The investigators performed a network meta-analysis of randomized trials comparing the effectiveness of currently available strategies for the treatment of drug-eluting stent (DES) restenosis. ...Despite the widespread use of DES in patients who undergo percutaneous coronary intervention, the optimal treatment for DES restenosis remains poorly defined. A systematic search of electronic resources was performed. The primary end point was diameter stenosis at follow-up angiography. Seven trials were included, enrolling a total of 1,586 patients with 1,728 restenotic lesions. The following treatment options were found: balloon angioplasty (BA) in 343 patients (19.3%), iopromide-based paclitaxel-eluting balloons (PEB) in 343 (21.6%), sirolimus-eluting stents in 441 (27.8%), paclitaxel-eluting stents in 462 (29.1%), and everolimus-eluting stents in 34 (2.2%). Compared with BA, PEB (−17.74%, 95% credible interval CI −25.17% to −11.31%), everolimus-eluting stents (−14.93%, 95% CI −33.47% to 1.16%), paclitaxel-eluting stents (−15.3%, 95% CI −22.96% to −8.35%), and sirolimus-eluting stents (−11.08%, 95% CI −17.89% to −3.4%) had similar reductions in diameter stenosis at follow-up angiography. PEB (85%) and everolimus-eluting stents (68%) had the greatest probabilities for being the best treatment option. Furthermore, PEB were the best treatment in terms of late luminal loss (85%) and binary restenosis (85%). BA had the lowest efficacy with respect to all study end points. In conclusion, in patients with DES restenosis, repeat DES implantation and iopromide-based PEB are valid alternatives. However, PEB had greater angiographic efficacy and therefore should be considered the new benchmark comparator in the treatment of DES restenosis. The use of BA should be discouraged in patients with DES restenosis.
The present substudy from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial assessed the outcomes and their relation to different ...antithrombotic regimens in patients with previous coronary artery bypass grafting (CABG) treated with primary percutaneous coronary intervention. Of 3,599 patients with information regarding a history of CABG, 105 (2.9%) had previously undergone CABG. Of these 105 patients, 46 were randomized to heparin plus a glycoprotein IIb/IIIa inhibitor and 59 to bivalirudin. The patients with versus without previous CABG were less frequently triaged to primary percutaneous coronary intervention (83.8% vs 93.2%, p = 0.0002) and had a longer door-to-balloon time (median 1.9 vs 1.6 hours, p = 0.047), lower rates of final Thrombolysis In Myocardial Infarction flow grade 2 to 3 in the intervened vessel (92.6% vs 97.8%, p = 0.007), and less frequent rates of complete or partial ST-segment resolution (66.3% vs 77.6%, p = 0.019). At 3 years, previous CABG was associated with a significantly greater incidence of major adverse cardiovascular events (36.4% vs 21.4%, p <0.001) owing to greater rates of mortality (11.2% vs 6.7%, p = 0.08), reinfarction (11.6% vs 7.1%, p = 0.09), stroke (5.1% vs 1.8%, p = 0.013), and ischemic target vessel revascularization (23.6% vs 12.9%, p = 0.005). The outcomes did not differ significantly as a function of the antithrombotic regimen. On multivariate analysis, previous CABG was an independent predictor of 3-year ischemic stroke (hazard ratio 3.57, 95% confidence interval 1.09 to 11.66). Intervention on the saphenous vein graft versus the native vessel predicted 3-year major adverse cardiovascular events (hazard ratio 2.69, 95% confidence interval 1.17 to 6.19). In the HORIZONS-AMI trial, previous CABG was associated with a delay to mechanical reperfusion and lower rates of percutaneous coronary intervention and patency of the infarct related vessel along with worse clinical outcomes.
