Objective: T-Flex registry was designed to investigate the safety and clinical performance of the ultrathin (60 µm) strut biodegradable polymercoated sirolimus-eluting stent (SES) with a unique long dual Z (LDZ) link design on a cobalt-chromium stent platform (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in a real-world all-comer population including high-risk subgroups. Methods: This was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. A total of 1,203 patients treated with an ultrathin biodegradable polymer-coated SES, irrespective of lesion complexity, comorbidities, and acute presentation were analyzed from May 2016 to January 2017. The primary endpoint was the one-year incidence of target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (TV-MI), and clinically-indicated target lesion revascularization (CI-TLR). Stent thrombosis was assessed as an additional safety endpoint.Results: At the one-year follow-up, TLF was observed in 3.8% [95% confidence interval (CI) 2.9-5.1] patients, composed of 0.6% (95% CI: 0.3-1.3) cardiac death, 1.3% (95% CI: 0.8-2.2) TV-MI, and 1.9% (95% CI: 1.3-2.9) CI-TLR. In the high-risk subgroups, TLF at one-year was 6.8% (95% CI: 4.6-9.8) in patients with diabetes, 5.2% (95% CI: 3.4-8) in patients with small-vessel disease, 6.1% (95% CI: 3.9-9.6) in patients with ST-elevation myocardial infarction, and 4.5% (95% CI: 2.4-8.3) in patients with total occlusion. During follow-up, stent thrombosis was reported in 0.8% (95% CI: 0.4-1.5) patients in the overall population. Conclusion: Low event rates of TLF and stent thrombosis at one-year follow-up indicate that this ultrathin biodegradable polymer-coated SES has encouraging safety and clinical performance in real-world all-comer populations as well as in high-risk subgroups.

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Aim: Arterial stiffness, a major marker of vascular impedance, has been identified as a predictor of adverse cardiac outcomes. The present study determined the relationship between blood pressure (BP) and arterial stiffness measured noninvasively using a periscope in hypertensive patients. It has also evaluated the usefulness of indices of arterial stiffness in cardiovascular (CV) risk stratification and the necessity to implement these aortic pressure parameters in clinical practice. Methods: The prospective, observational study involved patients with hypertension between the age of 18 and 80 years. The demographic and anthropometric measurements of all the participants were recorded and various central and peripheral (brachial) arterial pressure parameters were measured using a periscope. The clinical variables were compared separately for different CV risk grades and arterial stiffness index (ASI) using Kruskal–Wallis test for non-normal data and chi-square test for count data. The correlation of different parameters with CV risk grade and ASI were evaluated using Spearmen’s correlation method. The agreement of different ASI indices with CV risk grades was assessed using Kappa method. Results: The study recruited a total of 3,032 patients with hypertension. Classification of the subjects for CV risk grades had demonstrated that major proportion of the patients (n = 713) had moderate and severe CV risks (n = 708). The classification of hypertensive patients for arterial stiffness had shown that 1,037 subjects had severe arterial stiffness. Classification of arterial stiffness based on BP levels had demonstrated that 623 patients with severe arterial stiffness and 315 with borderline arterial stiffness had stage II hypertension, and 480 patients with normal BP had no arterial stiffness. Brachial ASI had a strong correlation with systolic BP (SBP). A very good agreement with K value 0.871 was noted for Kappa agreement of arterial stiffness indices with CV risk. Conclusion: The present study corroborates the use of central BP parameters as indicators of arterial stiffness in hypertensive subjects. Noninvasive measurement of these indices has wider implications in personalized risk assessment of CV risk in subjects with hypertension.

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