Feature | January 31, 2013

CONFIRM Study Highlights Effectiveness of Orbital Atherectomy in Treating PAD

With more than 3,100 patients and 4,700 lesions, study is largest atherectomy dataset ever for PAD

January 31, 2013 — Cardiovascular Systems Inc. (CSI) announced CONFIRM study series data presented at the 2013 International Symposium on Endovascular Therapy (ISET). Results show that CSI’s minimally invasive orbital atherectomy system is an effective treatment for peripheral arterial disease (PAD). CSI’s technology protects healthy vessel tissue while removing even the most difficult-to-treat plaque throughout the leg with fewer complications. The study, titled “Procedural Effectiveness of Orbital Technology in More Than 3,100 Patients with Infra-inguinal Disease: Results from the CONFIRM Series,” was part of a late-breaking presentation at ISET.

“The 3,000-plus real-world patients studied in the CONFIRM series shows that CSI’s orbital atherectomy system safely and effectively treats moderate-to-severely calcified lesions,” said presenter Tony Das, M.D., of Cardiology and Interventional Associates in Dallas. “Orbital atherectomy led to low bailout-stent usage, low adverse procedural-event rates and improved lesion compliance. Additionally, smaller randomized studies point to improved vessel durability and long-term outcomes — both of which are a first for atherectomy trials in the peripheral vascular space.”

The prevalence of arterial calcium is vastly underestimated in medicine today. Calcium, even if not visible through angiography, is present in about 65 percent of the 2.5 million people diagnosed annually with PAD. Moreover, calcium leads to poor outcomes and higher treatment costs when traditional balloon and stent therapies are used — including dissection, vessel wall trauma and stent fracture.

David L. Martin, CSI president and CEO, said, “CONFIRM reinforces the effectiveness of CSI’s orbital atherectomy in treating 'real world' patients. The dataset presented is the largest ever for PAD, and the CONFIRM study series shows consistent, repeatable results across numerous interventional physicians. CONFIRM gives physicians confidence that our technology is an effective and safe PAD treatment for patients.”

The CONFIRM series consisted of three studies that enrolled more than 3,100 patients with 4,700 lesions at 350 sites across the United States from 2009 to 2011. A majority of the lesions had moderate to severe calcium. During the initial study, physicians treated lesions to maximize the luminal gain, while the second and third study focused on removing calcium to change vessel compliance. Each study utilized a progressively smaller crown, which reduced slow flow, vessel closure and spasms.

Data shows that vessel preparation with CSI’s orbital atherectomy system enables low-pressure adjunctive balloon angioplasty across the studies, with low procedural events and bailout stents — which preserve treatment options in the future.

Overall Procedural Outcomes:

Per Lesion

 

 

CONFIRM I n=1,146

 

 

CONFIRM II n=1,734

 

 

CONFIRM III n=1,886

Mean Inflation

 

 

5.7 atms

 

 

5.4 atms

 

 

5.9 atms

Bailout Stent (due to dissections)

 

 

3.8%

 

 

5.8%

 

 

5.2%

Perforation

 

 

0.9%

 

 

0.6%

 

 

0.7%

Distal Embolization

 

 

n/a

 

 

2.2%

 

 

2.2%

Vessel Closure

 

 

2.1%

 

 

1.2%

 

 

1.4%

CALCIUM 360° Study 12-Month Results
Also presented at ISET was a study, titled “Comparison of Orbital Atherectomy Plus Balloon Angioplasty vs. Balloon Angioplasty Alone in Patients With Critical Limb Ischemia: Results of the CALCIUM 360 Randomized Pilot Trial,” by Jonathan Ellichman, M.D., of Southern Cardiovascular in Memphis, Tenn. Results demonstrated that orbital atherectomy treatment with low-pressure percutaneous transluminal angioplasty (PTA) safely restores flow in patients with critical limb ischemia and reduces major serious adverse events, compared to PTA alone.

