CardioExchange Archive

1. The IMPROVE-IT Trial will complete and show no reduction in morbidity-mortality with addition of ezetimibe to simvastatin
2. The new NCEP Cholesterol Guidelines will be released and will no longer
   recommend treating to target LDL levels.
3. The HPS Thrive Study will complete and show no benefits for the combination of niacin and laropiprant.

1. Continued scrutiny about appropriateness of imaging, EP, and interventional procedures
2. Continued consolidation of health care, leading to hospitals merging and an even greater share of physicians becoming hospital employees
3. Further shift away from fee-for-service models and toward accountable care organizations

1. With the Affordable Care Act upheld by the supreme court, we will start to see dramatic changes in the healthcare landscape in preparation
2. After much anticipation, we’ll finally see the JNC 8, ATP IV and prevention guidelines from the NHLBI and they might be controversial
3. More evidence will emerge to support the safety of earlier discontinuation of dual antiplatelet therapy with newer stents; practice will begin to change

1. After initial political resistance, the insurance exchanges and effective realities of the Affordable Care Act will begin to be seen in health care delivery across the US.
2. Niacin will fail to show an outcomes benefit in terms of MI/Stroke/Death from the HPS2 THRIVE study, but the majority of physicians will still argue in favor of prescribing it.
3. The FDA will streamline the medical device approval process which will result in earlier introduction of medical devices and improved patient access.

1. The country will slowly accept the reality of the ACA.
2. Congress will continue to kick the can down the road on the medicare sustainable growth rate (SGR) and true reform of this program.
3. We will continue to over diagnose and over treat patients because our incentives are not aligned with the best interests of our patients.

1. ATP IV and its sister guidelines reinforce the importance of primary prevention in high risk patients with multiple risk factors. One of the most important debates in Preventive Cardiology involves the appropriate use of statins in primary prevention. In 2012 members of the Archives of Internal Medicine were outspoken about their position that statins are not appropriate for anyone in primary prevention until trials can unequivocally show an overall mortality benefit with statins. Our group at Hopkins, in conjunction with other leaders in the Preventive Cardiology community continued to endorse selective use of statins in all patients with an elevated estimated absolute risk of a cardiovascular event. This debate spilled over from the Wall Street Journal to JAMA (see here and here) to the Archives of Internal Medicine to the American Journal of Medicine and to Clinical Cardiology. In 2012, the CTT meta-analysis showed benefit with statins across the spectrum of cardiovascular risk, and across the spectrum of LDL levels. However, this paper in Lancet generated many letters to the editor by those advocating for lifestyle therapy only in primary prevention.
2. Niacin shows modest but significant benefit in HPS-2 THRIVE. The leaders in the field of atherosclerosis imaging endorse serial high fidelity carotid IMT studies using ultrasound and MRI to help select drugs for development to reduce future atherosclerotic events.
3. Digital medicine (as described by Eric Topol) increasingly revolutionizes healthcare and begins to save substantial sums of money for the healthcare system. Eric becomes a regular guest on the Dr. Oz television show with periodic appearances on the Oprah network. His outstanding book becomes the subject of the next Steven Spielberg movie with cameo appearances by Harlan Krumholz and Bill Clinton.

1. Obamacare rollout will accelerate. Some of it for better and possibly some for worse. The regulations will largely determine the individual results. And the States’ responses to insurance exchanges and Medicaid expansion will largely determine the success.
2. CMS will continue to make cuts and changes. There will be many unintended consequences like costs going up when the intention was that costs would go down.
3. Electronic medical record use will continue to increase. This will also increase costs but hopefully will improve care.
4. The ACC will launch a new digital strategy.  This will change the public look but mainly will add member value.

James de Lemos, MD

1. Hospital systems “game” heart failure care to minimize financial penalties from readmissions, resulting in an overnight cottage industry of heart failure observation units.
2. Spotlight is shined on “off label” creep in TAVR procedures
3. Applications for cardiology fellowships drop, as applicants (always 3 steps ahead) read the tealeaves regarding changes in compensation forcardiologists.

JoAnne M. Foody, MD

1. HPS2 THRIVE predict that this will be negative and reestablish primacy of
   LDL reduction
2. PARTNER IIb in high risk patients.
3. expansion oral anticoagulants in ACS, AF and PE

Sanjay Kaul, MD

1. Increasing data will emerge to clarify the role of renal denervation as a treatment option in managing refractory hypertension.
2. The line between hype, hope, and reality of stem cell therapy for cardiovascular indications will continue to become increasingly blurred.
3. The data from IMPROVE-IT and HPS2-THRIVE will force a rethink of the regulatory standard for approval of lipid modifying drugs from biomarker-based to outcome-based.

