Journal of interventional cardiology
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Randomized Controlled Trial
Anesthetic ointment only (lidocaine/prilocaine) instead of injectable local lidocaine in trans-radial catheterization: A viable no-needle alternative.
The aim of the present study was to assess the level of access site pain in patients undergoing transradial coronary catheterization by using topical application of an anesthetic ointment (lidocaine/prilocaine-AO) compared to standard local anesthesia (LA) by means of injectable lidocaine. ⋯ Pain levels measured by VAS were found to be similar between the two groups during sheath insertion (VAS: AO: 4.84 ± 1.0 vs 4.82 ± 1.2, P = NS), as well as 30 min after sheath removal (VAS: AO: 0.07 ± 0.5 vs LA: 0.15 ± 0.6, P = NS). The time to obtain radial access was also not affected by the use of anesthetic ointment (AO: 62.24 ± 25.7 s vs LA: 64.04 ± 18.78 sec, P = NS). The rate of clinical or angiographic radial artery spasm was similar (8-10%) between the groups (P = NS) CONCLUSION: Use of a local anesthetic ointment, versus injectable lidocaine, in trans-radial cardiac catheterization as means of local anesthesia, was found to be equally effective in terms of pain, artery spasm, or artery cannulation speed.
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of biodegradable polymer versus durable polymer sirolimus-eluting stenting in patients with acute st-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of the RESOLVE study.
Sirolimus-eluting stents (SES) with a biodegradable polymer coating have demonstrated promising results but have not been compared to SES with a durable polymer in high-risk patients. We compared the efficacy of these 2 stent types in patients with acute myocardial infarction (STEMI). ⋯ In patients undergoing primary PCI for STEMI, the use of biodegradable polymer SES was associated with noninferior 1-year rates of MACE compared with durable polymer SES.
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Randomized Controlled Trial
Rationale and design of the on-treatment PLAtelet Reactivity-Guided Therapy Modification FOR ST-Segment Elevation Myocardial Infarction (PLATFORM) randomized trial.
The present trial aims at examining whether antiplatelet regimen modification, guided by assessment of the on-treatment platelet reactivity, might result with clinical benefit in moderate to high-risk patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). ⋯ U.S. National Institutes of Health (NIH) at www.clinicaltrials.gov. ClinicalTrials.gov Identifier: NCT01739556, and Current Controlled Trials at www.controlledtrials.com. International Standard Randomized Controlled Trial Number ISRCTN83081599.
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Randomized Controlled Trial Multicenter Study
Bivalirudin versus unfractionated heparin during percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndrome initially treated with fondaparinux: results from an international, multicenter, randomized pilot study (SWITCH III).
We aimed to determine the optimal adjunctive anticoagulation regimen for percutaneous coronary intervention (PCI) in patients presenting with acute coronary syndrome (ACS) initially treated with fondaparinux. The optimal adjunctive anticoagulation regimen for PCI in these patients is unclear. In this open-label, prospective, randomized, multicenter pilot study, we compared treatment with unfractionated heparin (UFH) versus bivalirudin in patients with non-ST-segment elevation ACS initially treated with fondaparinux and undergoing early invasive strategy. ⋯ There was no death, Q-wave MI, or acute revascularization in either group. There was no documentation of stent thrombosis, reinfarction, and catheter thrombus. Data from this prospective, multicenter pilot study suggest that bivalirudin, compared to standard-dose UFH, has a similar safety profile in terms of peri-PCI bleeding and thrombotic events and can be used safely in ACS patients initially treated with upstream fondaparinux who undergo PCI.
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Randomized Controlled Trial
One-year results of the CRISTAL Trial, a randomized comparison of cypher sirolimus-eluting coronary stents versus balloon angioplasty for restenosis of drug-eluting stents.
We compared the efficacy of the Cypher Select (Cordis Corporation, Bridgewater, NJ, USA) sirolimus-eluting stent (SES) versus balloon angioplasty (BA) in in-stent restenosis (ISR) of Taxus or Taxus Liberté paclitaxel-eluting stents (PES; Boston Scientific, Natick, MA, USA) or Cypher/Cypher Select SES. ⋯ In this angiographic randomized trial comparing SES and BA in SES or PES restenosis, 12 month MLD, immediate and net gain, and %DS favored SES whereas no difference was noted in LLL. Condensed abstract optimal treatment strategies have not been identified for sirolimus-(SES) or paclitaxel-eluting stent (PES) in-stent restenosis (ISR). We randomized patients with a native coronary artery SES or PES ISR to SES or BA. In addition, a control group included BMS ISR treated with SES. There was no difference in the primary end-point, late lumen loss (LLL) at 12 months between the SES and BA groups. However, follow-up MLD and immediate and net gain favored SES.