Table of Contents
REVIEW ARTICLE
Year : 2016  |  Volume : 1  |  Issue : 2  |  Page : 38-44

China expert consensus on clinical application of the drug-coated balloon


1 Department of Cardiology, Peoples Liberation Army General Hospital, Beijing, China
2 Department of Cardiology, Second Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou, China
3 Department of Cardiology, Second Affiliated Hospital of Jilin University, Changchun, China
4 Department of Cardiology, Beijing Hospital, Beijing, China
5 Department of Cardiology, First Affiliated Hospital of Zhengzhou University, Henan, China
6 Department of Cardiology, Fuwai Cardiovascular Hospital, Beijing, China
7 Department of Cardiology, Guangdong General Hospital, Guangzhou, China
8 Department of Cardiology, Second Hospital of Hebei Medical University, Shijiazhuang, China
9 Department of Cardiology, Henan Province People's Hospital, Zhengzhou, China
10 Department of Cardiology, Shanxi Cardiovascular Hospital, Shanxi, China
11 Department of Cardiology, People's Hospital of Liaoning Province, Shenyang, China
12 Department of Cardiology, Peking University First Hospital, Beijing, China
13 Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China

Date of Web Publication26-Dec-2018

Correspondence Address:
Prof. Yundai Chen
The People's Liberation Army General Hospital, Beijing
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2470-7511.248364

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  Abstract 


Percutaneous coronary intervention (PCI) has become the mainstay in the treatment of coronary heart disease (CHD). In the past 10 years, the number of PCI procedures for CHD has maintained an annual growth of 15%–20% on average in China. As a consequence, in-stent restenosis (ISR) has become an increasingly serious problem with the wide application of coronary stents. Certainly, current treatment regimens for ISR are unsatisfactory in some aspects. Coronary artery bypass surgery has many risk factors and contradictions and a second stent implantation is associated with the risk for recurrent ISR and additional stent implantations; the rate of recurrent ISR in lesions after plain old balloon angioplasty is high (up to 27%). Therefore, all these regimens are suboptimal for the treatment of ISR. In recent years, drug-coated balloon (DCB), a novel interventional technique, has been increasingly used in coronary and peripheral artery interventions in Europe and Asia. In China, several DCB products have been or will be marketed for clinical application. The introduction of DCB provides a new choice for the treatment of coronary artery diseases in China. Based on several national and international clinical trials, >20 experienced experts in the PCI field from China have proposed the China expert consensus on clinical application of the DCB with evidence-based validation and session discussion in order to promote the standardized application of the DCB in the treatment of coronary artery diseases in China.

Keywords: Bifurcation lesions, coronary artery diseases, de novo coronary lesions, drug-coated balloon, in-stent restenosis, small vessel lesions


How to cite this article:
Chen Y, Wang J, Liu B, Ji F, Qiu C, Qiao S, Chen J, Fu X, Gao C, li B, Li Z, Huo Y, Ge J. China expert consensus on clinical application of the drug-coated balloon. Cardiol Plus 2016;1:38-44

How to cite this URL:
Chen Y, Wang J, Liu B, Ji F, Qiu C, Qiao S, Chen J, Fu X, Gao C, li B, Li Z, Huo Y, Ge J. China expert consensus on clinical application of the drug-coated balloon. Cardiol Plus [serial online] 2016 [cited 2020 Sep 19];1:38-44. Available from: http://www.cardiologyplus.org/text.asp?2016/1/2/38/248364




  Preface Top


Percutaneous coronary intervention (PCI) has become the mainstay in the treatment of coronary heart disease (CHD). In the past 10 years, the number of PCI procedures for CHD has maintained an annual growth of 15%–20% on average in China.[1] As a consequence, in-stent restenosis (ISR) has become an increasingly serious problem with the wide application of coronary stents.[2] Certainly, the current treatment regimens for ISR are unsatisfactory in some aspects.[3] Coronary artery bypass surgery has many risk factors and contradictions and a second stent implantation is associated with the risk for recurrent ISR and additional stent implantations; the rate of recurrent ISR in lesions after plain old balloon angioplasty is high (up to 27%).[4] Therefore, all these regimens are suboptimal for the treatment of ISR.

