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Objectives: This study assessed the ability of the dual-antiplatelet therapy (DAPT) score in stratifying ischemic and bleeding risk in a contemporary percutaneous coronary intervention (PCI) population., Background: The DAPT score is recommended by guidelines as a tool to stratify ischemic and bleeding risk. Its utility in contemporary PCI is unknown., Methods: The study studied patients in GLOBAL LEADERS (A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) who were free of major ischemic and bleeding events and adhered to antiplatelet strategy during the first year after PCI. The primary ischemic endpoint was the composite of myocardial infarction or stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium type 3 or 5. Outcomes from 12 to 24 months after PCI were compared according to the DAPT score., Results: Of 11,289 patients that were event-free after the first year, 6,882 and 4,407 patients had low (<2) and high (≥2) DAPT scores, respectively. Compared with a low DAPT score, patients with a high DAPT score had a higher rate of the composites of myocardial infarction or stent thrombosis (0.70% vs. 1.55%; p < 0.0001). The rate of Bleeding Academic Research Consortium type 3 or 5 bleeding was 0.54% and 0.30% in the low and high DAPT score groups, respectively (p = 0.058). The effect of ticagrelor versus aspirin monotherapy on primary ischemic and bleeding endpoints during the second year were no different among the 2 groups., Conclusions: The DAPT score can stratify ischemic but not bleeding risk in a contemporary PCI population during the second year. The score did not provide additional value for selection of antiplatelet strategy beyond the first year., (Copyright © 2020 American College of Cardiology Foundation. All rights reserved.)

Background: The bio-engineered COMBO stent (OrbusNeich Medical BV, The Netherlands) is a dual-therapy pro-healing stent. This novel technology may allow a shorter duration of dual antiplatelet therapy (DAPT) after stenting. We present the first 3 year clinical outcomes of patients treated with COMBO stent., Methods and Results: The prospective, multicenter, investigator-initiated, all-comers REMEDEE Registry evaluates clinical outcomes after COMBO stent treatment. A 1,000 patients were enrolled between June 2013 and March 2014. Patients had a mean of 65 years ±11, 26% of the patients were females and 18% diabetics. More than 50% of patients presented with acute coronary syndrome, 60% of treated lesions were AHA/ACC lesion type B2 or C. Target lesion failure (TLF) at 3 year follow-up occurred in 10.7% of patients (N = 105). The separate components cardiac death, target vessel myocardial infarction and target lesion revascularization occurred in 4.1%, 2.0%, and 7.1%, respectively of patients. Definite stent thrombosis (ST) was observed in 0.7% of all patients. At 3-year follow-up there were only 73 patients taking DAPT., Conclusions: At 3-year follow-up, patients treated with COMBO stent in the present large prospective all-comers cohort, continue to show good clinical outcomes. Clinicaltrials.gov identifier: NCT01874002., Condensed Abstract: The COMBO stent is a sirolimus-eluting stent with a luminal anti-CD34-antibody layer, that binds endothelial progenitor cells. These cells can differentiate to endothelial cells and stimulate early endothelialization of the stent. The REMEDEE Registry is the first large, multicenter, prospective, cohort study evaluating the clinical outcomes of 1,000 all-comers patients treated with COMBO stent. Target lesion failure at 3 year follow-up was 10.7% and the rate of definite ST was 0.7%., (© 2018 Wiley Periodicals, Inc.)

Background: Several studies have found that among patients with ST-segment elevation myocardial infarction (STEMI) treated by thrombolysis, female sex is associated with a worse outcome. However, still controversial is the prognostic impact of gender in primary angioplasty, especially in the era of drug-eluting stents (DES). Therefore, the aim of this study was to investigate sex-related differences in clinical outcome in patients with STEMI treated with primary angioplasty with Bare-Metal Stent (BMS) or DES., Methods: Our population is represented by 6298 STEMI patients undergoing primary angioplasty and stent implantation included in the DESERT database. Follow-up data were collected from 3 to 6 years after primary angioplasty., Results: Female gender was observed in 1466 (23.2%) out of 6298 STEMI patients. Women were older (65.3 ± 12.4 vs 59.3 ± 11.4 years, p < 0.001), with higher prevalence of diabetes (18.6% vs 14.5%, p < 0.001), hypertension (52.4% vs 41.4%, p < 0.001), slightly longer ischemia time (272 ± 247 vs 258 ± 220 min, p = 0.06). No difference was observed in terms of angiographic and procedural characteristics. Follow-up data were available at a mean of 1201 ± 441 days. At long-term follow-up female gender was associated with a significantly higher rate of death (11.7% vs 8.5%, HR [95% CI] = 1.45 [1.18-1.78], p < 0.001), while no difference was observed in terms of reinfarction (HR [95% CI] = 1.14 [0.89-1.45], p = 0.3), ST (HR [95% CI] = 1.12 [0.85-1.48], p = 0.4), with similar temporal distribution (acute, subacute, late and very late) between male and female patients, and no difference in TVR (HR [95% CI] = 1.11 [0.95-1.3], p = 0.2, p = 0.2). These results were confirmed in both patients receiving BMS or DES. The impact of female gender on mortality disappeared after correction for baseline confounding factors (HR [95% CI] = 0.88 [0.71-1.09], p = 0.25)., Conclusions: This study shows that in patients with STEMI treated by primary angioplasty, female gender is associated with higher mortality rate in comparison with men, and this is mainly due to their higher clinical and angiographic risk profiles. In fact, female sex did not emerge as an independent predictor of mortality., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Despite mechanical reperfusion, elderly patients with ST-segment elevation myocardial infarction (STEMI) still experience unsatisfactory outcomes. Drug-eluting stents (DES) have significantly reduced target-vessel revascularization (TVR), but concerns have emerged about the higher risk of late stent thrombosis, which may be more pronounced in elderly patients. Therefore, the aim of this study was to evaluate the impact of age on outcome in patients with STEMI who underwent primary angioplasty with bare-metal stents (BMS) or DES. Our population comprised 6,298 patients who underwent primary angioplasty and stent implantation included in the Drug-Eluting Stent in Primary Angioplasty (DESERT) Cooperation database. Age was significantly associated with female gender (p <0.001), diabetes (p <0.001), hypertension (p <0.001), previous myocardial infarction (MI; p <0.001), ischemia time (p <0.001), and anterior MI (p <0.001) but inversely related to smoking (p <0.001). Elderly patients most often had infarct-related artery located in the descending artery (p = 0.014) and impaired postprocedural thrombolysis in myocardial infarction flow (p <0.001). Elderly patients were less often on clopidogrel at follow-up. At long-term follow-up, age was associated with a higher rate of death (hazard ratio [95% confidence interval] = 2.17 [1.97 to 2.39], p <0.0001), whereas no impact was observed on reinfarction (p = 0.36), stent thrombosis (p = 0.84), and TVR (p = 0.54). These results were confirmed in patients receiving both BMS and DES. The impact of age on mortality was confirmed after correction for baseline confounding factors (gender, diabetes hypertension, hypercholesterolemia, smoking, ischemia time, anterior MI, infarct-related artery location, and postprocedural thrombolysis in myocardial infarction 3 flow; adjusted hazard ratio [95% confidence interval] = 2.13 [1.78 to 2.56], p <0.001). In conclusion, this study shows that in patients with STEMI who underwent primary angioplasty, age is independently associated with higher mortality, observed with both BMS and DES, whereas no impact was observed on the rate of reinfarction, stent thrombosis, and TVR., (Copyright © 2013 Elsevier Inc. All rights reserved.)

