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April 12, 2011

What’s New at the American College of Cardiology 2011?

The American College of Cardiology Annual Scientific Sessions was held recently in New Orleans. Interesting reports of clinical trials and other studies are outline below for your benefit:

PARTNER study compared transcatheter aortic valve replacement (TAVR) with standard aortic valve replacement (AVR):

Conclusions: [ Essentially keyhole aortic valve replacement is the same as standard open heart aortic valve replacement at 1 year]

•The primary endpoint of the trial was met:
–In patients with aortic stenosis at high risk for operation, TAVR was non-inferior to AVR for all-cause mortality at
1 year (24.2% vs. 26.8%, p=0.001 for non inferiority)
–Transfemoral TAVR subgroup was also non-inferior to
AVR (p=0.002 for non-inferiority)
•Death at 30 days was lower than expected in both
arms of the trial:
–TAVR mortality (3.4%) was the lowest reported in any series, despite an early generation device and limited previous operator  experience
–AVR mortality (6.5%) was lower than the expected operative mortality (11.8%)
•Both TAVR and AVR were associated with important but different peri-procedural hazards:
–Major strokes at 30 days (3.8 vs. 2.1%, p=0.20) and
one year (5.1% vs. 2.4%, p=0.07) and major vascular complications were more frequent with TAVR
(11.0% vs. 3.2%, p<0.001)
–Major bleeding (9.3% vs. 19.5%, p<0.001) and new
onset atrial fibrillation (8.6% vs. 16.0%, p<0.001) were
more frequent with AVR
•TAVR and AVR are both acceptable therapies in these
high-risk patients; differing peri-procedural hazards should influence case-based decision-making
•Symptom improvement (NYHA class and 6-min walk
distance) favored TAVR at 30 days and was similar
to AVR at one year
•Echo findings indicate:
–Small hemodynamic benefit with TAVR vs. AVR at 1 year  (mean gradient p=0.008, AVA p=0.002)
–Increased para-valvular regurgitation associated with TAVR (p<0.001)
•Preliminary subgroup analyses should be interpreted
cautiously:
–Possible TAVR benefit in women and patients without
prior CABG
PRECOMBAT:
Comparison of sirolimus eluting stent (drug-coated stent) vs CABG (bypass surgery) in unprotected left main coronary artery (ULMCA) stenosis:

suggests that PCI with sirolimus-eluting stent appears a potential alternative to CABG with a noninferior incidence of 2-year MACCE for patients with ULMCA stenosis.

STICH:

The hypothesis: In patients with HF, LVD and CAD amenable to surgical revascularization, CABG added to intensive medical therapy (MED) will decrease all-cause mortality compared to MED alone.

Results and conclusions:

•As randomized, CABG led to a 14% RRR in all-cause mortality compared to MED.
•CABG compared to MED led to statistically significant lower rates —
§cardiovascular death: 19% RRR
§death or cardiovascular hospitalization: 24% RRR
•When receiving CABG, patients are exposed to an early risk for 2 years.
•CAD should be assessed among all patients presenting with HF.
•In HF patients with CAD on medical therapy, CABG should now be considered to reduce cardiovascular mortality and morbidity.
•The durability of CABG benefits to be tested in the STICH Extension Study which is ongoing.
RAPS: Radial Artery and Saphenous Vein Patency more than 5-years Following Coronary Artery Bypass Surgery:
oRadial arteries are associated with reduced rates of functional and complete graft occlusion than  saphenous veins.
oRadial arteries are associated with less graft disease than saphenous veins.

ISAR-CABG:
Randomized, Superiority Trial of Drug-Eluting-Stent and Bare Metal Stent in Safenous Vein Graft Lesions

Out to 12 months drug-eluting stents are superior to bare metal stents in a large-scale study powered for clinical endpoints.

The need for repeat revascularizations was reduced by ~50% with DES as compared to BMS.

DES were comparable to BMS regarding safety parameters – stent thrombosis, death or MI.