הודעה שנשלחה אלינו, והמוצגת בהמשך במלואה, ע”י חברת J&J מציגה מס’ עדכונים הנוגעים לסטנט המצופה תרופה ( Sirolimus) ,הסייפר, אשר הוצגו בכנס PCR בפאריס לאחרונה.

ע”פ דיווח החברה עולה שחולים סוכרתיים (שלהם בדרך כלל עורקים בקוטר קטן יותר מאשר לאנשים ללא סוכרת) אשר עד לאחרונה הגישה המקובלת בטיפול ברה-וסקולריזציה בהם הייתה באמצעות ניתוח מעקפים (CABG ) , הרי ע”פ הנתונים האחרונים נראה כי טיפול בהם  באמצעות הסייפר משיג תוצאות דומות, עם כמובן התערבות פחות פולשנית.

במחקר הבלתי תלוי , ה-DIABETES , בוצעה השוואה בין סייפר לסטנט מתכתי רגיל ב-160 חולי סוכרת בסיכון גבוה, עם קוטר עורקים ממוצע של  2.34 מ”מ. לאחר 9 חודשים, בחולים שעברו אנגיוגרם נמצא שאיבוד נפח העורק בו בוצעה ההשתלה במטופלי הסייפר היה קטן ב-88% מזה שנמצא במטופלים בסטנט מתכתי רגיל. גם שיעור ההיצרות החוזרת (רהסטנוסיס) היה 7% בלבד במטופלי הסייפר לעומת 33% במטופלי הסטנט הרגיל. המסקנה והמשמעות הקלינית מעשית לפי עורכי המחקר היא שבחולים סוכרתיים שבהם יש צורך לבצע השתלת סטנט יש לשקול בחיוב רב שימוש בסטנט מצופה תרופה מסוג סייפר. (הערכת המערכת: התוצאות הללו בסייפר בחולי סוכרת כבר נראות כברות השוואה לתוצאות CABG בחולים בסיכון גבוה – ראה סקירה מה-NEJM שהשוותה בין CABG ל-PCI )

מחקר נוסף בלתי תלוי עליו מדווחת J&J הוא ה-ISAR-DIABETES אשר בו נעשתה השוואה בין  סייפר לטקסוס (הסטנט מצופה התרופה paclitaxel של חברת בוסטון סיינטיפיק, אשר טרם משווק בישראל מסיבות של סכסוך משפטי) בקרב 250 חולים סוכרתיים. לפי דיווח החברה תוצאות המחקר הראו כי הסייפר היה יעיל יותר מהטקסוס בכל הפרמטרים שנבדקו במחקר, כשהבולט ביניהם הוא ירידה בסיכון היחסי של רהסטנוסיס של 58%.

גם מחקר ה-SIRTAX שכלל תת קבוצה של חולים סוכרתיים הראה כי הסיכון לאירוע קרדיאלי או צורך בהתערבות ניתוחית היה גבוה יותר במטופלי הטקסוס בהשוואה למטופלי הסייפר.  שיעור מטופלי הסייפר שסבל לאחר 9 חודשים מרהסטינוסיס היה 3.2% בהשוואה ל-7.6% במטופלי הטקסוס.

להלן ההודעה המלאה לתקשורת מטעם חברת J&J :

New Trend In Treating Heart Disease in Diabetics

… Clinical Evidence Grows for the CYPHER® Sirolimus-eluting Coronary Stent …

The World Health Organisation has predicted an increase in the worldwide prevalence of diabetes of epidemic proportions (1). Eighty percent of people with diabetes will die from cardiovascular complications stroke and/ or coronary heart disease (CHD)(1.1).

CHD causes narrowing of sections of one or more arteries. Diabetics are four to six times more likely to die of coronary artery disease (CAD) than non-diabetics (2). Treatment aims to restore restricted blood flow to the heart and avoid a heart attack.

Traditionally, the best therapeutic option for diabetics has been coronary artery bypass graft (CABG) surgery, particularly when more than one vessel is involved. Now, growing clinical evidence suggests that angioplasty using the CYPHER® Sirolimus-eluting Coronary Stent may offer diabetic patients the choice of a new, less invasive treatment with similar outcomes to CABG.

During angioplasty a small wire mesh tube (stent) is placed in the coronary artery via a wire inserted into the groin to open a narrowed section of a coronary artery. Diabetics tend to have smaller diameter arteries which places them at a higher risk of recurrent narrowing restenosis following angioplasty using traditional bare metal stents (BMS). In fact, as many as 30 per cent of patients may have renarrowing due to an ingrowth of tissue that limits or obstructs the blood flow(3).