The National Institute for Clinical Excellence (NICE) guidelines recommend the use of bare-metal stents (BMS) in non-complex lesions with a low risk of restenosis (diameter ≥3 mm and lesion length ≤15 mm) and the use of drug-eluting stents (DES) in more complex lesions with a high risk of restenosis (diameter <3.0 mm or lesion length >15 mm). However, the guidelines were created based on studies evaluating BMS and DES only. We performed an analysis of patients undergoing non-urgent percutaneous coronary intervention with the novel endothelial cell capturing stent (ECS). The ECS is coated with CD34(+) antibodies that attract circulating endothelial progenitor cells to the stent surface, thereby accelerating the endothelialization of the stented area. We analyzed all patients enrolled in the worldwide e-HEALING registry that met the NICE criteria for either low-risk or high-risk lesions and were treated with ≥1 ECS. The main study outcome was target vessel failure (TVF) at 12-month follow-up, defined as the composite of cardiac death or MI and target vessel revascularization (TVR). A total of 4,241 patients were assessed in the current analysis. At 12-month follow-up, TVF occurred in 7.0% of the patients with low-risk lesions and in 8.8% of the patients with high-risk lesions (p = 0.045). When evaluating the diabetic patients versus the non-diabetic patients per risk group, no significant differences were found in TVF, MI or TVR in either risk group. The ECS shows good clinical outcomes in lesions carrying either a high or a low risk of restenosis according to the NICE guidelines with comparable rates of cardiac death, myocardial infarction, and stent thrombosis. The TVF rate with ECS was slightly higher in patients with high-risk lesions, driven by higher clinically driven TLR. The risk of restenosis with ECS in patients carrying high-risk lesions needs to be carefully considered relative to other risks associated with DES. Furthermore, the presence of diabetes mellitus did not influence the incidence of TVF in either risk group.

Background: Concerns have emerged regarding a higher risk of stent thrombosis after drug-eluting stent (DES) implantation, especially in the setting of ST-segment elevation myocardial infarction (STEMI). Our objective was to perform a meta-analysis using individual patient data to evaluate the long-term safety and effectiveness of DES compared with bare-metal stents (BMS) in patients undergoing primary percutaneous coronary intervention for STEMI., Data Sources: Formal searches of electronic databases (MEDLINE and CENTRAL) and scientific session presentations from January 2000 to June 2011., Study Selection: We examined all completed randomized trials of DES for STEMI., Data Extraction: Individual patient data., Data Synthesis: Individual patient data were obtained from 11 of 13 trials identified, including a total of 6298 patients (3980 [63.2%] randomized to DES [99% sirolimus-eluting or paclitaxel-eluting stents] and 2318 [36.8%] randomized to BMS). At long-term follow-up (mean [SD], 1201 [440] days), DES implantation significantly reduced the occurrence of target-vessel revascularization (12.7% vs 20.1%; hazard ratio [95% CI], 0.57 [0.50-0.66]; P < .001, P value for heterogeneity, .20), without any significant difference in terms of mortality, reinfarction, and stent thrombosis. However, DES implantation was associated with an increased risk of very late stent thrombosis and reinfarction., Conclusions: The present pooled patient-level meta-analysis demonstrates that among patients with STEMI undergoing primary percutaneous coronary intervention, sirolimus-eluting and paclitaxel-eluting stents compared with BMS are associated with a significant reduction in target-vessel revascularization at long-term follow-up. Although there were no differences in cumulative mortality, reinfarction, or stent thrombosis, the incidence of very late reinfarction and stent thrombosis was increased with these DES.

Aims: To compare the angiographic and clinical performance of a paclitaxel-eluting stent using reservoirs technology and a bioabsorbable polymer, without surface coating (CoStar), vs. an equivalent bare metal stent (BMS) using an identical metallic platform., Methods and Results: Three hundred and three (303) patients (335 lesions) with de novo coronary artery stenosis suitable for elective percutaneous treatment were randomised in an international multicentre single-blind trial to receive the CoStar stent (n=152) or the equivalent BMS (n=151). At eight months, the primary endpoint of in-segment binary restenosis was significantly lower in the CoStar than in the BMS group (17.6 vs. 30.3%, p=0.029). In-stent late loss (0.41 vs. 0.81 mm; p<0.0001) and all the other angiographic secondary endpoints also favoured CoStar. The composite of cardiac death, myocardial infarction related to the target vessel and target lesion revascularisation was significantly lower at eight months in the CoStar arm (19.7 vs. 29.1%; hazard ratio 0.54, 95% CI: 0.34-0.87; p=0.010), mainly due to lower incidence of target lesion revascularisation (15.1 vs. 26.5%; 95% CI: hazard ratio 0.45, 95% CI: 0.27-0.76; p=0.002)., Conclusions: As compared with a bare metal stent of identical design, the paclitaxel elution from reservoirs results in significantly less binary restenosis, less late loss and lower revascularisation rates at eight months. Therefore, based on these data, the CoStar paclitaxel-eluting stent was found to be effective and safe.

