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In patients with multivessel disease and STEMI undergoing primary PCI, fractional flow reserve–guided complete revascularization of non–infarct-related arteries resulted in a lower risk of a composite cardiovascular outcome than treatment of the infarct-related artery only. Patients presenting with acute ST-segment elevation myocardial infarction (STEMI) are best treated with percutaneous coronary intervention (PCI) of the infarct-related coronary artery and the implantation of stents. 1 , 2 Approximately 50% of these patients have additional, severe stenotic lesions in non–infarct-related coronary arteries. 3 – 6 The need for a high-quality, evidence-directed treatment strategy for non–infarct-related coronary artery lesions remains. On the basis of nonrandomized clinical trials, a conservative approach to non–infarct-related coronary artery lesions has been advocated previously. 1 , 2 , 7 Two randomized clinical trials challenged this concept by showing that the preventive use of stents for non–infarct-related coronary artery lesions in the . . .

Patients with CAD at bleeding risk received a umirolimus-coated stent or a bare-metal stent, along with dual antiplatelet therapy. A composite end point (cardiac death, MI, or stent thrombosis) and clinically driven target-lesion revascularization occurred less often with the coated stent. Among patients undergoing percutaneous coronary intervention (PCI), it is estimated that 15% or more are at high risk for bleeding. 1 , 2 Such patients are usually excluded from trials of stents and adjunctive therapy, and the default management of their care, supported by current guidelines, 3 , 4 favors the use of either a second-generation drug-eluting stent with a shortened course of dual antiplatelet therapy or a bare-metal stent followed by 1 month of dual antiplatelet therapy. The latter strategy, driven by the need to minimize the risk of bleeding, is associated with a higher risk of restenosis and reintervention than that observed . . .

In this trial, patients with acute MI and cardiogenic shock who were expected to undergo coronary revascularization were randomly assigned to receive or not to receive intraaortic balloon support. Balloon support had no effect on 30-day mortality. The rate of death among patients with cardiogenic shock complicating acute myocardial infarction is high even when the patients undergo early revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). 1 – 4 Intraaortic balloon counterpulsation is the most widely used form of mechanical hemodynamic support in this clinical setting. 5 In U.S. and European guidelines, the use of an intraaortic balloon in the treatment of cardiogenic shock is given a class IB and class IC recommendation, respectively. 6 – 8 However, evidence is based mainly on registry data, and there is a lack of adequately powered randomized trials. A meta-analysis that . . .

In current international guidelines the recommendation for intra-aortic balloon pump (IABP) use has been downgraded in cardiogenic shock complicating acute myocardial infarction on the basis of registry data. In the largest randomised trial (IABP-SHOCK II), IABP support did not reduce 30 day mortality compared with control. However, previous trials in cardiogenic shock showed a mortality benefit only at extended follow-up. The present analysis therefore reports 6 and 12 month results. The IABP-SHOCK II trial was a randomised, open-label, multicentre trial. Patients with cardiogenic shock complicating acute myocardial infarction who were undergoing early revascularisation and optimum medical therapy were randomly assigned (1:1) to IABP versus control via a central web-based system. The primary efficacy endpoint was 30 day all-cause mortality, but 6 and 12 month follow-up was done in addition to quality-of-life assessment for all survivors with the Euroqol-5D questionnaire. A masked central committee adjudicated clinical outcomes. Patients and investigators were not masked to treatment allocation. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00491036. Between June 16, 2009, and March 3, 2012, 600 patients were assigned to IABP (n=301) or control (n=299). Of 595 patients completing 12 month follow-up, 155 (52%) of 299 patients in the IABP group and 152 (51%) of 296 patients in the control group had died (relative risk [RR] 1·01, 95% CI 0·86–1·18, p=0·91). There were no significant differences in reinfarction (RR 2·60, 95% CI 0·95–7·10, p=0·05), recurrent revascularisation (0·91, 0·58–1·41, p=0·77), or stroke (1·50, 0·25–8·84, p=1·00). For survivors, quality-of-life measures including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression did not differ significantly between study groups. In patients undergoing early revascularisation for myocardial infarction complicated by cardiogenic shock, IABP did not reduce 12 month all-cause mortality. German Research Foundation; German Heart Research Foundation; German Cardiac Society; Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte; University of Leipzig—Heart Centre; Maquet Cardiopulmonary; Teleflex Medical.

