In the Journals

REAL PTX: DES, DCB similar in patency

Douglas E. Drachman
Douglas E. Drachman

Drug-eluting stents and drug-coated balloons had similar patency in patients with peripheral artery disease at 1 year, although there was a trend favoring DES at 3 years, according to the results of the REAL PTX study.

The researchers conducted a randomized trial of 150 patients with symptomatic femoropopliteal disease to compare safety and effectiveness of a DES (Zilver PTX, Cook Medical) with that of DCBs (IN.PACT Admiral or IN.PACT Pacific, Medtronic; or Lutonix, BD/Bard).

All patients were Rutherford category 2 to 5. In the DES group, mean age was 70 years, 76% were men, mean lesion length was 155.5 mm and 52% had a total occlusion. In the DCB group, mean age was 68 years, 60% were men, mean lesion length was 149.7 mm and 53.3% had a total occlusion.

The primary efficacy endpoint was primary patency at 1 year. Safety endpoints of interest included mortality, major target limb amputation and clinically driven target lesion revascularization.

In the DCB group, 25.3% of patients required bailout stenting, Yvonne Bausback, MD, from the division of angiology, department of internal medicine, neurology and dermatology, University Hospital Leipzig, Germany, and colleagues wrote.

Outcomes similar

The Kaplan-Meier estimates of primary patency at 1 year were 79.3% in the DES group and 79.9% in the DCB group (rate difference, 0.6; P = .96), according to the researchers.

At 3 years, the difference in Kaplan-Meier estimate of primary patency widened favoring the DES group, but remained nonsignificant (DES, 56.7%; DCB, 42.4%; rate difference, –14.3), the researchers wrote. The results were consistent in analyses separating the patients in the DCB group with and without bailout stenting.

Predictors of restenosis included presence of total occlusion (HR = 2.1; 95% CI, 1.2-3.8), diabetes (HR = 1.9; 95% CI, 1.1-3.3), poor below-the-knee runoff (HR = 2; 95% CI, 1.2-3.3) and lesion length (HR per cm = 1.03; 95% CI, 1-1.1), Bausback and colleagues wrote.

Among patients with stenotic lesions, the DES group had better patency, but in patients with total occlusion, there was no difference between the groups (P for interaction = .09), according to the researchers.

Freedom from clinically driven TLR was 92.5% in the DES group and 90% in the DCB group at 1 year (rate difference, 2.5; P = .34) and 71.3% in the DES group and 68.9% in the DCB group at 3 years (rate difference, 2.4; P = .74).

The composite outcome of 30-day mortality plus 12-month clinically driven TLR and target limb major amputation was reached in 7% of the DES group and 8% of the DCB group (P = .77), whereas 3-year mortality rates were 10.7% in the DCB group and 4% in the DES group (P = .12), with one death in the DCB group categorized as procedure-related.

At 3 years, patients from both groups improved in ankle-brachial index, Rutherford category and Walking Impairment Questionnaire scores, according to the researchers.

More study needed

In a related editorial, Douglas E. Drachman, MD, director of the cardiology and interventional cardiology fellowship programs at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, wrote that, “Larger-scale studies will be required to confirm whether the durability of DCB effect — particularly in long, complex lesions where bailout stenting is frequently required — may not provide the equivalent balance of short-term gain to late loss as is conferred by DES.”

He wrote that remaining questions include whether DCB outcomes are improved by use of tools such as atherectomy and lithotripsy, whether either DES or DCB eventually prove cost-effective, whether newer technologies with different doses and modes of release of paclitaxel produce different results from the older technologies in the present study and whether the findings from a recent meta-analysis suggesting the paclitaxel doses from DES and DCB technologies confer a mortality risk are confirmed. – by Erik Swain

Disclosures: The study was supported by Cook Medical. Bausback reports she has consulted for C.R. Bard and Medtronic. Drachman reports he has consulted for Abbott Vascular, Boston Scientific, Cardiovascular Systems Inc. and Corindus and received research grants from Atrium Medical and C.R. Bard/Lutonix. Please see the study for all other authors’ relevant financial disclosures.

