Shelley Wood
Managing Editor, heartwire
theheart.org
Kelowna, BC
Disclosure: Shelley Wood has disclosed no relevant financial relationships.
Steven Rourke
Manager, Editorial programming
theheart.org
Montreal, QC
Disclosure: Steven Rourke has disclosed no relevant financial relationships.
Lisa Nainggolan, theheart.org
London, UK
Disclosure: Lisa Nainggolan has disclosed no relevant financial relationships
Sue Hughes, theheart.org
London, UK
Disclosure: Sue Hughes has disclosed no relevant financial relationships.
Reed Miller, theheart.org
Bethesda, Maryland
Disclosure: Reed Miller has disclosed no relevant financial relationships.
Michael O'Riordan, theheart.org
Toronto, Ontario, Canada
Disclosure: Michael O'Riordan has disclosed no relevant financial relationships.
Steve Stiles, theheart.org
Fremont, California
Disclosure: Steve Stiles has disclosed no relevant financial relationships.
The 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium took place in Washington, DC September 21-25, 2010. Key trials presented at the meeting include:
Placement of Aortic Transcatheter Valve Trial (PARTNER): Transcatheter valves slash deaths and hospitalizations compared with standard care.
Zilver® PTX® (Cook Inc., Bloomington, Ind): Paclitaxel-eluting peripheral stent bests bare-metal stents in largest randomized peripheral endovascular trial ever.
Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST 4) and Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT-OUT) 4: Everolimus-eluting stent holds its own against the Cypher® stent (Cordis Corp., Bridgewater, NJ).
COMPARE and SPIRIT IV: Two-year results confirm the superiority of the everolimus-eluting Xience V™ (Abbott Laboratories, Abbott Park, Illinois) stent over 2 iterations of the paclitaxel-eluting Taxus Liberté® (Boston Scientific Corp., Natick, Mass) stent.
Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI): Final follow-up at 3 years cements earlier findings.
BioFreedom™ (Biosensors International USA, Newport Beach, Calif): Polymer-free biolimus stent reduces late lumen loss compared with Taxus Liberté®.
Watchman® Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT-AF) and Continued Access PROTECT AF Registry
(CAP): Watchman® (Atritech Inc., Plymouth, Minn) updates point to better safety, enduring efficacy with left atrial appendage closure device for stroke.
Robotically assisted percutaneous coronary intervention (PCI): The "first-in-humans" report showed that robotically assisted PCI is safe and feasible.
PARTNER
Results: Survival was markedly higher and the risk for a composite endpoint of death or repeat hospitalization was reduced for patients with severe aortic disease unable to undergo surgery who were treated with a novel percutaneous valve, the Sapien transcatheter valve (Edwards Lifesciences LLC, Irvine, Calif), compared with those treated with standard therapy, including balloon valvuloplasty. Risk for stroke and vascular complications was higher in the transcatheter aortic-valve implantation (TAVI) group.
"[The findings] show a clear benefit for the device at an acceptable price," said Dr. Craig Smith (Columbia University, New York, NY), co-primary investigator for the trial. That price -- the strokes and vascular injuries -- were "not unexpected," based on previous studies, he added.
See Transcatheter Valves Slash Deaths, Hospitalizations vs Standard Care: PARTNER and Digesting PARTNER: Physicians React With Superlatives to TAVI Results for more information.
TCT Career Achievement Award
Dr. Alain G. Cribier honored with TCT Career Achievement Award. This year's TCT Career Achievement Award was given to Dr. Alain G Cribier, from the Charles Nicolle Hospital in Rouen, France. Dr. Cribier worked for more than 20 years to help find a therapeutic solution for patients with aortic disease unable to undergo surgery. He conducted the first transcatheter aortic-valve implantation in 2002. As well as receiving the Career Achievement Award, Dr. Cribier was rewarded for his efforts by the results of PARTNER, which highlighted the positive outcomes of his years of hard work.
Zilver® PTX®
Results: The Zilver® PTX® paclitaxel-eluting peripheral stent beat both percutaneous transluminal angioplasty (PTA) and provisional bare-metal stenting in a randomized trial of 479 patients with moderate-to-severe symptomatic femoropopliteal artery disease with an average lesion length of 6.6 cm. Approximately half the patients were diabetic. After 1 year, 83.1% of the stented segments treated with the Zilver® PTX® were still patent, compared with only 32.8% of the vessels in the PTA-treated patients (P < .01). Even when only the optimal PTAs were considered, the Zilver® PTX® still performed much better than PTA, 83.1% compared with 65.3% (P < .01).
