Impact of Sex on Comparative Outcomes of Radial Versus Femoral Access in Patients With Acute Coronary Syndromes Undergoing Invasive Management: Data From the Randomized MATRIX-Access Trial.

OBJECTIVES: This study sought to assess whether transradial access (TRA) compared with transfemoral access (TFA) is associated with consistent outcomes in male and female patients with acute coronary syndrome undergoing invasive management. BACKGROUND: There are limited and contrasting data about sex disparities for the safety and efficacy of TRA versus TFA for coronary intervention. METHODS: In the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) program, 8,404 patients were randomized to TRA or TFA. The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACCE or major bleeding. RESULTS: Among 8,404 patients, 2,232 (26.6%) were women and 6,172 (73.4%) were men. MACCE and NACE were not significantly different between men and women after adjustment, but women had higher risk of access site bleeding (male vs. female rate ratio [RR]: 0.64; p = 0.0016), severe bleeding (RR: 0.17; p = 0.0012), and transfusion (RR: 0.56; p = 0.0089). When comparing radial versus femoral, there was no significant interaction for MACCE and NACE stratified by sex (pint = 0.15 and 0.18, respectively), although for both coprimary endpoints the benefit with TRA was relatively greater in women (RR: 0.73; p = 0.019; and RR: 0.73; p = 0.012, respectively). Similarly, there was no significant interaction between male and female patients for the individual endpoints of all-cause death (pint = 0.79), myocardial infarction (pint = 0.25), stroke (pint = 0.18), and Bleeding Academic Research Consortium type 3 or 5 (pint = 0.45). CONCLUSIONS: Women showed a higher risk of severe bleeding and access site complications, and radial access was an effective method to reduce these complications as well as composite ischemic and ischemic or bleeding endpoints.

Polymer-Free Drug-Coated Coronary Stents Are Cost-Effective in Patients at High Bleeding Risk: Economic Evaluation of the LEADERS FREE Trial.

AIMS: In patients at high risk of bleeding who undergo PCI the biolimus A9 polymer-free drug coated stent (DCS) has superior efficacy and safety compared to a bare metal stent (BMS). We estimated the cost effectiveness of DCS vs. BMS. METHODS AND RESULTS: The Leaders FREE-based economic evaluation estimated service use and quality of life data collected prospectively. The entire trial population was analysed using cost-weights from England, France, Germany, Italy, Scotland and Spain. Country-specific QALYs were derived from EQ-5D scores. We estimated cost per event averted and per QALY gained. DCS use resulted in -0.095 cardiac deaths, target vessel MI, stent thrombosis and revascularization per patient (0.152 vs. 0.237;p<0.001). One-year QALYs were non-significantly higher in the DCS group. Total costs for the index admission were similar between groups. One-year costs using cost-weights from each of the 6 countries, including the additional €300 per DCS stent, ranged from €4,664-8,593 for DCS and €4,845-9,742 for BMS and were lower in the DCS group (England:€-428, France:€-137, Germany:€-33, Italy:€-522, Scotland:€-298, Spain:€-854). CONCLUSIONS: The probability that DCS dominated BMS was >50% in all countries. At a threshold of €10,000 per event averted DCS had a 98% probability of being cost-effective in all 6 countries.

Instantaneous wave-free ratio and fractional flow reserve for the assessment of nonculprit lesions during the index procedure in patients with ST-segment elevation myocardial infarction: The WAVE study.

BACKGROUND: Functional assessment of non-infarct-related artery lesions during primary percutaneous coronary intervention (PCI) might be useful to avoid revascularization of nonsignificant stenosis and staged procedures, thus reducing hospital stay. We aimed to assess the diagnostic performance of instantaneous wave-free ratio (iFR) as compared with fractional flow reserve (FFR) in this setting. METHODS: In the WAVE study, a prospective, observational, single-center registry (NCT02869906), paired iFR and FFR measurements were performed at the level of non-IRA lesions in patients with ST-segment elevation myocardial infarction both during primary PCI and during staged procedures (5-8 days after). RESULTS: Paired iFR and FFR measurements were available for 66 non-IRA lesions in 50 patients. The iFR and FFR values of non-IRA lesions did not change significantly between the index and staged procedure. Bland-Altman analysis did not show systematic bias for either iFR or FFR repeated measures. Receiver operating characteristic curve analysis showed high accuracy of iFR to identify positive (≤0.80) FFR measurements in the index procedure with an area under the curve of 0.95. A cutoff of ≤0.89 for iFR in the index procedure had the best combination of sensitivity (95%) and specificity (90%) with positive and negative predictive values of 86% and 97%, respectively. Finally, iFR measured during the index procedure was significantly correlated with FFR (r=0.71, r2=0.51; P<.0001). CONCLUSIONS: The WAVE study shows that iFR yields similar diagnostic accuracy to FFR in functional evaluation of non-IRA stenosis in patients with STEMI and multivessel CAD, with the advantage of being adenosine free.