In recent years, drug-coated balloon (DCB), a novel interventional technique,[5] has been increasingly used in coronary and peripheral artery interventions in Europe and Asia.[6] In China, several DCB products have been or will be marketed for clinical application. The introduction of DCB provides a new choice for the treatment of coronary artery diseases in China.[7] Based on the several national and international clinical trials, more than 20 experienced experts in the PCI field from China have proposed the China expert consensus on clinical application of the DCB with evidence-based validation and session discussion in order to promote the standardized application of the DCB in the treatment of coronary artery diseases in China.


  Mechanism of Action and Features of the Drug-Coated Balloon Top


DCB inhibits neointimal proliferation by releasing antiproliferative drugs into the coronary artery wall.[8] Unlike drug-eluting stent (DES), the DCB has no polymer matrix or wire mesh residues, thus reducing the intimal inflammatory response, lowering the risk for thrombosis greatly and shortening the duration of dual antiplatelet therapy (DAPT, requiring only 1–3 months of DAPT after DCB-only procedure).[9] In addition, DCB therapy avoids the need for foreign body implantation, making it possible to receive subsequent therapy when necessary.

To date, >10 DCB products have been marketed worldwide [Table 1].[10] These products all use paclitaxel-based coating because paclitaxel has good lipid solubility and a stable antiproliferative effect.[11] Preclinical studies have demonstrated that paclitaxel may block early promoters for cell proliferation, inhibit the production of cytoskeletons, block mitosis, suppress effectively the quick proliferation of cells, and inhibit the migration and phenotype changes of smooth muscle cells, as well as the neointimal proliferative inflammation.[12] When the DCB releases drugs, the balloon adhering to the arterial wall provides an adequate contact area for drug delivery, allowing the lipid soluble paclitaxel being quickly taken up by the arterial wall.
Table 1: Commercially available coronary drug-coated balloon in China and overseas

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However, DCBs based on pure paclitaxel coating have a drawback, that is, a low bioavailability. To improve the bioavailability of the drug coating, DCB products commonly used in clinical practice nowadays all use a paclitaxel-based matrix coating. For example, SeQuent Please®, the first clinically proven DCB in the world, utilizes PACCOCATH® technology which adds hydrophilic iopromide on the basis of paclitaxel so as to improve the bioavailability of paclitaxel, increase the contact area between the drug and the blood vessel wall, and reduce the attraction among the drug molecules. With SeQuent Please®, a single drug release antagonizes the proliferation of smooth muscle cells for >14 days and inhibits the neointimal proliferation through 4 weeks after treatment.


  Clinical Indications and Evidence-Based Studies of the Drug-Coated Balloon Top


Since PACCOCATH ISR (a clinical trial of the first DCB, a prototype of SeQuent Please®, in treatment of ISR) was initiated in December 2003,[13] several clinical trials have consistently shown the efficacy and safety of the DCB in treatment of various coronary stenotic lesions, small vessel lesions, and bifurcation lesions [Table 2] and [Table 3] for more details]. In China, the DCB has been approved for treatment of ISR, and therefore, it is recommended by Chinese experts.
Table 2: Summary of major clinical trials of drug-coated balloon in treatment of in-stent restenosis

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Table 3: Summary of major clinical trials of drug-coated balloon in treatment of de novo lesions, small vessel lesions, and bifurcation lesions

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In-stent restenosis

ISR is the preferred indication and also the clinical indication of the DCB approved by the State Food and Drug Administration. Studies have shown that the DCB has better efficacy and safety in treatment of ISR when compared with ordinary balloons and DES.[13],[14],[41],[42],[43]