Aims: e-HEALING is a worldwide, internet-based registry designed to capture post marketing clinical data on the use of the Genous™ EPC capturing R stent™. Rapid restoration of a healthy endothelial layer after stent placement by capturing circulating endothelial progenitor cells may reduce both stent thrombosis (ST) and in-stent-restenosis., Methods and Results: We planned a 5,000 patient registry with ≥1 lesion suitable for stenting. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularisation. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularisation (TLR), and individual outcomes including ST. A total of 4,939 patients received ≥1 Genous stent between 2005 and 2007. Baseline characteristics showed a median age of 63 years, 79% males, 25% diabetics, and 37% with prior MI. A total of 49% of lesions treated were ACC/AHA type B2 or C; 1.1 stents per lesion were used. At 12 months, TVF occurred in 8.4% and the composite of cardiac death, MI or TLR in 7.9%. Twelve-month TLR and ST were 5.7% and 1.1%, respectively., Conclusions: Coronary stenting with the Genous results in good clinical outcomes, and low incidences of repeat revascularisation and ST.

Background: We evaluated the Genous™ Bio-engineered R stent™ in elderly patients undergoing non-urgent percutaneous coronary intervention. The elderly have an increased risk of (temporary) discontinuation of clopidogrel, which is associated with a higher risk of developing stent thrombosis (ST)., Methods and Results: In the e-HEALING registry, 2,651 patients were <65, 1,403 were 65-74 and 869 were ≥ 75 years old. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related car-diac death or myocardial infarction and target vessel revascularization. Secondary outcomes included target lesion revascularization (TLR) and ST. Cumulative event rates were estimated with the Kaplan-Meier method and compared with a log-rank test. TVF occurred significantly more often in elderly patients compared with younger patients (7.0% in patients aged < 65, 8.8% in patients aged 65-74 and 11.7% in patients aged ≥ 75 years, P<0.001). There was a trend to higher TLR with increasing age (log-rank P=0.06) and no difference in ST., Conclusions: The 1-year results of the Genous stent in a population of elderly patients show a significantly higher TVF rate compared with younger patients, mainly driven by a higher mortality. Although there was a trend to higher TLR rates with increasing age, there was no difference in ST. This attests to the safety of this therapy for the elderly, in whom there could be concerns with administering long-term dual antiplatelet therapy.

Background: More than 10 years ago, survival benefit of primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) was demonstrated in several randomized trials. Since then, primary PCI has been implemented in routine daily practice and is in the guidelines of the preferred reperfusion therapy for patients with STEMI. We aimed to assess time-dependent changes in baseline characteristics, concomitant treatment and prognosis in patients with STEMI treated with primary PCI., Methods: Individual patient data from all 4732 patients admitted for primary PCI for STEMI between 1994 and 2004 in our hospital were recorded. Patient characteristics, concomitant treatment and one-year outcome were evaluated., Results: During the 11-year period, mean age and proportion of female were increasing, whereas door to balloon time decreased. Stent implantation rates increased from 2% to 84%. At discharge, prescription of aspirin, beta-blockers, statins, and ADP receptor blockers increased significantly. From 1994 to 2004, hospital stay shortened from 10.4 to 4.5 days p<0.001. Hospital and one-year mortality decreased, from 6.7% to 1.4% and 9% to 4.9% (both p<0.001), respectively., Conclusions: Between 1994 and 2004, utilization of stents and recommended pharmacotherapies increased remarkably. Hospital stay and both hospital and one-year mortality decreased significantly.

Background: Primary angioplasty has been shown to improve the outcome in selected patients with ST-segment elevation myocardial infarction. However, no data have been reported of patients with proximal left anterior descending artery occlusion. In the Zwolle-6 randomized trial, a total of 1683 consecutive patients with ST-segment elevation myocardial infarction were randomized to stenting or balloon angioplasty without any exclusion criteria. The aim of this substudy was to investigate the benefits of coronary stenting as compared to balloon angioplasty in patients with proximal left anterior descending artery occlusion., Methods: From April 1997 to October 2001, among a total of 1683 consecutive patients with ST-segment elevation myocardial infarction randomized to stenting or balloon angioplasty before the initial angiography, a total of 218 patients underwent primary angioplasty of proximal left anterior descending artery occlusion. One-year follow-up data were available from all patients., Results: A total of 107 patients were randomized to stent and 111 patients to balloon angioplasty. The cross-over rates from balloon to stent and stent to balloon were 35.1 and 13.1%, respectively (P<0.0001). The groups were comparable in terms of postprocedural thrombolysis in myocardial infarction flow, myocardial blush grade, distal embolization, and ST-segment resolution. Stenting was associated with benefits in terms of restenosis (27.6 vs. 53.8%, P=0.03) and target vessel revascularization (15.0 vs. 24.3%, P=0.081), whereas no difference was observed in mortality (11.2 vs. 13.5%, P>0.1) and reinfarction (11.2 vs. 8.1%, P>0.1) as compared with balloon angioplasty., Conclusion: As compared with balloon angioplasty, routine stenting does reduce angiographic restenosis, without significant benefits in terms of death and reinfarction among patients undergoing primary angioplasty for ST-segment elevation myocardial infarction due to proximal left anterior descending artery occlusion.