At 12 months, CSI’s technology provided superior outcomes:

 

 

 

Orbital Atherectomy plus PTA

 

 

PTA alone

Mean Inflation

 

 

5.9 atms

 

 

9.4 atms

Dissections

 

 

3.4%

 

 

17.1%

Perforation

 

 

0%

 

 

2.8%

Distal Embolization

 

 

0%

 

 

2.8%

Bailout Stenting

 

 

6.9%

 

 

14.3%

Freedom from Major Serious Adverse Events

 

 

93.3%

 

 

57.9%

CALCIUM 360° is a prospective, multicenter, randomized study that compared treatment of below-the-knee lesions with orbital atherectomy versus PTA. All 50 patients had critical limb ischemia (CLI) and calcified lesions. These conditions are challenging to treat in the small arteries below the knees and often a precursor to amputation.

CSI Poster Session at ISET
Barry Weinstock, M.D., Mid-Florida Cardiology Specialists, Orlando, Fla., and Raymond Dattilo, M.D., (presenter), St. Francis Health Center, Topeka, Kan., presented “Cost Consequences of Orbital Atherectomy Plus Angioplasty vs. Angioplasty Alone for Treatment of Calcified Femoropopliteal Lesions” in a poster session at ISET.

Data showed that orbital atherectomy plus balloon angioplasty has a significantly lower average stenosis rate, exhibiting compelling short- and longer-term health and economic data for the use of atherectomy in the treatment of calcified femoropopliteal lesions.

For more information: www.csi360.com

Related Content

Mount Sinai Heart, TANSNIP-PESA study, worksite lifestyle intervention, cardiovascular risk
News | Cardiac Diagnostics| February 09, 2016
Mount Sinai Heart is undertaking a three-year study to determine whether a workplace-based lifestyle intervention,...
cardiomyocytes, electrical stimulation, human stem cells, Columbia Engineering

Electrically conditioned human cardiomyocytes. Striated ultrastructure containing troponin ( stained in green) forms around cell nuclei (stained in blue.) Image courtesy of Benjamin Lee, Columbia Engineering

News | Stem Cell Therapies| February 09, 2016
Columbia Engineering researchers have shown, for the first time, that electrical stimulation of human heart muscle...
ACC late breakers
News | ACC| February 09, 2016
February 9, 2016 — The late-breaking clinical trial presentations have been announced for the 2016 American College o
transcatheter repair of a mitral valve paravalvular leak

Transcatheter repair of a surgical mitral replacement paravalvular leak with an Amplatzer Vascular Plug II.

Feature | Heart Valve Repair| February 08, 2016 | Dave Fornell
Off-label use of the St.
News | Cardiac Diagnostics| February 08, 2016
February 8, 2016 — A parent’s incarceration has immediate, devastating effects on a family.
Stentys, commercialization, BTK stent, below-the-knee arteries
News | Stents Peripheral| February 08, 2016
Stentys announced the first distribution agreements for its drug-eluting stent for treating below-the-knee (BTK)...
medical imaging, low-dose radiation, cancer, LNT model study
News | Radiation Dose Management| February 04, 2016
The widespread belief that radiation from X rays, CT scans and other medical imaging can cause cancer is based on an...
caffeine consumption, extra heartbeats, UCSF study, UC San Francisco, Journal of the American Heart Association
News | EP Lab| February 04, 2016
Contrary to current clinical belief, regular caffeine consumption does not lead to extra heartbeats, which, while...
sleep apnea, heart failure readmissions, Thomas Jefferson University study
News | Heart Failure| February 04, 2016
Early diagnosis and treatment of sleep apnea may reduce six-month readmissions for patients hospitalized with heart...
Stereotaxis, Philips, collaboration, Niobe ES remote magnetic navigation system, Allura Xper FD10 cardiovascular X-ray

Niobe ES image courtesy of Stereotaxis Inc.

Technology | Cath Lab| February 04, 2016
February 4, 2016 — Stereotaxis and Philips have signed an addendum pursuant to their existing Development and Coopera
Overlay Init