Displaying publications 21 - 22 of 22 in total

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  1. Thin strut bare metal stents in patients with atrial fibrillation: Is there still a need for BMS?
    Leschke M, Waliszewski M, Pons M, Champin S, Nait Saidi L, Mok Heang T, et al.
    Catheter Cardiovasc Interv, 2016 Sep;88(3):358-66.
    PMID: 26650913 DOI: 10.1002/ccd.26261
    OBJECTIVES: This observational study assessed the 9-month clinical outcomes in an « all comers » population with a focus on patients with atrial fibrillation (AF) after thin strut bare metal stenting.

    BACKGROUND: Drug eluting stent (DES) implantation is the treatment of choice for coronary artery disease (CAD) leaving only marginal indications for the use of bare metal stents (BMS). However, selected treatment populations with DES contraindications such as patients who cannot sustain 6-12 months of dual antiplatelet therapy (DAPT) remain candidates for BMS implantations.

    METHODS: Thin strut bare metal stenting in a priori defined subgroups were investigated in a non-randomized, international, multicenter «all comers» observational study. Primary endpoint was the 9-month TLR rate whereas secondary endpoints included the 9-month MACE and procedural success rates.

    RESULTS: A total of 783 patients of whom 98 patients had AF underwent BMS implantation. Patient age was 70.4 ± 12.8 years. Cardiovascular risk factors in the overall population were male gender (78.2%, 612/783), diabetes (25.2%, 197/783), hypertension (64.1%, 502/783), cardiogenic shock (4.9%, 38/783) and end stage renal disease (4.9%, 38/783). In-hospital MACE was 4.1% (30/783) in the overall population. The 9-month TLR rate was 4.5% (29/645) in the non-AF group and 3.3% (3/90) in the AF group (P = 0.613). At 9 months, the MACE rate in the AF-group and non-AF group was not significantly different either (10.7%, 69/645 vs. 6.7%, 6/90; P = 0.237). Accumulated stroke rates were 0.3% (2/645) in the non-AF subgroup at baseline and 1.1% (1/90) in the AF subgroup (P = 0.264).

    CONCLUSION: Bare metal stenting in AF patients delivered acceptably low TLR and MACE rates while having the benefit of a significantly shorter DAPT duration in a DES dominated clinical practice. © 2015 Wiley Periodicals, Inc.

    Matched MeSH terms: Platelet Aggregation Inhibitors/administration & dosage
  2. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial
    Connolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dyal L, Lanas F, et al.
    Lancet, 2018 01 20;391(10117):205-218.
    PMID: 29132879 DOI: 10.1016/S0140-6736(17)32458-3
    BACKGROUND: Coronary artery disease is a major cause of morbidity and mortality worldwide, and is a consequence of acute thrombotic events involving activation of platelets and coagulation proteins. Factor Xa inhibitors and aspirin each reduce thrombotic events but have not yet been tested in combination or against each other in patients with stable coronary artery disease.

    METHODS: In this multicentre, double-blind, randomised, placebo-controlled, outpatient trial, patients with stable coronary artery disease or peripheral artery disease were recruited at 602 hospitals, clinics, or community centres in 33 countries. This paper reports on patients with coronary artery disease. Eligible patients with coronary artery disease had to have had a myocardial infarction in the past 20 years, multi-vessel coronary artery disease, history of stable or unstable angina, previous multi-vessel percutaneous coronary intervention, or previous multi-vessel coronary artery bypass graft surgery. After a 30-day run in period, patients were randomly assigned (1:1:1) to receive rivaroxaban (2·5 mg orally twice a day) plus aspirin (100 mg once a day), rivaroxaban alone (5 mg orally twice a day), or aspirin alone (100 mg orally once a day). Randomisation was computer generated. Each treatment group was double dummy, and the patients, investigators, and central study staff were masked to treatment allocation. The primary outcome of the COMPASS trial was the occurrence of myocardial infarction, stroke, or cardiovascular death. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.

    FINDINGS: Between March 12, 2013, and May 10, 2016, 27 395 patients were enrolled to the COMPASS trial, of whom 24 824 patients had stable coronary artery disease from 558 centres. The combination of rivaroxaban plus aspirin reduced the primary outcome more than aspirin alone (347 [4%] of 8313 vs 460 [6%] of 8261; hazard ratio [HR] 0·74, 95% CI 0·65-0·86, p<0·0001). By comparison, treatment with rivaroxaban alone did not significantly improve the primary outcome when compared with treatment with aspirin alone (411 [5%] of 8250 vs 460 [6%] of 8261; HR 0·89, 95% CI 0·78-1·02, p=0·094). Combined rivaroxaban plus aspirin treatment resulted in more major bleeds than treatment with aspirin alone (263 [3%] of 8313 vs 158 [2%] of 8261; HR 1·66, 95% CI 1·37-2·03, p<0·0001), and similarly, more bleeds were seen in the rivaroxaban alone group than in the aspirin alone group (236 [3%] of 8250 vs 158 [2%] of 8261; HR 1·51, 95% CI 1·23-1·84, p<0·0001). The most common site of major bleeding was gastrointestinal, occurring in 130 [2%] patients who received combined rivaroxaban plus aspirin, in 84 [1%] patients who received rivaroxaban alone, and in 61 [1%] patients who received aspirin alone. Rivaroxaban plus aspirin reduced mortality when compared with aspirin alone (262 [3%] of 8313 vs 339 [4%] of 8261; HR 0·77, 95% CI 0·65-0·90, p=0·0012).

    INTERPRETATION: In patients with stable coronary artery disease, addition of rivaroxaban to aspirin lowered major vascular events, but increased major bleeding. There was no significant increase in intracranial bleeding or other critical organ bleeding. There was also a significant net benefit in favour of rivaroxaban plus aspirin and deaths were reduced by 23%. Thus, addition of rivaroxaban to aspirin has the potential to substantially reduce morbidity and mortality from coronary artery disease worldwide.

    FUNDING: Bayer AG.
    Matched MeSH terms: Platelet Aggregation Inhibitors/administration & dosage
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