Transcatheter aortic valve implantation (TAVI) in patients with aortic valve stenosis is associated with an improvement of clinical outcomes, quality of life, and self-sufficiency. The most feared ...TAVI-related complication is the occurrence of stroke. In order to reduce peri-procedural cerebral embolizations, diverse cerebral protection devices have been developed. These devices work though deflection or filtering of emboli, and are in different stages of testing. Silent cerebral infarctions identified by diffusion-weighted magnetic resonance imaging (DW-MRI) are used as surrogate primary outcomes, but the clinical significance is still unclear. This review provides a synopsis of the diverse cerebral protection devices and summarizes the current evidence on their efficacy during TAVI.
The optimal duration of dual antiplatelet therapy (DAPT) after myocardial infarction (MI) in patients treated with second-generation drug-eluting stent (DES) is unclear, therefore, we aim to evaluate ...the ischemic and bleeding risk according to DAPT duration using a pooled-analysis of two randomized trials.
MI patients treated with durable-polymer second-generation DES from two randomized trials, SMART-DATE and DAPT-STEMI, were pooled. The primary endpoint was a composite of net adverse clinical events (NACEs) defined by all-cause mortality, any MI, stroke and BARC 3-5 bleeding, between 6 and 18 months after index percutaneous coronary intervention.
A total of 2016 patients were analyzed, 1014 were treated with 6-month DAPT versus 1002 patients with ≥12-month DAPT duration. The primary endpoint occurred in 2.7% vs 2.5% (HR 1.07; 95%CI 0.62–1.85, p = 0.80) of cases, in 6 vs ≥ 12-month DAPT, respectively. The composite of cardiac death, MI and stroke was similar (2% vs 1.6%, HR 1.24, 95%CI 0.65–2.4, p = 0.52). BARC 3-5 bleeding occurred more frequently in the ≥12-month DAPT (0.2% vs 0.9%, HR 0.22, 95%CI 0.05–1.02 p = 0.05, log rank p = 0.03). MI occurred more frequently in the 6-month DAPT (1.6% vs 0.6%, HR 2.66, 95%CI 1.04–6.79, p = 0.04). Stent thrombosis was similar in both arms (0.7% vs 0.5%, p = 0.26).
Six vs ≥ 12-month DAPT, followed by aspirin alone, resulted in comparable NACEs in patients with event-free MI at six months after durable-polymer DES implantation. However, single therapy with aspirin beyond the 6 months reduced bleeding rates but was associated with a higher rate of MI compared to ≥12-month DAPT.
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•6 vs ≥ 12-month dual antiplatelet therapy (DAPT) in myocardial infarction (MI) patients treated with drug-eluting stent resulted in comparable net adverse clinical events.•After percutaneous coronary intervention for MI, 6 months of DAPT is safe in terms of stent related ischemic events.•Aspirin alone beyond the 6 months reduced bleeding but increased the rate of MI.•After 6 months, DAPT duration should be tailored on ischemic and bleeding risk.
Patients with prior coronary artery bypass grafting (CABG) frequently require repeat percutaneous revascularization due to advanced age, progressive coronary artery disease and bypass graft failure. ...Percutaneous coronary intervention (PCI) of either the bypass graft or the native coronary artery may be performed. Randomized trials comparing native vessel PCI with bypass graft PCI are lacking and long-term outcomes have not been reported.
PROCTOR (NCT03805048) is a prospective, multicenter, randomized controlled trial, that will include 584 patients presenting with saphenous vein graft (SVG) failure and a clinical indication for revascularization, as determined by the local Heart Team. The trial is designed to compare the clinical and angiographic outcomes in patients randomly allocated in a 1:1 fashion to either a strategy of native vessel PCI or SVG PCI. The primary study endpoint is a 3-year composite of major adverse cardiac events (MACE: all-cause mortality, non-fatal target coronary territory myocardial infarction MI, or clinically driven target coronary territory revascularization). At 3-years, after evaluation of the primary endpoint, follow-up invasive coronary angiography will be performed. Secondary endpoints comprise individual components of MACE at 1, 3 and 5 years follow-up, PCI-related MI, MI >48 hours after index PCI, target vessel failure, target lesion revascularization, renal failure requiring renal-replacement therapy, angiographic outcomes at 3-years and quality of life (delta Seattle Angina Questionnaire, Canadian Cardiovascular Society Grading Scale and Rose Dyspnea Scale).
PROCTOR is the first randomized trial comparing an invasive strategy of native coronary artery PCI with SVG PCI in post-CABG patients presenting with SVG failure.
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