Study Debunks Notion Paclitaxel-Coated Balloons Increase Mortality Risk

While a previous study indicated an increase in risk of mortality in patients with paclitaxel drug-coated balloons (DCB), new research from a team of European Investigators has found use of paclitaxel DCBs for treatment of coronary artery disease was not associated with increased mortality and long-term data suggests it may actually decrease mortality risk.

Results of the meta-analysis, which included data on more than 4000 patients from 26 randomized clinical trials, found the risk of death was not increased when using DCBs and use correlated with a 27% lower risk of all-cause and 47% lower risk of cardiovascular mortality over a 3-year follow-up period.

In response to a meta-analysis suggesting DCB use in the superficial femoral artery increased mortality risk, investigators sought to investigate available data on survival after coronary intervention with DCB from randomized trials occurring between 2006 and 2019. Using PubMed, Web of Science, and the Cochrane Library databases, a study was designed to comparisons DCB and non-DCB devices for the treatment of coronary in-stent restenosis or de novo lesions.

For inclusion in the present analysis, trials needed to have at least 6 months of follow-up and analyze paclitaxel-coated balloon versus non-DCV device. Trials were excluded that analyzed DCBs in patients for peripheral artery disease or treatment dysfunctional hemodialysis arteriovenous fistulas. In total, 26 trials met the investigators’ criteria. From these trials, 4590 patients were identified—of which, 2322 received DCBs and 2268 received an alternative treatment.

The primary outcome of the analysis was all-cause mortality and, when all-cause mortality was not recorded, cardiovascular mortality. Investigator assessed the primary outcome at different points—6-12 months, 2 years, and at least 3 years of follow-up—according to available data. Differences in mortality rates were assessed using Forest plat as risk ratios for each trial.

Of the studies included, the most common comparators included conventional balloon angioplasty, bare-metal stents, and drug-eluting stents. In total, 26 trials included follow-up data for a range of 6-12 months, 8 recorded data at 2 years, and 9 recorded data at 3 years.

At 6-12 months of follow-up analysis of 4590 patients indicated there was no significant difference in all-cause mortality, but DCB treatment was associated with lower mortality risk (RR: 0.74; 95% CI 0.51 to 1.08; P = .116), according to results of the study. At the 2 year follow-up, which included data on 1477 patients, the risk of death between the groups was similar (RR: 0.84; 95% CI: 0.51 to 1.37; P = .478). At 3 years, 1775 patients were included and data from the group indicated all-cause mortality was significantly lower in the DCB group (RR: 0.73; 95% CI: 0.53 to 1.00; P = .047) —with a number needed-to-treat of 36 to prevent 1 death.

When examining cardiovascular mortality, investigators observed comparable rates of mortality after 1 year and 2 years (RR: 0.58; 95% CI: 0.29 to 1.19; P = .140) of follow-up. Similarly to all-cause mortality rates, results of the analysis including 3 years of follow-up indicated DCB treatment was associated with a significantly lower risk of cardiovascular mortality (RR: 0.53; 95% CI: 0.33 to 0.85; P = .009).

In an editorial comment, Fernando Alfonso, MD, and Fernando Rivero, MD, of the Department of Cardiology at Hospital Universitario de La Princease in Spain, along with Juan Granada, MD, of Columbia University Medical Center, commended investigators for the results of their study.

“Results of this large meta-analysis including data of all available RCTs with long-term clinical follow-up are highly compelling, demonstrating that the use of (paclitaxel-coated balloons) in the coronary territory is not associated with increased mortality,” the authors wrote. “In contrast, the lower total and cardiac mortality seen at very long-term follow-up after (paclitaxel-coated balloons) confirms the safety profile of this therapeutic modality.”

This study, “Survival After Coronary Revascularization With Paclitaxel-Coated Balloons,” was published in Journal of the American College of Cardiology.