OCTOPUS Looks at Vessel Healing After DES vs. BMS Plus Paclitaxel Balloon
MUNICH, Germany—Bare-metal stents (BMS) postdilated with a drug-eluting balloon (DEB) offer similar strut coverage and protection against restenosis at 6 months compared with everolimus-eluting stents. However, in imaging data presented August 27, 2012, at the European Society of Cardiology Congress, the BMS plus DEB combination showed more neointimal proliferation.
Tudor C. Poerner, MD, PhD, of the University Hospital of Jena (Jena, Germany), reported findings from the OCTOPUS (Optical Coherence Tomography to Compare Paclitaxel-Eluting Balloons with Everolimus-Eluting Stents) trial, which included 91 patients (116 lesions) scheduled for elective PCI to treat a native coronary stenosis. Patients were randomly assigned to everolimus-eluting Xience V stents (Abbott Vascular, Santa Clara, CA) or Coroflex Blue BMS (B. Braun Melsungen, Melsungen, Germany) postdilated with a paclitaxel-eluting Sequent Please Balloon (B. Braun Melsungen).
Treatment was successful in 100 lesions (n = 52 DES, n = 48 BMS+DEB). At 6 months, the follow-up rate was 85%. Reintervention was required in 1 DES patient and 2 BMS plus DEB patients.
On optical coherence tomography (OCT), the 2 approaches resulted in a similar percentage of uncovered stent struts (primary endpoint) and comparable peak focal in-stent stenosis. In-stent neointimal proliferation, however, was higher at 6 months after treatment with BMS plus DEB compared with DES (table 1).
Table 1. OCT Outcomes at 6 Months
|
DES |
BMS + DEB |
P Value |
Standardized PVola |
11.2 ± 5.3 |
15.7 ± 7.6 |
0.002 |
Maximal Proliferation Area, mm2 |
2.07 ± 1.0 |
2.73 ± 1.2 |
< 0.05 |
Median Proliferation Area, mm2 |
1.09 ± 0.4 |
1.61 ± 0.8 |
< 0.05 |
Peak Area Stenosis |
37.0 ± 15.9% |
39.4 ± 13.5% |
NS |
Uncovered Struts |
4.1 ± 8.9% |
3.8 ± 7.3% |
NS |
a Neointimal proliferation volume per cm stent length.
The positive results in both arms “allowed us to stop clopidogrel in all patients,” Dr. Poerner said, though he noted some limitations to the study: the lack of baseline OCT measurement, use of an older OCT technique, and absence of angiographic comparison.
Dr. Poerner concluded that, based on the current study, “clopidogrel might probably be discontinued at 6 months after both BMS+DEB and DES treatment for stable CAD. However, OCT findings need further clinical validation at long-term follow-up.”
Caution in Using OCT to Direct Antiplatelet Therapy
Apart from questioning 1 methodological issue—the choice to measure minimal lumen area proximal to the stent, since an occlusive technique such as this would be expected to collapse the vessel in that location—session co-chair Patrick W. Serruys, MD, PhD, of Erasmus Medical Center (Rotterdam, The Netherlands) characterized the study as “otherwise . . . quite remarkable.”
Another attendee criticized OCTOPUS for attempting to compare devices eluting “hydrophilic and hydrophobic drugs like everolimus and paclitaxel. I completely understand that on the market we only have 1 or 2 limus-coated balloons, and mostly with a specific formulation of the drug, but again, can we compare [such different drugs]?” Mechanism and time of release would differ, he stressed.
Dr. Poerner disagreed, saying that the study should not be viewed as a contest between 2 devices. Rather, the focus should be on clinical outcomes.
One general safety concern, Dr. Serruys noted, is that “people are designing trials where they will do OCT, judge the situation, and stop [dual antiplatelet therapy].” He emphasized, however, that dual therapy should continue at least 1 month after OCT assessment to make sure that healing is truly adequate.
Source:
Poerner TC. A prospective randomized trial using optical coherence tomography to compare the Xience V everolimus-eluting stent with a bare-metal stent postdilated with a paclitaxel-eluting balloon (OCTOPUS trial). Presented at: European Society of Cardiology Congress; August 27, 2012; Munich, Germany.
Disclosures:
Dr. Poerner reports having non-financial relationships with numerous drug and device companies.
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Caitlin E. Cox is News Editor of TCTMD and Associate Director, Editorial Content at the Cardiovascular Research Foundation. She produces the…
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