1. The FREEDOM trial clearly demonstrating that CABG is superior to PCI in diabetic patients
2. The failure of dalcetrapib based upon a futility analysis raises questions about the HDL hypothesis
3. Preliminary data on several new PCSK9 inhibitors show very large LDL reductions with administration once or twice per month

1. Expansion of approved indications for TAVR to include high-risk surgical patients.
2. Long term data demonstrating the durability of renal denervation for resistant hypertension.
3. Supreme Court upholding the Affordable Care Act.

1. The IABP SHOCK-II trial challenged our traditional thoughts of who needs balloon pump support in setting of acute MI and cardiogenic shock.
2. Although the final data are not yet published, the preliminary results of the WOEST trial brought us one step closer towards answering the triple therapy conundrum.
3. This year we saw the emergence of the “natural randomized controlled trial” in cardiology in a trial which used SNPs associated with low LDL in a “mendelian randomization analysis”. Mostly hypothesis generating, this metanalysis introduced a new and interesting way to study effects on a population level (reference is: J Am Coll Cardiol. 2012 Oct 9).

1. Progress and setbacks for novel anticoagulants: Agents such as dabigatran, rivaroxaban, and apixaban become increasingly relevant for AF as well as expanded use in DVT/PE. However, the FDA rejects rivaroxaban for ACS, and the the first report of failed dabigatran study in mechanical valves reinforces the need for caution and further study.
2. The FREEDOM trial definitively shows the superior role of CABG in Diabetic patients with multi-vessel disease. This nullifies any argument about DES not being fairly represented in historical trials, but also makes us wonder what advances have truly been made since the CASS registry of old.
3. The arrival of the generics: Clopidogrel, atorvastatin and valsartan come off patent. However, generic atorvastatin from Ranbaxy is marked by glass contamination and generic valsartan has yet to be marketed.

1. Supreme Court allows the Affordable Care Act to essentially remain intact.
2. Over half of states do not implement insurance exchanges, adding back an element of uncertainty.
3. Amid all of the uncertainty surrounding the practice of medicine, we still need to pay attention to the science. Lambert, et al reported the outcomes for patients with both atrial fibrillation and acute coronary syndromes treated with triple-drug therapy (Circulation 2012;126:1185-1193). The short and long term risk of bleeding was significantly higher in patients on triple-drug therapy, compared with those on dual-drug therapy, without any measurable benefit. First do no harm!

1. The efficacy and short to intermediate term safety of PCSK9 inhibitors were established in phase 2 studies (GAUSS, RUTHERFORD, RN316).
2. Cardiac CT got patients with atypical chest discomfort home quicker and saved important healthcare dollars in patients triaged for chest pain in the emergency room (ROMICAT II, ACRIN-PA).
3. There was a neutral effect of dalcetrapib in Dal-OUTCOMES. This further calls into question whether raising HDL-Cholesterol provides incremental benefits on top of moderate to high dose statin therapy.

Thad F Waites, MD

1. The Supreme Court decision on Obamacare. The Chief Justice surprised most everyone. He made a decision that was as apolitical as one could get and helped salvage the Supreme Court to be as a non-political as it can be. Of course in my opinion only.
2. The reelection of President Obama. Obamacare continues on.
3. The burgeoning national debt has burgeoned.  And the percentage of that debt that is caused by medical system costs is a major national crisis.

James de Lemos, MD

1. PCSK9 inhibitors knock the lights out of LDL-cholesterol.
2. HDL-raising therapies continue their downward spiral after AIM HIGH and DAL-Outcomes.
3. CABG wins comeback player of the year with favorable data from FREEDOM and long term Syntax data.

JoAnne M. Foody, MD

1. Emerging body of data for alternatives to warfarin: dabigatran and rivaroxaban
2. Insights into lipid lowering: PCSK9 phase II trials, Failure of Dal-OUTCOMES, strike two for CETP inhibitors
3. TAVR

Sanjay Kaul, MD

1. For the first time in 13 years, the FDA approved 2 anti-obesity drugs – Qsymia and Belviq. Despite this major development, pharmacologic approach is unlikely to make a significant impact on the obesity epidemic.
2. For the first time, the FDA, the CMS and the professional societies (ACCF, STS) collaborated in providing a roadmap for the judicious and responsible use of TAVR for patients with inoperable and high-risk aortic valve stenosis.
3. In a major setback to personalized cardiovascular medicine, several null trials made the case for tailored antiplatelet therapy using genomic or platelet function testing virtually impossible to justify.