Paclitaxel-eluting versus bare metal stents in primary PCI: a pooled patient-level meta-analysis of randomized trials.

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). Therefore, we performed a meta-analysis based on individual patient data to evaluate long-term safety and effectiveness of paclitaxel-eluting stent (PES) as compared to bare metal stents (BMS) in patients undergoing primary percutaneous coronary intervention (PCI) for STEMI. We examined all completed randomized trials on PES for STEMI. Individual patient data were obtained from six trials. We performed survival analyses with the use of Cox-regression analysis stratified according to trial. Kaplan-Meier survival curves are presented with event rates reported as estimated probabilities. A subsequent landmark analysis was performed for patients who were event-free at 1-year follow-up in order to define outcome in terms of early (≤1 year) and late (>1 year) events. A total of six trials were finally included in the meta-analysis with 4435 patients, 2875 (64.8 %) assigned to PES and 1560 (35.2 %) to BMS. No significant differences in baseline characteristics were observed between the two groups. However, a significantly higher percentage of patients in the DES group were on dual antiplatelet therapy during 3-year follow-up, as compared to BMS. At long-term follow-up (1,095 [1,090-1,155] days), no significant difference between PES and BMS was observed in mortality (9.2 vs 11.9 %, respectively, HR [95 % CI] = 0.84 [0.67, 1.06], p = 0.15, pheterogeneity = 0.59), reinfarction (8.8 vs 7 %, respectively; HR [95 % CI] = 1.10 [0.84, 1.44], p = 0.51, pheterogeneity = 0.32), stent thrombosis (6.7 vs 4.0 % respectively, HR [95 % CI] = 1.13 [0.82, 1.55], p = 0.45, pheterogeneity = 0.99) and TVR (11.9 vs 20.0 %; HR [95 % CI] = 0.64 [0.54, 0.77], p < 0.0001, pheterogeneity = 0.25). Landmark analysis showed that PES was associated with a significantly higher rate of very late reinfarction (>1 year) (5.6 vs 3.9 %, HR [95 % CI] = 1.61 [1.05-2.47], p = 0.03, pheterogeneity = 0.51], very late ST (2.9 vs 1.1 %, HR [95 % CI] = 1.88 [1.00-3.54], p = 0.05, pheterogeneity = 0.94]. The present pooled patient-level meta-analysis demonstrates that among STEMI patients undergoing primary PCI, PES compared to BMS is associated with a significant reduction in TVR 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 PES.

Impact of hypertension on clinical outcome in STEMI patients undergoing primary angioplasty with BMS or DES: insights from the DESERT cooperation.

BACKGROUND: Hypertension is a well known risk factor for atherosclerosis. However, data on the prognostic impact of hypertension in patients with ST elevation myocardial infarction (STEMI) are inconsistent and mainly related to studies performed in the thrombolytic era, with very few data in patients undergoing primary angioplasty. Therefore, the aim of the current study was to evaluate the impact hypertension on clinical outcome in STEMI patients undergoing primary PCI with BMS or DES. METHODS: Our population is represented by 6298 STEMI patients undergoing primary angioplasty included in the DESERT database from 11 randomized trials comparing DES vs BMS for STEMI. RESULTS: Hypertension was observed in 2764 patients (43.9%), and associated with ageing (p<0.0001), female gender (p<0.001), diabetes (p<0.0001), hypercholesterolemia (p<0.0001), previous MI (p=0.002), previous revascularization (p=0.002), longer time-to-treatment (p<0.001), preprocedural TIMI 3 flow, and with a lower prevalence of smoking (41% vs 53.9%, p<0.001) and anterior MI (42% vs 45.9%, p=0.002). Hypertension was associated with impaired postprocedural TIMI 0-2 flow (Adjusted OR [95% CI]=1.22 [1.01-1.47], p=0.034). At a follow-up of 1,201 ± 440 days, hypertension was associated with higher mortality (adjusted HR [95% CI]=1.24 [1.01-1.54], p=0.048), reinfarction (adjusted HR [95% CI]=1.31 [1.03-1.66], p=0.027), stent thrombosis (adjusted HR [95% CI]=1.29 [0.98-1.71], p=0.068) and TVR (adjusted HR [95% CI]=1.22 [1.04-1.44], p=0.013). CONCLUSIONS: This study showed that among STEMI patients undergoing primary angioplasty with DES or BMS, hypertension is independently associated with impaired epicardial reperfusion, mortality, reinfarction and TVR, and a trend in higher ST.

