The Take Home

The Take Home: VIVA

VIVA Physicians held its annual conference from Sept. 11 to 14 in Las Vegas. Cardiology Today’s Intervention attended the meeting and interviewed key opinion leaders on the most important science from the meeting.

Interviewees included Mark W. Burket, MD, professor of medicine, chief of the division of cardiovascular medicine and director of vascular medicine at University of Toledo Health; D. Christopher Metzger, MD, FACC, FSCAI, interventional cardiologist at Wellmont CVA Heart Institute in Kingsport, Tennessee; Krishna J. Rocha-Singh, MD, FACC, FAHA, FSCAI, FSVM, chief scientific officer at Prairie Heart Institute of Illinois, Springfield; and John H. Rundback, MD, FAHA, FSVM, FSIR, medical director of the interventional institute at Holy Name Medical Center and managing partner of Advanced Interventional Radiology Services LLP in Teaneck, New Jersey.

IN. PACT SFA

Rocha-Singh: The IN.PACT SFA study enrolled 331 patients with symptomatic Rutherford class 2 to 4 femoropopliteal lesions to treatment with the IN.PACT Admiral drug-coated balloon (Medtronic) or percutaneous transluminal angioplasty. At 4 years, the Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization was 76.8% in the DCB group vs. 70.4% in the PTA group (log-rank P = .0399). Additionally, time to first clinically driven TLR within 4 years was longer in the DCB group than the PTA group (739 days vs. 303 days; P < .001).

Krishna J. Rocha-Singh

These results may be perceived as disappointing to some because the difference in clinically driven TLR between the groups is less at 4 years than it was at previous time points. But we have to consider this in the context that CMS is now reviewing this technology for reimbursement. If they focus on the fact that these are claudicants who are not dying any time soon and because of that it may be difficult to determine a value proposition, they may lose sight of the fact that in the PTA arm, there are substantially more clinically driven TLRs for the first several years. In the first year, there was a clear improvement in symptoms with the DCB, which may not be reflected because that wasn’t evaluated out to 4 years.

Photo credit: Cardiology Today’s Intervention

All of us are now anticipating the 2-year data from the ILLUMENATE U.S. pivotal trial of the Stellarex DCB, which will be presented next year at the Leipzig Interventional Course. We already have insights on the Bard device (Lutonix 035). We may have hit a glass ceiling with regard to DCBs in TASC II A and B lesions. Now we need to work together to figure out what to do with the more complex patients. The REALITY study, enrolling now, may provide some answers in the future.

Metzger: It is encouraging that we can do a balloon procedure and three out of the four patients are not going to need another intervention in 4 years. It can be done safely, and there is nothing left behind. Because the prognosis of people with peripheral vascular disease is often bad, if we have kept them free of more procedures for 4 years, we have done them a great service and hopefully improved their quality of life.

ILLUMENATE

Rundback: The ILLUMENATE EU trial randomly assigned 294 patients with symptomatic femoropopliteal disease on a 3:1 basis to receive the Stellarex DCB (Spectranetics/Philips) or PTA. At 2 years, primary patency was 75.2% in the DCB group vs. 61.2% in the PTA group (log-rank P = .004). Rates of freedom from clinically driven TLR at 2 years were 88.9% vs. 71.8%, respectively (log-rank P < .001). Major adverse events at 2 years were higher in the PTA group.

These are the best 2-year results we have seen with a DCB, and are comparable only to those seen with the Eluvia drug-eluting stent (Boston Scientific). If that is sustained in long-term results, it will be a real differentiator. Generally, DCBs have changed how we treat these patients. We used to sit down with patients with superficial femoral artery disease and tell them there was a 1 in 4 chance, often more, that they would need revascularization. Now, I tell them there is a 1 in 10 chance they will need revascularization. The impact to the patients, payers and physicians is dramatic.

I would like to know if the investigators will be parsing out those results by high-risk lesion features.

