CMO Newsletter by jazz84

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									                            CMO Newsletter
                            Chuck Simonton, MD
                            Chief Medical Officer, Abbott Vascular
                                                                                                                              Q3 2009



                             XIENCE V ® Demonstrates Clinical Superiority
                             and Safety Compared to TAXUS® in Landmark
                             Studies Presented at TCT 2009

                             Dear Colleagues,
                             I would like to take a moment to share with you important data that were recently presented
                             at TCT 2009 in San Francisco, California. The XIENCE V ® drug-eluting stent was the subject
                             of two late breaking clinical trials including:
                             1) One-year primary endpoint data from SPIRIT IV (3,690 patients)
                             2) One-year primary endpoint data from COMPARE, an investigator-initiated 1,800 patient
                                randomized trial
                             Also presented were PROSPECT, presenting first of its kind data on the state of vulnerable
                             plaque; three-year follow-up data from the XIENCE V ® SPIRIT III trial; and numerous oral and
                             poster abstracts on complex patient subgroups from the SPIRIT III trial. Alexandra J. Lansky,
                             MD received an award for presenting one of the top 25 abstracts selected for her work in
                             Side-Branch Occlusion with XIENCE V ® Everolimus-Eluting and TaXuS ® Express2TM
                             Paclitaxel-Eluting Stents: 2-Year results from the SPIRIT III randomized trial.
                             The greatest anticipation of data at TCT was the one-year primary endpoint data from the
                             SPIRIT IV trial, presented by the trial PI, Gregg W. Stone, MD. SPIRIT IV represented the
                             largest randomized clinical trial between two drug-eluting stents that have presented primary
                             endpoint data (specifically, XIENCE V ® and TAXUS ® Express2TM {TAXUS ®}). The trial evaluated
                             3,690 patients with an endpoint of target lesion failure (TLF* {cardiac death, target vessel
                             MI, ischemia-driven TLR}) at one-year, in the absence of angiographic follow-up and with
                             100% patient monitoring. In addition, SPIRIT IV studied a number of subgroups including the
                             diabetic patient population.
                             * Note: TLF is the new endpoint standard established to harmonize the definition of major
                             adverse cardiac events across various drug-eluting stent trials.
                             The primary endpoint of TLF showed an absolute 2.7% difference in favor of XIENCE V®
                             over TAXUS ® with a significant p-value of 0.0008 demonstrating superiority
                             (Figure 1). The composite endpoint was driven by a 45% reduction in the incidence of ID-TLR
                             with 2.5% for XIENCE and 4.6% for TAXUS ®, p=0.001, and a 38% reduction in the incidence
                             of target vessel MI with event rates of 1.8% for XIENCE V ® and 2.9% for TAXUS ®, p=0.04
                             (Figure 2). The incidence of MACE was virtually identical to TLF.




                             For Important Safety Information, see the end of this newsletter.
                             AP2930926 Rev. B                                                                                        1




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        CMO Newsletter
                                                                                                                                                                        Q3 2009




                             FIgURE 1

                                                                                                      TLF Through 1 Year
                                                                        10                                                                        HR [95% CI]
                                                                                      XIENCE V®                                                 0.61 [0.46, 0.82]
                                                                                      TAXUS®                                                       p=0.0008
                                            Target Lesion Failure (%)

                                                                        8
                                                                                                                                                     6.6%
                                                                        6
                                                                                                                                                   Δ 2.7%
                                                                        4

                                                                                                                                                      3.9%
                                                                        2


                                                                        0
                                                                             0                    3               6                   9                       12
                                                                                                                Months
                                                Number at Risk
                                                XIENCE V® 2458                                   2390               2362             2323                     2298
                                                TAXUS®                       1229                1165               1137             1119                     1104
                                                TLF= cardiac death, target vessel MI, or ischemia-driven TLR
                                                                                 SPIRIT IV 1-year data presented by Gregg Stone, MD at TCT 2009




                             FIgURE 2

                                                                                         TLF Components Through 1 Year
                                                                                                                                        RR [95%CI]
                                                                             6                                                        0.55 [0.38, 0.78]
                                                                                        XIENCE V®                                         p=0.001
                                                                                        TAXUS®
                                                                             5                                RR [95%CI]                              4.6
                                                                                                            0.62 [0.40, 0.96]
                                                                                                                p=0.04
                                                                             4

