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Heart attack patients in North Carolina who were rushed directly to hospitals equipped to do percutaneous coronary intervention (PCI) received treatment significantly faster than patients first taken to hospitals unequipped to perform PCI and then later transferred for treatment, according to research reported at the American Heart Association’s Quality of Care and Outcomes Research 2012 Scientific Sessions.

The study focused on the most serious form of heart attack, ST-elevation myocardial infarction (STEMI). A STEMI typically involves complete blockage of the blood flow to the heart. Opening the blocked artery as quickly as possible is crucial to improving survival.

Physicians often use PCI, also known as angioplasty, to open blocked coronary arteries. A tiny balloon is inserted through a catheter, or tube, into the affected area. The balloon is inflated to widen the blocked areas. Physicians often combine the procedure with the insertion of a stent to help prop the artery open and decrease the chance of another blockage.

Opening the blockage with clot-busting drugs is used when timely access to PCI is not an option.

Many emergency medical services (EMS) guidelines for transporting STEMI patients recommend bypassing hospitals that can’t provide PCI and going to one that can.

“Until now, no well designed study had examined this recommendation,” said Emil L. Fosbol, M.D., Ph.D., the study’s first author and a research fellow at Duke University in Durham, N.C. “The only rationale we had was the sooner you get there, the better.”

The researchers reviewed North Carolina’s EMS records from June 2008 to September 2010 and linked these to a clinical registry of patients with STEMI. Of the 1,224 STEMI patients who met the study’s specifications, 765 (63 percent) went directly to a PCI-capable hospital (bypass group), and 479 (37 percent) stopped first at a non-PCI hospital (non-bypass group) before being transferred for a PCI procedure.

Researchers found:

• The time from first medical contact (FMC) to artery-opening treatment — PCI or clot-busting drug — averaged 93 minutes for the bypass group and 124 minutes for the non-bypass group, a substantial time difference that could improve a STEMI patient’s chances of surviving.
• For patients who received only PCI, the time from FMC to PCI averaged 93 minutes for the bypass group and 161 minutes for the non-bypass arm.
• Patients in the bypass group were almost three times as likely to get treatment within guideline recommendations compared to the non-bypass group.

“PCI is contingent on getting the patient very quickly to a hospital with a catheter lab,” Fosbol said. “Our results suggest that when logistically feasible, EMS should transfer STEMI patients directly to the nearest PCI-capable hospital.”

Co-authors are Christopher Granger, M.D.; James Jollis, M.D.; Lisa Monk, M.D.; Li Lin, M.D.; Barbara Lytle, M.D.; Ying Xian, M.D.; Lee Garvey, M.D.; Greg Mears, M.D.; Claire M Corbett, M.D.; Eric D Peterson, M.D.; and Seth Glickman, M.D.

The American Heart Association-Pharmaceutical Roundtable and David and Stevie Spina funded the study. Additional disclosures are on the abstract.

The American Heart Association’s Mission: Lifeline®-STEMI program supports systems of care to improve emergency response and treatment by quickly getting patients to the facilities with the most appropriate care. Additionally, the American Heart Association’s Mission: Lifeline® Heart Attack Referring/Receiving Center Accreditation program recognizes hospitals for their ability to quickly and appropriately treat heart attack patients. Learn more at www.heart.org/myhospital.

Statements and conclusions of study authors presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect the association’s policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies)

MINNEAPOLIS –– February 20, 2012 –– Advancing the clinical practice of interventional cardiovascular medicine, Medtronic Inc. (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Resolute Integrity™ Drug-Eluting Stent (DES) for the treatment of coronary artery disease (CAD).

The new heart device’s FDA approval stems from the results of a global series of studies involving the Resolute DES, which showed consistently powerful clinical performance across a broad spectrum of patients –– including those with diabetes, a common contributor to coronary artery disease that complicates treatment. The Resolute DES uses the same drug-and-polymer combination as the Resolute Integrity DES.

The Resolute Integrity DES builds on the success of the market-leading Integrity bare metal stent. The Integrity platform’s rapid adoption in the United States is the result of a proprietary engineering advance called continuous sinusoid technology (CST).

CST encompasses one continuous, single strand of wire that is molded into a sinusoidal wave and then wrapped in a helical pattern and laser-fused at certain points, making each stent comparable to a flexible spring.

