Polymer-based or polymer-free stents in patients at high bleeding risk

BACKGROUND Polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited. METHODS In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus­coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority. RESULTS A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drugcoated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P=0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P=0.007 for noninferiority). CONCLUSIONS Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.). (AU)

Who needs a permanent pacemaker after transcatheter aortic valve implantation?

INTRODUCTION: We aimed to identify predictive factors for pacemaker requirement and determine the rate of pacemaker dependency in a single centre patient group. METHODS AND REULTS: Out of 116 patients, who underwent transcatheter aortic valve implantation at our institution. Absence of atrial fibrillation at time of procedure, pulmonary hypertension, obesity and severity of aortic valve stenosis were predictive for the need of permanent pacemaker implantation after transcatheter aortic valve implantation. CONCLUSION: Only persisting periprocedural and early-onset complete heart block were permanent and resulted in patients' pacemaker dependency. Definite predictors of persistence of conduction impairment are yet to be identified. We can predict only pacemaker dependency, but the real need of pacing in our risky patients with softer indications for permanent pacemaker after transcatheter aortic valve implantation cannot be clearly identified, essential in context of improving quality of their lives in avoiding symptomatic bradycardia, which can be intermittent, especially in such a group of elderly patients often with fragile and degenerate conduction system (Tab. 5, Ref. 34).

Percutaneous paravalvular leak closure for symptomatic aortic regurgitation after CoreValve transcatheter aortic valve implantation.

OBJECTIVES: We present a case series of five patients in whom percutaneous paravalvular leak closure with the AVP4 device has been undertaken for symptomatic aortic regurgitation after CoreValve TAVI. BACKGROUND: Significant post-procedure aortic regurgitation (AR) is often difficult to assess, and is an important predictor of adverse outcome following TAVI. Paravalvular leak closure is an established procedure for surgical aortic prostheses, and has been undertaken for Edwards TAVIs, but has not been described for closure of CoreValve paravalvular leaks. METHODS AND RESULTS: Five patients were treated (mean age 81 ± 4 years) with residual grade 3-4 AR following placement of a single CoreValve (n = 2), double CoreValve (n = 2) or CoreValve within a bioprosthetic AVR (n = 1). The mean time post TAVI implantation was 308 ± 269 days. All patients were symptomatic with persistent NYHA Grade III dyspnoea. 6 devices were deployed successfully, with mean procedure time of 109 ± 23 min. There were no procedural complications and all patients were discharged home by Day 2. Residual AR after treatment was grade 0 (n = 2), grade 1 (n = 1), grade 2 (n = 1) and grade 3 (n = 1). Symptomatic improvement was noted in all 4 patients who have been reviewed in clinic since. CONCLUSIONS: This small series demonstrates the feasibility of paravalvular leak closure with the CoreValve TAVI, despite the adverse aortic lattice. The AVP4 device is ideally suited to this situation as it will pass through a 0.038' lumen and can therefore be delivered down standard diagnostic catheters.