Introduction: Although stenting has been shown to reduce the need for target vessel revascularization (TVR) in acute myocardial infarction (AMI), the benefits in terms of mortality and reinfarction are still unclear. Previous meta-analyses have failed to include all currently available randomized trials. The aim of the current study was to perform an updated meta-analysis to evaluate the benefits of coronary stenting for AMI in terms of mortality, reinfarction, and TVR, and whether these benefits correlated with the patient's risk profile., Methods: The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL) from January 1990 to September 2006. We examined all completed, published, randomized trials of coronary stenting for AMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, rescue angioplasty, stenting, and balloon angioplasty. Information on study design, type of stent, inclusion and exclusion criteria, primary endpoint, number of patients, angiographic and clinical outcome, were extracted by two investigators. Disagreements were resolved by consensus., Results: A total of 13 randomized trials were identified and analyzed involving 6922 patients (3460 or 50% randomized to stent and 3462 or 50% to balloon). Stenting was not associated with a significant reduction in 30-day (2.9% versus 3.0%, p=0.81) and 1-year mortality (5.1% versus 5.2%, p=0.81), as compared to balloon angioplasty. However, a significant relationship was observed between patient's risk profile and mortality benefits from coronary stenting at 30-day (beta -0.63 [-25.4; -2.45], p=0.022) and 1-year follow-up (beta -0.61 [-15.9; -0.76], p=0.034). Stenting was associated with benefits in terms of TVR at both 30-day (3.1% versus 5.1%, p<0.0001) and 6 to 12 months (11.3% versus 18.4%, p<0.0001) follow-up, without any difference in terms of reinfarction., Conclusions: Among AMI patients undergoing primary angioplasty, coronary stent implantation, when anatomically and technically feasible, may be considered, in addition to benefits in terms of TVR, to reduce mortality in high-risk patients, who may be identified by the use of validated risk scores.

Background: Coronary stenting has been shown to improve clinical outcome in comparison with balloon angioplasty in patients with ST-segment elevation myocardial infarction (STEMI). However, few data have been reported so far in the elderly. Thus, the aim of the current study was to evaluate the benefits from routine stenting in this high-risk subset of patients., Methods: In the Zwolle-6 randomized trial a total of 1683 consecutive patients with STEMI was randomized to stenting or balloon angioplasty without any exclusion criteria. One year follow-up data were available from all patients., Results: Among a total of 143 patients older than 75 years, 73 were randomized to stent and 67 to balloon angioplasty. No difference was observed in 1-year mortality (17.1% vs 11.9%, p=NS), reinfarction (9.2% vs 11.9%, p=NS), target vessel revascularization (15.8% vs 14.9%, p=NS) or major adverse cardiac events (28.9% vs 26.9%, p=NS) between the groups at 1-year follow-up., Conclusion: In conclusion, our study showed that as compared to balloon angioplasty, the clinical benefits of routine coronary stenting in the setting of acute myocardial infarction may not be necessarily applicable to elderly patients.

Background: Primary angioplasty has been shown to improve outcomes in selected patients with ST-segment elevation myocardial infarction. However, no information has been reported so far in small vessels. In the Zwolle-6 randomized trial, consecutive patients with ST-segment elevation myocardial infarction were randomized to stenting or to balloon angioplasty without any exclusion criterion. In this study, we present data on patients with small vessels (< 3.0 mm)., Methods: From April 1997 to October 2001, 798 patients randomized to balloon angioplasty or to stenting before their initial angiogram underwent primary angioplasty of small vessels, defined according to a postprocedural reference diameter < or = 3 mm. One-year follow-up data were available from all patients., Results: Three hundred eighty-seven patients were randomized to stent, whereas 411 were to balloon. The crossover rates from balloon to stent and from stent to balloon were 28% and 13.9%, respectively (P < .001). The groups were comparable in terms of postprocedural TIMI flow, myocardial blush grade, distal embolization, and ST-segment resolution. No difference was observed in 1-year mortality (7.2% vs 5.8%, P = not significant [NS]), target vessel revascularization (17.8% vs 22.1%, P = NS), and major adverse cardiac events (24.8% vs 29.0%, P = NS) between the groups., Conclusions: As compared with balloon angioplasty, routine stenting does not seem to improve clinical outcomes in patients undergoing primary angioplasty of small vessels. Future trials are certainly needed to evaluate the safety and benefits of drug-eluting stents in this high-risk subset of patients.

Background: Recurrent infarction after fibrinolytic therapy has been shown to be associated with increased mortality. The aim of this study was to analyze predictors and outcome of reinfarction in a consecutive series of patients undergoing primary angioplasty., Methods: Our population is represented by a total of 1955 patients with ST-segment elevation myocardial infarction treated by primary angioplasty between 1997 to 2002. All clinical, angiographic, and follow-up data were prospectively collected. Early reinfarction was defined when two clinical criteria were satisfied within 30 days after the procedure: (1) recurrent ischemic symptoms for >15 minutes after resolution of symptoms from initial MI; (2) new ST-T-wave changes or new Q waves; (3) reelevation in creatine kinase (CK) or CK-MB to higher levels than normal (or by another 20% if already higher than normal)., Results: Early reinfarction was observed in 75 (3.8%) patients. At multivariate analysis, advanced Killip class (P = .002), poor preprocedural TIMI flow (P = .014), administration of IIb-IIIa inhibitors (P = .02), and diabetes (P = .038) were independent predictors of 30-day reinfarction. A total of 107 (5.6%) patients had died. Early reinfarction was associated with a significantly higher mortality (22.7% vs 4.9%, P < .001), even after adjustment for confounding factors (blood pressure, diabetes, Killip class, preprocedural TIMI flow, coronary stenting, multivessel disease, anterior infarct location, preprocedural stenosis, and administration of IIb-IIIa inhibitors) (HR 3.32, 95% CI 1.88-5.84, P < .0001)., Conclusions: This study showed that, among patients undergoing primary angioplasty for ST-segment elevation myocardial infarction, advanced Killip class at presentation, poor preprocedural TIMI flow, the use of IIb-IIIa inhibitors, and diabetes are independently associated with 30-day reinfarction. Early reinfarction is an independent predictor of 1-year mortality.