“The Resolute Integrity DES offers several notable benefits, starting with outstanding deliverability, which means it’s exceptionally easy to navigate the stent on the delivery system through the coronary vasculature to the narrowed arterial segment that requires treatment,” explained Martin B. Leon, M.D., director of the center for interventional vascular therapy at New York-Presbyterian/Columbia University Medical Center, founder and chairman emeritus of the Cardiovascular Research Foundation, and a principal investigator (PI) of the RESOLUTE US clinical study. “Its approval by the FDA is based on the impressive performance of the Resolute DES in a wide variety of patients. With the device’s compelling combination of deliverability, efficacy and safety, not to mention that it is the first DES approved for patients with diabetes, the Resolute Integrity DES promises to gain rapid acceptance in cath labs nationwide.”

Clinical Performance

The global RESOLUTE clinical program consisted of a large randomized controlled trial and a series of confirmatory single-arm studies involving nearly 250 sites in 32 countries. In total, the program enrolled more than 5,100 patients who received a Resolute DES; about a third (1,535) of these patients had diabetes, a proportion that mirrors the U.S. patient mix.

RESOLUTE US enrolled 1,402 patients across 128 U.S.-based clinical trial sites. It was led by Dr. Leon and his co-PIs: Laura Mauri, M.D., chief scientific officer of the Harvard Clinical Research Institute and an interventional cardiologist at Brigham and Women’s Hospital in Boston; andAlan Yeung, M.D., director of interventional cardiology at Stanford University School of Medicine in Palo Alto, Calif.
At one year of follow-up in RESOLUTE US, the results included low rates of target lesion failure (TLF, 4.7%), clinically-driven target lesion revascularization (TLR, 2.8%) and definite/probable stent thrombosis (def/prob ST, 0.1%). These results were achieved despite 34 percent of the patients in the study having diabetes, which typically drives higher event rates.

One year of follow-up in a pre-specified analysis of patients with diabetes who received a Resolute DES as participants in the Resolute clinical program also demonstrated low rates of TLF (6.6%), TLR (3.4%) and def/prob ST (0.3%).

In two separate large randomized controlled trials, the Resolute DES matched the safety and effectiveness of Abbott Laboratories’ Xience V® DES, which represents the market-leading DES platform in the United States.

The Resolute All-Comers study, sponsored by Medtronic, enrolled nearly 2,300 patients at 17 centers and was led by Prof. Patrick Serruys, M.D., Ph.D., director of the Thoraxcenter at Erasmus University in Rotterdam, the Netherlands; Prof. Stephan Windecker, M.D., with University Hospital in Bern, Switzerland; and Prof. Sigmund Silber, M.D., of the Heart Catheterization Centre in Munich, Germany. The one- and two-year results of RESOLUTE All Comers were published in The New England Journal of Medicine and The Lancet, respectively.

While not part of the FDA dataset, the TWENTE study, supported jointly by Medtronic and Abbott Laboratories, enrolled nearly 1,400 patients at a single center and was led by Prof. Clemens von Birgelen, M.D., Ph.D., co-director of the Department of Cardiology at Thoraxcentrum Twente and professor of cardiology at the University of Twente in the Netherlands. Prof. von Birgelen presented the one-year results of TWENTE at the 2011 Transcatheter Cardiovascular Therapeutics (TCT) meeting. The results are also reported in a recent issue of the Journal of the American College of Cardiology.
“The new Resolute Integrity DES comes to U.S. cath labs with compelling clinical evidence and a highly differentiated stent platform,” said Sean Salmon, president of Medtronic’s coronary and renal denervation business. “Our next-generation zotarolimus-eluting coronary stent has gained wide global acceptance for its remarkable ability to successfully meet clinical and anatomic challenges that interventional cardiologists confront in their everyday practice. We are excited to provide this important advanced technology to U.S. patients and practitioners.”

With the approval of the Resolute Integrity DES, U.S. patients with both CAD and diabetes now have access for the first time to a medical device that has been approved by the FDA as a treatment option specifically studied and clinically validated for their particularly complex and potentially life-threatening health conditions. Historically patients with diabetes who undergo PCI have been a difficult-to-treat patient population. They tend to have smaller and often tortuous arteries, longer lesions, diffuse disease and a higher rate of treatment failures including relatively high rates of repeat procedures and stent thrombosis.

U.S. Launch

The U.S. release of the Resolute Integrity DES also marks the first major product launch to leverage Medtronic’s entire U.S. Cardiac and Vascular Group (CVG) sales force, which includes nearly 3,000 field representatives whose collective objective is to serve the needs of hospital systems, integrated delivery networks and individual hospital administrators.