This study compared two new-generation drug-eluting coronary stents that release zotarolimus or everolimus. Clinical and angiographic outcomes were similar with the two stents, although there was a somewhat higher rate of stent thrombosis with the zotarolimus stent. In this study comparing two new-generation drug-eluting coronary stents, clinical and angiographic outcomes were similar, although there was a somewhat higher rate of stent thrombosis with the zotarolimus stent. The use of early drug-eluting stents consisting of a metal platform and the controlled release of a therapeutic agent from a durable polymer matrix has partially addressed the problem of restenosis. 1 , 2 Although these first-generation polymers were considered biocompatible, they have been associated with allergic reactions and inflammation, which in combination with incomplete strut endothelialization have led to early and late stent thrombosis. 3 New-generation polymer coatings aim more specifically at mimicking the endothelial lining in order to prevent thrombotic complications. In addition, basic research has shown that some of these polymeric materials could potentially up-regulate genes related to thrombosis, inflammation, . . .

BackgroundIn the PREPARE-CALC trial, severely calcified lesion preparation with rotational atherectomy (RA) before biodegradable polymer sirolimus-eluting stent (SES) implantation demonstrated higher procedural success and comparable rates of acute lumen gain and late lumen loss compared to modified balloons (MB) (scoring/cutting). We aimed to analyze the 5-year outcomes of both lesion preparation strategies.MethodsPREPARE-CALC randomly assigned 200 patients 1:1 to MB or RA, followed by SES implantation. The principal endpoint of the current analysis was target vessel failure (TVF) at 5 years.ResultsAt 5 years, MB had comparable rates of TVF to RA (19% vs. 21%, HR 1.14, 95% CI 0.60–2.16, p = 0.687). Subgroup analysis showed a lesion length treatment interaction, favoring MB for short lesions and RA for long ones (p for interaction = 0.042). Target lesion revascularization (TLR) was significantly less common with RA (12 vs. 3%, HR 0.28, 95% CI 0.08–0.98, p = 0.048). In a multivariate analysis, RA was independently protective against TLR (adj. HR 0.17, 95% CI 0.04–0.78, p = 0.022), while ostial lesions were associated with higher TLR independent of treatment strategy (adj. HR 11.3, 95% CI 2.98–42.6, p < 0.001).ConclusionIn patients with severely calcified coronary lesions, using MB or RA for lesion preparation followed by biodegradable polymer SES implantation was associated with comparable rates of TVF at 5 years. However, a significant reduction of TLR was observed after RA. PREPARE-CALC is the first randomized trial showing potential clinical advantages of RA over MB during long-term follow-up.Clinical Trial RegistrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT02502851.

ObjectiveTo compare Orsiro biodegradable-polymer sirolimus-eluting stent (Orsiro BP-SES) with durable-polymer everolimus-eluting stent (DP-EES) regarding target lesion failure (TLF) after rotational atherectomy (RA), with a focus on small stents (diameter ≤ 3 mm) where Orsiro BP-SES has 60 µm strut thickness, while DP-EES remains with 81 µm strut thickness.BackgroundNew-generation drug-eluting stent (DES) is superior to early-generation DES in all percutaneous coronary intervention (PCI) settings including RA. Recently, the Orsiro BP-SES was superior to a DP-EES in an all comer’s population.MethodsAmong patients who underwent RA at a single center, 121 were treated with Orsiro BP-SES and 164 with DP-EES (Promus and Xience). Those treated with other stent types, presenting with acute myocardial infarction or had a chronic total occlusion were excluded. Incidence of TLF was assessed.ResultsAfter 2 years, the TLF rate in Orsiro BP-SES and DP-EES groups was 10% and 18%, respectively (adjusted HR 0.55, 95%CI 0.26–1.16, p = 0.115). The rate of TLF was significantly lower in small Orsiro BP-SES with ultra-thin struts as compared to DP-EES with the same diameters (adjusted HR 0.19, 95% CI 0.04–0.87, p = 0.032), driven by lower rates of clinically driven target lesion revascularization (log-rank p = 0.022). Age (p = 0.035), total stent length (p = 0.007) and diabetes mellitus (p = 0.011) emerged as independent predictors of TLF in the whole population.ConclusionIn the whole cohort, Orsiro BP-SES and DP-EES had comparable rates of long-term TLF after RA. In the small stent subgroup, the Orsiro BP-SES with ultra-thin struts showed significant lower rate of TLF at 2 years.Graphic abstract

