Angina Blog on Angina.com

BOSTON, MA—Percutaneous coronary intervention (PCI), also known as coronary angioplasty or angioplasty, is a procedure used to treat acute coronary syndromes. PCI involves opening a blocked blood vessel by threading and inflating a balloon-tipped tube into the vessel. Sometimes a stent is also inserted to keep the blood vessel open.

While undergoing PCI treatment, doctors usually give patients medicine to prevent complications that may occur from the procedure.

In a new study by researchers at Brigham and Women’s Hospital (BWH), types and timing of cardiovascular disease and heart attack (CVD/MI) complications were tracked in patients undergoing PCI after an acute coronary syndrome and taking medications to prevent these complications.

The study is being presented at the American College of Cardiology 2012 Annual Scientific Session, March 24 to 26 in Chicago.

Utilizing patients from the TRITON-TIMI 38 study, researchers examined 12,844 patients who had at least one stent and were randomized to receive either the anti-blood clotting drugs prasugrel (Effient) or clopidogrel (Plavix). These drugs work by blocking activation of platelets (a component in blood involved in clotting).

The researchers observed the patients over a median follow-up of 14.5 months.

Researchers classified CVD/MI events under three categories: stent thrombosis (when a blood clot forms in the stent), procedural-related (in the setting of PCI or bypass surgery), or spontaneous (not related to stents nor procedures, but indicating a thrombosis in a different artery than the one that caused the first acute coronary syndrome event).

There were 1,306 CVD/MI events. 186 (14 percent) were stent thrombosis-related, 606 (46 percent) were procedural-related, and 514 (40 percent) were spontaneous.

For events occurring after 30 days, the majority were spontaneous (383, 81.2 percent), followed by stent thrombosis-related (63, 13.5 percent), and procedural-related (22, 4.7 percent).

CVD/MI events that occurred within the first 30 days tended to be stent thrombosis-related and procedural-related. Spontaneous CVD/MI events occurred more often in the later phase (more than 30 days after PCI).

When comparing the two drugs in the study, prasugrel reduced the incidence of CVD/MI in each event category, both early and late, with the benefit most marked among stent thrombosis-related events.

The researchers concluded that more potent anti-blood clotting drugs directly reduces complications from PCI, as well as preventing the formation of new, symptomatic thrombotic lesions in other arteries.

“These data from TRITON-TIMI 38 provide clinicians with new information regarding the timing and benefit of more potent anti-platelet agents following PCI for an acute coronary syndrome,” said Benjamin Scirica, MD, MPH, BWH Cardiovascular Division, Department of Medicine, and lead study author. “It reminds us that these agents are not only preventing stent-related complications, which tend to occur early after PCI, but are also preventing the formation of new, spontaneous, thrombotic lesions throughout the coronary artery tree.”

from Eurekalert January 9 2012

A registry -which includes every patient in Sweden having percutaneous coronary intervention (PCI) for the treatment of acute and stable coronary artery disease- has found that PCI implantations using a new generation of drug-eluting stents is associated with lower rates of relapse (restenosis), stent thrombosis and subsequent mortality than older generation drug-eluting stents and bare-metal stents.(1)

The findings, from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), reported in the European Heart Journal, represent the outcome of treatment in a large “real-world population”, and were derived from an analysis of 94,384 consecutive stent implantations performed in Sweden between November 2006 and October 2010.

An earlier study from the SCAAR registry, evaluating stent implantations between 2003 and 2004, had dramatically shown that those treated with drug-eluting stents (DES) had a higher rate of later mortality than those receiving bare-metal stents (BMS).(2) The results caused uproar, and prompted an immediate decline in the use of DES and an urgent review of their safety. However, follow-up of the same patient cohort two years later (with data extended to 2006) found no increased risk of death between the two groups.(3) The difference in outcome was largely explained by improvements in cardiology practice (including the application of dual antiplatelet therapy after PCI) and the introduction of improved devices.

Conclusions in this latest report, from what is the world’s largest PCI registry with the longest follow-up of data, now confirm that mortality rates associated with both the new and old generations of DES were significantly lower than found with BMS. The risk of death was 28% lower with the old generation DES and 45% lower with the new generation; moreover, the new generation DES were associated with a 23% lower mortality rate at two years than the old generation DES.