“No other medical device company has a U.S. field footprint as robust as Medtronic,” said Mike Coyle, president of Medtronic’s CVG. “We intend to use the launch of the Resolute Integrity DES to demonstrate the impact that our unrivaled scale can deliver for physicians, hospitals and patients looking for safe, effective and cost-effective solutions for cardiac and vascular diseases.”

In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.

ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology –– alleviating pain, restoring health and extending life for millions of people around the world.

source: Medtronic

SAN FRANCISCO, CA – NOVEMBER 9, 2011 – A clinical trial of patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) and stable angina showed that a strategy of rapid genotyping followed by selective administration of prasugrel to carriers of a common genetic variant (CYP2C19*2) resulted in a decreased rate of high on-treatment platelet reactivity (platelet non-responder rate) compared to standard therapy.

The investigation also demonstrated that point-of-care genetic testing is clinically feasible and is capable of facilitating rapid personalization of antiplatelet therapy. Results from the RAPID GENE trial were presented today at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The RAPID GENE (Reassessment of Anti-Platelet Therapy Using An Individualized Strategy Based on Genetic Evaluation) study utilized a novel point-of-care genetic test to identify carriers of the CYP2C19*2 allele and evaluated a pharmacogenetic approach to dual antiplatelet therapy following PCI.

The CYP2C19*2 allele, a common genetic variant found in up to 25% of Caucasians and 40% of Asians, is associated with increased rates of major adverse cardiovascular events (MACE) following percutaneous coronary intervention in individuals receiving clopidogrel. In March 2010, the US FDA issued a boxed warning indicating that patients carrying these genetic variants may not receive adequate protection from clopidogrel.

The RAPID GENE investigators hypothesized that a strategy of rapid genotyping followed by selective administration of prasugrel to CYP2C19*2 carriers would decrease the rate of high on-treatment platelet reactivity (platelet non-responders) compared to standard therapy. The primary objective of the study was to evaluate the first point-of-care genetic test in medicine for its accuracy and potential clinical utility.

Existing genetic testing methods are time-consuming, require laboratory expertise and cannot be performed at the clinical bedside. These limitations preclude timely identification of the CYP2C19*2 allele in patients undergoing PCI.

In the RAPID GENE study, which was conducted by a team of investigators at the University of Ottawa Heart Institute, 200 patients undergoing PCI for ACS or stable angina were randomized to a strategy of rapid point-of-care genotyping with selective administration of 10 mg of prasugrel to CYP2C19*2 carriers or to standard therapy with 75 mg of clopidogrel daily.

The study utilized the first point-of-care genetic test in medicine, which overcame many of the previous obstacles that had prevented routine clinical genetic testing. The test featured: • A saliva (buccal) swab performed by clinical nurses with no prior training in genetic laboratory techniques • A one step insertion of the swab into testing machine • Sixty minutes to identify whether individuals carried the at-risk genetic variant.

The primary endpoint was the proportion of CYP2C19*2 carriers with impaired anti-platelet therapy response (high on-treatment platelet reactivity) in the rapid genotyping arm compared to those in the standard therapy arm after seven days. Secondary endpoints included sensitivity and specificity of the point-of-care test compared to conventional genetic testing, other measures of platelet function among CYP2C19*2 carriers and the whole cohort by randomization, MACE, and bleeding risk measured by the TIMI scale.

Enrollment of the study was completed in July 2011. In total, 187 patients completed follow-up with 91 patients in the rapid genotyping group and 96 patients in the standard therapy group.

The primary endpoint showed that the proportion of CYP219*2 carriers with high on-treatment platelet reactivity (PRU> 234) was 0% in the rapid genotyping group compared with 30.4% in the standard therapy group.

Secondary clinical outcomes showed there were no major adverse cardiovascular events in either group at seven and 30 days. There was no significant difference in TIMI major bleeding between the groups with 2.2% in the rapid genotyping group versus 1.0% in the standard therapy group.

The RAPID GENE trial demonstrated that point-of-care genetic testing following PCI performed at the bedside by clinical nurses permits accurate identification of CYP2C19*2 carriers. It further showed that point-of-care genetic testing is clinically feasible and facilitates rapid personalization of antiplatelet therapy.

“RAPID GENE is the first study to report the use of a point-of-care genetic test in medicine,” said lead researcher, Derek So, MD. Dr. So is a Staff Cardiologist at the University of Ottawa Heart Institute and an Assistant Professor in the Department of Medicine at the University of Ottawa.