Background/Objectives: We sought to confirm the performance and safety of the Pantera Lux paclitaxel-coated balloon (pDCB) when used as per the instructions for use at a single high-volume center. Methods: In this retrospective analysis, 386 consecutive patients were categorized into three groups: the treatment of drug-eluting stent in-stent restenosis (DES-ISR) lesions (n = 191), bare-metal stent in-stent restenosis (BMS-ISR) lesions (n = 127), and de novo lesions (n = 68). The primary endpoint at 12 months was target-lesion revascularization (TLR). Secondary endpoints were device success, target-vessel myocardial infarction (TV-MI), and cardiac death. Results: The baseline characteristics were balanced between the groups, with a median age of 71.3 years, 25% being female, 32% being diabetic. The majority presented with chronic coronary syndrome (82.9%). Type C lesions were more often observed in the DES-IRS group as compared with the BMS-IRS and de novo groups (15.6% vs. 7.9% vs. 7.4%, p < 0.001). Cutting balloons were more often used in the DES-IRS group (41.0% vs. 19.7% vs. 1.5%, p < 0.001). The residual stenosis rate was 7.6% vs. 3.3% vs. 7.3% (p = 0.002). The TLR at 12 months was 8.9% vs. 2.4% vs. 1.5% (p = 0.013). Device success was achieved in 98.8% vs. 98.5% vs. 100% of cases (p = 0.8). TV-MI occurred in 3.2% vs. 0.8% vs. 1.5% (p = 0.5) and cardiac death in 2.6% vs. 0.0% vs. 2.9% (p = 0.13) in DES-IRS vs. BMS-IRS vs. de novo lesions. Conclusions: In this single-center observation, we confirmed the safety and efficacy of the Pantera Lux paclitaxel-coated balloon for the treatment of DES-IRS, BMS-IRS, and de novo lesions with low TLR rates at 12 months.

Comparative assessment of clinical outcomes after use of drug-eluting stents versus bare-metal stents for treatment of aortocoronary saphenous vein graft lesions has not been undertaken in large randomised trials. We aimed to undertake a comparison in a randomised trial powered for clinical endpoints. In this randomised superiority trial, patients with de-novo saphenous vein graft lesions were assigned by computer-generated sequence (1:1:1:3) to receive either drug-eluting stents (one of three types: permanent-polymer paclitaxel-eluting stents, permanent-polymer sirolimus-eluting stents, or biodegradable-polymer sirolimus-eluting stents) or bare-metal stents. Randomisation took place immediately after crossing of the lesion with a guidewire, and was stratified for each participating centre. Investigators assessing data were masked to treatment allocation; patients were not masked to allocation. The primary endpoint was the combined incidence of death, myocardial infarction, and target lesion revascularisation at 1 year. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT00611910. 610 patients were allocated to treatment groups (303 drug-eluting stent, 307 bare-metal stent). Drug-eluting stents reduced the incidence of the primary endpoint compared with bare-metal stents (44 [15%] vs 66 [22%] patients; hazard ratio [HR] 0·64, 95% CI 0·44–0·94; p=0·02). Target lesion revascularisation rate was reduced by drug-eluting stents (19 [7%] vs 37 [13%] patients; HR 0·49, 95% CI 0·28–0·86; p=0·01). No significant differences were seen between drug-eluting stents and bare-metal stents regarding all-cause mortality (15 [5%] vs 14 [5%] patients; HR 1·08, 95% CI 0·52–2·24; p=0·83), myocardial infarction (12 [4%] vs 18 [6%]; HR 0·66, 95% CI 0·32–1·37; p=0·27), or definite or probable stent thrombosis (2 [1%] in both groups; HR 1·00, 95% CI 0·14–7·10; p=0·99). In patients undergoing percutaneous coronary intervention for de-novo saphenous vein graft lesions, drug-eluting stents are the preferred treatment option because they reduce the risk of adverse events compared with bare-metal stents. Deutsches Herzzentrum.

Bivalirudin is a new direct thrombin inhibitor. In patients undergoing PCI for stable coronary disease, bivalirudin and unfractionated heparin resulted in similar overall outcomes, but there was less major bleeding with bivalirudin. Bivalirudin is a new direct thrombin inhibitor. In patients undergoing PCI for stable coronary disease, bivalirudin and unfractionated heparin resulted in similar overall outcomes, but there was less major bleeding with bivalirudin. Percutaneous coronary intervention (PCI) is commonly used to treat patients with coronary artery disease. To minimize the risk of thrombotic complications during and shortly after the procedure, many different antithrombotic regimens have been investigated and are currently in use. Increasing evidence of the adverse consequences of periprocedural bleeding suggests that protection from thrombotic complications should not be the sole measure by which antithrombotic therapies are evaluated. 1 Aspirin, clopidogrel, and heparin are established antithrombotic drugs that are widely recommended according to current guidelines on PCI. 2 Pretreatment with 300 to 600 mg of clopidogrel increasingly is used before PCI because of mounting . . .