The authors note that this is the first time any mortality reduction has been shown between DES and BMS, either in randomised trials or in reports from the SCAAR registry itself.

The study also found that the new generation of DES was associated with a 38% lower risk of restenosis and a 43% lower risk of stent thrombosis within two years of implantation than BMS. Late stent thrombosis has been a recurring safety concern with the original DES; the authors suggest that the new generation DES, with “thin, more biocompatible polymers” and greater flexibility, may have contributed to lowering this thrombotic risk.

Speaking on behalf of the SCAAR investigators, cardiologist Dr Stefan James from Uppsala University Hospital in Sweden described the latest findings as “intriguing” – not just because of the lower rates of restenosis with the latest generation of DES, which were expected, but also of stent thrombosis and mortality. “The low rates of restenosis and stent thrombosis correspond with the results of several recent randomised trials,” said Dr James, “and this may well translate into mortality reduction in a sufficiently large study population.”

However, he warned that all observational data should be interpreted with caution. “Despite the use of appropriate statistical methods,” he said, “there may be residual confounding because of differences in concealed baseline variables.” Nevertheless, this SCAAR analysis included only patients who where treated after 2006, to ensure that both the older and newer generation DES were used. “Since 2006 no major changes in recommendations for antithrombotic strategies or duration of dual antiplatelet therapy have occurred in Sweden,” said Dr James, “so it seems likely that our more favourable outcomes are true findings.”

The investigators say their results now add further weight to the strong recommendation for the use of DES as a default strategy in patients expected to tolerate extended dual antiplatelet therapy, in the treatment of coronary artery disease. “But our results also reinforce the need for randomised trials to evaluate the optimal strategy and duration of antithrombotic therapy following PCI in various indications,” said Dr James.

Reference:

1. Sarno G, Lagerqvist B, Frober O, et al. Lower risk of stent thrombosis and restenosis with unrestricted use of ‘new-generation’ drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J 2012; doi:10.1093/eurheartj/ehr479

CHICAGO – Among selected low-risk Medicare patients who underwent an elective percutaneous coronary intervention (PCI; procedures such as balloon angioplasty or stent placement used to open narrowed coronary arteries), same-day discharge was rarely implemented, but was not associated with an increased risk of being rehospitalized or having a higher risk of death at 2 days or at 30 days, than patients who remained in the hospital overnight, according to a study in the October 5 issue of JAMA.

“Percutaneous coronary intervention is one of the most commonly performed cardiac procedures with more than 1 million episodes of care annually among Medicare recipients. Risks associated with PCI are highest within the first 24 to 48 hours after the procedure and include periprocedural myocardial infarction [MI; heart attack], acute stent thrombosis [blood clot formation within the stent], bleeding, or renal failure,” according to background information in the article. “However, short- and long-term outcomes after PCI have improved because of the evolution in device technology and pharmacotherapy. Despite this improvement, patients are usually observed overnight in the hospital after elective PCI to monitor for PCI-related complications.” The safety of same-day discharge among older individuals undergoing this procedure is not known. Same-day discharge would increase bed availability for the hospital and reduce medical expenses.

Sunil V. Rao, M.D., of the Duke Clinical Research Institute, Durham, N.C., and colleagues conducted a study to examine the prevalence of same-day discharge among older individuals following PCI and the rates of death or rehospitalization. The study included data from 107,018 patients 65 years or older undergoing elective PCI procedures at 903 sites participating in the CathPCI Registry between November 2004 and December 2008 and were linked with Medicare Part A claims. Patients were divided into 2 groups based on their length of stay after PCI: same-day discharge or overnight stay. The primary outcomes measured were rehospitalization or death occurring within 2 days and by 30 days after PCI.

The researchers found that prevalence of same-day discharge was 1.25 percent (n = 1,339 patients), with significant variation across facilities. There was no significant difference in the rates of procedural success between the 2 groups. Patient characteristics were similar between the 2 groups, although same-day discharge patients underwent shorter procedures with less multivessel intervention. Patients who were discharged home the same day were more often categorized in the lowest quintile of predicted risk for death or rehospitalization, while there were approximately equal proportions of lower- and higher-risk patients observed overnight.