Results of the 2-year follow-up of PACCOCATH ISR[14] have demonstrated the safety of the DCB in treatment of coronary ISR and the reduction in the rate of repeated revascularization. The PEPCAD II study[16] has shown that the DCB is at least as effective as DES in treatment of coronary ISR, but DCB has better tolerability and does not require stent reimplantation. The ISAR DESIRE-3 study[19] has demonstrated that the DCB is as effective as DES in treatment of ISR and has a better safety profile. In PEPCAD-DES,[17] it was shown that the DCB is more effective and safer than ordinary balloons in treatment of complex lesions which have undergone >2 interventions. The PEPCAD China ISR study[25] has demonstrated the safety and efficacy of the DCB. The DCB is the preferred choice in treatment of DES-ISR due to the avoidance of an additional stent implantation.

Based on the results of aforementioned studies, the 2014 European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) Guidelines on myocardial revascularization[44] recommend the DCB for treatment of various ISRs including bare-metal stent ISR (BMS-ISR) and DES-ISR with an I A level of evidence. Meanwhile, the DCB has become the first device recommended by The National Institute for Health and Care Excellence (NICE) assessment program. Currently, available evidence indicates that the effect of the DCB in ISR treatment varies by products and DCB products have no “class effects.”[24],[45]

De novo coronary lesions

In addition to the benefits in ISR, DCB has also shown some advantages in the treatment of de novo coronary lesions including small vessel lesions and bifurcation lesions and has been approved in the European Union (EU, CE Mark) for treatment of small vessel lesions.

Small vessel lesions

Although stent technologies are constantly being improved, the rate of restenosis after stent implantation in the small coronary vessels with an inner diameter of 2.25–2.8 mm remains high.[31] The prospective PEPCAD I study[26],[27] is the first clinical trial of the DCB in treatment of high-risk small vessel lesions. In this study, coronary angiography follow-up results have shown that the DCB is significantly better than DCB + BMS in terms of late lumen loss and the incidence of in-segment restenosis is lower in the DCB group. Clinical follow-up at 12 and 36 months has shown a lower incidence of major adverse cardiac event (MACE). This study demonstrated that the DCB-only regimen is superior to a DCB + BMS combination therapy in the management of small vessel lesions. In the BELLO study,[28] the largest ever clinical randomized trial comparing DCB and DES in the treatment of small vessel disease (SVD), angiography at 6 months showed that the DCB is noninferior or even superior to DES in terms of late lumen loss; there was no significant difference in the rate of restenosis and target lesion revascularization or the incidence of MACE at 6 months between the two groups. BELLO indicated that the DCB, especially the DCB-only regimen, is significantly superior to DES in preventing in-stent late lumen loss. Based on the results of abovementioned studies, the China Expert Consensus recommends that DCB-only regimen may be the preferred choice in the treatment of SVD.

Bifurcation lesions

The interventional therapy for bifurcation lesions remains a great challenge despite continuous improvement made in intervention technologies and strategies.[40] Dual stenting is a complex procedure and associated with a higher risk for ISR and thrombosis and may require prolonged DAPT. The results of the PEPCAD V study[30] on bifurcation lesions have demonstrated the feasibility of DCB in treatment of bifurcations lesions, while the PEPCAD-BIF study[46] has shown that the DCB is superior to ordinary balloons in treatment of bifurcation lesions.

In addition, results of a recently published study provide further evidence supporting that DCB-only for treatment of de novo coronary lesions may significantly increase late lumen diameter.[47] Therefore, the DCB-only regimen seems to be a good alternative to DES in the treatment of de novo lesions including small vessel lesions and bifurcation lesions.

Based on the above evidence, the China Expert Consensus recommends DCB-only regimen for treatment of primary coronary lesions.