                                                                                                                            2.9
                                                       (%)




                                                                             3
                                                                                                                                          2.5
                                                                                      RR [95%CI]
                                                                             2      0.99 [0.34, 2.89]         1.8
                                                                                        p=1.00

                                                                             1
                                                                                     0.4        0.4
                                                                                  10/2416      5/1195       44/2416        35/1195    61/2416       55/1195
                                                                             0
                                                                                    Cardiac Death          Target Vessel MI                 ID-TLR
                                                            TLF= cardiac death, target vessel MI, or ischemia-driven TLR
                                                            1 Year = 365 ± 28 days
                                                                                 SPIRIT IV 1-year data presented by Gregg Stone, MD at TCT 2009




                             For Important Safety Information, see the end of this newsletter.
                             AP2930926 Rev. B                                                                                                                              2




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        CMO Newsletter
                                                                                                                                                    Q3 2009




                             Relative to DES safety, clinicians often ask “is it possible to achieve low lumen late
                             loss and not sacrifice safety with DES?” I am pleased to report that the answer is:
                             “YES, you can have outstanding efficacy and safety in a single DES.” Stent
                             thrombosis rates defined by ARC definite/probable were 0.29% for XIENCE V® and
                             1.10% for TAXUS ® with a p-value of 0.004 (Figure 3). To our knowledge, this was the first
                             time a head-to-head DES trial showed a stent thrombosis reduction with a low late lumen loss
                             stent. The cardiac death/MI rates were 2.2% for XIENCE V ® and 3.3% for TAXUS ®, p=0.07.


                             FIgURE 3

                                                                       Stent Thrombosis (ARC Definition)*
                                                                 Acute                    Subacute                        Late
                                                                 (0-24 hours)             (> 24 hours-30 days)            (> 30 days-1 year)**



                                      XIENCE V®                                   0.29%
                                                              0.16        0.13
                                        n=2458

                                                                                                                             p=0.004

                                          TAXUS®                                   0.57      0.16           0.42           1.10%
                                          n=1229



                                                          0                            0.5                       1                      1.5
                                       *Definite or Probable per ARC definition
                                      **Categorical data, 365 ± 28 days
                                                                                      Stent Thrombosis (%)

                                                                SPIRIT IV 1-year data presented by Gregg Stone, MD at TCT 2009




                             For Important Safety Information, see the end of this newsletter.
                             AP2930926 Rev. B                                                                                                          3




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        CMO Newsletter
                                                                                                                                                  Q3 2009




                             SPIRIT IV, which included 1,140 diabetic patients, demonstrated no statistical difference in the
                             incidence of TLF between XIENCE V ® (6.4%) and TAXUS ® (6.9%), p=0.80 in the diabetic
                             subgroup. Target vessel MI, ID-TLR, and stent thrombosis all numerically-trended in favor of
                             XIENCE V ® (Figure 4).


                             FIgURE 4

                                                                            Impact of Diabetes
                                                       8        p=0.80                                          XIENCE V® (n=786)
                                                                    6.9                                         TAXUS® (n=399)
                                                              6.4
                                                       6
                                                                                  p=0.65
                                                                                       4.7
                                                                                 4.2                 p=0.87
                                                                                                          3.7
                                                (%)




                                                       4                                            3.4


                                                                                                                        p=0.52
                                                       2
                                                                                                                             1.3
                                                                                                                       0.8

                                                       0
                                                                 TLF                TLR       Cardiac Death/MI         ST ARC
                                                                                                                       Def/Prob
                                                TLF= cardiac death, target vessel MI, or ischemia-driven TLR

                                          Data in Figure 4 taken from SPIRIT IV 1-year data results presented by Gregg Stone, MD at TCT 2009




                             For Important Safety Information, see the end of this newsletter.
                             AP2930926 Rev. B                                                                                                        4




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        CMO Newsletter
                                                                                                                                                                                                   Q3 2009