“There were no significant differences in the rates of death or rehospitalization at 2 days (same-day discharge, 0.37 percent vs. overnight stay, 0.50 percent or at 30 days (same-day discharge, 9.63 percent vs. overnight stay, 9.70 percent). Among patients with adverse outcomes, the median [midpoint] time to death or rehospitalization did not differ significantly between the groups (same-day discharge, 13 days vs. overnight stay, 14 days). After adjustment for patient and procedure characteristics, same-day discharge was not significantly associated with 30-day death or rehospitalization,” the authors write.

The researchers note that despite the apparent safety of same-day discharge for selected patients, the present analysis demonstrates that this approach is rarely practiced among sites represented in the National Cardiovascular Data Registry. “This may reflect reluctance on the part of clinicians to discharge patients the same day as the PCI procedure because of concerns over early post-PCI complications. Although these concerns are well founded, the rates of vascular or bleeding complications were extremely low (less than 1 percent) among the patients in our analysis, with no clinically significant differences between groups.”

“These data suggest that a proportion of low-risk patients currently observed overnight may be eligible for same-day discharge without an increase in early or intermediate-term adverse events.”

The authors add that according to published guidelines, same-day discharge can be considered for patients undergoing PCI who have low-risk clinical features, successful procedures without prolonged post-procedure use of parenteral (by injection) antithrombotic agents, and adequate social support.

MAYWOOD, Ill. — Research at Loyola University Chicago Stritch School of Medicine could help lead to new ways to prevent coronary arteries from reclogging after balloon angioplasties.

The latest in a series of studies in this effort is published online ahead of print in Arteriosclerosis, Thrombosis and Vascular Biology, a journal of the American Heart Association. Senior author is Allen M. Samarel, MD, and first author is Yevgeniya E. Koshman, PhD.

In an angioplasty, a tiny balloon is inflated to open a clogged coronary artery. Typically, a stent is deployed to prevent the artery from collapsing after the balloon is deflated.

The procedure itself irritates the interior walls of the artery. In response, smooth muscle cells migrate to the site and form scar tissue. In roughly one-third of cases, the artery reclogs and another angioplasty is needed.

Newer stents release drugs that prevent migration of muscle cells to the site. But these drugs have the unwanted effect of also stopping endothelial cells from moving to the site. Endothelial cells are needed to repair the irritation to the walls of the artery. (The angioplasty removes endothelial cells that line the inside walls of the artery. This increases the risk that clots will form, break loose and cause heart attacks and strokes. Consequently, patients must take anti-clotting medications for months after their angioplasties.)

The Loyola study points to a new strategy for preventing the unwanted migration of muscle cells while allowing the beneficial movement of endothelial cells. The study involved cell cultures as well as rats that had received balloon angioplasties in their carotid arteries.

Researchers focused on two proteins, known as FAK and FRNK. Both proteins are products of the same gene, but have opposite effects: FAK jump-starts the migration of muscle cells to the angioplasty site, while FRNK inhibits such migration. (FAK stands for focal adhesion kinase; FRNK stands for FAK-related nonkinase.)

Introducing FRNK early on in the course of an angioplasty could prevent the migration of artery-clogging muscle cells while allowing the movement of artery-repairing endothelial cells, Samarel said.

Earlier this year, Koshman presented an abstract of the study to the American Heart Association Arteriosclerosis, Thrombosis and Vascular Biology 2011 Scientific Sessions, where it was judged among the top 10 percent of accepted abstracts.

Samarel is the William B. Knapp Professor of Medicine and Physiology and Koshman is a research associate at Loyola University Chicago Stritch School of Medicine. Other co-authors are Miensheng Chu, PhD.; Steven J. Engman, MD, PhD.; Taehoon Kim, MS; Rekha Iyengar, MBA; and Seth Robia, PhD.

The study was supported by the National Institutes of Health and the Dr. Ralph and Marian Falk Medical Research Trust. During the course of the study, Koshman was an American Heart Association postdoctoral fellow and Engman was a heart association predoctoral fellow.

Despite changes in standard treatment practice guidelines issued by the American College of Cardiology, American Heart Association and the European Society of Cardiology several years ago, there has been no meaningful change in the nation’s practice of opening completely blocked coronary arteries with balloons and stents in the days after a heart attack, according to a new study published in the July 11, 2011, issue of Archives of Internal Medicine. The new study concludes that cardiologists in the United States are still performing this procedure late after a heart attack.

