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TOBI Newsletter July 2011 |
SCIENTIFIC NEWS |
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TECHNOLOGY AND INDUSTRY NEWS |
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1. Drug eluting stents for the treatment of BMS In-stent Restenosis (ISR); long-term outcomes in the real-world practice.
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 Educational slide available to download: SLIDE 1
It is well-known that drug-eluting stents have been successful in treating patients with de-novo lesions at high-risk for restenosis, reducing significantly the need for repeat revascularization procedures at long-term.
However, the efficacy of DES in treating patients with BMS-ISR was not well appreciated, even though it is widely used in everyday clinical practice.
Previous studies have demonstrated that routine usage of DES in treating patients with BMS-ISR reduced the number of target lesion and vessel revascularization (TLR & TVR) without, however, reaching statistical significance, over a period of 3 to 4 years. Recently, Appleby CE et al from Manchester Heart Center, Manchester, UK, reported at Eurointervention their own experience in treating BMS - ISR patients with DES. Sixty-nine consecutive patients with significant BMS-ISR were treated with DES implantation.
Sirolimus DES were used in 43 patients and paclitaxel DES in 26. Over a mean follow period of 4.9 years, the first event MACE rate was 20% (17 events in 14 patients - eight deaths of which three were cardiac, two non-fatal myocardial infarctions and seven TVR). Excluding non-cardiac death, the adjusted MACE rate was 14.5% (12 events in 10 patients).
At long-term follow-up, mean Canadian angina class decreased from 2.3 ± 0.7 pre-procedure to 1.2 ± 0.4, 65% of patients were angina free and 80% were free of MACE. No differences in long-term outcomes were observed between patients receiving paclitaxel and sirolimus DES. The authors concluded that DES are effective to treat the BMS - ISR improving the clinical status and reducing the number of re-interventions.
2. 5-years outcome of patients treated with zotarolimus eluting stents (ZES) reveal favorable results, especially as regard the “hard” clinical endpoints of cardiac death and myocardial infarction. Results from the ENDEAVOR III trial.
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 Educational slide available to download: SLIDE 2
Data from the ENDEAVOR randomized controlled trial comparing 323 patients treated with ZES and 113 patients treated with SES. Importantly, patients were treated for de-novo lesions only with relative low anatomic and clinical risk. At 5 years (completeness of follow-up: 95.2%), pre-specified endpoints of all-cause mortality (5.2% vs. 13.0%, p = 0.02), myocardial infarction (1.0% vs. 4.6%, p = 0.03), and the composite event rates of cardiac death/myocardial infarction (1.3% vs. 6.5%, p = 0.009) and major adverse cardiac events (14.0% vs. 22.2%, p = 0.05) were significantly lower among patients treated with ZES. Rates of target lesion (8.1% ZES vs. 6.5% SES, p = 0.68) and target vessel revascularization were similar between treatment groups. Stent thrombosis was infrequent and similar in both groups (0.7% ZES vs. 0.9% SES, p = 1.0). Between 9 months and 5 years, progression of major adverse cardiac events was significantly more common with SES than with ZES (16.7% vs. 7.8%, p = 0.015). Patients treated with ZES may benefit more than patients treated with SES in long-term period of follow-up. Despite the fact that angiographic parameters, like late lumen loss, studied at the first pre-specified period of study protocol, the occurrence of clinical events was significantly lower than the patients treated with SES.
3. CTO recanalization provide significant reduction of ischemic burden, especially with patients with large baseline ischemic burden.
From Cath Cardiovasc Interv 2011.
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Recanalization of CTOs is not yet completely justified. Several trails and randomized studies have concluded that offer no benefit in terms of long-term outcomes, especially as regard as the occurrence mortality and myocardial infarction. Safley et al tried to identify whether successful PCI in CTO lesions could reduce the ischemic burden. In 301 patients myocardial perfusion imaging (MPI) was performed within 12 ± 3 months before and a follow-up study within 12 ± 3 months after PCI. Of them, 53.5% of patients met criteria for improvement following PCI. Factors associated with significant reduction of ischemic burden were: male gender, non-diabetic patients, CTO located in the left anterior descending artery, and high ischemic burden at baseline. Average baseline ischemic burden was 13.1% ± 11.9% and decreased to 6.9% ± 6.5% (P < 0.001) during follow-up. Authors suggest that a threshold of 12.5% of ischemic burden, as this measured with myocardial perfusion studies, should be considered as an important criterion for performing PCI in the setting of CTO.
4. Presence of right coronary artery occlusion plays important role in the outcome of patients undergoing PCI for unprotected LM disease. From J Am Coll Cardiol, 2011; 58:125-130.
