Response to Letter Regarding Article, “Intensifying Platelet Inhibition With Tirofiban in Poor Responders to Aspirin, Clopidogrel, or Both Agents Undergoing Elective Coronary Intervention: Results From the Double-Blind, Prospective, Randomized Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel Study”
We thank Dr Doraiswamy for his interest in our recent prospective double-blind randomized controlled trial investigating the benefit of adding tirofiban to standard care in patients who are poor responders to aspirin and/or clopidogrel and are undergoing elective percutaneous coronary intervention.1
If statistics is not an opinion, then it is obvious that all cardiovascular risk factors, including diabetes, hypertension, and hypercholesterolemia, did not differ in the 2 study groups as shown in Table 1. Intervention through a radial approach is widespread in Italy, France, and Belgium, where patients have been recruited, thus explaining the relatively low rate of transfemoral approach in our investigation. Given the unquestionable advantages of early mobilization and low site access bleeding complications of transradial over transfemoral approach, the former should be regarded as the standard of care and not vice versa simply because it is more commonly performed. As extensively described in our article, the dose of unfractionated heparin differed in the 2 study arms in accordance with recommendations set out by both American and European guidelines, and no patient received prolonged heparin infusion after the procedure. The patient in the placebo group who died from a massive pulmonary embolism received transradial intervention and was accordingly mobilized immediately after stenting, thus ruling out the possibility that prolonged hospitalization may have accounted for this fatality.
Primary or secondary prevention medications, including aspirin and clopidogrel, were given according to guidelines and are extensively detailed in the article.
Finally, we fully agree that information on the rate of periprocedural ischemic events in patients being fully responsive to both aspirin and clopidogrel may complement our findings. Accordingly, this information is being collected as a prespecified substudy and will be reported in the peer-reviewed medical literature shortly.
Dr Valgimigli has received honoraria for lectures/advisory boards from Merck/Iroko, The Medicines Company, Eli Lilly Co, and Daiichi Sankyo, Inc; and research grants from Merck/Iroko and Eli Lilly Co. Dr Angiolillo has received honoraria for lectures/advisory boards from Bristol-Myers Squibb, Sanofi-Aventis, Eli Lilly Co, Daiichi Sankyo, Inc, The Medicines Company, Portola, and Novartis. Dr Hamon has received honoraria for lectures from The Medicines Company, GlaxoSmithKline, Nycomed, and Merck.
Valgimigli M, Campo G, de Cesare N, Meliga E, Vranckx P, Furgieri A, Angiolillo DJ, Sabatè M, Hamon M, Repetto A, Colangelo S, Brugaletta S, Parrinello G, Percoco G, Ferrari R; Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel (3T/2R) Investigators. Intensifying platelet inhibition with tirofiban in poor responders to aspirin, clopidogrel, or both agents undergoing elective coronary intervention: results from the double-blind, prospective, randomized Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel study. Circulation. 2009; 119: 3215–3222.