TCT 2012 Clinical Trial Results Summary FAME2 Trial: FFR (fractional flow reserve) guided PCI in all target lesions Patients with significant ischemia, randomized 1:1 Control arm: not hemodynamically significant lesion Stopped early due to primary endpoints, a statistically significant reduction in the need for unplanned hospital readmission and urgent revascularisation was found when FFR-guided assessment was used in treatment QOL @ 1 month FFR-Guided was significantly higher utility Cumulative higher costs higher in FFR-guided treatment Cost effectiveness ratio, $53,000/QALY, 3 year projection $32,000/QALY 86% relative reduction in the risk for ACS requiring unplanned hospital readmission with urgent revascularization FFR-guided treatment helped reduce the risk of urgent revascularization by a factor of eight Panel at press conference stated that this study will likely increase FFR use based on this study FFR-Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Therapy vs. Optimal Medical Therapy Alone in Patients with Stable Coronary Artery Disease MASTER Trial: MGUARD for Acute ST Elevation Reperfusion Embolis protection device (not a stent) Stent delivers the mesh device PCI with bare metal stent (BMS) or drug eluting stent (DES) vs DCI with MGuard Difference = 13.2% Trial showed a trend toward lower mortality (0% vs. 1.9%, P=0.06) at 30 days, cardiac mortality: 4 deaths in control group, 0 deaths in MGuard group No difference between the groups in the secondary endpoint of myocardial blush grade (MBG) Patients with acute STEMI with emergent PCI MGuard is better Significantly more patients treated with the MGuard EPS achieved complete ST resolution STEMI patients are particularly susceptible (reason for study)
ISAR-LEFT MAIN 2: Everolimus- and Zotarolimus-eluting Stents for Treatment of Unprotected Left Main Coronary Artery Disease (650 patients) Randomized multi-center trial Study done because patients undergoing invasive treatment of unprotected left main coronary artery (ulmca) lesions are at high-risk of ACE (Adverse cardiovascular events) PCI v CABG mortality was similar at first Hypothesis: Endeavor Resolute stent is not inferior to Xience stent Primary end point: incidence of major adverse cardiac events (MACE) - death, MI (myocardial infarction) or target lesion revascularization at one-year MACE was 17.5 percent in the ZES group and 14.3 percent in the EES group Restenosis occurred in 21.5 percent of the ZES group and 16.8 percent of the EES group Non-inferiority trial (met non-inferiority) Trial results indicate that the use of second generation drug-eluting stents in unprotected left main coronary artery lesions in relatively unselected patients is safe and effective PARTNER Cohort B, three year: TAVR vs standard therapy in inoperable aortic stenosis patients (3 years) PARTNER Trial compared SAPIEN valve to standard therapy at three years 358 patients enrolled with severe, symptomatic aortic stenosis deemed inoperable for traditional open-heart surgery Kaplan-Meier curves continue to diverge more every year Kaplan-Meier estimated rates of death at 3 years were 54.1 percent in TAVR group and 80.9 percent in standard-therapy group (P<0.0001) Looking at survival and repeat hospitalization Showed sustained benefits for both mortality and hospital readmissions, as well as found that valve durability was demonstrated with no increase in transvalvular gradient or attrition of valve area Mortality or stroke huge difference in Kaplan-Meier curves (P-value) EOA 0.6 because 1.5 after 30 days and sustained over 3 years Data continues to support role of TAVR as standard of care for symptomatic patients with aortic stenosis who are not surgical candidates FDA has approved SAPIEN valve for high-risk surgical patients (previously only approved for inoperable patients)
Trilogy ACS Angiographic Cohort: Effectiveness and safety of prasugral in high-risk patients with acute coronary syndrome (ACS) who are medically managed without revascularization 9,326 patients with unstable angina or NSTEMI on aspirin Prasugrel vs Clopidogrel Triaged with angiography, triaged without angiography, overall event rates higher without angiography 43% of the patients had angiography performed and coronary anatomy determined before being triaged Angio big difference; No Angio no difference Excess major bleeding in both arms of the study Consistent with previous studies Study showed that Prasugrel does not reduce the frequency of ischemic events compared with Clopidogrel Overall the trial was a negative trial Study may make it possible to identify a subset of medically managed patients who benefit from more intensive platelet blockade (needs to be studied further) ETAP: Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions Balloon Angioplasty versus primary Stenting Multicenter, randomized study First trial comparing primary stenting in popliteal artery vs POBA Stent vs PTA Patients with chronic PAD RCC 1-4 (no restrictions in lesion length) Primary endpoint: Restenosis rate at 12 months (duplex PSVR > 2.4) Lifestent placement results in a significant higher primary patency rate as compared to POBA Lifestent placement in popliteal artery is safe RESPECT Trial: Randomized evaluation of recurrent stroke comparing PFO closure to established current standard of care treatment Investigated whether PFO closure with the AMPLATZER PFO Occluder is more effective than the standard of care treatment (medications to prevent blood clots) in preventing recurrent cryptogenic stroke AMPLATZER PFO Occluder o Double-disc device o Nitinol mesh and polyester fabric
