Objective To compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents.Design Mixed treatment comparison meta-analysis of 258 544 patient years of follow-up from randomized trials.Data sources and study selection PubMed, Embase, and Central were searched for randomized trials comparing any of the Food and Drug Administration approved durable polymer drug eluting stents (sirolimus eluting, paclitaxel eluting, cobalt chromium everolimus eluting, platinum chromium everolimus eluting, zotarolimus eluting-Endeavor, and zotarolimus eluting-Resolute) or biodegradable polymer drug eluting stents, with each other or against bare metal stents.Outcomes Long term efficacy (target vessel revascularization, target lesion revascularization) and safety (death, myocardial infarction, stent thrombosis). Landmark analysis at more than one year was evaluated to assess the potential late benefit of biodegradable polymer drug eluting stents.Results From 126 randomized trials and 258 544 patient years of follow-up, for long term efficacy (target vessel revascularization), biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.66, 95% credibility interval 0.57 to 0.78) and zotarolimus eluting stent-Endeavor (0.69, 0.56 to 0.84) but not to newer generation durable polymer drug eluting stents (for example: 1.03, 0.89 to 1.21 versus cobalt chromium everolimus eluting stents). Similarly, biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.61, 0.37 to 0.89) but inferior to cobalt chromium everolimus eluting stents (2.04, 1.27 to 3.35) for long term safety (definite stent thrombosis). In the landmark analysis after one year, biodegradable polymer drug eluting stents were superior to sirolimus eluting stents for definite stent thrombosis (rate ratio 0.29, 0.10 to 0.82) but were associated with increased mortality compared with cobalt chromium everolimus eluting stents (1.52, 1.02 to 2.22). Overall, among all stent types, the newer generation durable polymer drug eluting stents (zotarolimus eluting stent-Resolute, cobalt chromium everolimus eluting stents, and platinum chromium everolimus eluting stents) were the most efficacious (lowest target vessel revascularization rate) stents, and cobalt chromium everolimus eluting stents were the safest with significant reductions in definite stent thrombosis (rate ratio 0.35, 0.21 to 0.53), myocardial infarction (0.65, 0.55 to 0.75), and death (0.72, 0.58 to 0.90) compared with bare metal stents.Conclusions Biodegradable polymer drug eluting stents are superior to first generation durable polymer drug eluting stents but not to newer generation durable polymer stents in reducing target vessel revascularization. Newer generation durable polymer stents, and especially cobalt chromium everolimus eluting stents, have the best combination of efficacy and safety. The utility of biodegradable polymer stents in the context o...
-Contemporary second-generation drug-eluting stents (DES) have superior efficacy and safety compared with early generation stents in patients undergoing percutaneous coronary intervention (PCI), in part related to their thinner struts. Whether newer generation ultra-thin DES further improve clinical outcomes compared with older second-generation thicker strut DES is unknown. -We searched PUBMED, EMBASE, and CENTRAL for randomized clinical trials that compared newer generation ultra-thin strut DES (defined as strut thickness<70 microns) versus thicker strut second-generation DES and reported clinical outcomes. The primary outcome was target lesion failure (TLF) (composite of cardiovascular death, target vessel myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR)) evaluated at 1-year follow-up. Tests for subgroup effects based on the ultra-thin strut DES type and based on the comparator DES type were performed using meta-regression analysis. -We identified 10 trials that randomized 11,658 patients and evaluated 3 newer generation ultra-thin strut DES: Orsiro stent (60 μm), MiStent (64 μm) and BioMime (65 μm). When compared with thicker strut second-generation DES, newer generation ultra-thin strut DES were associated with a 16% reduction in TLF (RR=0.84; 95% CI 0.72-0.99) driven by less MI (RR=0.80; 95% CI 0.65-0.99). Ultra-thin strut DES were also associated with qualitatively lower rates of any stent thrombosis (RR=0.72; 95% CI 0.51-1.01). Tests for subgroup effects based on the ultra-thin strut DES type (P=0.58) and the comparator DES type (P=0.98) were not significant, suggesting consistent outcomes across the three ultra-thin strut DES and with the different DES comparators. -In patients undergoing PCI, newer generation ultra-thin strut DES further improve 1-year clinical outcomes compared with contemporary thicker strut second-generation DES.
ObjeCtiveTo evaluate the outcomes with use of renin angiotensin system (RAS) blockers compared with other antihypertensive agents in people with diabetes. Design Meta-analysis.Data sOurCes anD stuDy seleCtiOn PubMed, Embase, and the Cochrane central register of controlled trials databases for randomized trials of RAS blockers versus other antihypertensive agents in people with diabetes mellitus. Outcomes were death, cardiovascular death, myocardial infarction, angina, stroke, heart failure, revascularization, and end stage renal disease. resultsThe search yielded 19 randomized controlled trials that enrolled 25 414 participants with diabetes for a total of 95 910 patient years of follow-up. When compared with other antihypertensive agents, RAS blockers were associated with a similar risk of death (relative risk 0.99, 95% confidence interval 0.93 to 1.05), cardiovascular death (1.02, 0.83 to 1.24), myocardial infarction (0.87, 0.64 to 1.18), angina pectoris (0.80, 0.58 to 1.11), stroke (1.04, 0.92 to 1.17), heart failure (0.90, 0.76 to 1.07), and revascularization (0.97, 0.77 to 1.22). There was also no difference in the hard renal outcome of end stage renal disease (0.99, 0.78 to 1.28) (power of 94% to show a 23% reduction in end stage renal disease). COnClusiOnsIn people with diabetes, RAS blockers are not superior to other antihypertensive drug classes such as thiazides, calcium channel blockers, and β blockers at reducing the risk of hard cardiovascular and renal
In patients with hypertension, a on-treatment systolic BP target of <130 mm Hg achieved optimal balance between efficacy and safety.