Drug-eluting stents in patients with anterior STEMI undergoing primary angioplasty: a substudy of the DESERT cooperation.

BACKGROUND: Several concerns have emerged on the higher risk of in-stent thrombosis after drug-eluting stent (DES) implantation, especially in the setting of STEMI patients. Few data have even been reported in high-risk patients, such as those with anterior MI. Therefore this represents the aim of the current study. METHODS: The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of DES for STEMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, sirolimus-eluting stent (SES), Cypher, paclitaxel-eluting stent (PES), Taxus. No language restrictions were enforced. RESULTS: Individual patient's data were obtained from 11 out of 13 trials, including a total of 2,782 patients with anterior MI [1,739 or 62.5% randomized to DES and 1,043 or 37.5% randomized to bare-metal stent (BMS)]. At long-term follow-up, no significant benefit was observed with DES as compared to BMS in terms of mortality [9.8 vs 10.9%, HR (95% CI) = 0.81 (0.61, 1.07), p = 0.13, p heterogeneity = 0.18], reinfarction [8.8 vs 6.4%, respectively; HR (95% CI) = 1.14 (0.80, 1.61), p = 0.47, p heterogeneity = 0.82], and stent thrombosis [5.6 vs 5%, OR (95% CI) = 0.88 (0.59, 1.30), p = 0.51, p heterogeneity = 0.65], whereas DES was associated with a significant reduction in terms of target-vessel revascularization (TVR) [13.7 vs 23.4%; OR (95% CI) = 0.56 (0.46, 0.69), p < 0.0001, p het = 0.81] that was observed at both early (within 1 year) [7 vs 14.7%, HR (95% CI) = 0.56 (0.46, 0.69), p < 0.0001, p het = 0.81] and late (>1 year) follow-up [7.2 vs 9%, HR (95% CI) = 0.67 (0.47, 0.96), p = 0.03, p het = 0.96]. CONCLUSIONS: This study showed that among patients with anterior STEMI undergoing primary angioplasty, SES and PES, as compared to BMS, are associated with a significant reduction in TVR at long-term follow-up. No concerns were found with the use of first-generation DES in terms of mortality.

Gender-related differences in outcome after BMS or DES implantation in patients with ST-segment elevation myocardial infarction treated by primary angioplasty: insights from the DESERT cooperation.

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.

Time course, predictors and clinical implications of stent thrombosis following primary angioplasty. Insights from the DESERT cooperation.

Primary percutaneous coronary intervention (pPCI) has improved survival as compared to thrombolysis. Concerns still remain regarding the risk of stent thrombosis in the setting of STEMI, especially after drug-eluting stent (DES) implantation. Therefore, the aim of this study was to report on the timing of stent thrombosis (ST) with both DES and bare metal stents (BMS) and its prognostic significance in patients undergoing pPCI. The Drug-Eluting Stent in Primary Angioplasty (DESERT) cooperation is based on a pooled database including individual data of randomised trials that evaluate the long-term safety and effectiveness of DES as compared to BMS in patients undergoing pPCI for STEMI. Follow-up data were collected for 3-6 years after the procedure. ST was defined as definite or probable, based on the ARC definition. The study population consists of 6,274 STEMI patients undergoing primary angioplasty with BMS or DES. At 1201 ± 440 days, ST occurred in 267 patients (4.25%). Most of the events were acute or subacute (within 30 days) and very late (> 1 years), with different distribution between DES vs BMS. Patients with ST were more often diabetic (21.7% vs 15.1%, p=0.005), more frequently had post-procedural TIMI 0-2 flow (14.0% vs 9.3%, p = 0.01), and were less often treated with dual antiplatelet therapy at one year follow-up. Diabetes (p = 0.036), post-procedural TIMI 0-2 Flow (p = 0.013) and ischaemia time > 6 hours (p = 0.03) were independent predictors of ST. Post-procedural TIMI 0-2 flow (p = 0.001) and ischaemia time > 6 hours (p < 0.001) were independent predictors of early ST, ischaemia time > 6 hours (p = 0.05) was independent predictor of late ST, whereas diabetes (p = 0.022) and use of DES (p = 0.002) were independent predictors of very late ST. ST was associated with a significantly higher mortality (23.6% vs 6%, p < 0.001). The greatest impact on mortality was observed with subacute (40.4%) and late (20.9%) ST, as compared to acute (12.5%) and very late (9.1%) ST. ST was an independent predictor of mortality (HR [95%CI] = 3.73 [2.75-5.07], p < 0.001). In conclusion, ST occurs relatively frequently also beyond the first year for up to six years after pPCI in STEMI, with higher late occurrence rates among patients treated with first generation DES. ST after pPCI is a powerful predictor of mortality, especially subacute ST.