                             Importantly, the COMPARE trial was also presented during the late breaking presentations.
                             COMPARE is a single site, investigator-initiated, real-world, all comer study of 1,800 patients
                             conducted in Rotterdam, The Netherlands comparing XIENCE V ® to the TAXUS ®
                             LibertéTM stent, and was presented by Peter C. Smits, MD, PhD, of Maasstad Ziekenhuis.
                             This trial included a complex patient population (34% calcification; 27% multivessel; 25% AMI;
                             and 19% ostial lesions, to name a few). The results mirror those of SPIRIT IV showing the
                             primary MACE endpoint significantly reduced for XIENCE V ® over TAXUS ® LibertéTM
                             by 31% (6.2% XIENCE V ® vs. 9.1% TAXUS ® LibertéTM, p-value=0.023 {Figure 5}). Also,
                             directly mirroring SPIRIT IV are the ARC definite/probable stent thrombosis rates which
                             were significantly reduced in favor of XIENCE V ® (0.7% XIENCE V ® vs. 2.6% TAXUS ®
                             LibertéTM, p=0.002 {Figure 6}).


                             FIgURE 5

                                                                                                                          Primary Endpoint Result
                                                             Cumulative Incidence of Events (%)




                                                                                                               MACE (all death, non-fatal MI and TVR)
                                                                                                  15               XIENCE V®             p=0.023 (log-rank test)                     9.1%
                                                TAXUS RESULT RR=0.69 (0.50-0.95)
                             INSERT PRIMARY ENDPOINT ®
                                                                                                                                                                                   Δ 2.9%
                                                                                                  10
                                                                                                                                                                                     6.2%
                                                                                                      5
                                                                                                               Δ 1.1%
                                                                                                      0
                                                                                                          0   30      60    90      120 150 180          210 240 270        300    330   360
                                                                                                                                  Time After Initial Procedure (Days)

                                            # Patients at Risk
                                            XIENCE V®                                                 897     872     870   867    865      864   858    854   851    849    844   842    840
                                            TAXUS®                                                    903     868     865   860    853      849   842    838   833    825   823    822    819

                                                                                                      COMPARE data presented by Peter C. Smits, MD, PhD at TCT 2009



                             FIgURE 6

                                                                                                                      Secondary Endpoint Result
                                                                                         Stent Thrombosis (Definite and probable according to ARC)
                                                Cumulative Incidence of Events (%)




                                                                                                  3            XIENCE V®                   p=0.002 (log-rank test)                  2.6%
                                                                                                               TAXUS®                      RR=0.26 (0.11-0.64)

                                                                                                  2



                                                                                                  1                                                                                 0.7%

                                                                                                  0
                                                                                                      0       30     60     90    120 150 180       210 240          270    300    330   360
                                                                                                                                   Days Since Index Procedure

                                                                                                       COMPARE data presented by Peter C. Smits, MD, PhD at TCT 2009


                             For Important Safety Information, see the end of this newsletter.
                             AP2930926 Rev. B                                                                                                                                                         5




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        CMO Newsletter
                                                                                                                                                       Q3 2009




                             It appears that we have reached a new plateau for drug-eluting stents in terms of safety and
                             efficacy based on the results of SPIRIT IV, demonstrated in a well-designed, randomized
                             clinical trial with 100% patient monitoring. Patients who received XIENCE V ® had significantly
                             lower TLF than patients receiving TAXUS ® Express2TM while, at the same time, maintaining
                             statistically lower stent thrombosis rates at one-year follow-up. The COMPARE trial showed
                             similar results for the safety and efficacy of XIENCE V ® only as tested against TAXUS ®
                             LibertéTM vs. TAXUS ® Express2TM in SPIRIT IV.


                             During the TCT Drug-eluting Stent Summit, three-year follow-up of the SPIRIT III trial was
                             presented by Gregg W. Stone, MD. SPIRIT III, a randomized controlled trial of 1,002 patients
                             from 65 hospitals across the United States, compared XIENCE V ® to TAXUS ® Express2TM. At
                             three years, MACE rates were significantly reduced from 15.7% to 9.1%, p=0.003 for
                             XIENCE V ® over TAXUS ®. SINgLE DIgIT MACE AT 3 YEARS FOR XIENCE V ® is a
                             remarkable achievement when looking back over the history of PCI. There was an
                             additional 1.0% absolute separation of the event curves from years two to three (Figure 7). By
                             three years, the difference in MACE events was the equivalent of 66 fewer events per 1,000
                             patients treated just by choosing one DES over another DES.