"[This] is a very important trial and potentially now groundbreaking in terms of how we can conceive of superficial femoral artery disease and popliteal treatment going forward," said study investigator Dr. William Gray (New York Presbyterian Hospital, NY).
See Zilver PTX Bests Bare-Metal Stents in Largest Randomized Peripheral Endovascular Trial Ever for more information.
ISAR-TEST 4 and SORT-OUT 4
Results: The ISAR-TEST 4 trial showed that the newer-generation everolimus-eluting Xience V™ stent had comparable clinical outcomes out to two years compared with the sirolimus-eluting stent Cypher®. And SORT-OUT 4 investigators showed the Xience V™ stent was statistically noninferior to Cypher® for the reduction of major adverse cardiac events (MACE) at 9 months.
"A lot of the time, the SORT-OUT investigators come up with the same questions and present similar data, perhaps using similar methodology," said Dr. Robert Byrne, the lead investigator of the ISAR-TEST 4 study, during a press conference at the TCT. "Most of the time, we come to the same conclusion. Here, in these two studies, we both fail to detect any significant clinical difference between the two stents, Cypher® and Xience™."
See Blinding Me With Xience: Everolimus-Eluting Stent Holds Its Own Against Cypher Stent for more information.
Live Case Demonstrations
High-definition live cases were transmitted from sites spanning 18 locations around the globe. These included: the CardioVascular Center in Frankfurt, Germany; the Cardiovascular Institute and Fu Wai Hospital in Beijing, China; the Instituto Cardiovascular de Buenos Aires in Argentina; the John Radcliffe Hospital in Oxford, UK; the Quebec Heart and Lung Institute, QC; the Baptist Cardiac and Vascular Institute, in Miami, Florida; the Duke Heart Center in Durham, North Carolina; the New York-Presbyterian Hospital/Columbia University Medical Center, NY; the Rush Center for Congenital and Structural Heart Disease at the Rush University Medical Center in Chicago, Illinois; and Scripps Green Hospital in La Jolla, California.
COMPARE and SPIRIT IV
Results: In COMPARE, an investigator-initiated, all-comers trial, researchers showed that the everolimus-eluting stent remained superior to the Taxus Liberté® stent, with significant differences in the composite endpoint of death, nonfatal myocardial infarction, and target vessel revascularization observed at 2 years.
The SPIRIT IV investigators also showed sustained benefit of the Xience V™ stent over the older Taxus Express® stent. At 2 years, treatment with the everolimus-eluting stent resulted in a relative 30% reduction in target lesion failure, a composite end point reflecting cardiac death, target vessel MI, or ischemia-driven target lesion revascularization.
"The other revelation is that the very late stent-thrombosis rates with the Xience V are low, either with or without extended dual antiplatelet therapy," said SPIRIT IV investigator Dr. Dean Kereiakes (The Christ Hospital, Cincinnati, Ohio). "Our trial had 72% of patients taking dual antiplatelet therapy at 2 years, while their trial [COMPARE] had just about 10% of the Xience V cohort on dual therapy at 2 years. Either way, the very late stent-thrombosis rates were very low with the Xience V® stent. Not so in the Taxus arm.”
See COMPARE and SPIRIT IV: "Durable, Progressive Relative Benefit" of Xience V Over Taxus for more information.
HORIZONS AMI
Results: At 3 years, major bleeding remained statistically lower in the bivalirudin patients compared with the unfractionated heparin/GP IIb/IIIa inhibitor group. Both all-cause mortality and cardiac mortality, which were significantly lower in bivalirudin patients at 1 year, remained lower at 3 years, with event rates widening slightly over time. In the drug-eluting vs bare-metal stent randomization, the reduction in repeat target lesion revascularization seen at 1 year persisted at 3 years, both in patients who had undergone angiography and in those who had not. Rates of major adverse cardiac events and of all other clinical endpoints showed no differences between the 2 groups.
In his concluding remarks, principal investigator Dr. Gregg Stone emphasized the enduring reduction in major bleeding, reinfarction, cardiac mortality, and all-cause mortality in the bivalirudin-treated patients, as well as the 40% reduction in TLR [target lesion revascularization] among patients randomized to the paclitaxel stent. He also drew attention to the high rates of stent thrombosis seen in the trial -- ranging from 4% to 5% in all study groups -- despite the fact that patients tended to maintain the same level of dual antiplatelet therapy.
See HORIZONS-AMI: Final Follow-Up Cements Earlier Findings for more information.
BioFreedom™
Results: After 1 year, the novel polymer-free biolimus A9-eluting stent was statistically noninferior to the paclitaxel-eluting stent in patients with coronary artery disease in terms of in-stent late lumen loss, and trending toward superiority, report investigators.