Douglas E. Drachman
Douglas E. Drachman

Drug-eluting stents and drug-coated balloons had similar patency in patients with peripheral artery disease at 1 year, although there was a trend favoring DES at 3 years, according to the results of the REAL PTX study.

The researchers conducted a randomized trial of 150 patients with symptomatic femoropopliteal disease to compare safety and effectiveness of a DES (Zilver PTX, Cook Medical) with that of DCBs (IN.PACT Admiral or IN.PACT Pacific, Medtronic; or Lutonix, BD/Bard).

All patients were Rutherford category 2 to 5. In the DES group, mean age was 70 years, 76% were men, mean lesion length was 155.5 mm and 52% had a total occlusion. In the DCB group, mean age was 68 years, 60% were men, mean lesion length was 149.7 mm and 53.3% had a total occlusion.

The primary efficacy endpoint was primary patency at 1 year. Safety endpoints of interest included mortality, major target limb amputation and clinically driven target lesion revascularization.

In the DCB group, 25.3% of patients required bailout stenting, Yvonne Bausback, MD, from the division of angiology, department of internal medicine, neurology and dermatology, University Hospital Leipzig, Germany, and colleagues wrote.

Outcomes similar

The Kaplan-Meier estimates of primary patency at 1 year were 79.3% in the DES group and 79.9% in the DCB group (rate difference, 0.6; P = .96), according to the researchers.

At 3 years, the difference in Kaplan-Meier estimate of primary patency widened favoring the DES group, but remained nonsignificant (DES, 56.7%; DCB, 42.4%; rate difference, –14.3), the researchers wrote. The results were consistent in analyses separating the patients in the DCB group with and without bailout stenting.

Predictors of restenosis included presence of total occlusion (HR = 2.1; 95% CI, 1.2-3.8), diabetes (HR = 1.9; 95% CI, 1.1-3.3), poor below-the-knee runoff (HR = 2; 95% CI, 1.2-3.3) and lesion length (HR per cm = 1.03; 95% CI, 1-1.1), Bausback and colleagues wrote.

Among patients with stenotic lesions, the DES group had better patency, but in patients with total occlusion, there was no difference between the groups (P for interaction = .09), according to the researchers.

Freedom from clinically driven TLR was 92.5% in the DES group and 90% in the DCB group at 1 year (rate difference, 2.5; P = .34) and 71.3% in the DES group and 68.9% in the DCB group at 3 years (rate difference, 2.4; P = .74).

The composite outcome of 30-day mortality plus 12-month clinically driven TLR and target limb major amputation was reached in 7% of the DES group and 8% of the DCB group (P = .77), whereas 3-year mortality rates were 10.7% in the DCB group and 4% in the DES group (P = .12), with one death in the DCB group categorized as procedure-related.

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At 3 years, patients from both groups improved in ankle-brachial index, Rutherford category and Walking Impairment Questionnaire scores, according to the researchers.

More study needed

In a related editorial, Douglas E. Drachman, MD, director of the cardiology and interventional cardiology fellowship programs at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, wrote that, “Larger-scale studies will be required to confirm whether the durability of DCB effect — particularly in long, complex lesions where bailout stenting is frequently required — may not provide the equivalent balance of short-term gain to late loss as is conferred by DES.”

He wrote that remaining questions include whether DCB outcomes are improved by use of tools such as atherectomy and lithotripsy, whether either DES or DCB eventually prove cost-effective, whether newer technologies with different doses and modes of release of paclitaxel produce different results from the older technologies in the present study and whether the findings from a recent meta-analysis suggesting the paclitaxel doses from DES and DCB technologies confer a mortality risk are confirmed. – by Erik Swain

Disclosures: The study was supported by Cook Medical. Bausback reports she has consulted for C.R. Bard and Medtronic. Drachman reports he has consulted for Abbott Vascular, Boston Scientific, Cardiovascular Systems Inc. and Corindus and received research grants from Atrium Medical and C.R. Bard/Lutonix. Please see the study for all other authors’ relevant financial disclosures.