A study comparing the Resolute Onyx drug-eluting stent from Medtronic (NYSE:MDT) and the BioFreedom stent made by Biosensors International (PINK:BSNRY) showed the Medtronic device to be non-inferior in patients on a one-month dual anti-platelet therapy regimen, according to results presented yesterday at the annual Transcatheter Cardiovascular Technologies conference in San Francisco.
Medtronic launched the 2,000-patient study in August 2017. It’s designed to compare a one-month course of aspirin and an anti-coagulant in conjunction with the Resolute Onyx device or the BioFreedom stent. The zotorolimus-eluting Resolute Onyx is made from a single strand of cobalt alloy, formed into a sinusoidal wave with a radio-opaque core. The Biosensors device is a polymer-free drug-coated stent.
One-year results from the Onyx One trial for the primary safety endpoint, a composite of cardiac death, myocardial infarction and definite or probable stent thrombosis, showed a 17.1% rate for Resolute Onyx and 16.9% for the BioFreedom stent. There were no differences for the secondary effectiveness endpoint, target lesion failure at one year, and the stents showed similar rates of target-vessel MI in both groups (Resolute Onyx 12.8%, BioFreedom 14.0%). But a landmark analysis showed that the rate of target-vessel MI with the Medtronic device was significantly lower, at 3.7% compared with 5.9% for the BioFreedom device.
Lead investigator Dr. Stephan Windecker, of the Swiss Cardiovascular Center in Bern, Switzerland, addressing concerns that the trial was not designed to compare longer DAPT treatment, said the study raises the issue of "whether one month of DAPT is truly the optimal balance between safety and efficacy in this patient population," TCTMD reported.
“With a growing proportion of PCI patients at a high risk of bleeding, we knew it was critical to generate randomized clinical evidence to evaluate outcomes in this under-represented patient population at increased risk for adverse outcomes,” Windecker said in prepared remarks. “This study provides important advances in evidence for physicians determining the optimal duration of DAPT following PCI among high bleeding risk patients. Data like these are very informative for clinical practice.”
“We are committed to generating clinical evidence to help clinicians better respond to the needs of complex patient populations,” added coronary & renal denervation GM Dave Moeller. “Resolute Onyx DES continues to deliver excellent outcomes for a wide range of patients. With these new data presented today, the evidence provides greater confidence in treating complex patients with Resolute Onyx and a shortened course of DAPT.”
Short DAPT with Boston Scientific’s Synergy equals a year with Abbott’s Xience, but high adverse event rates draw doubts
A four-month course of dual anti-platelet therapy with the Synergy stent made by Boston Scientific (NYSE:BSX) equaled year-long DAPT with the Abbott (NYSE:ABT) everolimus-eluting Xience stent in patients with left main coronary artery disease, according to one-year results from the 818-patient Ideal-LM study.
Synergy’s bioabsorbable polymer is designed to dissolve completely after delivering its payload of the anti-restenosis drug everolimus for about three months, leaving behind a bare-metal stent. The rate of major adverse cardiac events was 14.6% for the Synergy cohort and 11.4% for teh Xience group. But adverse events including myocardial infarction, ischemia-driven target vessel revascularization, definite or probable stent thrombosis and bleeding were roughly double for the Synergy arm.
Lead investigator Dr. Robert-Jan van Geuns of Radboud University Medical Center in Nijmegen, Holland, said the trial showed that short-term DAPT is a viable option for treating left main disease.
"A lot of interventional cardiologists will say, ‘If I did a left main, I will never do short DAPT,’" van Gruens said, according to TCTMD. "I think we have shown that it’s a possibility."
"The guidelines suggest DAPT duration should be based on each individual’s ischemic and bleeding risk rather than the type of stent that has been implanted or the location of the stent implanted," Dr. Marco Valgimigli, of the University of Bern, Switzerland, told the website.
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Heart attack, blood clot rates equal for Boston Scientific’s Synergy on short DAPT, but beeling rates are higher
Another study involving Boston’s Synergy stent and a three-month DAPT course in 2,009 high bleeding risk patients showed no increased rates of myocardial infarction or stent thrombosis but a higher bleeding rate
The Evolve Short DAPT study’s rate of death or MI from three to 15 months was 5.6% for the short DAPT arm and 5.7% for the 12-month control group. The experimental arm showed a 0.3% rate of stent thrombosis compared to 1.0% in the year-long DAPT comparator. But the bleeding rate was 6.3% for the treatment arm and 4.2% for the control group.
