium term clinical efficacy and safety of Firebird sirolimus eluting stent (SES) in coronary artery disease. The sample was 509 consecutive patients with coronary artery disease (CAD) who were treated by Firebird SES and finished three-year clinical follow-up. The occurrences of major adverse cardiac events (MACE) and Academic Research Consortium defined stent thrombosis (ST) were evaluated in patients with and without diabetes mellitus. Three hundred and thirty three patients (65.4%) were treated by Firebird SES by off label indications. Angiographic success was achieved in 98.3% of the lesions. MACE and target vessel revascularization rates at 6-month, 1 year's and 3 years' clinical follow-up were 2.4% and 1.4%, 4.1% and 2.8%, 7.9% and 5.1%, respectively. The cumulative 3-year MACE free survival rate was 92.1%. After 3 years, DM patients had significantly higher rates of MACE (13.7% vs 6.4%, P < 0.05) and TVR (9.8% vs 4.0%, P < 0.05) and the cumulative MACE free survival rate was very significantly lower in the DM group (86.4% vs 93.6%, P < 0.05). ST occurred in 7 patients (1.4%) at the end of 3 years' follow-up, 5 of them had definite ST with 4 cases presenting with myocardial reinfarction and 1 with unstable angina, the other 2 with probable ST had reinfarction in the stented coronary territory without angiographic follow-up. There was no difference in occurrence of ST between off label (1.5%) and on label groups (1.1%, P = 0.07). In daily practice, about 2/3 of patients were treated by Firebird SES by off label indications. Medium term clinical follow-up of 3 years indicated CAD patients treated by Firebird SES had a low MACE and acceptable ST rate. DM patients had higher rates of adverse events and than non DM.

Sirolimus-eluting cobalt-chromium stents: two-year clinical results from first-in-man study on the Firebird 2TM stent

Drug-eluting stents (DES) have been shown to significantly reduce clinical events and angiographic restenosis in the treatment of coronary artery disease (CAD). This study was conducted to assess the long-term efficacy and safety of the polymer-based sirolimus-eluting cobalt-chromium Firebird 2 stents in the treatment of patients with CAD. This first-in-man study using the Firebird 2 stent is a prospective, historically-controlled multicenter clinical study, which enrolled 67 patients with CAD who were treated with the sirolimus-eluting cobalt-chromium stent (Firebird 2, Microport Shanghai, Firebird 2 group), compared to another 49 patients treated with a bare cobalt alloy stent (Driver, Medtronic, control group). Continued 2-year clinical follow-up was performed after getting the initial 6-month angiographic and 1-year clinical follow-up. The incidence of major adverse cardiac events (MACE) including cardiac death, reinfarction and target lesion revascularization (TLR) and stent thrombosis were compared between the two groups. All patients in the Firebird 2 group (100.0%) and 48 patients in the control group (98.0%) completed the 2-year clinical follow-up. At the 1-year follow-up the use of the Firebird 2 stent was highly effective, resulting in a significant 94% decrease of TLR (26.5% in the control group and 1.5% in the Firebird 2 group, P<0.0001). A significant difference in TLR was maintained at 2-year follow-up, Firebird 2 group 1.5% and the control group 31.3% (P<0.0001). Between 1- and 2-year post-stenting, no more TLR occurred in the Firebird 2 group compared with two cases in the control group (P>0.05). There was a 1.5% incidence of MACE at 1- and 2-year follow-up in the Firebird 2 group, compared with 26.5% and 33.3% in the control group, respectively (all P<0.0001). The cumulative 1- and 2-year MACE free survival rates were 98.5% in the Firebird 2 group vs 73.5% and 66.7% in the control group (log rank P<0.0001). No case of stent thrombosis occurred during 2-year follow-up in the Firebird 2 group, compared with one case that suffered a definite stent thrombosis in the control group at 19-month post-stenting: this patient presented with unstable angina pectoris and was treated by balloon angioplasty. Compared with the bare cobalt alloy stent, the Firebird 2 sirolimus-eluting cobalt-chromium stent is safe and effective in treating patients with CAD. The use of this stent was associated with a sustained clinical benefit and significantly lower rate of TLR and MACE up to 2 years post-stenting.

A novel ultra-thin bare metal stent (BMS): results from a worldwide registry

To evaluate a new generation, thin strut, stainless steel Tsunami coronary stent in a contemporary percutaneous coronary intervention (PCI) practice across a wide geographical area. Patients (n=1,437) with single or multiple vessel coronary artery disease undergoing PCI in 82 sites in Europe, Asia, and Australia were enrolled in the MATSURI registry. Clinical follow-ups were scheduled at 1, 6 and 18 months. Primary endpoint was major adverse cardiac events (MACE) rate at 6 months. Diabetes was present in 25% of patients, 40% had unstable angina, 54% multivessel disease and 31% previously underwent PCI/CABG. Procedural success was achieved in 98.1% of patients. MACE rate was 1.8%, 7.3%, and 12.6% for 1, 6 and 18 month follow-up, respectively. At 6 months, the incidence of cardiac death, MI and TLR were 1%, 1.9% and 4.5% respectively, and confirmed stent thrombosis occurred in 0.2% of patients. Lower risk patients (43% of registry population) had six months MACE free survival of 96.7%. Based on the results of this large registry we can conclude that the Tsunami BMS combines excellent deliverability and safety for all, together with very low MACE rates for lower risk patients. Long term follow-up confirmed sustained clinical benefit.

The Long-Term Clinical Outcomes of Primary PTCA with Heparin-Coated Stent in Acute Myocardial Infarction

Background and Objectives:Primary percutaneous coronary intervention (PCI) has been reported to be effective reperfusion therapy for acute myocardial infarction (AMI). In the very thrombotic environment of AMI, primary PCI, with heparin-coated stents, has been known to reduce the early reocclusion of the stented vessel by preventing thrombosis. However, little data exist regarding the long-term clinical outcomes. The aim of our study was to evaluate the safety, feasibility and long-term efficacy of heparin-coated stents in AMI. Subjects and Methods:Between January 1998 and July 2002, primary PCI with heparin-coated stents was performed in 132 consecutive patients (98 males, with a mean age of 56.3±10.7 years) admitted with the diagnosis of AMI within 12 hours from the onset of the chest pain. Major adverse cardiac events (MACE), including death, MI, TLR (target lesion revascularization) and CABG, were recorded during hospitalization and the follow-up period. Angiograms were obtained at the baseline, after stent implantation and at 6 months following implantation. Results:The angiographic and procedure success rate was 96.2%. During hospitalization, there was no evidence of reocclusion of stented vessel, but 1 patient underwent a repeat PCI due to dissection. There were no bleeding complications. A six-month angiographic follow-up was completed in 47.2% of eligible patients and binary restenosis was present in 20.1%. During the long-term clinical followup (mean follow-up period 37.2±17.2 months), there were 12 deaths, 1 myocardial infarction and 18 TLR. The MACE free survival rate was 76.5%. Conclusion:Primary PCI, with heparin-coated stents, shows favorable long-term clinical outcomes. (Korean Circulation J 2004;34(6):540-547)