Defined cryptogenic stroke population Have to determine the chance that the stroke is related to a PFO Primary analysis was not statistically significant Secondary analysis suggested superiority Primary end point: composite of recurrence of nonfatal stroke, post-randomized death or fatal ischemic stroke As patients continue to be followed the investigators will be able to continue to report results No significant difference in atrial fibrillation between the two groups Could be particularly beneficial for those who want to get off of anti-coagulants (i.e. a woman who is or would like to become pregnant) Clinical risk reduction was observed across the totality of analyses with rates ranging from 46.6%-72.7% AMPLATZER PFO Occluder has a very low risk of device or procedure-related complications The PC Trial: PC (Percutaneous Closure of Patent Foramen Ovale versus Medical Treatment in Patients with Cryptogenic Embolism) Trial Cause effect analysis on the relationship between PFO & stroke Transient ischemic attack (TIA) or cryptogenic stroke 414 patients randomized Primary endpoint: composite of death, non-fatal stroke, TIA, and peripheral embolism Limitation: event rate in the control group was 50% lower than expected Trial was unable to detect meaningful differences in the outcomes of the two therapies POSEIDON: A Prospective trial of sliding-scale hydration for prevention of contrast nephropathy LVEDP guided hydration 396 patients randomized, 196 in the LVEDP group and 200 in the standard hydration group GFR<60 + 1 additional risk factor (diabetes, MI, etc) Contrast-induced acute kidney injury (CI-AKI) or Contrast nephropathy: complication of contrast exposure Primary endpoint: 25% of 0.5 mg/dl increase in serum creatinine Kidney damage found in 6.7 percent of the LVEDP guided hydration group and in 16.3 percent of the standard hydration group (P = 0.005)
No significant differences between groups for baseline renal function or LVEDP 59% relative reduction in event rate statistically significant Low cost, low risk solution to a significant problem ADAPT-DES Study: Investigative drug: Clopidogrel Assessment of Dual Anti-Platelet Therapy with Drug Eluting Stents 11,000 DES patients Multivariable propensity score adjusted risk Not independently predictive of 1 year mortality in DES recipients Increased risk of thrombosis offset by lower risk of bleeding Hyporesponsiveness to aspirin was unrelated to ST, MI, or death, but may be related to bleeding, questioning the utility of aspirin in patients treated with DES AIDA STEMI MRI Study: Randomized, open-label, multicenter trial in patients presenting with ST-elevation myocardial infarction (STEMI) comparing intracoronary (IC) versus intravenous (IV) abciximab during PCI with subsequent 12 hour intravenous infusion Enrolled 703 patients within the overall trial in a cardiac magnetic resonance imaging sub-study o 394 patients randomized intracoronary group, 401 patients randomized intravenous group Amount of myocardium at risk and final infarct size did not differ significantly between the IC versus the IV abciximab groups No differences in microvascular obstructions POST Trial: Prospective randomized trial of post-conditioning in patients with ST-Segment Elevation Myocardial Infarction Ischemic post conditioning Four episodes of one-minute balloon occlusion and one-minute deflation within one minute after restoration of coronary flow after PCI 700 patients randomized (1:1) o 350 patients randomized to postconditioning, 350 randomized to standard PCI Chemical and angiographic findings were not significant between the two groups Investigators determined that the study was not done with an adequate sample size o Sample size may have been too small to make definite conclusions on clinical outcomes
RESOLUTE US: Or the treatment of long lesions and small vessels Long lesions o 222 patients o 38mm Resolute stent for lesions less than or equal to 35mm in length o 1 year target lesion failure (TLF) rate of 5.4% o 1 year rate of clinically-driven target lesion revascularization in those patients with diabetes was 2.4% Small vessels o 1,956 patients o Resolute stent for the treatment of coronary lesions of no greater than 2.5mm in diameter o 2 year target lesion failure (TLF) rate of 10.1% o Showed low rates of clinical events and stent thrombosis AMI: Future Trials CORE: relationship between infarction size and impact microscopal distal emboli MGuard Concept: Stainless steel, mesh sleeve fibers) - Residual thrombus MASTER: MGuard for Acute ST Elevation Reperfusion Apposition V (IDE): Stentys Euro Max: European Ambulance ACS Angiox Trial Stent Thormbosis Meta-Analysis Horizons-AMI II - Surgery, Promus EES, Omega BMS