“Our new finding is disappointing; a lot of painstakingly gathered clinical trial evidence is being disregarded a few years after its publication and guideline changes,” says Judith S. Hochman, MD, the Harold Snyder Family Professor of Cardiology at NYU Langone Medical Center and senior author of the study.

In the new study, Dr. Hochman and her colleagues examined a registry of angioplasty and stent procedures performed in nearly 29,000 patients at nearly 900 hospitals in the United States. The monthly rate of late procedures showed no sign of declining during the period from 2005 to 2008.

“There continues to be reimbursement for the late procedure, and many patients expect their physicians to open their arteries, regardless of the delay, so these physicians may be concerned about malpractice suits if they don’t comply,” says Dr. Hochman. “However, the existence of national clinical guidelines should protect physicians from that liability.”

Dr. Hochman was the lead author of the landmark Occluded Artery Trial (OAT), published in 2006 in the New England Journal of Medicine. It concluded that opening a totally blocked heart attack-related coronary artery more than 24 hours after a heart attack does not reduce patients’ chances of death, a second heart attack, or heart failure, compared to more conservative treatment with medication alone and selective use of the opening procedure in a small subset of these patients. “We found evidence in substudies that both groups improved their heart function (ejection fraction) substantially and to the same degree,” says Dr. Hochman.

The OAT study finding led to new treatment guidelines in 2007. Dr. Hochman and her colleagues, however, have learned that cardiologists are still doing the procedure in patients 24 hours or more after a heart attack. “It’s intuitive that having an open artery is better than having a closed artery, and many people don’t want to let go of that belief,” she says.

Heart bypass surgery is considered the gold standard for most patients with left main coronary artery disease, one of the most serious types of heart disease and one that affects thousands.

But a new UCLA study reports favorable long-term outcomes for lower-risk patients with this condition who underwent angioplasty with medication-coated stents, rather than bypass surgery.

A more minimally invasive procedure than surgery, angioplasty is performed by snaking a tiny wire up through an artery in the groin to the blocked area of the heart. The clogged artery is cleaned out, and a stent — a tiny wire-mesh tube — is placed in the artery to help keep it open, allowing blood to flow freely through the heart again.

Published in the June issue of the journal Catheterization and Cardiovascular Interventions, the study found that for patients with left main coronary artery disease who had normal artery function, the more minimally invasive procedure may be a safe and effective option.

“This is one of the first studies assessing the long-term outcomes of this procedure in lower-risk patients,” said Dr. Michael Lee, an assistant professor of cardiology at the David Geffen School of Medicine at UCLA.

According to Lee, current national guidelines recommend angioplasty with stenting only for patients who are poor candidates for surgery. He said that this may change in the future, if more studies like this one demonstrate the procedure’s effectiveness in a wider range of patients.

Researchers reviewed data, taken from an international registry, on 221 patients who had left main coronary artery disease with normal artery function. All patients had undergone

angioplasty with drug-eluted stents between 2002 and 2009 at one of four institutions. The average patient age was 68, and the majority were male.

Patients sought angioplasty with stenting instead of surgery for a number of reasons, including high surgical risk due to health issues like chronic obstructive pulmonary disease or a severely calcified artery, older age, or a preference for the more minimally invasive procedure.

“The study provided a window into “real-world” experience and is reflective of what is seen in everyday clinical practice,” Lee said.

In examining 30-day outcomes for patients in the study group, the team found no reports of cardiac death, stroke, re-clogging of the artery or blood clots forming related to the stent. Seven patients (3 percent) experienced a mild heart attack that can occur during the procedure. According to Lee, these are mild events with little long-term clinical impact.

Follow-up angiographs or heart images were available for 136 (62 percent) of the patients, which helped further track their heart health status.

At one year, the cumulative event-free survival rate for cardiac death was 97.7 percent, and the event-free rate for artery re-clogging was 92.9 percent.

Over the course of the study, 22 patients needed to be retreated due to the artery re-clogging, and this occurred mostly in the first year. Of those patients, 14 underwent a repeat angioplasty and eight had bypass surgery.