Background: Primary stenting for ST-segment elevation myocardial infarction (STEMI) has been shown to improve the outcome because of the benefits in terms of restenosis. However, still controversial are the benefits in terms of reperfusion. In the Zwolle-6 randomized trial, a consecutive cohort of patients with STEMI was randomized to balloon angioplasty or stenting, without exclusion criteria. In this study, we analyzed data on myocardial perfusion and the extent of myocardial necrosis., Methods: From April 1997 to October 2001, a total of 1683 consecutive patients with STEMI were randomized to stenting or balloon angioplasty. No exclusion criteria were applied. Myocardial perfusion was evaluated by myocardial blush grade and ST-segment resolution. The extent of myocardial necrosis was evaluated by enzymatic infarct size and predischarge ejection fraction. All data were prospectively collected., Results: A total of 785 patients (92.5%) in the stent group and 763 patients (91.5%) in balloon group underwent primary angioplasty. The 2 groups showed similar baseline characteristics. No difference was observed between stent and balloon in myocardial blush grade, complete ST-segment resolution, distal embolization, enzymatic infarct size, and predischarge ejection fraction at both intention-to-treat and actual treatment analysis, even when restricted to patients with anterior infarction. Time delay to treatment (earlier or later than 6 hours) did not affect the results. No difference was observed in 1-year mortality (6.0% vs 5.9%, P = NS)., Conclusions: As compared with balloon angioplasty, routine stenting does not improve myocardial perfusion, the rate of distal embolization, and the extent of myocardial necrosis in a large cohort of unselected patients with STEMI.

Improvement of stent deployment techniques and advances in antiplatelet therapy have shown that stenting in the setting of ST-elevation myocardial infarction (STEMI) is safe and effective. Randomized trials have found that as compared to balloon angioplasty, coronary stenting does not reduce mortality and reinfarction, despite the reduction in target vessel revascularization. Furthermore, these benefits seem to be reduced when applied to unselected patients with STEMI. Direct stenting represents an attractive strategy with potential benefits in terms of myocardial perfusion. Future randomized trials are needed to evaluate if this strategy is associated with a significant impact on outcome, and to provide cost-benefit analysis of an unrestricted use of drug-eluting stent in this high-risk subset of patients. Data from randomized trials have shown that the additional use of abciximab reduces mortality in primary angioplasty. Since the feasibility of long-distance transportation has been shown in several randomized trials, early pharmacological pretreatment may confer further advantages by early recanalization and shorter ischemic time, particularly in high-risk patients. Further large randomized trials are needed to clarify the potential role of small molecules in primary angioplasty for STEMI.

Advances in anti-platelet therapy and improvement of stent deployment techniques have improved the safety and efficacy of stenting in the setting of ST-segment-elevation myocardial infarction (STEMI). However, in randomized trials, routine coronary stenting does not reduce mortality and re-infarction, compared to balloon angioplasty. Further, the benefits in target vessel revascularization seem to be reduced when applied to unselected patients with STEMI. Direct stenting represents an attractive strategy with potential benefits in terms of myocardial perfusion. Future large randomized trials are needed to evaluate whether this strategy has a significant impact on outcome, and to provide a cost-benefit analysis of the unrestricted use of drug-eluting stents in this high-risk subset of patients. The additional use of abciximab reduces mortality in primary angioplasty. Since the feasibility of long-distance transportation has been shown in several randomized trials, early pharmacological pre-treatment may confer further advantages by early recanalization and shorter ischaemic time, particularly in high-risk patients. Further randomized trials are needed to clarify the potential benefits from early abciximab administration and the potential role of small molecules in primary angioplasty for STEMI.

Objective: To evaluate the impact of routine stenting, compared with balloon angioplasty, in unselected patients presenting with ST segment elevation myocardial infarction (STEMI)., Design: Randomised trial., Setting: Tertiary referral centre., Participants: All patients presenting with STEMI randomly assigned to stenting or balloon angioplasty. No exclusion criteria were applied., Main Outcome Measure: The primary end point was combined death or reinfarction at one year's follow up., Results: 1683 consecutive patients with STEMI were randomly assigned before angiography to stenting (n = 849) or balloon angioplasty (n = 834). A total of 785 patients (92.5%) in the stent group and 763 patients (91.5%) in the balloon group actually underwent primary angioplasty. The groups were comparable in terms of postprocedural TIMI (thrombolysis in myocardial infarction) flow, myocardial blush grade, and distal embolisation. No difference was observed in clinical outcome at both intention to treat (14% v 12.5%, not significant) and actual treatment analyses (12.4% v 11.3%, not significant)., Conclusions: Compared with balloon angioplasty, routine stenting does not seem to reduce death and reinfarction in a large cohort of unselected patients with STEMI.

The aim of this multicenter registry was to examine the in-hospital and long-term clinical outcomes of patients who underwent Tsunami SV stent implantation for the treatment of lesions involving coronary arteries with a reference diameter of <2.5 mm. The angiographic success rate was 97.5%. No in-hospital or 30-day major adverse cardiac events occurred. During the 6-month follow-up, there was 1 cardiac death (1%), and 5 subjects (4.8%) underwent repeat target lesion revascularization.

Background: Vitamin therapy to lower homocysteine levels has recently been recommended for the prevention of restenosis after coronary angioplasty. We tested the effect of a combination of folic acid, vitamin B6, and vitamin B12 (referred to as folate therapy) on the risk of angiographic restenosis after coronary-stent placement in a double-blind, multicenter trial., Methods: A total of 636 patients who had undergone successful coronary stenting were randomly assigned to receive 1 mg of folic acid, 5 mg of vitamin B6, and 1 mg of vitamin B12 intravenously, followed by daily oral doses of 1.2 mg of folic acid, 48 mg of vitamin B6, and 60 microg of vitamin B12 for six months, or to receive placebo. The angiographic end points (minimal luminal diameter, late loss, and restenosis rate) were assessed at six months by means of quantitative coronary angiography., Results: At follow-up, the mean (+/-SD) minimal luminal diameter was significantly smaller in the folate group than in the placebo group (1.59+/-0.62 mm vs. 1.74+/-0.64 mm, P=0.008), and the extent of late luminal loss was greater (0.90+/-0.55 mm vs. 0.76+/-0.58 mm, P=0.004). The restenosis rate was higher in the folate group than in the placebo group (34.5 percent vs. 26.5 percent, P=0.05), and a higher percentage of patients in the folate group required repeated target-vessel revascularization (15.8 percent vs. 10.6 percent, P=0.05). Folate therapy had adverse effects on the risk of restenosis in all subgroups except for women, patients with diabetes, and patients with markedly elevated homocysteine levels (15 micromol per liter or more) at baseline., Conclusions: Contrary to previous findings, the administration of folate, vitamin B6, and vitamin B12 after coronary stenting may increase the risk of in-stent restenosis and the need for target-vessel revascularization., (Copyright 2004 Massachusetts Medical Society)

