Background: Drug-coated balloon (DCB) has been proved efficacy for coronary small vessel disease, but data regarding outcomes of DCB in common de novo lesions (including reference vessel diameter more than 3.0mm) compared with new-generation drug-eluting stent (DES) are lacking. We hypothesized that a DCB-only strategy for coronary de novo lesions would be non-inferior to DES treatment on angiographic outcomes. Methods: In this randomized controlled trial, we compared the effect of DCB with DES on late lumen loss (LLL) at 9-month angiographic follow-up and 12-month major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR). Results: From July 2017 to July 2018, 288 consecutive patients with reference vessel diameter (RVD) between 2.25 and 4.0mm were screened. After proper pre-dilation, 170 patients were enrolled and randomized to the DCB and the DES groups at 1:1 ratio. Seven patients withdrew the consent forms during hospital stay (1 in DCB group, 6 in DES group). Two patients in DCB group underwent bailout stenting due to severe dissection after DCB release. The primary endpoint of 9-month LLL was −0.19±0.49mm with the DCB versus 0.03±0.64mm with the DES. The one-sided 97.5% upper confidence limit of the difference was −0.04mm, achieving non-inferiority of the DCB compared with the DES (P=0.019). The 12-month cumulative MACE rate was similar in the DCB and DES groups (2.44% vs. 6.33%, P=0.226). Conclusions: In this prospective study, the DCB only strategy for de novo lesion was non-inferior to the new-generation DES in terms of 9-month late lumen loss.

It becomes a common understanding that central aortic systolic and/or pulse pressures (CAP) provide direct and accurate prediction for cardiovascular structural damage and cardiovascular outcomes. Existing methods for CAP measurement and estimation, namely, method based on general transfer function, and N-point moving averaging method, are rather empirical, and lack of theoretical foundation. Those methods also have inherent drawback that there are not personalized, and missing individual aortic characteristics. Here in this paper, we present a novel method of model-based central aortic pressure measurement and computing, referred to as MCAP. MCAP has solid theoretical foundation; a novel human aortic network model is proposed and developed based on viscous fluid mechanics theory. In MCAP, model parameters of individuals are computed from measured pulse wave of radial artery and brachial artery, the central aortic - radial artery transfer function is derived from the model, and finally, the central aortic pressure and pulse wave are obtained. We conducted an experiment at Cardiovascular Department of Beijing Hospital. Experimental results on 50 test cases have shown better performance of MCAP with comparison to GTF and N-point average method (r_MCAP = 0:9667, r_GTF = 0:9025, r_NPMA = 0:8099). The MCAP accuracy (Mean(SBP/DBP) =3.9 mmHg/3.6 mmHg, Stdev (SBP/DBP) = 7.7 mmHg/2.9 mmHg) of central artery systolic pressure and diastolic pressure is up to the standard of AAMI (Mean≤65 mmHg, Stdev≤68 mmHg).