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瑞士巴赛尔大学Raban V Jeger团队比较了药物涂层球囊与药物洗脱支架治疗小冠状动脉疾病的长期有效性和安全性。2020年10月19日，该研究发表在《柳叶刀》杂志上。

在新发冠状动脉小血管疾病的治疗中，就12个月以下的临床结局而言，药物涂层球囊（DCB）不逊于药物洗脱支架（DES），但1年以上的数据很少。

为了评估DCB在经皮冠状动脉介入治疗的所有人群中的长期疗效和安全性，研究组在德国、瑞士和奥地利的14个临床机构进行了一项预先设定的多中心、随机、开放标签、非劣效性试验的长期随访。

2012年4月10日至2017年2月1日，研究组招募了758名冠状动脉小于3 mm的新发病变和有经皮冠状动脉介入治疗适应症的患者，按1：1随机分组，其中382名接受DCB治疗，376名接受第二代DES治疗。所有患者均随访3年，追踪重大心脏不良事件（即心源性死亡、非致命性心肌梗塞和靶血管血运重建[TVR]）、全因死亡、可能或确定的支架血栓形成和大出血的发生率。

在DCB组和DES组中，重大心脏不良事件的估计发生率均为15%，其中心源性死亡的估计发生率分别为5%和4%，非致命性心肌梗塞均为6%，TVR均为9%，均相差不大。DCB组与DES组患者的全因死亡率非常相似，均为8％。DCB组中发生可能或确定的支架血栓形成或大出血的发生率分别为1%和2%，均低于DES组，分别为2%和4%，但差异不显著。

综上，经过长达3年的随访，DCB与DES在治疗新发冠状动脉小血管疾病方面的有效性和安全性不分伯仲。

附：英文原文

Title: Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial

Author: Raban V Jeger, Ahmed Farah, Marc-Alexander Ohlow, Norman Mangner, Sven Mbius-Winkler, Daniel Weilenmann, Jochen Whrle, Georg Stachel, Sinisa Markovic, Gregor Leibundgut, Peter Rickenbacher, Stefan Osswald, Marco Cattaneo, Nicole Gilgen, Christoph Kaiser, Bruno Scheller, Peter Ammann, Belal Awad, Margarete Baumgartner, Michael Boehm, Steffen Bohl, Leonhard Bruch, Dominik Buckert, Peter Buser, Christian Butter, Yvonne P. Clever, Bodo Cremers, Florim Cuculi, Gudrun Dannberg, Paul Erne, Sebastian Ewen, Gregor Fahrni, Marcus Franz, Philipp Haager, Andrea Harder-Allgoewer, Andreas Hoffmann, Robert Hllriegel, Frank Hlschermann, Timo Jerichow, Lucas Joerg, Ioannis Kapos, Boris Keweloh, Behrouz Kherad, Michael Kühne, Bernward Lauer, Karsten Lenk, Corinna Lenz, Dirk Von Lewinski, Axel Linke, Olev Luha, Micha Maeder, Felix Mahfoud, Christian Mueller, Michael Neuss, Ella Niederl, Michel Noutsias, Dominique Nuessli, Ismet Oenal, Sylvia Otto, Rima Paliskyte, Sabine Perl, Burkert Pieske, Bjoern Plicht, Tudor C Poerner, Stefan Richter, Hans Rickli, Florian Riede, Hans Roelli, Alexandra Roettgen, Franziska Rohner, Stephan Schirmer, Albrecht Schmidt, Matthias Schreiber, Mirko Seidel, Frank-Peter Stephan, Christian Sticherling, Berthold Struck, Ralf Surber, Grit Tambor, Stefan Toggweiler, Lukas Trachsel, Raphael Twerenbold, Andreas Wagner, Bastian Wein, Sebastian Winkler, Ephraim Winzer, Alexander Wolf, Michael Zellweger

Issue&Volume: 2020-10-19

Abstract:

Background

In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention.

Methods

In this prespecified long-term follow-up of a multicentre, randomised, open-label, non-inferiority trial, patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention were randomly assigned 1:1 to DCB or second-generation DES and followed over 3 years for major adverse cardiac events (ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation [TVR]), all-cause death, probable or definite stent thrombosis, and major bleeding (Bleeding Academic Research Consortium bleeding type 3–5). Analyses were performed on the full analysis set according to the modified intention-to-treat principle. Dual antiplatelet therapy was recommended for 1 month after DCB and 6 months after DES with stable symptoms, but 12 months with acute coronary syndromes. The study is registered with ClinicalTrials.gov, NCT01574534 and is ongoing.

Findings

Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68–1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63–2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45–1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58–1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62–1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07–1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17–1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance.

Interpretation

There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years.

DOI: 10.1016/S0140-6736(20)32173-5

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32173-5/fulltext

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