One of the most common side effects of angioplasty with stenting in the past has been the re-closing of the artery after treatment. Lee says that with drug-eluting stents, this is occurring less frequently.

“Our analysis found that the short-term outcomes were excellent,” he said. “Patients who survived after the first year had very good long-term survival and a low incidence of retreatment.”

At nearly four years, the event-free survival rate for cardiac death was 95.5 percent, and the event-free rate for re-clogging of the artery was 88.9 percent. Twenty of the 221 patients had died and nine deaths were cardiac-related.

“We found that this procedure had a low overall risk profile and may prove to be a viable alternative for this patient group,” Lee said.

Lee added that the next step would be a clinical trial comparing angioplasty with drug-eluting stents to coronary bypass surgery in this lower-risk patient population.

The study took place at four hospitals; they were located in Los Angeles and Santa Barbara in the U.S., and in Turin and Padua in Italy. The type of drug-eluting stents used in the study was at the discretion of the interventional cardiologist.

No outside funding was used in the study.

(Reuters) – Johnson & Johnson will stop selling drug-coated heart stents, a former profit driver for the diversified healthcare company that has stumbled due to safety concerns and fierce competition from rival products.

J&J said on Wednesday that it would end development of its Nevo heart stent and cease manufacturing its Cypher stent, widening the field for rivals like Abbott Laboratories Inc and Boston Scientific Corp.

The company’s Cordis unit will stop selling the drug-coated stents — tiny mesh tubes that prop open heart arteries — by year’s end. It will continue to sell its far less lucrative bare metal stents.

“The stents were kind of an albatross,” said Gabelli & Co analyst Jeff Jonas, adding that “the remaining cardiovascular business is attractive.”

J&J expects to take a second-quarter charge of $500 million to $600 million related to restructuring plans for Cordis. It will close manufacturing facilities in San German, Puerto Rico, and Cashel, Ireland, and expects to cut up to 1,000 jobs.

Cypher, which was introduced with great fanfare in 2003, once had annual sales of $2.6 billion, but the stent was on track for only about $400 million this year, according to Jonas. Its sales generate about 1 percent of company profit, he said. J&J has also had trouble developing new stents, including Nevo.

Jonas said Cordis now has potential for double-digit annual sales growth, based on devices to treat atrial fibrillation and stents placed in the neck, the legs and other parts of the body to prevent conditions such as stroke.

He estimates that Boston Scientific, which has about $1.5 billion in annual stent sales, stands to gain about half of J&J’s stent business, representing an extra $200 million in annual sales. Abbott’s Xience will likely attract the rest of J&J’s lost sales.

J&J shares fell 1.4 percent to $66.14 in afternoon trading. Abbott shares were little changed, while Boston Scientific gained 3.9 percent.

SAFETY QUESTIONS

Johnson & Johnson has been beset with quality-control lapses at its factories in the past two years, forcing repeated recalls of Tylenol and other consumer products, artificial hips, insulin cartridges and contact lenses.

Cypher was the first stent that released a drug designed to prevent re-clogging of arteries after being implanted in patients — a common issue with earlier bare-metal stents. But there is controversy over whether Cypher and other drug-coated stents cause dangerous blood clots months or years after being implanted in heart arteries.

Shares of SurModics Inc, which makes the drug-delivering polymer used in Cypher, were down 15 percent. The company receives royalties from sales of the stent.

J&J acquired Nevo through its $1.4 billion purchase of cardiac stent maker Conor Medsystems in 2007. The stent was designed to minimize the risk of clots, by releasing its drug directly into heart arteries rather than into the bloodstream. But it has been plagued by development delays and redesigns of its delivery system.

In addition, U.S. regulators in February warned J&J that it had failed to ensure that Cypher and other heart devices made at the San German plant met specifications and were otherwise manufactured with consistency.

“The warning letter had no impact on our decision” to stop selling Cypher, said Sandra Pound, a spokeswoman for the New Brunswick, New Jersey-based company.

Global Cypher sales plunged 41 percent in the first quarter, excluding the impact of foreign exchange. Market share for the product, which was once the top global brand, slipped to 12 percent, down 6 percentage points from the year-earlier period. The company’s total medical device and diagnostics sales rose slightly, mainly because of the weaker dollar.

