Post-stEnting assessment of Re-endothelialization with optical Frequency domain imaging aftEr Chronic Total Occlusion procedure: The PERFE-CTO Study Design and Rationale.

BACKGROUND: The treatment of chronic total occlusion of coronary arteries by percutaneous coronary intervention (CTO PCI) is one of the most representative technical advances in ischemic cardiomyopathy of last decade. However, how the complex histopathological remodeling and the new techniques affect healing processes after stent implantation remains unknown. OBJECTIVE: The objective of the PERFE-CTO study is to analyze stent coverage, malapposition and other mechanical abnormalities 3 months after CTO recanalization using intravascular imaging. METHODS: In a French prospective interventional multicenter study, stent strut coverage, acquired malapposition and neointimal hyperplasia (NIH) proliferation will be systematically assessed with 3 months angiogram control and intracoronary optical frequency domain imaging (OFDI) after successful CTO PCI of >20 mm in length. The impact of routine systematical intracoronary imaging after these complex procedures will also be evaluated by measuring the rate of significant mechanical abnormalities (strut malapposition, edge dissection, thrombus) that was undetected by fluoroscopy alone and by complementary PCI when needed. Secondarily, these data will be compared according to clinical characteristics, antiplatelet therapy use or desobstruction technique (antegrade vs. retrograde, true lumen vs. subintima). Each patient will undergo a one-year clinical follow-up. A total of 150 analyzed CTO lesions is expected. CONCLUSION: The PERFE-CTO study will provide essential understanding of the early history after CTO recanalization and the identification of inadequate evolution (stent thrombosis, restenosis or late delayed stent endothelization and cardiovascular outcomes) using intravascular imaging to improve long-term CTO results.

Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation. BACKGROUND: Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR). METHODS: This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days. RESULTS: Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001). CONCLUSIONS: Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).

Clinical outcomes after multilesion percutaneous coronary intervention: comparison between exclusive and selective use of drug-eluting stents.

OBJECTIVES: This study compared acute and late outcomes following a strategy of selective drug-eluting stent (DES) use guided by a set of 4 criteria defining higher risk of in-stent restenosis compared to an exclusive DES strategy in 362 patients with multilesion (n = 900) percutaneous coronary interventions. RESULTS: At a mean follow up of 412 +/- 110 days, major adverse cardiac events (death, myocardial infarction, revascularization) were 16.8% in the exclusive DES group compared to 18.4% in the selective DES group (p = 0.78). By univariate analysis, revascularization rates (9.9% in the exclusive DES group versus 10.5% in the selective DES group; p = 1.0) and target lesion revascularization (TLR) rates (5.5% versus 6.2%; p = 0.77) were similar in the 2 groups. By multivariate analysis adjusted by propensity score to account for differences in baseline characteristics, the strategy of exclusive DES use was not associated with lower risks of revascularization (hazard ratio [HR]: 0.91, 95% confidence interval [CI] 0.64-1.29) or TLR (HR: 0.81, 95% CI 0.59-1.08) compared with selective DES use. Using the Academic Research Consortium criteria, stent thrombosis occurred in 6/161 (3.7%) cases in the exclusive DES group and in 1/201 (0.5%) case in the selective DES group (p = 0.03). CONCLUSIONS: In patients with multiple coronary lesions, a selective DES strategy for lesions at higher risk of restenosis and bare-metal stents for other lesions was safe and effective when compared to the exclusive use of DES. A large, prospective, randomized trial is required to validate a criteria-based selective DES strategy compared to systematic DES use.