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ATLANTA — In December when members of the American College of Cardiology (ACC, Washington) were planning for this year's healthcare reform forum, the focus was going to be geared toward implementation of a new bill that was already signed into law. Little did ACC members know that lawmakers would still not have settled on a plan.

For about an hour and thirty minutes at this year's annual ACC meeting held here in Atlanta, Congressman Paul Ryan (R-Wisconsin) hashed it out with Chris Jennings, who serves as president of Jennings Policy Strategies (JPS), a nationally-respected health policy and advocacy consulting firm in Washington, D.C.

The session turned into a full-fledged debate and for several moments during the discussion the two went back and forth sharply divided over the upcoming healthcare bill.

“[This plan] federalizes the regulation of healthcare, Ryan told the audience. “This is the creation of a new open entitlement program that will rival the cost of Medicare and Medicaid.“

Ryan, who comes from a family of cardiologists as well as his uncle serving as past ACC President, added that Medicare and Medicaid already have an under filled promise of $76 trillion.

“This is not a path to go down,“ he said. “We believe that the healthcare system should hook the patient back up with the doctor. We want to fix what's broken in healthcare and not break what's working in healthcare.“

Ryan,who is also the House Budget Committee Ranking Republican, said that the bill in its form gives the government way too much control in the healthcare market.

“What smart 22-year-old wanting to go into the field of medicine would say that they wanted to rack up $300,000 in student loans just so they could be a de facto employee of the federal government.“

Instead Ryan is proposing a plan that would:

• Provide a refundable tax credit — $2,300 for individuals and $5,700 for families — to purchase coverage in any state, and keep it with them if they move or change jobs.

• Allow Medicaid recipients to take part in the same variety of options by using the tax credit to purchase high-quality care;

• and establish and fully fund Medical Savings Accounts (MSA) for low-income beneficiaries to cover out-of-pocket costs, while continuing to allow all beneficiaries, regardless of income, to set up tax-free MSAs.

Jennings, who said that he highly disagreed with Ryan's stance and parts of his plan instead said that rhetoric and fear were the two leading causes of opposition to President Obama's healthcare plan.

“Healthcare reform is far too often fought over fear,“ he told the audience. “The language of socialism, rationing, one size fits all . . . “This is the language we hear all the time, as if our current system is nirvana. We need to step back and say we need to stop the rhetoric and role up our sleeves.“

He said that many organizations were at the table because they see the inadequacies in healthcare. Jennings then made a volley to gain support for President Obama's healthcare bill.

“They know the current trendline is unsustainable and we need a change. The mistake is not to take the opportunity to shake the system up.“

But there still remains the question if the bill under consideration – which was already passed in the House, will be signed into law. There has been some opposition from Democrats who say that parts of the bill need to be fixed and that a plan to address those sketchy parts after passage would be too difficult and complicated.

According to the Associated Press The House contains 253 Democrats, but a number of those lawmakers are certain to vote against the bill. In a recent survey 34 Democrats are judged to be a “firm no,“ “leaning no,“ or “likely no.“ An additional 73 Democrats are categorized as “undecided.“

Ryan told the group that his best guess was that Democrats were down seven to 10 votes in order for passage, but he cautioned the audience against counting out House Speaker Nancy Pelosi (D-California) and said she could easily gain those votes.

“We can't turn this safety net into a hammock,“ Ryan told the audience. “But the problem is that our safety net has gaping holes in it.“

As it stands a vote on healthcare could come late in the week. One thing that both sides agree with is that healthcare does need some type of reform measure.

“We do have problems in healthcare that need to be fixed,“ Ryan said. “Costs are going through the roof.“

Bare-Metal stents better than DES?

Drug-eluting stents have been a source of controversy for years. Many question their safety or their efficacy, while others say that these popular devices are being implanted far too often. But one of the greatest questions surrounding the device: is it safer than a bare metal stent (BMS)?

According to two research studies that were released at the ACC meeting, the answer is maybe . . . perhaps . . . but more research is needed to know for sure.

In the first study presented at the meeting Danish researchers looked at 626 patients examining the effectiveness and risks of the two types of stents implanted right after a major heart attack for a three-year-period.