Treatment of left main coronary artery bifurcation lesions might depend on the ostial left circumflex (LC) or ostial left anterior descending (LAD) disease severity. We sought to evaluate whether ...intravascular ultrasound assessment of the side branch ostium requires direct imaging or is accurate from the main vessel. Our retrospective analysis included 126 patients with left main coronary artery bifurcation disease (plaque burden ≥40% by intravascular ultrasound scanning). We analyzed pullbacks from the LAD and the LC. First, during the main vessel pullback (ie, from the LAD), we evaluated the side branch ostium (ie, of the LC). Second, we compared this oblique view with the direct ostial measurements during LC pullback. Finally, we repeated this process, imaging the ostial LAD from the LC. From the LAD, the oblique LC ostial lumen diameter was 3.0 ± 0.8 mm compared to the directly measured lumen diameter of 2.9 ± 0.6 mm. From the LC, the oblique LAD ostial lumen diameter was 2.9 ± 1.1 mm compared to the directly measured lumen diameter of 2.8 ± 0.5 mm. However, Bland-Altman plots showed significant variation in the oblique versus direct comparisons. The 95% limits of agreement ranged from −1.84 to 1.14 mm (mean difference −0.35, SD 0.75) for the LAD and −1.69 to 1.22 mm (mean difference −0.23, SD 0.73) for the LC. The “oblique view” detection of any plaque in the side branch predicted 40% or 70% plaque burden with good sensitivity but poor specificity. In conclusion, intravascular ultrasound evaluation of a side branch ostium from the main vessel is only moderately reliable, especially for distal left main coronary artery lesions. For an accurate assessment of the side branch ostium, direct imaging is necessary.
Abstract Objectives The purpose of this study was to investigate the safety and efficacy of new-generation drug-eluting stents (DES) versus early-generation DES in women undergoing complex ...percutaneous coronary intervention (CPCI). Background Whether the benefits of new-generation DES are preserved in women undergoing complex percutaneous revascularization is unknown. Methods We pooled patient-level data from women enrolled in 26 randomized trials of DES. Study population was categorized according to the presence or absence of CPCI, which was defined as the composite of total stent length >30 mm, ≥2 stents implanted, ≥2 lesions treated, or bifurcation lesion as target vessel. The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. Results Of 10,241 women included in the pooled database, 4,629 (45%) underwent CPCI. Compared with non-CPCI, women who underwent CPCI had a higher 3-year risk of MACE (adjusted hazard ratio HR: 1.63; 95% confidence interval CI: 1.45 to 1.83; p < 0.0001). In women who underwent CPCI, use of new-generation DES was associated with significantly lower 3-year risk of MACE (adjusted HR: 0.81; 95% CI: 0.68 to 0.96), target lesion revascularization (adjusted HR: 0.74; 95% CI: 0.57 to 0.95), and definite or probable stent thrombosis (ST) (adjusted HR: 0.50; 95% CI: 0.30 to 0.83). The benefit of new-generation DES on efficacy and safety outcomes was uniform between CPCI and non-CPCI groups, without evidence of interaction. By landmark analysis, new-generation DES were associated with low rates (≤0.4%) of very-late ST irrespective of procedural complexity. Conclusions Women undergoing CPCI remain at higher risk of adverse events. The long-term ischemic benefits of new-generation DES platforms are uniform among complex and non-complex percutaneous revascularization procedures in women.
Objectives We investigated the outcomes of switching to bivalirudin after initial administration of heparin in patients with acute ST-segment elevation myocardial infarction undergoing primary ...percutaneous coronary intervention. Background Unfractionated heparin (UFH) is frequently administered early in ST-segment elevation myocardial infarction. Whether the benefits of bivalirudin documented in the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial persist in patients previously administered UFH is unknown. Methods We analyzed the outcomes of the 2,357 patients from HORIZONS-AMI treated with UFH before enrollment according to their subsequent randomization to bivalirudin (switch group, n = 1,178) or UFH plus a glycoprotein IIb/IIIa inhibitor (control group, n = 1,179). Results At 30 days, major bleeding occurred in 7.6% of the switch group versus 12.3% of the control group (p = 0.0001). Switch patients had lower 30-day rates of cardiac mortality (1.6% vs. 2.9%, p = 0.04). At 2-year follow-up, switch patients experienced lower rates of major bleeding (8.4% vs. 13.0%, p = 0.0003), cardiac mortality (2.3% vs. 3.8%, p = 0.04), and reinfarction (4.0% vs. 7.1%, p = 0.0002). Two-year rates of definite/probable stent thrombosis were similar in switch and control patients (3.1% vs. 4.3%, p = 0.17). Conclusions In ST-segment elevation myocardial infarction patients who receive early treatment with UFH, switching to bivalirudin before primary percutaneous coronary intervention results in reduced rates of major bleeding and improved early and late cardiac survival.