J&J’s consumer product sales have suffered due to the Tylenol recall and others, falling 2.2 percent to $3.68 billion in the first quarter. At the same time, its prescription drugs business has enjoyed a revival, with sales rising 7.5 percent to $6.1 billion in the first quarter.

Wall Street is counting on recently approved J&J drugs and promising ones in development to bolster its results, after two successive years of declining global company sales.

(Editing by Michele Gershberg and Gerald E. McCormick)

NEW YORK, NY – June 13, 2011 – Data from the landmark HORIZONS-AMI clinical trial demonstrated that the administration of the anticoagulant medication bivalirudin enhanced survival compared to the use of heparin plus a glycoprotein (GP) IIb/IIIa inhibitor in heart attack patients undergoing angioplasty after 3 years. Use of a drug-eluting stent (paclitaxel) was also shown to be more effective than a bare-metal stent, with equivalent safety. Final 3-year results of the trial were published in the June 13, 2011, issue of The Lancet.

After 3 years, treatment with bivalirudin alone compared to heparin plus a GP IIb/IIIa inhibitor resulted in significantly reduced rates of all-cause mortality (5.9% vs. 7.7%), cardiac mortality (2.9% vs. 5.1%), reinfarction (6.2% vs. 8.2%) and major bleeding not related to bypass graft surgery (6.9% vs. 10.5%). There were no significant differences in the incidence of ischemia-driven target vessel revascularization, stent thrombosis, stroke, or composite adverse events.

In addition, at 3 years, the implantation of a paclitaxel-eluting stent compared to a bare-metal stent resulted in significantly lower rates of ischemia-driven target lesion revascularization (9.4% vs. 15.1%) with no significant differences in the rates of death, reinfarction, stroke, or stent thrombosis.

“The results at 3 years demonstrate that use of bivalirudin alone, as opposed to a combination of heparin and a GP IIb/IIIa inhibitor, can save lives. The reported reduction in all-cause mortality seen in the trial equates to 18 lives saved per 1,000 patients treated with bivalirudin,” said Gregg W. Stone, MD, Professor of Medicine at Columbia University College of Physicians and Surgeons, Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center and Co-Director of the Medical Research and Education Division at the Cardiovascular Research Foundation (CRF). Dr. Stone is the principal investigator of the HORIZONS-AMI trial.

“Additionally, results of the trial showed that patients who received a paclitaxel-eluting stent had a 40% reduction in risk of ischemia-driven target lesion revascularization after 3 years compared with those patients given a bare-metal stent,” Dr. Stone said.

While previous studies of drug-eluting stents have often focused on their use in patients with stable or unstable chest pain, this is the largest study to focus on the appropriate use of anticoagulation medications and drug-eluting stents in patients experiencing the most dangerous form of heart attack (ST-elevation myocardial infarction).

Sponsored by the Cardiovascular Research Foundation, with research grant support from Boston Scientific Corporation and The Medicines Company, the HORIZONS AMI (Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction) trial enrolled 3,602 patients presenting with a heart attack to hospitals in 11 countries. More than 120 national and international interventional cardiology centers participated in the trial.

Three-year results of the trial were first reported at the 2010 Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium, sponsored by CRF.

MAYWOOD, Ill. — The availability of an in-house, around-the-clock interventional cardiology team dramatically decreases the time it takes to restore blood flow to heart attack patients, according to data presented this week. These findings were reported by researchers from Loyola University Health System (LUHS) at the American College of Cardiology annual meeting in New Orleans.

In April 2009, Loyola became the first hospital in Illinois to launch a Heart Attack Rapid Response Team (HARRT). This group includes an interventional cardiologist, a nurse and other members of the cardiac catheterization team who are available at the hospital 24 hours a day, seven days a week. Most hospitals do not have such teams on site during nights and weekends.

“Valuable time is lost when nurses, doctors and technicians have to be called in from home,” said interventional cardiologist John Lopez, MD, study investigator and HARRT co-director, LUHS. “Our staff is on hand and prepared all of the time to meet patients when they arrive and require immediate care.”

A task force of the American College of Cardiology and American Heart Association recommends that patients undergoing heart attacks receive balloon angioplasties as soon as possible or within 90 minutes of arriving at the hospital — known as the “door-to-balloon” time.