The group discovered patients who received BMS systems were far more likely to have complications - such as requiring more intervention for blockages, while patients who had drug-eluting stent (DES) systems implanted were more likely to die from heart-related problems.

A little more than 6% of patients in the study who received DES treatment died, compared with the 2% who got the BMS, according to Peter Clemmensen, MD, of Copenhagen University, a lead researcher for the study.

“It could have been a play of chance, that we had sicker patients in the DES arm,“ Clemmensen said during a media press conference.“We have seen a signal here. But before doctors stop using these devices perhaps they could wait for longer term studies for a larger trial.“

During the press conference Clemmensen said that an ideal number of patients would be 18,000 for this type of trial and would be a more useful number to determine if the “deaths“ were a direct side affect of treatment with the DES.

But the chances of doing an 18,000 patient trial tracking mortality rates in DES usage would be difficult and extremely time consuming, according to David Holmes Jr. MD, a moderator for the press conference.

In the PASSION study, a separate trial, five-year findings from it suggest that safety and benefits of DES compared with BMS in acute heart attack show there is no statistically significant difference in either the safety or efficacy between the two groups.

The findings of this study contrast with researchers' belief that the paclitaxel-eluting stent would perform significantly better for cardiac death, recurrent heart attack, and target lesion revascularization. The results also failed to show a statistically significant difference between the two stent types in preventing very late stent thrombosis.

Research also pointed out a two-fold increase in the occurrence of definite stent thrombosis in the DES group compared with the BMS group – at 3.6 % and 1.7%, respectively – the occurrence of both definite and probable stent thrombosis, was comparable, at 3.9% and 3.4%,respectively.

The five-year data follow in line with both PASSION's one-year data and two-year data – which also found no statistically significant safety or benefit differences between the two stents – but the study shows that the five-year results are especially important to examine in light of data in clinical registries that associate DES use with very late stent thrombosis.

“This is a difficult choice to make,“said Maarten Vink, MD, of the Onze Lieve Vrouwe Gasthuis Hospital (Amsterdam, the Netherlands). “There is no difference between DES and BMS - but there is a chance of stent thrombosis with DES.“ He added that based on the results of the PASSION trial, “there was no reason to implant older generation DES in patients.“

PASSION was undertaken between March 2003 and December 2004 and randomized 619 patients with acute heart attack received either treatment with a BMS or DES.

But the elephant in the room for the PASSION trial is the same as for Clemmensen's study – there were just not enough patients to take part to come to a more solid conclusion.

It's a sticking point that Vink acknowledges.

“Right now, the clinical guidelines are not conclusive concerning the use of drug-eluting stents in angioplasty for acute heart attack, as the European Society of Cardiology does not define if they should be used, while the American College of Cardiology provides an indication for them,“ Vink said. “Because the guidelines are not uniform, I think their use will remain an issue—one without a definite answer— until we have data from more large, randomized, long-term studies.“

Another issue is the fact that the PASSION study tested older generation DES and does not account for the recent breakthroughs with the stents.

Vink was asked if he thought it would be feasible to have a study testing more current generation devices.

“The way technology is evolving you're always going to be a step behind,“ he told reporters during the conference.

“Already later generation devices have shown better results than the stents we've used in [PASSION].“

So what is the answer? Which is better?

At this point researchers point out that larger studies must be done.

Next generation DES safer than previous iterations

While the jury is still out on drug-eluting stents being safer and more effective than bare metal stents, there is one question about the popular devices that can be conclusively answered. That is that the latest generation of DES seem to be much safer than their predecessors, according to a panel at the 59th Annual Scientific Session of the ACC.

As many crowded their way into the early morning session, which provided an update on DES, as well as key long-term data on several clinical studies regarding the devices, it seemed as if this particular part of the device's efficacy debate was at long last put to rest.

“The benefits of drug-eluting stents significantly outweigh a possibly small increased risk for stent thrombosis,“ Debabrata Mukherjee, MD, a cardiologist with the University of Michigan Health Center (Ann Arbor). “As compared with bare metal stents, drug eluting stents are associated with a similar long-term incidence of death or myocardial infarction but provide a clinically important decrease in the rate of restenosis among high-risk patients.“

But on top of the benefits, issues still tend to remain regarding the popular treatment option.