Peripheral DES Registry

D. Christopher Metzger

Metzger: Michael D. Dake, MD, presented subgroup analyses of a postmarket surveillance study of the first 905 patients implanted with the Zilver PTX DES (Cook Medical) in Japan. The subanalyses focused on performance of the DES in real-world patients with chronic renal failure, no patent runoff vessels and in-stent restenosis. At 4 years, in the overall cohort, the rate of freedom from clinically driven TLR was 78.4% and the rate of clinical benefit was 72.7%. There was no difference in freedom from clinically driven TLR at 2 years among patients with and without chronic renal failure (81.4% vs. 84.9%, respectively, P = .24) and patients with and without continuous patent infrapopliteal runoff vessels (83.8% vs. 81.3%; P = .87). Freedom from clinically driven TLR at 2 years was lower among patients with in-stent restenosis vs. those without (76.6% vs. 85.3%; P = .05).

This study showed nice, durable results in real-world lesions long-term with stenting. Freedom from TLR, for me, is a challenging endpoint to assess because, for example, if a patient has a long lesion with in-stent restenosis treated the first time with a DES, and it occludes again, do the clinicians decide not to do another procedure? Otherwise, the results look very good in very long, real-world, complex lesions.

SAFE-DCB Registry

Mark W. Burket

Burket: The SAFE-DCB results presented here were from an interim analysis of 627 patients with de novo or restenotic lesions up to 150 mm in the native superficial femoral or popliteal arteries who had achieved 12-month follow-up after treatment with the Lutonix 035 DCB (Bard Peripheral Vascular). It is encouraging that in a real-world population, there was a rate of freedom from TLR of just over 90% at 12 months (95% CI, 88.1-93.1). Freedom from composite safety events (device- or procedure-related perioperative death, target limb major amputation or target vessel revascularization) at 30 days was 98.5% (95% CI, 97.3-99.3).

One concern is that some DCB trials have shown that results can look one way after 365 days, but a completely different way after a 30-day window beyond that. I would like to see those data, but if these results hold up, it is a positive development. The researchers noted patients will be followed up to 3 years.

ACT 1

Rundback: Two subanalyses of the ACT 1 trial were presented here, showing that carotid artery stenting benefited women and patients with the worst atherosclerotic burden compared with carotid endarterectomy.

John H. Rundback

The one prespecified analysis compared 212 women vs. 278 men with 5-year follow-up from the ACT 1 study. From 31 days to 5 years, the rate of freedom from ipsilateral stroke was 99.2% among women assigned CAS vs. 96.5% among women assigned carotid endarterectomy (P = .02). The difference was not observed in men (CAS group, 96.9%; surgery group, 97.9%; P = .54).

The second analysis compared outcomes among 161 patients with carotid atherosclerosis only, 141 with carotid disease and CAD, 65 with carotid disease and peripheral artery disease, and 109 with carotid disease, CAD and PAD who completed 5-year follow-up. In the group with the highest atherosclerotic burden, patients assigned CAS had a higher rate of freedom from death, stroke or MI at 30 days and ipsilateral stroke between 31 days and 5 years vs. those assigned surgery (93.9% vs. 85.6%; P = .04). The rate of freedom from ipsilateral stroke between 31 days and 5 years was also higher in the highest-burden group (CAS group, 97.8%; surgery group, 91.8%; P = .04).

While this study was of a selected group of individuals from a trial with a high operator skillset, it proves that in the asymptomatic population — and 80% of patients with carotid artery disease who undergo treatment are asymptomatic — stenting is extraordinarily effective, regardless of sex.

I’m not sure why there was a high rate of delayed events in endarterectomy. Perhaps endarterectomy needs to be revisited in this population if there is a predisposition toward late embolic events.

The take-home message is that carotid stenting is a therapy that is ready for prime time. We need to find a way to be able to use it.

Disclosures: Burket reports no relevant financial disclosures. Metzger reports he has received minor speaking honoraria from Medtronic. Rocha-Singh reports he receives honoraria from Alumend, Medtronic, VIVA Physicians and Zimmer/Biomet; consults for SoundBite Medical; and receives research funding from Medtronic. 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.