                             FIgURE 7

                                                                      Major Adverse Cardiac Events
                                                                XIENCE V®
                                                                                                                                   3-year HR
                                                                TAXUS®                                                          0.57 [0.39, 0.83]
                                                                                                           2-year HR
                                                                                                        0.55 [0.37, 0.82]           p=0.003
                                                     20
                                                                               1-year HR                    p=0.003
                                                                            0.56 [0.35, 0.90]                                        15.7%
                                                                                 p=0.01                       13.1%
                                          MACE (%)




                                                     15
                                                                                  9.9%                                              Δ 6.6%
                                                     10                                                       Δ 5.6%
                                                                                  Δ 4.2%                                             9.1%
                                                     5                                                        7.5%
                                                                                  5.7%

                                                     0
                                                          0     3      6     9     12      15     18    21     24      27    30     33      36
                                                                                                 Months
                                      Number at risk
                                      XIENCE V®       669      652   643    628    612     598    597   591    581     576   574    572    569
                                      TAXUS®          332      312   308    291    286     275    272   269    266     264   260    258    255

                                      MACE = cardiac death, MI, or ischemia-driven TLR
                                                              SPIRIT III 3-year data presented by Gregg Stone, MD at TCT 2009




                             For Important Safety Information, see the end of this newsletter.
                             AP2930926 Rev. B                                                                                                             6




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        CMO Newsletter
                                                                                                                                                            Q3 2009




                             The SPIRIT IV stent thrombosis results remove the earlier hypothesis in our field that higher
                             late loss within a stent would be needed to protect against the risk of stent thrombosis, and a
                             one-year landmark analysis of the SPIRIT III 3-year data shows the same, with only 0.3% rate
                             of very late stent thrombosis (VLST) from one to three years for XIENCE V ® (average of 0.15%
                             per year, with NO events in the third year) (Figure 8). This rate of VLST is very similar to that
                             reported for bare metal stents (BMS).


                             FIgURE 8

                                                                     Landmark Analysis Stent Thrombosis
                                                                              (ARC Definition)
                                                                 XIENCE V®
                                                                 TAXUS®
                                                                                                               2-year HR                3-year HR
                                                                                                            0.32 [0.05, 1.93]        0.32 [0.05, 1.93]
                                                       1.5          1-year HR                                    p=0.19                   p=0.19
                                                                 1.48 [0.30, 7.31]
                                                                      p=0.63                                        1.0%                    1.0%
                                          ARC ST (%)




                                                        1

                                                                            0.9%                                Δ 0.7%                  Δ 0.7%
                                                       0.5              Δ -0.6%                                     0.3%                    0.3%

                                                                            0.3%
                                                        0
                                                             0   3      6      9     12   15    18    21       24     27        30     33     36
                                                                                               Months

                                           p-values are displayed for descriptive purposes only
                                                                 SPIRIT III 3-year data presented by David A. Cox, MD at TCT 2009




                             For Important Safety Information, see the end of this newsletter.
                             AP2930926 Rev. B                                                                                                                  7




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        CMO Newsletter
                                                                                                                                             Q3 2009




                             Looking beyond simple lesions into more complex patients and anatomy, several abstracts
                             (Figure 9) were presented from SPIRIT III in multiple subsets. These analyses looked at the
                             elderly population, female subgroup, jailed side branches, and dual vessels treated. In every
                             population XIENCE V ® had significant reductions in the incidence of MACE out to two years.