Impact of age on long-term outcome after primary angioplasty with bare-metal or drug-eluting stent (from the DESERT cooperation).

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.

Meta-analysis comparing efficacy and safety of first generation drug-eluting stents to bare-metal stents in patients with diabetes mellitus undergoing primary percutaneous coronary intervention.

Several concerns have emerged regarding the higher risk for stent thrombosis (ST) after drug-eluting stent (DES) implantation, especially in the setting of ST-segment elevation myocardial infarction (STEMI). Few data have been reported so far in patients with diabetes mellitus, which is associated with high rates of target vessel revascularization after bare-metal stent (BMS) implantation but also higher rates of ST after DES implantation. Therefore, the aim of this study was to perform a meta-analysis of individual patients' data to evaluate the long-term safety and effectiveness of DES compared with BMS in patients with diabetes who undergo primary percutaneous coronary intervention for STEMI. Published reports were scanned by formal searches of electronic databases (MEDLINE and CENTRAL). All completed randomized trials of DES for STEMI were examined. No language restrictions were enforced. Individual patients' data were obtained from 11 of 13 trials, including a total of 972 patients with diabetes (616 [63.4%] randomized to DES and 356 [36.6%] to BMS). At long-term follow-up (median 1,095 days, interquartile range 1,087 to 1,460), DES significantly reduced the occurrence of target vessel revascularization (hazard ratio 0.42, 95% confidence interval 0.29 to 0.59, p <0.0001), without any significant difference in terms of mortality, late reinfarction, and ST (>1 year) with DES. In conclusion, this meta-analysis, based on individual patients' data from 11 randomized trials, showed that among patients with diabetes with STEMIs who undergo primary percutaneous coronary intervention, sirolimus-eluting stents and paclitaxel-eluting stents, compared with BMS, are associated with a significant reduction in target vessel revascularization at long-term follow-up, without any apparent concern in terms of mortality, despite the trend toward higher rates of reinfarction and ST.

Impact of diabetes on long-term outcome after primary angioplasty: insights from the DESERT cooperation.

OBJECTIVE: Diabetes has been shown to be associated with worse survival and repeat target vessel revascularization (TVR) after primary angioplasty. The aim of the current study was to evaluate the impact of diabetes on long-term outcome in patients undergoing primary angioplasty treated with bare metal stents (BMS) and drug-eluting stents (DES). RESEARCH DESIGN AND METHODS: Our population is represented by 6,298 ST-segment elevation myocardial infarction (STEMI) patients undergoing primary angioplasty included in the DESERT database from 11 randomized trials comparing DES with BMS. RESULTS: Diabetes was observed in 972 patients (15.4%) who were older (P < 0.001), more likely to be female (P < 0.001), with higher prevalence of hypertension (P < 0.001), hypercholesterolemia (P < 0.001), and longer ischemia time (P < 0.001), and without any difference in angiographic and procedural characteristics. At long-term follow-up (1,201 ± 441 days), diabetes was associated with higher rates of death (19.1% vs. 7.4%; P < 0.0001), reinfarction (10.4% vs. 7.5%; P < 0.001), stent thrombosis (7.6% vs. 4.8%; P = 0.002) with similar temporal distribution--acute, subacute, late, and very late--between diabetic and control patients, and TVR (18.6% vs. 15.1%; P = 0.006). These results were confirmed in patients receiving BMS or DES, except for TVR, there being no difference observed between diabetic and nondiabetic patients treated with DES. The impact of diabetes on outcome was confirmed after correction for baseline confounding factors (mortality, P < 0.001; repeat myocardial infarction, P = 0.006; stent thrombosis, P = 0.007; TVR, P = 0.027). CONCLUSIONS: This study shows that among STEMI patients undergoing primary angioplasty, diabetes is associated with worse long-term mortality, reinfarction, and stent thrombosis in patients receiving DES and BMS. DES implantation, however, does mitigate the known deleterious effect of diabetes on TVR after BMS.

Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials.

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.