Other indications

In addition to the abovementioned indications, DCB is also indicated for the following populations: patients with a high risk for bleeding, such as those with hemophilia, a previous history of hemorrhage, peptic ulcer, severe renal failure; patients on anticoagulation agents or undergoing surgery recently, such as those with atrial fibrillation or cardiac valve replacement; and patients with vascular endothelial dysfunction, a history of previous subacute in-stent thrombosis, or refusing foreign body implantation.


  Procedures and Precautions of Clinical Application of the Drug-Coated Balloon Top


Procedures of clinical application

Predilatation

The general rule of predilatation is to use a conventional or semi-compliant balloon with a balloon/vessel ratio of 0.8–1.0 under a moderate pressure between 8 and 14 atm to prevent dissection. In case of inadequate dilatation, a noncompliant balloon or a cutting balloon may be used for adequate predilatation; blood vessel imaging techniques such as intravenous ultrasound and optical coherence tomography and function tests such as fractional flow reserve could also be used as an additional tool.

How to judge the effect of predilatation

After adequate predilatation is achieved, we should determine whether it is appropriate to perform DCB therapy or not based on the effect of predilatation. When all of the following three criteria are met, DCB therapy can begin: no dissection of blood vessels, or Type A/B dissection; thrombolysis in myocardial infarction grade 3 flow; and residual stenosis ≤30%. If anyone of these three criteria is not met after adequate predilatation is achieved, alternative interventional therapy such as DES, BMS, or biodegradable stent should be considered.

Drug-coated balloon therapy

The diameter of the DCB should match with the diameter of the target blood vessel and the reference ratio of balloon/vessel is between 0.8 and 1.0. Recommend dilatation against the arterial wall last for 30–60 s. Expand the drug balloon under a nominal pressure of 7–8 atm to prevent dissection. It is important to note that the DCB is a tool for drug delivery and not intended for eliminating the blood vessel stenosis.

To avoid geographic mismatch between the preconditioning area or the stent and the balloon in the use of DCB, make sure the balloon fully covers the length of the preconditioned area and extends beyond both margins by 2–3 mm. Furthermore, the DCB should be introduced into the target lesion within 2 min after it enters the human body.

Postprocedural dual antiplatelet therapy

The duration of postprocedural DAPT is 1–3 months when DCB treatment is used stand-alone. If the DCB is combined with stent treatment, the DAPT should follow the dosing schedule required by the respective stent treatment.

Procedures of clinical application of the DCB are summarized in [Figure 1].[48]
Figure 1: Flowchart of drug-coated balloon use

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Other precautions in drug-coated balloon use

  1. Do not touch the drug balloon with your hands; do not immerse the balloon in blood or contrast media to avoid drug loss; retrograde flushing of the wire lumen with saline is possible
  2. The balloon is a disposable device. Its repeated use is not allowed because the drug is almost completely released into the target lesion after the balloon expansion, thus making repeated use incapable of delivering drug
  3. If a serious dissection occurs after the use of DCB, a rescue DES implantation is required. Furthermore, the balloon should fully cover the length of the target area and extends beyond both margins of DES by 2–3 mm to avoid geographic mismatch between the stent and the balloon.



  Prospective Top


Abundant clinical evidence has proved the good efficacy of DCB in management of ISR. Meanwhile, additional evidence supports that DCB is indicated for treatment of small vessel lesions, bifurcation lesions, and some de novo coronary lesions, as well as patients intolerant to or unsuitable for long-term oral DAPT. Therefore, the DCB will have an important position in the CHD interventional field in the 21st century.

Nevertheless, there are still some problems with the DCB to be addressed.[10] For example, only a few studies with a short duration of observation have investigated the use of DCB in the treatment of de novo coronary lesions and evidence from these studies is not strong enough. Although the DCB is effective in inhibiting neointimal proliferation, it does not suppress the elastic recoil of the arterial wall which plays an important role in the development of restenosis. Consequently, the DCB cannot replace DES completely at present and more clinical data, especially data in Chinese population, is needed. In addition, the product design requires further improvements in the future.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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