The effectiveness and safety of the RESTORE R drug-eluting balloon versus a drug-eluting stent for small coronary vessel disease： study protocol for a multi-center, randomized, controlled trial

bjective Small coronary vessel disease （disease affecting coronary vessels with main branch diameters of 〈 2.75 mm） is a common and intractable problem in percutaneous coronary intervention （PCI）. This study was designed to test the theory that the effectiveness and safety of drug-eluting balloons for the treatment of de novo lesions in small coronary vessels are non-inferior to those of drug-eluting stents. Methods We designed a prospective, multicenter, randomized, controlled clinical trial aiming to assess the effectiveness and safety of the RESTORE R （Cardionovum, Bonn, Germany） drug-eluting balloon （DEB） versus the RESOLUTE R （Medtronic, USA） drug-eluting stent （DES） in the treatment of small coronary vessel disease. This trial started in August 2016. A total of 230 patients with a reference vessel diameter （RVD） 〉 2.25 mm and 〈 2.75 mm were randomly assigned to treatment with a DEB or a DES at a 1：1 ratio. The study was also designed to enroll 30 patients with an RVD 〉 2.00 mm and 〈 2.25 mm in the tiny vessel cohort. Results The key baseline data include demographic characteristics, relative medical history, baseline angiographic values and baseline procedural characteristics. The primary endpoint is in-segment diameter stenosis at nine months after the index procedure. Secondary endpoints include acute success, all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization and stent thrombosis. Conclusions The study will evaluate the clinical efficacy, angiographic outcomes, and safety of DEBs compared to DESs in the treatment of de novo coronary artery lesions in small vessels.

Efficacy and safety of FIREHAWK abluminal groove filled biodegradable polymer sirolimus-eluting stents for the treatment of long coronary lesions： nine-month angiographic and one-year clinical results from TARGET I trial lona cohort

Background Previous studies indicated that long coronary lesions are one of the key predictors of drug-eluting stent （DES） failure. The purpose of this study was to evaluate the efficacy and the safety of the long length FIREHAWK stent in long coronary artery disease. Methods The long cohort of TARGET I was a prospective, multicenter, single arm trial. It was planned to enroll 50 patients undergoing percutaneous coronary intervention （PCI） for the treatment of de novo long lesions in a native coronary artery. The major inclusion criteria of the trial was that patients were intended to undergo the treatment of a long target lesion（s） with diameter stenosis 〉70% and reference vessel diameter 2.5 mm to 4.0 mm by visual estimate, that needed to be covered by at least one 33 mm or 38 mm stent or multiple long stents overlapped. The angiographic follow-up was planned at 9-month and the clinical follow-up will be up to 5 years. The primary end point was in-stent late lumen loss at 9-month. Results Fifty patients （mean age （57.6±10.2） years） with 59 de novo long lesions （reference vessel diameter （2.85±0.44） mm, lesion length （35.2±9.4） mm, and stent length （41.8±11.3） mm） were enrolled. The angiographic follow-up rate was 92% at 9-month. The in-stent late loss was （0.16±0.16） mm. Proximal edge, distal edge and in-segment late loss （mm） were 0.21±0.35, 0.03±0.33, and 0.07±0.26, respectively. No in-segment binary restenosis was observed. At 1-year no death, Q wave myocardial infarction （MI）, or stent thrombosis occurred. Non-Q-wave MI occurred in two patients （4%） due to procedural complications. Conclusions Treatment of long coronary lesions with the FIREHAWK stent is able to produce similar results as observed in the FIREHAWK~ FIM clinical trial. Based on this result, we are confident in the treatment prospect of the FIREHAWK for long coronary lesions.

Decrease of plasma N-terminal pro p-type natriuretic peptide as a predictor of clinical improvement after cardiac resynchronization therapy for heart failure

Background N-terminal pro β-type natriuretic peptide （NT pro BNP） has been shown to predict the prognosis and could guide the treatment of heart failure. We aimed to investigate the values of NT pro BNP in predicting the clinical response to cardiac resynchronization therapy （CRT）. Methods A total of 44 patients with chronic heart failure （34 male and 10 female, mean age of （58±13） years, New York Heart Association （NYHA） class 3.3±0.5, QRS duration （150±14） milliseconds） who underwent successful implantation of a CRT system were enrolled in this study. Pharmacotherapy remained stable during the first 3 months of follow-up. Plasma levels of NT pro BNP were evaluated before and 3 months after implantation. Clinical, echocardiographic and exercise parameters were monitored at each clinical visit after CRT implantation. Receiver operating characteristic analysis and a paired ttest were performed to analyze the data. Results After a mean of （16.3±5.5） months of follow-up, 11 nonresponders were identified. CRT resulted in a significant reduction in NT pro BNP （（1.70±1.28） vs （1.07±0.88） pmol/ml, P 〈0.001） in responders. Percentage change in NT pro BNP level （△BNP%） was a statistically significant predictor of long term clinical improvement at 3 months of follow-up. Conclusions △BNP% from baseline to 3 months of follow-up is a predictor of long term response to CRT. NT pro BNP may be a simple method for monitoring the effects of CRT.