These data revealed Loyola has far exceeded this standard since the HARRT program launched, with a median door-to-balloon time of just 47 minutes. All patients received angioplasties within 90 minutes and 82 percent received them within 60 minutes. These results greatly exceed the national standards and results from the best hospitals in the country.

During a heart attack, a blockage in an artery stops blood flow. Heart muscle begins to die due to lack of blood and oxygen. But a balloon angioplasty, if done in time, can stop a heart attack by restoring blood flow.

“Having a team on site 24/7 is the best way to enhance emergency angioplasty times,” said Michelle Fennessy, APN, study investigator, LUHS. “By treating patients quickly, you save more lives and improve their prognosis.”

Other study investigators from Loyola included Wojciech Nowak DO, PhD, Fred Leya, MD, Robert S. Dieter, MD, Bruce Lewis, MD, Lowell Steen, MD, Mark E. Cichon, DO, Beatrice Probst, MD, Michael Ryan, MD, Jayson Liu, MD, Catherine Smith, RN, MBA, Michael Jarotkiewicz, MBA, David Wilber, MD, and Brian Nguyen, MD.

Hamilton, ON (April 4, 2011) -

A landmark international study coordinated by the Population Health Research Institute of McMaster University and Hamilton Health Sciences has found accessing blocked arteries through the forearm compared to groin led to fewer vascular complications and similar success rates for angioplasty.

The large, multi-centre randomized trial – the first of its kind to compare radial access and femoral access – found that both entry points for angioplasty resulted in similar outcomes, including rates of death, heart attack, stroke or non-bypass-related major bleeding. As well, radial access – or entry through the forearm – led to better outcomes in hospitals that conducted a large number of these procedures and in patients suffering heart attacks in which a coronary artery was completely blocked by a blood clot (a condition known as STEMI, or ST-segment elevation myocardial infarction).

Results of the RIVAL (RadIal Vs. femorAL access for coronary angiography or intervention) trial are being presented by Dr. Sanjit Jolly, an interventional cardiologist and assistant professor of medicine in the Michael G. DeGroote School of Medicine, at the annual American College of Cardiology meeting.

The study is also being published simultaneously in The Lancet.

Estimates suggest that more than 10 million coronary angiograms are performed each year worldwide, three million of them in the United States. Entry through the groin, or femoral arterial access, has been the dominant route for coronary angiography and intervention for more than 20 years. It still accounts for approximately 95 per cent of procedures in the United States and 80 per cent of procedures worldwide.

The radial artery, accessed through the wrist, is a superficial and easily compressible site for arterial puncture, and used to avoid femoral bleeding complications. However, there have been concerns that radial access could be associated with reduced angioplasty success rates.

The RIVAL trial, conducted by researchers from 36 countries, was designed to help determine the optimal access site for invasive coronary procedures, such as angioplasty. The study involved 7,021 patients undergoing coronary angiography, with possible angioplasty, who had unstable angina or a heart attack. Patients were randomized to either radial or femoral access for their coronary angiography/intervention.

“Our data suggest that radial compared to femoral access reduces local vascular access site complications with similar angioplasty success rates,” said Dr. Jolly, the principal investigator of the RIVAL Trial Group. “However, greater expertise and procedural volume with radial access may improve the results of the radial approach.”

The researchers concluded both access sites are safe and effective for conducting invasive coronary procedures in patients with acute coronary syndrome, a spectrum of cardiac conditions ranging from unstable angina to heart attack.

“This is the first multi-centre international trial to address this important question,” said Dr. Shamir Mehta, a RIVAL co-investigator, interventional cardiologist, and associate professor of medicine in the Michael G. DeGroote School of Medicine.

“Given the results of previous small trials, we were surprised to not find a difference between the two strategies for the primary outcome. This means either a radial or femoral approach can be used safely and effectively.”

The RIVAL study was supported by Sanofi-Aventis, Canadian Network and Centre for Trials Internationally (CANNeCTIN)/Canadian Institutes of Health Research (CIHR) and the Population Health Research Institute but was independently conducted by the Population Health Research Institute along with an international steering committee.

Dr. Salim Yusuf, the RIVAL study chair, is supported by the Heart and Stroke Foundation of Ontario as the Marion W. Burke Chair in Cardiovascular Disease.