                             FIgURE 9

                                                Incidence of MACE in Complex Subgroups to Two Years
                                                                Age ≥ 65                                       Female Subgroup
                                          20%                                                   20
                                                    XIENCE V®                                          XIENCE V®
                             What about VULNERABLE 2-year HR
                                             TAXUS®         PLAQUE? PROSPECT, a prospective natural history study of
                                                                                        TAXUS® 1-year HR           2-year HR
                             700 patients with ACS who had PCI of a culprit lesion, followed by three vessel multimodality
                                    15%
                                                         0.41 [0.21, 0.80]
                                                             p=0.007             15
                                                                                              0.48 [0.25, 0.95] 0.49 [0.26, 0.92]
                                                                           13.1%                  p=0.031           p=0.024
                             imaging to identify those lesions which place patients at risk for future unexpected MACE,  17.8%
                             attempted to identify those specific “vulnerable” lesions.              15.9%
                                          10%                                                   10
                                                                                     Δ 7.6%                                      Δ 8.6%
                                                                                                                   Δ 7.7%
                                          5%                                                    5                   8.2%          9.2%
                                                                                       5.5%
                             In patients with ACS, treated with PCI and contemporary medical therapies, 20.4% develop
                                      0%                                          0
                             MACE within three years, with adverse events equally attributable to12 15 lesions and
                                          0   3   6    9   12  15  18   21  24      0   3    6   9   culprit 18 21 24
                             non-culprit coronary segments (Figure 11). Those patients who do develop events from
                                                         Months                      Time Post Index Procedure (Months)
                             non-culprit lesions typically present with increasing angina (14.5%) or unstable angina (8.0%),
                                                  with Side serious clinical events such as cardiac death, cardiac arrest or
                             and less frequently Jailedmore Branches                    p=0.01
                             MI (4.9%).
                                     20%                                                  61%       31.3
                                                    XIENCE V®       2-year HR         18.1%          Reduction
                                                    TAXUS®       0.34 [0.13, 0.87]
                                                                      p=0.02
                             FIgURE 11
                                  15%

                                                                                     Δ 11.8%
                                          10%
                                                                                                       12.2

                                          5%                                           6.3%

                                                                                                       12/98         15/48
                                          0%
                                                0   3   6   9     12     15    18     21   24
                                                                                                      Dual vessels treated
                                                                Months
                                                            Hermiller J. Am J Cardiol 2009; 104:6 Supplement 1 142D
                                                            Lansky AJ. CCI; Published Online: 24 March 2009
                                                            Applegate RJ. Am J Cardiol 2009; 104:6 Supplement 1 135D
                                                            Applegate RJ. Am J Cardiol 2009; 104:6 Supplement 1 150D




                             For Important Safety Information, see the end of this newsletter.
                             AP2930926 Rev. B                                                                                                   8




AV1521-004 CMO Nwsltr Q3_RevB M2.indd 8                                                                                                   10/28/09 2:22:23 PM
        CMO Newsletter
                                                                                                                                           Q3 2009




                             What about VULNERABLE PLAQUE? PROSPECT, a prospective natural history study of
                             700 patients with ACS who had PCI of a culprit lesion, followed by three vessel multimodality
                             imaging to identify those lesions which place patients at risk for future unexpected MACE,
                             attempted to identify those specific “vulnerable” lesions.
                             In patients with ACS, treated with PCI and contemporary medical therapies, 20.4% develop
                             MACE within three years, with adverse events equally attributable to culprit lesions and
                             non-culprit coronary segments (Figure 10). Those patients who do develop events from
                             non-culprit lesions typically present with increasing angina (14.5%) or unstable angina (8.0%),
                             and less frequently with more serious clinical events such as cardiac death, cardiac arrest or
                             MI (4.9%).


                             FIgURE 10

                                                                              PROSPECT: MACE
                                                                       All
                                                                       Culprit lesion (CL) related
                                                                       Non-culprit lesion (NCL) related
                                                            25
                                                                       Indeterminate
                                                                                                                          20.4%
                                                            20                                       18.1%
                                                                                   13.2%
                                                 MACE (%)




                                                            15                                                            12.9%
                                                                                                     11.4%
                                                                                    7.9%
                                                            10                                                            11.6%
                                                                                                       9.4%
                                                            5                       6.4%                                  2.7%
                                                                                    0.9%               1.9%

                                                            0
                                                                 0                 1                   2                    3
                                                Number at Risk
                                                                                       Time in Years
                                                ALL                  697                557                   506                 480
                                                CL Related           697                590                   543                 518
                                                NCL Related          697                595                   553                 521
                                                Indeterminate        697                634                   604                 583

                                                                 PROSPECT data presented by Gregg Stone, MD at TCT 2009




                             For Important Safety Information, see the end of this newsletter.
                             AP2930926 Rev. B                                                                                                 9




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        CMO Newsletter
                                                                                                                                                                                                                 Q3 2009




                             In examining the imaging data from non-culprit lesions, the identification of angiographically
                             mild plaques prone to develop MACE, can be enhanced by characterization of the underlying
                             morphology. By measuring an IVUS plaque burden ≥ 70% combined with a VH-Thin Cap
                             Fibroatheroma (TCFA), one can identify those lesions that have a 15% incidence of MACE
                             (Figure 11). These lesions occur in about 11% of patients and now help to identify which
                             plaques will cause problems down the road. The next question is what to do with them once
                             they are identified. At the moment, there is no answer to the question. However, vulnerable
                             plaque continues to be an area of great interest requiring ongoing clinical research.


