Validation of the DAPT score in patients randomized to 6 or 12 months clopidogrel after predominantly second-generation drug-eluting stents (original) (raw)
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Journal of the American College of Cardiology, 2014
Background: A sizeable proportion of patients treated with PCI are unable to take dual antiplatelet therapy (DAPT) for the guideline-recommended period of 6-12 months. Optimal treatment of patients at high bleeding risk thus remains uncertain. The BioFreedomÔ drug-coated stent (DCS) (Biosensors Europe SA, Morges, Switzerland) is polymer-and carrier-free, releases Biolimus A9 into the vessel wall over a period of 28 days, and then technically becomes a BMS. Methods: 2465 patients at high bleeding risk from 68 centers in Europe, Asia, and Canada were enrolled from Dec 2012 to May 2014 in a double-blinded randomized 1:1 comparison of GazelleÔ BMS (Biosensors Europe SA, Morges, Switzerland) vs. BioFreedom DCS with a 1 month course of DAPT only, in both arms. The 2 primary endpoints at 1 year are a composite of cardiovascular death, MI and stent thrombosis for safety and the rate of ci-TLR for efficacy. The DSMB is monitoring all safety data at 4 months. Results: In the overall trial population, the most frequently used inclusion criteria were: advanced age (64%), need for long term oral anticoagulation (36%), anemia, recent bleeding or transfusion (21%), renal insufficiency (19%), planned surgery (15%) and concomitant cancer (9%). When compared to those included in "all-comer" trials, patients were markedly older (76AE9.4 years), and had more co-morbidities (diabetes 33%, atrial fibrillation 34%, peripheral vascular disease 16%, heart failure 13%, prior stroke 10%, COPD 11%). 1.7 stents/patients were implanted for a total stent length of 32 mm/patient. Technical procedure success was high at 96%. 66% of patients were discharged on DAPT alone, 30% on DAPT + oral anticoagulation, and 2% on a single antiplatelet agent + oral anticoagulation. Current data are preliminary; Data from all recruited patients will be available at time of presentation. Conclusions: The trial is a first in 3 ways: it focuses on a never previously studied high bleeding risk population, characterized by advanced age and more comorbid conditions. It is the first evaluation of a DCS with clinical endpoints and it comprises the shortest ever DAPT course with an active stent to be evaluated for both safety and efficacy.
Circulation, 2014
Introduction: The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent implantation (DES) is not certain. The AHA/ACC guidelines recommend 12 months of DAPT based on observational trials. Recently, several large randomized controlled trials (RCT) suggested a noninferiority of shorter duration of DAPT and other trials showed a benefit from extended duration of DAPT after 12 months of DES implantation. Methods: Pub-Med databases were searched for RCTs comparing the continued use of DAPT to shorter duration of DAPT (aspirin alone) for variable durations beyond 3 months of DES implantation. Our analysis was limited to trials with clinical outcomes. Odds ratio (OR) and 95% confidence intervals (CI) were calculated using fixed and random-effects models. Subgroup analyses were performed for second generation DES and for trials comparing 12 months of DAPT vs. earlier interruption or longer duration of DAPT. Results: We identified 10 RCTs including 32,136 subjects randomized to continued use of DAPT vs. aspirin alone for variable durations after 3 months of DES implantation. There was no significant heterogeneity among studies (Q test P > 0.1). Compared to shorter DAPT, longer DAPT resulted in a significant reduction in stent thrombosis (0.3% vs. 0.7%, P < 0.01) and myocardial infarction (1.3% vs. 2%, P < 0.01), and a significant increase in major bleeding (0.8% vs. 0.4%, P < 0.01). There was no difference in cardiac deaths or stroke. All-cause deaths were slightly lower with shorter DAPT compared to longer DAPT (OR 0.8, 95% CI 0.7 to 0.99, P = 0.04). A small number of subjects were included between 3 and 6 months after DES implantation. Conclusion: DAPT continued beyond 6 months after second generation DES implantation decreases stent thrombosis and myocardial infarction, but increases major bleeding and all-causes mortality compared to shorter DAPT (aspirin alone). There was no difference in cardiac mortality or stroke.
Background The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is unclear, and its risks and benefits may vary according to DES generation. Objectives We sought to evaluate efficacy and safety of DAPT extent after DES implantation. Methods We included randomized controlled trials (RCTs), which tested different duration of DAPT after DES implantation: shorter DAPT (S-DAPT) defined as the per-protocol minimum duration of DAPT after the procedure and longer DAPT (L-DAPT) defined as the per-protocol period of more prolonged DAPT. Primary efficacy and safety outcomes were definite/probable stent thrombosis (ST) and clinically significant bleeding (CSB), respectively. Results Ten RCTs (n = 32,135) were included. Compared with L-DAPT, S-DAPT had an overall higher rate of ST (odds ratio [OR]: 1.71; 95% confidence interval [CI]: 1.26-2.32; p = 0.001). The effect on ST of S-DAPT was attenuated with use of second-generation DES (OR: 1.54; 95% CI: 0.96-2.47) compared with use of first-generation DES (OR: 3.94, 95% CI: 2.20-7.05; p for interaction = 0.008). S-DAPT had an overall significantly lower risk of CSB (OR: 0.63; 95% CI: 0.52-0.75; p < 0.001). Finally, a numerically lower all-cause mortality was observed with S-DAPT (OR: 0.87; 95%CI: 0.74-1.01; p = 0.073), without statistical significance. Conclusions S-DAPT had overall lower rates of bleeding yet higher rates of ST compared with L-DAPT; the latter effect was significantly attenuated with use of second-generation DES, although this analysis may have been limited by the different DAPT durations among studies. All-cause mortality was numerically higher with L-DAPT without reaching statistical significance. Prolonging DAPT requires careful assessment of the trade-off between ischemic and bleeding complications.