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

Abstract

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.

Long-term outcomes of biodegradable versus durable polymer drug-eluting stents in patients with acute ST-segment elevation myocardial infarction: a pooled analysis of individual patient data from three randomised trials

“…Although PCI with DES improves efficacy outcomes in patients with STEMI, maintenance of superior safety outcomes in the long term has not yet been conclusively demonstrated in comparison to BMS in STEMI, even for newer-generation DES [5][6][7][8] . Late adverse events have been linked to an inflammatory reaction and delayed arterial healing -at least in part due to durable polymer coatings -and the extent of this problem may be more pronounced in the setting of STEMI.…”

Incidence and Clinical Predictors of Stent Restenosis and Early Stent Occlusion in Patients with Acute Myocardial Infarction Treated by Bare Metal Stents: Importance of Infarct Location and Serum Creatinine Level

“…Many studies [1][2][3][4][5][6][7] have shown that uncoated BMS placement is inferior to DES use in terms of reducing target lesion or vessel revascularization during a 1 to 3 year follow-up period after emergency stent implantation at the site of coronary occlusion. No significant difference was observed between BMS and DES in terms of the incidence of death and recurrent AMI [1,2,6,[10][11][12].…”

“…No significant difference was observed between BMS and DES in terms of the incidence of death and recurrent AMI [1,2,6,[10][11][12]. On the other hand, accumulating data began to show a higher risk of stent thrombosis in those treated with DES over a 1-year follow-up period [3,6,9]. Kalesan et al [8] demonstrated in meta-analysis that 1 year after AMI treatment, very late SO is significantly more likely to occur in patients receiving DES than in those with BMS placement.…”

“…As compared to uncoated Bare Metal Stents (BMS), many studies [1][2][3][4][5][6][7] have shown that Drug-Eluting Stent (DES) implantation at the infarct-related lesion can reduce target lesion revascularization markedly during a 1 to 3 year follow-up period. However, there is accumulating evidence that raises concerns regarding a higher risk of stent thrombosis after DES placement, especially in the setting of AMI [3-6, 8, 9].…”

Local Stent-Based Release of Transforming Growth Factor–β1 Limits Arterial In-Stent Restenosis

“…3,[5][6][7] Drug-eluting stents (DES) designed to directly address ISR have further reduced restenosis rates to less than 10% but are associated with an increased risk of late in-stent thrombosis, and the long-term effects after complete elution of the therapeutic agents remain unclear. [8][9][10] To further develop strategies to prevent ISR, continued elucidation of the pathobiologic processes underlying neointima formation following placement of BMS remains warranted.…”