                             FIgURE 11

                                           PROSPECT: Correlates of Non-culprit Lesion Related Events
                                                                                 20          Present
                                           Median 3.4 Yr MACE Rate (%) per lsn




                                                                                             Absent                                                                                          17.2
                                                                                                                                                                           15.3
                                                                                 15


                                                                                                                                                          10.2
                                                                                 10                                      9.1             9.2


                                                                                                        5.4
                                                                                       4.4
                                                                                 5

                                                                                                                                               1.5               1.6               1.5              1.8
                                                                                             1.2              1.1              1.2

                                                                                 0
                                                                                         TCFA             MLA            PB ≥70%            MLA           PB ≥70% +         PB ≥70%        PB ≥70% + MLA
                                                                                                        ≤4.0 mm2                          ≤4 mm2          MLA ≤4 mm2         +TCFA         ≤4 mm2 + TCFA
                                                                                                                                           +TCFA
                                                Lesion HR                             3.8 (2.2, 6.6)   5.0 (2.9, 8.7)   7.9 (4.6, 13.8) 6.4 (3.4, 12.2)   6.7 (3.4, 13.0) 10.8 (5.5, 21.0) 10.8 (4.3, 27.2)
                                                p-value                                <0.0001          <0.0001           <0.0001         <0.0001           <0.0001          <0.0001          <0.0001
                                                Prevalence*                             51.2%            49.1%             30.7%           17.4%             15.4%            11.0%             4.6%
                                           * Likelihood of one or more such lesions being identified per patient. PB = plaque burden at the MLA

                                                                                             PROSPECT data presented by Gregg Stone, MD at TCT 2009




                            For Important Safety Information, see the end of this newsletter.
                             AP2930926 Rev. B                                                                                                                                                                      10




AV1521-004 CMO Nwsltr Q3_RevB M2.indd 10                                                                                                                                                                      10/28/09 2:22:24 PM
        CMO Newsletter
                                                                                                                                   Q3 2009




                             Finally, given the fact that heart disease is now the #1 killer of women worldwide, Abbott
                             Vascular is investing significant time and resources to advance therapies that will improve
                             outcomes for women with heart disease. For example, one important initiative is our SPIRIT
                             Women study, a prospective trial evaluating gender in PCI. This study has been conducted
                             outside the United States and has completed enrollment in the single arm registry (n=1,600);
                             the randomized substudy (n=450) has enrolled two thirds of the patient cohort that will
                             compare XIENCE V ® to CYPHER ® in women in a 2:1 randomization. We expect the substudy
                             to complete enrollment by year end. The results for both arms will be reported at a major
                             interventional conference in 2010. We are also actively working to identify gaps in education
                             in the referral pathway for women and will continue to develop and offer educational materials
                             to address those gaps.
                             The cumulative Abbott Vascular sponsored and investigator-initiated study experience with
                             XIENCE V ®, to date, is close to 30,000 patients. Studies continue to demonstrate the safety
                             and efficacy of the device. A high standard for the performance of the XIENCE V ®
                             drug-eluting stent – a 2.5% TLR rate and 0.3% stent thrombosis rate has
                             been established.
                             Abbott Vascular’s clinical and research teams continue to study DES and other technologies
                             that will advance science and therapeutic treatments in the cardiovascular space. Our recent
                             entry in the structural heart area, through the acquisition of E-Valve, and a strategic alliance
                             with Coherex Medical outside the United States, reinforces our commitment to offer a broad
                             spectrum of therapies for physicians and their patients with cardiovascular disease.