Objectives The purpose of the study was to systematically evaluate the significance of platelet reactivity on clopidogrel treatment on adverse cardiovascular events using a collaborative ...meta-analysis using patient-level data for the VerifyNow P2Y12 assay (Accumetrics, San Diego, California). Background Clinical evidence has been controversial regarding the influence of clopidogrel on treatment platelet reactivity and ischemic outcomes. Methods MEDLINE, Scopus, and the Cochrane library databases were searched through January 2010. A database containing individual patient-level time-to-event data was generated from identified studies. The primary outcome of interest was a composite of death, myocardial infarction (MI), or stent thrombosis. Secondary outcomes included the incidence of: 1) death; 2) MI; and 3) stent thrombosis. Results A total of 6 studies with 3,059 patients was included. In each study, clopidogrel responsiveness was assessed using the same point-of-care assay after percutaneous coronary intervention. The primary endpoint occurred more frequently in higher quartiles of P2Y12 reaction unit (PRU) values: quartile I, 5.8%; quartile II, 6.9%; quartile III, 10.9%; quartile IV, 15.8% (p < 0.001). Taking quartile I as referent, the hazard ratios (HRs) for the primary endpoint were as follows: quartile II, HR: 1.13 (95% confidence interval CI: 0.72 to 1.78; p = 0.60); quartile III, HR: 1.82 (95% CI: 1.20 to 2.75; p = 0.005); quartile IV, HR: 2.62 (95% CI: 1.78 to 3.87; p < 0.001). On a continuous scale, every 10-U increase in PRU was associated with a significantly higher rate of the primary endpoint (HR: 1.04; 95% CI: 1.03 to 1.06; p < 0.0001). According to receiver-operating characteristic curve analysis, a PRU value of 230 appeared to best predict death, MI, or stent thrombosis (p < 0.001). A PRU value ≥230 was associated with a higher rate of the composite primary endpoint (HR: 2.10; 95% CI: 1.62 to 2.73; p < 0.0001), as well as the individual endpoints of death (HR: 1.66; 95% CI: 1.04 to 2.68; p = 0.04), MI (HR: 2.04; 95% CI: 1.51 to 2.76; p < 0.001), and stent thrombosis (HR: 3.11; 95% CI: 1.50 to 6.46; p = 0.002). Conclusions In this collaborative meta-analysis, the level of on-treatment platelet reactivity according to the P2Y12 assay is associated with long-term cardiovascular events after percutaneous coronary intervention, including death, MI, and stent thrombosis.