“These results will be integral for the application of future pharmacogenetic strategies in antiplatelet therapy in the context of percutaneous coronary intervention for acute coronary syndrome and stable angina. This represents the validation of the first point-of-care genetic test in clinical medicine. This proof-of-concept study will be applicable to all areas of medicine and will lead to larger scale trials evaluating the role pharmacogenomic treatment strategies,” Dr. So said.

The RAPID GENE trial is funded by Spartan Biosciences Inc. Dr. So reported no financial relationship with the company.

Source: Eurekalert

SAN FRANCISCO, CA – NOVEMBER 9, 2011 – A clinical trial comparing prasugrel to clopidogrel for patients with high on-clopidogrel platelet reactivity (HCPR) following percutaneous coronary intervention (PCI) was ended early due to relatively few occurrences of cardiac death or myocardial infarction – the primary endpoint – at six month follow up.

Results of the TRIGGER-PCI (Testing platelet Reactivity In patients underGoing elective stent placement on clopidogrel to Guide alternative thErapy with pRasugrel) trial were presented today at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The risk of ischemic events after percutaneous coronary intervention (PCI) is elevated in patients with high on-clopidogrel platelet reactivity (HCPR). Novel P2Y12-receptor antagonists, such as prasugrel, are more potent than clopidogrel and may, thus, improve outcome with respect to ischemic events, but may also increase bleeding risk.

The trial was a multi-center, double-blind, randomized controlled trial. Platelet reactivity was assessed two to seven hours after the first maintenance dose of clopidogrel 75 mg on the day after PCI following loading with clopidogrel 600 mg and randomized to either prasugrel or clopidogrel. TRIGGER-PCI aimed to randomize 2,150 patients to have a 93% power for detecting a 50% relative risk reduction on prasugrel in the primary study endpoint (cardiovascular death or myocardial infarction within six months).

The study was terminated prematurely for futility at March 18, 2011 at which 236 patients completed the six-month follow up. Only one clinical endpoint, a peri-procedural myocardial infarction, was observed.

“High on-clopidogrel platelet reactivity (>208 PRU by VerifyNow P2Y12 test) was observed less frequently than expected,” said Dietmar Trenk PhD. Dr. Trenk is Professor and Head of Clinical Pharmacology at Herz-Zentrum Bad Krozingen in Germany.

Dr. Trenk noted that the trial demonstrated that compared with standard-dose clopidogrel 75 mg, prasugrel 10 mg substantially decreased platelet reactivity in patients with high on-clopidogrel platelet reactivity after elective PCI.

“Given the low event rate in elective PCI patients without peri-procedural complications, it was not possible to assess the risk/benefit ratio with prasugrel treatment. Therefore, the study was terminated prematurely for futility,” Dr. Trenk said.

The trial is sponsored by Eli Lilly and Company and Daiichi Sankyo Co., Ltd. Dr. Trenk reported consulting fees/honoraria and speaker honoraria from both companies, AstraZeneca and Sanofi-Aventis.

Source: Eurekalert

‘Bridging’ stent patients to cardiac surgery

SAN FRANCISCO (Nov. 9, 2011) – Late breaking clinical trial results from testing of cangrelor, an investigational intravenous antiplatelet, showed patients can be “bridged” from the time that their physicians stop their oral antiplatelet drugs until they undergo cardiac surgery. Study results demonstrated cangrelor maintained target levels of platelet inhibition known to be associated with a low risk of thrombotic events, such as stent thrombosis, vs. placebo. The BRIDGE Trial results were presented here today at the Cardiovascular Research Foundation (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) conference.

“Patients with coronary stents require drugs that block platelets that can stick to their stents and cause clots. When these patients require surgery, the oral drugs must be stopped days in advance to wear off and reduce the risk of surgical bleeding; however, this puts them at an increased risk of thrombotic events,” said Eric Topol, MD, cardiologist and chief academic officer at Scripps Health and BRIDGE Trial primary investigator. “With nothing available that blocks platelets and then goes away quickly, we are between the rock of thrombosis and the hard place of surgical bleeding.”

BRIDGE results showed 99 percent of cangrelor-treated patients maintained target levels of platelet inhibition for all time points measured over the bridging period compared to 19 percent of placebo patients (p<0.001). The primary safety measure demonstrated no significant excess in surgical bleeding complications (data below).

The results were presented by Dominick J. Angiolillo, MD, PhD, medical director, cardiovascular research program at the University of Florida College of Medicine Jacksonville, “BRIDGE results support the hypothesis that intravenous cangrelor may be a feasible and well tolerated management strategy in patients who require prolonged platelet P2Y12 inhibition after thienopyridine discontinuation prior to cardiac surgery. Results also show control of platelet function as there was a rapid offset of platelet inhibition after stopping the cangrelor infusion prior to surgery.”

