Based on current evidence, the benefits of paclitaxel-coated devices for treatment of peripheral artery disease outweigh the risks, but doctors should discuss concerns about mortality risk with their patients, according to a statement issued by the Society for Cardiovascular Angiography and Interventions.
As Cardiology Today’s Intervention previously reported, a summary-level meta-analysis published in the Journal of the American Heart Association found that patients with PAD receiving paclitaxel-coated balloons or stents had higher mortality risk at 2 and 5 years compared with controls. The analysis prompted two trials of paclitaxel-coated devices to be paused and the FDA to launch its own investigation. The FDA stated it currently believes that the benefits of the devices outweigh the risk and is not recommending any market withdrawals or trial cessations.
“At present, SCAI concurs with FDA that the benefits of paclitaxel devices continue to outweigh any potential risks,” David A. Cox, MD, MSCAI, president of SCAI, director of the cardiac catheterization laboratory at Brookwood Baptist Health and interventional cardiologist at Cardiovascular Associates of the Southeast in Birmingham, Alabama, said in the statement. “However, we strongly encourage our members to discuss the findings of the meta-analysis with their patients and to report any safety concerns to FDA.”
“In such a short time, we have been fortunate to have so much data and a statement from the FDA,” Cardiology Today’s Intervention Editorial Board Member Mehdi Shishehbor, DO, PhD, MPH, who spoke on behalf of SCAI, said in an interview. “Our recommendation is for doctors to continue to treat their patients the way that they were treating them utilizing these devices.”
The statement from SCAI noted that a number of patient-level meta-analyses presented at the Leipzig Interventional Course (LINC) found no elevated mortality risk in patients who received paclitaxel-coated devices compared with controls.
“Data from these trials show comparable mortality rates among patients treated with paclitaxel-coated or -eluting devices compared to angioplasty or bare-metal stents,” the society stated. “We expect further details from these meta-analyses to be examined in peer-reviewed journals in the near future. Additional patient-level analyses are underway by FDA, independent physicians and industry, and SCAI is closely monitoring this evolving situation.”
Cardiology Today’s Intervention previously reported that a patient-level meta-analysis of four studies of Medtronic’s drug-coated balloon (IN.PACT Admiral) presented at LINC showed no elevated mortality risk at 5 years for patients who received the device and no relationship between paclitaxel dose and mortality. Other patient-level analyses presented at LINC included:
- In the RANGER SFA trial, there was no difference in mortality at 3 years between those assigned a DCB (Ranger, Boston Scientific) and those assigned percutaneous transluminal angioplasty (DCB, 13.8%; PTA, 10.7%).
- In trials of Boston Scientific’s drug-eluting stent, there were no significant mortality differences between those assigned the DES (Eluvia) and those assigned other devices (IMPERIAL trial: Eluvia, 2% at 1 year; Zilver PTX [Cook Medical], 2.3% at 1 year; MAJESTIC trial: Eluvia, 3.6% at 3 years; PTA, 3.8% at 2 years).
- In the ZILVER PTX randomized trial, the 5-year Kaplan-Meier estimates of mortality were 18.7% in the DES arm and 17.6% in the PTA or BMS arm (P = .53), and there was no relationship between paclitaxel dose and mortality across all studies of the Zilver PTX.
- In a pooled analysis of the randomized and nonrandomized trials of the Stellarex DCB (Spectranetics/Philips), there was no difference in 3-year mortality between those treated with the DCB and controls (DCB, 7.9%; controls, 9.9%; P = .78).
- A 5-year analysis of the LEVANT 2 trial of the Lutonix DCB (BD) showed no significant difference in mortality (DCB, 14.1%; controls, 10.6%; P = .22); similar results were seen in other randomized trials of the device.
“We recommend that physicians have a clear communication with their patients to express the findings of the meta-analysis but also the additional data presented at LINC,” Shishehbor, professor of medicine at Case Western Reserve University School of Medicine, director of the interventional cardiovascular center at University Hospitals and co-director of the vascular center at Harrington Heart and Vascular Institute, University Hospitals, told Cardiology Today’s Intervention. “If there are any complications or concerns that arise from treating patients with these conditions, they should notify the FDA.”
Surveys conducted by SCAI indicate that “for the most part, doctors continue to practice the way they were before the JAHA meta-analysis, except that they are communicating more with their patients and they are being more conscientious and vigilant about any potential risks these devices may have,” Shishehbor said. “The society takes patient safety very seriously.” – by Erik Swain
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For more information:
Mehdi Shishehbor, DO, PhD, MPH, can be reached at firstname.lastname@example.org; Twitter: @shishem.
Disclosures: Cox reports he consults for Abbott Vascular, Boston Scientific and Medtronic. Shishehbor reports he is a consultant and adviser to Abbott Vascular, Boston Scientific, Cook Medical, Medtronic, Philips/Spectranetics and Terumo.