umirolimus and Non-ST-Elevated-Myocardial-Infarction

Although a true clinical challenge, high bleeding risk patients with an acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) have never been specifically studied. Leaders Free ACS, a pre-specified Leaders Free sub-study, determined efficacy, and safety of a combination of 1-month dual anti-platelet therapy (DAPT) with implantation of either a polymer-free Biolimus-A9-coated stent (BA9-DCS) or a bare-metal stent (BMS) in these patients.. Leaders Free included 2466 patients undergoing PCI who had at least 1 of 13 pre-defined factors for an increased bleeding risk. Of these, 659 ACS patients were included in this analysis (BA9-DCS 330, BMS 329). At 12-month follow-up, treatment with the BA9-DCS was more effective (clinically driven target-lesion revascularization 3.9 vs. 9.0%, P = 0.009) and safer (cumulative incidence of cardiac death, myocardial infarction, or definite or probable stent thrombosis 9.3 vs. 18.5%, P = 0.001), driven by significantly lower rates of cardiac mortality (3.4 vs. 6.9%, P = 0.049) and myocardial infarction (6.9 vs. 13.8%, P = 0.005).. We believe that the results of this sub-analysis from the Leaders Free trial are likely to significantly impact clinical practice for high bleeding risk patients presenting with an ACS: the use of a BMS can, in our view, no longer be recommended, and, given the paucity of available data for second-generation DES with shortened DAPT in these patients, the BA9-DCS should currently be considered as the device with the strongest evidence to support its use for this indication.

Topics: Acute Coronary Syndrome; Aged; Double-Blind Method; Drug Therapy, Combination; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Hemorrhage; Humans; Immunosuppressive Agents; Male; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Risk Factors; Sirolimus; ST Elevation Myocardial Infarction; Treatment Outcome

Women with acute myocardial infarction (MI) undergoing mechanical reperfusion remain at increased risk of adverse cardiac events and mortality compared with their male counterparts. Whether the benefits of new-generation drug-eluting stents (DES) are preserved in women with acute MI remains unclear.. To investigate the long-term safety and efficacy of new-generation DES vs early-generation DES in women with acute MI.. Collaborative, international, individual patient-level data of women enrolled in 26 randomized clinical trials of DES were analyzed between July and December 2016. Only women presenting with an acute coronary syndrome were included. Study population was categorized according to presentation with unstable angina (UA) vs acute MI. Acute MI included non-ST-segment elevation MI (NSTEMI) or ST-segment elevation MI (STEMI).. Randomization to early- (sirolimus- or paclitaxel-eluting stents) vs new-generation (everolimus-, zotarolimus-, or biolimus-eluting stents) DES.. Composite of death, MI or target lesion revascularization, and definite or probable stent thrombosis at 3-year follow-up.. Overall, the mean age of participants was 66.8 years. Of 11 577 women included in the pooled data set, 4373 (37.8%) had an acute coronary syndrome as clinical presentation. Of these 4373 women, 2176 (49.8%) presented with an acute MI. In women with acute MI, new-generation DES were associated with lower risk of death, MI or target lesion revascularization (14.9% vs 18.4%; absolute risk difference, -3.5%; number needed to treat [NNT], 29; adjusted hazard ratio, 0.78; 95% CI, 0.61-0.99), and definite or probable stent thrombosis (1.4% vs 4.0%; absolute risk difference, -2.6%; NNT, 46; adjusted hazard ratio, 0.36; 95% CI, 0.19-0.69) without evidence of interaction for both end points compared with women without acute MI (P for interaction = .59 and P for interaction = .31, respectively). A graded absolute benefit with use of new-generation DES was observed in the transition from UA, to NSTEMI, and to STEMI (for death, MI, or target lesion revascularization: UA, -0.5% [NNT, 222]; NSTEMI, -3.1% [NNT, 33]; STEMI, -4.0% [NNT, 25] and for definite or probable ST: UA, -0.4% [NNT, 278]; NSTEMI, -2.2% [NNT, 46]; STEMI, -4.0% [NNT, 25]).. New-generation DES are associated with consistent and durable benefits over 3 years in women presenting with acute MI. The magnitude of these benefits appeared to be greater per increase in severity of acute coronary syndrome.

Topics: Acute Coronary Syndrome; Aged; Angina, Unstable; Antineoplastic Agents, Phytogenic; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Middle Aged; Mortality; Myocardial Infarction; Myocardial Revascularization; Non-ST Elevated Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Randomized Controlled Trials as Topic; Recurrence; Sirolimus; ST Elevation Myocardial Infarction; Treatment Outcome

We report a case of bioresorbable vascular scaffold restenosis which could be caused by abnormal resorption 17months after implantation.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Prosthesis Design; Retreatment; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome