In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease.

Objectives: The aim of this postmarket clinical study was to assess the safety and efficacy of the latest generation polymer-free sirolimus-eluting stents (PF-SES) in an all-comers population comparing outcomes in stable coronary artery disease (CAD) versus acute coronary syndrome (ACS) in France. Background: The efficacy and safety of the first-generation PF-SES have already been demonstrated by randomized controlled trials and "all-comers" observational studies. Methods: For this all-comers observational, prospective, multicenter study, 1456 patients were recruited in 22 French centers. The primary endpoint was target lesion revascularization (TLR) rate at 12 months and secondary endpoints included major adverse cardiac events (MACE) and bleeding. Results: 895 patients had stable CAD and 561 had ACS. At 12 months, 2% of patients had a TLR, with similar rates between stable CAD and ACS (1.9% vs 2.2%, p = 0.7). The overall MACE rate was 5.2% with an expected higher rate in patients with ACS as compared to those with stable CAD (7.3% vs 3.9%, p = 0.007). The overall bleeding event rate was 4.5%, with similar rates in stable CAD as compared to ACS patients (3.8% vs 5.6%, p = 0.3). Dual antiplatelet therapy (DAPT) interruptions prior to the recommended duration occurred in 41.7% of patients with no increase in MACE rates as compared to patients who did not prematurely interrupt DAPT (3.9% vs 6.1%, p = 0.073). Conclusions: The latest generation PF-SES is associated with low clinical event rates in these all-comers patients. There was a high rate of prematurely terminated DAPT, without any effect on MACE at 12 months. This trial is registered with NCT03809715.

Screening coronary artery disease with computed tomography angiogram should limit normal invasive coronary angiogram, regardless of pretest probability.

BACKGOUND: Performing functional testing (FT) or a computed tomography angiogram (CCTA) before invasive coronary angiogram (ICA) is recommended for coronary artery disease (CAD). We aimed to evaluate, in a real life setting, the rate of strictly normal ICA following a positive noninvasive test result. METHODS: We included all patients who underwent an ICA with a prior positive FT or CCTA. Patients were categorized in 5 subgroups, according to pretest probability (PTP) of having a CAD. Main results of ICA were defined as normal ICA, nonobstructive CAD (non-oCAD), and obstructive CAD (oCAD). RESULTS: For 4,952 patients who underwent ICA following either a positive FT (3276, 66.2%) or CCTA (1676, 33.8%) result, the PTP was (1) low (<15%; n = 968, 19.5%), (2) lower intermediate (15%-35%; n = 1336, 27.0%), (3) higher intermediate (35%-50%; n = 806, 16.3%), (4) high (50%-65%; n = 806, 17.7%), and (5) very high (> 65%; n = 965, 19.5%). ICA showed no CAD (819 patients, 16.5%), non-oCAD (1,193 patients, 24.1%), or oCAD (2940 patients, 59.4%). Without considering the PTP values, CCTA compared to FT showed less frequently normal ICA (7% vs 16.5%), and more frequently CAD (non-oCAD 27.9% vs 22.2%; oCAD 65.1% vs 56.4%) (all P < .0001). When we considered the different PTP values, CCTA always showed lower rates of normal ICA than the FT. In low- and lower intermediate-risk patients, CCTA detected more frequently oCAD compared to FT (P < .001). CONCLUSIONS: CCTA is a better alternative than FT to limit unnecessary ICA regardless of PTP value, without missing abnormal ICA.