Controversy still surrounds the question, which antiplatelet drug should be added to aspirin in patients undergoing coronary stent implantation. The aim of the current study was to compare ticlopidine and clopidogrel in a consecutive series of patients with ST-segment elevation myocardial infarction (STEMI) treated with primary stenting. Our population is represented by 883 consecutive patients with STEMI undergoing primary stenting from April 1997 to October 2001. All clinical, angiographic, and follow-up data were prospectively collected. A total of 523 patients on clopidogrel were compared with 360 patients on ticlopidine after primary stenting. Except for age and statin therapy, no difference in demographic and clinical characteristics was observed between the two groups. Patients on clopidogrel had a higher rate of successful reperfusion (80.7% vs 73.1%, p = 0.008). No difference was observed between the two groups at both 30-day and 1-year follow-up. These data were confirmed after correction for age, successful reperfusion and statin therapy. This study shows no difference in long-term clinical outcome between clopidogrel and ticlopidine as adjunctive antiplatelet therapy in patients with STEMI undergoing stent implantation.

Background: Stenting improves cardiac outcome in comparison with balloon angioplasty. Compared with conventional surgery, off-pump bypass surgery on the beating heart without cardiopulmonary bypass may reduce morbidity, hospital stay, and costs. The purpose, therefore, was to compare cardiac outcome, quality of life, and cost-effectiveness 1 year after stenting and after off-pump surgery., Methods and Results: Patients referred for angioplasty (n=280) were randomly assigned to stenting (n=138) or off-pump bypass surgery. At 1 year, survival free from stroke, myocardial infarction, and repeat revascularization was 85.5% after stenting and 91.5% after off-pump surgery (relative risk, 0.93; 95% CI, 0.86 to 1.02). Freedom from angina was 78.3% after stenting and 87.0% after off-pump surgery (P=0.06). Quality-adjusted lifetime was 0.82 year after stenting and 0.79 year after off-pump surgery (P=0.09). Hospital stay after the initial procedure was 1.43 and 5.77 days, respectively (P<0.01). Stenting reduced overall costs by 2933 dollars (26.2%) per patient (8276 dollars versus 11 209 dollars; P<0.01). Stenting was more cost-effective in 95% of the bootstrap estimates., Conclusions: At 1 year, stenting was more cost-effective than off-pump surgery while maintaining comparable cardiac outcome and quality of life. Stenting rather than off-pump surgery, therefore, can be recommended as a first-choice revascularization strategy in selected patients.

Objectives: To determine the safety and efficacy of a post-stenting anti-platelet regimen of aspirin without additional ticlopidine or clopidogrel after successful heparin-coated stent implantation., Methods: A prospective, non-randomized, multi-center pilot study of patients undergoing percutaneous coronary intervention, including those with acute coronary syndromes and small vessels with one-month clinical follow-up, was undertaken. Patients received a heparin-coated stent and were treated with aspirin only., Results: Over a period of 6 months, a total of 122 patients were recruited in 6 centers. Their mean age was 57.2 10.0 years, 79% were male and 31% had unstable angina. Most (75%) had single-vessel disease, predominantly of the left anterior descending artery (51%), with a mean reference diameter of 2.44 mm 0.44 mm at baseline and 2.48 0.41 mm post stenting. At a 1-month clinical follow-up, no major adverse cardiovascular events (including subacute stent thrombosis) had occurred. Five patients were readmitted to hospital for symptoms unrelated to the interventional procedure., Conclusions: Heparin-coated stent implantation using an antiplatelet regimen of aspirin only, appears to be safe and feasible. A randomized trial of a larger number of patients appears warranted.

Objectives: We sought to assess the relationship between completeness of revascularization and adverse events at one year in the ARTS (Arterial Revascularization Therapies Study) trial., Background: There is uncertainty to what extent degree of completeness of revascularization, using up-to-date techniques, influences medium-term outcome., Methods: After consensus between surgeon and cardiologist regarding the potential for equivalence in the completeness of revascularization, 1,205 patients with multivessel disease were randomly assigned to either bypass surgery or stent implantation. All baseline and procedural angiograms and surgical case-record forms were centrally assessed for completeness of revascularization., Results: Of 1,205 patients randomized, 1,172 underwent the assigned treatment. Complete data for review were available in 1,143 patients (97.5%). Complete revascularization was achieved in 84.1% of the surgically treated patients and 70.5% of the angioplasty patients (p < 0.001). After one year, the stented angioplasty patients with incomplete revascularization showed a significantly lower event-free survival than stented patients with complete revascularization (i.e., freedom from death, myocardial infarction, cerebrovascular accident and repeat revascularization) (69.4% vs. 76.6%; p < 0.05). This difference was due to a higher incidence of subsequent bypass procedures (10.0% vs. 2.0%; p < 0.05). Conversely, at one year, bypass surgery patients with incomplete revascularization showed only a marginally lower event-free survival rate than those with complete revascularization (87.8% vs. 89.9%)., Conclusions: Complete revascularization was more frequently accomplished by bypass surgery than by stent implantation. One year after bypass, there was no significant difference in event-free survival between surgically treated patients with complete revascularization and those with incomplete revascularization, but patients randomized to stenting with incomplete revascularization had a greater need for subsequent bypass surgery.

Objectives: We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm)., Background: Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length., Methods: A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) <30% by on-line quantitative coronary angiography (QCA). "Bail-out stenting" was performed for flow-limiting dissections or >50% DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms., Results: Bailout stenting was necessary in 149 patients (34%) and was associated with a significantly increased risk of peri-procedural infarction (p < 0.02). Among the 288 randomized patients, the mean lesion length was 27+/-9 mm, and the vessel diameter was 2.78+/-0.52 mm. The procedural success rate was 90% for the 143 patients assigned to BA alone (control group), as compared with 93% in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p < 0.001) and led to reduced angiographic restenosis (27% vs. 42%, p = 0.022). Freedom from MACE at nine months was 77% in both groups., Conclusions: A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months.