According to 2009 data from the Organisation for Economic Co-operation and Development (OECD), more than 2.5 million PCIs are performed globally per year. Treatment guidelines in the United States and Europe recommend stent patients receive oral P2Y12 inhibitors for up to 12 months following percutaneous coronary intervention (PCI). It is estimated that up to 25 percent of these patients with stents in place will require a surgical procedure during the first five years after PCI.

Dimitrios Goundis, PhD, head of R&D at The Medicines Company added, “With strong patient enrollment in the Phase 3 PHOENIX trial of cangrelor in PCI patients and these results from the BRIDGE trial, there is great momentum with the cangrelor program, which is an important part of our portfolio of acute and intensive care hospital compounds.”

Summary methods and results

The first stage of BRIDGE identified the cangrelor dose that maintains a ‘thienopyridine-like’ level of platelet inhibition. The second stage reported today was a prospective, randomized, double-blind, placebo-controlled trial in 210 patients with an acute coronary syndromes (ACS) or treated with a coronary stent (bare metal stent or drug eluting stent) on a thienopyridine awaiting coronary artery bypass grafting (CABG). After thienopyridine discontinuation (<72 hours), patients were administered cangrelor or placebo for at least 48 hours and up to 7 days, which was discontinued 1-6 hours prior to CABG. The objective was to demonstrate that a cangrelor IV infusion would maintain levels of platelet reactivity <240 P2Y12 Reaction Units (PRU) throughout the pre-operative period as measured by a P2Y12 assay. Platelet inhibition results are shown in this press release:

ABOUT CANGRELOR

Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting of the cardiac catheterization laboratory including in patients undergoing PCI. In October 2010, The Medicines Company initiated a Phase 3 clinical trial called PHOENIX to evaluate cangrelor in patients undergoing PCI.

Source: Eurekalert

NATICK, Mass., Oct. 5, 2011 /PRNewswire/ — Boston Scientific Corporation  has started patient enrollment in the OMEGA clinical trial, designed to evaluate the safety and effectiveness of the Company’s OMEGA™ Platinum Chromium Bare-Metal Coronary Stent System in treating patients with a single coronary artery lesion.  This prospective, single-arm trial will enroll 328 patients at 40 sites in the U.S. and Europe.  The first patient was enrolled this week by Prof. Andrejs Erglis, M.D., OMEGA Principal Investigator, at Paul Stradins Clinical University Hospital in Riga, Latvia.  The trial’s Coordinating Principal Investigators are John Wang, M.D., of Union Memorial Hospital in Baltimore, Maryland, and Prof. Christian Hamm, M.D., of the Kerckhoff Heart and Thorax Center in Bad Nauheim, Germany.

“I am enthusiastic about enrolling patients in the OMEGA trial and the potential this advanced bare-metal stent platform holds as a treatment option for patients with coronary artery disease,” said Dr. Wang.  ”The new alloy and design of the OMEGA stent promise to offer improved deliverability and visibility, even in patients with complex and challenging anatomy.”

The primary endpoint of the OMEGA trial is nine-month target lesion failure (TLF), a composite measure that includes target lesion revascularization, myocardial infarction and cardiac death.  TLF rates will be compared to a pre-specified performance goal based on historical clinical studies of cobalt-chromium and stainless steel bare-metal stents.  Patients will undergo clinical follow-up at 30 days, nine months and 12 months post-procedure.  Trial data will be used to support U.S. Food and Drug Administration (FDA) approval.

The OMEGA Stent System is part of Boston Scientific’s Platinum Chromium (PtCr) Stent series, which includes the ION™ Paclitaxel-Eluting Stent System(1) and the PROMUS Element™ Everolimus-Eluting Stent System(2). This family of stents features the novel PtCr alloy and an innovative stent design, which combine to offer greater radial strength and flexibility while reducing stent recoil.  The higher density alloy provides enhanced visibility while permitting thinner struts compared to prior-generation Boston Scientific stents(3).

“Our platinum chromium drug-eluting stents have been well received by physicians in approved markets, and we look forward to offering a bare-metal stent in the U.S. built on the same advanced platform,” said Keith D. Dawkins, M.D., Senior Vice President and Chief Medical Officer for Boston Scientific’s Cardiology, Rhythm and Vascular Group.  ”The OMEGA Stent will complement our existing portfolio and give interventional cardiologists the option to treat patients with paclitaxel-eluting, everolimus-eluting or bare-metal stents.”