Mukherjee specifically spoke on the mechanisms of DES failures, and with a plethora of slides and talking points, he guided the audience through some of the key reasons for potential failures in DES.

“Restenosis following a DES implantation is an infrequent phenomenon but given widespread use of DES affects a significant amount of patients, “Mukherjee said. “Stent thrombosis may be seen up to three years after implantation, a complication rarely or not seen with BMS.“

He added that as compared with BMS, DES are associated with a similar long-term incidence of death or myocardial infarction but provide a clinically important decrease in the rate of restenosis among high-risk patients.

But the failures, he said, don't outweigh the benefit of these devices and measures have been taken to help ensure that there is a safer experience for patients who undergo DES implantation.

Perhaps one of the biggest advancements comes from thinner struts that are now used in the devices.

Panelists pointed to applications such as Boston Scientific's (Natick, Massachusetts) Taxus Liberté paclitaxel-eluting coronary stent, which incorporates the thin-strut feature. The company recently took part in the DAPT Clinical Study an independently managed large scale evaluation of DES.

“Thinner cobalt strut stents allow for easier delivery and have safer outcomes,“ said panel member David Moliterno MD, University of Kentucky (Lexington) College of Medicine division of cardiology chief. “I do think the thin struts are a step forward.“

Moliterno also said that the amount of stenting procedures have increased and that the price of DES have also dropped tremendously, since inception.

“I think one of the most significant advances from the old to new generation of DES is that the devices were roughly $3,600 now they're under $2,000,“ Moliterno told the audience. “Also we're seeing a number of the [DES stenting procedures] increase.“

But perhaps the next biggest push in the world of DES is the new polymer-free DES which is being touted as being even more effective than models on the market now.

“The durablilty of antirestenoic efficacy seen with both the Endeavor and the polymer-free dual-drug-eluting stent is encouraging and lends some support to the hypothesis that modifications in second- and next-generation drug-eluting stent systems have the capacity to impact late patient outcomes,“ said Robert Byrne, of the German Heart Center (Munich).

The spread of these new stents could perhaps even further boost the DES market, which is slightly increasing since it stumbled a few years ago.

During a Tuesday afternoon meeting with reporters, David Holmes Jr., MD, a moderator for the press conference said that he only saw the market for DES on the uptake and that new and safer drugs would only continue to push the device in popularity.

“The concern with DES is stent thrombosis, but with new agents that are available that cuts the occurrence by half,“ Holmes said. “I think [the market] will only continue to increase.“

Genetic test allows for proper Warfarin dosage

Wafarin, like other blood thinners are very tricky medications. Oftentimes it takes weeks, sometimes months to get a patient on a steady dose. A great bit of it is actually due to trial and error, which can be taxing to the patient and also lead to hospitalization.

But according to results from the Medco-Mayo Wafarrin Effectiveness Study presented at the meeting, a new genetic test will alleviate the dosing issue and help to significantly reduce the number of hospitalization.

Mayo Clinic (Rochester, New York) along with Medco Health Solutions, (Franklin Lakes, New Jersey) headed up the study.

Results proved that hospital admissions were cut by one third, for either excess bleeding or unwanted bloodclotting.

The assay tests for variations in two key genes that strongly influence the patient's sensitivity to the blood thinner warfarin.

“We found that the closer to the warfarin dosage the genotyping was done, the better the outcome,“ Robert Epstein, CMO and president of the Medco Research Institute, said during a Tuesday morning press conference. “We found that there was a nearly 30% reduction in a six-month period for people using the genotype.“

For the study, researchers recruited 896 patients who were beginning warfarin therapy. All study participants were members of a prescription benefits plan managed by Medco Health Solutions. They came from 49 of 50 states and a variety of practice settings.

Shortly after starting warfarin therapy, patients gave a blood sample or a cheek swab, which was analyzed at the Mayo Clinic For each patient, the ordering physician received a report on the genetic expression of two genes, CYP2C9 and VKORC1, as well as clinical information on how to interpret the findings.