Aims: To prospectively evaluate the influence of stent length on 6 month clinical and angiographic outcome, in patients with native coronary lesions up to 45 mm in length, undergoing elective Magic Wallstent implantation., Methods and Results: On the basis of pre-procedural angiography, 276 patients (aged 61.3+/-10.2 years; 78.6% male; 41.7% unstable angina) with a total of 302 lesions were prospectively assigned to one of five different length categories of Magic Wallstent. Angiography in multiple matched projections before and after implantation and at 6 months follow-up was analysed at the core laboratory. Primary end-points for the efficacy analysis were cumulative incidence of major adverse cardiac events and quantitative coronary angiography analysis 6 months after stent implantation. Magic Wallstent implantation was successful in 301 of 302 lesions and in 98.6% a residual stenosis <20% by online quantitative coronary angiography was achieved. At 30 days, 6.2% (1.8% subacute occlusion) of patients had experienced major adverse cardiac events, 27.5% at 6 months and 30.4% at 9 months. Angiographic restenosis occurred in 37%. Restenosis rates for the mini, extra-short, short, medium and long Wallstent groups were 25.9%, 25%, 22.6%, 36.2% and 67.5%, respectively. Multivariate analysis revealed stent length to be independently associated with greater angiographic restenosis and major adverse cardiac events., Conclusions: While shorter Magic Wallstents provided late outcomes comparable with short balloon-expandable stents, excessive restenosis with longer Wallstents should obviate their use in elective percutaneous intervention. Long coronary lesions provide a challenging substrate for emerging antirestenosis therapies, such as stent coatings and brachytherapy., (Copyright 2001 The European Society of Cardiology.)

Objective: To investigate the long term clinical outcome and cost-effectiveness of stenting compared with balloon angioplasty in patients with acute myocardial infarction., Methods: Patients with acute myocardial infarction were randomly allocated to primary stenting (112) or balloon angioplasty (115). The primary end point was the cumulative first event rate of death, non-fatal reinfarction, or target vessel revascularisation. Secondary end points were restenosis at six months and the cost-effectiveness at follow up., Results: After 24 months, the combined clinical end point of death/reinfarction was 4% after stenting and 11% after balloon angioplasty (p = 0.04). Subsequent target vessel revascularisation was necessary in 15 patients (13%) after stenting and in 39 (34%) after balloon angioplasty (p < 0.001). The cumulative cardiac event-free survival rate was also higher after stenting (84% v 62%, p < 0.001). The angiographic restenosis rate after stenting was less than after balloon angioplasty (12% v 34%, p < 0.001). Despite the higher initial costs of stenting (Dfl 21 484 v Dfl 18 625, p < 0.001), the cumulative costs at 24 months were comparable with those of balloon angioplasty (Dfl 31 423 v Dfl 32 933, p = 0.83)., Conclusions: Compared with balloon angioplasty, primary stenting for acute myocardial infarction results in a better long term clinical outcome without increased cost.

Objectives: This study was performed to assess whether angiography six months after coronary balloon angioplasty or stent implantation has an influence on clinical management and one-year outcome., Background: The Benestent II study randomized 827 patients to balloon angioplasty or stent implantation. A subrandomization was undertaken allocating patients to six-month clinical follow-up (CF) or clinical and angiographic follow-up (AF)., Methods: Seven hundred and six patients (349 CF and 357 AF) had no intercurrent angiography, so that restenosis and disease progression elsewhere remained unknown until the time of six-month follow-up. These two groups, which were well matched at enrolment, were compared with respect to symptoms, medication and major cardiac events defined as death, myocardial infarction and need for revascularization at six and 12 months., Results: At six-month follow-up, 53 (15%) of the CF and 76 (21%) of the AF patients had stable angina (p = 0.041), while 5 (1%) and 4 (1%) had symptoms of unstable angina. At 12-month follow-up, 44 (13%) patients in both groups had stable angina, and only 1 patient in the CF group had unstable angina. Seventy-seven patients (27 CF and 50 AF; p < 0.01) had major cardiac events between 6 and 12 months. Of the 349 patients in the CF group, 21 underwent repeat percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery between 6 and 12 months, compared with 44 of the 357 patients in the AF group (relative risk 2.05 [1.24 to 3.37], p = 0.003)., Conclusions: Patients who had AF six months after balloon angioplasty or stent implantation experienced more repeat revascularization procedures than those who had CF. They also had significantly more angina at six-month follow-up but this may be due to bias.

Although the benefits of primary angioplasty for acute myocardial infarction have been demonstrated, several areas for improvement remain. The initial results of randomized trials have shown that primary stenting for acute myocardial infarction is feasible and effective with a low complication rate. Primary stenting results in a reduction in recurrent infarction and in the need for subsequent re-intervention, when compared to balloon angioplasty. Whether long-term clinical and angiographic outcome is also favourable has yet to be confirmed in large-scale multicentre trials, before primary stenting can be adopted as routine approach for acute myocardial infarction.

Background: Although the benefits of primary angioplasty in acute myocardial infarction have been demonstrated, several areas for improvement remain. Therefore, a prospective randomized trial comparing primary stenting with balloon angioplasty in patients with acute myocardial infarction was conducted., Methods and Results: Patients with acute myocardial infarction were randomly assigned to undergo either primary stenting (n=112) or balloon angioplasty (n=115). The clinical end points were death, recurrent infarction, subsequent bypass surgery, or repeat angioplasty of the infarct-related vessel. The overall mortality rate at 6 months was 2%. Recurrent infarction occurred in 8 patients (7%) after balloon angioplasty and in 1 (1%) after stenting (P=0.036). Subsequent target-vessel revascularization was necessary in 19 (17%) and 4 (4%) patients, respectively (P=0.0016). The cardiac event-free survival rate in the stent group was significantly higher than in the balloon angioplasty group (95% versus 80%; P=0.012)., Conclusions: In selected patients with acute myocardial infarction, primary stenting can be applied safely and effectively, resulting in a lower incidence of recurrent infarction and a significant reduction in the need for subsequent target-vessel revascularization compared with balloon angioplasty.