Background-Coronary artery bypass graft surgery (CABG) compared with percutaneous coronary intervention (PCI) reduces mortality in patients with diabetes mellitus. However, prior trials compared CABG with balloon angioplasty or older generation stents, and it is not known if the gap between CABG and PCI can be reduced by newer generation drugeluting stents. Methods and Results-PUBMED/EMBASE/CENTRAL search for randomized trials comparing mode of revascularization in patients with diabetes mellitus. Primary outcome was all-cause mortality. Secondary outcomes were myocardial infarction, repeat revascularization, and stroke. Mixed treatment comparison analyses were performed using a randomeffects Poisson regression model. Sixty-eight randomized trials that enrolled 24 015 diabetic patients with a total of 71 595 patient-years of follow-up satisfied our inclusion criteria. Bangalore et al CABG or PCI in Diabetics 519It is not clear whether the mortality benefit of CABG in patients with diabetes mellitus will remain significant or be of the same magnitude when compared with PCI using newer generation DES. In the absence of a specific randomized trial addressing this question, we undertook a mixed treatment comparison (MTC) analysis to further assess this hypothesis. Methods Study Search and Eligibility CriteriaWe performed a systematic search, without language restriction, using PUBMED, EMBASE, EBSCO, Cochrane CENTRAL, CINAHL, Web of Science, Google Scholar, and conference proceedings/abstracts of the following societies: Transcatheter Cardiovascular Therapeutics, Euro-PCR, Society of Cardiovascular Angiography and Intervention, American College of Cardiology, American Heart Association, and European Society of Cardiology, for randomized clinical trials comparing revascularization modalities (PCI or CABG or comparing various DES) in patients with diabetes mellitus. The search of the databases was from their inception through December 2013 (last week) using terms that included CABG, PCI, balloon angioplasty, and the names of individual Food and Drug Administration-approved DES systems (paclitaxel-eluting stent [PES], sirolimus-eluting stent [SES], zotarolimus-eluting stent-endeavor, zotarolimus-eluting stentresolute [ZES-R], platinum-chromium everolimus-eluting stent, and CoCr EES; Table I in the Data Supplement). We checked the reference lists of original trials, review articles, and meta-analyses to find other eligible trials. The review was kept updated using automated weekly e-mail alerts, and for studies that did not report outcomes of interest, we contacted the authors via e-mail.Inclusion criteria for eligible trials required each of the following: (1) randomized clinical trial (RCT) comparing CABG versus PCI (POBA/BMS or DES) or comparing a DES either with a different DES or with BMS in patients undergoing PCI; (2) RCTs enrolling patients with diabetes mellitus or reporting data on a diabetes mellitus subgroup; (3) RCTs enrolling ≥50 patients with follow-up of ≥6 months; and (4) RCTs reporting the outcomes o...
Objective To critically evaluate the efficacy of renin angiotensin system inhibitors (RASi) in patients with coronary artery disease without heart failure, compared with active controls or placebo.Design Meta-analysis of randomized trials.Data sources PubMed, EMBASE, and CENTRAL databases until 1 May 2016.Eligibility criteria for selecting studies Randomized trials of RASi versus placebo or active controls in patients with stable coronary artery disease without heart failure (defined as left ventricular ejection fraction ≥40% or without clinical heart failure). Each trial had to enroll at least 100 patients with coronary artery disease without heart failure, with at least one year’s follow-up. Studies were excluded if they were redacted or compared use of angiotensin converting enzyme inhibitors with angiotensin receptor blockers. Outcomes were death, cardiovascular death, myocardial infarction, angina, stroke, heart failure, revascularization, incident diabetes, and drug withdrawal due to adverse effects.Results 24 trials with 198 275 patient years of follow-up were included. RASi reduced the risk of all cause mortality (rate ratio 0.84, 95% confidence interval 0.72 to 0.98), cardiovascular mortality (0.74, 0.59 to 0.94), myocardial infarction (0.82, 0.76 to 0.88), stroke (0.79, 0.70 to 0.89), angina, heart failure, and revascularization when compared with placebo but not when compared with active controls (all cause mortality, 1.05, 0.94 to 1.17; Pinteraction=0.006; cardiovascular mortality, 1.08, 0.93 to 1.25, Pinteraction<0.001; myocardial infarction, 0.99, 0.87 to 1.12, Pinteraction=0.01; stroke, 1.10, 0.93 to 1.31; Pinteraction=0.002). Bayesian meta-regression analysis showed that the effect of RASi when compared with placebo on all cause mortality and cardiovascular mortality was dependent on the control event rate, such that RASi was only beneficial in trials with high control event rates (>14.10 deaths and >7.65 cardiovascular deaths per 1000 patient years) but not in those with low control event rates.Conclusions In patients with stable coronary artery disease without heart failure, RASi reduced cardiovascular events and death only when compared with placebo but not when compared with active controls. Even among placebo controlled trials in this study, the benefit of RASi was mainly seen in trials with higher control event rates but not in those with lower control event rates. Evidence does not support a preferred status of RASi over other active controls.
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