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At present, percutaneous coronary intervention with DES implantation is still the mainstay of interventional therapy for symptomatic coronary heart disease. However, the complications following DES implantation, such as restenosis, late in-stent thrombosis, bleeding risk associated with long-term double anti-platelet therapy are still of great concern. Drug-coated balloon (DCB), which has been widely used to treat ISR has been recommended by ESC/EACT Coronary Intervention Guideline 2014 with an IA level of evidence . In recent years, numerous trials reported that the effect of DCB to treat de novo lesions are non-inferior to those with DES . But most of these trials are limited to small vessel disease (SVD) involving coronary arteries with diameters of < 2.8 mm. No specific report about DCB only strategy for de novo coronary lesions with diameters of >2.8mm(large vessel disease, LVD) is currently available. In this study, we prospectively observed patients receiving DCB alone for de novo coronary lesions at Beijing Hospital Heart Center and compared the clinical efficacy of DCB for coronary lesions both in LVD and SVD.
We performed a prospective study of 215 consecutive patients with 238 de novo lesions( 90 lesions as LVD group with reference vessel diameter (RVD) ≥2.8 mm, the other 148 lesions as SVD group with RVD <2.8 mm) received drug coated balloon (DCB) angioplasty in Beijing Hospital cardiac catheter lab. Clinical characteristic was recorded and coronary angiography was analyzed with Quantitative Coronary Angiography (QCA)software.
Patients in LVD group are much younger than in small vessel group (60.1 ± 11.1 vs. 65.0 ± 10.6 ， P<0.001), less patients had diabetes (24.7% vs. 43.1% ， P<0.01), three-vessel disease (35.5% vs. 53.6% ， P<0.05) and complex lesions ( 34.4% vs. 50.0% ， P<0.05) than in SVD group. During pre-dilation, 76.4% of lesions could be treated well only by plain old balloons in SVD group, while only 58.9% of lesions in LVD group (P<0.01) with additional use of non-compliant (NC) balloons. Each group had one failure case that was bailout stented with drug-eluting stents (DES). The success rate of DCB angioplasty were similar in LVD group and SVD group (98.9% vs. 99.3%, p>0.05). There was one acute myocardial infarction requiring emergent target lesion revascularization (TLR) in SVD group during hospitalization. No MACE was observed in LVD group during hospitalization. Forty-two patients with 53 lesions, including 27 LVD lesions underwent coronary angiography at average 9.4 months after DCB intervention. The QCA analysis showed follow-up MLD in SVD group increased significantly than that of post-procedure （ 1.71± 0.36mm vs.1.52±0.30mm, P<0.05 ） , while in LVD group the MLD of follow-up had no statistical difference with that of post-procedure(2.35±0.48mm vs. 2.19±0.34mm, P>0.05). At average 9.1 months clinical follow-up, the MACE rate in LVD group was 0% and 2.3% in SVD group, with TLR rates was 0% and 1.5% respectively (P>0.05). No death was observed in either group.
Applying DCB for de novo coronary lesions was safe and effective both for SVD and LVD.
CORONARY: Drug-Eluting Balloons and Local Drug Delivery