Cath Lab Digest

This month I wanted to review the last area that we have not fully reviewed as of yet—drug-eluting technologies in the superficial femoral arteries (SFA). To date we have seen just the glimmer of data from the balloon technologies that have additional drugs added in the SFA.

To start, we have seen from THUNDER that in an SFA lesion subset of 7.4 cm, the addition of paclitaxel to a balloon using contrast as the medium for transfer clearly is better than POBA (“plain old balloon angioplasty”) in this lesion’s subset. Further, the data also included patients with in-stent restenosis and occlusions. In the longer lesions, a group not published separately has been intimated to be equally durable. The next step from Paccocath has been in limbo from an IP standpoint that is currently still under negotiation. What may be useful for the future using this technology through MEDRAD is the DEFINITIVE AR trial that is currently underway in Europe to see the added benefit, if any, regarding directional atherectomy and drug-eluting balloons.

The second trial presented was the Fem-Pac trial. Here this trial was basically THUNDER but on a smaller lesion subset (4.1 cm). The outcomes were similar to the THUNDER trial and slightly improved given the smaller lesions subset. This group did not enroll or publish a longer lesion subset though they did enroll in-stent restenosis in the trial.

More recently, LEVANT I was presented and led to the LEVANT II trial in the U.S. This trial has just recently started enrolling with the first patient enrolled in August 2011. In LEVANT I the MOXY balloon is used as a proprietary medium for the transfer of paclitaxel. The lesion length in LEVANT 1 was 8.1 cm with an outcome of 81% primary patency.

Clearly, the evidence from the drug-eluting trials from our colleagues in Europe seems compelling, though they remain untested in our country or at the least in a robust trial. Critical to this statement is that we need to have “optimal” PTA compared with any of the devices with drug elution in a large-scale randomized trial. If we do not see this from industry, then we can, unfortunately, only conclude the same outcomes for DEB will be in a subset of our patients and not in our real world patients we treat everyday.

________________________________________________________________________________

Dr. Garcia received his B.A. and M.D. degrees from the University of Arizona. He was an intern and resident at Parkland Memorial Hospital, University of Texas at Southwestern in Dallas, Texas. He received his training in cardiology at the University of Iowa Hospitals and Clinics in Iowa City, Iowa, and as an interventional cardiologist at the Beth Israel Deaconess Medical Center, Harvard Medical School. Further, he received his peripheral vascular training at St. Elizabeth’s Medical Center, Tuft’s University, Boston, Massachusetts. He then served as the Chief of Vascular Medicine and Peripheral Vascular Interventions for the Florida Heart Group in Orlando, Florida. Dr. Garcia returned to Harvard’s Beth Israel Hospital as a full-time interventional cardiologist and Director of the Peripheral Cardiovascular Program and Peripheral Interventions at the Beth Israel Deaconess Medical Center as well as the Director of the Interventional Fellowship Program. This program developed into one of the busiest in the city of Boston, performing over 600 peripheral procedures per year.

Dr. Garcia has now returned to St. Elizabeth’s Medical Center as Chief of the Section of Interventional Cardiology and as Associate Director of the Vascular Medicine Program. Dr. Garcia’s work has largely focused on arterial occlusion-reperfusion models and the efficacy of therapeutic modalities or interventions with regard to free radical generation or endovascular stenting outcomes. Dr. Garcia continues his research interests in a wide variety of studies including acute MI studies, unstable angina studies, interventional trials, peripheral interventional trials, angiogenesis trials, imaging modality studies, and numerous device trials for both the coronary and peripheral circulations. His work has been presented in numerous manuscripts, abstracts, textbooks and textbook chapters.