The CYPHER® Stent, developed by Cordis Corporation, a Johnson & Johnson company, elutes an anti-proliferative and anti-inflammatory drug called sirolimus that protects the arterial lining, allowing it to heal naturally after angioplasty. Several independent, randomized clinical trials have demonstrated strong results to support the use of this particular stent in diabetic patients, which are among the most complex patient groups with CHD.

Importantly, these trials were either specifically designed to assess clinical results of drug-eluting stents in diabetic patients alone or had pre-specified in the protocol that data would be analysed in diabetic patients, and were not conducted by the manufacturer of the stents.

The independent, multicentre, prospective randomised DIABETES trial compared the CYPHER® Stent with traditional bare metal stents in 160 diabetic patients. High-risk patients with among the smallest arteries treated in any clinical trial average vessel diameter of 2.34mm were included.

In this study, late lumen loss was measured after nine months as a sensitive marker for efficient healing of the arterial lining over the stent (the greater the loss, the narrower the artery becomes). In patients who had a follow- up angiogram at nine months, there was a significant reduction in late lumen loss (88 per cent) with the CYPHER® stent compared to the bare metal stent(4).

Dr. Manel Sabatי of Hospital Clinico San Carlos in Madrid remarks: “Undoubtedly, the CYPHER® Stent patients in the study had markedly better clinical outcomes. Only 7.7 percent had reblockage (restenosis) compared to 33 per cent of patients receiving the bare metal stent. This is a challenging patient population to treat and these results are very encouraging across the board.”

“With significant reductions in restenosis and in major adverse cardiac events (MACE: death, MI and additional revascularization procedure), the CYPHER® Stent confers a considerable benefit that justifies clinicians using drug-eluting stents rather than conventional stents in diabetic patients,” he added.

Another independent study, ISAR-DIABETES, compared the CYPHER® Stent with Taxus* a stent which delivers a different type of drug – paclitaxel. Assessment of 250 diabetic patients in this trial showed that CYPHER® Stents are more effective than Taxus* in preventing restenosis in diabetic patients(5), with a 58 per cent relative reduction in restenosis.

Dr. Adnan Kastrati of the Technische Universitt in Munich, Germany, says: “We set out to demonstrate in ISAR-DIABETES that Taxus* was not inferior to the CYPHER® Stent. However, the CYPHER® Stent outperformed Taxus* in this complex group of patients, showing consistently better results in all major parameters.”

Two further trials have shown promising outcomes for diabetic patients. The independent SIRTAX trial, conducted in Switzerland, enrolled a wide variety of patients, representing a real-life situation, and compared CYPHER® Stent with Taxus* in 1012 patients — 201 of whom were diabetic.

SIRTAX patients receiving Taxus* were 74 per cent more likely to have a serious cardiac event or undergo subsequent surgery than those treated with the CYPHER® Stent.(6). Furthermore, in follow up angiography after nine months, fewer CYPHER® patients suffered restenosis (3.2 per cent) than those with Taxus* stents (7.6 per cent).

Dr. Angela Wilson, Director of Research at Diabetes UK said, “Heart disease is one of the major complications for people with diabetes. The risk of developing heart disease and other complications can be reduced through effective control of blood glucose levels, a healthy diet and regular physical activity. However, in patients where heart disease has developed, any procedure that offers a less invasive and safer approach to treatment is to be welcomed. We await the results of further trials with interest.”

The wealth of data on the CYPHER® Stent reinforces its suitability for treating diabetic patients and may offer many an alternative to coronary bypass grafting. Additional data on the CYPHER® Stent will be presented at the EuroPCR Congress in Paris, France from May 24 27, 2005.

About the CYPHER® Stent:

The CYPHER® Stent continues to break new ground in fighting one of the most formidable challenges in the treatment of heart disease: restenosis (reblockage). Developed and manufactured by Cordis Corporation, the CYPHER® Stent is currently available in 80 countries and has been used by doctors to treat more than 1,000,000 patients worldwide.

– Ends –

REFERENCES

1.1. Barnet and OGara. 2003. Diabetes and the Heart. Churchill Livingstone.

NOTES TO THE EDITOR

Sirolimus is a naturally occurring antibiotic marketed under the name Rapamune® (a registered trademark of Wyeth Pharmaceuticals). Cordis has an exclusive license agreement with Wyeth Pharmaceuticals for delivery of sirolimus via a stent.

*TAXUS is a trademark of SciMed Life Systems, Inc.