VIVA Physicians held its annual conference from Sept. 11 to 14 in Las Vegas. Cardiology Today’s Intervention attended the meeting and interviewed key opinion leaders on the most important science from the meeting.

Interviewees included Mark W. Burket, MD, professor of medicine, chief of the division of cardiovascular medicine and director of vascular medicine at University of Toledo Health; D. Christopher Metzger, MD, FACC, FSCAI, interventional cardiologist at Wellmont CVA Heart Institute in Kingsport, Tennessee; Krishna J. Rocha-Singh, MD, FACC, FAHA, FSCAI, FSVM, chief scientific officer at Prairie Heart Institute of Illinois, Springfield; and John H. Rundback, MD, FAHA, FSVM, FSIR, medical director of the interventional institute at Holy Name Medical Center and managing partner of Advanced Interventional Radiology Services LLP in Teaneck, New Jersey.

IN. PACT SFA

Rocha-Singh: The IN.PACT SFA study enrolled 331 patients with symptomatic Rutherford class 2 to 4 femoropopliteal lesions to treatment with the IN.PACT Admiral drug-coated balloon (Medtronic) or percutaneous transluminal angioplasty. At 4 years, the Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization was 76.8% in the DCB group vs. 70.4% in the PTA group (log-rank P = .0399). Additionally, time to first clinically driven TLR within 4 years was longer in the DCB group than the PTA group (739 days vs. 303 days; P < .001).

Krishna J. Rocha-Singh

These results may be perceived as disappointing to some because the difference in clinically driven TLR between the groups is less at 4 years than it was at previous time points. But we have to consider this in the context that CMS is now reviewing this technology for reimbursement. If they focus on the fact that these are claudicants who are not dying any time soon and because of that it may be difficult to determine a value proposition, they may lose sight of the fact that in the PTA arm, there are substantially more clinically driven TLRs for the first several years. In the first year, there was a clear improvement in symptoms with the DCB, which may not be reflected because that wasn’t evaluated out to 4 years.

Photo credit: Cardiology Today’s Intervention

All of us are now anticipating the 2-year data from the ILLUMENATE U.S. pivotal trial of the Stellarex DCB, which will be presented next year at the Leipzig Interventional Course. We already have insights on the Bard device (Lutonix 035). We may have hit a glass ceiling with regard to DCBs in TASC II A and B lesions. Now we need to work together to figure out what to do with the more complex patients. The REALITY study, enrolling now, may provide some answers in the future.

Metzger: It is encouraging that we can do a balloon procedure and three out of the four patients are not going to need another intervention in 4 years. It can be done safely, and there is nothing left behind. Because the prognosis of people with peripheral vascular disease is often bad, if we have kept them free of more procedures for 4 years, we have done them a great service and hopefully improved their quality of life.

PAGE BREAK

ILLUMENATE

Rundback: The ILLUMENATE EU trial randomly assigned 294 patients with symptomatic femoropopliteal disease on a 3:1 basis to receive the Stellarex DCB (Spectranetics/Philips) or PTA. At 2 years, primary patency was 75.2% in the DCB group vs. 61.2% in the PTA group (log-rank P = .004). Rates of freedom from clinically driven TLR at 2 years were 88.9% vs. 71.8%, respectively (log-rank P < .001). Major adverse events at 2 years were higher in the PTA group.

These are the best 2-year results we have seen with a DCB, and are comparable only to those seen with the Eluvia drug-eluting stent (Boston Scientific). If that is sustained in long-term results, it will be a real differentiator. Generally, DCBs have changed how we treat these patients. We used to sit down with patients with superficial femoral artery disease and tell them there was a 1 in 4 chance, often more, that they would need revascularization. Now, I tell them there is a 1 in 10 chance they will need revascularization. The impact to the patients, payers and physicians is dramatic.

I would like to know if the investigators will be parsing out those results by high-risk lesion features.