                             Best regards,
                             Chuck Simonton, MD
                             Chief Medical Officer, Abbott Vascular




                             TAXUS®, TAXUS® LibertéTM, and TAXUS® Express2TM are trademarks of Boston
                             Scientific and its affiliates.
                             CYPHER® is a registered trademark of Johnson & Johnson Corporation.
                             For Important Safety Information, see the end of this newsletter.
                             AP2930926 Rev. B                                                                                        11




AV1521-004 CMO Nwsltr Q3_RevB M2.indd 11                                                                                        10/28/09 2:22:24 PM
        CMO Newsletter
                                                                                                                                      Q3 2009




                             The XIENCETM V Everolimus Eluting                    repeat dilatation of the stent is presently
                             Coronary Stent on the MULTI-LINK                     unknown.
                             MINI-VISION® or MULTI-LINK                         •	Risks and benefits should be considered
                             VISION® Delivery System                              in patients with severe contrast agent
                                                                                  allergies.
                             INDICATIONS                                        •	Care	should	be	taken	to	control	the	
                             The XIENCE V Everolimus Eluting Coronary             guiding catheter tip during stent delivery,
                             Stent System (XIENCE V stent) is indicated           deployment and balloon withdrawal. Use
                             for improving coronary luminal diameter in           fluoroscopy to avoid arterial damage.
                             patients with symptomatic heart disease due        •	Stent	thrombosis	is	a	low-frequency	event	
                             to de novo native coronary artery lesions            that current drug-eluting stent (DES) clinical
                             (length ≤ 28 mm) with reference vessel               trials are not adequately powered to fully
                             diameters of 2.5 mm to 4.25 mm.                      characterize. Stent thrombosis is frequently
                             CONTRAINDICATIONS                                    associated with myocardial infarction (MI)
                             The XIENCE V stent is contraindicated for            or death.
                             use in patients:                                   •	When	DES	are	used	outside	the	specified	
                             •	Who	cannot	receive	antiplatelet	and/or	            Indications for Use, patient outcomes may
                               anti-coagulant therapy                             differ from the results observed in the
                             •	With	lesions	that	prevent	complete	                XIENCE V SPIRIT family of trials.
                               angioplasty balloon inflation or proper          •	Compared	to	use	within	the	specified	
                               placement of the stent or stent delivery           Indications for Use, the use of DES in
                               system                                             patients and lesions outside of the labeled
                             •	With	hypersensitivity	or	contraindication	         indications, including more tortuous
                               to everolimus or structurally-related              anatomy, may have an increased risk of
                               compounds, cobalt, chromium, nickel,               adverse events, including stent thrombosis,
                               tungsten, acrylic, and fluoropolymers.             stent embolization, MI, or death.
                                                                                •	Orally	administered	everolimus	combined	
                             WARNINgS                                             with cyclosporine is associated with
                             •	Ensure	that	the	inner	package	sterile	barrier	     increased serum cholesterol and
                               has not been opened or damaged prior               triglycerides levels.
                               to use.                                          •	A	patient’s	exposure	to	drug	and	polymer	
                             •	Judicious	patient	selection	is	necessary	          is proportional to the number of and total
                               because device use has been associated             length of implanted stents. See Instructions
                               with stent thrombosis, vascular                    for use for current data on multiple stent
                               complications, and/or bleeding events.             implantation.
                             •	This	product	should	not	be	used	in	patients	     •	Safety	and	effectiveness	of	the	XIENCE	V	
                               who are not likely to comply with the              stent have not been established for subject
                               recommended antiplatelet therapy.                  populations with the following clinical
                             PRECAUTIONS                                          settings:
                             •	Stent implantation should only be                  •	Patients	with	prior	target	lesion	or	
                               performed by physicians who have received            in-stent restenosis related brachytherapy,
                               appropriate training.                                patients in whom mechanical atherectomy
                             •	Stent	placement	should	be	performed	at	              devices or laser angioplasty devices are
                               hospitals where emergency coronary artery            used simultaneously, women who are
                               bypass graft surgery is accessible.                  pregnant or lactating, men intending
                                                                                    to father children, pediatric patients,
                             •	Subsequent	restenosis	may	require	repeat	
                                                                                    unresolved vessel thrombus at the lesion
                               dilatation of the arterial segment containing
                                                                                    site, coronary artery reference vessel
                               the stent. Long-term outcomes following
                                                                                    diameters < 2.5 mm or > 4.25 mm or




                             AP2930926 Rev. B                                                                                           12




AV1521-004 CMO Nwsltr Q3_RevB M2.indd 12                                                                                           10/28/09 2:22:24 PM
        CMO Newsletter
                                                                                                                                       Q3 2009