The OMEGA Stent received CE Mark approval in March 2011.  It is offered in 48 sizes, ranging in diameter from 2.25 mm to 4.50 mm and lengths from 8 mm to 32 mm.  The Company received CE Mark approval for the PROMUS Element Stent System in October 2009 and for the TAXUS Element Stent System in May 2010.  The ION Stent System received FDA approval in April 2011.  Boston Scientific has the industry’s most comprehensive coronary stent portfolio, offering physicians and their patients the broadest size matrix and two distinct drug-polymer platforms.

In the U.S. and at participating E.U. clinical sites, the OMEGA Stent System is an investigational device, limited by applicable law to investigational use and not available for sale.

(1) Sold in CE Mark countries as the TAXUS® Element™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System.
(2) In the U.S., the PROMUS Element™ Stent System is an investigational device, limited by applicable law to investigational use and not available for sale.
(3) Based on bench testing.  Data on file with Boston Scientific.

About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.  For more information, please visit: www.bostonscientific.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding new product launches and launch cadence, regulatory approvals, clinical trials, product performance and competitive offerings.  If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors.  All of these factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter.  We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.  This cautionary statement is applicable to all forward-looking statements contained in this document.

Newswise — Between 2001 and 2008, the annual rate of coronary artery bypass graft surgeries performed in the United States decreased by more than 30 percent, but rates of percutaneous coronary interventions (PCI; procedures such as balloon angioplasty or stent placement used to open narrowed coronary arteries) did not change significantly, according to a study in the May 4 issue of JAMA.

“Coronary revascularization, comprising coronary artery bypass graft (CABG) surgery and PCI, is among the most common major medical procedures provided by the U.S. health care system, with more than 1 million procedures performed annually,” according to background information in the article. Several innovations in coronary revascularization, such as drug-eluting stents (DES) and minimally invasive CABG surgery have been adopted widely in the past decade, with the promise of improved clinical outcomes compared with older revascularization technologies and techniques. “During this period of technological innovation, new published evidence, and updated guidelines, it is not well known whether or how the volume of coronary revascularization and its constituent types changed in the United States.

Substantial changes in the overall volume of revascularizations or the relative use of CABG surgery vs. PCI would have important ramifications on clinical outcomes, health care costs, and the future organization and delivery of hospital-based cardiovascular care.”

Andrew J. Epstein, Ph.D., of the Philadelphia Veterans Affairs Medical Center and University of Pennsylvania, Philadelphia, and colleagues conducted a study using a representative national sample of hospitalization claims to estimate trends in the annual volume of coronary revascularization procedures. The study included data on patients undergoing CABG surgery or PCIs between 2001 and 2008 at U.S. hospitals in the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample, which reports inpatient coronary revascularizations. These data were supplemented by Medicare outpatient hospital claims.

The researchers found that there was a 15 percent decrease in the annual rate of coronary revascularizations from 2001-2002 to 2007-2008. There was a substantial decrease in the rate of CABG surgery, with approximately one-third fewer CABG surgeries being performed in 2008 compared with 2001. The annual CABG surgery rate decreased steadily from 1,742 CABG surgeries per million adults per year in 2001-2002 to 1,081 CABG surgeries per million adults per year in 2007-2008, but PCI rates did not significantly change (3,827 PCI per million adults per year in 2001-2002 vs. 3,667 PCI per million adults per year in 2007-2008).

“Between 2001 and 2008, the number of hospitals in the Nationwide Inpatient Sample providing CABG surgery increased by 12 percent, and the number of PCI hospitals increased by 26 percent. The median (midpoint) CABG surgery caseload per hospital decreased by 28 percent and the number of CABG surgery hospitals providing fewer than 100 CABG surgeries per year increased from 23 (11 percent) in 2001 to 62 (26 percent) in 2008,” the authors write.

The researchers write that the findings of this study “suggest the possibility that several thousand patients who underwent PCI in 2008 would have undergone CABG surgery had patterns of care not changed markedly between 2001 and 2008. Our data imply a sizeable shift in cardiovascular clinical practice patterns away from surgical treatment toward percutaneous, catheter-based interventions.”

“In conclusion, although the total rate of U.S. coronary revascularization decreased modestly between 2001 and 2008, there was a substantial decrease in the CABG surgery rate. Between 2001 and 2008, the rate of PCI did not significantly change; however, there were continual changes in the frequency of stent types used for PCI.”