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Though already known from the clinical practice, a significant proportion of patients treated with PCI for unprotected LM (UPLM) disease, present chronic total occlusion (CTO) of the RCA. The importance of this finding, has been underestimated. Recently, Migliorgini A et al, have looked at the outcome of patients who had been treated with PCI of UPLM having CTO of the RCA and compared with those who had no CTO of the RCA. They found that 6-month mortality and 3-year mortality is significantly increased in those UPLM PCI patients who had also CTO of the RCA. The authors conclude that presence of the should be considered as an important factor to be counted when considering PCI in UPLM.
5. Left radial approach offers similar doses of radiation comparing to the right radial artery. Results from the TALENT dosimetric substudy.
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 Educational slide available to download: SLIDE 3
Radial approach for coronary interventions gain more and more acceptance from the Interventional community. The number of operators implicating Radial approach is continuously increasing. Moreover, once right radial artery (RRA) is used once or multiple times for coronary interventions or when RRA is considered not suitable for further interventions due to anatomical and technical issues, many operators use the left radial artery (LRA) instead of converting to the femoral approach. In the present study, Sciahbasi A et al, looked into the issue of radiation exposure during radial approach. Is LRA radiation exposure more than the RRA or the opposite? Three operators were equipped with 5 different dosimeters (left wrist, shoulder, thorax outside the lead apron, thorax under the lead apron, and thyroid) during RRA or LRA for coronary procedures. From February to December 2009, 390 patients were randomly assigned to the RRA (185 patients; age, 66±11 years) or the LRA (185 patients; age, 66±11 years).There were no significant differences in monthly radiation dose at the thorax (0.85±0.46 mSv for RRA and 1.12±0.78 mSv for LRA, P=0.33), at the thyroid (0.36±0.2 mSv for RRA and 0.34±0.3 mSv for LRA, P=0.87), and at the shoulder (0.73±0.44 mSv for RRA and 0.94±0.42 mSv for LRA, P=0.27). The dose at the wrist was significantly higher for the RRA (2.44±1.12 mSv) compared with the LRA (1±0.8 mSv, P=0.002). In both radial approaches, the thoracic radiation dose under the lead apron was undetectable. The authors conclude that both LRA and RRA provide the same amount of radiation exposure, with some advantage in the wrist radiation exposure for the LRA.
1. Micell Technologies Inc. & Coronary DES
Micell Technologies, Inc. announced that it has completed its review of the scheduled four-month follow-up on the first 10 patients from the DESSOLVE I first-in-human trial of the MiStent Drug-Eluting Coronary Stent System ("MiStent DES"), an ultra-thin drug-eluting stent distinguished by a rapid-absorbing drug/polymer coating formulation. Based on results observed in the DESSOLVE I trial, Micell has reduced the sample size in its DESSOLVE II CE Mark study from 270 to 171 planned subjects. DESSOLVE I, the first-in-human study of the MiStent DES comprising 30 patients with documented stable or unstable angina pectoris, completed enrollment earlier this year. The primary endpoint is in-stent late lumen loss, as measured by the angiography core laboratory in de novo lesions ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 23 mm length stent. The DESSOLVE II CE Mark trial is an ongoing multi-center study of patients with documented stable or unstable angina pectoris. The primary endpoint is superiority of the MiStent DES in minimizing in-stent late lumen loss at nine months, compared to Medtronic's Endeavor® Sprint DES, as measured by the angiography core laboratory in de novo lesions ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 30 mm length stent. Updated information on the DESSOLVE II trial will be provided at ClinicalTrials.gov.
2. SYMPLICITY HTN-3
Food And Drug Administration has conditionally approved the protocol for SYMPLICITY HTN-3, the company's U.S. clinical trial of renal denervation with the Symplicity Catheter System for the treatment of resistant hypertension. Medtronic said FDA approval of the SYMPLICITY HTN-3 protocol enabled it to become the first company to conduct a randomized, controlled trial of renal denervation in the United States. The novel treatment approach is a catheter-based intervention for patients with resistant hypertension who have been unable to achieve target blood pressure levels despite multiple medications. Having received Europe's CE mark and a listing with Australia's Therapeutic Goods Administration, Medtronic's Symplicity Catheter System is commercially available in Europe and Australia. The Symplicity Catheter System is not approved by the FDA for U.S. commercial distribution. SYMPLICITY HTN-3 is a single-blind, randomized, controlled trial designed to evaluate the safety and effectiveness of renal denervation with the Symplicity Catheter System in patients with resistant hypertension. Across 60 U.S. medical centers, the study will enroll approximately 500 patients who will be randomized to receive either renal denervation and treatment with anti-hypertensive medications or treatment with anti-hypertensive medications alone.
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