An increasing hemoglobin A1c (HbA1c) level portends an adverse cardiovascular prognosis; however, the association between glycemic control, platelet reactivity, and outcomes after percutaneous ...coronary intervention (PCI) with drug-eluting stents (DES) is unknown. We sought to investigate whether HbA1c levels are associated with high platelet reactivity (HPR) in patients loaded with clopidogrel and aspirin, thereby constituting an argument for intensified antiplatelet therapy in patients with poor glycemic control. In the prospective, multicenter Assessment of Dual Antiplatelet Therapy With Drug Eluting Stents registry, HbA1c levels were measured as clinically indicated in 1,145 of 8,582 patients, stratified by HbA1c <6.5% (n = 551, 48.12%), 6.5% to 8.5% (n = 423, 36.9%), and >8.5% (n = 171, 14.9%). HPR on clopidogrel and aspirin was defined after PCI as P2Y12 reaction units (PRU) >208 and aspirin reaction units >550, respectively. HPR on clopidogrel was frequent (48.3%), whereas HPR on aspirin was not (3.9%). Patients with HbA1c >8.5% were younger, more likely non-Caucasian, had a greater body mass index, and more insulin-treated diabetes and acute coronary syndromes. Proportions of PRU >208 (42.5%, 50.2%, and 62.3%, p <0.001) and rates of definite or probable stent thrombosis (ST; 0.9%, 2.7%, and 4.2%, p = 0.02) increased progressively with HbA1c groups. Clinically relevant bleeding was greatest in the intermediate HbA1c group (8.2% vs 13.1% vs 9.5%, p = 0.04). In adjusted models that included PRU, high HbA1c levels (>8.5) remained associated with ST (hazard ratio 3.92, 95% CI 1.29 to 12.66, p = 0.02) and cardiac death (hazard ratio 4.24, 95% CI 1.41 to 12.70) but not bleeding at 2-year follow-up. There was no association between aspirin reaction units >550 and HbA1c levels. In conclusion, in this large-scale study, HbA1c and HPR were positively associated, but the clinical effect on adverse outcome was driven by poor glycemic control, which predicted ST and cardiac death after PCI regardless of PRU levels, warranting efforts to improve glycemic control after DES implantation in patients with diabetes mellitus.
Stent Thrombosis Claessen, Bimmer E., MD, PhD; Henriques, José P.S., MD, PhD; Jaffer, Farouc A., MD, PhD ...
JACC. Cardiovascular interventions,
October 2014, Letnik:
7, Številka:
10
Journal Article
Recenzirano
Odprti dostop
Abstract The invention of intracoronary stents greatly increased the safety and applicability of percutaneous coronary interventions. At this time, >1 million coronary stent implantations are ...performed each year in the United States. But together with the growing use of stents, stent thrombosis, the most feared complication after stent implantation, has emerged as an important entity to understand and prevent. Adjunct pharmacological therapy, stent design, and deployment technique have been adjusted ever since to reduce its occurrence. The current clinical overview of stent thrombosis ranges from its pathophysiology to current state-of-the-art technical and pharmacological recommendations to avoid this complication.
Objectives We evaluated the impact of the everolimus-eluting stent (EES) on the frequency of stent thrombosis (ST), target vessel revascularization (TVR), myocardial infarction (MI), and cardiac ...death in randomized controlled trials comparing the EES to non–everolimus-eluting drug-eluting stents (EE-DES). Background Whether or not the unique properties of the EES translate into reductions in ST remains unknown. Methods We searched MEDLINE, Scopus, the Cochrane Library, and Internet sources for articles comparing outcomes between EES and non–EE-DES without language or date restriction. Randomized controlled trials reporting the frequency of ST were included. Variables relating to patient and study characteristics and clinical endpoints were extracted. Results We identified 13 randomized trials (n = 17,101) with a weighted mean follow-up of 21.7 months. Compared with non–EE-DES, the EES significantly reduced ST (relative risk RR: 0.55; 95% confidence interval CI: 0.38 to 0.78; p = 0.001), TVR (RR: 0.77; 95% CI: 0.64 to 0.92; p = 0.004), and MI (RR: 0.78; 95% CI: 0.64 to 0.96; p = 0.02). There was no difference in cardiac mortality between the groups (RR: 0.92; 95% CI: 0.74 to 1.16; p = 0.38). The treatment effect was consistent by different follow-up times and duration of clopidogrel use. The treatment effects increased with higher baseline risks of the respective control groups with the strongest correlation observed for ST (R2 = 0.89, p < 0.001). Conclusions Intracoronary implantation of the EES is associated with highly significant reductions in ST with concordant reductions in TVR and MI compared to non–EE-DES. Whether these effects apply to different patient subgroups and DES types merits further investigation.
Coronary Artery Aneurysms After Drug-Eluting Stent Implantation Jiro Aoki, Ajay Kirtane, Martin B. Leon, George Dangas Several studies have indicated that drug-eluting stents (DES) may delay healing ...after vascular injury. The DES implantation may be theoretically associated with a risk of coronary artery aneurysm formation. In this report, we summarize the current status of DES-associated coronary aneurysm from the published, medical literature.
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