Peripheral DES Registry

D. Christopher Metzger

Metzger: Michael D. Dake, MD, presented subgroup analyses of a postmarket surveillance study of the first 905 patients implanted with the Zilver PTX DES (Cook Medical) in Japan. The subanalyses focused on performance of the DES in real-world patients with chronic renal failure, no patent runoff vessels and in-stent restenosis. At 4 years, in the overall cohort, the rate of freedom from clinically driven TLR was 78.4% and the rate of clinical benefit was 72.7%. There was no difference in freedom from clinically driven TLR at 2 years among patients with and without chronic renal failure (81.4% vs. 84.9%, respectively, P = .24) and patients with and without continuous patent infrapopliteal runoff vessels (83.8% vs. 81.3%; P = .87). Freedom from clinically driven TLR at 2 years was lower among patients with in-stent restenosis vs. those without (76.6% vs. 85.3%; P = .05).

This study showed nice, durable results in real-world lesions long-term with stenting. Freedom from TLR, for me, is a challenging endpoint to assess because, for example, if a patient has a long lesion with in-stent restenosis treated the first time with a DES, and it occludes again, do the clinicians decide not to do another procedure? Otherwise, the results look very good in very long, real-world, complex lesions.

SAFE-DCB Registry

Mark W. Burket

Burket: The SAFE-DCB results presented here were from an interim analysis of 627 patients with de novo or restenotic lesions up to 150 mm in the native superficial femoral or popliteal arteries who had achieved 12-month follow-up after treatment with the Lutonix 035 DCB (Bard Peripheral Vascular). It is encouraging that in a real-world population, there was a rate of freedom from TLR of just over 90% at 12 months (95% CI, 88.1-93.1). Freedom from composite safety events (device- or procedure-related perioperative death, target limb major amputation or target vessel revascularization) at 30 days was 98.5% (95% CI, 97.3-99.3).

One concern is that some DCB trials have shown that results can look one way after 365 days, but a completely different way after a 30-day window beyond that. I would like to see those data, but if these results hold up, it is a positive development. The researchers noted patients will be followed up to 3 years.

PAGE BREAK

ACT 1

Rundback: Two subanalyses of the ACT 1 trial were presented here, showing that carotid artery stenting benefited women and patients with the worst atherosclerotic burden compared with carotid endarterectomy.

John H. Rundback

The one prespecified analysis compared 212 women vs. 278 men with 5-year follow-up from the ACT 1 study. From 31 days to 5 years, the rate of freedom from ipsilateral stroke was 99.2% among women assigned CAS vs. 96.5% among women assigned carotid endarterectomy (P = .02). The difference was not observed in men (CAS group, 96.9%; surgery group, 97.9%; P = .54).

The second analysis compared outcomes among 161 patients with carotid atherosclerosis only, 141 with carotid disease and CAD, 65 with carotid disease and peripheral artery disease, and 109 with carotid disease, CAD and PAD who completed 5-year follow-up. In the group with the highest atherosclerotic burden, patients assigned CAS had a higher rate of freedom from death, stroke or MI at 30 days and ipsilateral stroke between 31 days and 5 years vs. those assigned surgery (93.9% vs. 85.6%; P = .04). The rate of freedom from ipsilateral stroke between 31 days and 5 years was also higher in the highest-burden group (CAS group, 97.8%; surgery group, 91.8%; P = .04).

While this study was of a selected group of individuals from a trial with a high operator skillset, it proves that in the asymptomatic population — and 80% of patients with carotid artery disease who undergo treatment are asymptomatic — stenting is extraordinarily effective, regardless of sex.

I’m not sure why there was a high rate of delayed events in endarterectomy. Perhaps endarterectomy needs to be revisited in this population if there is a predisposition toward late embolic events.

The take-home message is that carotid stenting is a therapy that is ready for prime time. We need to find a way to be able to use it.

Disclosures: Burket reports no relevant financial disclosures. Metzger reports he has received minor speaking honoraria from Medtronic. Rocha-Singh reports he receives honoraria from Alumend, Medtronic, VIVA Physicians and Zimmer/Biomet; consults for SoundBite Medical; and receives research funding from Medtronic. 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.