Safety of Percutaneous Coronary Intervention Without P2Y12 Inhibitor Pretreatment From a Cohort of Unselected Patients.

OBJECTIVES: Recent studies have challenged systematic pretreatment with a P2Y12 inhibitor before percutaneous coronary intervention (PCI) in elective and non-ST segment elevation myocardial infarction (NSTEMI) patients. The aim of this study was to assess outcomes after performing PCI immediately after coronary angiography with an exclusive "on-the-table" P2Y12 inhibitor loading dose, by evaluating ischemic and bleeding complications in unselected patients. METHODS: Consecutive patients admitted for elective PCI or NSTEMI were included in this two-center, prospective, observational study, and received a P2Y12 inhibitor after coronary angiography when PCI was decided. The primary composite endpoint was first occurrence of cardiovascular death, myocardial infarction, stroke, urgent revascularization, or use of bail-out glycoprotein IIb/IIIa inhibitors at 30 days after PCI. Stent thrombosis and bleeding criteria (Bleeding Academic Research Consortium [BARC]) were evaluated. RESULTS: Among 299 included patients, a total of 188 were admitted for elective PCI and 111 for NSTEMI. The incidence of the primary endpoint was 8.5% (95% confidence interval [CI], 5.7-12.4). No definite stent thrombosis occurred. Three independent predictive factors were associated with the primary endpoint: NSTEMI setting (odds ratio [OR], 5.61; 95% CI, 1.75-17.98), thrombotic coronary lesion (OR, 4.26; 95% CI, 1.45-12.54), and longer procedure duration (OR, 1.06; 95% CI, 1.03-1.09). Clinically relevant bleedings (BARC 2, 3, or 5) occurred in 5.4% of patients. CONCLUSIONS: In an unselected population admitted for elective PCI or NSTEMI in real-world clinical practice, administration of a P2Y12 inhibitor only after coronary angiography is associated with a low rate of ischemic and bleeding events at 30 days.

Vascular Complications and Bleeding After Transfemoral Transcatheter Aortic Valve Implantation Performed Through Open Surgical Access.

Major vascular complications (VC) remain frequent after transcatheter aortic valve implantation (TAVI) and may be associated with unfavorable clinical outcomes. The objective of this study was to evaluate the rate of VC after transfemoral TAVI performed using an exclusive open surgical access strategy. From 2010 to 2014, we included in a monocentric registry all consecutive patients who underwent transfemoral TAVI. The procedures were performed with 16Fr to 20Fr sheath systems. VC were evaluated within 30 days and classified as major or minor according to the Valve Academic Research Consortium 2 definition. The study included 396 patients, 218 were women (55%), median age was 85 years (81 to 88), and the median logistic Euroscore was 15.2% (11 to 23). The balloon-expandable SAPIEN XT and the self-expandable Medtronic Core Valve prosthesis were used in 288 (72.7%) and 108 patients (27.3%), respectively. The total length of the procedure was 68 ± 15 minutes including 13 ± 5 minutes for the open surgical access. Major and minor VC were observed in 9 (2.3%) and 16 patients (4%), respectively, whereas life-threatening and major bleeding concerned 18 patients (4.6%). The median duration of hospitalization was 5 days (interquartile range 2 to 7), significantly higher in patients with VC (7 days [5 to 15], p <0.001). Mortality at 1-month and 1-year follow-up (n = 26, 6.6%; and n = 67, 17.2%, respectively) was not related to major or minor VC (p = 0.6). In multivariable analysis, only diabetes (odds ratio 2.5, 95% confidence interval 1.1 to 6.1, p = 0.034) and chronic kidney failure (odds ratio 3.0, 95% confidence interval 1.0 to 9.0, p = 0.046) were predictive of VC, whereas body mass index, gender, Euroscore, and lower limb arteriopathy were not. In conclusion, minimal rate of VC and bleeding can be obtained after transfemoral TAVI performed using an exclusive surgical strategy, with a particular advantage observed in high-risk bleeding patients.

Flow cytometric assessment of vasodilator-stimulated phosphoprotein: prognostic value of recurrent cardiovascular events after acute coronary syndromes.

BACKGROUND: Clopidogrel fails to elicit an adequate antiplatelet response in 4-30% of patients. Assessing the phosphorylation of intraplatelet vasodilator-stimulated phosphoprotein (VASP) is an easy and reliable method of evaluating biological response to clopidogrel. AIM: To assess the prognostic value of clopidogrel in patients with an acute coronary syndrome (ACS) without persistent ST-segment elevation. METHODS: We studied clopidogrel response prospectively in 49 patients treated with a loading dose of 300 mg clopidogrel followed by a maintenance dose of 75 mg/day. VASP index was calculated from the median fluorescence intensity (MFI) of samples incubated with prostaglandin E1 (PGE1) and adenosine diphosphate according to the formula [(MFI(PGE1)-MFI(PGE1-ADP))/MFI(PGE1)]x100, and was determined at baseline and at days 1 and 4 after starting clopidogrel. We correlated VASP index with occurrence of recurrent cardiovascular events over six-month follow-up. RESULTS: There was a significant stepwise decrease in VASP index from baseline (86+/-6%) to day 1 (71+/-13%) and day 4 (61+/-16%; p<0.001) with marked interindividual variability. Patients who experienced recurrent cardiovascular events displayed a higher VASP index compared with those free of events (76+/-3% versus 59+/-16%, p=0.006). Five of six recurrent events occurred in patients in the upper quartile of VASP index measured at day 4. The best cut-off of platelet reactivity index of VASP to predict high-risk ACS patients was at 70%. CONCLUSION: Assessment of VASP index in ACS patients identifies low responders to clopidogrel who are at increased risk of recurrent cardiovascular events.