                                 lesion lengths > 28 mm, lesions located          to antiplatelet drugs or contrast agent,
                                 in saphenous vein grafts, unprotected            Aneurysm, Arterial perforation and injury
                                 left main coronary artery, ostial lesions,       to the coronary artery, Arterial rupture,
                                 chronic total occlusions, lesions located at     Arteriovenous fistula, Arrhythmias, atrial
                                 a bifurcation or previously stented lesions,     and ventricular, Bleeding complications,
                                 diffuse disease or poor flow (TIMI < 1)          which may require transfusion, Cardiac
                                 distal to the identified lesions, excessive      tamponade, Coronary artery spasm,
                                 tortuosity proximal to or within the lesion,     Coronary or stent embolism, Coronary
                                 recent acute myocardial infarction (AMI)         or stent thrombosis, Death, Dissection of
                                 or evidence of thrombus in target vessel,        the coronary artery, Distal emboli (air, tissue
                                 moderate or severe lesion calcification,         or thrombotic), Emergent or non-emergent
                                 multivessel disease, in-stent restenosis,        coronary artery bypass graft surgery,
                                 and patients with longer than 24 months          Fever, Hypotension and / or hypertension,
                                 follow-up                                        Infection and pain at insertion site, Injury to
                             •	Everolimus	has	been	shown	to	reduce	the	           the coronary artery, Ischemia (myocardial),
                               clearance of some prescription medications         Myocardial infarction (MI), Nausea and
                               when it was administered orally along with         vomiting, Palpitations, Peripheral ischemia
                               cyclosporine (CsA). Formal drug interaction        (due to vascular injury), Pseudoaneurysm,
                               studies have not been performed with the           Renal Failure, Restenosis of the stented
                               XIENCE V stent because of limited systemic         segment of the artery, Shock/pulmonary
                               exposure to everolimus eluted from XIENCE V.       edema, Stroke / cerebrovascular accident
                             •	Everolimus	is	an	immunosuppressive	agent.	         (CVA), Total occlusion of coronary artery,
                               Consideration should be given to patients          Unstable or stable angina pectoris,
                               taking other immunosuppressive agents or           Vascular complications including at the
                               who are at risk for immune suppression.            entry site which may require vessel repair,
                                                                                  Vessel dissection
                             •	Oral	everolimus	use	in	renal	transplant	
                               patients was associated with increased           Adverse events associated with daily
                               serum cholesterol and triglycerides that in      oral administration of everolimus to organ
                               some cases required treatment.                   transplant patients include but are not
                                                                                limited to:
                             •	Non-clinical	testing	has	demonstrated	
                               that the XIENCE V stent, in single and in        •	Abdominal	pain,	Acne,	Anemia,	
                               overlapped configurations up to 68 mm              Coagulopathy, Diarrhea, Edema,
                               in length, is MR Conditional. It can be            Hemolysis, Hypercholesterolemia,
                               scanned safely under the conditions in the         Hyperlipidemia, Hypertension,
                               Instructions for use.                              Hypertriglyceridemia, Hypogonadism
                                                                                  male, Infections: wound infection, urinary
                             •	The	XIENCE	V	stent	should	be	handled,	
                                                                                  tract infection, pneumonia, pyelonephritis,
                               placed, implanted, and removed according
                                                                                  sepsis and other viral, bacterial and fungal
                               to the Instructions for use.
                                                                                  infections, Leukopenia, Liver function test
                             POTENTIAL ADVERSE EVENTS                             abnormality, Lymphocele, Myalgia, Nausea,
                             Adverse events (in alphabetical order) which         Pain, Rash, Renal tubular necrosis, Surgical
                             may be associated with coronary stent use            wound complication, Thrombocytopenia,
                             in native coronary arteries include but are not      Venous thromboembolism, Vomiting
                             limited to:                                        Prior to use, please reference the Instructions
                             •	Abrupt	closure,	Access	site	pain,	               for use at www.abbottvascular.com/ifu
                               hematoma, or hemorrhage, Acute                   for more information on indications,
                               myocardial infarction, Allergic reaction         contraindications, warnings, precautions,
                               or hypersensitivity to contrast agent or         and adverse events.
                               cobalt, chromium, nickel, tungsten, acrylic
                               and fluoropolymers; and drug reactions




                             AP2930926 Rev. B                                                                                            13




AV1521-004 CMO Nwsltr Q3_RevB M2.indd 13                                                                                            10/28/09 2:22:24 PM

								
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