The DCB Revolution
Drug-coated balloons show significant promise, but face reimbursement and data challenges.
In recent years, advances in endovascular therapy have expanded the treatment options for patients with peripheral artery disease. Although percutaneous transluminal angioplasty and stenting form the backbone of endovascular therapy, drug-coated balloons represent a breakthrough in treatment of femoropopliteal disease.
One reason the use of DCBs may be so attractive to physicians is that it is in line with a popular philosophy regarding treatment, according to experts who spoke with Cardiology Today’s Intervention.
“Many physicians believe that a ‘leave-nothing-behind’ strategy may be superior to a direct stenting strategy when DCBs are utilized,” George L. Adams, MD, MHS, MBA, associate clinical professor of medicine at the University of North Carolina at Chapel Hill and director of cardiovascular and peripheral vascular research at Rex Hospital, told Cardiology Today’s Intervention.
Data Positive, Cost Uncertain
Most importantly, the data to date have been positive, Adams noted. Currently, the FDA has approved three DCBs: Lutonix 035 DCB (Bard Peripheral Vascular), IN.PACT Admiral DCB (Medtronic) and Stellarex DCB (Spectranetics/Philips).
“Above the knee, each of these three DCBs has shown superiority in their primary efficacy endpoint of primary patency compared with percutaneous transluminal angioplasty (PTA) at 12 months. In addition, they were noninferior to PTA regarding their safety endpoint,” Adams wrote in an email.
Nevertheless, the issue of reimbursement may hinder increased use of the technology. At the end of 2017, the CMS’ transitional pass-through code for DCBs is expiring, leaving the future uptake of DCBs uncertain, according to Sean P. Lyden, MD, chairman of the department of vascular surgery, Sydell and Arnold Miller Family Heart and Vascular Institute, Cleveland Clinic; and chief medical officer at Excelerate Strategic Health Sourcing.
CMS on Nov. 1 released its final rule on outpatient hospital reimbursement for 2018, which indicated that the transitional pass-through code for all DCB indications will expire on Dec. 31, 2017. The agency stated that it is continuing to analyze the payment structure for DCBs.
“Multiyear data demonstrate that this technology produces significant improvement without leaving a permanent implant behind,” he told Cardiology Today’s Intervention. “To me, that’s revolutionary for patient care. Unfortunately, in our economic era, use of DCBs must also make financial sense, and those two issues are diametrically opposed right now.”
Physicians remain hopeful, though, that the issue will ultimately be resolved, said Michael D. Dake, MD, Thelma and Henry Doelger professor of cardiovascular surgery and medical director of the catheterization and angiography laboratories at Stanford Health Care.
“In the short term, there may be winners and losers, and these economic challenges may also impede further growth of the market share. However, in the long term, people will adapt. We don’t have to worry about this technology disappearing,” Dake said in an interview.
The Current Market
Although early data have demonstrated the benefits of DCBs, more recently reported study results on longer-term outcomes and more complex lesions (see Table) further support use of the technology for peripheral interventions, experts told Cardiology Today’s Intervention.
Despite the promising data on these DCBs, all of which are coated with paclitaxel, the devices still differ in terms of dosing, the excipients used and the coating technology.
“It is clearer now that not all DCBs are created equal,” Lawrence A. Garcia, MD, chief of the section of interventional cardiology and vascular interventions, director of vascular medicine, director of noninvasive vascular labs and associate professor of medicine at Tufts University School of Medicine and St. Elizabeth’s Medical Center, Boston, told Cardiology Today’s Intervention.
“Our European and Asian colleagues were able to treat their patients for up to 5 years before these devices made their way to the United States, so we had high hopes once they became available,” he wrote in an email. “After a couple of pivotal trials, though, it became clear that the amorphous vs. crystalline excipients for the paclitaxel clearly have distinct outcomes with regard to long-term patency. The newer amorphous/less crystalline design [of the recently approved Stellarex DCB] may change this metric.”
The differences in devices also pose a challenge in practice, as not all physicians have access to all three DCBs, which can be the result of a number of factors, Dake noted. For instance, a physician’s institution may limit use to only one or two devices to prevent inventory problems or to lower costs.
Even so, he said one device may be better suited than another for a particular patient. The Lutonix 035 DCB, for example, is the only DCB with a dialysis indication and, therefore, has larger balloons than the other available DCBs. Therefore, having only one DCB available can be problematic.
“It is not possible to compare the devices with regards to superiority because they have never undergone randomized head-to-head comparisons,” Krishna Rocha-Singh, MD, FACC, chief scientific officer for Prairie Heart Institute in Springfield, Illinois, told Cardiology Today’s Intervention. “From the data that exist, we can infer that these devices are not commodities. The results achieved by one device cannot be equated to all devices.”
Cost is also a significant factor, Rocha-Singh noted.
