Background: The safety and efficacy of direct coronary artery stenting without predilatation using drug eluting stents has not been firmly established. Concerns have been raised that this technique may be associated with increased risk of immediate and short term complications.
Methods: 68 consecutive patients with chronic stable angina and angiographically proven single vessel disease were randomised to undergo either direct coronary artery stenting or stenting after balloon predilation. All patients underwent Pressure Wire directed percutaneous coronary intervention (PCI) and drug eluting stents were deployed. Pre and post-PCI fractional flow reserve (FFR) was assessed following administration of intravenous adenosine. Post-procedure troponin I (TNI) and creatine kinase-MB (CK-MB) were compared. 51 of the 68 patients successfully completed a 6 month treadmill exercise test.
Results: There were no significant differences in the demographic, risk factor or angiographic profiles between the two groups except for hyperlipedemia and statin therapy. Drug eluting stents were deployed in all patients. Majority of the lesions were relatively simple (all lesions were either type A or B1). The pre-procedure FFR [mean(SD)]was marginally lower in the pre-dilatation group compared to the direct stenting group [0.57(0.17) versus 0.64(018); p=0.04]. The post-procedure FFR was similar in both groups [0.97(0.05) versus 0.98(0.03); p=0.26]. There was no difference in the post-procedure rise of either TNI or CK-MB in both groups. At 6 months, no major adverse cardiac events (death, MI or revascularisation) were observed in all patients. A positive exercise test was seen in 5 patients (10%) and there was no difference between the two groups.
Conclusion: A strategy of direct stenting of appropriate coronary lesions with drug eluting stents in patients with chronic stable angina is associated with similar functional results as balloon predilatation followed by stenting.