SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) March 19, 2001
NOVOSTE CORPORATION
(Exact name of registrant as specified in its charter)
Florida 0-20727 59-2787476
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification)
3890 Steve Reynolds Blvd., Norcross, GA 30093
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (770) 717-0904
(Former name or former address, if changed since last report)
Item 5. Other Events
Beta-Cath System Trial Results
On March 18, 2001, the Registrant announced the results of the Beta-Cath
System Trial. While the primary clinical endpoint of the overall Trial did not
demonstrate a significant benefit of beta radiation when the two branches of the
Trial (balloon and stent) were combined, beta radiation was shown to
significantly reduce the risk of angiographic restenosis in the lesion for
patients undergoing either balloon angioplasty or stent implantation, when
compared to the placebo group.
Trial Design
Designed in 1996 and begun in July 1997, the BETA-CATH System Trial was
the first randomized, multicenter, placebo-controlled study of vascular
brachytherapy. Vascular brachytherapy is radiation therapy delivered inside an
artery with the objective of reducing the incidence of restenosis. The Trial is
also the first pivotal study to evaluate intracoronary radiation in the primary
prevention of coronary restenosis subsequent to either PTCA ("percutaneous
transluminal coronary angioplasty" or "balloon angioplasty") or first time stent
placement.
The BETA-CATH System Trial was originally designed to enroll 1,100
patients into one of two branches, either the PTCA branch or the Provisional
Stent branch. According to the clinical trial protocol, patients enrolled in the
Trial were initially treated with balloon angioplasty. If the cardiologist
achieved a satisfactory result, the patient would remain in the PTCA branch and
then be treated with the BETA-CATH System. If balloon angioplasty was
sub-optimal, the patient would be entered into the Provisional Stent branch.
Prior to stent placement, the patient would be treated with the BETA-CATH
System, after which a stent would be implanted. All patients were randomized to
either an inactive (placebo) or active 30-mm Strontium-90 (beta radiation)
source train, and treatment times ranged from two to four minutes.
In March 1999, the Trial's Data Safety and Monitoring Board proposed
creating a new stent branch comprised of only those patients receiving a longer
duration of anti-platelet therapy (APT), a change first implemented by Novoste
in November 1998 to address late stent thrombosis concerns. Patient recruitment
continued until September 1999, at which time 1,455 patients had been enrolled
into the Trial at 59 investigational sites in North America and Europe.
On average, patients enrolled in the study had 12.5-mm long lesions in
arteries 3.0-mm in diameter. Depending on the artery diameter, a dose of either
16 or 21 gray was administered. Patients returned for follow-up examinations
eight months after the vascular brachytherapy procedure.
Data Presentation
The Trial was first analyzed by comparing the clinical outcomes of the
total radiation cohort (those receiving either PTCA or a stent with extended
APT) to the overall placebo group. Then the data was analyzed by reviewing the
PTCA and the stent branches individually. The clinical data from the total
combination of PTCA and stent patients is as follows.
BETA-CATH(TM) System Trial Clinical Data
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Combined Group: PTCA + Stent (Extended APT) Branches
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Beta Placebo
Radiation Control Percent
Clinical Outcomes (N = 492) (N = 464) Difference
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Target Lesion Revascularization (TLR) 13.7% 15.4% (12%)
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Target Vessel Revascularization (TVR) 15.6% 17.4% (10%)
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Major Adverse Cardiac Events (MACE) 18.7% 20.6% (9%)
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In this combined group of PTCA and stent patients, those who received beta
radiation exhibited modest improvements in their clinical endpoints, although
not statistically significant. Upon analysis of the two Trial branches as
discussed below, it was clear that patients in the PTCA branch clinically
benefited more from radiation than did those in the Stent branch, thereby
leading to a less pronounced effect when the two branches were combined.
BETA-CATH(TM) System Trial Data: PTCA Branch
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Beta Placebo
Radiation Control Percent
Angiographic Results (N = 264) (N = 240) Difference
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Restenosis Rate:
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Lesion Segment 21.4% 34.3% (38%)
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Analysis Segment 31.0% 36.0% (14%)
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Clinical Outcomes
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Target Lesion Revascularization (TLR) 10.0% 15.3% (35%)
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Target Vessel Revascularization (TVR) 12.3% 17.0% (28%)
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Major Adverse Cardiac Events (MACE) 14.2% 20.4% (30%)
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In the PTCA branch, restenosis in the legion segment was significantly
reduced by 38% in the group receiving radiation versus placebo. In addition, the
effect of beta radiation on all clinical outcomes in the PTCA branch
demonstrated a strong positive trend.
BETA-CATH(TM)System Trial Data: Stent w/extended APT Branch
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Beta Placebo
Radiation Control Percent
Angiographic Results (N = 228) (N= 224) Difference
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Restenosis Rate:
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Lesion Segment 21.1% 33.0% (36%)
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Analysis Segment 44.9% 35.3% 21%
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Clinical Outcomes
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Late Stent Thrombosis 1.3% 1.3% 0%
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Target Lesion Revascularization (TLR) 18.0% 15.5% 14%
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Target Vessel Revascularization (TVR) 19.4% 17.7% 9%
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Major Adverse Cardiac Events (MACE) 23.9% 20.8% 13%
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In the Stent branch, angiographic restenosis in the lesion was also
reduced significantly (by 36%) as in the PTCA branch; however, radiation did not
improve restenosis in the much longer analysis segment. This was likely due to
`geographic miss', the mismatch of the radiation source train relative to the
placement of the stent, which was implanted after the radiation catheter was
removed. In reviewing the clinical endpoints of the Stent branch, the data did
not show a beneficial effect of radiation on improving outcomes. The incidence
of late thrombosis, however, was the same (1.3%) in both the radiation and the
placebo groups, indicating that the extended antiplatelet therapy resolved the
problems of thrombosis observed in the original stent branch.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Dated: March 19, 2000
NOVOSTE CORPORATION
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(Registrant)
By: /S/EDWIN B. CORDELL, JR
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Edwin B. Cordell, Jr.
Chief Finanical Officer