“In institutions right now, there are ongoing price wars that point to the desire for a bottom-line price, but they do not necessarily reflect the quality of the present data,” he said.
“Although some institutions, with input from physicians, may opt to carry only one or two of these DCBs for cost-containment purposes, other institutions may carry all three and the physician can decide which may be best for the patient,” Adams said. “For those who are able to personalize their choice, they may consider various aspects such as length of the lesion (amount of paclitaxel delivered in total), location of the lesion (mid-superficial femoral artery vs. P2-P3 segment of the popliteal), morphology of the lesion (calcified vs. not calcified) and the need for a 5F platform.”
Despite these challenges, however, physicians appear to have embraced the use of DCBs for peripheral interventions with enthusiasm, with utilization ranging from about 25% to 40%, experts told Cardiology Today’s Intervention.
Nevertheless, John H. Rundback, MD, FSIR, FSDM, FACC, medical director of the Interventional Institute at Holy Name Medical Center in Teaneck, New Jersey, said uptake could be higher. For example, an increasing number of procedures are being performed in office-based labs, where there is no transitional pass-through code and uptake, therefore, remains low, as opposed to ambulatory surgical centers, according to Rundback.
The three available DCBs have proved safe and effective in randomized clinical trials, but questions remain about how they fare in real-world settings as well as their performance when compared with other endovascular therapies, experts told Cardiology Today’s Intervention.
Certain studies, such as IN.PACT Global, suggest that DCBs still perform well in a larger, less restricted population, noted Gary M. Ansel, MD, FACC, system medical chief of vascular services at OhioHealth in Columbus and a Cardiology Today’s Intervention Editorial Board Member.
“We divided more than 1,500 patients into those who fit the profile for patients enrolled in an investigational drug exemption-type trial vs. patients with more complex disease, such as more calcified lesions and more chronic total occlusions, and we found that the need for repeat procedures was less than 10% in both groups, indicating that the DCB is performing very well in long lesions,” he said.
However, although global registry data show that the effects of DCBs in real-world populations are remarkably similar to those observed in the randomized controlled trials, these studies are not ideal, according to Garcia.
“The principal issue is a significant increase in provisional stenting in all global registries, with stent use being greater than 50% in at least one global registry. Therefore, it is difficult to determine if the outcomes are attributable to the DCBs or the endoprosthesis,” he said.
“We have now seen the glass ceiling with regards to the use of DCBs and where the need is for adjunct technology, including atherectomy for vessel preparation, to improve not only acute procedural results that will reduce the need for provisional stenting but also will improve the durability of the clinical effect beyond 1 year,” Rocha-Singh said.
He also said more high-quality data are needed to determine how best to use not only DCBs but other technologies, such as drug-eluting stents.
“When there’s no beacon — no high level of evidence — there are just a lot of recommendations, which is where we are right now in the field,” he said.
As the CMS’ transitional pass-through payment (TPT) code is about to expire, physicians recognize that reimbursement will significantly affect the landscape of DCB technology and its use in treatment of PAD, according to experts who spoke with Cardiology Today’s Intervention.
“Transitional pass-through payments were established by Congress in 2000 to foster innovative medical devices, drugs and biologics,” Lyden said. “The Medicare TPT reimbursement is paid on top of an ambulatory surgical centers facility fee for a limited amount of time under the Hospital Outpatient Protective Payment System. A TPT is designed to end after 2 years, allowing accrual of data for the amount of spend on a new technology. If a new technology exceeds spend as defined by the two times rule — the guideline that the highest calculated cost of an individual procedure categorized to any given Ambulatory Payment Classification (APC) code cannot exceed two times the calculated cost of the lowest-costing procedure categorized to that same APC — Medicare can potentially reassign it to a different APC code.”
Unfortunately, he noted, the average spend in the Medicare pricing file for a DCB angioplasty case was just less than twice than the average spend for standard angioplasty cases, so CMS was not required to adjust payment and in November opted to continue to pay with the same APC code as angioplasty.
“Certainly, we are surprised by the CMS decision on peripheral payment in response to the DCB data,” Ansel said. “There is a large amount of rigorous, randomized trial data from both the United States and Europe demonstrating strong efficacy for at least several years in a broad range of patient populations. This lack of payment for standalone DCB will make it very difficult for our medical institutions to continue to offer this effective vascular therapy to our patients.”
Although physicians said they hope for a solution, this decision could have serious ramifications for DCB technology, Ansel noted. When faced with significant profit loss, physicians and hospital systems will likely have to scale back their use of DCBs.
“The DCB market could be severely affected,” he said. “Also, it may lead to more stent or atherectomy usage in patients who may not have needed that procedure.”