Objectives: This study sought to determine the 1-year clinical follow-up of patients included in the Benestent trial., Background: The Benestent trial is a randomized study comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in patients with stable angina and a de novo coronary artery lesion. Seven-month follow-up data have shown a decreased rate of restenosis and fewer clinical events in the stent group. It is not established whether this favorable clinical outcome is maintained for longer periods or whether coronary stenting defers restenosis and its subsequent clinical manifestations., Methods: To clarify this uncertainty, we updated clinical information on all but 1 of 516 patients enrolled in the Benestent trial (257 in balloon group, 259 in stent group) at least 12 months after the intervention. Major clinical events (primary clinical end point) were tabulated according to the intention to treat principle and included death, the occurrence of a cerebrovascular accident, myocardial infarction, the need for bypass surgery or a further percutaneous intervention in the previously treated lesion., Results: After 1 year, no significant differences in mortality (1.2% vs. 0.8%), stroke (0.0% vs. 0.8%), myocardial infarction (5.0% vs. 4.2%) or coronary bypass graft surgery (6.9% vs. 5.1%) were found between the stent and balloon angioplasty groups, respectively. However, the requirement for a repeat angioplasty procedure was significantly lower in the stent group (10%) than the balloon angioplasty group (21%, relative risk [RR] 0.49, 95% confidence interval [CI] 0.31 to 0.75, p = 0.001), and overall primary end points were less frequently reached by stent group patients (23.2%) than those in the balloon group (31.5%, RR 0.74, 95% CI 0.55 to 0.98, p = 0.04). No differences were found between groups with respect to functional class angina and prescribed medication at the time of follow-up., Conclusions: These clinical follow-up data show that the benefit of elective native coronary artery stenting in patients with stable angina is maintained to at least 1 year after the procedure and results in a significantly reduced requirement for repeat intervention.

Background: The purpose of the Benestent-II Pilot Study was to evaluate the safety of delaying and eliminating anticoagulant therapy in patients receiving a heparin-coated stent in conjunction with antiplatelet drugs., Methods and Results: The study consisted of three initial phases (I, II, III) during which resumption of heparin therapy after sheath removal was progressively deferred by 6, 12, and 36 hours. In phase IV, coumadin and heparin were replaced by 250 mg ticlopidine and 100 mg aspirin. Of the 207 patients with stable angina pectoris and a de novo lesion in whom heparin-coated stent implantation was attempted, implantation was successful in 202 patients (98%). Stent thrombosis did not occur during all four phases, and the overall clinical success rate at discharge was 99%. Bleeding complications requiring blood transfusion or surgery fell from 7.9% in phase I to 5.9%, 4%, and 0% in the three following phases. Hospital stay was 7.4, 6.1, 7.2, and 3.1 days for the consecutive phases. The restenosis rate for the combined four phases was 13% (15% in phase I, 20% in phase II, 11% in phase III, and 6% in phase IV). The overall rate of reintervention for the four phases was 8.9%. At 6 months, 84%, 75%, 94%, and 92% of the patients of phases I to IV, respectively, were event free. For the four phases, the event-free rate was 86%, which compares favorably with the rate observed in the Benestent-I study (80%; relative risk, 0.68 [0.45 to 1.04])., Conclusions: The implantation of stents coated with polyamine and end-point-attached heparin in stable patients with one significant de novo coronary lesion is well tolerated, is associated with no (sub)acute stent thrombosis, and results in a favorable event-free survival after 6 months.

During a 2-year period, 136 self-expanding Wallstents were implanted in saphenous vein bypass grafts in 69 patients with end-stage coronary artery disease. All patients had severe symptoms and the majority were poor candidates for either repeat surgery or conventional bypass coronary angioplasty because of unfavorable native anatomy, impaired left ventricular function, or a high-risk bypass lesion anatomy for coronary angioplasty. All procedures were technically successful without major complications and a need for emergency bypass surgery. However, during the hospital stay acute thrombotic complications occurred in seven patients (10%) resulting in one death and acute myocardial infarction in five patients and necessitating emergency repeat PTCA in two patients and repeat CABG in four. Twenty-three patients had serious hemorrhagic complications directly related to the rigorous anticoagulation schedule. Two patients died of fatal cerebral bleeding. During follow-up, another five patients died accounting for a total mortality rate of 12%. At late angiographic follow-up (4.9 +/- 3.4 months, n = 53), 25 patients (47%) had a restenosis (greater than or equal to 50% DS) within or immediately adjacent to the stent, necessitating reintervention in 19 patients (PTCA, n = 12; repeat CABG, n = 7). In the group without stent-related restenosis (n = 28), 15 patients had progression of disease in either the native or bypass vessels leading to recurrence of major anginal symptoms within 1 to 24 months. Ten of these patients required further intervention (stent, n = 6; PTCA, n = 3; repeat CABG, n = 1). Stenting in saphenous coronary bypass grafts can be performed safely with excellent immediate angiographic and clinical results.(ABSTRACT TRUNCATED AT 250 WORDS)

Stent implantation in native coronary arteries may be complicated by acute thrombosis, despite the use of stringent anticoagulation. Thrombotic occlusion of stented venous grafts may occur less frequently, possibly because of the larger caliber of these grafts. We report our experience with 46 stents (Wallstent, Medinvent, Lausanne, Switzerland) implanted in 35 lesions of 24 consecutive patients (mean age 64 years, range 43 to 75). Two overlapping stents were implanted in seven patients, and three overlapping stents were positioned in two. After implantation, activated partial thromboplastin time was maintained at two to three times the control level by intravenous administration of heparin (160 to 550 mg daily) until thrombotest values were reduced 5% to 10% by acenocoumarol. Impending thrombotic occlusion was recognized in two suboptimally anticoagulated patients: patient A after implantation of four stents and patient B after anticoagulation therapy was discontinued because of acute upper gastrointestinal bleeding. Coronary artery bypass grafting was performed successfully in both patients. A third patient had a myocardial infarction on day 7 after stent implantation, in spite of adequate anticoagulation and optimal medical drug therapy. It is concluded that stringent anticoagulation therapy appears mandatory to maintain graft patency after stent implantation.