"These data prospectively demonstrate a low rate of adverse events for patients who are at high risk for bleeding and who then stop DAPT at three months," lead investigator Dr. Ajay Kirtane, of New York City’s Columbia University Irving Medical Center, said in prepared remarks. "This is critically important information because the required duration of DAPT following implantation of current generation drug-eluting stent platforms was previously unknown. These data better inform physicians on how best to tailor the recommended duration of DAPT to the bleeding risk of the patients they treat."
“We are pleased the study presented today provided robust safety data on shortened DAPT following implantation of the Synergy [bioabsorbable polymer] stent for this patient population, as the reduced length of therapy can be a clinically significant differentiator,” added Boston Scientific global CMO Dr. Ian Meredith. “We continue to build upon the body of evidence supporting the excellent clinical outcomes of the Synergy BP stent and look forward to submitting these data to regulatory authorities to support an indication for use of this stent in patients at high risk of experiencing a bleeding event.”
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Twilight finds anti-clot drug alone beats DAPT after stenting
Results from the Twilight study comparing ticagrelor plus aspirin with ticagrelor alone showed a lower rate of bleeding events without a higher adverse event risk in high-risk patients after percutaneous coronary intervention and three months of DAPT.
The 9,006-patient, placebo-controlled study randomized event-free patients to aspirin plus ticagrelor or a placebo plus ticagrelor for 12 months after the initial short DAPT regimen.
The incidence of major bleeding was 4.0% for the ticagrelor-alone arm and and 7.1% for the DAPT arm. Rates of all-cause death, myocardial infarction or stroke were 3.9% for both groups, with all-cause death rates of 1.0% vs. 1.3%; myocardial infarction rates if 2.7% vs. 2.7%; and definite or probable stent thrombosis rates of 0.4% vs. 0.6%. The rate of ischemic stroke was 0.5% for the ticagrelor-alone patients and 0.2% for the DAPT control arm.
"Lowering bleeding risk while preserving ischemic benefit is critically important, especially in high risk patients," Dr. Roxana Mehran, of New York City’s Mount Sinai School of Medicine, said in prepared remarks. "This study shows that among high-risk PCI patients who were treated with ticagrelor and aspirin for three months, an antiplatelet strategy of continuing ticagrelor alone, compared with ticagrelor plus aspirin, results in substantially less bleeding without incurring ischemic harm over one year. These results suggest that ticagrelor monotherapy may be a suitable antiplatelet strategy to lower bleeding while preserving ischemic benefit in this group of patients.
"This landmark study unequivocally shows that withdrawal of aspirin in patients already on ticagrelor and ASA for three months reduces bleeding significantly without incurring harm. This global collaboration with our colleagues was central to achieving the successful completion of this trial. For this I am most grateful. These are important questions for clinicians," Mehran said.
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Abiomed touts Protect III data for Impella 2.5, Impella CP
Abiomed (NSDQ:ABMD) yesterday said the Protect III post-market study of its Impella 2.5 and Impella CP heart pumps showed a reduction in the primary endpoint of death, stroke, MI and repeat procedures at 90 days, compared to its Protect II trial.
The interim analysis on 898 patients showed a 90-day adverse event rate of 16.8% for the Impella arm, compared with 31.0% for the Protect II arm treated with intra-aortic balloon pump.
"The totality of clinical data in favor of Impella supported high-risk PCI allows interventional cardiologists to be confident they are using the optimal treatment and technologies to help achieve complete revascularization in a single setting, improve procedural hemodynamic stability and improve patient quality of life," Dr. William O’Neill, of Detroit’s Henry Ford Hospital, said in prepared remarks.
"Based on the learnings from the Protect studies, decisions to provide hemodynamic support during PCI should be made in the context of providing complete revascularization and patient outcomes should include in-hospital and out-of-hospital improvements," added Dr. Jeffrey Popma of Boston’s Beth Israel Deaconess Medical Center, who presented the data at TCT. "Prior studies have demonstrated it is important to achieve complete revascularization because it can result in a 30-50% reduction in MACCE, compared to incomplete revascularization."
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