Rundback said expanding reimbursement to all points of service, including office-based labs, could lead to lower costs because, with a new market open to them, companies would not have to charge as much for the devices. Moreover, the regression in care with the potential need for more repeat procedures with the use of other technologies could drive up health care costs.
Optimal patient care, however, is the most important issue, he said.
“My general belief is that there should be absolutely no barriers to physicians utilizing the best technology as demonstrated by data for all patients who would benefit from that technology,” Rundback told Cardiology Today’s Intervention.
On the Horizon
The excitement surrounding DCB technology and its introduction to the market raises the question of what will come next in the field.
Currently, new balloons employing novel technologies are entering pivotal clinical trials, Lyden said. Among the DCBs in development are Chocolate Touch (QT Vascular), Orchid (Acotec Scientific), Ranger (Boston Scientific) and SurVeil (SurModics).
“The market seems to be trying to adopt better ways to coat the balloons to have less particulate debris as well as better drug transfer,” he said. “Eventually, interest will shift to the use of other drugs bound to the balloons.”
Physicians are also hoping for guidance or more definitive evidence on the optimal use of DCBs in peripheral interventions, according to Dake. He noted that evaluation of real-world scenarios is just beginning and there is more to be learned.
“Many like me have been big advocates of a ‘leave-nothing-behind’ strategy when it comes to the superficial femoral artery,” Garcia said. “We need to fully study and understand which group or groups perform the best with this technology and who does not.”
“What we’re going to see at the next series of congresses and medical meetings is presentation of longer-term data for DCBs, which will help physicians make decisions,” Rocha-Singh said. “We will also see adjudicated registry data that try to marry devices and synergized devices, which may incrementally answer questions about safety concerns such as embolization. And we will also see more research on vessel preparation, other disruptive technologies and more that will elevate the effectiveness of DCBs.” – by Melissa Foster
- Brodmann M, et al. Late-Breaking Clinical Trials. Presented at: VIVA 17; Sept. 14-17, 2017; Las Vegas.
- Schneider PA, et al. Late-Breaking Clinical Trials. Presented at: VIVA 17; Sept. 11-14, 2017; Las Vegas.
- Thieme M, et al. JACC Cardiovasc Interv. 2017;doi:10.1016/j.jcin.2017.04.041.
- Zeller T, et al. Late-Breaking Clinical Trials. Presented at: VIVA 17; Sept. 11-14, 2017; Las Vegas.
- For more information:
- George L. Adams, MD, MHS, MBA, can be reached at firstname.lastname@example.org.
- Gary M. Ansel, MD, FACC, can be reached at email@example.com.
- Michael D. Dake, MD, can be reached at Falk Cardiovascular Research Center, 300 Pasteur Drive, Stanford, CA 94305.
- Lawrence A. Garcia, MD, can be reached at firstname.lastname@example.org.
- Sean P. Lyden, MD, can be reached at email@example.com.
- Krishna Rocha-Singh, MD, FACC, can be reached at firstname.lastname@example.org.
- John H. Rundback, MD, FSIR, FSDM, FACC, can be reached at email@example.com.
Disclosures: Adams reports he is a consultant for Bard, Boston Scientific, Medtronic and Spectranetics. Ansel reports he receives honoraria from Bard Peripheral Vascular, Cook Medical, Cordis and Medtronic; and consults for 480 Biomedical, Abbott Vascular, Bard Peripheral Vascular, Best Doctors, Boston Scientific, Cardinal Health, Cook Medical, Cordis, Ostial, Reflow Medical, Philips, Shockwave Medical, SurModics, Veryan/Novate and W.L. Gore and Associates. Dake reports no relevant financial disclosures. Garcia reports he is a compensated consultant for Medtronic for any physician training and a noncompensated consultant for Abbott, Medtronic and Boston Scientific; he has equity interests in CV Ingenuity, Entellus, Essential Medical, Tissue Gen, Scion CV and Syntervention; and he is the founder of Innovation Vascular Partners Consulting. Lyden reports he receives honoraria from Endologix, consults for Biomet, Endologix, PQ Bypass and Spectranetics, receives research funding from Bard Peripheral Vascular, Biomet, Bolton Medical, Boston Scientific, Cook Medical, Cordis, Endologix, Sepctranetics and W.L. Gore and Associates, and is co-primary investigator for ILLUMENATE. Rocha-Singh reports he is a consultant for Alucent Medical, Medtronic, ROX Medical, Soundbite Medical and Zimmer-Biomet and is a compensated board member of VIVA Physicians. Rundback reports he has received honoraria from Abbott Vascular, Bard Peripheral Vascular, Cook Medical, Cardiovascular Systems Inc. and W.L. Gore and Associates; consulted for Abbott Vascular, Boston Scientific and Medtronic; held common stock in Eximo; and received research funding from Bayer, Bard Peripheral Vascular, Biomet, Cook Medical, Intact Vascular, Juventas and Mercator.