According to information presented on the study at the conference, a patient might be classified as having a high sensitivity to warfarin based on genotype. In this case, the physician would be advised to reduce the warfarin dose and monitor blood tests more frequently. If a patient were found to have a low sensitivity to warfarin, the report would recommend an increase in warfarin dose. Each physician was free to decide how to respond to the report and what action to take.

Patients in the gene-testing group were also 29% less likely to be hospitalized for bleeding or thromboembolism. The study's findings were even stronger when the analysis included only hospitalizations that occurred after genotyping. In this per-protocol analysis, patients who underwent genetic testing had a 33% lower risk of all-cause hospitalization and a 43% lower risk of hospitalization for bleeding or thromboembolism.

But in order for patients to get the maximum effect and benefit from the test it must be taken at the beginning of dosing.

Questions arose if the test, which carries a $400 price tag, was truly worth it.

“If we're able to reduce the hospitalization it would be more than $400,“ Epstein said. “Warfarin's been used for 50 years in this country but we still see a 22% hospital rate in the first six months of using.“

He added that if a patient is already stable on the medication, that the test probably isn't needed.

“If you're on a stable dose you don't need the genotyping test,“ Epstein said.

To date, there are about two million people that use warfarin therapy each year in the U.S. to prevent unwanted blood clots in certain high-risk medical conditions, such as atrial fibrillation or following surgery to replace a heart valve.

It's widely known that warfarin sensitivity varies. It can take weeks or even months of repeated blood tests and dose adjustments to determine the right dose for each patient.

Often times patients during this trial and error phase of dose adjustment patients are at an extremely high risk for either unwanted blood clotting (thromboembolism) from too little warfarin, or dangerous bleeding from too much warfarin.

Women survive heart attacks with invasive therapies

When it comes down to the rate at which men and women survive heart attacks and other cardio illnesses, there is a huge discrepancy between the two groups. A recent study shed more light on this discrepancy and revealed that women are more likely to survive a heart attack if they received the same level of therapy as males.

The multicenter study findings were presented during last week's American College of Cardiology's (ACC; Washington) 59th annual scientific session, and shows that women are far less likely to go to the cardiac catheterization laboratory for angiography or angioplasty and about twice as likely to die within a month of having the heart attack.

“This suggests that we could reduce mortality in female patients by using more invasive procedures [on women],“ said Francois Schiele, MD, professor of cardiology and cardiology chief at the University Hospital of Besancon (France). “When there are no clear contraindications, women should be treated with all recommended strategies, including invasive strategies.“

For the study, researchers analyzed data from a regional registry that included all patients treated for a heart attack between January 2006 and December 2007. Of the 3,510 patients in the study, 1 , 1 19 (32%) were women.

A comparison of raw data showed that women were, on average, nine years older than men, had more health problems, received fewer effective treatments for heart attack, and were nearly twice as likely to die, both during the initial hospital stay (9.7% vs. 5%) and throughout the following month (12.4% vs. 7%).

In previous studies the reason for a woman's higher risk of death after a heart attack has been unclear. According to Schiele, possible explanations include biological differences in the atherosclerotic process and clinical differences when the heart attack occurs – such as women tend to be older and have poorer overall health.

To obtain data, researchers used a statistical method known as propensity score matching that tries to reduce bias of treatment-effect estimates from observational studies, to create pairs of men and women closely matched according to baseline characteristics. According to study results this created a population of 1,298 patients composed of 649 pairs. A second population of matched pairs was created by taking into account not only baseline characteristics but also the treatments and strategies actually used for each patient. This population of 584 pairs represented 1, 1 68 patients.

When the researchers analyzed data from the first 649 pairs, they found that despite very similar clinical characteristics, men were 57% more likely than women to undergo coronary angiography.

Among patients who had an especially serious form of heart attack known as ST-elevation myocardial infarction, men were far more likely than women to receive therapy to reopen the blocked artery, whether by clot-busting drugs (used 72% more often in men) or by angioplasty (used 24% more often in men). The death rate during the initial hospital stay was 48% lower in men than in women, and the death rate within 30 days of the heart attack was about 30% lower in men, although this last finding was of borderline statistical significance.