A multi-center study of Restylane for treatment of nasolabial folds in China

Background Restylane, a hyaluronic acid gel, has been widely used as a dermal filler in USA and European countries. This study was designed to study the safety and efficacy of Restylane as a non-permanent dermal filler for facial augmentation therapy in China for the correction of nasolabial folds during a follow-up period of 6 months. Methods The study consisted of a screening visit, a baseline visit during which injection with Restylane was given, and follow-up visits after four weeks, three months and six months. The efficacy was subjectively assessed by comparing the treatment results between pre-treatment and post-treatment. Adverse events were analyzed by severity and duration. Results At six months post-baseline, the subjects and the investigators＇ independent assessment score of Wrinkle Severity Rating Scale was decreased. Global Aesthetic Improvement Scale was considered to have improved by over 90% in some cases. Adverse events related to product and injection was reported in 21.5% of the injections. A vast majority of the post-treatment reactions were mild. Conclusions The efficacy of Restylane for nasolabial fold in a Chinese population was excellent. Restylane was well tolerated and no systemic reactions or other safety concerns were raised.

Two-year clinical outcomes following elective drug-eluting versus bare-metal stent implantation： results from a large single-center database

Background In response to the increasing concern with the safety of the drug-eluting stent （DES）, the present study aimed to evaluate the long-term safety and efficacy of DES used for a Chinese patient population. Methods All patients, who underwent an index elective percutaneous coronary intervention with an implantation of either DES or bare-metal stent （BMS） in a single institution from April 2004 to December 2006, were included in the analysis. A propensity-score matching technique was applied to adjust and to minimize the impact of confounding factors. Results Overall, there were 1465 patients （20.2%） who had undergone an implantation of only BMS, and 5769 patients （79.8%） of only DES. The propensity-score matching technique set up 1321 pairs of patients for analysis. There were no significant differences between the rates of stent thrombosis （definite and probable） of the two groups （1.06% vs 1.21%, P=0.8580）. Although rates of mortality and myocardial infarction （MI） during the 2-year follow-up period had not differed significantly, rates of death/MI （3.0% vs 4.5%, P=0.0263）, target-lesion revascularization （TLR, 3.2% vs 8.5, P=0.0001）, target-vessel revascularization （TVR, 5.8% vs 9.5%, P 〈0.0001） and any revascularization （10.0% vs 13.3%, P=0.0066） were significantly lower for the DES group than for the BMS group. Among the patients in whom devices were implanted for off-label indications, the propensity-score matched rates of stent thrombosis, mortality, MI, and death/MI were not significantly different, while rates of TLR, TVR and any revascularization were significantly lower for the DES group than for the BMS group. Conclusions During the 2 years of follow-up post stenting, DES use is associated with lower rates of death/MI, TLR, TVR and any revascularization, compared with BMS, in propensity-score matched Chinese patient populations. In the setting of off-label usage, DES use is also associated with similar advantages.

Can ＂Hybrid stent implantation＂ improve long-term safety without adversely affecting efficacy when treating multilesion coronary artery disease in the drug-eluting stent era？

Background Though drug-eluting stent （DES） almost solved a problem of restenosis, safety issues related to stent thrombosis are still the major concern of DES. We hypothesized that hybrid stent implantation may decrease the use of DES, probably improving the long-term safety but not affecting efficacy adversely when treating multilesion coronary artery disease in the DES era. Methods From April 2004 to October 2006, 848 patients with multilesion disease underwent hybrid stent implantation. During the same period 5647 patients with multilesion coronary heart disease were treated by exclusive DES implantation in Fu Wai Hospital. According to propensity score matching, we chose 823 pairs of patients with multileison coronary artery disease for inclusion into our study. We obtained the 24-month clinical outcome including death, myocardial infarction （MI）, thrombosis, target lesion revascularization （TLR）, target vessel revascularization （TVR）, and major adverse cardiac events （MACE, the composite of death, MI, and TVR）. We used Cox＇s proportional-hazard models to assess relative risks of all the outcome measures after propensity match. Results At 24 months, patients in the hybrid stent implantation group showed a significantly higher risk of TLR （8.39% vs. 3.28%, HR2.38, 95% Cl. 1.50-3.70）, TVR （11.07% vs. 6.32%,/-/R 1.61, 95% Cl. 1.15-2.27） and MACE （13.75% vs. 8.75%, FIR 1.37, 95% Cl. 1.02-1.85）. No significant difference was apparent in terms of mortality （1.22% vs. 1.70%, HR 0.55, 95% Cl. 0.24-1.25）, MI （1.95% vs. 2.31%, HR0.73, 95% Cl. 0.37-1.42）, or thrombosis （definite＋probable） （0.73% vs. 1.58%, HR0.40, 95% Cl. 0.15-1.05）. Conclusions In patients with multilesion coronary artery disease, the exclusive DES implantation was associated with significantly lower risks of TLR, TVR and MACE, and the hybrid stent implantation did not result in any significant improvements regarding safety issues. Prospective studies are needed to confirm our results.