Meunier Ludovic, Eccleshall Simon, Bakdi Ronan, Godin Matthieu, Souteyrand Géraud, Mottin Benoît, Valy Yann, Benoit Christian, Lordet Vincent, Laurençon Virginie, Milhem Antoine, Waliszewski Matthias, Allix-Béguec Caroline
Cardiology Department, Centre Hospitalier la Rochelle, la Rochelle, France.
Norfolk and Norwich University Hospital, Norwich, UK.
Clin Cardiol. 2025 Aug;48(8):e70189. doi: 10.1002/clc.70189.
Drug-eluting stent (DES) angioplasty is the gold standard treatment for coronary lesions. Drug-coated balloon (DCB) is an option for in-stent restenosis, and has also shown promise for small-calibre coronary artery disease. We evaluated the 3-year effectiveness of a decision algorithm for percutaneous coronary intervention (PCI) that favoured a stent-less strategy (SLS) in primary angioplasty.
All patients who underwent angioplasty during 1 year were included in a prospective observational study. Patients eligible for SLS first underwent scoring balloon followed by DCB angioplasty or DES in case of mandatory bailout. Patients not eligible for SLS were unstable patients who underwent conventional drug-eluting stenting. The metal index, stent burden, was calculated by stent length divided by the total lesion length. A 36-month follow-up recorded target lesion revascularization (TLR).
Patients eligible for SLS represented 85% (n = 840) of patients who underwent PCI. TLR was required in 2.6% and 6% of patients in the DCB-only and bailout-DES groups, respectively. Median metal index was 0.25 (IQR: 0.5) in patients with TLR. There was a difference between TLR-free survival distributions in the DCB-only and bailout-DES groups (p = 0.016).
The SLS based on a combination of scoring balloon and DCB was effective at 3 years with a low rate of TLR. This rate was higher in patients with stent burden.
This study was registered with clinicaltrials. gov (NCT03893396, first posted on March 28, 2019).
药物洗脱支架（DES）血管成形术是冠状动脉病变的金标准治疗方法。药物涂层球囊（DCB）是治疗支架内再狭窄的一种选择，并且在小口径冠状动脉疾病治疗中也显示出前景。我们评估了一种经皮冠状动脉介入治疗（PCI）决策算法的3年有效性，该算法在初次血管成形术中倾向于无支架策略（SLS）。
将1年内接受血管成形术的所有患者纳入一项前瞻性观察性研究。符合SLS标准的患者首先接受评分球囊治疗，若有必要进行补救，则随后接受DCB血管成形术或DES治疗。不符合SLS标准的患者为接受传统药物洗脱支架置入术的不稳定患者。金属指数（即支架负荷）通过支架长度除以总病变长度来计算。36个月的随访记录了靶病变血运重建（TLR）情况。
符合SLS标准的患者占接受PCI患者的85%（n = 840）。单纯DCB组和补救DES组分别有2.6%和6%的患者需要进行TLR。发生TLR的患者中位金属指数为0.25（四分位间距：0.5）。单纯DCB组和补救DES组的无TLR生存率分布存在差异（p = 0.016）。
基于评分球囊和DCB联合应用的SLS在3年时有效，TLR发生率较低。支架负荷较高的患者TLR发生率更高。
本研究已在clinicaltrials.gov注册（NCT03893396，首次发布于2019年3月28日）。