According to study investigator Dr. Eberhard Grube, the hope is that the polymer-free biolimus A9-eluting stent can reduce late adverse events attributed to the polymer, such as stent thrombosis, and potentially reduce the duration of dual antiplatelet therapy.
See BIOFREEDOM: Polymer-Free Biolimus Stent Reduces Late Lumen Loss Compared With Taxus for more information.
Poster Sessions
Over 400 abstract posters were selected to be presented at the TCT. Awards were given to the top 25 and included:
Robotically-Assisted PCI: First-in-Human Study, Juan F. Granada, et al.
Selection Criteria for Drug-Eluting vs Bare Metal Stents: The HORIZONS-AMI Trial, Gregg W. Stone, et al.
Long-Term Results of Endovascular Aneurysm Repair (EVAR) vs Open Repair in Patients with Large Abdominal Aortic Aneurysm: Results of the UK EVAR Trial 1, Roger M. Greenhalgh, et al.
SYNTAX Score Reproducibility and Agreement Between Interventional Cardiologists and Core Laboratory Technician Measurements, Philippe Genereux, et al.
Correlates and Consequences of Gastrointestinal Bleeding Complicating Percutaneous Coronary Intervention, Michael A. Gaglia Jr, et al.
Approach to Treat Mitral Regurgitation: Human Data and Final Percutaneous Prototype, Richard R. Heuser, et al.
The Impact of Xience V™ Everolimus-Eluting Stent on Health Status in On-Label and Off-Label Patients: 1-Year Results from the Xience V™ USA Study, David R. Rutledge, et al.
PROTECT-AF
Results: Extended follow-up results on the Watchman® left atrial appendage closure device for stroke prevention in atrial-fibrillation patients suggest that, as more time passes postimplantation, the device continues to prevent strokes and deaths. Meanwhile, the safety issues that first raised flags for the procedure -- pericardial effusion, device retrievals, and different types of bleeding -- are, indeed, declining over time.
CAP RegistryResults: The CHADS2 score for patients was higher in CAP, while procedure time was reduced, implant success was greater, and the proportion of patients who discontinued warfarin at 45 days was significantly increased.
See Watchman Updates Point to Better Safety, Enduring Efficacy With LAA Closure Device for Stroke for more information.
Robotically Assisted PCI
Results: The "first-in-humans" report, presented at TCT 2010, showed that robotically assisted percutaneous coronary intervention (CorPath™ 200, Corindus, Natick, Mass) is technically feasible, with no occurrences of major adverse cardiac events at 30 days, and significantly reduced operator exposure to radiation, as well as reduced use of contrast.
"I think some of the main issues with interventional cardiology are the orthopedic injuries that people don't talk about, the radiation exposure, the quality of the intervention, and contrast use," said lead investigator Dr. Juan Granada (Cardiovascular Research Foundation, Orangeburg, NY). "What this system is trying to do is optimize the way we do angioplasty procedures and to decrease the risk, mainly the risk that the operator and the personnel are exposed to."
See First-in-Human Study Shows Robotically Assisted PCI Safe, Feasible for more information.
Opinions From TCT
Topolog
PARTNER triumph takes TAVI to the next level
Private practice with Dr Seth Bilazarian
Reacting to PARTNER
TCT 2010
More than 10 000 people attended the scientific symposia, late-breaking trials, live case presentations, "how-to-treat" theaters, oral abstract and poster abstract sessions, the nurse and technologist symposium, board review courses, maintenance-of-certification session, and FDA town hall meeting at the 22nd annual TCT meeting held in September 2010.
TCT 2011 will be held in San Francisco November 7-11.
Shelley Wood
Managing Editor, heartwire
theheart.org
Kelowna, BC
Disclosure: Shelley Wood has disclosed no relevant financial relationships.
Steven Rourke
Manager, Editorial programming
theheart.org
Montreal, QC
Disclosure: Steven Rourke has disclosed no relevant financial relationships.
Lisa Nainggolan, theheart.org
London, UK
Disclosure: Lisa Nainggolan has disclosed no relevant financial relationships
Sue Hughes, theheart.org
London, UK
Disclosure: Sue Hughes has disclosed no relevant financial relationships.
Reed Miller, theheart.org
Bethesda, Maryland
Disclosure: Reed Miller has disclosed no relevant financial relationships.
Michael O'Riordan, theheart.org
Toronto, Ontario, Canada
Disclosure: Michael O'Riordan has disclosed no relevant financial relationships.
Steve Stiles, theheart.org
Fremont, California
Disclosure: Steve Stiles has disclosed no relevant financial relationships.
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